Acuitive Technologies' CITREPORE Receives FDA Clearance as Novel Bone Void Filler
Key Insights
Acuitive Technologies (search) secured FDA 510(k) clearance for CITREPORE (search), a synthetic bioactive bone void (search) filler utilizing CITREGEN (search)® technology, designed for orthopedic procedures.
CITREPORE (search) is engineered to resorb predictably, facilitating bone regeneration by releasing citrate, which enhances bone metabolism and formation during the healing process.
The unique bone void (search) filler features over 80% porosity, enabling high fluid absorption, and is available in various shapes and sizes for versatile surgical applications.
Acuitive Technologies (search), Inc. has announced the FDA 510(k) clearance of CITREPORE (search), a synthetic bioactive bone void (search) filler. This innovative product leverages Acuitive's patented CITREGEN (search)® biomaterial technology and is designed for use in orthopedic procedures to fill voids and gaps in the skeletal system.
Mechanism of Action
CITREPORE (search) functions by being resorbed predictably after placement, allowing it to be replaced by the patient’s own bone. A key feature of CITREPORE is its release of citrate, a critical intermediate in the Krebs cycle, which plays a vital role in bone metabolism and formation. Research indicates that citrate stimulates human stem cells, enhancing genetic signaling for metabolism, osteoinduction, osteoconduction, and extracellular matrix production.
Richard Tran, PhD, VP of Research at Acuitive Technologies (search), highlighted research from the University of Galway and Colorado State University, noting that citrate is highly concentrated in native bone and closely associated with bone metabolism and formation.
Key Features and Benefits
CITREPORE (search) offers several notable features:
- High Porosity: Greater than 80% porosity allows for exceptional absorption and retention of fluids, including saline, autogenous blood, and bone marrow aspirate.
- Predictable Resorption: The material resorbs predictably, mitigating chronic inflammation.
- Osteoconductive and Bioactive: CITREPORE supports bone growth and actively participates in the healing process.
- Versatile Application: Available in various pre-formed shapes and sizes, CITREPORE can be easily customized during surgery.
Clinical Application
CITREPORE (search) is indicated for filling voids or gaps in the skeletal system (extremities and pelvis) that do not compromise the stability of the bony structure. This makes it suitable for a range of orthopedic procedures where bone void (search) filling is necessary.
Acuitive Technologies' Perspective
CITREPORE (search) represents a significant addition to Acuitive’s product line, offering a unique approach to bone void (search) filling by providing citrate to support the natural healing process. The company focuses on developing innovative biomaterials and orthopedic devices that work in harmony with the body's natural healing mechanisms.