Q: Who is Pelvital and what is Flyte?

A: Pelvital is a women’s health medical device company. We often call ourselves a FemTech sector company, and we’re best known by our product name, Flyte.

Flyte is a novel FDA-cleared treatment for female urinary incontinence. What is exciting about us is that by using a novel mechanism of action, we deliver both continence rates and durability of treatment effect comparable to surgery in a fast, convenient in-home treatment.

Q: What sets the Flyte device apart from the competition?

A: We are the first and only product to use a device to deliver a treatment modality called mechanotherapy to the pelvic floor. Mechanotherapy is the clinical application of a scientific principle called mechanotransduction for tissue repair and rehabilitation. Mechanotransduction is the principle under which cells sense and respond to mechanical stimuli.

There are two effects: first, there’s a cellular level effect, where applying mechanical forces to cells essentially causes micro-injury, and the cell responds with tissue repair. The second is on the neuromuscular level; by stimulating the tonic vibration reflex, you ultimately create neuromuscular memory. So, you have tissue repair and the creation of neuromuscular memory, which drives outcomes, both in terms of initial outcomes and the durability of effect.

Other devices either use electrical stimulation, which is very different from mechanical stimulation, or use biofeedback, also called a Kegel trainer, which gives a woman information on whether she’s doing her Kegels correctly but does not deliver a therapeutic treatment.

Q: In the FemTech space, how is this technology delivering a solution among women?

A: Urinary incontinence has historically been stigmatized or not openly discussed, similar to how mental health used to be. We’re beginning to have better conversations about it, but studies show that in the U.S., urinary incontinence impacts 60 percent of women at some point in their lives. So, it’s a big, big problem.

And historically, there has been a lack of clinically proven conservative options. Commonly, when a woman goes into her OB/GYN or primary care with incontinence, that clinician really has two options: 1) refer the woman to urogynecology, and that path is typically going to lead to surgery or potentially a bulking agent, or 2) refer the woman to pelvic floor physical therapy. Pelvic floor physical therapy is the only conservative treatment that has been clinically shown to be efficacious. However, only 1% of physical therapists specialize in the pelvic floor, an issue impacting so many women.

Flyte offers an alternative to surgery and pelvic floor PT when accessing PT is difficult. Flyte can be used with pelvic floor PT, but we’re also a great option when there’s no access to pelvic floor PT specifically for incontinence.

Q: Among healthcare professionals, what are some verticals outside of women’s care where Flyte is experiencing traction or interest?

A: Right now, women can still purchase Flyte over-the-counter on our website. But our focus is entirely on  B2B contracts. We are committed to reimbursement coverage for Flyte because 1) insurance coverage is the key to broad access, and 2) a woman should not have to pay out-of-pocket to treat her incontinence.

We’re currently working with early adopter payers, and we do have traction now with two payers and driving utilization in the clinics within those payer systems.

Beyond OB/GYN, primary care, and pelvic floor PT, we have champions among urologists and urogynecologists. Fundamentally however, Flyte is an upstream conservative treatment, so the best place to save both money and avoid unnecessary procedures for the woman and the healthcare system is prescription of Flyte as high upstream as possible, typically OB/GYN, primary care, or PT.

Q: How long does a woman need to use Flyte to overcome urinary incontinence?

A: In our studies, Flyte has durability at two years among women who used Flyte for five minutes per day for six weeks. That said, we don’t claim that you can use Flyte for six weeks when you’re 35, and then at age 85, you’re still continent. In our consumer data, women really vary. Some women use Flyte for six weeks, achieve their desired results, and stop using it. Other women use it once weekly or monthly—the frequency varies. It’s whatever works for an individual woman or what her clinician recommends for her.

Q: Does Flyte pair with a mobile application to track and store user’s performance and usage?

A: Yes, in Q1  2024, with our new Flyte product. This will provide a lot of interesting data regarding usage because we’ll have anonymized data to analyze, looking at what percentage of women continue to use Flyte after six weeks and their outcomes.

Q: How has the Boomerang Ventures’ partnership helped Flyte?

A: Boomerang Ventures’ lead investment in Flyte’s seed round has been pivotal in our efforts, and the Boomerang team’s introductions among health systems and payers have been very helpful. Plus, Boomerang brought other investors to the table, and Boomerang’s due diligence has been very helpful with other groups. Boomerang is an excellent collaborative partner. They are good people to talk with about challenges and help find solutions.

Q: Looking ahead at future products from Pelvital, what are some aspirations for innovations in this space?

A: Mechanotherapy really is a platform technology. The first is expanding into different additional pelvic health indications, and we can grow into male health as well, even though we’re a FemTech company presently. Plus, the IP contemplates applications beyond the pelvic floor.

Q: On the consumer side, what offers or resources do you provide women on the fence about purchasing Flyte?

A: We offer a performance money-back guarantee, meaning if you purchase Flyte and it doesn’t work for you, you can return it and get your money back. We have about a 1.2% return rate, so the proof is in the pudding regarding efficacy. Also, for a woman who is considering Flyte or even unsure what to do about pelvic health, we have a “Free Ask a Pelvic PT” service where you can speak with an actual pelvic floor Doctor of Physical Therapy. This free service can help guide you on whether Flyte is a good fit or direct you to other resources.

Q: Final thoughts to share?

A: We’re empowering both clinicians and women with a clinically proven, effective, durable in-home treatment that’s comparable to surgery. That is a powerful thing. We seek to transform that gold standard of care for conservative incontinence treatment. In the last six months, we’ve made tremendous strides. We have traction with two payers. Now, it’s about raising awareness and driving utilization. And lastly, we committed to increasing access by obtaining broad reimbursement coverage for Flyte.

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Learn more about Flyte by Pelvital, visit https://flytetherapy.com/.