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CORRESP
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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