Regenerative medicine company Collagen Matrix Inc stated on Friday that it has passed US FDA 510(k) market clearance for its innovative line of Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix through its Spine business unit.
The company disclosed that the Bioactive Moldable Bone Graft Matrix is a perfect trio of anorganic carbonate apatite bone mineral, 45S5 bioactive glass and highly purified Type I collagen that can be moulded into putty for filling irregular defect sites. The matrix is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. OssiMend Bioactive Moldable is slowly resorbed and replaced by new bone tissue during the natural healing process.
In addition, the matrix is available in various sizes including a unique 25cm long, 40cc strip for complex spine fusion surgeries, revealed the company.
Following the US FDA clearance, the company said OssiMend Bioactive Moldable joins its wide range of implantable collagen and mineral based medical devices.
AbbVie's ELAHERE receives full US FDA approval
Johnson & Johnson's OPSYNVI receives US FDA approval
Outlook Therapeutics receives positive CHMP opinion for ONS-5010 in wet AMD treatment
Human Immunology Biosciences receives ODD from FDA for felzartamab
Eton Pharmaceuticals acquires PKU GOLIKE, expanding rare disease portfolio
Vertex receives FDA clearance for VX-407 Investigational New Drug Application for ADPKD
Phanes Therapeutics receives FDA Fast Track designation for PT886
Bio-Thera Solutions signs new licensing agreement with SteinCares
FDA accepts resubmission of Citius Pharmaceuticals, Inc's BLA for LYMPHIR
GSK Plc reports positive Phase III Jemperli data for endometrial cancer
ImmVira receives FDA Fast Track designation for MVR-T3011 IT