Loaded from persisted store.
Loaded from cache.
Threads
All Filings
SEC Comment Letters
Company Responses
Letter Text
KESTRA MEDICAL TECHNOLOGIES, LTD.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
KESTRA MEDICAL TECHNOLOGIES, LTD.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
KESTRA MEDICAL TECHNOLOGIES, LTD.
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2025-01-29
KESTRA MEDICAL TECHNOLOGIES, LTD.
Filing - SEC Comment Letter to KESTRA MEDICAL TECHNOLOGIES, LTD.
UPLOAD · 2025-01-29
Generating summary...
↓
Company responded
2025-02-27
KESTRA MEDICAL TECHNOLOGIES, LTD.
Filing - Correspondence from KESTRA MEDICAL TECHNOLOGIES, LTD.
CORRESP · 2025-02-27
Generating summary...
↓
Company responded
2025-03-03
KESTRA MEDICAL TECHNOLOGIES, LTD.
Filing - Correspondence from KESTRA MEDICAL TECHNOLOGIES, LTD.
CORRESP · 2025-03-03
Generating summary...
↓
KESTRA MEDICAL TECHNOLOGIES, LTD.
Awaiting Response
0 company response(s)
High
KESTRA MEDICAL TECHNOLOGIES, LTD.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-12-08
KESTRA MEDICAL TECHNOLOGIES, LTD.
Filing - SEC Comment Letter to KESTRA MEDICAL TECHNOLOGIES, LTD.
UPLOAD · 2021-12-08
Generating summary...
KESTRA MEDICAL TECHNOLOGIES, LTD.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-09-29
KESTRA MEDICAL TECHNOLOGIES, LTD.
Filing - SEC Comment Letter to KESTRA MEDICAL TECHNOLOGIES, LTD.
UPLOAD · 2021-09-29
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-01 | Company Response | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | N/A | Read Filing View |
| 2025-12-01 | Company Response | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | N/A | Read Filing View |
| 2025-03-03 | Company Response | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | N/A | Read Filing View |
| 2025-03-03 | Company Response | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | N/A | Read Filing View |
| 2025-02-27 | Company Response | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | N/A | Read Filing View |
| 2025-01-29 | SEC Comment Letter | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | 377-05412 | Read Filing View |
| 2025-01-07 | SEC Comment Letter | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | 377-05412 | Read Filing View |
| 2021-12-08 | SEC Comment Letter | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | 377-05412 | Read Filing View |
| 2021-09-29 | SEC Comment Letter | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | 377-05412 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-01-29 | SEC Comment Letter | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | 377-05412 | Read Filing View |
| 2025-01-07 | SEC Comment Letter | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | 377-05412 | Read Filing View |
| 2021-12-08 | SEC Comment Letter | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | 377-05412 | Read Filing View |
| 2021-09-29 | SEC Comment Letter | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | 377-05412 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-01 | Company Response | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | N/A | Read Filing View |
| 2025-12-01 | Company Response | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | N/A | Read Filing View |
| 2025-03-03 | Company Response | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | N/A | Read Filing View |
| 2025-03-03 | Company Response | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | N/A | Read Filing View |
| 2025-02-27 | Company Response | KESTRA MEDICAL TECHNOLOGIES, LTD. | Bermuda | N/A | Read Filing View |
2025-12-01 - CORRESP - KESTRA MEDICAL TECHNOLOGIES, LTD.
CORRESP 1 filename1.htm CORRESP December 1, 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. 20549-6010 Attn: Juan Grana Margaret Sawicki Al Pavot Terence O’Brien Re: Kestra Medical Technologies, Ltd. Registration Statement on Form S-1 (File No. 333-291854) Request for Acceleration of Effective Date Ladies and Gentlemen: In connection with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), we hereby join in the request of Kestra Medical Technologies, Ltd. (the “ Registrant ”) that the effective date of the Registration Statement be accelerated so that it will be declared effective at 4:00 p.m., Washington, D.C. time, on December 2, 2025, or as soon as thereafter practicable, or at such later time as the Registrant or its outside counsel, Kirkland & Ellis LLP, may orally request via telephone call to the staff of the U.S. Securities and Exchange Commission. Please be advised that we have not distributed any copies of the Preliminary Prospectus dated December 1, 2025 (the “ Preliminary Prospectus ”) through the date hereof, but pursuant to Rule 460 under the Act there will be distributed to underwriters, dealers, institutions and others who are reasonably anticipated to be invited to participate in the distribution of the shares as many copies of the Preliminary Prospectus as appears to be reasonable to secure adequate distribution of the Preliminary Prospectus. Very truly yours, BOFA SECURITIES, INC. PIPER SANDLER & CO. J.P. MORGAN SECURITIES LLC GOLDMAN SACHS & CO. LLC As Representatives of the several underwriters [ Signature Pages Follow ] BOFA SECURITIES, INC. By: /s/ Milton Hsu Name: Milton Hsu Title: Managing Director PIPER SANDLER & CO. By: /s/ Neil Riley Name: Neil Riley Title: Managing Director J.P. MORGAN SECURITIES LLC By: /s/ Benjamin Burdett Name: Benjamin Burdett Title: Managing Director, Head of Healthcare Equity Capital Markets GOLDMAN SACHS & CO. LLC By: /s/ Lyla Bibi Maduri Name: Lyla Bibi Maduri Title: Managing Director As representatives of the several underwriters cc: Ilir Mujalovic, Allen Overy Shearman Sterling US LLP [ Signature Page to Acceleration Request Letter ]
2025-12-01 - CORRESP - KESTRA MEDICAL TECHNOLOGIES, LTD.
CORRESP 1 filename1.htm CORRESP KESTRA MEDICAL TECHNOLOGIES, LTD. 3933 Lake Washington Blvd NE, Suite 200 Kirkland, Washington 98033 December 1, 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: Juan Grana Margaret Sawicki Al Pavot Terence O’Brien Re: Kestra Medical Technologies, Ltd. Registration Statement on Form S-1, as amended (File No. 333-291854) Request for Acceleration of Effective Date Ladies and Gentlemen: Kestra Medical Technologies, Ltd. (the “ Registrant ”) hereby requests that the U.S. Securities and Exchange Commission (the “ Commission ”) take appropriate action to cause the above-referenced Registration Statement on Form S-1, as amended, to become effective at 4:00 p.m., Washington, D.C. time, on December 2, 2025, or as soon thereafter as is practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes each of Sophia Hudson and Christie W.S. Mok of Kirkland & Ellis LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Sophia Hudson of Kirkland & Ellis LLP, counsel to the Registrant, at (212) 446-4750, or in her absence, Christie W.S. Mok at (212) 390-4546. [ Signature Page Follows ] Very truly yours, KESTRA MEDICAL TECHNOLOGIES, LTD. By: /s/ Brian Webster Name: Brian Webster Title: President, Chief Executive Officer and Director cc: Traci S. Umberger Kestra Medical Technologies, Ltd. Sophia Hudson, P.C. Christie W.S. Mok Kirkland & Ellis LLP Ilir Mujalovic Allen Overy Shearman Sterling US LLP [C OMPANY S IGNATURE P AGE TO A CCELERATION R EQUEST ]
2025-03-03 - CORRESP - KESTRA MEDICAL TECHNOLOGIES, LTD.
CORRESP 1 filename1.htm CORRESP KESTRA MEDICAL TECHNOLOGIES, LTD. 3933 Lake Washington Blvd NE, Suite 200 Kirkland, Washington 98033 March 3, 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: Juan Grana Margaret Sawicki Al Pavot Terence O’Brien Re: Kestra Medical Technologies, Ltd. Registration Statement on Form S-1, as amended (File No. 333-284807) Request for Acceleration of Effective Date Ladies and Gentlemen: Kestra Medical Technologies, Ltd. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement on Form S-1, as amended, to become effective at 4:00 p.m., Washington, D.C. time, on March 5, 2025, or as soon thereafter as is practicable, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission. The Registrant hereby authorizes each of Sophia Hudson and Christie W.S. Mok of Kirkland & Ellis LLP, counsel to the Registrant, to make such request on its behalf. Once the Registration Statement has been declared effective, please orally confirm that event with Sophia Hudson of Kirkland & Ellis LLP, counsel to the Registrant, at (212) 446-4750, or in her absence, Christie W.S. Mok at (212) 390-4546. [Signature Page Follows] Very truly yours, KESTRA MEDICAL TECHNOLOGIES, LTD. By: /s/ Brian Webster Name: Brian Webster Title: President, Chief Executive Officer and Director cc: Traci S. Umberger Kestra Medical Technologies, Ltd. Sophia Hudson, P.C. Christie W.S. Mok Kirkland & Ellis LLP Ilir Mujalovic Allen Overy Shearman Sterling US LLP [COMPANY SIGNATURE PAGE TO ACCELERATION REQUEST]
2025-03-03 - CORRESP - KESTRA MEDICAL TECHNOLOGIES, LTD.
CORRESP 1 filename1.htm CORRESP March 3, 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. 20549-6010 Attn: Juan Grana Margaret Sawicki Al Pavot Terence O’Brien Re: Kestra Medical Technologies, Ltd. Registration Statement on Form S-1, as amended (File No. 333-284807) Request for Acceleration of Effective Date Ladies and Gentlemen: In connection with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we hereby join in the request of Kestra Medical Technologies, Ltd. (the “Registrant”) that the effective date of the Registration Statement be accelerated so that it will be declared effective at 4:00 p.m., Washington, D.C. time, on March 5, 2025, or as soon as thereafter practicable, or at such later time as the Registrant or its outside counsel, Kirkland & Ellis LLP, may orally request via telephone call to the staff of the U.S. Securities and Exchange Commission. Pursuant to Rule 460 under the Act, please be advised that we have distributed approximately 1,854 copies of the Preliminary Prospectus dated February 26, 2025 (the “Preliminary Prospectus”) through the date hereof, to underwriters, dealers, institutions and others. In connection with the Preliminary Prospectus distribution for the above-referenced issue, the prospective underwriters have confirmed that they are complying with the 48-hour requirement in Rule 15c2-8(b) under the Securities Exchange Act of 1934, as amended. Very truly yours, BOFA SECURITIES, INC. GOLDMAN SACHS & CO. LLC PIPER SANDLER & CO. As Representatives of the several underwriters [Signature Pages Follow] BOFA SECURITIES, INC. By: /s/ Michael Liloia Name: Michael Liloia Title: Director GOLDMAN SACHS & CO. LLC By: /s/ Lyla Bibi Maduri Name: Lyla Bibi Maduri Title: Managing Director PIPER SANDLER & CO. By: /s/ Neil Riley Name: Neil Riley Title: Managing Director As representatives of the several underwriters cc: Ilir Mujalovic, Allen Overy Shearman Sterling US LLP [Signature Page to Acceleration Request Letter]
2025-02-27 - CORRESP - KESTRA MEDICAL TECHNOLOGIES, LTD.
CORRESP 1 filename1.htm CORRESP 601 Lexington Avenue New York, NY 10022 United States Facsimile: +1 212 446 4800 +1 212 446 4900 www.kirkland.com February 27, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, N.E. Washington, D.C. 20549 Attention: Juan Grana Margaret Sawicki Al Pavot Terence O’Brien Re: Kestra Medical Technologies, Ltd. Registration Statement on Form S-1 Filed on February 10, 2025 CIK No. 0001877184 Ladies and Gentlemen: This letter sets forth the responses of Kestra Medical Technologies, Ltd. (the “Company”) to the verbal comments of the staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission, provided on February 19, 2025, with respect to the above-referenced Registration Statement on Form S-1 (the “Registration Statement”). The Company also notes that it has filed an Amendment No. 1 to the Registration Statement (the “Amended Registration Statement”) on February 26, 2025. Registration Statement on Form S-1 Prospectus Summary Recent Developments Preliminary estimated selected financial results as of and for the three months ended January 31, 2025, page 8 1. Staff’s verbal comment with respect to the disclosure on page 8 of the Registration Statement. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has revised the disclosure on page 8 of the Amended Registration Statement in response to the Staff’s comment. Austin Bay Area Beijing Boston Brussels Chicago Dallas Frankfurt Hong Kong Houston London Los Angeles Miami Munich Paris Riyadh Salt Lake City Shanghai Washington, D.C. Securities and Exchange Commission Office of Industrial Applications and Services February 27, 2025 Page 2 Executive Compensation Equity Incentive Compensation Incentive Units, page 169 2. Staff’s verbal comment with respect to the disclosure on page 169 of the Registration Statement. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has revised the disclosure on page 175 of the Amended Registration Statement in response to the Staff’s comment. Executive Compensation Grants in Connection with This Offering, page 172 3. Staff’s verbal comment with respect to the disclosure on page 172 of the Registration Statement. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the Company has revised the disclosure on page 178 of the Amended Registration Statement in response to the Staff’s comment. Exhibits 4. Staff’s verbal comment with respect to Exhibits 3.1 and 3.2 of the Registration Statement. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that pursuant to the requirements of Bermuda law, no amendment to the Company’s Certificate of Incorporation and Memorandum of Association is necessary to increase the Company’s authorized share capital. Under Bermuda law, the Company’s authorized share capital may be increased by resolutions of the Company’s Board of Directors and sole shareholder, effective upon the adoption of such resolutions, without any amendment to the Company’s Certificate of Incorporation and Memorandum of Association. The Company advises the Staff that the Company’s Board of Directors and sole shareholder authorized an increase to the Company’s authorized share capital to US$100,000,000 divided into 100,000,000 common shares of par value of US$1.00 each pursuant to resolutions adopted by the Board of Directors and the sole shareholder of the Company prior to the filing of the Amended Registration Statement, which increase was effective immediately upon the adoption of such resolutions by the Company’s Board of Directors and sole shareholder. Securities and Exchange Commission Office of Industrial Applications and Services February 27, 2025 Page 3 The Company advises the Staff that it has revised the disclosure on page 186 of the Amended Registration Statement in response to the Staff’s comment. We hope that the foregoing has been responsive to the Staff’s comments. If you have any questions related to this letter, please contact Sophia Hudson, P.C. of Kirkland & Ellis LLP by telephone at (212) 446-4750 or by email at sophia.hudson@kirkland.com. Sincerely, /s/ Sophia Hudson Sophia Hudson, P.C. Via E-mail: cc: Brian Webster Traci S. Umberger Kestra Medical Technologies, Ltd. Christie W.S. Mok Kirkland & Ellis LLP Ilir Mujalovic Allen Overy Shearman Sterling US LLP
2025-01-29 - UPLOAD - KESTRA MEDICAL TECHNOLOGIES, LTD. File: 377-05412
January 29, 2025
Brian Webster
Chief Executive Officer
Kestra Medical Technologies, Ltd.
3933 Lake Washington Blvd NE, Suite 200
Kirkland, WA 98033
Re:Kestra Medical Technologies, Ltd.
Amendment No. 3 to Draft Registration Statement on Form S-1
Submitted January 17, 2025
CIK 0001877184
Dear Brian Webster:
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 7, 2025 letter.
Amendment No. 3 to Draft Registration Statement on Form S-1
Prospectus Summary
Our Market Opportunity, page 4
We note your response to comment 1, including your disclosure on page 5 that
"indications for use of WCDs include patients with a LVEF less than or equal to 35%
and a MI within the past 40 days, patients who have had a revascularization procedure
within the past three months, or patients with nonischemic cardiomyopathy with heart
failure symptoms and potentially reversible causes; patients with documented VT/VF
or an inherited genetic condition that places them at high risk for SCA; or patients
who have had their ICD temporarily explanted." Given it appears that patients who do 1.
January 29, 2025
Page 2
not have a low LVEF are eligible for WCD therapy, please revise to explain why you
base your U.S. and international total market opportunity on patients with low LVEF
rather than all patients eligible for WCD therapy, or advise. Please also revise your
disclosures on page iii to briefly explain how you selected the various select
international markets.
Use of Proceeds, page 92
2.We note your response to comment 3. Please revise to more specifically identify
the approximate amount of your net proceeds to be used for each of the principal
purposes disclosed. Refer to Item 504 of Regulation S-K.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Gross Margin, page 103
3.It appears that your explanation for the October 31 gross profit variance is
substantially identical to your explanation for the April 30 variance. However, it is not
clear why you were able to generate a 36% gross profit margin on the $27 million of
sales generated in the October 31, 2024 period whereas the margin on your $27
million of sales in the April 30, 2024 period was only 1%. Please expand your
disclosure to identify the primary causes for this disparity i.e. changes in pricing,
impairment charges, uncollectible accounts, etc.
Critical Accounting Policies, page 113
4.We have read your response to prior comment 6 and reissue in part. Please expand
your disclosure to clearly explains the material risks that impact the valuation of this
asset. In this regard, your risk factor on page 32 addresses potential losses from
damage and return failures but does not state whether such losses have historically
been material. Such disclosure is necessary for readers to fully assess the magnitude
of this risk.
Business
Our Clinical Results and Studies, page 136
5.We note your response to comment 9. Please revise to briefly discuss how you
collected the real-world evidence in connection with the ACE-PAS study.
Unaudited Condensed Consolidated Financial Statements of West Affum Intermediate
Holdings Corp.
Note 10, page F-20
6.It appears that the disclosures here and on page F-42 should state the the stock was
issued to the Parent. The existing disclosure states that the Company issued stock "of
the Parent".
Note 11, page F-20
7.Please clarify this disclosure to explain why the stock is characterized as "Redeemable
Ordinary Shares" given your stated conclusion that the stock "is not considered
redeemable". Please also tell us how you considered ASC 480-10-S99-3A regarding
the classification of the stock.
January 29, 2025
Page 3
Please contact Al Pavot at 202-551-3738 or Terence O'Brien at 202-551-3355 if you
have questions regarding comments on the financial statements and related matters. Please
contact Juan Grana at 202-551-6034 or Margaret Sawicki at 202-551-7153 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Sophia Hudson, P.C.
2025-01-07 - UPLOAD - KESTRA MEDICAL TECHNOLOGIES, LTD. File: 377-05412
January 7, 2025
Brian Webster
Chief Executive Officer
Kestra Medical Technologies, Ltd.
3933 Lake Washington Blvd NE, Suite 200
Kirkland, WA 98033
Re:Kestra Medical Technologies, Ltd.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted December 11, 2024
CIK 0001877184
Dear Brian Webster:
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. 2 to Draft Registration Statement on Form S-1
Prospectus Summary
Our Market Opportunity, page 4
We note your disclosure here and elsewhere that "[you] estimate there are
approximately 1.8 million indicated patients with low LVEF in select international
markets, representing an approximately $14 billion total annual market opportunity
outside the U.S." Please revise to explain how you estimated that there are
approximately 1.8 million low LVEF indicated patients in select international
markets, disclose these select international markets, and discuss the assumptions
underlying the total annual market opportunity outside the U.S. Please also revise to
clarify, if true, that you do not currently have any regulatory approvals to 1.
January 7, 2025
Page 2
commercialize your products outside of the U.S. We also note your statement on page
2: "In the U.S., we estimate that approximately 850,000 cardiac patients each year
may be eligible for WCD therapy, representing a $10 billion annual addressable
market based on current Medicare reimbursement rates and our average WCD wear
prescription lengths." Please revise to clarify why your addressable market in the U.S.
is based on patients eligible for WCD therapy whereas your addressable international
market is based on patients with low LVEF. Define the criteria you are using for
determining a patient is eligible for WCD therapy and clarify whether all patients with
low LVEF would be eligible for WCD therapy.
If we do not obtain international regulatory registrations, clearances, certifications or
approvals for our products, we will be unable..., page 71
2.We note your disclosure that "[you] are currently pursuing a CE Mark for [y]our
ASSURE WCD, which is the regulatory approval required to market medical devices
in Europe." Please disclose whether you have submitted an application for the CE
Mark.
Use of Proceeds, page 90
3.We note that you intend to use the net proceeds from the offering to "finance the
continued commercialization of [y]our ASSURE WCD, the further build out of [y]our
sales and marketing infrastructure, future clinical trials and [y]our continued product
development and research and development activities, as well as for working capital
and general corporate purposes." Please revise to elaborate further on each of these
uses.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Revenue, page 100
4.Please expand your disclosure to clearly describe the extent to which the sales
variance was impacted by each causal factor. See Item 303(b)(2)(iii) of Regulation S-
K.
Results of Operations, page 101
5.We note your disclosure that "[t]he increase in gross margin was primarily due to
growth in [y]our revenue due to the increased number of patients using [y]our product
and improved collection efforts, as well as savings generated from volume purchases
of reusable and disposable components and continued focus on manufacturing process
improvements within cost of revenues." Please revise to discuss these improved
collection efforts and manufacturing process improvements.
Critical Accounting Policies, page 105
Given the significance of your medical rental equipment asset on page F-16, please
provide a policy disclosure that clearly explains the material risks that impact the
valuation of this asset. Specifically, disclose whether a physical inventory count is
performed, the frequency thereof, and whether such counts have ever resulted in any
material adjustments to your financial statements. Given the risk factor on page 30,
please describe the extent to which these assets have historically been written-off 6.
January 7, 2025
Page 3
when the corresponding rental agreement is terminated -- the materiality of such
losses is not clear. Also, please disclose why the estimated useful lives of these assets
range from 1.5 to 7 years.
Business
Our Growth Strategies, page 117
7.We note your disclosure that "[you] are expanding [y]our commercial organization,
currently comprised of approximately 130 team members, including regional sales
leaders, territory managers, associate sales representatives, and clinical care
specialists" and "in the future, [you] intend to strategically commercialize in select
international countries" and "anticipate Western Europe to be [y]our initial focus due
to favorable market dynamics." Please revise to further discuss your plans to expand
internationally, including the timing for any such expansion.
8.Please disclose when the ASSURE wearable ECG was commercially launched and
note the markets where it is currently being prescribed.
Our Clinical Results and Studies, page 127
9.Please revise to disclose the eligibility criteria for the subjects, and the mean age and
gender breakdown of patients participating in the ACE-DETECT and ACE-
CONVERT studies. Please also revise to provide additional detail regarding the ACE-
PAS study, including whether there were any restrictions on patient eligibility, the
gender breakdown of the patients, and how the false alarm rate and median daily
usage figures were calculated.
Intellectual Property, page 134
10.We note your disclosure that "[you] have rights to 220 issued U.S. and foreign patents
and 137 pending published and unpublished U.S. and foreign patent applications."
Please disclose the jurisdiction of your foreign patents.
Underwriting
Reserved Shares, page 201
11.Please revise to disclose the process that prospective participants will follow to
participate in the reserved shares program, the manner in which you will communicate
with prospective participants about the program, when and how you will determine
the allocation for the program, whether such allocation will change depending on the
interest level of potential participants, and any other material features of the program.
Disclose whether such shares will be subject to the lock-up agreement. We note the
shares will be offered to "certain individuals associated with [you]," including "team
members and business associates." Revise to identify with more specificity the
category of persons eligible to participate in the program.
Exhibits
12.Please revise to file the Director Agreement with Ms. Ladone and the agreement
with Ms. Mishan, mentioned on page 160, as exhibits pursuant to Item 601(b)(10) of
Regulation S-K.
January 7, 2025
Page 4
General
13.We note your disclosure regarding the WCD market and your competitive position in
the market, including:
•"In our top 50 hospitals, we believe we have successfully captured approximately
45% of the currently available prescriptions;"
•"In one study, patients with an LVEF of 30% or less were two times more likely
to suffer from SCA compared to patients with an LVEF of more than 40%.
Another study showed that the absolute risk of SCA is highest during the early
period following a cardiac event, especially within the first 30 days;"
•"As a result of these features, only 6% of our patients experience a false alarm,
compared to 46% for the competitor’s device;"
•"This rapid payor coverage adoption reflects payors’ desire for a second choice to
the competitor product, our solution addressing an unmet need with a female-
specific garment and the overall patient compliance benefits of the ASSURE
WCD;"
•"The LifeVest WCD only comes in one style, intended to fit both genders, which
has been reported to cause significant discomfort, especially for women given
many must wear a bra over the garment;"
•"Commonly cited reasons for patients or providers failing to use the competitor
device include high false alarm frequency, poor wearability and patient
discomfort, a unisex-only garment, low utility data and limited connectivity with
patients;" and
•"We estimate that there are approximately 2,700 hospitals in the U.S. that actively
prescribe WCDs as of November 30, 2024. We further estimate that
approximately 80% of U.S. WCD prescription volume is generated by
approximately 30% of these hospitals."
Please revise to provide support for these statements and the other various statements
that you make regarding your competitive position and the competitiveness of your
products.
Please contact Al Pavot at 202-551-3738 or Terence O'Brien at 202-551-3355 if you
have questions regarding comments on the financial statements and related matters. Please
contact Juan Grana at 202-551-6034 or Margaret Sawicki at 202-551-7153 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Sophia Hudson, P.C.
2021-12-08 - UPLOAD - KESTRA MEDICAL TECHNOLOGIES, LTD. File: 377-05412
United States securities and exchange commission logo
December 8, 2021
Brian Webster
Chief Executive Officer
Kestra Medical Technologies, Ltd.
3933 Lake Washington Blvd NE Suite 200,
Kirkland, Washington 98033
Re:Kestra Medical Technologies, Ltd.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted November 23, 2021
CIK 0001877184
Dear Mr. Webster:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
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 our comments apply 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 these comments 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
Business, page 104
1.We note your disclosures on page 8 and page 111 describing your exclusive partnership
with Global Medical Response. Please revise your Business section, where appropriate, to
describe the material terms of this partnership agreement and file the agreement as an
exhibit to your registration statement. Alternatively, provide the basis for your belief that
it is not required to be filed as an exhibit.
Exhibits
2.Your disclosure throughout the prospectus indicates that the prospectus includes
information from a study by the IBM Watson group that you funded. Please tell us what
FirstName LastNameBrian Webster
Comapany NameKestra Medical Technologies, Ltd.
December 8, 2021 Page 2
FirstName LastName
Brian Webster
Kestra Medical Technologies, Ltd.
December 8, 2021
Page 2
consideration you gave to filing a third party consent as an exhibit to the registration
statement as required by Section 7 of the Securities Act and Securities Act Rule 436.
You may contact Sasha Parikh at 202-551-3627 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Sophia Hudson, P.C.
2021-09-29 - UPLOAD - KESTRA MEDICAL TECHNOLOGIES, LTD. File: 377-05412
United States securities and exchange commission logo
September 29, 2021
Brian Webster
Chief Executive Officer
Kestra Medical Technologies, Ltd.
3933 Lake Washington Blvd NE Suite 200,
Kirkland, Washington 98033
Re:Kestra Medical Technologies, Ltd.
Draft Registration Statement on Form S-1
Submitted August 25, 2021
CIK 0001877184
Dear Mr. Webster:
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
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 our comments apply 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 these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1
Prospectus Summary, page 1
1.Please revise your Summary to provide a more balanced discussion of your company and
your product. By way of example only, relocate your risk factors summary to immediately
follow the the discussion of "Our Success Factors" and "Our Growth Strategies"
beginning on page 3 and expand the discussion of your risk factors to ensure the
discussion is as prominent as the discussion of your success factors and growth strategy.
In your Summary revisions, please also disclose the amount of your indebtedness, the
interest rate and the amount of debt payments made in recent periods.
2.Please provide support for your statement that the false alarm rate of Zoll's Life Vest
WCD is one every 3.4 days.
FirstName LastNameBrian Webster
Comapany NameKestra Medical Technologies, Ltd.
September 29, 2021 Page 2
FirstName LastNameBrian Webster
Kestra Medical Technologies, Ltd.
September 29, 2021
Page 2
Our Clinical Studies and Commercialization, page 3
3.We note your statements here and on page 101 that (i) you are committed to continuing to
develop clinical evidence to further demonstrate the safety and effectiveness of your
product and (ii) you believe your post-market surveillance study will further raise
awareness of and validate your ASSURE System. Please revise these statements to reflect
your disclosure on page 21 that subsequent clinical trials may not be consistent with your
findings to date and could impede the adoption of your product.
Our Success Factors, page 3
4.We note your statement that you estimate that the near-term achievable market for WCDs
in the U.S. as of 2021 is approximately $3 billion, representing one-half of the total
addressable market opportunity, and is approximately 23% penetrated. Please revise your
disclosure here and throughout to specify what is meant by "near-term achievable market"
and discuss the differences between the approximate $1 billion global market that you
estimate for 2022 and the "near-term achievable market" of approximately $3 billion.
Please also revise to disclose the assumptions underlying your estimates of near-term
achievable market, total addressable market and market penetration and discuss the risks
related to these assumptions.
5.We note your disclosure on page 5 indicating that you have established infrastructure to
support adjacent follow-on products in the cardiac patient continuum of care. However,
the prospectus does not appear to contain a discussion of any follow-on products under
development. Please revise here and throughout the prospectus where you discuss follow-
on products to clarify, if true, that you do not have any additional products under
development. Alternatively, to the extent you have additional products in development,
please revise your prospectus to discuss these products.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Key Components of Our Results of Operations
Revenue, page 89
6.As you have noted that you are in the process of commercially launching your ASSURE
System and expect to begin generating revenues during your 2022 fiscal year, please
disclose your revenue recognition policy.
Business, page 99
7.Your disclosure on pages 51, 57 and 58 indicates that you in-license certain of your
patents and technology from third parties and that you are also party to out-bound licenses
with third parties. Please revise your Business section to describe the terms of your
material license agreements and file the agreements as exhibits to your registration
statement. Alternatively, please tell us why this would not be required.
FirstName LastNameBrian Webster
Comapany NameKestra Medical Technologies, Ltd.
September 29, 2021 Page 3
FirstName LastName
Brian Webster
Kestra Medical Technologies, Ltd.
September 29, 2021
Page 3
Intellectual Property, page 120
8.Please revise this section to disclose the jurisdictions of your patents. In addition, your
disclosure here indicates that the earliest expiry date for issued patents owned or used by
you is in 2025, but your disclosure on page 51 states that your earliest U.S. patent will
expire in 2022. Please reconcile your disclosure or advise.
General
9.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
You may contact Sasha Parikh at 202-551-3627 or Lynn Dicker at 202-551-3616 if you
have questions regarding comments on the financial statements and related matters. Please
contact Alan Campbell at 202-551-4224 or Suzanne Hayes at 202-551-3675 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Sophia Hudson, P.C.
Keep this ticker handy
Private to this browserSave KMTS to a local list so you can return to this research path without creating an account.
Save this research path
Create a free accountSave this ticker search and return to the same filing timeline in one click. You can also create alerts for new SEC correspondence after signing up.