Exec Chat: Miach Orthopaedics Bullish On BEAR For Repairing, Not Replacing, Torn ACLs
Medtech Insight spoke with Martha Shadan, CEO of Miach Orthopaedics, about the company’s marketing efforts for its US FDA-cleared BEAR implant for treating anterior cruciate ligament (ACL) tears, ongoing clinical trials, plans for the rest of the year, and highlights from the AAOS 2022 event.
Miach Orthopaedics’ CEO Martha Shadan expressed excitement about surgeons’ uptake of its now commercially available bio-engineered Bridge-Enhanced ACL Restoration, BEAR implant, designed to get patients with anterior cruciate ligament tears back on their feet and back to their sports faster post-surgery compared with standard ACL reconstruction.
Since Miach launched the BEAR implant this January, after receiving US Food and Drug Administration de novo clearance in December 2020, it significantly exceeded revenue expectations. Miach’s revenues were up 400% in the first quarter compared with the prior quarter, and more than 300% above expected first-quarter revenues, Shadan told Medtech Insight. She declined to give revenue figures.
“What I can say is, we budget a certain number of physician users and were significantly above what we budgeted, as well as the repeat usage by surgeons is much higher than we had expected for the initial quarter,” Shadan said.
Capt. Raquel Peat, director for the FDA’s Center for Devices and Radiological Health’s Office of Orthopedic Devices, noted at the time of the de novo clearance, “Torn ACLs are among the most common knee injuries in the US, but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon and bone from other parts of the body, or obtained from a tissue bank, to complete the reconstruction.” (Also see "Start-Up Spotlight: Miach’s BEAR Implant Helps Body Repair Torn ACL" - Medtech Insight, 9 Oct, 2019.)
Unlike ACL reconstruction, which uses allograft, autograft or suture-only repair, the BEAR Implant is a resorbable implant made from bovine collagen and is secured via suture to bridge the gap between the torn ends of a patient’s ACL. The patient’s own blood is injected into the implant during the surgical implantation to form a device-protected clot that allows the body to heal. Within about eight weeks, the BEAR Implant is absorbed and replaced by the body’s own tissue, the FDA said.
The de novo clearance was based on a study of 65 patients receiving the BEAR Implant and a 35-member control group that was treated with ACL reconstruction using their own tendon from another part of the body. At two-year follow-up, patients who received the BEAR implant reported an average score of 88.6 and the control group reported an average score of 84.6 using the International Knee Documentation Committee (IKDC) Subjective Score, a questionnaire where patients rate symptoms including pain, stiffness, knee function and sports activity.
Shadan declined to give an exact number for how many patients have been implanted using the BEAR technique, but said it has been used in “several hundred” surgical procedures, including clinical study participants.
The BEAR Implant is currently being evaluated in two clinical studies: The BEAR III study will enroll 250 participants and aims to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL restoration as defined by an 11.5 point difference on the IKDC subjective score at two years post-surgery; the BEAR Moon study will enroll 200 participants and compare the BEAR procedure against ACL reconstruction using a bone-patellar tendon-bone graft.
To date, the privately held Westborough, MA-based company has raised $32m -- $22.5m in a series A financing and $9.5m in a bridge loan from insiders, Shadan said. Shadan hopes to raise another $30m in a series B financing round, which would carry the company to break even.
Shadan discusses below more details on the continued evaluation of the BEAR implant, their marketing plans for the US and beyond, and the rising role of digital technologies in orthopedics.
[Shadan’s answers have been slightly edited in the interest of length and clarity].
They don't normally do a comparison like this with a product, but there's high interest on their part in terms of the promise for BEAR compared to standard of care. All of our studies, except for the BEAR Moon study, we extended the follow-ups to six to 10 years. The two-year follow-up for BEAR III is expected in March of 2026 [which is] the same for the BEAR Moon study. We are six years out on BEAR I – those assessments are in process and six-year assessments in BEAR II are starting in April of this year. So, we have a long-term follow-up. The next assessment after the six will be 10 years. The BEAR Moon is only a two-year follow-up study. All BEAR studies have the two-year endpoint, six-year assessments and 10-year assessments. (Also see "AAOS Results Recap: Stryker’s Knee-Surgery Robot And Miach’s New ACL Scaffold" - Medtech Insight, 15 Mar, 2019.)
In addition to that, we will be initiating a registry called the Bridge registry, and that gets started in about a month to two months and that'll be 30 sites, 750 patients. The registry will track patient satisfaction, time back to driving, time back to work, time back to sport, time back to same level of sport. We will track pain scores, rate of contralateral tears and improvement in quality of life. Those are some of the bigger ones.
[On use of virtual reality, augmented reality and mixed reality] my son is a second-year orthopedic resident and he’s using it. In terms of training these kids, it's really helpful to get them proficient faster. I also think it's going to elevate the ability of surgeons across the board, whether it gives them more confidence, there’s more precision, they can do it faster, better.