What Flyte does

Flyte, a trade name of Pelvital USA, Inc., is a femtech medical device company headquartered in Eagan, Minnesota, that develops the FDA-cleared Flyte device — an at-home therapeutic stimulation system for the treatment of stress urinary incontinence (SUI) and pelvic floor muscle weakness in women. The device delivers clinically proven pelvic floor muscle stimulation and rehabilitation in a home-use setting, positioning it as a non-invasive alternative to surgery and a substitute for repeated clinic-based pelvic floor therapy visits. The company was founded in 2016 and currently operates with 1-10 employees, reflecting its early-stage commercial posture despite regulatory clearance.

The company's business model is built on one-time hardware sales of the Flyte device to individual consumers, primarily women experiencing SUI, accessed through a direct-to-consumer e-commerce storefront at flytetherapy.com. Pricing is not publicly disclosed; customers are funneled through a 'Request Flyte' quote flow, with a sales-assisted 'Ask an Expert' concierge channel staffed by physical therapists. A secondary healthcare-provider channel is operated through a dedicated clinician portal at flytesystem.com, which supports clinician education, prescription, and patient referrals into the consumer purchase flow. The product is supported by an educational content marketing strategy (blog, incontinence quiz) targeting top-of-funnel awareness and a recently published peer-reviewed clinical study in ScienceDirect that strengthens clinical credibility with providers and patients.

Across its history, Pelvital has raised roughly $6.8M in disclosed funding across five rounds (2019-2024), with the most recent activity being a $2.32M seed-plus round in April 2024 led by Boomerang Ventures, following a $2.68M seed round in August 2023. Leadership comprises Lydia Zeller (President & CEO), Ryan Willemsen (COO), and Luke Dery (Co-Founder and VP Operations). The company operates exclusively in the U.S. market and competes in a pelvic floor health technology market projected to grow from USD 1.4B (2026) to USD 3.0B (2035) at an 8.6% CAGR.

Name

Flyte

Legal name

Pelvital USA, Inc.

Website

https://pelvital.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

1–10 employees

Short description

Flyte, a trade name of Pelvital USA, Inc., is a Minnesota-based femtech company that sells an FDA-cleared at-home medical device for treating stress urinary incontinence and pelvic floor muscle weakness in women, distributed via direct-to-consumer e-commerce and a clinician referral channel.

Ownership category

akta.pro rank

Product category

Pelvic Floor Therapy Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Pelvic Floor Physical Therapy (Women’s & Men’s Health) (HSADAIAG)

Keywords

• Pelvic floor therapy
• Urinary incontinence treatment
• At-home medical device
• Women's health device
• Stress incontinence therapy

Headquarters

HQ city

Minneapolis

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Marketing or Sales, Operations, Personnel

Revenue model

1. Medical Device Sales: Sale of FDA-cleared Flyte device for at-home pelvic floor treatment. One-time hardware purchase with potential for consumables/accessories. Targets patients with stress urinary incontinence seeking non-surgical treatment alternatives.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Flyte is an FDA-cleared at-home medical device that uses therapeutic stimulation technology to treat stress urinary incontinence and pelvic floor muscle weakness. The product enables women to self-administer clinically proven pelvic floor therapy at home as a non-invasive alternative to surgery, with healthcare provider referrals supported through a separate clinical portal.

Product overview

Flyte is a single FDA-cleared at-home treatment device designed for stress urinary incontinence and pelvic floor muscle weakness. The product consists of an implantable-like device system that patients use at home for pelvic floor therapy. Pelvital offers the device through their consumer website (flytetherapy.com) and also serves health professionals through a separate portal (flytesystem.com).

Differentiator

Problem solved

Functional benefit

Products and services

• Flyte FDA-cleared at-home medical device that uses therapeutic stimulation technology to treat stress urinary incontinence and pelvic floor muscle weakness in women, offered as a non-invasive alternative to surgery.

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Atlantic Therapeutics (INNOVO): Atlantic Therapeutics manufactures INNOVO, an FDA-cleared, non-invasive at-home electrical stimulation device for stress urinary incontinence, directly competing with Flyte's mechanism, regulatory clearance, and D2C/prescriber go-to-market.
• Renovia: Renovia developed the Leva pelvic floor device for at-home treatment of SUI, competing head-to-head with Flyte in clinical positioning, FDA-cleared electrical muscle stimulation, and a clinician-channel + D2C model in women's pelvic health.
• InControl Medical: InControl Medical markets Apex, an FDA-cleared at-home device for incontinence and pelvic floor therapy. It competes with Flyte on product mechanism (intravaginal stimulation), target patient (women with SUI), and prescriber/D2C distribution.
• Elvie: Elvie is a femtech brand selling consumer pelvic floor trainers (Elvie Trainer) alongside maternal health hardware. It overlaps with Flyte on women's pelvic floor strengthening and D2C e-commerce positioning, though its device is more lifestyle/coach than FDA-cleared therapy.
• Perifit: Perifit sells app-connected Kegel trainer devices targeting at-home pelvic floor strengthening. It competes with Flyte on the at-home pelvic floor category and D2C e-commerce marketing, though it leans more biofeedback than electrical stimulation.

Broad incumbents

• Hologic: Hologic is a large women's health company with diagnostics, surgical, and medical device portfolios. It overlaps with Flyte on women's pelvic health and provider-channel relationships, though its core business is broader capital equipment and diagnostics rather than at-home SUI therapy.
• CooperSurgical: CooperSurgical is a major women's health medical device company serving OB/GYNs and reproductive specialists. Its provider footprint makes it an overlapping channel partner for Flyte's clinician-referral motion, though its core portfolio is broader than SUI therapy.

Regional players

• Joyu: Joyu is a China-based femtech company developing at-home pelvic floor devices, comparable in product mechanism (electrical stimulation) and target condition, but operating primarily in a different geography than Flyte's US focus.

Emerging players

• MysteryVibe: MysteryVibe builds app-connected pelvic floor devices targeting sexual health and incontinence. It overlaps with Flyte on women's pelvic floor therapy and D2C distribution, but is earlier-stage and more lifestyle-adjacent.
• Analytic Technologies (PeriCoach): PeriCoach was an FDA-cleared pelvic floor training system with biofeedback for at-home SUI therapy, directly comparable to Flyte's clinical positioning. Note: the company's current operating status is uncertain from public sources.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds5 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Flyte