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Tendon and ligament injuries have historically been a challenge, as revisions and repeat operations are common and full recovery can be slow or impossible. Low cellular activity and vascularity in connective tissues can result in long rehabilitation and increased risk of reinjury. One study by the Multicenter Orthopaedic Outcomes Network Group showed that 57% of athletes with reconstructed anterior cruciate ligaments did not return to pre-injury activity level.
Typically, ligament and tendon repairs rely on surgical intervention wherein injured tissues are replaced with soft tissue allografts or autografts and/or reinforced with resorbable or permanent devices with the hope that the surgical repair will heal over time. Historically, both biologic and synthetic materials have been used to reinforce or augment these repairs with mixed results. With about one million connective tissue repairs or reconstructions per year in the United States alone, the market is ripe for innovation.
Biorez developed the BioBrace implant that they believe will reduce the potential for reinjury, speed the healing process and overcome limitations of other products. The BioBrace implant is a biocomposite soft tissue scaffold that reinforces tendon and ligament procedures by providing an optimum balance of strength for reinforcement of tissue and porous biologic scaffold for regeneration of tissue.
The BioBrace device includes a highly absorbent microporous collagen scaffold reinforced with resorbable polymer microfilaments. It’s cell-friendly, meaning that a patient’s cells can grow directly into the implant to rebuild new functional tissue. “There’s a lot of interest in how to improve the strength and durability of connective tissue repairs as well as accelerate the healing process,” said Kevin Rocco, Chief Executive Officer of Biorez. “There has been tremendous innovation in instrumentation, in fixation and hardware, but a lack of innovation in implant materials. Failure rates for ACL reconstruction in young active patient populations can be over 20%. Even when it goes well, the biologic healing process is often not complete for two years or more.”
Strength, Durability and Regenerative Properties
BioBrace’s highly-porous collagen matrix is embedded with bioresorbable polymer microfilaments that provide a strong, open 3D biologic scaffold. The product is more than 80% porous with interconnected pores and a scaffold structure, meaning that patient cells can quickly integrate and create new tissue within the implant. After the healing process is complete, the implant resorbs.
“The vision is to address some of the technical shortcomings of past products to better enable the body’s own healing process,” Mr. Rocco said. “The current paradigm in sports medicine is to reapproximate soft tissues and wait for the tissue to heal. These are usually relatively large, dense pieces of tissue requiring a long time for the body to biologically re-integrate into the repaired site. The BioBrace is designed with tissue matching stiffness and a more open scaffold for the tissue to heal into the repair more quickly. When a surgeon uses a BioBrace, the intention is to both reinforce (with mechanical strength) and augment healing (with BioBrace/new tissue).”
Other materials and competitive products are available, but usually only serve one of these two objectives, either to reinforce or to augment the healing process. BioBrace is the first product designed to do both.
Planning for the Future
BioBrace recently received FDA 510(k) clearance from the FDA with the indications to reinforce soft tissue where weakness exists. In the short term, Mr. Rocco said the company is focusing on clinical indications with the most need, such as augmenting tissue grafts used in ACL surgeries, augmenting large rotator cuff tears and other situations where there is a high risk of failure with existing techniques.
“There’s really no reason not to give the patient the best chance for healing in these difficult situations,” he said. “From there, we’re looking to obtain clinical data that supports clinical efficacy and validates the value proposition of the BioBrace implant.”
The plan is to first proceed with a limited commercial release of the BioBrace implant working with the company’s key advisors in knee and shoulder specialties. Beyond augmenting ACL and rotator cuff repairs, Biorez is considering targeted indications such as the Achilles tendon, the ulnar collateral ligament of the elbow, extra articular ligaments of the knee, and others. “There are a number of potential applications for BioBrace, and we’re excited to partner with surgeons to explore the potential of this technology,” Mr. Rocco said.
“The timing is right. The science is now established that tendons and ligaments have a capacity for regeneration. In parallel, advances in tissue engineering allow for the rational design of an implant material and architecture to function as we intend clinically,” he said. “Our BioBrace technology could be a first step towards replacing autograft and allograft materials all together. I think we can all agree that at some point in the near future, we’re going to stop using harvested tissues from cadavers as implants for sports medicine procedures, it’s risky, expensive, and often does not work. I think a more logical choice going forward is the BioBrace implant.”
Tendon and ligament injuries have historically been a challenge, as revisions and repeat operations are common and full recovery can be slow or impossible. Low cellular activity and vascularity in connective tissues can result in long rehabilitation and increased risk of reinjury. One study by the Multicenter Orthopaedic Outcomes Network Group...
Tendon and ligament injuries have historically been a challenge, as revisions and repeat operations are common and full recovery can be slow or impossible. Low cellular activity and vascularity in connective tissues can result in long rehabilitation and increased risk of reinjury. One study by the Multicenter Orthopaedic Outcomes Network Group showed that 57% of athletes with reconstructed anterior cruciate ligaments did not return to pre-injury activity level.
Typically, ligament and tendon repairs rely on surgical intervention wherein injured tissues are replaced with soft tissue allografts or autografts and/or reinforced with resorbable or permanent devices with the hope that the surgical repair will heal over time. Historically, both biologic and synthetic materials have been used to reinforce or augment these repairs with mixed results. With about one million connective tissue repairs or reconstructions per year in the United States alone, the market is ripe for innovation.
Biorez developed the BioBrace implant that they believe will reduce the potential for reinjury, speed the healing process and overcome limitations of other products. The BioBrace implant is a biocomposite soft tissue scaffold that reinforces tendon and ligament procedures by providing an optimum balance of strength for reinforcement of tissue and porous biologic scaffold for regeneration of tissue.
The BioBrace device includes a highly absorbent microporous collagen scaffold reinforced with resorbable polymer microfilaments. It’s cell-friendly, meaning that a patient’s cells can grow directly into the implant to rebuild new functional tissue. “There’s a lot of interest in how to improve the strength and durability of connective tissue repairs as well as accelerate the healing process,” said Kevin Rocco, Chief Executive Officer of Biorez. “There has been tremendous innovation in instrumentation, in fixation and hardware, but a lack of innovation in implant materials. Failure rates for ACL reconstruction in young active patient populations can be over 20%. Even when it goes well, the biologic healing process is often not complete for two years or more.”
Strength, Durability and Regenerative Properties
BioBrace’s highly-porous collagen matrix is embedded with bioresorbable polymer microfilaments that provide a strong, open 3D biologic scaffold. The product is more than 80% porous with interconnected pores and a scaffold structure, meaning that patient cells can quickly integrate and create new tissue within the implant. After the healing process is complete, the implant resorbs.
“The vision is to address some of the technical shortcomings of past products to better enable the body’s own healing process,” Mr. Rocco said. “The current paradigm in sports medicine is to reapproximate soft tissues and wait for the tissue to heal. These are usually relatively large, dense pieces of tissue requiring a long time for the body to biologically re-integrate into the repaired site. The BioBrace is designed with tissue matching stiffness and a more open scaffold for the tissue to heal into the repair more quickly. When a surgeon uses a BioBrace, the intention is to both reinforce (with mechanical strength) and augment healing (with BioBrace/new tissue).”
Other materials and competitive products are available, but usually only serve one of these two objectives, either to reinforce or to augment the healing process. BioBrace is the first product designed to do both.
Planning for the Future
BioBrace recently received FDA 510(k) clearance from the FDA with the indications to reinforce soft tissue where weakness exists. In the short term, Mr. Rocco said the company is focusing on clinical indications with the most need, such as augmenting tissue grafts used in ACL surgeries, augmenting large rotator cuff tears and other situations where there is a high risk of failure with existing techniques.
“There’s really no reason not to give the patient the best chance for healing in these difficult situations,” he said. “From there, we’re looking to obtain clinical data that supports clinical efficacy and validates the value proposition of the BioBrace implant.”
The plan is to first proceed with a limited commercial release of the BioBrace implant working with the company’s key advisors in knee and shoulder specialties. Beyond augmenting ACL and rotator cuff repairs, Biorez is considering targeted indications such as the Achilles tendon, the ulnar collateral ligament of the elbow, extra articular ligaments of the knee, and others. “There are a number of potential applications for BioBrace, and we’re excited to partner with surgeons to explore the potential of this technology,” Mr. Rocco said.
“The timing is right. The science is now established that tendons and ligaments have a capacity for regeneration. In parallel, advances in tissue engineering allow for the rational design of an implant material and architecture to function as we intend clinically,” he said. “Our BioBrace technology could be a first step towards replacing autograft and allograft materials all together. I think we can all agree that at some point in the near future, we’re going to stop using harvested tissues from cadavers as implants for sports medicine procedures, it’s risky, expensive, and often does not work. I think a more logical choice going forward is the BioBrace implant.”
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Heather Tunstall is an ORTHOWORLD Contributor and owner of Tunstall Content.
