Data from First-in-Human Clinical Studies of the Hyalex Freestyle Knee Implant to be Presented at the ICRS Congress 2025

LEXINGTON, Mass., Oct. 6, 2025 /PRNewswire/ -- Hyalex Orthopaedics, a privately held medical device company developing joint preservation technologies based on the transformative HYALEX Hydrosurf^™ materials platform, today announced that data from the company's first-in-human clinical studies of its HYALEX Freestyle^™ Knee Implant will be highlighted in a presentation at the International Cartilage Regeneration and Joint Preservation Society (ICRS) Congress 2025. Presented data will include findings from the company's U.S.-based Early Feasibility Study (EFS) and its Poland-based first-in-human trial. The ICRS Congress 2025 is taking place October 11-14, 2025, in Boston, MA.

Details of the HYALEX Freestyle^™ Knee Implant presentation are as follows:

Title:  First-in-human Study of a Synthetic Cartilage Implant to Treat Painful Knee Cartilage Lesions

Presenting Author:  Sabrina M. Strickland, M.D., Orthopedic Surgeon at Hospital for Special Surgery, New York, NY.

Session:  14.3 "Fixation & Integration"

Session Date/Time:  Monday, October 13, 2025, at 3:45 p.m. Eastern Time

Presentation Date/Time:  Monday, October 13, 2025, at 4:10 p.m. Eastern Time

The HYALEX Freestyle Knee Implant is designed to enable patients suffering from cartilage damage and early osteoarthritis of the femoral condyle(s) to regain an active lifestyle by replicating the function and structure of natural cartilage. Dr. Strickland will present preliminary findings from the company's first-in-human studies of the HYALEX Freestyle Knee Implant, which represent the first clinical applications of the transformative implant technology.

Hyalex recently announced that it is expanding its U.S.-based EFS, as well as its ex-U.S. first-in-human study, to a global pivotal trial, which is currently enrolling patients. This trial expansion was allowed based on the U.S. Food and Drug Administration's approval of Hyalex's supplemental Investigational Device Exemption (IDE) application for the HYALEX Freestyle Knee Implant, supporting the company's continued efforts to bring this next-generation orthopedic solution to patients in need. 

To learn more about the HYALEX Freestyle Knee EFS, please visit https://clinicaltrials.gov/study/NCT06368700.

About Hyalex Orthopaedics

Hyalex is a privately held medical device company headquartered in Lexington, MA, developing transformational joint preservation technologies for diseased and damaged joints. The HYALEX Hydrosurf^™ materials platform is protected by more than 17 patents and trademarks worldwide. The HYALEX Freestyle Knee system has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration for a clinical trial in the United States.

For more information: www.hyalex.com

Contact Information:

Tim Brons
Vida Strategic Partners (media)
646-319-8981
[email protected]

SOURCE Hyalex Orthopaedics