As one chapter closes, another is about to unfold for serial entrepreneur Jonathan (Jon) Coe, previously co-founder and CEO of Fogarty company Prescient Surgical, which successfully treated more than 10,000 patients with technology proven to reduce the risk of surgical site infection (SSI) by over 80%.
Throughout his journey, Coe has focused on giving back to the community, including having served as a Ferolyn Fellowship host mentor and strategic advisor to several companies, most recently KelaHealth. In fact, his industry prominence sparked this new opportunity when a connection introduced him to Acoustic Wave Cell Therapy (AWCT), founded by Dr. Tom Lue, part of the team behind the discovery of Viagra, a therapy that was initially targeted for hypertension and angina.
Originating with Dr. Lue’s NIH-funded research on the effects of low-intensity shockwaves on erectile dysfunction, AWCT was founded to commercialize novel therapies focused on women’s health, with a promising concept designed to treat female stress urinary incontinence, a condition that affects 24 to 45% of women older than 30.
An overdue solution to a silent epidemic
The external therapy delivers low-intensity shockwaves that activate progenitor cells to promote the growth of new muscle, nerve, and vascular tissue. As Coe explains it, “Over time, these biological benefits improve the quality of the urothelial lining and strengthen the ability to hold back when our bladders say it’s time to pee. Normally, when we think ‘not now’ our brain activates the striated muscle in the external urinary sphincter to prevent leakage. But as we age, this muscle weakens, and we can’t directly exercise this critical structure. AWCT’s approach directly strengthens this muscle ”
The therapy consists of an 11-minute treatment twice a week for five to eight weeks, with results typically emerging within a month. There has been much interest in the current pivotal study, which started in March and includes 130 women in seven different centers across the United States. Coe anticipates the study will conclude at the end of 2026, at which point they will seek FDA approval. “So far we’ve received really positive feedback from the women who have been treated, confirming it’s a promising and comfortable therapy,” he said.
The therapy has an immense potential to change lives. “When I talk with women who live with incontinence, the recurring themes revolve around shame and insecurity,” he said. “So many women are what we call ‘silent sufferers,’ and have resigned themselves to daily pad or diaper wear. These are the women we are excited to serve.”
The causes are many—from unresolved childbirth-related issues to conditions including diabetes, multiple sclerosis, obesity and more. Coe repeatedly hears that women would welcome an alternative to current incontinence treatments, which are often ineffective and inconvenient, such as Kegel exercises under the supervision of a physical therapist, or overly invasive, including sling surgery or a gel injected into the urethra.
The AWCT team consists of a cross-functional group of experts, including two who have been affiliated with Fogarty: Jeremy Koehler, also formerly of Prescient, who is vice president of research and development; and Tammy Morton, formerly of Materna Medical, who is vice president of clinical affairs. Another pivotal team member is Roger Dmochowski, AWCT’s medical advisor.
An appreciation for the “Fogarty family”
Coe is currently working on raising the remainder of series C funding as they build out their commercialization strategy. It’s a topic in which he’s well-versed, having frequently participated in relevant workshops sharing his own stories, but also having learned from others like Marga Ortigas-Wedekind, Fogarty’s chief commercial strategy officer.
Coe recalls Ortigas-Wedekind’s observation that sometimes a non-linear approach to the business model makes sense. This strategy has led to a somewhat unconventional introduction plan: While the company eventually plans to pursue reimbursement—allowing the therapy to be administered by urologists, gynecologists and other physicians—because a specialist is not required, the initial marketing strategy will focus on private medical clinics treating a range of aesthetic and medical conditions, many of which already have the relevant set-up and a steady stream of potential patients.
As he enters the underserved women’s health market, Coe appreciates the opportunity to talk with other successful Fogarty-affiliated companies in this area, such as Tracy MacNeal, CEO of Materna Medical. “It’s so helpful to collaborate with other CEOs and help each other out—especially as we aim to focus on meaningful clinical outcomes and patient benefits. The market is big enough for all of us to win, and it’s a community with built-in trust.”