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New Real-World Data for Miach Orthopaedics’ BEAR® Implant Demonstrate Low Retear Rates and Clinically Meaningful Improvements Following ACL Restoration

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New Real-World Data for Miach Orthopaedics’ BEAR® Implant Demonstrate Low Retear Rates and Clinically Meaningful Improvements Following ACL Restoration
Business

Business

New Real-World Data for Miach Orthopaedics’ BEAR® Implant Demonstrate Low Retear Rates and Clinically Meaningful Improvements Following ACL Restoration

2026-10-07 21:06 Last Updated At:21:20

WESTBOROUGH, Mass.--(BUSINESS WIRE)--Oct 7, 2026--

Miach Orthopaedics, Inc., developer of the BEAR ® Implant for anterior cruciate ligament (ACL) restoration, today announced publication of new two-year results from the post-commercialization Bridge Registry, published in Knee Surgery, Sports Traumatology, Arthroscopy (KSSTA)1, demonstrating low ACL retear rates and excellent patient-reported outcomes in real-world clinical practice. Publication coincides with the milestone of more than 10,000 patients treated with the BEAR Implant in the U.S. since commercial launch.

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In the first 100 Bridge Registry patients followed for two years, the overall ACL retear rate was 5.6%, with no retears during the first postoperative year. Among patients treated using a modified surgical technique, the retear rate was 2.5%, compared to 8.0% with the original technique. Patient-reported outcomes demonstrated substantial and continued improvement in knee function: At two years, mean IKDC was 87.4, while KOOS scores were 94.7 for pain, 97.6 for activities of daily living, and 88.2 for sports and recreational function. The study authors reported that these improvements were clinically significant and meaningful, with postoperative scores exceeding established patient-acceptable symptom-state thresholds.

“These two-year outcomes reflect real-world use of the BEAR Implant after its commercial release, and they show low retear rates across a broader range of patients than the original trials studied,” said Jocelyn Wittstein, MD, lead author of the Bridge Registry two-year analysis. “The registry includes younger patients at high risk and older patients at lower risk. Seeing low rates of retear and continued improvement in patient-reported outcomes through two years gives surgeons greater confidence as they counsel patients and select candidates for ACL restoration.”

Clinical Experience Improves Outcomes

While the BEAR Implant itself has remained unchanged since commercial launch, the study documents how the BEAR Implant procedure has evolved through commercial experience. Surgeons have increasingly adopted modified approaches involving different fixation methods, stronger sutures and alternative suture patterns.

The BEAR Implant rehabilitation protocol has also evolved based on surgeon and physical therapist experience, with refinements designed to support healing while helping patients safely progress toward their functional goals. A central focus of the refined protocol is guiding each patient’s progression toward return to activity at a pace that supports the healing ligament. Most patients in the Bridge Registry who played sports before their injury returned to play, with 87.2% back in sport by two years, underscoring why a measured return matters.

“The Bridge Registry results are outstanding and provide real-world validation of the BEAR Implant procedure after commercial launch,” said Jamal Rushdy, president and chief executive officer of Miach Orthopaedics. “Combined with the experience of more than 10,000 patients, these data demonstrate the momentum we see with surgeon adoption. Miach is on a path to define the standard of care for joint preservation through ACL restoration.”

About the Bridge Registry

The Bridge Registry ( NCT05398341 ) was initiated in May 2023 to assess real-world outcomes for the BEAR Implant. Primary outcomes being tracked include knee function and feeling measured by the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation at two years and knee laxity measured with Lachman scoring at one year; Knee Injury and Osteoarthritis Outcome Score (KOOS) domains were also measured at two years. A total of 300 patients were enrolled at nine sites: AdventHealth, Boston Children’s Hospital, Duke University, Hospital for Special Surgery, Oregon Health and Science University, Stanford University School of Medicine, Steamboat Orthopaedic & Spine Institute, Victory in Motion/Auburn Community Hospital and Virtua Health.

About the BEAR ® Implant

The BEAR (Bridge-Enhanced ACL Restoration) Implant was first granted De Novo Approval from the U.S. Food and Drug Administration in 2020. In 2025, the FDA expanded the indication to include children as young as age 2, with no upper age limit, as well as partial ACL tears. In 2026, the FDA updated BEAR Implant labeling to reflect a reduced risk of post-traumatic osteoarthritis (PTOA) compared with ACL reconstruction using hamstring tendon autograft.

The BEAR Implant is a proprietary collagen-based implant used to facilitate healing of the torn ACL. The BEAR Implant is the first medical technology to demonstrate, with Level 1 clinical evidence, that it enables the body to heal its own torn ACL. Unlike ACL reconstruction (ACLR), which is the current standard of care, the BEAR Implant does not require a second surgical wound site to remove a healthy tendon from another part of the leg or the use of a donor tendon. The BEAR Implant acts as a bridge to help ends of the torn ACL heal together. The surgeon injects a small amount of the patient’s own blood into the implant and attaches it between the torn ends of the ACL in a minimally invasive procedure. The combination of the BEAR Implant and the patient’s blood enables the body to heal the torn ends of the ACL back together while maintaining the ACL’s original attachments to the femur and tibia. As the ACL heals, the BEAR Implant is resorbed by the body.

In patients 14 years and older who have an ACL injury with concomitant knee injuries, ACL restoration with the BEAR Implant reduces the risk of developing PTOA (Kellgren-Lawrence grade 2 or higher), at 6-years post-surgery, compared to ACLR surgery using hamstring tendon autograft.

The BEAR Implant is indicated for adults, adolescents and children with a complete or partial rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair. Children with open physes must have sufficient bone in the femoral and tibial epiphyses on either side of the intended tunnel locations to avoid disruption of the growth plates. Visit www.miachortho.com for complete product information, including Instructions for Use.

About Miach Orthopaedics, Inc.

Miach Orthopaedics, Inc., is a privately held company located in Westborough, Massachusetts, dedicated to developing surgical implants to facilitate connective tissue restoration. The company’s initial focus is the BEAR ® Implant, which represents a paradigm shift in the treatment of ACL tears. For more information on Miach Orthopaedics and its products, visit www.miachortho.com and follow the company on LinkedIn.

BEAR ® Implant is a registered trademark of Miach Orthopaedics.

1 Wittstein J, Strickland S, Gomoll A, Sherman S, Lau B, Taylor D, Kramer D, Keyes S, Meininger AK, Pietropaoli M, McMillan S, Brady J. Two-year follow-up of postcommercialisation cohort of 100 bridge-enhanced anterior cruciate ligament restorations shows low retear rate and good patient-reported outcomes. Knee Surg Sports Traumatol Arthrosc. 2026 Sep 30. doi: 10.1002/ksa.70606. PMID: 42814471

New Real-World Data for Miach Orthopaedics’ BEAR® Implant Demonstrate Low Retear Rates and Clinically Meaningful Improvements Following ACL Restoration

New Real-World Data for Miach Orthopaedics’ BEAR® Implant Demonstrate Low Retear Rates and Clinically Meaningful Improvements Following ACL Restoration

STOCKHOLM (AP) — Scientists Henri B. Kagan and Kenso Soai won the Nobel Prize in chemistry Wednesday for untangling mysterious mirror images in molecules, a discovery that has been used to develop countless drugs and transformed modern medicine.

Many molecules come in versions that look alike but are not exactly identical, like right and left hands. One mirror image of the chemical carvone smells like mint, for example, while the other has a whiff of caraway, a spice often used in rye bread.

Even life itself prefers one mirror image over the other. DNA twists to the right, and the proteins in human bodies are made of mostly left-handed building blocks.

Versions of the same molecule can behave differently when interacting with other chemicals. When designing drugs to treat diseases, scientists want to be choosy about which mirror image they get. They want the version of a molecule to treat a cold, not one that will make the sniffles worse.

Kagan, who is from France, and Soai, from Japan, found ways to make chemistry pick a side, designing and manipulating reactions to produce the desired mirror image.

“This is probably the coolest experiment in organic chemistry,” said Peter Somfai, a member of the Nobel Committee for Chemistry. “Taken together, the groundbreaking discoveries by Henri Kagan and Kenso Soai have reshaped our understanding of molecular chirality,” a term that comes from the Greek word for “hand.”

Scientists paid tribute to Kagan and Soai's work, which the Nobel committee described as a feat never previously achieved by anyone “other than life itself.”

“It might be difficult to say that this drug, or that drug, was developed using this,” Somfai said. “I would say all of them, because we use this as a tool, we use this as an understanding, how to develop catalysts, how they function.”

In the 1980s, Kagan’s work showed there might be a way to design reactions to produce one form of a molecule over the other. Years later, Soai perfected the process. He created the first-ever chemical reaction to efficiently produce only one of a molecule’s mirror images, in what’s now known as the Soai reaction.

“The medicines we have today would not be possible without this chemistry,” said Rigoberto Hernandez, president of the American Chemical Society.

Kagan, 95, is affiliated with the Université Paris-Sud in Orsay, France. Soai, 76, is affiliated with the Tokyo University of Science.

The French Academy of Sciences, of which Kagan is a member, congratulated the two scientists and expressed its pride in the prize.

Neither the Université Paris-Sud nor the Tokyo University of Science immediately responded to requests for comment from The Associated Press.

“I’m very excited to receive the very nice news,” Soai told the committee and journalists by phone. “Of course this is one of the most exciting days in my life.”

He said he was shopping near his home when he was reached by the Nobel committee.

The Royal Swedish Academy of Sciences announced the winner in Stockholm.

Last year, three scientists won the chemistry Nobel for their development of new molecular structures that can trap vast quantities of gas inside, laying the groundwork to potentially suck greenhouse gases out of the atmosphere or harvest moisture from desert environments.

This year's prizes began with the Nobel for medicine, awarded Monday to three scientists whose work led to a tool that uses light to help unravel how the brain works. The physics award Tuesday recognized a scientist's efforts to demystify a rare group of neutrinos.

The literature prize is set to be awarded Thursday. After Friday’s peace prize is awarded, the Nobel Memorial Prize in Economic Sciences will be announced Monday.

The prize money this year is 12 million Swedish kronor (about $1.2 million), whether for an individual, a small group of laureates or an organization.

This story has been corrected to clarify that Kagan, not Soai, is 95.

Ramakrishnan reported from New York. Dazio reported from Berlin. Associated Press journalists Alexa St. John in Detroit, Catherine Gaschka in Paris and Mari Yamaguchi in Tokyo contributed to this report.

AP Nobel Prizes: https://apnews.com/hub/nobel-prizes

Japanese chemist Kenso Soai, who won the 2026 Nobel Prize in Chemistry, leaves home for a press conference, in Shiki, Saitama prefecture, Wednesday, Oct. 7, 2026. (Kyodo News via AP)

Japanese chemist Kenso Soai, who won the 2026 Nobel Prize in Chemistry, leaves home for a press conference, in Shiki, Saitama prefecture, Wednesday, Oct. 7, 2026. (Kyodo News via AP)

Japanese scientist Kenso Soai, winner of the 2026 Nobel Prize in Chemistry, leaves home for a press conference, in Shiki, Saitama prefecture, Wednesday, Oct. 7, 2026. (Kyodo News via AP)

Japanese scientist Kenso Soai, winner of the 2026 Nobel Prize in Chemistry, leaves home for a press conference, in Shiki, Saitama prefecture, Wednesday, Oct. 7, 2026. (Kyodo News via AP)

Portraits of Henri Kagan and Kenso Soai are shown on the screen as they are awarded the 2026 Nobel Prize in Chemistry, at the Royal Swedish Academy of Sciences in Stockholm, Sweden, on Oct. 7, 2026. Photo: (Fredrik Sandberg/TT News Agency via AP)

Portraits of Henri Kagan and Kenso Soai are shown on the screen as they are awarded the 2026 Nobel Prize in Chemistry, at the Royal Swedish Academy of Sciences in Stockholm, Sweden, on Oct. 7, 2026. Photo: (Fredrik Sandberg/TT News Agency via AP)

Portraits of Henri Kagan and Kenso Soai are shown on the screen as they are awarded the 2026 Nobel Prize in Chemistry, at the Royal Swedish Academy of Sciences in Stockholm, Sweden, on Oct. 7, 2026. Photo: (Fredrik Sandberg/TT News Agency via AP)

Portraits of Henri Kagan and Kenso Soai are shown on the screen as they are awarded the 2026 Nobel Prize in Chemistry, at the Royal Swedish Academy of Sciences in Stockholm, Sweden, on Oct. 7, 2026. Photo: (Fredrik Sandberg/TT News Agency via AP)

FILE - A close-up view of a Nobel Prize medal at the National Institutes of Health (NIH) in Bethesda, Md., Dec. 8, 2020. (AP Photo/Jacquelyn Martin, File)

FILE - A close-up view of a Nobel Prize medal at the National Institutes of Health (NIH) in Bethesda, Md., Dec. 8, 2020. (AP Photo/Jacquelyn Martin, File)

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