Anika Therapeutics files IDE with FDA for Hyalofast

Anika Therapeutics, a manufacturer of products for tissue protection, healing and repair based on hyaluronic acid, has filed an investigational device exemption with the FDA to conduct a phase III clinical trial for Hyalofast, a biodegradable, 3D, HA-based scaffold with autologous bone marrow aspirate concentrate.

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“We are excited to progress Hyalofast toward commercialization in the United States,” said Charles H. Sherwood, Ph.D., Anika’s president and CEO. “We have seen very positive clinical outcomes from Hyalofast in the treatment of knees and ankles internationally, which bodes well as we advance the product in the clinic domestically. As the only HA-based scaffold for regeneration, Hyalofast has distinct advantages over other products constructed of different biomaterials or synthetics. We look forward to commencing our Phase III pivotal trial later this year.”

 

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