Vendors offer new approaches to treating pelvic disorders
by James Cavuoto, editor
March 2022 issue, BioElectRx Business Report
The market for treating bowel and bladder disorders with bioelectronic medicine therapies has become more crowded in recent months as new vendors have entered the space and existing competitors have expanded their product offerings. The primary indication vendors are targeting is overactive bladder, though there are also applications in treating fecal incontinence and other forms of urinary incontinence.
Industry leader Medtronic, who offers the InterStim II implanted sacral nerve stimulation system, has lost market share recently to upstart Axonics Inc. To counteract Axonics’ rechargeable SNM system, Medtronic recently introduced its own rechargeable system, the InterStim Micro, which, at 2.8 cm3 is the smallest device on the market. Axonics, for its part, introduced a primary cell version of its device to compete with InterStim II. The device received FDA approval earlier this month. The two firms are engaged in patent litigation regarding the Axonics implant.
“Axonics is keenly focused on developing innovative, best-in-class, patient-centric SNM solutions as well as expanding awareness and access to this life-changing therapy,” said Raymond Cohen, CEO of Axonics. “Our rechargeable system introduced innovations to the SNM category in late 2019 that clinicians and patients had been requesting for years—longevity in the body, full-body MRI compatibility, a miniaturized implant, fuss-free therapy and a patient remote control that is easy for patients to use. The new Axonics F15 recharge-free SNM system is similarly groundbreaking—a small and thin INS with an expected life in the body of well over a decade that does not require any element of the system to be recharged—and sets a new standard for what is possible in this category. We expect to begin shipping the Axonics F15 system in April.”
Another promising new entrant in the sacral nerve stimulation market is Neuspera Medical. The company’s implantable SNM system is comprised of a minimally-invasive implant and convenient external wearable designed to provide relief from the life-limiting symptoms of urinary urgency incontinence.
In 2021, Neuspera closed a $65 million C round. The round was co-led by Vertex Ventures HC and Treo Ventures. Lori Hu, a managing director at Vertex Ventures HC and Mudit Jain, managing partner, Treo Ventures, joined the board of directors. Returning investors include Action Potential Venture Capital and Windham Venture Partners. The proceeds will fund the company’s SANS-UUI pivotal clinical study of its miniaturized implantable neuromodulation technology platform for use in subjects with urinary urgency incontinence, a symptom of overactive bladder. “We are excited to see the first cohort of patients experiencing the known benefits of sacral nerve stimulation through the use of our ultra-miniaturized neuromodulation platform—driven by the support of the physician investigators in the SANS-UUI clinical trial,” said Milton Morris, president and CEO of Neuspera Medical. “We are excited to continue our focused efforts on enabling access to the known benefits of neuromodulation to patients who are struggling with chronic and debilitating medical conditions.”
Tibial nerve stimulation
Another new player in the market, Valencia Technologies Corp., announced FDA approval of its eCoin leadless tibial neurostimulator for the treatment of urinary urge incontinence, which affects over 60% of patients who suffer from OAB. FDA approval was supported by the efficacy and favorable safety profile demonstrated in the eCoin pivotal trial. The company also announced the publication of these results in the Journal of Urology.
eCoin is a nickel-sized neurostimulator implanted subcutaneously in the lower leg during a minimally invasive, outpatient procedure utilizing a local anesthetic. The device contains a primary battery and once programmed, automatically delivers intermittent stimulation to the tibial nerve to reduce UUI symptoms. The device does not require ongoing patient management of a power source or a stepped programmer. The therapy is clinically different from sacral nerve stimulation which typically requires general anesthesia after a testing period as well as ongoing patient device management.
“This is a landmark approval for physicians and UUI patients as eCoin is now the first and only implantable tibial nerve stimulator approved by the FDA,” said Jeff Greiner, founder of Valencia. “eCoin will facilitate a paradigm shift for UUI treatments by offering physicians an efficient option for implantation with high patient satisfaction. The simplicity and effectiveness of eCoin will enable more patients to achieve the help they desperately need.”
The eCoin device is implanted just above the ankle over the tibial nerve and its, dome-shaped stimulation field delivers regular stimulation to the nerve to calm the bladder and provide relief from bladder leakage. “Beyond delivering impressive results achieved without the need for prior screening, the eCoin procedure is easily understood by patients, reproducible amongst physicians, and accomplished in a safe and effective manner,” said Rebecca McCrery, an investigator in the eCoin pivotal trial. “Under 5% of OAB patients select burdensome third line interventions due to invasiveness or potential side effects of available therapies and limitations in access, resulting in a staggering unmet clinical need. The effortless relief provided by the automatic nature of eCoin neuromodulation therapy will potentially better treat the vast population—often desperate for relief—who are not well managed by the current options available to them.”
The PMA application for eCoin was based upon results from the pivotal trial which followed 133 women and men in the U.S. who were implanted with eCoin. In the per protocol population, 75% of patients responded with at least a 50% reduction in Urinary Urge Incontinence (UUI) episodes. There was no trial or screen prior to implantation. 81% of patients responded that they felt “better” to “very much better” one year post procedure. Per the publication, implanted patients reported an excellent experience, with 97% stating that the procedure was adequately explained to them and 89% stating that they would recommend eCoin therapy to friends or family.
“eCoin is neuromodulation for the masses”, stated Scott MacDiarmid, investigator in the feasibility and pivotal trials of the eCoin device. “Being the first leadless neurostimulator for bladder control is groundbreaking and paves the way for further applications.” The company expects to launch eCoin commercially this month with physician training beginning next month.
Last year, BlueWind completed enrollment in its OASIS trial, a 150-patient prospective clinical study designed to demonstrate the safety and efficacy of the company’s RENOVA iStim system to reduce symptoms of urgency incontinence, including urinary urgency and urinary frequency. Patients were screened and implanted at 23 centers in the U.S., U.K., The Netherlands, and Belgium.
“We are thrilled that enrollment has been completed in the OASIS study” said Dan Lemaitre, CEO of Bluewind Medical. “I am proud of our courageous field team that traveled throughout the pandemic, who along with our R&D colleagues in Israel, collaborated to ensure investigative sites and patients had optimal support during the study’s enrollment period.” The system consists of a wirelessly powered miniature implant that delivers targeted electric stimulation to the tibial nerve, a patient wearable, a clinician programmer, and a patient remote control. It received CE Mark in 2016.
Laborie Medical markets a percutaneous tibial nerve stimulation system called Urgent PC. The device has been in use for 12 years with more than one million treatments to date. Laborie acquired Cogentix Medical, which developed the system, for $214 million in 2018. Medtronic also offers a percutaneous tibial nerve stimulation system called NURO. In 2020, European device manufacturer Coloplast acquired Nine Continents Medical, Inc., an early stage company developing an implantable tibial nerve stimulation system, for $145 million plus milestone payments.
Yet another target for bioelectronic medicine treatment of OAB is the saphenous nerve. A Minnesota startup called EBT Medical is developing a system called Nina, a noninvasive wearable that stimulates the saphenous nerve in the upper calf.
EBT raised a $10 million series A in 2019 co-led by SV Health Investors and Genesys Capital. “We believe EBT’s patented Saphenous nerve approach is a potential game-changer, enabling the first at-home, noninvasive neuromodulation therapy for OAB. OAB is a massive market with large unmet needs: drugs have dangerous side effects, Botox requires invasive bladder injections, and existing neuromodulation therapies are also highly invasive, involving spinal implants and needles,” said Greg Madden, partner at SV Health.
At the annual meeting of the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) last month, EBT presented neuroanatomy and a mechanism of action supporting the company’s OAB therapy.