Business
Anika Continues to Expand Addressable Market for Tactoset® Injectable Bone Substitute with Additional 510(k) Clearance from FDA
Tactoset cleared by the FDA to be combined with autologous bone marrow aspirate, a core element for regenerative healing Anika reaches agreement to distribute
About this update from Anika Therapeutics Inc.
[{"type":"text","content":"Tactoset cleared by the FDA to be combined with autologous bone marrow aspirate, a core element for regenerative healing Anika reaches agreement to distribute the Marrow Cellution™ Bone Marrow Aspiration Needle in the U.S. and commences launch Launches enhanced Tactoset cannulas, which improve targeting and ease of use in a variety of foot and ankle procedures BEDFORD, Mass., April 03, 2023 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company focused on early intervention orthopedics, today announced that it has received an additional 510(k) clearance from FDA for Tactoset Injectable Bone Substitute. This new indication expands the use of Tactoset to be combined with autologous bone marrow aspirate (“BMA”). BMA is a rich source of various cellular and molecular components which have demonstrated positive effects on tissue regeneration in musculoskeletal injuries. This increases Tactoset’s commercial reach by combining BMA with Tactoset for the treatment of bone defects such as osteoporotic bone, cysts, and insufficiency fractures. Tactoset is an injectable, settable, calcium phosphate-based bone graft substitute that incorporates Anika’s core hyaluronic acid (HA) technology. The HA component of Tactoset makes the product highly flowable, easily injectable, and able to interdigitate into trabecular bone architecture with improved handling characteristics compared to competitive products. Once injected, Tactoset hardens and mimics the properties of normal trabecular bone initially before remodeling into healthy bone over time. “Combining Tactoset with BMA gives surgeons the ability to better address the needs of patients where healing is a concern, such as areas of the body with poor vascularity,” said Anil Ranawat, MD, Chief, Hip and Knee Division of Sports Medicine Institute, Hospital for Special Surgery, New York, NY. “Mesenchymal stem cells (MSCs) found within marrow play a role in bone defect repair by differentiating to become bone-forming osteoblasts and aiding in the remodeling processes.” As Anika continues to focus on early intervention orthopedics with regenerative solutions, offering a novel product with a BMA solution is a foundational component of a regenerative platform and a key catalyst for leveraging a patient’s own biology. To that end, Anika has signed an agreement to...