Colleyville, Texas, July 13, 2022 /OrthoSpineNews/— Bone Solutions Inc. (BSI), a Colleyville, Texas-based orthobiotechnology company, today announced that it has received FDA 510(k) clearance for expanded indications for its Mg OSTEOINJECT. Mg OSTEOINJECT is the first drillable, adhesive, and injectable bone filler in the United States to incorporate magnesium, an essential component for bone health and development.
The expanded indication includes the use of the material as an adjunct to hardware fixation by supporting bone fragments during surgery. Mg OSTEOINJECT based on magnesium showed an anchoring force nearly 30% higher than traditional PMMA.1
Mg OSTEOINJECT also provides a minimally invasive treatment option for insufficiency and micro-fractures via percutaneous skeletal fixation. The adhesive properties and unique resorption profile of Mg OSTEOINJECT provide stability, increased cell proliferation and advanced mineralization which result in improved bone regeneration in a wide range of orthopedic applications.
Mg OSTEOINJECT is currently being distributed to surgical facilities and centers nationwide for immediate clinical use.
About Bone Solutions Inc.
Bone Solutions Inc. (“BSI”) is a medical device company dedicated to improving clinical outcomes through biologically safe and fully resorbable magnesium-based orthopedic implant solutions, with an emphasis on complex procedures and cost reduction. The company is developing various new orthopedic technologies within its FDA-approved magnesium-based platform.
1Bertone, AL; DeMaria, MG; Johnson, AL; Weisbrode, SE; Kowaleski, MP, Comparative Orthopedic Research and Bone Laboratories, College of Veterinary Medicine, The Ohio State University, Columbus, OH, 52nd Annual Meeting of the Orthopedic Research Society, Document No: 0876 “The degradable magnesium cement adheres to the stainless steel screws in the bone.”
“Mg OSTEOINJECT” is a registered trademark of Bone Solutions, Inc.
Media Contact: Paul Williams, MediaLine Communications, 310-569-0023
Company Contact: Drew Diaz, Bone Solutions Inc., 817-809-8850