At the end of 2017, Anika Therapeutics, Inc. announced FDA 510(k) clearance of its injectable hyaluronic acid (HA) based bone void filler.
FDA Clears Anika Therapeutics’ HA Bone Void Filler
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Secondary
Hyaluronic acid is a component of synovial fluid that acts as a joint lubricant during shear stress and a shock absorber during compressive stress.
According to the company’s December 27, 2017 announcement, the 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.”
Anika’s CEO Charles Sherwood, Ph.D., said the new treatment represents a “promising revenue growth opportunity,” for the company.
The company noted that while the use of autologous bone has been the gold standard of treatment for bone grafting, “the increased risk of complications has caused a shift towards alternate treatments, such as synthetic, resorbable bone graft substitute materials.”
According to John Tierney, D.O., an orthopedic surgeon affiliated with New England Baptist Hospital, who has worked with the company’s 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.”
Over the past 25 years, the company says its therapies have been used in over 25 million treatments. The company’s orthopedic medicine portfolio includes Orthovisc, Monovisc, and Cingal, which replenishing depleted HA, and Hyalofast, a solid HA-based scaffold to aid cartilage repair and regeneration.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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