OAB Vendors Report Progress Toward Commercialization
by James Cavuoto, editor
November 2023 issue, BioElectRx Business Report
The bioelectronic medicine market for treating overactive bladder and related disorders is likely to become more congested as new players enter the arena with new targets and new technology. Market leaders Medtronic and Axonics currently own the vast majority of the market for implanted sacral nerve stimulation systems.
In recent weeks three new competitors in this space reported progress toward commercial development. In the SNS product category, Neuspera Medical, Inc., the San Jose, CA manufacturer of neuromodulation systems, announced the completion of the 100th implant of its wireless system as part of the SANS-UUI Phase II clinical trial. SANS-UUI is an international study that’s evaluating the safety and efficacy of the Neuspera system, a minimally invasive implant designed to provide patients personal control and relief from urinary urge incontinence, a symptom of overactive bladder.
“I’m always looking for the most advanced and effective treatment methods to offer my patients suffering from overactive bladder that will provide them relief and help them get back to living their lives as normally as possible,” said Derrick Sanderson, a urogynecology clinician at Women’s Health Advantage in Fort Wayne, IN. “I’m excited to be a part of this clinical trial and the potential of this minimally invasive and discreet sacral neuromodulation therapy option.”
Neuspera’s system is designed to provide patients who have failed medication management a minimally invasive, more approachable way of benefiting from sacral neuromodulation, a clinically proven effective treatment that’s been used for more than 30 years to treat UUI associated with OAB. The system is comprised of a minimally invasive, ultra-miniaturized pulse generator that is 100 times smaller than the smallest commercially available sacral neuromodulation pulse generator. It is designed to be discreet, to provide patients with freedom from inconvenient and visible batteries, and to empower them to regain control of their quality of life. The device works together with an external wearable to activate the system that is designed to fit into patients’ lifestyles and give them the personal control and relief from their symptoms that have been controlling them and their life for some time.
“We’re grateful to all of the physicians and patients for their enthusiastic participation in this study,” said Steffen Hovard, CEO of Neuspera Medical. “We have positive feasibility data from phase one of SANS-UUI, and this phase two pivotal study is an important step in getting closer to being able to potentially fill a gap in the sacral and tibial neuromodulation market that meets patient demand for a discreet, effective solution.”
The Neuspera system has FDA approval for peripheral nerve stimulation and is undergoing clinical trials as an investigational device for the use of treating UUI.
Meanwhile, two competitors in the tibial nerve stimulation category reported progress. Avation Medical, Inc., the Columbus, OH manufacturer of wearable neuromodulation systems, announced the publication of safety and efficacy results from a multi-center study, “FREEOAB,” for its Vivally system in the journal Urology.
“The Vivally system represents a significant advancement in bladder control therapy as a noninvasive, patient-centered therapy providing patients with effective treatment, performed in the home, without the need for surgery or drugs,” said Colin Goudelocke, principal investigator for the FREEOAB study. “In our study, significant reductions in symptom burden were observed at 12 weeks which, notably, persisted out to 12 months, even with a reduction in frequency of therapy sessions.”
“Physician and patient response to Vivally has been overwhelmingly positive. Vivally will bring meaningful relief to millions of patients seeking treatment for symptoms of OAB that do not want the risks of surgery, or the side-effects of drug therapies,” said Avation CEO, Jill Schiaparelli. “We are grateful to the investigators and patients that participated in the study for helping us bring the Vivally system to market.”
The Vivally system is a noninvasive bladder control therapy device and companion mobile application to treat patients with UUI and urinary urgency caused by OAB, without the need for surgery, drugs, or needle-electrodes. Vivally is the only noninvasive, wearable neuromodulation system for bladder control with personalized calibration and automated closed-loop adjustment through electromyographic) monitoring cleared for sale in the U.S. Worn on the ankle, Vivally is used at-home with therapy sessions lasting only 30 minutes, as little as once per week.
Results of the FREEOAB Study demonstrated significant reductions in three-day diary parameters for daily void, incontinence, and urgency episodes at 12 weeks. Quality of life measures exceeded the minimal clinically important difference in all questionnaires. Long-term efficacy results remained robust at 12 months, with sustained improvement in diary parameters. Device-related adverse events were mild and there were no device-related significant adverse events. Mean therapy compliance at 12 weeks was 88.5%. High satisfaction rates were also reported for the device overall, including device ease of use.
BlueWind Medical, Ltd., the Israeli manufacturer of neuromodulation systems, announced that as part of the calendar year 2024 Hospital Outpatient Prospective Payment System final rule, the Centers for Medicare & Medicaid Services finalized the facility payment for subfascial procedures for tibial neuromodulation that pertain to its Revi device. In the final rule, CMS determined that the new subfascial tibial neuromodulation CPT code, 0817T, will be assigned to Ambulatory Payment Classification 5464 for hospital outpatient services with an unadjusted national average payment rate of $20,854.
The establishment of payment, which is effective January 1, 2024, will enable access to cutting-edge care for Medicare beneficiaries with UUI who could benefit from Revi, a new treatment for this debilitating condition. The FDA granted a De Novo marketing request on August 16, 2023, for Revi for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. In addition, the FDA noted that clinicians should follow clinical guidelines and use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using Revi.
Revi is the only subfascial iTNM system on the market and features a miniature implant along with wearable technology to power the device. Revi is implanted near the ankle during a single outpatient procedure performed under local anesthesia, with or without sedation, and without the potential adverse events seen with other surgical UUI therapies. When activated, the Revi implant stimulates the posterior tibial nerve to provide relief from UUI. For activation, a lightweight wireless wearable is placed around the ankle once to twice daily to provide stimulation at the patient’s convenience.
In October the American Medical Association CPT Editorial Panel announced the final CPT code to describe the subfascial tibial neuromodulation implant procedure, 0817T, which is also effective January 1, 2024. CPT codes are used by providers to report medical services and procedures to Medicare and commercial health plans for reimbursement.
“We applaud CMS and the AMA for recognizing the value and importance of the subfascial tibial neuromodulation procedure and Revi technology,” said Dan Lemaitre, CEO of BlueWind Medical. “BlueWind Medical is changing the treatment paradigm for UUI by offering a patient-centric alternative to less effective or less convenient third line therapies, and to medications, which are often less effective and that can trigger troublesome side effects. Revi offers a safe and effective solution for the countless individuals and will be a welcome alternative to current therapy.”