June 2022 issue, BioElectRx Business Report
June 30, 2022 | The market for treating bowel and bladder disorders using bioelectronic medicine therapies is currently dominated by two public companies offering implanted sacral nerve stimulation systems, Medtronic and Axonics. But recently, two startup firms have reported progress at novel approaches to treating these disorders.
Neuspera Medical, the San Jose, CA developer of neuromodulation systems, recently announced it will begin enrollment in its pivotal clinical trial, SANS-UUI, a single-arm study that will enroll 145 patients at 25 sites globally. The study will evaluate the safety and efficacy of Neuspera’s Nuvella system designed to treat overactive bladder for patients with urinary urgency incontinence symptoms. The system is the first sacral neuromodulation device that offers a minimally invasive option, which may allow for a better patient experience and greater procedural versatility.
“We are very pleased the SANS-UUI trial has reached this important enrollment milestone, as we are now one step closer to bringing the life-changing benefits of this technology to patients,” said Alexander Yeh, Founder and CTO at Neuspera. “The Nuvella system is the smallest available SNM device designed to minimize post-procedure discomfort and have no visible external appearance of the implant.”
The feasibility phase results of SANS-UUI were presented at the annual meeting of the American Urological Association last year and at the winter meeting of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) in this year. In 34 patients implanted with the Nuvella system, 90% of subjects demonstrated a 50% improvement in UUI symptoms at 6 and 12 months with 2 hours of daily stimulation, while 52% were completely dry at the 12-month visit. “These results are very promising,” said Steven Siegel, CMO at Neuspera Medical. “In addition to the clinical benefits seen, Nuvella demonstrated safety consistent with other commercially available devices.”
A second startup firm, Thermaquil, presented a novel approach to treating bowel and bladder dysfunction in individuals with spinal cord injury at the recent meeting of the International Neuromodulation Society in Barcelona. Their approach involves sending a retention signal to the bladder to prevent it from contracting, except during voiding, combined with relaxing the external sphincter, which enables micturation. “In order to relax the external sphincter, you have to do a simultaneous two-sided block of the pudendal nerve, and then you can contract the bladder and get normal voiding,” said Thermaquil CEO Stephen Popielarski. For bowel function in SCI, Thermaquil stimulates S2 at 7 to 10 Hz using intermittent stimulation, 1 minute on, 1 minute off. “The colon doesn’t get tired at all,” Popielarski said. “The whole colon is constracting and everything is moving.” The company is planning to do its first human implants this summer.
Thermaquil was formed in 2017 when Changfeng Tai, an associate professor of urology at the University of Pittsburgh School of Medicine and Popielarski won a $100,000 grant through the Pitt Innovation Challenge to accelerate the commercial translation of their technology. The founding team then began to map out a product development and regulatory strategy that included a series of proposals for grants and contract from federal agencies.Those efforts resulted in two significant developments in 2020.
First, the company was awarded a $1 million Small Business Innovative Research grant to fund further development and human testing of a non-invasive nerve block device. Almost simultaneously, Thermaquil partnered with Tai’s lab to be the commercialization partner for a $10.4 million DARPA grant to further develop a nerve blocking and stimulating device to fully restore bladder function for people with complete spinal cord injuries, literally at the press of a button. Thermaquil is responsible for defining product requirements, clinical trials, regulatory submissions, and eventual commercialization.
Through the five-year DARPA award, Tai’s lab and Thermaquil will develop a fully implantable, wirelessly controlled and chargeable stimulator to restore bladder, bowel ,and sexual functions for people with SCI. Restoring these visceral functions remains a top priority for functional recovery in people with SCI, and can dramatically improve the quality of life and prevent potential kidney failure caused by bladder-sphincter dyssynergia.
