A Columbus startup plans to start sales of its wearable medical device for bladder control this spring after raising $22 million.
Avation Medical Inc.'s Vivally System is worn as an ankle brace, paired with a mobile app, that delivers electrical signals to stimulate a nerve running up the back of the leg. Existing treatments for overactive bladder and other types of incontinence involve surgery, drugs with side effects, or stimulating the nerve with a needle implant that requires weekly doctor visits.
“This new capital will jump-start the highly anticipated launch of Vivally, which sets a new standard for (overactive bladder) care," Avation co-founder and CEO Jill Schiaparelli said in a news release.
New investors ShangBay Capital and Asahi Kasei led the over-subscribed Series C round, which the release said remains open. Other first-time investors also participating include Angelini Ventures and JobsOhio Growth Capital Fund, a sidecar investment vehicle for the private economic development organization.
Several previous investors also joined the round, including Arboretum Ventures, Tonkawa, the medical device maker Medtronic and Avestria Ventures.
"This is a remarkable achievement against a backdrop of a very challenging fundraising environment and sends a strong message that our new and existing investors share in Avation Medical’s vision to set a new standard in bladder control therapy," Schiaparelli said in a LinkedIn post announcing the funding. She was not immediately available for an interview.
Vivally is approved by the U.S. Food and Drug Administration and will be available by prescription in select U.S. markets this spring, according to the release.
Symptoms were significantly reduced at 12 weeks in a clinical trial, and the improvement lasted a full year even if patients were wearing the device less often, according to a study published in November in the journal Urology.
“The Vivally System represents a significant advancement in bladder control therapy as a non-invasive, patient-centered therapy providing patients with effective treatment, performed in the home, without the need for surgery or drugs,” Dr. Colin Goudelocke, the study's lead investigator at Ochsner Medical Center in New Orleans, said in a news release.
Avation was one of the first two companies started by Neurotechnology Innovations Translator, a Columbus company formed in collaboration with Ohio State University to invest in and nurture neuromodulation startups. It was first named Veressa but changed its name to Avation in 2019.
Before starting Avation with NIT in 2017, Schiaparelli was CEO for two years of InteloMed, a Pittsburgh company developing telehealth technology, according to her LinkedIn profile. She had previous roles over two decades with medical device companies AxoGen, ApaTech and Johnson & Johnson.
The other NIT company, Sollis Therapeutics Inc., is recruiting patients for the third phase of clinical trials for its injected "micropellet" of a drug to treat sciatica, intense leg pain, according to its website. The study runs through 2025, according to clinicaltrials.gov. If successful, phase three trials usually lead to seeking FDA approval.
Ohio Third Frontier awarded $21 million to the NIT in 2014, although there was a delay in releasing the state funds. Private investments from OSU, Cardinal Health Inc. Medtronic and others were to bring the total funding to $161 million in cash and in-kind services. The goal was to launch two companies a year, creating hundreds of jobs. After the first two, there were no further announcements, and NIT filed its dissolution with the Ohio Secretary of State in June 2019.
Representatives of OSU Wexner Medical Center and Ohio Department of Development, which manages Third Frontier, were not immediately available.
