Anterior cruciate ligament (ACL) reconstruction continues to be one of the costliest and most common orthopedic procedures, with over 200,000 surgeries performed each year in the U.S. However, retear rates of 5-15% remain a major challenge—driving avoidable reoperations and multimillion-dollar spend for health systems.

One novel solution is BioBrace, a soft tissue augmentation implant made of a biocomposite material that combines mechanical integrity with the body’s natural healing process. The highly porous 3D DNA absent collagen sponge is reinforced with PLLA microfilaments for strength. BioBrace is used in 45 different procedures for the knee, shoulder, elbow, hip, and foot and ankle—including ACL reconstruction.

The BioBrace biocomposite soft tissue scaffold was first created by New Haven, Conn.-based startup Biorez and received U.S. Food and Drug Administration (FDA) 510(k) clearance in 2021. The company was then bought by Conmed a year later.

In June of this year, the “One-Year Clinical Outcomes Following Anterior Cruciate Ligament Reconstruction Augmented with a Reinforced Bioinductive Implant” study of BioBrace was published in the journal Surgical Technology International. The study was led by led by Dr. Sean McMillan, an orthopedic surgeon and sports medicine specialist.

Dr. McMillan’s peer-reviewed results showed a 1.4% graft retear rate and a 4.2% overall reoperation rate using BioBrace, compared to typical rates of 5-15% and 10-20%, respectively. Also reported were significant gains in pain, function, and mobility, with no device-related complications. These outcomes suggest a significant advancement in graft durability and surgical success.

For device developers and OEMs, this data highlights the potential of BioBrace as a next-generation solution in sports medicine. To glean more understanding about ACL reconstruction and BioBrace, ODT spoke with Dr. McMillan:

Sam Brusco: What are the current challenges with ACL reconstruction?

Dr. Sean McMillan: ACL reconstruction is a very successful procedure—however, it is not without drawbacks. One of the most devastating sequelae that can occur after ACL reconstruction is re-repair.

While it is rare, if it does occur, it can be catastrophic to a patient physically, mentally, emotionally, and financially. Aside from the risk of re-tear, “donor site morbidity” (pain, deformity, weakness) is associated with harvesting a patient’s own tissue for reconstruction. This is a drawback that can have downstream effects on a patient.

Brusco: How does BioBrace address the unmet clinical needs in ACL reconstruction?

Dr. McMillan: The addition of a reinforced bioinductive implant like BioBrace serves several purposes.

It increases the load to failure and strength of the ACL graft from the moment it is implanted. We know that with a standard ACL reconstruction, the graft placed in the knee is actually weaker two months after surgery than it was on the day it was implanted.

This weakening can contribute to re-injury and complications in some cases. In patients undergoing ACL reconstruction with a cadaver graft, the addition of BioBrace also enhances healing potential and graft strength. Literature has shown that cadaver grafts may have higher failure rates due to limited incorporation by the body.

Finally, using BioBrace to fill the graft harvest site can reduce pain at the site and minimize tendon weakness (whether from the quadriceps or patellar tendon).

Brusco: What is BioBrace’s method of action, and what’s involved in the surgical procedure?

Dr. McMillan: BioBrace provides a two-pronged benefit when used for ACL reconstruction.

First, it increases the mechanical strength and stiffness of the graft, making it stronger and, in theory, reducing the risk of complications or re-injury. The implant then works through bioinduction. In other words, it stimulates the body to produce more collagen, promote healing, and enhance vascularity.

This encourages more natural tissue regeneration and may lower the risk of long-term complications.

Brusco: What is the potential future for reinforced bioinductive implants for ACL reconstruction and beyond?

Dr. McMillan: As research into reinforced bioinductive implants continues, we are likely to see overall decreases in re-injury rates and, hopefully, reduced pain associated with the use of autografts. In addition, these implants may help minimize weakness and tendinitis related to graft harvest from the patellar or quadriceps tendon.