#United States #Boston #Hyalex Orthopaedics #HYALEX Freestyle #ICRS Congress

Revolutionary Developments in Knee Implant Technology

In an exciting advancement for orthopedic medicine, Hyalex Orthopaedics, known for its cutting-edge joint preservation technologies, will be presenting crucial findings from its first-in-human clinical studies on the HYALEX Freestyle Knee Implant. These findings will be showcased at the International Cartilage Regeneration and Joint Preservation Society (ICRS) Congress 2025, which is set to take place from October 11 to 14, 2025, in Boston, Massachusetts.

Overview of the HYALEX Freestyle Knee Implant

The HYALEX Freestyle Knee Implant is designed to cater to patients suffering from painful knee cartilage lesions and early osteoarthritis, enabling them to return to an active lifestyle. This innovative implant mimics the function and structure of natural cartilage, setting a new benchmark in the treatment of knee injuries. The company’s groundbreaking approach is rooted in its proprietary HYALEX Hydrosurf™ materials platform, which has garnered attention within the medical community for its potential to transform joint restoration methods.

Presentation Details

The presentation will feature preliminary findings from the U.S.-based Early Feasibility Study (EFS) alongside a first-in-human trial conducted in Poland. The session titled First-in-human Study of a Synthetic Cartilage Implant to Treat Painful Knee Cartilage Lesions will be led by Dr. Sabrina M. Strickland, an orthopedic surgeon affiliated with the Hospital for Special Surgery in New York. Here are the key details:

• - Session: 14.3 “Fixation Integration”
• - Date/Time: Monday, October 13, 2025, at 3:45 PM Eastern Time
• - Presentation: Monday, October 13, 2025, at 4:10 PM Eastern Time

Expansion of Clinical Trials

Hyalex Orthopaedics recently announced an expansion of its U.S. EFS and its ex-U.S. first-in-human study into a global pivotal trial that is currently enrolling participants. This expansion was made possible following the U.S. Food and Drug Administration’s (FDA) approval of Hyalex’s supplemental Investigational Device Exemption (IDE) application for the Freestyle Knee Implant. This major regulatory milestone signifies the company's progress in introducing its next-generation orthopedic solutions to patients worldwide.

Looking Forward: The Impact on Patient Care

With the upcoming presentation at the ICRS Congress 2025, Hyalex aims not only to share vital data but to pave the way for a broader discourse on the future of knee treatments. By leveraging its advanced materials and innovative designs, the company is committed to enhancing the quality of life for patients facing the challenges of knee pain and mobility issues.

To learn more about the HYALEX Freestyle Knee EFS, interested parties can visit clinicaltrials.gov.

About Hyalex Orthopaedics

Founded and headquartered in Lexington, Massachusetts, Hyalex Orthopaedics develops innovative joint preservation technologies aimed at treating diseased and damaged joints. Its advanced HYALEX Hydrosurf™ materials platform is fortified by over 17 patents and trademarks globally, underlining the company’s commitment to innovation in the medical device sector.

For further details, visit www.hyalex.com.

This groundbreaking study underscores Hyalex's pivotal role in shifting the landscape of orthopedic treatment and highlights its mission to empower patients by enhancing their mobility and quality of life.