Non-Surgical Solution Or Fecal Incontinence: Interview with Miles Rosen, CEO of Pelvalon

Fecal incontinence can be extremely challenging for those who suffer it. The condition can be embarrassing, making it difficult for people to tell others or even their doctor about it, and it is more common than you might think. Fecal incontinence can affect anyone, but a key group of patients includes women during menopause, in whom it is often associated with previous pelvic trauma, such as that which occurs during child-birth.

Treatment options are relatively limited and either tend to be minimalist, such as lifestyle changes, or pretty intense, such as expensive surgical implants. There was a gap for a low-risk and low-cost treatment that could still achieve impressive efficacy. This is the niche that Pelvalon, a medtech company based in Santa Clara, California, hopes to fill.

Pelvalon’s Eclipse system is conceived as a minimally invasive solution to fecal incontinence in women. It consists of a vaginal insert that can be inflated to control the nearby rectum, where gentle pressure from the inflated insert obstructs the passage of stool. When the user needs to use the restroom, the insert can easily be deflated for that purpose.

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Medgadget had the opportunity to speak with Miles Rosen, founder and CEO at Pelvalon, about the technology.

Conn Hastings, Medgadget: Please give us an overview of fecal incontinence, and the consequences it can have for patients.

Miles Rosen, Pelvalon: Just like loss of bladder control, loss of bowel control is a pelvic floor disorder, in which symptoms often begin around the age of menopause and can trace back to child delivery or other past trauma to the pelvic region. Nerve or muscle damage in the pelvic region can affect bowel control, as can diarrhea, Irritable Bowel Syndrome or other gastrointestinal conditions. It can be embarrassing, even devastating in the wrong circumstances. Women who lose control of their bowels often feel like they have lost control of their life.

Medgadget: How common is fecal incontinence? It is rare for people to talk about it, so most are likely unaware when someone is suffering from the condition.

Miles Rosen: Since many people don’t talk about loss of bowel control, it’s more common than you might think. It affects 10-15% of women, with the average age of onset being 47 to 55. Accidents can happen on a monthly or more frequent basis. Many women report fearing a simple trip to work or the grocery store, not being able to exercise, and missing out on valuable time with friends and family. Unfortunately, many women don’t bring it up with their doctor due to embarrassment and a belief that there are not good treatment options out there.

Medgadget: How is the condition currently treated, and what are the limitations with these approaches?

Miles Rosen: Typical first-line treatments include dietary changes, exercise and medications. Until now, there really weren’t any conservative treatments that had been proven effective short of invasive surgical implants. The most widely covered therapy is a surgical device that costs over $30,000 to implant. Physicians have commented that lower risk treatments are desperately needed, as there is a large gap in the treatment algorithm.

Medgadget: Please give us an overview of the Eclipse System and how it works.

Miles Rosen: A non-surgical vaginal insert, Eclipse is placed in a similar position as a tampon and has been cleared by the Food and Drug Administration (FDA) to treat loss of bowel control. The insert contains no hormones or drugs, and can be inserted or removed at any time. A well-fit insert will be comfortable for almost all women. In fact, 96% of women who were successfully fit with the insert and completed a clinical study found it to be comfortable and either could not feel it or reported that if they could feel it, it was comfortable.

A detachable and discreet pump is used to inflate and deflate a balloon on the insert. The balloon is designed to control the rectum and prevent stool from passing before a trip to the bathroom. After a bowel movement, the balloon can be inflated again. This design allows women to actively control their bowels, while keeping the insert in place throughout the day.

Medgadget: How was the system conceived?

Miles Rosen: When I started working in the space, I was shocked to learn that fecal incontinence affects so many young, active women. Through the course of clinical trials, I’ve spoken to over a hundred patients about their condition. It strips women of having control over their lives, forcing them to give up careers, social engagements, and exercise. The uncertainty and fear associated with their loss of bowel control can be debilitating and isolating.

In talking with physicians, they would tell me that they didn’t have great solutions to offer patients, especially less invasive treatment ones. To fill this need, we worked with gynecologists to develop a new, non-surgical option for women that’s as easy to use and just as comfortable as other commonly-used female products. The technology originated from Stanford University’s Byers Center for Biodesign, a health technology innovation training program.

Medgadget: What are the advantages of the system compared with other solutions for fecal incontinence?

Miles Rosen: Eclipse has a huge advantage when it comes to the risk and cost profile. As I mentioned earlier, the only effective treatment to date is a surgical implant placed near the spine that costs over $30,000 to implant, plus ongoing annual costs. As a non-surgical vaginal insert, Eclipse can easily be removed at any time and has a dramatically different risk profile. In 10 years of clinical testing, there has never been a serious adverse event associated with the device.

Another advantage of the insert is that it is familiar to women and providers. Vaginal inserts have been used for decades with other conditions so it’s something providers and patients are used to. The user acceptance has been affirmed in the clinical data, with 96% of patients reporting that the insert was comfortable.

Additionally, Eclipse is quick and effective. Patients can leave the office continent on day one whereas with other treatments, the mechanism of action kicks in over time. Multiple clinical studies have shown the device to be over 80% effective, which is high in any disease state, but especially fecal incontinence, which has notoriously been difficult to treat.

The largest barrier for us has been reimbursement. Due to Eclipse being new type of device, it didn’t have an appropriate code and payment. With that now in place, it will significantly improve access to the technology. It will also provide cost savings to payers, as it is significantly cheaper and less invasive than the alternative treatments. Eclipse has already made a huge difference in the lives of the patients who have used it and we look forward to bringing this solution to more clinicians across the country.

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