Bone Solutions’ Mg OSTEOCRETE and Mg OSTEOINJECT Receive FDA Clearance for Pediatric Use in Patients Aged Six and Older

COLLEYVILLE, Texas--(BUSINESS WIRE)--Bone Solutions Inc., a Colleyville-based orthobiologics company specializing in magnesium-based technologies, announced that the U.S. Food and Drug Administration (FDA) has granted pediatric clearance for its Mg OSTEOCRETE and Mg OSTEOINJECT products. The clearance allows use of the technologies in pediatric patients aged six years and older.

This expanded indication highlights the adaptability of Bone Solutions’ proprietary magnesium-based platform, particularly in the Sclerograft procedure—a minimally invasive outpatient technique for treating unicameral bone cysts. The procedure involves chemical curettage of the cyst wall with doxycycline, followed by injection of Mg OSTEOINJECT, a low-viscosity bone graft substitute. Mg OSTEOINJECT is designed to fill bone voids or defects in the extremities or pelvis resulting from tumor or cyst removal, trauma, or subchondral cystic changes due to osteoarthritis.

“We’re thrilled to bring this innovative, minimally invasive solution to the pediatric market,” said Drew Diaz, CEO of Bone Solutions Inc. “This clearance means children can receive effective treatment and return home faster than with traditional methods. Our mission remains focused on enhancing patient outcomes through advanced magnesium-based orthopedic technologies.”

What sets Mg OSTEOCRETE and Mg OSTEOINJECT apart is their magnesium oxide-based formulation, which initiates a crystallization reaction with phosphate compounds to deliver optimal osteoconductivity. This promotes osteoblast activity, including cell adhesion, proliferation, and extracellular matrix formation—key factors in bone regeneration.

Beyond clinical performance, these products are drillable and offer exceptional handling properties. After less than a minute of mixing, the material becomes moldable or injectable, demonstrating cohesive adhesion and radiopacity—making it highly suitable for surgical use.

Mg OSTEOCRETE and Mg OSTEOINJECT are available for immediate use in surgical centers and healthcare facilities nationwide.

Bone Solutions Inc. is a medical device company committed to improving orthopedic outcomes through biologically safe, fully resorbable magnesium-based implants. The company continues to expand its FDA-cleared platform with new technologies aimed at simplifying complex procedures and reducing healthcare costs.

Sclerograft is a registered trademark (U.S. Patent 12,090,065) of Shankar Rajeswaran M.D., LLC.