Atreon Orthopedics Gains FDA 510(k) Clearance of BioCharge

Atreon Orthopedics, a Columbus-based innovator in tissue healing and regenerative technologies, received 510(k) clearance from the Food and Drug Administration (FDA) and announced the full market launch of BioCharge Autobiologic Matrix.

BioCharge is a bioresorbable synthetic implant designed as an onlay scaffold to address biological failure modes in rotator cuff repair while improving repair integrity and long-term patient outcomes.

“We’re excited to expand our rotator cuff augmentation portfolio, building on the proven success of our flagship product, the ROTIUM Bioresorbable Wick,” said Ronald Bracken, CEO of Atreon. “Retear rates remain high due to the complexities of tendon disease. With the introduction of BioCharge, Atreon is the only company offering solutions engineered to support native remodeling at both the tendon-bone and tendon-suture interfaces, resulting in improved treatment options for surgeons and their patients.”

Atreon’s electrospun nanofiber platform technology distinguishes itself from traditional augmented devices, which rely on animal-processed collagen or human dermal allografts that carry inherent patient compatibility risks and have a costly manufacturing process. 

The BioCharge Autobiologic Matrix uses wick active biology at the tendon’s bursal side of the rotator cuff repair to kickstart the natural healing process. It also promotes cellular activity for native collagen remodeling and reinforces the suture-tendon interface. 

With 17 years of tissue remodeling research, Atreon’s design mimics the natural structure of tissues and drives cellular attachment and proliferation more effectively than market-leading collagen-based products¹. Additionally, the resorption process of the fibers poly(glycolic acid) (PGA) and poly(lactide-co-caprolactone) (PLCL) serves a purpose—breaking down in a way that offers benefits to the healing cascade, including anti-inflammatory effects, enhanced vascular remodeling, and accelerated cellular migration¹.

Reference:

¹ Data on file.