SecProbe.io

CORRESP
 1
 filename1.htm

 August
8, 2025

 VIA
EDGAR

 U.S.
Securities and Exchange Commission

 Division
of Corporation Finance

 Office
of Industrial Applications and Services

 100
F Street, N.E.

 Washington,
DC 20549

 Attention:
Jeanne Baker and Li Xao

 Re:
 Picard Medical,
 Inc.

 Registration
 Statement on Form S-1, as amended

 Filed on April
 1, 2025

 File No. 333-286295

 Ladies
and Gentlemen:

 Pursuant
to Rule 461 under the Securities Act of 1933, as amended (the "Securities Act"), we, as
representative of the underwriters of the proposed initial public offering of securities of Picard Medical, Inc. (the "Company"),
hereby join the Company's request that the effective date of the above-referenced Registration Statement on Form S-1 be accelerated
so that it will be declared effective at 4:00 p.m., Eastern Time, on August 12, 2025, or at such later time as the Company or its counsel
may orally request via telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange Commission.

 Pursuant
to Rule 460 under the Securities Act, we, as representative of the underwriters, wish to advise you that there will be distributed to
each underwriter, who is reasonably anticipated to participate in the distribution of the security, as many copies of the proposed form
of preliminary prospectus as appears to be reasonable to secure adequate distribution of the preliminary prospectus.

 The
undersigned advises that it has complied and will continue to comply, and that it has been informed by the participating underwriters
that they have complied with and will continue to comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934,
as amended.

 [Remainder
of Page Intentionally Left Blank]

 Very
 truly yours,

 WestPark
 Capital, Inc.

 By:
 /s/
 Richard Rappaport

 Name:
 Richard
 Rappaport

 Title:
 Chief
 Executive Officer

 cc: Richard
A. Friedman, Sheppard, Mullin, Richter & Hampton LLP

 Michael
Blankenship, Winston & Strawn LLP

CORRESP
 1
 filename1.htm

 PICARD
MEDICAL, INC.

 1992
E Silverlake

 Tucson
AZ, 85713

 August
8, 2025

 VIA
EDGAR

 U.S.
Securities and Exchange Commission

 Division
of Corporation Finance

 Office
of Industrial Applications and Services

 100
F Street, N.E.

 Washington,
D.C. 20549

 Attention:
Jeanne Baker and Li Xiao

 RE: Picard
Medical, Inc.

 Registration
Statement on Form S-1, as amended

 Filed
on April 1, 2025

 File
No. 333-286295

 Dear
Ms. Baker and Ms. Xiao

 Pursuant
to Rule 461 of the rules and regulations promulgated under the Securities Act of 1933, as amended, Picard Medical, Inc. respectfully
requests that the effective date of the above-referenced Registration Statement be accelerated so as to permit it to become effective
at 4:00 p.m. Washington D.C. time on August 12, 2025, or as soon thereafter as practicable.

 Please
call Michael Blankenship of Winston & Strawn LLP at (713) 651-2678 to provide notice of the effectiveness of the Registration Statement.

 [ Signature
Page Follows ]

 Very truly yours,

 Picard Medical, Inc.

 By:
 /s/ Patrick NJ Schnegelsberg

 Name:
 Patrick NJ Schnegelsberg

 Tite:
 Chief Executive Officer

 cc: Michael
Blankenship, Winston & Strawn LLP

CORRESP
 1
 filename1.htm

 July
30, 2025

 VIA
EDGAR

 Division
of Corporation Finance

 Office
of Industrial Applications and Services

 U.S.
Securities and Exchange Commission

 100
F Street, NE

 Washington,
D.C. 20549

 Re:
 Picard
 Medical, Inc.

 Amendment
 No. 5 to Registration Statement on Form S-1

 Filed
 July 18, 2025

 File
 No. 333-286295

 Ladies
and Gentlemen:

 This
letter sets forth the responses of Picard Medical, Inc. (the " Company ") to comments received in a letter from the
staff of the Division of Corporation Finance (the " Staff ") of the U.S. Securities and Exchange Commission, dated July
25, 2025, (the " Comment Letter ") with respect to the above referenced Amendment No. 5 to Registration Statement on
Form S-1 (the " Registration Statement ").

 Concurrently
with the submission of this letter, the Company is filing, via EDGAR, an Amendment No. 6 to Registration Statement on Form S-1 (" Amendment
No. 6 "), incorporating the Company's responses to the Staff's Comment Letter.

 For
the convenience of the Staff, the Company has included the text of the Staff's comments in the Comment Letter in bolded text and
the Company's responses thereto.

 Amendment
No. 5 to Registration Statement on Form S-1 filed on July 18, 2025

 Cover
Page

 1. We
note your revised disclosure on page 51 that Dr. Richard Fang, one of Hunniwell's three managers, will serve as director of Picard following
the completion of the initial public offering. You also disclose that Hunniwell will control a majority of the voting power of the company's
outstanding common stock after the offering, and disclose on page 112 that Hunniwell will own 54.8% of your common stock immediately
after the offering. Please revise your cover page to disclose, as you do on page 51, that Dr. Richard Fang will effectively
be able to determine the outcome of all matters requiring shareholder approval. Please also quantify Hunniwell's ownership interest in
your company after the offering.

 Response :
The Company acknowledges the Staff's comment and advises the Staff that it has revised the cover page of Amendment No. 6 to address
the Staff's comment.

 Prospectus
Summary

 The
Offering, page 20

 2. We
note your revised disclosure on page 21 that the number of shares of common stock outstanding immediately following this offering excludes
shares of common stock issued to "the U.S. Unicorn Foundation, Inc. ('Unicorn Foundation') for services and that will vest
and expense contemporaneously with the closing of this offering, with a fair value of 0.80 per share and shares of common stock, the
equivalent of 3%of the Company equity, to be issued should Unicorn Foundation complete a following-on financing within 12 months of the
closing of this offer." We also note your disclosure in the footnotes to the financial statements describing your agreement with
U.S. Unicorn. Please revise your summary to discuss the material terms of your advisory agreement with the U.S. Unicorn Foundation, and
revise your risk factors to discuss any risks related to this agreement, including any potential dilution to shareholders based on the
terms of the agreement.

 Response : The
Company acknowledges the Staff's comment and advises the Staff that it has revised pages 17 and 50 of Amendment No. 6 to
address the Staff's comment.

 Use
of Proceeds, page 55

 3. We
note your revised disclosure that you intend to use up to $4.05 million of the proceeds from this offering to fund research and development
activities of your fully implantable system, general operational expenses, working capital, and other general corporate purposes. Please
clarify the portion of the funds you intend to use for research and development, general operational expenses, working capital and general
corporate purposes, respectively. Please also tell us why you are reserving up to $6.0 million to satisfy your Senior Secured Notes when
you also disclose that the Senior Secured Notes have a total principal plus interest amount of approximately $5.4 million. As a related
matter, please revise your disclosure to describe all of the working capital loans for which you are reserving $2.0 million in net proceeds,
given that the working capital related party loans discussed on page 55 do not total $2.0 million.

 Response : The Company
acknowledges the Staff's comment and advises the Staff that it has revised page 56 of Amendment No. 6 to address the Staff's
comment. To further clarify, the related party working capital loans plus interest that total $2.0 million are the total of loans under
section Certain Relationships and Related Transaction (pages 107-110) numbered 19, 20, 21, 23, 24 and 25. The Senior Secured Notes have
been updated to include interest in the Use of Proceeds.

 Principal
Stockholders, page 112

 4. Please
revise to disclose the natural person(s) with voting and dispositive control of Sindex SSI Financing, LLC.

 Response :
The Company acknowledges the Staff's comment and advises the Staff that it has revised page 113 of Amendment No. 6 to address the
Staff's comment.

 Exclusive
Forum Selection, page 116

 5. We
note your disclosure here that your Charter will contain a forum selection provision but that "such forum selection provisions
will not apply to suits brought to enforce any liability or duty created by the Securities Act or the Exchange Act or any other claim
for which the federal courts of the United States have exclusive jurisdiction," and that "[t]he Charter also provides
that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America
will be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act." It
appears that both Article Eleven of your Form of Proposed Second Amended and Restated Certificate of Incorporation and Section 56 of
your Form of Proposed Amended and Restated Bylaws include separate forum selection provisions, but they do not appear to include the
Exchange Act and Securities Act provisions noted in this section of the prospectus. Please reconcile your prospectus disclosure with
the applicable forum selection provision in your governance documents. Additionally, please clarify if both your Charter and Bylaws
will contain forum selection provisions and how the dual provisions would work in the event of any discrepancy between them.

 Response :
The Company acknowledges the Staff's comment and advises the Staff that it has revised the Form of Proposed Second Amended and
Restated Certificate of Incorporation of the Company to include the federal forum selection provisions, and, for clarity's sake,
removed the exclusive forum provisions from the Form of Proposed Amended and Restated Bylaws of the Company, filed as Exhibits 3.5 and
3.6, respectively.

 2

 If
you have any questions, please feel free to contact me at (713) 651-2678. Thank you for your cooperation and prompt attention to this
matter.

 Sincerely,

 /s/
 Michael J. Blankenship

 Michael
 J. Blankenship

 cc: Patrick
NJ Schnegelsberg, Chief Executive Officer, Picard Medical, Inc.

 3

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 July 25, 2025

Patrick NJ Schnegelsberg
Chief Executive Officer
Picard Medical, Inc.
1992 E Silverlake
Tucson AZ, 85713

 Re: Picard Medical, Inc.
 Amendment No. 5 to Registration Statement on Form S-1
 Filed July 18, 2025
 File No. 333-286295
Dear Patrick NJ Schnegelsberg:

 We have reviewed your amended registration statement and have the
following
comments.

 Please respond to this letter by amending your registration statement
and providing
the requested information. If you do not believe a comment applies to your
facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing any amendment to your registration statement and the
information
you provide in response to this letter, we may have additional comments. Unless
we note
otherwise, any references to prior comments are to comments in our May 19, 2025
letter.

Amendment No. 5 to Registration Statement on Form S-1 filed July 18, 2025
Cover Page

1. We note your revised disclosure on page 51 that Dr. Richard Fang, one of
Hunniwell's
 three managers, will serve as director of Picard following the
completion of the initial
 public offering. You also disclose that Hunniwell will control a
majority of the voting
 power of the company's outstanding common stock after the offering, and
disclose on
 page 112 that Hunniwell will own 54.8% of your common stock immediately
after the
 offering. Please revise your cover page to disclose, as you do on page
51, that Dr.
 Richard Fang will effectively be able to determine the outcome of all
matters
 requiring shareholder approval. Please also quantify Hunniwell's
ownership interest in
 your company after the offering.
 July 25, 2025
Page 2
Prospectus Summary
The Offering, page 20

2. We note your revised disclosure on page 21 that the number of shares of
common
 stock outstanding immediately following this offering excludes shares of
common
 stock issued to "the U.S. Unicorn Foundation, Inc. ('Unicorn
Foundation') for services
 and that will vest and expense contemporaneously with the closing of
this offering,
 with a fair value of 0.80 per share and shares of common stock, the
equivalent of 3%
 of the Company equity, to be issued should Unicorn Foundation complete a
 following-on financing within 12 months of the closing of this offer."
We also note
 your disclosure in the footnotes to the financial statements describing
your agreement
 with U.S. Unicorn. Please revise your summary to discuss the material
terms of your
 advisory agreement with the U.S. Unicorn Foundation, and revise your
risk factors to
 discuss any risks related to this agreement, including any potential
dilution to
 shareholders based on the terms of the agreement.
Use of Proceeds, page 55

3. We note your revised disclosure that you intend to use up to $4.05
million of the
 proceeds from this offering to fund research and development activities
of your fully
 implantable system, general operational expenses, working capital, and
other general
 corporate purposes. Please clarify the portion of the funds you intend
to use for
 research and development, general operational expenses, working capital
and general
 corporate purposes, respectively. Please also tell us why you are
reserving up to $6.0
 million to satisfy your Senior Secured Notes when you also disclose that
the Senior
 Secured Notes have a total principal plus interest amount of
approximately $5.4
 million. As a related matter, please revise your disclosure to describe
all of the
 working capital loans for which you are reserving $2.0 million in net
proceeds, given
 that the working capital related party loans discussed on page 55 do not
total $2.0
 million.
Principal Stockholders, page 112

4. Please revise to disclose the natural person(s) with voting and
dispositive control of
 Sindex SSI Financing, LLC.
Exclusive Forum Selection, page 116

5. We note your disclosure here that your Charter will contain a forum
selection
 provision but that "such forum selection provisions will not apply to
suits brought to
 enforce any liability or duty created by the Securities Act or the
Exchange Act or any
 other claim for which the federal courts of the United States have
exclusive
 jurisdiction," and that "[t]he Charter also provides that, unless we
consent in writing to
 the selection of an alternative forum, the federal district courts of
the United States of
 America will be the exclusive forum for the resolution of any complaint
asserting a
 cause of action arising under the Securities Act." It appears that both
Article Eleven of
 your Form of Proposed Second Amended and Restated Certificate of
Incorporation
 and Section 56 of your Form of Proposed Amended and Restated Bylaws
include
 separate forum selection provisions, but they do not appear to include
the Exchange
 Act and Securities Act provisions noted in this section of the
prospectus. Please
 July 25, 2025
Page 3

 reconcile your prospectus disclosure with the applicable forum selection
provision in
 your governance documents. Additionally, please clarify if both your
Charter and
 Bylaws will contain forum selection provisions and how the dual
provisions would
 work in the event of any discrepancy between them.
 Please contact Jeanne Baker at 202-551-3691 or Li Xiao at 202-551-4391
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Conlon Danberg at 202-551-4466 or Katherine Bagley at 202-551-2545 with any
other
questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Industrial
Applications and
 Services
cc: Michael J. Blankenship, Esq.
</TEXT>
</DOCUMENT>

CORRESP
 1
 filename1.htm

 May 23, 2025

 VIA EDGAR

 Division of Corporation Finance
 Office of Industrial Applications and Services
 U.S. Securities and Exchange Commission
 100 F Street, NE
 Washington, D.C. 20549

 Re:
 Picard Medical, Inc.

 Amendment No. 2 to Registration Statement on Form S-1

 Filed May 9, 2025

 File No. 333-286295

 Ladies and Gentlemen:

 This letter sets forth the responses of Picard Medical, Inc. (the " Company ") to comments received in a letter from the staff of the Division of Corporation
 Finance (the " Staff ") of the U.S. Securities and Exchange Commission, dated May 19, 2025, (the " Comment Letter ") with respect to the above referenced Amendment No. 2 to Registration Statement on Form S-1 (the " Registration Statement ").

 Concurrently with the submission of this letter, the Company is filing, via EDGAR, an Amendment No. 3 to Registration Statement on Form S-1 (" Amendment No. 3 "), incorporating the Company's responses to the Staff's Comment Letter.

 For the convenience of the Staff, the Company has included the text of the Staff's comments in the Comment Letter in bolded text and the Company's responses thereto.

 Amendment No. 2 to Registration Statement on Form S-1 filed May 9, 2025

 Note 2. Summary of Significant Account Policies
 Revenue Recognition, page F-11

 1. We see from your revised disclosure in response to our
prior comment 1 that the hospital is your customer as it relates to the Syncardia TAH system (TAH kit) and C2 driver, Cart and Caddy
(C2 driver). We also note that the customer cannot benefit from the TAH kit without the C2 driver. Finally, we note that the C2 driver
is not rented but is provided free of charge to the hospital and that C2 driver maintenance costs, as well as labor costs of the C2 driver
technicians, are included in the product cost of revenues. We have the following additional comments:

 · Fully explain your C2 driver maintenance obligation and address why it is not a distinct performance obligation under ASC 606.
In this regard, tell us how you considered the guidance in ASC 606-10-25-14 through 25-22 and paragraphs BC 88 and 89 of ASU 2014-09.
If the Company's determination under ASC 606-10-25-14 through 25-22 is that it has separate performance obligations related to the
delivery of the TAH Kit and the maintenance of the C2 driver, explain, as previously requested, how the Company allocated the transaction
price to each performance obligation consistent with ASC 606-10-32-28 through 32-35 and how the Company considered the revenue recognition
guidance for each identified performance obligation consistent with ASC 606-10-25-23 through 25-30.

 Response : The Company acknowledges the Staff's
comment and advises the Staff that it has it has considered the following:

 May 23, 2025 Page 2

 As
a Company-owned asset, the C2 driver undergoes routine maintenance after 90 hours of cumulative use or every two years, whichever occurs
first. The associated costs are expensed as incurred. The Company does not charge a separate maintenance fee, nor is maintenance offered
as a stand-alone service. At March 31, 2025, the C2 drivers have a net book value of approximately $42,000.

 The
Identifying Distinct Goods:

 ASC
606-10-25-19: A good or service that is promised to a customer is distinct if both of the following criteria are met:

 a. The
customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer
(that is, the good or service is capable of being distinct).

 b. The
entity's promise to transfer the good or service to the customer is separately identifiable from other promises in the contract
(that is, the promise to transfer the good or service is distinct within the context of the contract).

 There
are no provisions in the Company's customer agreements that require SynCardia to perform maintenance on the C2 driver. Furthermore,
customers cannot derive benefit from the maintenance independently, as it is interdependent with the operation of the C2 driver. The
Company does not offer a separate maintenance plan to hospitals. Accordingly, under ASC 606-10-25-19(a), maintenance on the C2 driver
is not considered a distinct performance obligation.

 In
evaluating whether promised goods or services are separately identifiable in accordance with ASC 606-10-25-19(b), the Company concluded
that the C2 driver and the Total Artificial Heart (TAH) are not separately identifiable.

 Under
ASC 606-10-25-21(c), the Company assessed the use and function of the C2 driver and TAH and determined they are highly interdependent
and highly interrelated. Specifically, each component significantly affects the other: the C2 driver powers the TAH, and the TAH cannot
function without it. As the standard notes, "the entity would not be able to fulfill its promise by transferring each of the goods
or services independently." Therefore, the C2 driver and TAH are considered a single combined performance obligation. Please see
 Exhibit A to this letter for more information on driver differences.

 Regarding
 BC 88 and 89 of ASU 2014-09

 The
Company provides only assurance-type standard warranties to ensure the functionality of the C2 driver during the period in which the
TAH is implanted. These warranties are not sold separately and do not include any service beyond the assurance that the C2 driver meets
agreed-upon specifications. Accordingly, the warranties do not constitute separate performance obligations under ASC 606-10-55-30 through
55-35.

 As
such, the Company accounts for these assurance-type warranties in accordance with the guidance on product warranties under Subtopic 460-10.

 ● With
 reference to ASC 606-10-15-2 and 15-4 and your accounting for the C2 driver, tell us what
 consideration you gave to whether your contract(s) contain a lease. Refer to ASC 842-10-15-2
 through 15-15. If so, specifically address the guidance in ASC 842-10-15-28, 15-30 and 15-38.
 Identify the line item that includes the maintenance expense associated with your Companion
 2 drivers.

 Response :
The Company acknowledges the Staff's comment and advises the Staff that it has it has considered the following:

 May 23, 2025 Page 3

 In evaluating whether the placement of the C2 driver at hospital premises
constitutes a lease, the Company considered the guidance under ASC 842-10-15-3. Based on this assessment, the Company concluded that no
exchange of consideration is present within any customer agreements. The C2 driver is provided to hospitals at no charge and is returned
to the Company if the hospital ceases to operate as a Center. Additionally, the Company retains the right to substitute the C2 driver
at any time for maintenance or other reasons. This substitution right is substantive, as the Company benefits from replacing the unit
(extending its useful life) at a cost that is outweighed by the resulting operational benefit. Accordingly, the arrangement does not meet
the definition of a lease under ASC 842. As such, the Company does not separate this component from the contract under ASC 842-10-15-28,
nor is any consideration recognized under ASC 842-10-15-30.

 Maintenance costs related to the C2 driver are expensed as incurred
and included in cost of revenues.

 ● Expand your revenue recognition policies as necessary
to address the above bullets.

 Response : The Company acknowledges the Staff's comment and advises the Staff that it has revised page F-12 and F-13 and F-44 and F-45 of Amendment No. 3 to address the Staff's comment.

 If you have any questions, please feel free to contact me at (713) 651-2678. Thank
 you for your cooperation and prompt attention to this matter.

 Sincerely,

 /s/ Michael J. Blankenship

 Michael J. Blankenship

 cc: Patrick NJ Schnegelsberg, Chief Executive Officer, Picard Medical,
Inc.

 Exhibit A

 DRIVERS

 The SynCardia Total Artificial Heart (STAH) is an implantable device that replaces both sides of a failing heart and is powered
by external driver units. SynCardia provides two driver units, each designed for different use environments. The STAH cannot operate with
other driver types, and neither the STAH nor the driver units function independently.

 COMPANION 2 DRIVER

 The Companion 2 (C2) Driver powers the STAH during implantation and postoperative care in the hospital. It uses electronically controlled
valves and pressure regulators to provide beat-by-beat control, allowing independent adjustment of pressures, refill rates, beat rate,
and output for each heart side. A touchscreen display supports real-time monitoring. The C2 allows clinicians to tailor support to the
patient's physiology during recovery, bridging them to transplant or the Freedom Driver.

 FREEDOM DRIVER

 The Freedom Driver powers the STAH in stable patients outside the hospital, enabling discharge and home recovery. Weighing 11 pounds,
it sacrifices the C2's surgical precision for portability and improved quality of life. Clinicians set the heart rate before discharge;
the STAH autoregulates to meet changing flow needs. Patients remain transplant-listed and can receive care and support at home.

 A- 1

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 May 19, 2025

Patrick NJ Schnegelsberg
Chief Executive Officer
Picard Medical, Inc.
1992 E Silverlake
Tucson AZ, 85713

 Re: Picard Medical, Inc.
 Amendment No. 2 to Registration Statement on Form S-1
 Filed May 9, 2025
 File No. 333-286295
Dear Patrick NJ Schnegelsberg:

 We have reviewed your amended registration statement and have the
following
comment.

 Please respond to this letter by amending your registration statement
and providing
the requested information. If you do not believe a comment applies to your
facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing any amendment to your registration statement and the
information
you provide in response to this letter, we may have additional comments. Unless
we note
otherwise, any references to prior comments are to comments in our May 5, 2025
letter.

Amendment No. 2 to Registration Statement on Form S-1 filed May 9, 2025
Note 2. Summary of Significant Accounting Policies
Revenue Recognition, page F-11

1. We see from your revised disclosure in response to our prior comment 1
that
 the hospital is your customer as it relates to the Syncardia TAH system
(TAH kit) and
 C2 driver, Cart and Caddy (C2 driver). We also note that the customer
cannot benefit
 from the TAH kit without the C2 driver. Finally, we note that the C2
driver is not
 rented but is provided free of charge to the hospital and that C2 driver
maintenance
 costs, as well as labor costs of the C2 driver technicians, are included
in the product
 cost of revenues. We have the following additional comments:
 Fully explain your C2 driver maintenance obligation and address why
it is not a
 distinct performance obligation under ASC 606. In this regard, tell
us how you
 May 19, 2025
Page 2

 considered the guidance in ASC 606-10-25-14 through 25-22 and
paragraphs BC
 88 and 89 of ASU 2014-09. If the Company s determination under ASC
606-10-
 25-14 through 25-22 is that it has separate performance obligations
related to the
 delivery of the TAH Kit and the maintenance of the C2 driver,
explain, as
 previously requested, how the Company allocated the transaction
price to each
 performance obligation consistent with ASC 606-10-32-28 through
32-35 and
 how the Company considered the revenue recognition guidance for each
 identified performance obligation consistent with ASC 606-10-25-23
through 25-
 30.
 With reference to ASC 606-10-15-2 and 15-4 and your accounting for
the C2
 driver, tell us what consideration you gave to whether your
contract(s) contain a
 lease. Refer to ASC 842-10-15-2 through 15-15. If so, specifically
address the
 guidance in ASC 842-10-15-28, 15-30 and 15-38.
 Expand your revenue recognition policies as necessary to address
the above
 bullets.

 Please contact Julie Sherman at 202-551-3640 or Jeanne Baker at
202-551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please contact Conlon Danberg at 202-551-4466 or Katherine Bagley at
202-551-
2545 with any other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of
Industrial Applications and
 Services
cc: Michael J. Blankenship, Esq.
</TEXT>
</DOCUMENT>

CORRESP
 1
 filename1.htm

 May 9, 2025

 VIA EDGAR

 Division of Corporation Finance
 Office of Industrial Applications and Services
 U.S. Securities and Exchange Commission
 100 F Street, NE
 Washington, D.C. 20549

 Re:
 Picard Medical, Inc.

 Amendment No. 1 to Registration
 Statement on Form S-1

 Filed April 25, 2025

 File No. 333-286295

 Ladies and Gentlemen:

 This
letter sets forth the responses of Picard Medical, Inc. (the " Company ") to comments received in a letter from the
staff of the Division of Corporation Finance (the " Staff ") of the U.S. Securities and Exchange Commission, dated May
5, 2025, (the " Comment Letter ") with respect to the above referenced Amendment No. 1 to Registration Statement on
Form S-1 (the " Registration Statement ").

 Concurrently
with the submission of this letter, the Company is filing, via EDGAR, an Amendment No. 2 to Registration Statement on Form S-1 (" Amendment
No. 2 "), incorporating the Company's responses to the Staff's Comment Letter.

 For
the convenience of the Staff, the Company has included the text of the Staff's comments in the Comment Letter in bolded text and
the Company's responses thereto.

 Amendment
No. 1 to Registration Statement on Form S-1 filed on April 25, 2025

 Management's
Discussion and Analysis of Financial Condition and Results of Operations Revenues, page 64

 1. We
 note your response to prior comment 3, whereby you indicate that the driver is rented to
 the customer when they leave the hospital with the TAH implant. We also note that rental
 costs are mainly related to machine maintenance. Finally, we note your disclosure
 on page 69 that the drivers powering the SynCardia TAH are available for in-hospital use
 (Companion 2) and/or in-hospital and in-home use (Freedom Driver). Please address
 the following comments:

 ● Confirm
 that the patient is the customer for your Freedom Driver rental contracts. Also, confirm
 that the maintenance expense recognized as rental costs relate solely to your Freedom Drivers.
 In this regard, we note your disclosure on page 16 that you employ and train technicians
 who can service your Companion 2 and Freedom drivers.

 ● With
 reference to the contract terms associated with your Companion 2 drivers, please tell us
 and expand your disclosures, including your significant revenue recognition policies, to
 identify the customer (i.e. the medical center or the patient), the specific performance
 obligations under these contracts, and when you recognize revenue associated with Companion
 2 drivers. Ensure you explain your maintenance obligations and how the Company allocated
 the transaction price to each performance obligation consistent with ASC 606-10-32-28 through
 32-35. To the extent material, quantify the revenues associated with the Companion 2 drivers.

 ● Identify
 the line item that includes the maintenance expense associated with your Companion 2 drivers.

 Response :
 The Company acknowledges the Staff's comment and advises the Staff that it has revised page 64 of Amendment No. 2 to address
the Staff's comment. In addition, please also see our responses below for each of the bullet
points listed in the comment above.

 May 9, 2025 Page 2

 ● We identify that while the patient is the end user, our contracted customer is the Mechanical Circulatory
Support ("MCS") equipment management and distribution company. We further confirm that rental costs only include Freedom driver
related costs, as we have the capability to segregate technician labor hours between drivers by work order.

 ● We have elaborated that the hospital is our customer. In reference with ASC 606, the Company considers
that the sale of the TAH Kit is the sole performance obligation and the C2 driver, cart and caddy is equipment used in the hospital but
is not separately rented nor sold. It is sent free of charge to facilitate the implantation of TAH into the patient. Furthermore, we have
elaborated on the maintenance requirement for the C2 driver.

 ● As discussed, C2 driver maintenance costs are included in Cost of revenues: Product.

 If
 you have any questions, please feel free to contact me at (713) 651-2678. Thank you for your cooperation and prompt attention to
 this matter.

 Sincerely,

 /s/ Michael J. Blankenship

 Michael J. Blankenship

 cc: Patrick NJ Schnegelsberg, Chief Executive Officer, Picard Medical,
Inc.

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 May 5, 2025

Patrick NJ Schnegelsberg
Chief Executive Officer
Picard Medical, Inc.
1992 E Silverlake
Tucson AZ, 85713

 Re: Picard Medical, Inc.
 Amendment No. 1 to Registration Statement on Form S-1
 Filed April 25, 2025
 File No. 333-286295
Dear Patrick NJ Schnegelsberg:

 We have reviewed your amended registration statement and have the
following
comments.

 Please respond to this letter by amending your registration statement
and providing
the requested information. If you do not believe a comment applies to your
facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing any amendment to your registration statement and the
information
you provide in response to this letter, we may have additional comments. Unless
we note
otherwise, any references to prior comments are to comments in our April 14,
2025 letter.

Amendment No. 1 to Registration Statement on Form S-1 filed April 25, 2025
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Cost of Revenues, page 64

1. We note your response to prior comment 3, whereby you indicate that the
driver is
 rented to the customer when they leave the hospital with the TAH
implant. We also
 note that rental costs are mainly related to machine maintenance.
Finally, we note
 your disclosure on page 69 that the drivers powering the SynCardia TAH
are available
 for in-hospital use (Companion 2) and/or in-hospital and in-home use
(Freedom
 Driver). Please address the following comments:
 Confirm that the patient is the customer for your Freedom Driver
rental
 contracts. Also, confirm that the maintenance expense recognized as
rental costs
 relate solely to your Freedom Drivers. In this regard, we note your
disclosure on
 May 5, 2025
Page 2

 page 16 that you employ and train technicians who can service your
Companion 2
 and Freedom drivers.
 With reference to the contract terms associated with your
Companion 2 drivers,
 please tell us and expand your disclosures, including your
significant revenue
 recognition policies, to identify the customer (i.e. the medical
center or the
 patient), the specific performance obligations under these
contracts, and when you
 recognize revenue associated with Companion 2 drivers. Ensure you
explain your
 maintenance obligations and how the Company allocated the
transaction price to
 each performance obligation consistent with ASC 606-10-32-28 through
32-
 35. To the extent material, quantify the revenues associated with
the Companion 2
 drivers.
 Identify the line item that includes the maintenance expense
associated with your
 Companion 2 drivers.

 Please contact Julie Sherman at 202-551-3640 or Jeanne Baker at
202-551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please contact Conlon Danberg at 202-551-4466 or Katherine Bagley at
202-551-
2545 with any other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Industrial
Applications and
 Services
cc: Michael J. Blankenship, Esq.
</TEXT>
</DOCUMENT>

CORRESP
 1
 filename1.htm

 April 24, 2025

 VIA EDGAR

 Division of Corporation Finance
 Office of Industrial Applications and Services
 U.S. Securities and Exchange Commission
 100 F Street, NE
 Washington, D.C. 20549

 Re:
 Picard Medical, Inc.

 Registration Statement on Form S-1

 Filed April 1, 2025

 File No. 333-286295

 Ladies and Gentlemen:

 This letter sets forth the responses of Picard Medical, Inc. (the " Company ") to comments received in a letter from the staff of the Division of Corporation
 Finance (the " Staff ") of the U.S. Securities and Exchange Commission, dated April 14, 2025, (the " Comment Letter ") with respect to the above referenced Registration Statement on Form S-1 (the " Registration Statement ").

 Concurrently with the submission of this letter, the Company is filing, via EDGAR, an Amendment No. 1 to Registration Statement on Form S-1 (" Amendment No. 1 "), incorporating the Company's responses to the Staff's Comment Letter.

 For the convenience of the Staff, the Company has included the text of the Staff's comments in the Comment Letter in bolded text and the Company's responses thereto.

 Registration Statement on Form S-1 filed on April 1, 2025

 Risk Factors
 Our stockholders may be subject to significant dilution…, page 48

 1.
 We note your disclosure here that certain of your preferred shares and related party loans will convert into shares of your common stock upon consummation of this IPO.
 We also note your revised disclosure on page 105 describing the conversion terms of
 your notes and loans. To provide investors with additional context related to potential
 dilution, please provide an estimate of the number of shares of common stock into
 which your preferred shares and related party loans will convert.

 Response : The Company
acknowledges the Staff's comment and advises the Staff that it has revised pages 49 and 105 of Amendment No. 1 to address
the Staff's comment.

 April 24, 2025 Page 2

 Management's Discussion and Analysis of Financial Condition and Results of Operations Revenues,
 page 62

 2.
 You indicate that the decrease in revenues is related to the loss of a distributor
 in fiscal 2023. Please revise to quantify the lost revenues related to that particular
 distributor. In addition, please revise to further clarify what is meant by "the lost momentum
 in establishment of in-house sales personnel" and discuss any related trends.

 Response : The Company
acknowledges the Staff's comment and advises the Staff that it has revised page 63 of Amendment No. 1 to address the Staff's
comment.

 Cost of Revenues, page 63

 3.

 It appears that you have materially revised the cost of revenues for products and
 rental income for the year ended December 31, 2023. Please address the following:

 ● Tell us the reasons underlying this change.

 ● Based on your disclosures elsewhere in the filing, we
note that the SynCardia TAH consists of the SynCardia TAH implant, an external pneumatic driver and drivelines. Please clarify whether
the drivers are sold as part of the system sold. If so, clarify the nature of your maintenance obligations and confirm that your costs
of products sold include such costs.

 Response : The Company
 acknowledges the Staff's comment and advises the Staff that 2023 was changed for comparison purposes to the 2024 chart of
 accounts alignment. In 2023, our chart of accounts mapping grouped both TAH and Driver service costs (like job scrap, purchase price variance, material usage
variance and inventory adjustments) and into a COGS group referred to as Manufacturing costs which were entirely presented in COGS –
Product. In 2024, our Chart of Accounts was updated, and mapping corrected such that costs were aligned to segregate product and driver
service costs. Based on materiality, we reclassed 2023 to present the same segregation as what is presented in 2024.

 To clarify, the driver is rented to
the customer when they leave the hospital with the TAH implant, thereafter maintenance obligations for the drivers are included in
cost of goods sold for rentals (i.e. driver service costs).

 4.
 Your discussion regarding the cost of revenues appears to discuss the components of
 costs of revenues but does not explain the decrease in costs in fiscal 2024. Please explain what you mean by "...a $1.5 million in overhead variance for the drivers, $1.0 million overhead variance
 for the TAH, and $0.6 material usage variance for the TAH." Ensure your discussion
 addresses why your cost of products as a percentage of sales significantly decreased
 from 2023 to 2024.

 Response : The Company acknowledges the Staff's comment and advises the Staff that it has revised page 64 of Amendment No. 1 to address the Staff's comment.

 5.
 Please reconcile your disclosure here which indicates that rental revenue is earned when a patient is discharged from a hospital with a Freedom
 Driver and that rental revenue is "recognized when it becomes likely that we will
 receive payment," with your financial statement disclosure which indicates that "rental
 revenue is generally recognized over time on a ratable basis over the period of usage beginning
 on the date that the service is made available. Rental revenue is billed at month
 end and typically collected within 30 days."

 Response : The Company
acknowledges the Staff's comment and advises the Staff that it has revised page F-12 of Amendment No. 1 to address the Staff's
comment.

 April 24, 2025 Page 3

 Business
 Overview
 Our Business, page 69

 6.
 We note your revised disclosure in response to prior comment 1. However, the disclosure regarding outcomes from the use of LVADs and other temporary MCS compared to the outcomes obtained with the
 SynCardia TAH is still included on page 69 of the prospectus. To the extent that this disclosure is not based on head-to-head clinical trial data,
 please remove it throughout your filing.

 Response : The Company acknowledges the Staff's comment and advises the Staff that it has revised page 70 of Amendment No. 1 to address the Staff's comment.

 Certain Relationships and Related Transactions, page 104

 7.
 You refer to "Collateral" in your revised disclosure throughout this section. Given that this appears to be a defined term, please revise your disclosure to briefly describe
 the relevant collateral.

 Response : The Company
acknowledges the Staff's comment and advises the Staff that it has revised page 108 of Amendment No. 1 to address the Staff's
comment.

 Financial Statements
 Summary of Significant Accounting Policies - Segment Information, page F-15

 8.

 Please expand your disclosures to provide all the disclosures required by ASC 280-10-50. Ensure you address (i) your segment measure of profit or loss, (ii) the segment significant
 expense categories and amounts that regularly provided to the CODM and included in
 the reported segment profit or loss, (iii) other segment items with a qualitative description of the composition of other segment
 items and (iv) segment assets. See ASC 280-10-50-22, 50-25, 50-26 and 50-26A-C. See also ASC 280-10-55-15D through 15-F.

 Response : The Company acknowledges the Staff's comment and advises the Staff that it has revised page F-15 of Amendment No. 1 to address the Staff's comment.

 If you have any questions, please feel free to contact me at (713) 651-2678. Thank
 you for your cooperation and prompt attention to this matter.

 Sincerely,

 /s/ Michael J. Blankenship

 Michael J. Blankenship

 cc: Patrick NJ Schnegelsberg, Chief Executive Officer, Picard Medical,
Inc.

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 April 14, 2025

Patrick NJ Schnegelsberg
Chief Executive Officer
Picard Medical, Inc.
1992 E Silverlake
Tucson AZ, 85713

 Re: Picard Medical, Inc.
 Registration Statement on Form S-1
 Filed April 1, 2025
 File No. 333-286295
Dear Patrick NJ Schnegelsberg:

 We have reviewed your amended registration statement and have the
following
comments.

 Please respond to this letter by amending your registration statement
and providing
the requested information. If you do not believe a comment applies to your
facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing any amendment to your registration statement and the
information
you provide in response to this letter, we may have additional comments. Unless
we note
otherwise, any references to prior comments are to comments in our February 7,
2025 letter.

Registration Statement on Form S-1 filed April 1, 2025
Risk Factors
Our stockholders may be subject to significant dilution..., page 48

1. We note your disclosure here that certain of your preferred shares and
related party
 loans will convert into shares of your common stock upon consummation of
this IPO.
 We also note your revised disclosure on page 105 describing the
conversion terms of
 your notes and loans. To provide investors with additional context
related to potential
 dilution, please provide an estimate of the number of shares of common
stock into
 which your preferred shares and related party loans will convert.
 April 14, 2025
Page 2
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Revenues, page 62

2. You indicate that the decrease in revenues is related to the loss of a
distributor in
 fiscal 2023. Please revise to quantify the lost revenues related to that
particular
 distributor. In addition, please revise to further clarify what is meant
by "the lost
 momentum in establishment of in-house sales personnel" and discuss any
related
 trends.
Cost of Revenues, page 63

3. It appears that you have materially revised the cost of revenues for
products and rental
 income for the year ended December 31, 2023. Please address the
following:
 Tell us the reasons underlying this change.
 Based on your disclosures elsewhere in the filing, we note that the
SynCardia
 TAH consists of the SynCardia TAH implant, an external pneumatic
driver and
 drivelines. Please clarify whether the drivers are sold as part of
the system sold. If
 so, clarify the nature of your maintenance obligations and confirm
that your costs
 of products sold include such costs.
4. Your discussion regarding the cost of revenues appears to discuss the
components of
 costs of revenues but does not explain the decrease in costs in fiscal
2024. Please
 explain what you mean by "...a $1.5 million in overhead variance for the
drivers, $1.0
 million overhead variance for the TAH, and $0.6 material usage variance
for the
 TAH." Ensure your discussion addresses why your cost of products as a
percentage of
 sales significantly decreased from 2023 to 2024.
5. Please reconcile your disclosure here which indicates that rental
revenue is earned
 when a patient is discharged from a hospital with a Freedom Driver and
that rental
 revenue is "recognized when it becomes likely that we will receive
payment," with
 your financial statement disclosure which indicates that "rental revenue
is generally
 recognized over time on a ratable basis over the period of usage
beginning on the date
 that the service is made available. Rental revenue is billed at month
end and typically
 collected within 30 days."
Business
Overview
Our Business, page 69

6. We note your revised disclosure in response to prior comment 1. However,
the
 disclosure regarding outcomes from the use of LVADs and other temporary
MCS
 compared to the outcomes obtained with the SynCardia TAH is still
included on page
 69 of the prospectus. To the extent that this disclosure is not based on
head-to-head
 clinical trial data, please remove it throughout your filing.
Certain Relationships and Related Transactions, page 104

7. You refer to "Collateral" in your revised disclosure throughout this
section. Given that
 this appears to be a defined term, please revise your disclosure to
briefly describe the
 relevant collateral.
 April 14, 2025
Page 3

Financial Statements
Summary of Significant Accounting Policies - Segment Information, page F-15

8. Please expand your disclosures to provide all the disclosures required
by ASC 280-10-
 50. Ensure you address (i) your segment measure of profit or loss, (ii)
the segment
 significant expense categories and amounts that regularly provided to
the CODM and
 included in the reported segment profit or loss, (iii) other segment
items with a
 qualitative description of the composition of other segment items and
(iv) segment
 assets. See ASC 280-10-50-22, 50-25, 50-26 and 50-26A-C. See also ASC
280-10-55-
 15D through 15-F.
 Please contact Julie Sherman at 202-551-3640 or Jeanne Baker at
202-551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please contact Conlon Danberg at 202-551-4466 or Katherine Bagley at
202-551-
2545 with any other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Industrial
Applications and
 Services
cc: Michael J. Blankenship, Esq.
</TEXT>
</DOCUMENT>

CORRESP
 1
 filename1.htm

 VIA EDGAR

 Division of Corporation Finance

 Office of Industrial Applications and Services

 U.S. Securities and Exchange Commission

 100 F Street, NE

 Washington, D.C. 20549

 Re:
 Picard Medical, Inc.

 Amendment No. 3 to Draft Registration Statement on Form S-1

 Submitted January 24, 2025

 CIK No. 000203017

 Ladies and Gentlemen:

 This letter sets forth the
responses of Picard Medical, Inc. (the " Company ") to comments received in a letter from the staff of the Division of
Corporation Finance (the " Staff ") of the U.S. Securities and Exchange Commission, dated February 7, 2025, (the " Comment
Letter ") with respect to the above referenced Amendment No. 3 to Draft Registration Statement on Form S-1 (the " Draft
Registration Statement ").

 Concurrently with the submission
of this letter, the Company is filing, via EDGAR, a Registration Statement on Form S-1 (the " Registration Statement ")
incorporating the Company's responses to the Staff's Comment Letter.

 For the convenience of the
Staff, the Company has included the text of the Staff's comments in the Comment Letter in bolded text and the Company's responses
thereto.

 Amendment No.3 to Draft Registration Statement
on Form S-1 submitted January 24, 2025

 Prospectus Summary

 Our Business, page 1

 1.

 We note your revised disclosure in response to prior comment
2 including that "[s]tudies have shown that the use of LVADs and other temporary MCS results in poorer outcomes compared to the
outcomes obtained with the SynCardia TAH. For example, the 12-month survival after heart transplant in patients who were on LVADs or
other temporary MCS devices was 43% compared to 75% in patients who were on a SynCardia TAH." To the extent that this disclosure is
not based on head-to-head clinical trial data, please remove it from your filing.

 Response : The Company acknowledges
the Staff's comment and advises the Staff that it has revised page 2 of the Registration Statement to remove this statement from
the filing to address the Staff's comment.

 New Product Development, page 8

 2.
 We note your revised disclosure in response to prior comments 5 and 6 that your Unicorn and Emperor prototypes have been shown to achieve pulsatile flow with rates exceeding the minimum requirement of 3.5 liters per minute. Please briefly explain why 3.5 liters per minute is the applicable minimum requirement.

 Response : The Company acknowledges
the Staff's comment and advises the Staff that it has revised pages 8 and 9 of the Registration Statement to address the Staff's
comment.

 Management's Discussion and Analysis of Financial Condition and
Results of Operations Results of Operations, page 65

 March 31, 2025 Page 2

 3.
 Refer to our prior comment 7. We see that revenues increased 23% in the year ended December 31, 2024 as compared to the year end December 31, 2023 and you explain that it is related to change in the geographic sales market in favor of U.S. sales. Revise to provide further details regarding the underlying reason for the increase in U.S. sales.

 Response : The Company acknowledges
the Staff's comment and advises the Staff that it has revised page 62 of the Registration Statement to address the Staff's
comment.

 Executive Compensation, page 103

 4.
 Please revise to provide executive compensation as of your last completed fiscal year. See Item 402 of Regulation S-K.

 Response : The Company acknowledges the Staff's
comment and advises the Staff that it has revised the Executive Compensation Section of the Registration Statement to address the Staff's
comment.

 If you have any questions, please feel free to
contact me at (713) 651-2678. Thank you for your cooperation and prompt attention to this matter.

 Sincerely,

 /s/ Michael J. Blankenship

 Michael J. Blankenship

 cc: Patrick NJ Schnegelsberg, Chief Executive
Officer, Picard Medical, Inc.

February 7, 2025
Patrick NJ Schnegelsberg
Chief Executive Officer
Picard Medical, Inc.
1992 E Silverlake
Tucson AZ, 85713
Re:Picard Medical, Inc.
Amendment No. 3 to Draft Registration Statement on Form S-1
Submitted January 24, 2024
CIK No. 0002030617
Dear Patrick NJ Schnegelsberg:
            We have reviewed your amended draft registration statement and have the following
comments.
            Please respond to this letter by providing the requested information and either
submitting an amended draft registration statement or publicly filing your registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing the information you provide in response to this letter and your
amended draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, any references to prior comments are to comments in
our January 14, 2025 letter.
Amendment No. 3 to Draft Registration Statement on Form S-1 submitted January 24, 2025
Prospectus Summary
Our Business, page 1
1.We note your revised disclosure in response to prior comment 2 including that
"[s]tudies have shown that the use of LVADs and other temporary MCS results in
poorer outcomes compared to the outcomes obtained with the SynCardia TAH. For
example, the 12-month survival after heart transplant in patients who were on LVADs
or other temporary MCS devices was 43% compared to 75% in patients who were on
a SynCardia TAH." To the extent that this disclosure is not based on head-to-
head clinical trial data, please remove it from your filing.

February 7, 2025
Page 2
New Product Development, page 8
2.We note your revised disclosure in response to prior comments 5 and 6 that your
Unicorn and Emperor prototypes have been shown to achieve pulsatile flow with rates
exceeding the minimum requirement of 3.5 liters per minute. Please briefly explain
why 3.5 liters per minute is the applicable minimum requirement.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, page 65
3.Refer to our prior comment 7. We see that revenues increased 23% in the year ended
December 31, 2024 as compared to the year end December 31, 2023 and you explain
that it is related to change in the geographic sales market in favor of U.S. sales. Revise
to provide further details regarding the underlying reason for the increase in U.S.
sales.
Executive Compensation, page 103
4.Please revise to provide executive compensation as of your last completed fiscal year.
See Item 402 of Regulation S-K.
            Please contact Julie Sherman at 202-551-3640 or Jeanne Baker at 202-551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please contact Conlon Danberg at 202-551-4466 or Katherine Bagley at 202-551-
2545 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Michael J. Blankenship, Esq.

CORRESP
1
filename1.htm

January 23, 2025

VIA EDGAR

Division of Corporation Finance

Office of Industrial Applications and Services

U.S. Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

    Re:
    Picard Medical, Inc.

    Amendment No. 2 to Draft Registration Statement on Form S-1

    Submitted December 26, 2024

    CIK No. 000203017

Ladies and Gentlemen:

This letter sets forth the responses of Picard Medical, Inc. (the “Company”) to comments received in a letter from the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission, dated January 14, 2025, (the “Comment Letter”) with respect to the above referenced Amendment No. 2 to Draft Registration Statement on Form S-1 (the “Draft Registration Statement”).

Concurrently with the submission of this letter, the Company is confidentially submitting, via EDGAR, an Amendment No. 3 to Draft Registration Statement on Form S-1 (“Amendment No. 3”), incorporating the Company’s responses to the Staff’s Comment Letter.

For the convenience of the Staff, the Company has included the text of the Staff’s comments in the Comment Letter in bolded text and the Company’s responses thereto.

Amendment No.2 to Draft Registration Statement on Form S-1 submitted December 26, 2024

Prospectus Summary

Our Business, page 1

    1.
    We note your revised disclosure in response to comment 2. Please further revise your disclosure to clarify, at first instance, the difference between a Bridge to Transplantation (“BTT”) and Bridge to Candidacy (“BTC”) product.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 1 of Amendment No. 3 to address the Staff’s comment.

    2.
    We note your revised disclosure in response to comment 5, including that “[t]o our knowledge, there is limited clinical data available to support [the dual LVAD’s] safety and efficacy because it has never been part of an FDA-approved clinical trial.” Given that statements regarding safety and efficacy are within the purview of the FDA or a similar regulatory body, please remove this disclosure from your filing. As a related matter, please provide support for your disclosures about the costs of dual LVADs, including your disclosures about reimbursement. Also, tell us whether implantation of a single LVAD is a procedure that competes with your current or future products and if so, revise your disclosure accordingly, including the related costs and reimbursement.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 2 of Amendment No. 3 to address the Staff’s comment.

       January 23, 2025
 Page 2

History of SynCardia and SynCardia TAH Development, page 2

    3.
    We note your revised disclosure in response to comment 7, including that since June 2022, you have been “building up resources to address existing deficiencies and to update all documentation to align with MDR requirements and [you] are planning to reapply for an MDR CE mark during 2Q25.” Please further revise your disclosure to specify how you intend to address the deficiencies that led to the suspension of your CE mark in December 2021. Please also clarify whether, since 2021, the Company has notified their EU customers of the disclosed issues and suspension.

 Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised pages 3 and 94  of Amendment No. 3 to address the Staff’s comment.

Clinical Efficacy, page 7

    4.
    We note your revised disclosure that “[o]ne-year survival rates among patients who received the SynCardia TAH in RWD settings range from between 75% and 86.6%, depending on the experience of the center performing the procedures and on patient profiles.” Please revise your disclosure to describe how the experience of the centers and patient profiles impacted survival rates, providing specifics about the experience levels of the relevant centers and profiles of the relevant patients. As a related matter, we note your disclosure that you “have over 30 active certified centers and approximately twenty-one active centers that have completed at least one implant during the 24 months preceding the date of this prospectus.” Please revise your disclosure to discuss the criteria for certification of these centers and the difference between “active certified centers” and “active centers.”

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised pages 7 and 12 of Amendment No. 3 to address the Staff’s comment.

New Product Development, page 8

    5.
    We note your revised disclosure that “Unicorn” prototype iterations have been “shown to work utilizing [y]our standard bench test techniques,” and “[f]uture iterations of this design may be small and light enough to be implanted.” Please revise your disclosure to clarify next steps in achieving regulatory approval of Unicorn, your intended timeline, and that regulatory approval of this and the other new products discussed in this section is not guaranteed. In addition, please clarify what is meant by “shown to work” in this context.

 Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 8 of Amendment No. 3 to address the Staff’s comment.

    6.
    Your revised disclosure indicates that Emperor has “been shown to achieve pulsatile flow with rates of cardiac output that match [y]our on-market SynCardia TAH.” Given your disclosure that you expect to perform first-in-animal trials of this system in the first half of 2025, please clarify the trial, study, or test of the Emperor that has “shown” cardiac output matching your on-market product, and clarify what is meant by “match” in this context.

 Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 8 of Amendment No. 3 to address the Staff’s comment.

Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations, page 64

    7.
    Please refer to our prior comment 11. As previously requested, for each period presented, explain the underlying reasons for the increase/decrease in revenues related to sales in the U.S. market.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 62 of Amendment No. 3 to address the Staff’s comment.

       January 23, 2025
 Page 3

    8.
    Please refer to our prior comments 12 and 13. As previously requested, for all periods presented, revise to discuss cost of revenues as a percentage of sales and quantify the significant components that led to the change, including the amount of inventory charges in each period.

Response: The Company
acknowledges the Staff’s comment and advises the Staff that it has revised pages 63 and 65 of Amendment No. 3 to address the
Staff’s comment.

    9.
    Please refer to our prior comment 14 and address the following comments:

    ●
    Tell us where you provide expanded disclosure that provides more detail for your research and development expenses for each period presented, including but not limited to by product candidate as well as by the nature of the expenses. To the extent that you do not track expenses by product candidate, please disclose as such.

    ●
    Explain what you mean by your new disclosure that “While research and development supply expense are isolated by product, personnel are not.”

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised pages 62 and 64 of Amendment No. 3 to address the Staff’s comment.

Industry Overview, page 83

    10.
    We note your revised disclosure in response to comment 22, including that your total addressable market for total artificial hearts in the United States exceeds 15,000 patients, or approximately $2.6 billion, and that your serviceable addressable market is approximately $200 million for the BTT label and $500 million for the BTC and long-term indications, based on approximately 2,800 patients. Please revise to provide the underlying data supporting your total addressable market and serviceable addressable market calculations, including the data from your market research, physician interviews, and disclosed sources supporting your patient estimates, and how you arrived at market valuations using these patient estimates. In your discussion, please clarify how you estimated the market for the BTC and long-term indications, given that you have yet to receive regulatory approval to commercialize your product for these indications.

Response: The Company acknowledges
the Staff’s comment and advises the Staff that it has revised pages 10 and 83 to remove the disclosure related to the Company’s
total addressable market and service addressable market of Amendment No. 3 to address the Staff’s comment.

Enforcement of Civil Liabilities, page 101

    11.
    We note your revised disclosure in response to comment 26, including that you conduct certain operations through subsidiaries located outside of the United States and one of your directors resides outside the United States, and that it could be difficult or impossible for investors to effect service of process on you or this individual. Please further revise your disclosure to identify and discuss the difficulties presented by the relevant rules and regulations in the specific countries in which your subsidiaries operate and the country of residence of your director.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised pages 101 and 102 of Amendment No. 3 to address the Staff’s comment.

       January 23, 2025
 Page 4

Audited Financial Statements

Note 7. Commitments and Contingencies

(c) China Corporation, page F-19

    12.
    Please refer to our prior comment 29 and address the following comments:

    ●
    Please clarify what you mean by SynCardia Beijing’s “present form” and explain the nature of their current operations.

    ●
    With reference to the guidance in both Rule 11-01(d) and ASC 805-10-55-3A- 55-9, please provide a more detailed analysis to support your belief that SynCardia Beijing is not a business.

Response: The Company
acknowledges the Staff’s comment and respectfully advises that for the reasons below, the Company does not believe that SynCardia
Beijing qualifies as a “Business” under the guidance in both Rule 11-01(d) and ASC 805-10-55-3A-55-9. The present form of
SynCardia Beijing is that of an early-stage company where planned principal operations have not commenced and as a result no revenues
have yet to be generated from planned operations. The current operations include registration of the Company’s products, applying
for regulatory approval, and product development.

With reference to the guidance in Rule 11-01(d) we evaluated the facts
and circumstances involved and whether there is sufficient continuity of the entity’s operations prior to and after the planned
acquisition so that disclosure of prior financial information is material to an understanding of future operations. Among the facts and
circumstances, we note that prior to the planned acquisition and in the near future of the post-acquisition, there will be no revenue
producing activities (production, sales force, or customer base), or distribution system in place. Furthermore, operating rights and production
techniques will be revoked from SynCardia Beijing should the transaction not be completed or in the event product registration is not
achieved.

With reference to the guidance in ASC 805-10-55-3A-55-9, we considered the three elements of a business, defined therein as inputs, processes, and outputs, in determining that SynCardia Beijing does not qualify as a business. SynCardia Beijing does not have the inputs of economic resources or processes that can create or have the ability to create outputs. As of September 30, 2024 and for the nine months then ended, SynCardia Beijing has not commenced its planned primary operations, there are no revenues from the sale and distribution SynCardia’s products and no artificial heart inventories available for sale on-hand to distribute and as a result no outputs. Furthermore, SynCardia Beijing has no intellectual property, and no ability to obtain access to necessary materials or rights to produce or distribute artificial hearts.

Note 9. Temporary Equity and Stockholder’s Deficit

(a) Redeemable Convertible Preferred Stock, page F-20

    13.
    Please refer to our prior comment 30. Revise your disclosure to more fully explain the transactions regarding the December 2022 share issuance, similar to your response.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has
revised pages F-20 and F-21 of Amendment No. 3 to address the Staff’s comment.

Exhibits

    14.
    Please refile Exhibit 10.41 in the proper text-searchable format. Refer to Item 601(b)(10)(iv) of Regulation S-K and Item 301 of Regulation S-T.

Response: The Company acknowledges
the Staff’s comment and advises the Staff that it has refiled Exhibit 10.38, which was previously Exhibit 10.41, to address the
Staff’s comment.

       January 23, 2025
 Page 5

If you have any questions, please feel free to contact me at (713) 651-2678. Thank you for your cooperation and prompt attention to this matter.

    Sincerely,

    /s/ Michael J. Blankenship

    Michael J. Blankenship

    cc:
    Patrick NJ Schnegelsberg, Chief Executive Officer, Picard Medical, Inc.

January 14, 2025
Patrick NJ Schnegelsberg
Chief Executive Officer
Picard Medical, Inc.
4 Palo Alto Square, Suite 200
Palo Alto, CA 94025
Re:Picard Medical, Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted December 26, 2024
CIK No. 0002030617
Dear Patrick NJ Schnegelsberg:
            We have reviewed your amended draft registration statement and have the following
comments.
            Please respond to this letter by providing the requested information and either
submitting an amended draft registration statement or publicly filing your registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing the information you provide in response to this letter and your
amended draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, any references to prior comments are to comments in
our December 10, 2024 letter.
Amendment No. 2 to Draft Registration Statement on Form S-1
Prospectus Summary
Our Business, page 1
1.We note your revised disclosure in response to comment 2. Please further revise your
disclosure to clarify, at first instance, the difference between a Bridge to
Transplantation ("BTT") and Bridge to Candidacy ("BTC") product.
We note your revised disclosure in response to comment 5, including that "[t]o our
knowledge, there is limited clinical data available to support [the dual LVAD's] safety
and efficacy because it has never been part of an FDA-approved clinical trial." Given
that statements regarding safety and efficacy are within the purview of the FDA or a 2.

January 14, 2025
Page 2
similar regulatory body, please remove this disclosure from your filing. As a related
matter, please provide support for your disclosures about the costs of dual LVADs,
including your disclosures about reimbursement. Also, tell us whether implantation of
a single LVAD is a procedure that competes with your current or future products and
if so, revise your disclosure accordingly, including the related costs and
reimbursement.
History of SynCardia and SynCardia TAH Development, page 2
3.We note your revised disclosure in response to comment 7, including that since June
2022, you have been "building up resources to address existing deficiencies and to
update all documentation to align with MDR requirements and [you] are planning to
reapply for an MDR CE mark during 2Q25." Please further revise your disclosure to
specify how you intend to address the deficiencies that led to the suspension of your
CE mark in December 2021. Please also clarify whether, since 2021, the Company
has notified their EU customers of the disclosed issues and suspension.
Clinical Efficacy, page 7
4.We note your revised disclosure that "[o]ne-year survival rates among patients who
received the SynCardia TAH in RWD settings range from between 75% and 86.6%,
depending on the experience of the center performing the procedures and on patient
profiles." Please revise your disclosure to describe how the experience of the centers
and patient profiles impacted survival rates, providing specifics about the experience
levels of the relevant centers and profiles of the relevant patients. As a related matter,
we note your disclosure that you "have over 30 active certified centers and
approximately twenty-one active centers that have completed at least one implant
during the 24 months preceding the date of this prospectus." Please revise your
disclosure to discuss the criteria for certification of these centers and the difference
between "active certified centers" and "active centers."
New Product Development, page 8
5.We note your revised disclosure that "Unicorn" prototype iterations have been "shown
to work utilizing [y]our standard bench test techniques," and "[f]uture iterations of this
design may be small and light enough to be implanted." Please revise your disclosure
to clarify next steps in achieving regulatory approval of Unicorn, your intended
timeline, and that regulatory approval of this and the other new products discussed in
this section is not guaranteed. In addition, please clarify what is meant by "shown to
work" in this context.
6.Your revised disclosure indicates that Emperor has "been shown to achieve pulsatile
flow with rates of cardiac output that match [y]our on-market SynCardia TAH."
Given your disclosure that you expect to perform first-in-animal trials of this system
in the first half of 2025, please clarify the trial, study, or test of the Emperor that has
"shown" cardiac output matching your on-market product, and clarify what is meant
by "match" in this context.

January 14, 2025
Page 3
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, page 64
7.Please refer to our prior comment 11. As previously requested, for each period
presented, explain the underlying reasons for the increase/decrease in revenues related
to sales in the U.S. market.
8.Please refer to our prior comments 12 and 13. As previously requested, for all periods
presented, revise to discuss cost of revenues as a percentage of sales and quantify the
significant components that led to the change, including the amount of inventory
charges in each period.
9.Please refer to our prior comment 14 and address the following comments:

•Tell us where you provide expanded disclosure that provides more detail for your
research and development expenses for each period presented, including but not
limited to by product candidate as well as by the nature of the expenses. To the
extent that you do not track expenses by product candidate, please disclose as
such.

•Explain what you mean by your new disclosure that "While research and
development supply expense are isolated by product, personnel are not."
Industry Overview, page 83
10.We note your revised disclosure in response to comment 22, including that your total
addressable market for total artificial hearts in the United States exceeds 15,000
patients, or approximately $2.6 billion, and that your serviceable addressable market
is approximately $200 million for the BTT label and $500 million for the BTC and
long-term indications, based on approximately 2,800 patients. Please revise to provide
the underlying data supporting your total addressable market and serviceable
addressable market calculations, including the data from your market research,
physician interviews, and disclosed sources supporting your patient estimates, and
how you arrived at market valuations using these patient estimates. In your discussion,
please clarify how you estimated the market for the BTC and long-term indications,
given that you have yet to receive regulatory approval to commercialize your product
for these indications.
Enforcement of Civil Liabilities, page 101
11.We note your revised disclosure in response to comment 26, including that you
conduct certain operations through subsidiaries located outside of the United States
and one of your directors resides outside the United States, and that it could be
difficult or impossible for investors to effect service of process on you or this
individual. Please further revise your disclosure to identify and discuss the difficulties
presented by the relevant rules and regulations in the specific countries in which your
subsidiaries operate and the country of residence of your director.

January 14, 2025
Page 4
Audited Financial Statements
Note 7. Commitments and Contingencies
(c) China Corporation, page F-19
12.Please refer to our prior comment 29 and address the following comments:

•Please clarify what you mean by SynCardia Beijing's "present form" and explain
the nature of their current operations.

•With reference to the guidance in both Rule 11-01(d) and ASC 805-10-55-3A-
55-9, please provide a more detailed analysis to support your belief that
SynCardia Beijing is not a business.
Note 9. Temporary Equity and Stockholder's Deficit
(a) Redeemable Convertible Preferred Stock, page F-20
13.Please refer to our prior comment 30. Revise your disclosure to more fully explain the
transactions regarding the December 2022 share issuance, similar to your response.
Exhibits
14.Please refile Exhibit 10.41 in the proper text-searchable format. Refer to Item
601(b)(10)(iv) of Regulation S-K and Item 301 of Regulation S-T.
            Please contact Julie Sherman at 202-551-3640 or Jeanne Baker at 202-551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please contact Katherine Bagley at 202-551-2545 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Michael J. Blankenship

CORRESP
1
filename1.htm

December 26, 2024

VIA EDGAR

Division of Corporation Finance

Office of Industrial Applications and Services

U.S. Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

    Re:
    Picard Medical, Inc.

    Amendment No. 1 to Draft Registration Statement on Form S-1

    Submitted November 12, 2024

    CIK No. 000203017

Ladies and Gentlemen:

This letter sets forth the responses of Picard Medical, Inc. (the “Company”) to comments received in a letter from the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission, dated December 10, 2024, (the “Comment Letter”) with respect to the above referenced Amendment No. 1 to Draft Registration Statement on Form S-1 (the “Draft Registration Statement”).

Concurrently with the submission of this letter, the Company is confidentially submitting, via EDGAR, an Amendment No. 2 to Draft Registration Statement on Form S-1 (“Amendment No. 2”), incorporating the Company’s responses to the Staff’s Comment Letter.

For the convenience of the Staff, the Company has included the text of the Staff’s comments in the Comment Letter in bolded text and the Company’s responses thereto.

Amendment No.1 to Draft Registration Statement on Form S-1 submitted November 12, 2024

Prospectus Summary, page 1

    1.
    We note your disclosure on page 1 that “SynCardia was incorporated in Delaware in August 2001 as SynCardia Systems, Inc.” and your disclosure on page 3 noting that “[t]he 70cc SynCardia TAH is designed for implantation into adult patients and has supported over 1,939 patients globally since 1982.” Please revise your disclosure here and in your description of business to clarify the timeline of your operations, including the manufacturing and distribution of your products

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised pages 2 and 4   of Amendment No. 2 to address the Staff’s comment.

    2.
    We note your disclosures here and in your description of business that you manufacture and sell “the only U.S. FDA, and Health Canada approved implantable SynCardia TAH,” “the SynCardia TAH is an established alternative to heart transplantation for patients with biventricular failure in the U.S., and around the world,” and “[a] total artificial heart . . . does replace the heart.” Please revise your disclosure here and throughout the filing, including your business description, to clarify that your product is approved in the United States and Canada for temporary bridge to transplantation indication, and briefly explain this type of approval as compared to approval for a long-term indication. Where you discuss that your product is an established alternative to heart transplantation, please clarify that your product is indicated for short-term support, and revise your disclosure to define Bridge to Transplantation and Bridge to Decision.

   Page 2

Response:
The Company acknowledges the Staff’s comment and advises the Staff that it has revised pages 1 and 4 of Amendment No. 2 to
address the Staff’s comment.

    3.
    Please revise your prospectus summary to disclose that you have incurred net losses since inception and, as you disclose on page 59, that you expect to incur significant expenses and operating losses for the foreseeable future. Quantify your net losses and accumulated deficit for the financial periods presented in the filing.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 15 of Amendment No. 2 to address the Staff’s comment.

    4.
    We note your disclosure on page 4 that “[a]fter the introduction of the Freedom Driver, there have been documented accounts of patients playing golf and basketball, fishing, and hiking while on the SynCardia TAH.” Please revise your disclosure to provide support for this statement, including the entity or person that observed and documented these accounts, the specific implanted device, the patients’ health status prior to the implantation, the number of patients that were observed experiencing these outcomes, and any adverse events that occurred.

Response:
The Company acknowledges the Staff’s comment and advises the Staff that it has removed the referenced disclosure in Amendment No. 2 to address the Staff’s comment.

    5.
    We
    note your disclosure that your products are “superior to peers in total artificial heart category” and your discussion
    of your competitors products, regulatory approvals, and clinical trials. We also note your disclosure describing the limitations
    of LVADs compared to your TAH. To the extent that head-to-head trials have not been conducted, please revise to remove comparisons
    of your product’s performance or efficacy to other approved products.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 2 of Amendment No. 2 to address the Staff’s comment.

    6.
    Please revise your prospectus summary to disclose, as you do on page 59, that management has concluded that there is substantial doubt over your ability to continue as a going concern, and revise your risk factors to discuss the related risks to investors.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised pages 15, 22 and 46 of Amendment No. 2 to address the Staff’s comment.

    7.
    We note your disclosure on page 12 that, while you were working on the re- certification of the SynCardia TAH under MDD, BSI highlighted several post-market surveillance deficiencies and in May 2022, BSI suspended SynCardia’s CE mark pending completion of a post-market surveillance study needed to reinstate the CE mark under MDD. We also note your disclosure on page 36 that your managers have identified significant issues with your regulatory compliance regime and are actively working to solve these issues. Please revise your disclosure here and in your relevant risk factor to discuss the specific post-market surveillance deficiencies and issues with your regulatory compliance regime, and clarify how you intend to address those deficiencies and issues, including your intended timeline for the same.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised pages 14, 15, 41 and 94 of Amendment No. 2 to address the Staff’s comment.

Risk Factors, page 19

    8.
    We note your disclosure that in the event of a sale of shares in a public offering resulting in gross proceeds of $25 million to the Company, the conversion of your Series A-1 Preferred Stock will become mandatory. We also note your disclosure that, in the event of an initial public offering, your related party loan would be automatically converted into common stock. Please revise to include a risk factor discussing the risks to investors related to these conversions, including those related to dilution and volatility.

Response:
The Company acknowledges the Staff’s comment and advises the Staff that it has revised pages 17 and 48 of Amendment No. 2 to
address the Staff’s comment.

   Page 3

SynCardia has significant customer concentrations . . ., page 23

    9.
    We note your disclosure that a small number of your customers account for a substantial portion of your revenues. Please disclose, as you do in the notes to your financial statements, the customers that account for more than 10% of your revenue for the periods presented in the filing, and quantify the percentage contribution of each customer.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 27 of Amendment No. 2 to address the Staff’s comment.

Use of Proceeds, page 48

    10.
    We note your disclosure that a portion of your proceeds will be used to fund research and development activities of your products, and your disclosure elsewhere that you plan to conduct “first-in-animal trials” and clinical trials related to your products. Please identify any specific trials you intend to fund with proceeds from the offering and quantify the relevant amount of proceeds, as appropriate. In addition, please disclose the portion of proceeds you intend to use for each of the listed products.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 54 of Amendment No. 2 to address the Staff’s comment.

Management’s Discussion and Analysis of Financial Condition and Results of Operations Results of Operations, page 55

    11.
    In addition to quantifying your U.S. and non U.S. declines in revenues, expand your disclosures to address the specific underlying reason(s) for the $1.2 million decrease in revenues for the three months ended June 30, 2024 and the $.6 million decrease in revenues for the six months ended June 30, 2024.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 62 of Amendment No. 2 to address the Staff’s comment.

    12.
    Please expand your disclosures to discuss your cost of revenues as a percentage of revenues for each period presented. Address why you have negative gross margins for your rental revenues.

Response:
The Company acknowledges the Staff’s comment and advises the Staff that it has revised pages 62 and 63 of Amendment No. 2 to
address the Staff’s comment.

    13.
    Expand your discussion of the change in cost of revenues to quantify the additional inventory reserves and other significant underlying reasons for the decrease in cost of sales in the three and six months ended June 30, 2024. Specifically address the reasons underlying the changes in your inventory reserves. Address this comment as it relates to your fiscal year cost of revenues discussions.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 69 of Amendment No. 2 to address the Staff’s comment.

    14.
    We note the significance of your research and development expenses. Please expand your disclosure to provide more detail for your research and development expenses for each period presented, including but not limited to by product candidate as well as by the nature of the expenses. To the extent that you do not track expenses by product candidate, please disclose as such.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised pages 60, 62 and 65 of Amendment No. 2 to address the Staff’s comment.

   Page 4

Liquidity; Sources of Liquidity, page 60

    15.
    We note your disclosure that “[t]o date, we have funded its operations primarily with the proceeds from Series A-1 Preferred Stock and loans from related parties.” Please revise your disclosure in this section to discuss the material terms of the loans and Series A-1 Preferred Stock issuances, including relevant dates, parties, interest rates, accrued or undeclared dividends, outstanding amounts, and any other material terms. Discuss the impact of these loans, share issuances, undeclared dividends, and related obligations on your liquidity.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised pages 66 and 67 of Amendment No. 2 to address the Staff’s comment.

Critical Accounting Policies, page 61

    16.
    The disclosures of your critical accounting policies and estimates appear to be more descriptive of the accounting policies utilized, rather than any specific uncertainties underlying your estimates. Please revise the disclosures for each of your critical estimates made in preparing your consolidated financial statements to sufficiently explain to investors what each critical estimate is; the uncertainties associated with the critical estimates; the methods and assumptions used to make the critical estimates, including an explanation as to how you arrived at the assumptions used; the events or transactions that could materially impact the assumptions made; and how reasonably likely changes to those assumptions could impact your consolidated financial statements. Provide investors with quantified information to the extent meaningful and available. Refer to Item 303(b)(3) of Regulation S-K, Instruction 3 to Item (303)(b)(3), and Section V of Release No. 33-8350 for guidance.

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 68 of Amendment No. 2 to address the Staff’s comment.

Business; Our Components, page 67

    17.
    Please address the following comments related to your components.

    a.
    We note your disclosure that, on April 11, 2022, “Heitek Automation and we entered into a purchase order, which covers the terms for purchasing the pneumatic manifold drawings for the C2 Driver.” Please briefly describe the terms of this agreement, if material, and the significance to your business of purchasing these drawings.

    b.
    We note your disclosure that “we have started development of the C3 Driver, which is not expected to need this pneumatic manifold.” Please revise to provide additional detail regarding the significance of the development of this driver to your product and your business, including the timing for the development of this driver and the significance to the manufacturing of your product.

Response:
The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 76 of Amendment No. 2 and removed
the disclosure identified in 17(b) to address the Staff’s comment.

   Page 5

Clinical Efficacy, page 69

    18.
    We note your reference on page 66 to “the Freedom Driver System IDE Study that began in 2010,” your reference on page 69 to “more recent studies examining the clinical outcomes of patients reviewing SynCardia TAH as BTT therapy,” and your bulleted list of examples of a study, retrospective analysis, and prospective institutional database. Please revise your disclosure to clearly identify the studies, retrospective analysis and prospective institutional database. Clarify what is meant by an “all comer” patients, and disclose the criteria for selecting patients for the SynCardia TAH study between January 2014 and May 2019. Revise your disclosures to provide all material information about each study, including the sponsor of the study, number of participants, whether statistical significance was demonstrated, and the p-values supporting statistical significance. The first time you use the term p- value please explain what it measures and the p-value that you have to achieve in order to conclude a statistically significant result.

Response:
The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 77 through page 80 of Amendment
No. 2 to address the Staff’s comment.

Adverse Events, Including Those That Affected Outcomes. . ., page 70

    19.
    Please revise your disclosure to provide a more detailed explanation of the data presented within the Adverse Events table on page 70, including the specific studies and devices related to the data presented, and whether and to what extent the events reported in the table were Serious Adverse Events. For events in the table that are scientific or technical terms, please clarify the meaning of these terms in order to ensure that lay readers will understand the disclosure. In addition, please provide further detail regarding the differences noted within the footnotes, including the circumstances under which patients ineligible to receive the implant per protocol received and implant, clarify the relationship between the N-values and the figures presented, clearly label the two columns under “All Events,” and clarify whether the figures within all of the parentheticals represent percentages, as you indicate next to “number of patients (percent).”

Response: The Company acknowledges the Staff’s comment and advises the Staff that it has revised page 78 of Am

December 10, 2024
Patrick Schnegelsberg
Chief Executive Officer
Picard Medical, Inc.
4 Palo Alto Square, Suite 200
Palo Alto, CA 94025
Re:Picard Medical, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted November 12, 2024
CIK No. 0002030617
Dear Patrick Schnegelsberg:
            We have reviewed your amended draft registration statement and have the following
comments.
            Please respond to this letter by providing the requested information and either
submitting an amended draft registration statement or publicly filing your registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing the information you provide in response to this letter and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary, page 1
1.We note your disclosure on page 1 that "SynCardia was incorporated in Delaware in
August 2001 as SynCardia Systems, Inc." and your disclosure on page 3 noting
that "[t]he 70cc SynCardia TAH is designed for implantation into adult patients and
has supported over 1,939 patients globally since 1982." Please revise your disclosure
here and in your description of business to clarify the timeline of your operations,
including the manufacturing and distribution of your products.
We note your disclosures here and in your description of business that you
manufacture and sell "the only U.S. FDA, and Health Canada approved implantable
SynCardia TAH," "the SynCardia TAH is an established alternative to heart 2.

December 10, 2024
Page 2
transplantation for patients with biventricular failure in the U.S., and around the
world," and "[a] total artificial heart . . . does replace the heart." Please revise your
disclosure here and throughout the filing, including your business description, to
clarify that your product is approved in the United States and Canada for temporary
bridge to transplantation indication, and briefly explain this type of approval as
compared to approval for a long-term indication. Where you discuss that your product
is an established alternative to heart transplantation, please clarify that your product is
indicated for short-term support, and revise your disclosure to define Bridge to
Transplantation and Bridge to Decision.
3.Please revise your prospectus summary to disclose that you have incurred net losses
since inception and, as you disclose on page 59, that you expect to incur significant
expenses and operating losses for the foreseeable future. Quantify your net losses and
accumulated deficit for the financial periods presented in the filing.
4.We note your disclosure on page 4 that "[a]fter the introduction of the Freedom
Driver, there have been documented accounts of patients playing golf and basketball,
fishing, and hiking while on the SynCardia TAH." Please revise your disclosure to
provide support for this statement, including the entity or person that observed and
documented these accounts, the specific implanted device, the patients' health status
prior to the implantation, the number of patients that were observed experiencing
these outcomes, and any adverse events that occurred.
5.We note your disclosure that your products are "superior to peers in total artificial
heart category" and your discussion of your competitors products, regulatory
approvals, and clinical trials. We also note your disclosure describing the limitations
of LVADs compared to your TAH. To the extent that head-to-head trials have not
been conducted, please revise to remove comparisons of your product's performance
or efficacy to other approved products.
6.Please revise your prospectus summary to disclose, as you do on page 59, that
management has concluded that there is substantial doubt over your ability to continue
as a going concern, and revise your risk factors to discuss the related risks to
investors.
7.We note your disclosure on page 12 that, while you were working on the re-
certification of the SynCardia TAH under MDD, BSI highlighted several post-market
surveillance deficiencies and in May 2022, BSI suspended SynCardia's CE mark
pending completion of a post-market surveillance study needed to reinstate the CE
mark under MDD. We also note your disclosure on page 36 that your managers have
identified significant issues with your regulatory compliance regime and are actively
working to solve these issues. Please revise your disclosure here and in your relevant
risk factor to discuss the specific post-market surveillance deficiencies and issues with
your regulatory compliance regime, and clarify how you intend to address those
deficiencies and issues, including your intended timeline for the same.
Risk Factors, page 19
We note your disclosure that in the event of a sale of shares in a public offering
resulting in gross proceeds of $25 million to the Company, the conversion of your
Series A-1 Preferred Stock will become mandatory. We also note your disclosure that, 8.

December 10, 2024
Page 3
in the event of an initial public offering, your related party loan would be
automatically converted into common stock. Please revise to include a risk factor
discussing the risks to investors related to these conversions, including those related to
dilution and volatility.
SynCardia has significant customer concentrations . . ., page 23
9.We note your disclosure that a small number of your customers account for a
substantial portion of your revenues. Please disclose, as you do in the notes to your
financial statements, the customers that account for more than 10% of your revenue
for the periods presented in the filing, and quantify the percentage contribution of
each customer.
Use of Proceeds, page 48
10.We note your disclosure that a portion of your proceeds will be used to fund research
and development activities of your products, and your disclosure elsewhere that you
plan to conduct "first-in-animal trials" and clinical trials related to your products.
Please identify any specific trials you intend to fund with proceeds from the offering
and quantify the relevant amount of proceeds, as appropriate. In addition, please
disclose the portion of proceeds you intend to use for each of the listed products.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, page 55
11.In addition to quantifying your U.S. and non U.S. declines in revenues, expand your
disclosures to address the specific underlying reason(s) for the $1.2 million decrease
in revenues for the three months ended June 30, 2024 and the $.6 million decrease in
revenues for the six months ended June 30, 2024.
12.Please expand your disclosures to discuss your cost of revenues as a percentage of
revenues for each period presented. Address why you have negative gross margins for
your rental revenues.
13.Expand your discussion of the change in cost of revenues to quantify the additional
inventory reserves and other significant underlying reasons for the decrease in cost of
sales in the three and six months ended June 30, 2024. Specifically address the
reasons underlying the changes in your inventory reserves. Address this comment as it
relates to your fiscal year cost of revenues discussions.
14.We note the significance of your research and development expenses. Please expand
your disclosure to provide more detail for your research and development expenses
for each period presented, including but not limited to by product candidate as well as
by the nature of the expenses. To the extent that you do not track expenses by product
candidate, please disclose as such.
Liquidity
Sources of Liquidity, page 60
We note your disclosure that "[t]o date, we have funded its operations primarily with
the proceeds from Series A-1 Preferred Stock and loans from related parties." Please
revise your disclosure in this section to discuss the material terms of the loans and 15.

December 10, 2024
Page 4
Series A-1 Preferred Stock issuances, including relevant dates, parties, interest rates,
accrued or undeclared dividends, outstanding amounts, and any other material terms.
Discuss the impact of these loans, share issuances, undeclared dividends, and related
obligations on your liquidity.
Critical Accounting Policies, page 61
16.The disclosures of your critical accounting policies and estimates appear to be more
descriptive of the accounting policies utilized, rather than any specific uncertainties
underlying your estimates. Please revise the disclosures for each of your critical
estimates made in preparing your consolidated financial statements to sufficiently
explain to investors what each critical estimate is; the uncertainties associated with the
critical estimates; the methods and assumptions used to make the critical estimates,
including an explanation as to how you arrived at the assumptions used; the events or
transactions that could materially impact the assumptions made; and how reasonably
likely changes to those assumptions could impact your consolidated financial
statements. Provide investors with quantified information to the extent meaningful
and available. Refer to Item 303(b)(3) of Regulation S-K, Instruction 3 to Item
(303)(b)(3), and Section V of Release No. 33-8350 for guidance.
Business
Our Components, page 67
17.Please address the following comments related to your components.

•We note your disclosure that, on April 11, 2022, "Heitek Automation and
we entered into a purchase order, which covers the terms for purchasing the
pneumatic manifold drawings for the C2 Driver." Please briefly describe the terms
of this agreement, if material, and the significance to your business of purchasing
these drawings.

•We note your disclosure that "we have started development of the C3 Driver,
which is not expected to need this pneumatic manifold." Please revise to provide
additional detail regarding the significance of the development of this driver to
your product and your business, including the timing for the development of this
driver and the significance to the manufacturing of your product.
Clinical Efficacy, page 69
We note your reference on page 66 to "the Freedom Driver System IDE Study that
began in 2010," your reference on page 69 to "more recent studies examining the
clinical outcomes of patients reviewing SynCardia TAH as BTT therapy," and your
bulleted list of examples of a study, retrospective analysis, and prospective
institutional database. Please revise your disclosure to clearly identify the studies,
retrospective analysis and prospective institutional database. Clarify what is meant by
an "all comer" patients, and disclose the criteria for selecting patients for the
SynCardia TAH study between January 2014 and May 2019. Revise your disclosures
to provide all material information about each study, including the sponsor of the
study, number of participants, whether statistical significance was demonstrated, and 18.

December 10, 2024
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the p-values supporting statistical significance. The first time you use the term p-
value please explain what it measures and the p-value that you have to achieve in
order to conclude a statistically significant result.
Adverse Events, Including Those That Affected Outcomes. . ., page 70
19.Please revise your disclosure to provide a more detailed explanation of the data
presented within the Adverse Events table on page 70, including the specific studies
and devices related to the data presented, and whether and to what extent the events
reported in the table were Serious Adverse Events. For events in the table that are
scientific or technical terms, please clarify the meaning of these terms in order to
ensure that lay readers will understand the disclosure. In addition, please provide
further detail regarding the differences noted within the footnotes, including the
circumstances under which patients ineligible to receive the implant per protocol
received and implant, clarify the relationship between the N-values and the figures
presented, clearly label the two columns under "All Events," and clarify whether the
figures within all of the parentheticals represent percentages, as you indicate next to
"number of patients (percent)."
Our Pipeline, page 70
20.We note your disclosure that "[t]he exchange of information and data prior to
submission helps to align both parties and speeds up the approval timeline." Here and
throughout your filing where you discuss regulatory approvals, please disclose that
there is no guarantee you will receive regulatory approval, the timing is unknown, and
approval may take longer than planned. Make conforming changes throughout your
filing, including here and in your prospectus summary where you discuss the intended
timing for FDA approval of your products and indications.
New Product Development, page 71
21.We note your disclosure that "[t]hese prototypes have been shown to achieve pulsatile
flow with life-sustaining rates of cardiac output." Given that efficacy determinations
are solely within the authority of the U.S. Food and Drug Administration, please
revise this and all similar statements throughout your disclosure to remove such
implications. We do not object to the disclosure of objective data obtained in your
clinical studies.
Industry Overview, page 72
We note your disclosure that the total addressable market in the United States for the
BTT indication is approximately $1 billion and the total addressable market in the
United States for long-term indication is approximately $50 billion, based on 6,000
heart implants and approximately 300,000 patients, respectively. Please revise your
disclosure to clarify how you arrived at the $1 billion TAM for BTT indication based
on 6,000 patients, including how you determined that the market includes 6,000
patients and how you calculated these 6,000 patients represent a market opportunity of
$1 billion. In addition, please clarify how you determined that the market for long-
term indication included 300,000 patients and how you calculated a total market of
$50 billion based upon these patients. In your discussion, clarify why your TAM 22.

December 10, 2024
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includes long-term indication given that you have yet to receive regulatory approval
for this indication. As a related matter, where you discuss your serviceable
addressable market, please provide more detail regarding how you arrived at an
estimate of 1,400 implants in the United States, and how you calculated the $230
million SAM based on these heart implants. Please also clarify whether your SAM
includes your BTT indication and/or long-term indication.
23.Where you provide statistics and data about your industry, please provide support for
these statements or characterize the same as management's opinions or beliefs. If these
disclosures are the opinions or beliefs of management, please provide the basis for
their opinions or beliefs. In addition, where you refer to studies generally for support,
please identify the studies.
Government Regulation, page 78
24.We note your disclosure that "stockholders are required to perform their own analysis
of regulations that apply to our business." Given that Item 101 of Regulation S-K
requires disclosure of the material effect that compliance with government regulations
may have on your business, and because investors are entitled to rely upon your
disclosure within the registration statement, please revise your disclosure to remove
this qualification.
25.We note your references throughout your filing to Humanitarian Device Exemption as
a pathway for commercialization of your products. Please revise this section to
discuss the regulations related to HDE approval.
Management, page 83
26.We note your disclosures that you have wholly owned German and Australian