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SHOULDER INNOVATIONS, INC.
Response Received
4 company response(s)
High - file number match
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Company responded
2025-07-25
SHOULDER INNOVATIONS, INC.
References: July 24, 2025
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SHOULDER INNOVATIONS, INC.
Response Received
1 company response(s)
Medium - date proximity
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Company responded
2025-07-09
SHOULDER INNOVATIONS, INC.
References: July 3, 2025
SHOULDER INNOVATIONS, INC.
Awaiting Response
0 company response(s)
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SHOULDER INNOVATIONS, INC.
Awaiting Response
0 company response(s)
High
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-28 | Company Response | SHOULDER INNOVATIONS, INC. | DE | N/A | Read Filing View |
| 2025-07-28 | Company Response | SHOULDER INNOVATIONS, INC. | DE | N/A | Read Filing View |
| 2025-07-28 | Company Response | SHOULDER INNOVATIONS, INC. | DE | N/A | Read Filing View |
| 2025-07-25 | Company Response | SHOULDER INNOVATIONS, INC. | DE | N/A | Read Filing View |
| 2025-07-24 | SEC Comment Letter | SHOULDER INNOVATIONS, INC. | DE | 377-07913 | Read Filing View |
| 2025-07-09 | Company Response | SHOULDER INNOVATIONS, INC. | DE | N/A | Read Filing View |
| 2025-07-03 | SEC Comment Letter | SHOULDER INNOVATIONS, INC. | DE | 377-07913 | Read Filing View |
| 2025-06-09 | SEC Comment Letter | SHOULDER INNOVATIONS, INC. | DE | 377-07913 | Read Filing View |
| 2025-05-15 | SEC Comment Letter | SHOULDER INNOVATIONS, INC. | DE | 377-07913 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-24 | SEC Comment Letter | SHOULDER INNOVATIONS, INC. | DE | 377-07913 | Read Filing View |
| 2025-07-03 | SEC Comment Letter | SHOULDER INNOVATIONS, INC. | DE | 377-07913 | Read Filing View |
| 2025-06-09 | SEC Comment Letter | SHOULDER INNOVATIONS, INC. | DE | 377-07913 | Read Filing View |
| 2025-05-15 | SEC Comment Letter | SHOULDER INNOVATIONS, INC. | DE | 377-07913 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-28 | Company Response | SHOULDER INNOVATIONS, INC. | DE | N/A | Read Filing View |
| 2025-07-28 | Company Response | SHOULDER INNOVATIONS, INC. | DE | N/A | Read Filing View |
| 2025-07-28 | Company Response | SHOULDER INNOVATIONS, INC. | DE | N/A | Read Filing View |
| 2025-07-25 | Company Response | SHOULDER INNOVATIONS, INC. | DE | N/A | Read Filing View |
| 2025-07-09 | Company Response | SHOULDER INNOVATIONS, INC. | DE | N/A | Read Filing View |
2025-07-28 - CORRESP - SHOULDER INNOVATIONS, INC.
CORRESP 1 filename1.htm Document July 28, 2025 United States Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, N.E. Washington, DC 20549 Attn: Al Pavot Li Xiao Juan Grana Jane Park Re: Shoulder Innovations, Inc. (the “Registrant”) Registration Statement on Form S-1, as amended (File No. 333-288549) Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended, we wish to advise that between July 24, 2025 and the date hereof, approximately 2,840 copies of the Preliminary Prospectus, dated July 24, 2025, were distributed to prospective underwriters, institutional investors and prospective dealers in connection with the above-captioned Registration Statement, as amended. We wish to advise you that the participating underwriters have informed us that they have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. We hereby join in the request of the Registrant that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:00 p.m. Eastern Time, on Wednesday, July 30, 2025 or as soon thereafter as practicable. [signature page follows] Very truly yours, MORGAN STANLEY & CO. LLC GOLDMAN SACHS & CO. LLC PIPER SANDLER & CO. As representatives of the Underwriters MORGAN STANLEY & CO. LLC By: /s/ Chris Rigoli Name: Chris Rigoli Title: Managing 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 [Signature Page to Acceleration Request Letter]
2025-07-28 - CORRESP - SHOULDER INNOVATIONS, INC.
CORRESP 1 filename1.htm Document Shoulder Innovations, Inc. 1535 Steele Avenue SW, Suite B Grand Rapids, Michigan 49507 July 28, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Al Pavot Li Xiao Juan Grana Jane Park Re: Shoulder Innovations, Inc. Registration Statement on Form S-1, as amended (File No. 333-288549) Request for Acceleration of Effective Date To the addressees set forth above: In accordance with Rule 461 under the Securities Act of 1933, as amended, Shoulder Innovations, Inc. (the “ Company ”) hereby requests acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-288549) (as amended, the “ Registration Statement ”). The Company respectfully requests that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on July 30, 2025, or as soon as practicable thereafter, or at such other time as the Company or its legal counsel may request by telephone to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Ross McAloon at (714) 755-8051. Thank you for your assistance in this matter. [ Signature page follows ] Sincerely, Shoulder Innovations, Inc. By: /s/ Robert Ball Name: Robert Ball Title: Chief Executive Officer and Executive Chairman cc: Jeffrey Points, Chief Financial Officer, Shoulder Innovations, Inc. B. Shayne Kennedy, Latham & Watkins LLP J. Ross McAloon, Latham & Watkins LLP Denny Won, Cooley LLP Charles S. Kim, Cooley LLP Kristin VanderPas, Cooley LLP Dave Peinsipp, Cooley LLP
2025-07-28 - CORRESP - SHOULDER INNOVATIONS, INC.
CORRESP 1 filename1.htm Document Shoulder Innovations, Inc. 1535 Steele Avenue SW, Suite B Grand Rapids, Michigan 49507 July 28, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Al Pavot Li Xiao Juan Grana Jane Park Re: Shoulder Innovations, Inc. Registration Statement on Form S-1, as amended (File No. 333-288549) Request for Acceleration of Effective Date To the addressees set forth above: In accordance with Rule 461 under the Securities Act of 1933, as amended, Shoulder Innovations, Inc. (the “ Company ”) hereby requests acceleration of the effective date of the above-referenced Registration Statement on Form S-1 (File No. 333-288549) (as amended, the “ Registration Statement ”). The Company respectfully requests that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on July 30, 2025, or as soon as practicable thereafter, or at such other time as the Company or its legal counsel may request by telephone to the staff of the Division of Corporation Finance of the Securities and Exchange Commission. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Ross McAloon at (714) 755-8051. Thank you for your assistance in this matter. [ Signature page follows ] Sincerely, Shoulder Innovations, Inc. By: /s/ Robert Ball Name: Robert Ball Title: Chief Executive Officer and Executive Chairman cc: Jeffrey Points, Chief Financial Officer, Shoulder Innovations, Inc. B. Shayne Kennedy, Latham & Watkins LLP J. Ross McAloon, Latham & Watkins LLP Denny Won, Cooley LLP Charles S. Kim, Cooley LLP Kristin VanderPas, Cooley LLP Dave Peinsipp, Cooley LLP
2025-07-25 - CORRESP - SHOULDER INNOVATIONS, INC.
CORRESP 1 filename1.htm Document 650 Town Center Drive, 20th Floor Costa Mesa, California 92626-1925 Tel: +1.714.540.1235 Fax: +1.714.755.8290 www.lw.com FIRM / AFFILIATE OFFICES Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul Hamburg Silicon Valley Hong Kong Singapore Houston Tel Aviv London Tokyo Los Angeles Washington, D.C. Madrid July 25, 2025 VIA EDGAR AND ELECTRONIC MAIL Division of Corporation Finance Office of Industrial Applications and Services U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549-6010 Attention: Al Pavot Li Xiao Juan Grana Jane Park Re: Shoulder Innovations, Inc. Amendment No. 2 to Registration Statement on Form S-1 Submitted July 24, 2025 CIK No. 0001699350 To the addressees set forth above: On behalf of our client, Shoulder Innovations, Inc. (the “ Company ”), set forth below is the Company’s response to the comment of the Staff (the “ Staff ”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “ Commission ”) in its letter dated July 24, 2025, relating to the Company’s Amendment No. 2 to Registration Statement on Form S-1 publicly filed on July 24, 2025 (“ Amendment No. 2 ”). Simultaneously with the submission of this letter, the Company is publicly filing via EDGAR Amendment No. 3 to the Registration Statement on Form S-1 (the “ Amendment No. 3 ”) responding to the Staff’s comment and updating its disclosures in Amendment No. 3. July 25, 2025 Page 2 All terms used but not defined herein have the meanings assigned to such terms in Amendment No. 3. For ease of reference, we have set forth the Staff’s comment and the Company’s response below. Amendment No. 2 to Registration Statement on Form S-1 Underwriting, page 194 1. We note your disclosure that “[you] have requested that the underwriters make issuer directed allocations in the aggregate of shares of [y]our common stock to certain investors." Please advise whether any specific investors have been identified, and if so, revise your disclosure to identify these investors and to note the number of shares of common stock to be allocated to each. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 194 of Amendment No. 3. ********* July 25, 2025 Page 3 We hope that the foregoing has been responsive to the Staff’s comment and look forward to resolving any outstanding issues as quickly as possible. Please do not hesitate to contact me at (714) 755-8051 with any questions or further comments you may have regarding this filing or if you wish to discuss the above. Sincerely, /s/ Ross McAloon Ross McAloon of LATHAM & WATKINS LLP Enclosures cc: (via e-mail) Robert Ball, Chief Executive Officer, Shoulder Innovations, Inc. B. Shayne Kennedy, Latham & Watkins LLP J. Ross McAloon, Latham & Watkins LLP Denny Won, Cooley LLP Charles S. Kim, Cooley LLP Kristin VanderPas, Cooley LLP Dave Peinsipp, Cooley LLP
2025-07-24 - UPLOAD - SHOULDER INNOVATIONS, INC. File: 377-07913
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 24, 2025 Robert Ball Chief Executive Officer Shoulder Innovations, Inc. 1535 Steele Avenue SW, Suite B Grand Rapids, MI 49507 Re: Shoulder Innovations, Inc. Amendment No. 2 to Registration Statement on Form S-1 Filed July 24, 2025 File No. 333-288549 Dear Robert Ball: 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. Amendment No. 2 to Form S-1 Underwriting, page 194 1. We note your disclosure that [you] have requested that the underwriters make issuer directed allocations in the aggregate of shares of [y]our common stock to certain investors." Please advise whether any specific investors have been identified, and if so, revise your disclosure to identify these investors and to note the number of shares of common stock to be allocated to each. Please contact Li Xiao at 202-551-4391 if you have questions regarding comments on the financial statements and related matters. Please contact Juan Grana at 202-551-6034 or Jane Park at 202-551-7439 with any other questions. July 24, 2025 Page 2 Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Ross McAloon, Esq. </TEXT> </DOCUMENT>
2025-07-09 - CORRESP - SHOULDER INNOVATIONS, INC.
CORRESP 1 filename1.htm Document 650 Town Center Drive, 20th Floor Costa Mesa, California 92626-1925 Tel: +1.714.540.1235 Fax: +1.714.755.8290 www.lw.com FIRM / AFFILIATE OFFICES Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul Hamburg Silicon Valley Hong Kong Singapore Houston Tel Aviv London Tokyo Los Angeles Washington, D.C. Madrid July 9, 2025 VIA EDGAR AND ELECTRONIC MAIL Division of Corporation Finance Office of Industrial Applications and Services U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549-6010 Attention: Al Pavot Li Xiao Juan Grana Jane Park Re: Shoulder Innovations, Inc. Amendment No. 2 to Draft Registration Statement on Form S-1 Submitted June 18, 2025 CIK No. 0001699350 To the addressees set forth above: On behalf of our client, Shoulder Innovations, Inc. (the “ Company ”), set forth below are the Company’s responses to the comments of the Staff (the “ Staff ”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “ Commission ”) in its letter dated July 3, 2025, relating to the Company’s Amendment No. 2 to Draft Registration Statement on Form S-1 submitted on June 18, 2025 (“ Amendment No. 2 ”). Simultaneously with the submission of this letter, the Company is publicly filing via EDGAR Amendment No.1 to the Registration Statement on Form S-1 (the “ Amendment No. 1 ”) responding to the Staff’s comments and updating its disclosures in Amendment No. 1. The Company’s responses set forth in this letter are numbered to correspond to the numbered comments in the Staff’s letter. All terms used but not defined herein have the meanings assigned to such terms in Amendment No. 1. For ease of reference, we have set forth the Staff’s comments and the Company’s response for each item below. July 9, 2025 Page 2 Amendment No. 2 to Draft Registration Statement on Form S-1 Reverse Stock Split, page 13 1. As a reminder, please note the guidance in SAB 4:C and SAB 4:D regarding your impending stock split. Response: The Company respectfully acknowledges the Staff’s comment and confirms that it will consider SAB 4:C and SAB 4:D when it updates its historical financial statements and disclosure in a subsequent pre-effective amendment to the Registration Statement on Form S-1 once the reverse stock split has been completed. Critical Accounting Policies and Estimates, page 98 2. We have read your response to prior comment 4. Given the materiality of your inventory balance, please expand your disclosure to quantify the extent to which the asset account includes products for which there were no material sales during the most recent period. Reconcile this data with your conclusion that your March 31, 2025 inventory reserve is adequate. Your existing disclosure acknowledges the existence of aged inventory but does not provide any context enabling a reader to gauge their significance relative to the corresponding reserves. The risk factor on page 20 appears relevant in this regard. See Item 303(b)(3) of Regulation S-K. Response: In response to the Staff’s comment, the Company has revised the critical accounting policy disclosure on page 101 of Amendment No. 1 to include disclosure of $430,000 of inventories that, as of the most recent period end (March 31, 2025), did not have material sales during the preceding 12 months. The Company respectfully notes that substantially all of these inventories were implants with sizes that are less commonly used but that are included in the various implant families available to surgeons for use in surgery. The Company further notes that it generated revenue from the sale of more commonly used implants included in such implant families during the period. Statements of Operations, page F-4 3. We have read your response to prior comment 7. We understand from your disclosure on page F-24 that you have chosen to exclude depreciation and amortization expense from your cost of goods sold account balances on pages F-4 and F-16. Consequently, it appears that the guidance in SAB 11:B is applicable. It is not clear whether the absence of parenthetical disclosures, or the existing presentation of gross profit, are appropriate. Further, it appears that your discussion of COGS in MD&A should include a prominent clarification that your reported cost of goods sold balances do not include depreciation and amortization expense. The guidance in Item 10(e)(1) of Regulation S-K may also be applicable. Please revise accordingly or explain. Response: The Company respectfully acknowledges the Staff’s comment and submits to the Staff that the Company interprets the guidance in SAB 11:B to require a particular July 9, 2025 Page 3 presentation, including parenthetical disclosure, when there is depreciation, depletion and amortization attributable to revenue producing activity that is excluded from cost of goods sold. The Company purchases all finished goods from third party suppliers under contract manufacturing arrangements. Since the Company does not manufacture any of its products, it does not own or operate any equipment used in the manufacturing process of its products. Given that the Company does not own any such equipment, the Company believes that cost of goods sold includes all appropriate costs to bring inventory to a salable state and that gross profit is appropriately presented. Further, the Company’s depreciation related to surgical instruments, which comprises the majority of the Company’s depreciation expense (as disclosed on page F-28 in Amendment No. 1), is included in selling, general, and administrative expenses because such instruments are used in the sales process for the Company’s implants and are not considered a performance obligation. Similarly, the Company’s amortization related to its software license is included in selling, general and administrative expenses as the software is used as a marketing tool to prospective customers and not considered a performance obligation. The Company advises the Staff that it does not believe it has excluded depreciation or amortization from cost of goods sold and respectfully submits that it has appropriately classified this expense within selling, general, and administrative expenses based on the nature and use of the underlying long-lived assets, which are not directly associated with satisfying the performance obligation because the customer does not obtain control of the surgical instruments. As the Company believes that its existing presentation of depreciation in selling, general and administrative expenses is appropriate under US GAAP, the Company respectfully submits to the Staff that it believes its existing presentation of gross profit and the absence of related parenthetical disclosures are also appropriate and that it does not believe the relevant guidance in Item 10(e)(1) of Regulation S-K is applicable. ********* July 9, 2025 Page 4 We hope that the foregoing has been responsive to the Staff’s comments and look forward to resolving any outstanding issues as quickly as possible. Please do not hesitate to contact me at (714) 755-8051 with any questions or further comments you may have regarding this filing or if you wish to discuss the above. Sincerely, /s/ Ross McAloon Ross McAloon of LATHAM & WATKINS LLP Enclosures cc: (via e-mail) Robert Ball, Chief Executive Officer, Shoulder Innovations, Inc. B. Shayne Kennedy, Latham & Watkins LLP J. Ross McAloon, Latham & Watkins LLP Denny Won, Cooley LLP Charles S. Kim, Cooley LLP Kristin VanderPas, Cooley LLP Dave Peinsipp, Cooley LLP
2025-07-03 - UPLOAD - SHOULDER INNOVATIONS, INC. File: 377-07913
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 3, 2025 Robert Ball Chief Executive Officer Shoulder Innovations, Inc. 1535 Steele Avenue SW, Suite B Grand Rapids, MI 49507 Re: Shoulder Innovations, Inc. Amendment No. 2 to Draft Registration Statement on Form S-1 Submitted June 18, 2025 CIK No. 0001699350 Dear Robert Ball: 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 June 9, 2025 letter. Amendment No. 2 to Draft Registration Statement on Form S-1 Reverse Stock Split, page 13 1. As a reminder, please note the guidance in SAB 4:C and SAB 4:D regarding your impending stock split. July 3, 2025 Page 2 Critical Accounting Policies and Estimates, page 98 2. We have read your response to prior comment 4. Given the materiality of your inventory balance, please expand your disclosure to quantify the extent to which the asset account includes products for which there were no material sales during the most recent period. Reconcile this data with your conclusion that your March 31, 2025 inventory reserve is adequate. Your existing disclosure acknowledges the existence of aged inventory but does not provide any context enabling a reader to gauge their significance relative to the corresponding reserves. The risk factor on page 20 appears relevant in this regard. See Item 303(b)(3) of Regulation S-K. Statements of Operations, page F-4 3. We have read your response to prior comment 7. We understand from your disclosure on page F-24 that you have chosen to exclude depreciation and amortization expense from your cost of goods sold account balances on pages F-4 and F-16. Consequently, it appears that the guidance in SAB 11:B is applicable. It is not clear whether the absence of parenthetical disclosures, or the existing presentation of gross profit, are appropriate. Further, it appears that your discussion of COGS in MD&A should include a prominent clarification that your reported cost of goods sold balances do not include depreciation and amortization expense. The guidance in Item 10(e)(1) of Regulation S-K may also be applicable. Please revise accordingly or explain. Please contact Al Pavot at 202-551-3738 or Li Xiao at 202-551-4391 if you have questions regarding comments on the financial statements and related matters. Please contact Juan Grana at 202-551-6034 or Jane Park at 202-551-7439 with any other questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Ross McAloon, Esq. </TEXT> </DOCUMENT>
2025-06-09 - UPLOAD - SHOULDER INNOVATIONS, INC. File: 377-07913
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 9, 2025 Robert Ball Chief Executive Officer Shoulder Innovations, Inc. 1535 Steele Avenue SW, Suite B Grand Rapids, MI 49507 Re: Shoulder Innovations, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted May 23, 2025 CIK No. 0001699350 Dear Robert Ball: 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 May 14, 2025 letter. Amendment No. 1 to Draft Registration Statement on Form S-1 Prospectus Summary, page 2 1. We note your response to comment 1, including your revised disclosure on page 2 referencing "publicly available industry data, including from the National Institutes of Health." Please revise to provide the specific source for your estimate that shoulder conditions result in more than eight million physician visits annually in the United States and can require surgical intervention. 2. We note your revised disclosure in response to comment 2, including that "for the three months ended March 31, 2025, [you] estimate an implied utilization rate for [y]our ProVoyance technology of approximately 90% based on the number of surgical plans reported to have been created using ProVoyance technology and the number of [y]our implant systems sold during such period." We also note your response that June 9, 2025 Page 2 "this information is based on real-world data from [your] customers and the actual number of implant systems sold during the respective period," "[t]he ProVoyance technology tracks and reports each surgical plan it is used to create [and ba]sed on those reports . . . a total of 1,303 surgical plans were created using ProVoyance during the three months ended March 31, 2025," and "[d]uring the same period, [you] sold 1,443 implant systems, which, when considered against the 1,303 surgical plans created during the same period, yields an implied utilization rate of 90%." Please revise your disclosures on page 3 to include this additional information provided in your response to comment 2. Market Overview, page 4 3. We note your response to comments 5 and 6, including your revised disclosure on page 4 that, "[b]ased on [y]our internal estimates, knowledge of [y]our industry and third-party data regarding the number of shoulder arthroplasty procedures performed, [you] expect this market to grow by approximately 11% annually through 2029," and that "[you] believe a significant opportunity exists outside of the United States and, based on third-party industry reports and [y]our internal estimates, [you] estimate that the total international shoulder arthroplasty market is approximately $1.7 billion in 2025." You also disclose that "[t]ogether, [you] believe these markets represent a global annual shoulder arthroplasty market of approximately $3.4 billion." Please revise to cite the third-party data and industry reports referenced above, further discuss how these growth and total international market estimates were calculated, and elaborate on any material assumptions underlying such calculations. Critical Accounting Policies and Estimates, page 96 4. We note that inventories comprise over 20% of total assets and that inventory adjustments adversely impacted your 2024 gross margin. Given that the March 31, 2025 inventory balance is 40% higher than your annualized cost of goods sold (COGS), it is not clear whether the asset balance includes a substantial amount of aged inventory. Based on your response to prior comment 12, it is not clear whether you may have a material amount of inventory that has been re-sterilized upon expiration of its five year shelf life. We note that you track the age of your inventory items (page F-20), and that obsolescence and your markets sensitivity to new products and innovation have been identified as material risks on pages 19-31. Please provide a critical accounting policy disclosure that quantifies the extent to which your inventory asset balance includes products for which there were no material sales during the most recent quarter. Disclose the amounts of inventory on hand that you determined to be obsolete or unmarketable. Reconcile this data with your conclusion that your March 31, 2025 inventory reserve is adequate. See Item 303(b)(3) of Regulation S-K. 5. Based on your response to prior comment 12, we understand that you estimate your future twelve month sales levels when determining your non-current inventory amounts. Based on your December 31, 2023 inventory balance and your 2024 COGS balance, it appears that this estimate may have been off by 25% at December 31, 2023. Similarly, the disparity appears to exceed 45% at December 31, 2022. Further, it appears that you are classifying all of your inventory as current based on an expectation that 2025 sales will increase by over 90%. Consequently, it remains June 9, 2025 Page 3 unclear why you have not classified a portion of your inventory as non-current. Please revise or provide a critical accounting policy disclosure that addresses the accuracy of your prior estimates and quantifies the impact of your 2025 sales growth estimate on your inventory classification. See ASC 210-10-45-3 and Article 303(b)(3) of Regulation S-K. Competition, page 136 6. We note your response to comment 18, including your revised disclosure on page 136 that you "have seen and continue to see consolidation amongst [y]our competitors and have seen and continue to see [y]our competitors innovate and improve upon traditional implants and technologies." Please revise your disclosure in this section to note whether any of your competitors offer specific alternatives to traditional glenoid implants and humeral stem technologies. Statements of Operations, page F-4 7. Based on the disclosure on page F-27, it does not appear that depreciation expense is included in Cost of Goods Sold. Please clarify for us how your presentation here and on page F-16 complies with SAB 11:B. Surgical Instruments, page F-21 8. Regarding your response to prior comment 20, please provide an accounting policy disclosure that clarifies the basis for your statement that "the customers do not obtain control of the surgical instruments." In this regard, we understand that the surgical instruments are provided to customers at no cost and that there does not appear to be a legally enforceable contract governing your continuing ownership rights over these instruments. Further, it is not clear whether any material quantity of non- defective surgical instruments has ever been returned to you by your customers. Also, it is not clear whether you have an effective method to objectively verify the existence of these instruments after they are transferred to the customers which makes the application of a substantive impairment policy uncertain. The known factors you considered in assigning the 5 year useful life are similarly not clear. Given that surgical instruments appear to comprise over 15% of your total assets, please expand your disclosure to address these issues. Please contact Al Pavot at 202-551-3738 or Li Xiao at 202-551-4391 if you have questions regarding comments on the financial statements and related matters. Please contact Juan Grana at 202-551-6034 or Jane Park at 202-551-7439 with any other questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Ross McAloon, Esq. </TEXT> </DOCUMENT>
2025-05-15 - UPLOAD - SHOULDER INNOVATIONS, INC. File: 377-07913
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 14, 2025 Robert Ball Chief Executive Officer Shoulder Innovations, Inc. 1535 Steele Avenue SW, Suite B Grand Rapids, Michigan 49507 Re: Shoulder Innovations, Inc. Draft Registration Statement on Form S-1 Submitted April 17, 2025 CIK No. 0001699350 Dear Robert Ball: We have reviewed your 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. Draft Registration Statement on Form S-1 submitted April 17, 2025 Prospectus Summary, page 2 1. We note your statement that certain conditions that can result in shoulder pain and reduce functionality result in more than eight million estimated physician visits annually in the United States. Please provide the source of this estimate. 2. We note your statement that "for the three months ended March 31, 2025, nine surgical plans were created using ProVoyance for every ten surgical cases, representing an implied utilization rate of 90%." Please revise to provide greater detail of how this data was obtained, including the size, jurisdiction, and scope of the study, as applicable. Please also clarify what you mean by an implied utilization rate and explain the difference, if any, between an implied utilization rate and a utilization rate in this context. If known and to the extent it is materially different, please also May 14, 2025 Page 2 disclose the percentage of procedures using your advanced implant systems that also used your ProVoyance technology during the applicable period. 3. We refer to your disclosure that you initially launched your InSet Glenoid product in 2016, began using ProVoyance in 2021, and launched your initial I-Series system, the InSet 95 Humeral Stem, in 2023 and that you anticipate pursuing FDA clearance of additional I-Series implants, such as the InSet 70, InSet 135 and InSet 185 stems, over the next twelve months. You also state on page 48 that your systems are regulated as medical devices in the United States. Please revise your disclosure in this section to clarify the timeline for the development of each of your products since your inception. In your revised disclosure, please also discuss the FDA s classification of each product as a medical device into one of three classes (Class I, Class II, and Class III) depending on its level of risk, specify when you obtained FDA approval for each product, and disclose the current status of development of your InSet 70, InSet 135 and InSet 185 stem products. 4. We refer to your statements here and elsewhere in the registration statement that your ProVoyance technology is cleared by the FDA for preoperative shoulder planning on the FDA s AI/ML-enabled medical devices list. In an appropriate section of your registration statement, please describe the approval process for the FDA s AI/ML- enabled medical devices, including any material differences from the FDA s classification of and approval pathways for medical devices. Market Overview, page 4 5. We note your statement that the shoulder arthroplasty market in the United States is expected to grow by greater than 10% annually through 2029. Please revise to provide a specific estimated growth rate or a range of estimated growth rates. Additionally, please clarify whether this estimate is provided by a third party or made by your management and provide the basis, source and material assumptions for such estimate, as applicable. 6. Please disclose how the $1.7 billion estimate of the total international shoulder arthroplasty market for 2025 is calculated and discuss any material assumptions or estimates underlying the calculation. To the extent the estimate is based in part on your average sales price in the United States, please note whether any adjustments were made to the average sales price and any potential challenges or uncertainties regarding international sales, such as different reimbursement regimes or issues related to government payors. Product Liability Claims, page 23 7. In order for readers to better assess this risk, please expand this risk factor to disclose whether product liability claims, lawsuits or recalls have actually materially impacted your business, financial condition or results of operations. As a related matter, expand your financial statement notes to disclose your product warranty term, as well as any material product warranty liabilities in accordance with ASC 460-10-50-8. If not material, disclose that fact. May 14, 2025 Page 3 Risk Factors We are and in the future may be subject to claims that we or our employees have misappropriated the intellectual property..., page 46 8. We note your reference here to certain patents and patent applications licensed from Boston University that were made with financial assistance from the federal government. Please clarify if you license any material intellectual property rights other than pursuant to the software license agreement with Genesis Software. If so, please describe the material terms of the licenses and license agreements in the Intellectual Property section of your prospectus. Internal Controls, page 59 9. Please expand your disclosure to clarify whether there are any identified material weaknesses in your internal controls. Use of Proceeds, page 75 10. To the extent known, please revise to disclose the approximate amount of proceeds you intend to allocate toward each of the purposes identified in this section. Please also confirm whether you intend to use the proceeds of the offering towards the development of any specific products, and if so, how much you intend to allocate and how far the proceeds from the offering will allow you to proceed with such programs, as applicable. We note your disclosure on pages 84 and 86 that you anticipate that you will continue to invest significantly in product development and expect your research and development expenses to increase as you pursue development of new products and product enhancements. Refer to Instruction 3 to Item 504 of Regulation S-K. Net Revenue, page 85 11. Please expand your disclosure to address the historical and expected future impact of the downward pricing pressures highlighted on page 24. If the impact has been immaterial, please disclose that information here and on page 24. Critical Accounting Policies, page 94 12. We note that inventories constitute your largest asset and that inventory adjustments adversely impacted your 2024 gross margin. Given that the December 31, 2024 inventory balance is almost twice the amount of your annual cost of goods sold, it is not clear whether the asset balance includes a substantial amount of aged inventory. We note that you track the age of your inventory items (page F-9) and that obsolescence has been identified as a material risk (pages 28 and 30). Please provide a critical accounting policy disclosure that quantifies the extent to which your inventory asset balance includes products for which there were no material sales during the most recent quarter. Disclose the amounts of inventory on hand that you determined to be obsolete or unmarketable. Reconcile this data with your conclusion that the $287K inventory reserve at December 31, 2024 is adequate. Explain why none of your inventory has been classified as long-term. See Item 303(b)(3) of Regulation S-K. May 14, 2025 Page 4 Market Dynamics in Shoulder Arthroplasty, page 107 13. We note your statement that "ASCs have emerged as a low-cost site of care and ambulatory-based outcomes have been demonstrated to be positive relative to hospital-based outcomes." Please briefly describe the way ambulatory-based outcomes have been demonstrated to be positive relative to hospital-based outcomes, including any applicable metrics used to measure the relative outcomes. Independent Distributor Network, page 119 14. We refer to your disclosure here and on pages 20 and 102 that you rely on an independent distributor network comprised of 25 independent distributors with an aggregate of 140 trained agents to sell your implant systems to hospitals. Please also disclose whether you have entered into any agreements with the distributor network or independent distributors, and if so, please provide a brief description of the material terms of any such agreement. If material, please also file such agreement as an exhibit to the registration statement as required by Item 601(b)(10) of Regulation S-K, or explain to us why you believe you are not required to do so. Clinical Overview, page 120 15. We refer to your disclosure on page 121 that you have contributed to numerous publications since your founding. Please clarify in this section, including the table summarizing the select publications and studies, and in greater detail elsewhere in the registration statement to disclose whether you funded or sponsored the clinical studies and if your employees were involved in both the studies and publications. Intellectual Property, page 125 16. We note your statement that the estimated patent expiration dates you provided "should not be relied upon for any purpose." Please remove this statement as investors are entitled to rely on your disclosure. 17. We note your disclosure relating to your eleven issued U.S. patents, seven issued foreign patents, twelve pending U.S. non-provisional patent applications and seventeen pending foreign patent applications. Please expand your tabular disclosure to include each material pending patent application. For each material patent or patent application, please revise to include a more detailed description of the scope and technology for each patent or patent application, the type of patent protection (composition of matter, use, or process), and expiration dates. We also note that twelve issued U.S. patents are listed in the tabular disclosure of your owned patents. Please reconcile your disclosure accordingly. Competition, page 129 18. We note your disclosure throughout the registration statement that you currently offer highly differentiated shoulder implant systems for shoulder arthroplasty. We also refer to your disclosure here and on page 19 that you compete with large, multinational companies and smaller orthopedic companies, such as Arthrex, Enovis, Exectech, Johnson & Johnson, Smith & Nephew, Stryker, and Zimmer Biomet. Please revise your disclosure in this section to clarify whether any of your competitors also May 14, 2025 Page 5 offer alternatives to traditional glenoid implants and humeral stem technologies. Legal Proceedings, page 139 19. To the extent material, please provide a description of the factual basis alleged to underlie the counterclaim filed by Catalyst and the relief sought in the counterclaim. Please refer to Item 103(a) of Regulation S-K. Statements of Operations, page F-5 20. Based on your disclosures in Note 12, it appears that the cost of goods sold line item excludes depreciation and amortization expense. Please revise your presentation consistent with the guidance in SAB 11:B. You also disclosed in Note 1 that you reclassified depreciation expense on surgical instruments from cost of goods sold to selling, general and administrative expense for 2023 and since. Expand your disclosure to discuss your operating and sales process involving surgical instruments, including whether they are sold separately or in combination with your implant systems, or if they are distributed for free to surgeons and hospitals. Explain to us your consideration for their impact in revenue recognition, as well as your basis for reclassifying them from cost of goods sold. In that regard, we note instruments account as your largest property and equipment item as shown in Note 4. Revenue Recognition, page F-11 21. You disclose that in addition to your advanced implant system, your ecosystem is also comprised of ProVoyance preoperative planning technology, efficient instrument system, specialized support and surgeon-to-surgeon collaboration. Explain to us, and revise if necessary, whether any of these other components constitutes an additional performance obligation under ASC 606. General 22. Please provide us with supplemental 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. Please contact legal staff associated with the review of this filing to discuss how to submit the materials, if any, to us for review. May 14, 2025 Page 6 Please contact Al Pavot at 202-551-3738 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 Jane Park at 202-551-7439 with any other questions. Sincerely, Division of Corporation Finance Office of Industrial Applications and Services cc: Ross McAloon, Esq. </TEXT> </DOCUMENT>