Uro Medical

What Uro Medical does

Uro Medical Corporation is a privately held, urology-focused medical device company headquartered in Boca Raton, Florida, developing the Protect PNS neurostimulator system for the treatment of overactive bladder (OAB). The company's lead product is a wirelessly powered, battery-free microtechnology implant (0.1 cc in volume, 7 cm long, 1.35 mm in diameter) placed percutaneously at the tibial nerve via a needle, eliminating the need for invasive surgery. Therapy is delivered for approximately 8 hours per day via an external transmitter antenna embedded in clothing, with the Apple iPad serving as the programming device. The platform is designed to address refractory OAB patients who have failed first- and second-line pharmaceutical therapy, competing directly with traditional sacral neuromodulation systems that require implanted batteries replaced every 3-5 years.

Uro Medical is in a pre-commercial phase, currently enrolling patients in two FDA-regulated clinical trials: PROTECT (evaluating urgency urinary incontinence) and GUARDIAN (a ~600-subject randomized study versus standard pharmaceutical management). The company secured CMS coverage for GUARDIAN trial participants in June 2022, establishing a reimbursement pathway for the eventual commercial launch. In July 2021, Uro Medical acquired Micron Medical's urology assets, bringing in the StimGuard SNS System (CE Marked in Europe since May 2018) and adjacent neuromodulation IP. The company holds patented wireless neuromodulation technology and cites clinical outcomes including greater than 80% relief in incontinence episodes.

The intended business model is hardware sales of the Protect PNS implant plus the external transmitter system, distributed through urology and urogynecology clinical practices and hospitals, with reimbursement from Medicare, Medicaid, and private insurers post-FDA approval. No pricing has been publicly disclosed, and the company has no disclosed funding rounds, parent company, or institutional investor backing in the available data. Founded circa 2015 (under predecessor entity StimGuard, with the Uro Medical Corporation branding emerging post the 2021 Micron Medical acquisition), the company operates with 11-50 employees and is pursuing U.S. commercial launch contingent on FDA market authorization.

Name

Uro Medical

Legal name

Uro Medical Corporation

Website

https://uromedical.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Uro Medical is a privately held medical device company developing the Protect PNS, a wireless, battery-free microtechnology neurostimulator for treating refractory overactive bladder in patients who have failed pharmaceutical therapy, currently conducting FDA clinical trials ahead of U.S. commercial launch.

Ownership category

akta.pro rank

Product category

Urology Neuromodulation Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS) (HLAHAEAK)

Keywords

• Urology medical devices
• Neuromodulation systems
• Overactive bladder treatment
• Tibial nerve stimulation
• Wireless neurostimulator

Headquarters

HQ city

Boca Raton

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Medical Device Sales: Uro Medical is developing the Protect PNS neurostimulator system for FDA approval to treat overactive bladder. Once approved, the company plans to commercialize the device in the U.S. market with reimbursement coverage from Medicare/Medicaid and private insurers. Revenue will come from device sales and potentially ongoing therapy management services.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Uro Medical develops and manufactures the Protect PNS, a wireless, battery-free microtechnology neurostimulator system designed for the treatment of overactive bladder (OAB). The implant (0.1 cc, 7 cm long, 1.35 mm diameter) is placed at the tibial nerve via needle and powered by an external transmitter embedded in clothing, delivering approximately 8 hours of therapy per day. The company is currently in pre-commercial phase, supporting FDA market authorization through two multi-center clinical trials (PROTECT and GUARDIAN) targeting refractory OAB patients.

Product overview

Uro Medical is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, microtechnology neurostimulators for urology. The company's primary product is the Protect PNS System, an investigational neurostimulation device currently undergoing FDA review for market approval to treat overactive bladder (OAB). The Protect PNS consists of an implanted pulse generator (7 cm long, 1.35 mm diameter) placed at the tibial nerve with an external fabric-embedded transmitter. The company is also conducting two clinical trials (PROTECT and GUARDIAN) to support FDA approval and reimbursement coverage. The company acquired Micron Medical's urology assets including the StimGuard SNS System (CE Mark approved in Europe).

Differentiator

Problem solved

Functional benefit

Brands

• Protect PNS: Wireless powered, minimally invasive microtechnology neurostimulator system for treatment of overactive bladder (OAB). Currently under FDA regulatory review for market approval.

Products and services

• Protect PNS A wirelessly powered, minimally invasive, microtechnology neurostimulator intended to treat overactive bladder (OAB). The system consists of a 7 cm long, 1.35 mm diameter implanted pulse generator placed at the tibial nerve with an external fabric-embedded transmitter power source; therapy is administered for approximately 8 hours per day. Currently under FDA regulatory review for U.S. market approval; CE Mark approval held by predecessor StimGuard for European availability.
• StimGuard SNS System World's first wireless programmable neuromodulation device that can be introduced through a needle without surgery for treating overactive bladder. The CE Mark-approved system is 95% smaller than traditional options and uses Apple iPad as its programmer. Acquired by Uro Medical as part of Micron Medical's urology assets and serves as the European-market counterpart to the Protect PNS.

Quantifiable outcome

• Greater than 80 percent relief in incontinence episodes
• +1 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• Center for Medicare and Medicaid Services (CMS)coreOthers · 30 June 2022CMS established coverage for participants in the GUARDIAN clinical trial evaluating the Protect PNS neurostimulator device for overactive bladder treatment. This coverage supports the clinical trial and provides a pathway to future reimbursement coverage post-FDA approval.
• Micron MedicalcoreTechnology or Integration · 7 July 2021Uro Medical acquired Micron Medical's urology assets including technology and related assets. This acquisition provided Uro Medical with expanded urology-focused neurostimulation technology and assets.

Scale indicators3 records

Recent moves5 records

Expansion highlights4 records

Market position

Competitive moat3 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/uro-medical

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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

M&A1 record

Investments

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

Frequently asked questions about Uro Medical