Not yet approved in the US but looks like a study is starting soon.
Anika Therapeutics, Inc., (NASDAQ: ANIK) announced the enrollment of the first patient in its pivotal HYALOFAST® FastTRACK Phase III clinical study. http://www.streetinsider.com/Corporate+News/Anika+Therapeutics+(ANIK)+Enrolls+First+Patient+in+FastTRACK+Phase+III+HYALOFAST+Study/11180428.htmlDec 29, 2015: The HYALOFAST FastTRACK study is a prospective, randomized, active treatment-controlled, evaluator-blinded multicenter study to establish the superiority of a hyaluronan-based scaffold (HYALOFAST®) with autologous bone marrow aspirate concentrate (BMAC) in the treatment of articular knee cartilage defect lesions. The study will enroll approximately 200 patients at up to 30 sites in the U.S. and Europe.
HYALOFAST is a biodegradable scaffold that is used to enable cartilage regeneration in patients suffering from cartilage defects. European clinical data demonstrates that patients treated with HYALOFAST plus autologous BMAC in a one-step, minimally invasive arthroscopic procedure were able to successfully regenerate hyaline-like cartilage. HYALOFAST is CE Marked in Europe and is available commercially in 18 countries with more than 6,000 uses to date.
“HYALOFAST is an exciting, emerging product in our pipeline, representing Anika’s expansion into the rapidly evolving field of regenerative medicine in the orthopedics space,” said Dr. Charles H. Sherwood, President and Chief Executive Officer of Anika Therapeutics. “We have seen very positive clinical outcomes in the treatment of knees and ankles internationally using HYALOFAST. We believe the FastTRACK study will give us the pivotal clinical data to support a marketing application for an indication for the repair of cartilage defects of the knee in the U.S.”
HYALOFAST® Hyaluronic Acid Based Matrix Supports Regeneration of Hyaline-like Cartilage: http://www.anikatherapeutics.com/products/orthobiologics/hyalofast/"HYALOFAST is a non-woven 2×2 cm or 5×5 cm biodegradable hyaluronic acid-based scaffold for hyaline-like cartilage regeneration. It is used for the entrapment of mesenchymal stem cells (MSCs) to arthroscopically treat both chondral and osteochondral lesions in the knee and ankle."
