Tactoset Injectable Bone Substitute Now FDA Cleared for Hardware Augmentation

510(k) clearance expands the capability of Tactoset for augmenting suture anchor fixation

BEDFORD, Mass., Sept. 14, 2021 (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 by the FDA for Tactoset Injectable Bone Substitute. This new indication expands the use of Tactoset to include augmentation of hardware and the support of bone fragments during surgical procedures. This expands Tactoset’s addressable market to include augmentation of suture anchor fixation in addition to treatment of skeletal system defects such as insufficiency fractures.

“Poor quality bone and suture anchor pullout is a real problem for patients in our industry, and surgeons can now use Tactoset to augment their suture anchor fixation and reinforce it from inside the bone. We’ve taken our proprietary HA-enhanced Tactoset and opened an untapped market in the area of augmentation of hardware including soft tissue suture anchors,” says Ben Joseph, Vice President of US Commercial and Global Brand Management at Anika. “Tactoset is a key growth driver within our current regenerative solutions portfolio, and this augmentation clearance highlights the transformation of Anika as a joint preservation and restoration company. We have big plans for Tactoset in the market and expect to have additional indications coming in the future.”

Tactoset is a calcium phosphate based, biocompatible 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 trabecular bone architecture with overall improved handling characteristics compared to competitive products. Once injected, Tactoset hardens and mimics the properties of normal trabecular bone initially and remodels into healthy bone over time.

Since its launch in Q4 of 2019, Tactoset has been used for the treatment of bone voids, insufficiency fractures, and other skeletal defects, often performed in an outpatient surgical setting. With this expanded indication, surgeons can now use Tactoset in situations where augmenting hardware and/or bone fragments due to insufficient bone quality may be beneficial to their patients. Tactoset has been shown to increase the pull-out strength of a screw-in suture anchor two-fold¹ in an osteoporotic bone model when augmented with the cured Tactoset compared to a suture anchor alone.