FDA Grants Additional Clearance to Anika’s Tactoset Injectable Bone Substitute

Anika Therapeutics Inc. has received an additional 510(k) clearance from U.S. Food and Drug Administration (FDA) for Tactoset Injectable Bone Substitute. This new indication expands the use of Tactoset to be combined with autologous bone marrow aspirate (BMA), a rich source of various cellular and molecular components that have demonstrated positive effects on tissue regeneration in musculoskeletal injuries. This increases Tactoset’s commercial reach by combining BMA with Tactoset for treating 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, M.D., 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 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 distribute the Marrow Cellution Bone Marrow Aspiration Needle in the United States. This system utilizes a patented technology that combines aspiration and cannula motion to maximize cell recovery, while eliminating the need to remove materials from the sterile field for centrifuge processing. This drives efficiencies and mitigates risk to the patient compared to competitive systems. Finally, Anika also recently launched enhanced Tactoset delivery cannulas, which improve ease of use and simplify the targeting and delivery of the material, especially in foot and ankle procedures.
 
“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,” Anika Therapeutics President/CEO Cheryl R. Blanchard, Ph.D., said. “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. It also further reinforces our confidence that we can increase Tactoset’s addressable market to well beyond $100 million by creating a new market for hardware augmentation. The BMA clearance, together with the release of enhanced cannulas and our distribution of the Marrow Cellution Bone Marrow Aspiration Needle, highlight our continued investment in differentiated products that expand and reinforce our regenerative solutions portfolio and enhance growth and profitability for our shareholders.”
 
With the continued expansion of Tactoset, Anika is extending its track record of innovation and execution through the development of numerous new indications. In late 2021, Tactoset achieved approval for use in hardware augmentation, such as soft tissue anchors.
 
Anika Therapeutics is a global joint preservation company that creates and delivers advancements in early intervention orthopedic care. Leveraging its core expertise in hyaluronic acid and implant solutions, the firm partners with clinicians to provide minimally invasive products that restore active living for people. Its focus is on high opportunity spaces within orthopedics, including osteoarthritis pain management, regenerative solutions, sports medicine and arthrosurface joint solutions. Anika’s products are delivered in key sites of care, including ambulatory surgery centers. Anika’s global operations are headquartered outside of Boston.