The US Food and Drug Administration (FDA) has granted 510(k) clearance to the BioCharge Autobiologic Matrix, a bioresorbable synthetic implant developed by startup Atreon Orthopedics to enhance rotator cuff repair integrity.
The implant is set to improve the long-term outcomes of the individuals by tackling biological failure modes.
BioCharge will act as an “onlay scaffold” to initiate the natural healing response of the individual, promote cellular activity for native collagen remodelling, and decrease the risk of suture cut-through failure.
The company noted that the implant is engineered to improve the “healing” environment on the rotator cuff’s bursal side.
Its integrated delivery system requires no secondary fixation, which minimises the time needed for implantation and avoids the risk of additional tendon damage.
Atreon Orthopedics 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's electrospun nanofiber platform technology sets itself apart from traditional augment devices that depend on animal-processed collagen or human dermal allografts, which carry compatibility risks and involve expensive manufacturing processes, the company stated.
With more than a decade of tissue remodelling research, the company’s design claims to emulate the natural tissue structure driving cellular attachment and proliferation.
The device is currently available throughout the US following Atreon's full market launch announcement.
Integrating materials science with biologic expertise, the company focuses on tissue regeneration, developing biologic solutions for orthopaedic applications.
