Active Implants’ NUsurface meniscus implant offers a novel treatment for patients who have torn or otherwise damaged their meniscus and are not yet candidates for joint replacement.
NUsurface is made of polycarbonate-urethane (PCU), which mimics the properties of a natural meniscus. PCU is never absorbed or incorporated into the knee. Because the implant has similar properties to a natural meniscus, it is possible for the implants to tear or wear down over time. Market Scope spoke with Adam Klyce, the VP of marketing and clinical operations for Active Implants, about the company’s current and future plans.
Surgeons who adopt NUsurface are trained in the procedure. Klyce said the biggest difference for surgeons is removing nearly all of the meniscus; typically, they either take as little as possible or remove the entire anatomy for a TKA. It is crucial that surgeons leave the horns and the rim to accommodate space for the implant.
In the hands of an experienced surgeon an initial NUsurface placement surgery usually takes about one hour and requires a two- to three-inch arthrotomy incision to accommodate the implant. The patient’s natural meniscus is removed almost completely, except for the rim and anterior and posterior “horns,” which keep the implant in place. The manipulation required to place the implant sprains the joint, which is healed through physical therapy postoperatively. Patients are ambulatory right after surgery and can return to normal activities in six weeks.
If a patient needs a replacement for his or her NUsurface, the exchange procedure is easier than the initial placement. Klyce said the procedure takes only about 30 minutes, and the patient is able to return to normal activities in about two weeks. The difference is that the patient’s knee ligaments adjusted to the height of the implant when it was initially replaced, so the sprain is less severe the second time. The implant can be replaced as many times as it needs to be to prolong or prevent knee replacement surgery.
By preserving key components of the patient’s anatomy, the NUsurface implant is held in place without sutures. According to Klyce, the implant was sutured in early-stage ovine models, but the outcomes were not as favorable as the free-standing implants.
Currently, the NUsurface is only made for medial meniscus replacement. Forces placed on the lateral meniscus are more complex than those placed upon the medial; Klyce compared it to the amount of motion in the cervical spine versus the lumbar. Active Implants does plan to have a lateral meniscus implant in the future, but the current push is to get the medial implant on the global market. According to Klyce, nearly seven out of 10 meniscus procedures are performed on the medial aspect.
Thus far, NUsurface has been used in two clinical trials: VENUS and SUN. Results from these two studies are being pooled for analysis. There are three NUsurface patients for every control patient in the pool. Those in the control group received injections until 18 months into the 24-month study. An analysis of 100 patients was presented by Wayne Gersoff, MD, at the Deutscher Kongress für Orthopädie und Unfallchirurgie in Oct. 2019. At the six- and 12-month assessment, patients with the NUsurface implant had statistically significant improvement in KOOS pain scores compared with the control group. Klyce said the FDA pays closest attention to Knee Injury and Osteoarthritis Outcome Scores (KOOSs) for pain and overall improvement. Active Implants has set 20 points of improvement over baseline as its measure of clinical success for the NUsurface therapy.
For now, NUsurface trial patients must have prior meniscus surgery to qualify for the study. The company hopes that NUsurface will eventually become a first-line treatment for meniscus pain and tears, but it seeks to gain approval as a revision treatment for now. Klyce mentioned that approximately 1 million patients receive a meniscectomy every year and 150 thousand annually progress to become NUsurface candidates.
Active Implants is hoping to submit its FDA de novo application in mid-2020 after the last SUN trial patients have their two-year follow-up exams. Klyce mentioned that the implant’s breakthrough status has meant many meetings with the FDA over the past years; he is hopeful that the de novo will be approved quickly because many details of the implant have already been discussed.
Active Implants received CE marking for NUsurface in 2008, and the device was approved in Israel in 2011. Since then, the company has been seeking approvals and reimbursement in many other countries. Surgeons in Germany and the Lombardy province of Italy adopted the technology early, and many medical tourists have traveled to these areas to receive treatment.
According to Klyce, surgeons adopting the technology have achieved positive results for their patients. The company is working to amass 30 or more cases in the United Kingdom to support a NICE recommendation and thereby gain NHS coverage. When asked if Brexit would have an impact on Active Implants’ rollout plans in the UK, Klyce replied that the company has a full-service distributor and a notified body that will minimize the effects of the transition.
Active Implants has completed several funding rounds and has raised over $120 million to date.
Although the firm still faces several regulatory and reimbursement challenges, Active Implants’ NUsurface promises an alternative treatment for meniscus tears and pain without joint replacement.