US-based Atreon Orthopedics has received the Food and Drug Administration (FDA) 510(k) approval for BioCharge Autobiologic Matrix and announced its full market launch.
BioCharge is a bioresorbable synthetic implant intended for biological failure modes in rotator cuff repair, to improve repair integrity and ensure long-term patient outcomes.
The implant is designed as an onlay scaffold to promote the patient’s natural healing response, with wicking active biology at the tendon’s bursal side of the rotator cuff repair.
It promotes cellular activity with native collagen remodelling and deters scar tissue formation while strengthening the suture-tendon interface to minimise suture cut-through failure risk.
Atreon CEO Ronald Bracken said: “We’re excited to expand our rotator cuff augmentation portfolio, building on the proven success of our flagship product, the Rotium Bioresorbable Wick. 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 remodelling at both the tendon-bone and tendon-suture interfaces, resulting in improved treatment options for surgeons and their patients.”
Atreon said its electrospun nanofiber platform is designed based on its 17 years of tissue remodelling research and differs from the traditional augment devices.
The traditional devices often leverage animal-processed collagen or human dermal allografts and are associated with patient compatibility risks and high manufacturing costs.
The company said that its platform effectively mimics the natural structure of tissues, driving cellular attachment and proliferation more effectively than leading collagen-based products.
In addition, the resorption process of the fibres involves poly(glycolic acid) (PGA) and poly(lactide-co-caprolactone) (PLCL), providing benefits to the healing cascade.
The benefits include anti-inflammatory effects, enhanced vascular remodelling, and accelerated cellular migration, further enhancing the healing process.
Detroit Orthopaedic Institute founder and orthopaedic surgeon Shariff Bishai said: “The BioCharge implant was designed with user-friendliness and superior performance as a top priority.
“Having used BioCharge during the limited market launch, I’m pleased to report that at 5 months post-op, all my patients are thriving with no adverse events and I look forward to tracking their long-term clinical success.”
Central Indiana Orthopedics orthopaedic surgeon Brian Badman said: “With BioCharge, Atreon continues to set a new standard in rotator cuff repair.
“For complex tears, I can now use the Rotium inlay combined with BioCharge onlay using Atreon’s BioStack Kit, providing versatile, biologic-driven solutions for improved patient outcomes.”
