Acuitive Technologies Gains FDA Clearance for Synthetic Bioactive Bone Void Filler

The U.S. Food and Drug Administration has granted 510(k) marketing clearance to Acuitive Technologies Inc. for CITREPORE, a synthetic bioactive bone void filler that features the company’s patented CITREGEN biomaterial technology. Following placement in a bony void, CITREPORE is resorbed predictably and replaced by the patient’s bone, providing Citrate to guide the healing process metabolically.

Highlights of the CITREPORE Synthetic Bone Void Filler include:

• Greater than 80% porosity with the ability to absorb and retain fluids such as saline, autogenous blood, and bone marrow aspirate;
• Resorbs predictably while mitigating chronic inflammation;
• Is both osteoconductive and bioactive;
• Offered in various pre-formed shapes and sizes. It can be cut or morselized by pulling it apart by hand or with cutting instruments routinely available in the OR
• Indicated for voids or gaps in the skeletal system (extremities and pelvis) that are not intrinsic to bony structure stability

Richard Tran, Ph.D., vice president of Research at Acuitive Technologies, cites recent research from the University of Galway and Colorado State University that found Citrate—a critical intermediate in the Krebs cycle—to be “highly concentrated in native bone and is closely associated with bone metabolism and formation. In response to citrate, human stem cells increase genetic signaling for metabolism, osteoinduction, osteoconduction, and extracellular matrix production.”¹

CITREPORE provides a unique opportunity for its use in numerous orthopedic procedures. CITREPORE is reportedly the only bone void filler product that provides Citrate to support the natural healing process.

Allendale, N.J.-based Acuitive Technologies is a medical technology company developing biomaterials and orthopedic devices that participate in musculoskeletal tissues’ natural healing process while addressing current biomaterials’ shortcomings.

References
¹ A. Thirumaran,  M.N. Doulgkeroglou,  M. Sankar, J.T. Easley, B. Gadomski, A. Poudel, M. Biggs. Bioactive Materials 41 (2024), pp 207-220.