Initial Results of Hyalex Freestyle Knee Implant First-in-Human Clinical Studies to be Presented at the ISAKOS Congress 2025
LEXINGTON, Mass., May 29, 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 initial results of the company's first-in-human clinical studies of its Freestyle Knee Implant will be highlighted in a presentation at the International Society of Arthroscopy, Knee Surgery, and Orthopaedic Sports Medicine (ISAKOS) Congress 2025. Presented data will include findings from a Poland-based first-in-human trial and a U.S.-based Early Feasibility Study (EFS). The ISAKOS Congress 2025 is taking place June 8-11, 2025, in Munich, Germany.
Details of the HYALEX Freestyle™ Knee Implant presentation are as follows:
Title: First-in-Human Study of Biomimetic Synthetic Cartilage Implant to Treat Painful Knee Cartilage Lesions
Presenting Author: Marcin E. Domzalski, M.D., professor at Veteran's Memorial Hospital of Medical University of Lodz in Konstantynów Lódzki, lódzkie, Poland.
Session: Scientific Papers
Date/Time:Tuesday, June 10, 2025, 2:55 – 3:00 p.m. Central European Summer 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. Professor Domzalski will present preliminary findings from the company's first-in-human studies of the HYALEX Freestyle Knee Implant, which represents the first clinical applications of the transformative implant technology.
Hyalex recently announced that it intends to expand its U.S.-based EFS, as well as its ex-U.S. first-in-human study, to a global pivotal study. 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
tbrons@vidasp.com
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SOURCE Hyalex Orthopaedics