Anika Therapeutics receives additional FDA clearance for injectable bone substitute
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Key takeaways:
- Anika Therapeutics has announced additional FDA clearance of its Tactoset injectable bone substitute.
- Tactoset is now indicated for use with autologous bone marrow aspirate.
Anika Therapeutics Inc. has announced additional FDA 510(k) clearance of its Tactoset injectable bone substitute, which is now indicated for use with autologous bone marrow aspirate, according to a press release.
A combination of the Tactoset injectable bone substitute with autologous bone marrow aspirate (BMA) may facilitate improved healing for patients with osteoporosis, cysts and insufficiency fractures, according to the release.
“Tactoset, a regenerative solutions product, continues to be a key growth driver within our joint preservation and restoration portfolio, as it is positioned to address unmet needs in patients with insufficiency fractures and poor-quality bone including cysts where augmenting hardware, such as suture anchors, gives surgeons additional confidence in their repair constructs,” Cheryl R. Blanchard, PhD, president and CEO of Anika Therapeutics, said in the release. “This new FDA clearance for mixing Tactoset with BMA provides a product with improved regenerative capacity and showcases Anika’s commitment to developing solutions that are meaningful to our customers and their patients,” Blanchard said.
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