Anika Continues to Expand Addressable Market for Tactoset® Injectable Bone Substitute with Additional 510(k) Clearance from FDA

Tuesday, April 04, 2023

Anika Therapeutics, a global company focused on early intervention orthopedics, has announced an additional 510(k) clearance from the FDA for its Tactoset Injectable Bone Substitute. This clearance allows for the combination of Tactoset with autologous bone marrow aspirate (BMA), which contains cellular and molecular components known for their positive effects on tissue regeneration in musculoskeletal injuries. The expanded indication enables the use of Tactoset in conjunction with BMA for the treatment of various bone defects, including osteoporotic bone, cysts, and insufficiency fractures.

Tactoset is a calcium phosphate-based bone graft substitute that incorporates Anika's core hyaluronic acid (HA) technology. The inclusion of HA makes Tactoset highly flowable, easily injectable, and capable of integrating into trabecular bone architecture with improved handling compared to competing products. Once injected, Tactoset hardens and mimics the properties of normal trabecular bone before gradually remodeling into healthy bone over time.

Surgeons see the combination of Tactoset with BMA as a valuable solution for patients with compromised healing, particularly in areas of the body with poor vascularity. Mesenchymal stem cells (MSCs) found in the marrow play a crucial role in bone defect repair by differentiating into bone-forming osteoblasts and assisting in the remodeling process.

In line with Anika's focus on early intervention orthopedics and regenerative solutions, the company has signed an agreement to distribute the Marrow Cellution Bone Marrow Aspiration Needle in the U.S. This system maximizes cell recovery through a patented technology that combines aspiration and cannula motion, eliminating the need to remove materials from the sterile field for centrifuge processing. This improves efficiency and reduces risk for the patient compared to other systems. Anika has also introduced enhanced Tactoset delivery cannulas, simplifying the targeting and delivery of the material, particularly in foot and ankle procedures.

Cheryl R. Blanchard, President and CEO of Anika Therapeutics, emphasizes Tactoset's role as a key growth driver within their joint preservation and restoration portfolio. The combination of Tactoset with BMA enhances its regenerative capacity, expanding its addressable market and providing surgeons with greater confidence in repair constructs, especially when augmenting hardware. The new FDA clearance, along with the launch of enhanced cannulas and the distribution agreement for the Marrow Cellution system, reflects Anika's commitment to developing unique solutions that meet customer needs and contribute to growth and profitability.

Anika's continued expansion of Tactoset demonstrates their dedication to innovation and execution in the orthopedic field. The product has received recognition and an ACE Award from the American Orthopaedic Society for Sports Medicine (AOSSM) for its approval in hardware augmentation, such as soft tissue anchors. These new launches further broaden the indications and support for this innovative product.


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