Acuitive Technologies Receives FDA 510(k) Clearance for CITREPORE™, A New Synthetic Bioactive Bone Void Filler for Orthopedic Procedures
ALLENDALE, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) — Acuitive Technologies, Inc. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market CITREPORE, a unique synthetic bioactive bone void filler, using their 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 exceptional 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
- It is offered in an array of pre-formed shapes and sizes and can be cut or morselized by pulling it apart by hand or with cutting instruments routinely available in the OR
- It is indicated for voids or gaps in the skeletal system (extremities and pelvis) that are not intrinsic to the stability of the bony structure
Richard Tran, PhD, VP of Research at Acuitive Technologies, points to recent research from the University of Galway and Colorado State University, finding that “Citrate, a critical intermediate in the Krebs cycle, is 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 is an exciting addition to Acuitive’s product portfolio and provides a unique opportunity for its use in numerous orthopedic procedures. CITREPORE is the only bone void filler product that provides Citrate to support the natural healing process.
About Acuitive Technologies
Acuitive is a medical technology company developing innovative biomaterials and orthopedic devices that participate in the natural healing process of musculoskeletal tissues while addressing the shortcomings of current biomaterials. More information is available at www.acuitivetech.com.
A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Acuitive does not dispense medical advice and recommends that surgeons be trained in the use of any product before using it in surgery.
A surgeon must always refer to the package insert, product label and/or instructions for use before using any of Acuitive’s products. Please contact Acuitive directly if you have questions about the availability of products in your area.
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.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/83c31f45-f0de-46cf-b2c6-10312d1ec26e
