Anika Therapeutics (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid ("HA") technology, today announced that its HA-based bone void filler received 510(k) clearance from the FDA and is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis), which are not intrinsic to the stability of the bone, created during surgery or resulting from traumatic injury. The bone void filler, which is composed of a synthetic, biocompatible bone graft substitute material, is injected into a void, hardens at body temperature, and is then resorbed and replaced by the growth of new bone during the healing process.
Over one million musculoskeletal procedures performed in the U.S. involve bone void filling, also known as bone grafting,, and such procedures are most commonly required for spinal fusion, trauma, and revision total joint replacement procedures. We estimate the current market size for treating tibial plateau fractures, stress fractures around joints, and decompression of necrosed bone to be around $300 million.
"We’re proud to announce the U.S. regulatory clearance of our innovative injectable HA-based bone void filler, which represents the U.S. commercial debut of our robust regenerative medicine portfolio," said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. "The rapid 510(k) clearance is a testament to Anika’s operational and strategic expertise. In addition, this new treatment represents a promising revenue growth opportunity, and advances our mission to provide innovative treatments to patients that address the full continuum of orthopedic care."
While the use of autologous bone or autograft has been the gold standard of treatment for bone grafting, the increased risk of procedural complications has prompted a shift towards alternate treatments1, such as synthetic, resorbable bone graft substitute materials. According to Dr. John Tierney, D.O., an orthopedic surgeon affiliated with New England Baptist Hospital, who has worked with our bone repair treatment: "Anika’s 510(k) clearance allows for the marketing of one of only a handful of bone graft substitutes that can be administered in a minimally invasive manner. It offers physicians an additional option for treating bone defects or injuries, without the need for expensive and high risk surgeries, while also reducing the operating room time spent on each case." This positive physician feedback enhances our excitement about bringing this much-needed treatment to patients in the U.S.
About Bone Repair Treatment
Anika’s bone repair treatment is an injectable, HA-based, settable osteoconductive calcium phosphate bone graft substitute material, and is indicated for filling bone voids or defects of the skeletal system (i.e., extremities and pelvis) that are not intrinsic to the stability of bone structure. It is provided in a kit with two components (an aqueous solution in a pre-loaded syringe and a dry powder) that must be mixed, intra-operatively using the supplied mixing system, to form a cohesive paste, prior to administration. Anika’s bone void filler is provided sterile for single use in volumes ranging from 1.5cc to 4cc.
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 cartilage 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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