December 04, 2018
BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that it has resumed global distribution of its solid HA-based treatments, including HYALOFAST, a biodegradable, HA-based cartilage repair scaffold, after a voluntary, non-safety related recall in the second quarter of 2018. Following recent regulatory approvals in Thailand, the United Arab Emirates and Colombia, HYALOFAST has a commercial footprint in approximately 15 countries.
“Since May, our quality and operations teams have worked tirelessly to get us back on line to resume shipments before the end of this year, and we’ve delivered on that promise,” said Joseph Darling, President and CEO, Anika Therapeutics. “We are excited to bring the benefits of these products back to the patients who need them. HYALOFAST, in particular, is a truly remarkable advancement in the treatment of cartilage defects due to its flexible minimally-invasive means of application and adaptive fit to individual patient needs. These features have led to an overwhelmingly positive physician response to the therapy and illustrate its significant advantages over traditional microfracture surgeries and conventional scaffolds.”
HYALOFAST is a non-woven, single-step, off-the-shelf, biodegradable HA-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. To date, the Company has seen HYALOFAST used to treat more than 15,000 patients internationally and has compiled strong eight-year patient follow-up data. HYALOFAST is pending regulatory submission in the United States and its FastTRACK Phase III trial is currently enrolling patients across the U.S. and Europe.
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.
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