# EDGAR Filing Document

**Accession Number:** 0001699350
**File Stem:** 0001699350-25-000020
**Filing Date:** 2025-12
**Character Count:** 14616
**Document Hash:** 2e9c9cff49980b0387ac261e12b0fd1d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001699350-25-000020.hdr.sgml**: 20251203

**ACCESSION NUMBER**: 0001699350-25-000020

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20251203

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251203

**DATE AS OF CHANGE**: 20251203

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** SHOULDER INNOVATIONS, INC.
- **CENTRAL INDEX KEY:** 0001699350
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 270538764
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-42771
- **FILM NUMBER:** 251544983

**BUSINESS ADDRESS:**
- **STREET 1:** 1535 STEELE AVENUE SW, SUITE B
- **CITY:** GRAND RAPIDS
- **STATE:** MI
- **ZIP:** 49507
- **BUSINESS PHONE:** 616-566-0286

**MAIL ADDRESS:**
- **STREET 1:** 1535 STEELE AVENUE SW, SUITE B
- **CITY:** GRAND RAPIDS
- **STATE:** MI
- **ZIP:** 49507

?xml version='1.0' encoding='ASCII'? si-20251203

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

___________________________________________

**FORM 8-K**

___________________________________________

**CURRENT REPORT**

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): **December 3, 2025**

___________________________________________

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| | | |
|:---|:---|:---|
| **SHOULDER INNOVATIONS, INC.** | **SHOULDER INNOVATIONS, INC.** | **SHOULDER INNOVATIONS, INC.** |
| (Exact name of registrant as specified in its charter) | (Exact name of registrant as specified in its charter) | (Exact name of registrant as specified in its charter) |
| **Delaware** | **001-42771** | **27-0538764** |
| (State or other jurisdiction of<br>incorporation) | (Commission File Number) | (IRS Employer<br>Identification No.) |
| **1535 Steele Avenue SW, Suite B** <br>**Grand Rapids, Michigan** | **1535 Steele Avenue SW, Suite B** <br>**Grand Rapids, Michigan** | **49507** |
| (Address of principal executive offices) | (Address of principal executive offices) | (Zip Code) |

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Registrant's telephone number, including area code: **(616) 294-1026**

**Not Applicable**

(Former name or former address, if changed since last report)

___________________________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐&nbsp;&nbsp;&nbsp;&nbsp;Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐&nbsp;&nbsp;&nbsp;&nbsp;Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐&nbsp;&nbsp;&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐&nbsp;&nbsp;&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| <u>Title of each class</u> | <u>Trading symbol</u> | <u>Name of each exchange on which registered</u> |
| Common Stock,$0.001 par value per share | SI | New York Stock Exchange |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ⌧

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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**Item 7.01.&nbsp;&nbsp;&nbsp;&nbsp;Regulation FD Disclosure.**

On December 3, 2025, Shoulder Innovations, Inc. (the "Company") issued a press release announcing its strategic partnership with Interventional Systems to introduce a robotic platform for shoulder arthroplasty. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

**Item 9.01&nbsp;&nbsp;&nbsp;&nbsp;Financial Statements and Exhibits.**

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| | | |
|:---|:---|:---|
| (d) | Exhibits: | Exhibits: |
| | 99.1 | <u>[Press Release of the Company, dated December 3, 2025.](ex-991pressrelease12325.htm)</u> |
| | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

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**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | |
|:---|:---|
| Dated: December 3, 2025 | SHOULDER INNOVATIONS, INC.<br>(Registrant) |
| | /s/ Jeffrey Points |
| | Jeffrey Points |
| | Chief Financial Officer |

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## Exhibit 99.1

**Exhibit 99.1**

**Shoulder Innovations Announces Strategic Partnership with INS to Introduce a Robotic Platform for Shoulder Arthroplasty**

*Partnership will Expand Shoulder Innovations' Disruptive Ecosystem with Advanced Enabling Technology, Complementing Surgeon and Patient Needs in the ASC* 

*Management to Participate in a Fireside Chat at the Piper Sandler 37*<sup>th</sup> *Annual Healthcare Conference Today at 8:30 a.m. ET*

**Grand Rapids, MI – December 3, 2025 –** Shoulder Innovations, Inc. (Shoulder Innovations, or the Company) (NYSE: SI), a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market, today announced a strategic partnership with Interventional Systems (INS), a developer of robotic solutions for minimally invasive surgery, to introduce a transformative shoulder-specific micro-robotic solution designed to further enhance shoulder surgical precision, workflow efficiency, and enable exciting, new clinical approaches in the total shoulder arthroplasty and reverse shoulder arthroplasty markets.

This partnership will broaden Shoulder Innovations' disruptive ecosystem with more advanced enabling technology. Once developed, this new robotic solution will integrate with the Company's ProVoyance platform to deliver a comprehensive enabling technology solution, with the goal of improving surgical accuracy and workflow, while meeting the needs of patients and surgeons across all sites of care, particularly ambulatory surgery centers (ASCs). To further support mobility and ease of implementation, the robot is designed to be transported directly into the operating room as a portable unit.

With this system, Shoulder Innovations plans to address many of the challenges associated with robotic surgery, including high implementation costs, difficult mobility, costly perioperative inefficiencies, and steep technical learning curves. Orthopedic shoulder surgeons, healthcare facilities, and patients are expected to benefit from a portable solution that facilitates streamlined and consistent surgical workflows, ease-of-use, and real-time adjustments during surgery.

"We are thrilled to see our innovations resonating with the market and driving rapid share gains," said Rob Ball, CEO of Shoulder Innovations. "Our team has helped deliver some of the most transformative advances in shoulder arthroplasty and we are applying that experience and capital raised through our recent IPO to introduce a finely tuned enabling technology platform for shoulder surgical care. While this latest addition will improve shoulder surgery in its current form, we are excited about how we can further reshape the marketplace as the true capabilities of our broader technology are developed and deployed. These solutions stand to transform every operating room into a robotic environment, leveraging a platform from INS already proven in other markets to maximize our ability to execute efficiently."

"INS has a strong track record of deploying our micro-robotic technology across multiple U.S. healthcare markets with large strategic partners. We identified the fast-growing shoulder arthroplasty market as our next step and Shoulder Innovations as the ideal partner," said Pedro Costa, Chief Strategy Officer of INS. "We are excited to work together to bring this technology

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to market and advance our shared goal of using micro-robotics to make procedures more efficient, precise, and cost-effective."

For additional information on Shoulder Innovations' partnership with INS, please see this <u>video</u>.

**About Interventional Systems**<br> Interventional Systems (iSYS Medizintechnik GmbH) is a medical device company developing innovative robotic solutions for minimally invasive surgery and percutaneous procedures. Its flagship product, Micromate™ is a versatile miniature robotic platform, cleared for 2D and 3D image-guided, needle-based procedures. INS is headquartered in Kitzbühel, Austria, with offices in Austria, Germany, and Portugal. Further information is available at <u>www.interventional-systems.com</u>.

**About Shoulder Innovations**

Shoulder Innovations is a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market, with a current offering of advanced implant systems for shoulder arthroplasty. These systems are a core element of Shoulder Innovations' ecosystem, which is designed to improve core components of shoulder surgical care – preoperative planning, implant design and procedural efficiency – to benefit each stakeholder in the care chain. Shoulder Innovations' ecosystem is also comprised of enabling technologies, efficient instrument systems, specialized support and surgeon-to-surgeon collaboration. Together, these elements seek to address the long-standing clinical and operational challenges in the shoulder surgical care market by delivering predictable outcomes, procedural simplicity, and efficiency across all sites of care.

**Forward-Looking Statements**<br> This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements often use words such as "believe," "expect," "anticipate," "intend," "estimate," "project," "outlook," "forecast," "target," "trend," "plan," "goal," or other words of comparable meaning or future-tense or conditional verbs such as "may," "will," "should," "would," or "could."

Statements concerning the Company's future are forward-looking statements, and are based on management's current expectations, assumptions and beliefs about the Company's business, financial performance, creation of long-term shareholder value, operating results, the industry in which the Company operates and possible future events. These statements include, but are not limited to, statements regarding the Company's anticipated growth prospects, future operating and financial performance, and the expected benefits from the new robotics system under development with the Company and INS. Forward-looking statements convey the Company's expectations, intentions, or forecasts about future events, circumstances, results, or aspirations. Forward-looking statements are not guarantees of future results and are subject to risks, uncertainties, assumptions and other important factors, which may change over time and many of which are beyond the Company's control, and which could cause the Company's actual results to materially and adversely differ from those expressed in any forward-looking statement, including (i) the Company's history of significant net losses; (ii) failure to manage the growth of the

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Company's business; (iii) the Company's inability to compete successfully against its existing or potential competitors; (iv) failure to develop, retain, or expand an effective dedicated commercial leadership team; (v) risks associated with litigation; (vi) the Company's dependence upon the adoption of its implant systems by hospitals, ambulatory surgery centers, surgeons and patients; (vii) the Company's ability to enhance its implant systems, expand its indications and develop and commercialize additional products in a timely manner; (viii) risks associated with the Company's third-party manufacturers and suppliers; (ix) demand forecasts for the Company's implant systems; (x) the Company's ability to demonstrate to shoulder specialists or key opinion leaders the merits of its implant systems; (xi) federal and state healthcare laws and government regulation and oversight over the Company's devices and operations; (xii) the Company's ability to obtain and maintain patent and other intellectual property protection over its products; (xiii) risks associated with the Company's common stock; and (xiv) the other important factors described in the Company's most recently filed Quarterly Report on Form 10-Q and subsequent other filings with the Securities and Exchange Commission.

These documents are available in the Investor Relations section of the Company's website at <u>www.shoulderinnovations.com</u> (information on the website is not incorporated by reference into this presentation and should not be considered part of this document).

You should not place undue reliance on forward-looking statements. The information in this press release is provided as of today's date only, and, except as required by federal securities law, the Company does not undertake to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changing circumstances or for any other reason after today.

**Contact** <br>Brian Johnston or Sam Bentzinger<br>Gilmartin Group LLC<br><u>ir@shoulderinnovations.com</u>

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