Recon

Miach Orthopaedics Announces BEAR® Implant Activities at OSET 2024

byTim Allen

September 12, 2024

Scientific Presentations Highlight Patient Selection, Surgical Technique and Experience, Including Live Case

Interim Analysis of the Bridge Registry Study to be Presented for First Time

WESTBOROUGH, Mass., September 12, 2024 –(BUSINESS WIRE) —Miach Orthopaedics, Inc., a company transforming the treatment of anterior cruciate ligament (ACL) tears from reconstruction to restoration with the Bridge-Enhanced ACL Restoration (BEAR^®) Implant, today announced activities at the upcoming Orthopaedic Summit Evolving Techniques Conference 2024 (OSET 2024) in Las Vegas September 13-18. Scientific presentations and company-sponsored events will provide attendees with the opportunity to learn about BEAR Implant clinical trial results, surgical technique and patient selection and results.

The BEAR Implant is the first disruptive technology in ACL tear treatment in more than 30 years. The implant enables a torn ACL to heal and restores the natural function of the knee. It is a paradigm shift from the current standard of care – reconstruction that replaces the ACL with a graft. To date, more than 4,000 patients have been treated with the BEAR Implant through clinical trial and commercial use.

“We are entering a new era in data further supporting the safety and efficacy of the BEAR Implant to treat ACL tears,” said Patrick McBrayer, president and CEO, Miach Orthopaedics. “At OSET 2024, we are sharing key insights from the first interim analysis of 100 patients at one year in our Bridge Registry study assessing real-world performance of the BEAR Implant across a variety of surgical techniques.”

Scientific Presentations

The BEAR Implant will be highlighted in four scientific presentations:

Dr. Gregory DiFelice of Hospital for Special Surgery will perform a BEAR Implant surgery broadcast live from New York, with Dr. Daryl Osbahr of Rothman Orthopaedics and Dr. Alexander Meininger of Steamboat Orthopaedic & Spine Institute moderating. “Live Surgery: Arthroscopic Bridge-Enhanced ACL Restoration/Repair,” Monday, September 16 at 8:07 a.m. PT in Azure 1-2-5.
Dr. Osbahr will highlight use of the BEAR Implant in a panel discussion highlighting treatment options for a 21-year-old Division 1 soccer player with an acute Sherman Type 1 tear. “Pro: Bridge-Enhanced ACL Repair,” Monday, September 16 at 7:05 a.m. PT in Azure 1-2-5.
Dr. Scott Sigman of Orthopaedic Surgical Associates will share two-year experience with the BEAR Implant. “Evolving Technique: My Two-Year Registry Data for ACL Repairs: I Will Convince You All,” Monday, September 16 at 10:50 a.m. PT in Azure 1-2-5.
Dr. Michael Redler of Connecticut Orthopaedics will provide an update on ACL restoration with the BEAR Implant and discuss patient selection. “Evolving Technique Update: Bridge-Enhanced ACL Repairs: Where Are We & Who Is the Perfect Patient?” Sunday, September 15 at 7:05 a.m. PT in Azure 7-8.

“For more than 20 years I have been evolving my Preservation First^® approach to treating ACL tears with the goal of maintaining natural ACL anatomy while providing patients the least invasive surgery possible,” Dr. DiFelice said. “At this year’s OSET meeting, I will share my treatment algorithm for ACL injuries, which now, for the first time, includes biologic advancements with the BEAR Implant. I will discuss how tear type and tissue quality inform the appropriate surgical intervention for each patient and review both my experience and the new registry data.”

Company-Sponsored Events

In addition to an exhibit hall booth (#411), Miach will host the following BEAR Implant events:

Dr. DiFelice will discuss how biology plays a role in the future of ACL treatments in a luncheon presentation. In addition, an interim analysis of the Bridge Registry (NCT05398341), Miach’s multi-center post-market study assessing real-world performance of the BEAR Implant, will be shared for the first time. Tuesday, September 17 at 12:45 p.m. PT in Azure 1-2-5.
Dr. Sigman will highlight 36-month experience with the BEAR Implant, including patient case studies, in an invitation-only dinner for physicians. Monday, September 16. To RSVP, email cnabity@miachortho.com.

About The BEAR^® Implant

The Bridge-Enhanced ACL Restoration (BEAR^®) Implant is a proprietary bio-engineered 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 reconstruction, 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.

The BEAR Implant was granted De Novo Approval from the U.S. Food and Drug Administration in December 2020. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL as confirmed by MRI. Patients must have an ACL stump attached to the tibia to facilitate the restoration. Visit 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 bio-engineered surgical implants for connective tissue restoration. The company’s initial focus is the BEAR^® Implant, which represents a paradigm shift in the treatment of ACL tears from reconstruction to restoration. For more information on Miach Orthopaedics and its products, visit www.miachortho.com and follow the company on Facebook, Instagram, TikTok and LinkedIn.

BEAR^® Implant is a registered trademark of Miach Orthopaedics. All other trademarks are the property of their respective owners.