What BlueWind Medical does

BlueWind Medical is a privately held medical device company founded in 2010 by the Rainbow Medical Group and headquartered in Salt Lake City, Utah, with additional operations in Herzliya, Israel (R&D and engineering) and Galway, Ireland (EMEA). The company develops and commercializes the Revi System, an implantable tibial neuromodulation platform for the treatment of urge urinary incontinence (UUI) in adults. The system consists of a 3 cm × 3 mm leadless, battery-less implant placed near the tibial nerve in the ankle during a single outpatient procedure under local anesthesia, wirelessly powered by an external battery-operated Revi Wearable (~30 min/day of therapy). The platform is completed by an iPad-based Clinician Programmer for parameter customization and a Revi Hub that wirelessly transmits therapy data back to the clinician. The 10-year implant lifetime and MR Conditional (1.5T/3T) status are core design differentiators relative to traditional sacral neuromodulation.

The Revi System received FDA De Novo classification in August 2023 — making it the first FDA-cleared implantable neuromodulation device usable without prior failure on more conservative treatments — followed by FDA 510(k) clearance for an enhanced Revi Wearable in December 2025. Three-year OASIS pivotal data (N=151 enrolled, 23 centers across U.S./U.K./Europe; N=90 completers) showed 95% patient satisfaction, 79% with ≥50% UUI reduction, 63% with ≥75% reduction, and 28% dry on a 3-day diary at 36 months, with no device- or procedure-related serious adverse events. The OASIS data and 2024 AUA/SUFU idiopathic OAB guideline inclusion allow Revi to be considered earlier in the treatment journey.

BlueWind generates revenue primarily through hardware sales of the Revi System (Implant + Wearable + Clinician Programmer + Hub) to healthcare providers and outpatient facilities, with a recurring replacement stream from the 1-year service-life Wearable. CMS proposed a 2025 reimbursement rate of ~$19,464 per subfascial implantable tibial neuromodulation procedure — a ~38% YoY increase. The company goes to market via direct field sales to urologists and urogynecologists, a state-by-state U.S. rollout (Louisiana, Ohio, Texas, Utah, Florida), a provider self-service digital portal, and a patient-facing awareness motion; patient access is supported by the Revi Access program (powered by JDL Access) for prior authorization and appeals. Disclosed funding totals at least $111.8M ($64M in May 2022 and $47.8M in May 2026), and the company won the 2025 MedTech Breakthrough "Best New Technology Solution – Therapeutics" award.

Name

BlueWind Medical

Legal name

BlueWind Medical, Inc.

Website

https://bluewindmedical.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

101–250 employees

Short description

BlueWind Medical commercializes the Revi System, a leadless, battery-less implantable tibial neuromodulation platform for treating urge urinary incontinence in adults. Founded in 2010 by the Rainbow Medical Group, the Salt Lake City-based company received FDA De Novo in August 2023 and raised $47.8M in 2026.

Ownership category

akta.pro rank

Product category

Implantable Neuromodulation Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

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

akta.pro secondary industry

Remote Therapeutic Monitoring (RTM) & Digital Rehabilitation Platforms (HLALABAK)

Keywords

• Tibial neuromodulation systems
• Implantable neurostimulation devices
• Urinary incontinence treatment
• Wireless peripheral nerve stimulation
• Overactive bladder therapy

Headquarters

HQ city

Salt Lake City

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Revi System hardware sales (implant + wearable + clinician programmer + hub): Revenue from sale of the Revi neuromodulation system to healthcare providers/hospitals that perform the outpatient implantation procedure; aligned with expanding the commercial sales organization and broader market access.
2. Revi Wearable device replacement (1-year service life): Revi Wearable Device has a stated service life of 1 year, implying recurring replacement revenue from the external wearable component, separate from the 10-year implant lifespan.
3. Patient access / reimbursement support services via Revi Access: Revi Access (powered by partner JDL Access) supports providers and patients through prior authorizations, pre-service appeals, post-service appeals and external review (IRO) submissions, supporting realized reimbursement and procedure volume.

Pricing tiers

Go-to-market motion4 records

Distribution channels5 records

Marketing channels9 records

Core offering

BlueWind Medical develops and sells the Revi System, an implantable tibial neuromodulation platform for treating urge urinary incontinence (UUI) in adults. The system comprises a miniature leadless, battery-less implant (3 cm long, 3 mm diameter) placed near the tibial nerve in a single outpatient procedure, wirelessly powered by an external battery-operated Wearable, plus a clinician programmer (iPad-based) and a Hub that transmits therapy data.

Product overview

BlueWind Medical's offering is a single unified neuromodulation platform, the Revi® System, for treating urgency urinary incontinence (UUI) in adults. The platform is composed of four integrated hardware components that work together: the Revi Implant (a 3 cm leadless tibial implant), the Revi Wearable (an external battery-powered activator worn on the ankle), the Revi Clinician Programmer (an iPad-based clinician tool for parameter customization), and the Revi Hub (a wireless communicator that relays therapy data to clinicians). Together these deliver a single-procedure, externally-powered, MR-conditional therapy with no implanted battery and no leads. Surrounding the device, BlueWind also operates Revi Access (powered by JDL Access), a non-device patient access service that supports prior authorization and insurance appeals for the therapy.

Differentiator

Problem solved

Functional benefit

Products and services

• Revi System Integrated implantable tibial neuromodulation therapy for urgency urinary incontinence (UUI) in adults, consisting of a miniature leadless tibial implant activated wirelessly by an external battery-powered Wearable, plus a Clinician Programmer and Hub; delivered via a single outpatient procedure under local anesthesia. Designed for adult patients with UUI and the urologists/urogynecologists who implant it.
• Revi Implant Miniature battery-less implant (3 cm long, 3 mm in diameter) placed in the ankle region near the tibial nerve during a single outpatient procedure under local anesthesia. Delivers tibial neuromodulation via subfascial placement with direct visualization of the tibial nerve, intraoperative testing, and suture fixation. MR Conditional for 1.5T and 3T full body MR scans; 10-year implant lifetime. A component of the Revi System, sold to healthcare providers implanting it in UUI patients.
• Revi Wearable (Enhanced) Battery-operated external wearable worn around the ankle that wirelessly powers the Revi Implant and delivers therapy on the patient's schedule. Supports multiple pre-set treatment programs patients can adjust; water-resistant with a 1-year service life. A component of the Revi System, sold to healthcare providers for patient use.
• Revi Clinician Programmer iPad-based clinician programmer that customizes Revi therapy for each patient by adjusting frequency, pulse width, polarity, and amplitude, and supports intra-operative testing and post-implant reprogramming. Functions as a monitor during the surgical procedure outside the sterile field. A component of the Revi System, sold to healthcare providers.
• Revi Hub Wireless home communicator that automatically receives therapy data from the Revi Wearable when placed nearby, giving clinicians visibility into device usage and status to support and optimize patient therapy. A component of the Revi System, sold to healthcare providers.
• Revi Access (powered by JDL Access) Patient access support program powered by third-party partner JDL Access that helps providers and patients obtain insurance coverage for the Revi System via prior authorization submissions, pre-service and post-service claims appeals, eligibility/benefit verification, and external independent review organization (IRO) submissions.

Quantifiable outcome

• 95% patient satisfaction with Revi therapy at 36 months (OASIS completers, N=87)
• +6 more outcomes

Named customers1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Three partnerships are on record, tiered core operational partner and minor / community.

• JDL Access (Revi Access program)core operational partnerImplementation/ SI/ Consulting PartnerPowers the 'Revi Access' patient access program for BlueWind. JDL Access works directly with healthcare providers and patients' insurance companies to submit prior authorizations, pre-service and post-service appeals, and external (IRO) reviews until a final coverage decision is reached. Integrated into the provider enrollment workflow and offered to enrolled physician offices.
• MDMA (Medical Device Manufacturers Association)minor / communityOthersBlueWind Medical is a proud member of MDMA, displayed on the Compliance page with a logo linking to the MDMA membership site — a trade association for the medical device industry.
• AUA / SUFU (American Urological Association / Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction)Others

Scale indicators10 records

Recent moves11 records

Expansion highlights6 records

Broad incumbents

• Allergan / AbbVie (Botox): Markets onabotulinumtoxinA (Botox) for idiopathic OAB. Established third-line procedural therapy for UUI and a direct competitor for the refractory patient segment BlueWind is targeting with Revi.
• Laborie Medical Technologies: Large urology-focused medical device company offering a broad portfolio of diagnostic and therapeutic urology products. Acquired Cogentix/Urgent PC and competes with BlueWind through both tibial neuromodulation and adjacent urology categories.
• Inspire Medical Systems: Public neuromodulation company with an FDA-approved, implanted hypoglossal nerve stimulator for obstructive sleep apnea. Comparable specialty-neuromodulation commercial model and reimbursement-build playbook, though in a different therapeutic indication.
• Urovant Sciences (Sumitovant/Sumitomo): Urology-focused company commercializing vibegron (GEMTESA) for OAB, the leading oral pharmacotherapy competitor. Indirectly competes with Revi for the same UUI patient pool, particularly relevant given high medication discontinuation rates.

Emerging players

• Valencia Technologies (eCoin): Develops the eCoin leadless, coin-sized implantable tibial neuromodulation device for urge urinary incontinence. Closest direct implant-form-factor competitor to Revi, with overlapping regulatory and clinical positioning.
• Neuspera Medical: Miniaturized, wirelessly powered neuromodulation platform pursuing urology and other indications. Adjacent technology peer with overlapping miniaturized, battery-less implant architecture relevant to BlueWind's IP approach.

Direct peers

• Axonics (Boston Scientific): Sacral neuromodulation competitor to Revi in OAB/urinary incontinence, now owned by Boston Scientific. Offers miniaturized, MRI-conditional SNM systems targeting the same urology provider base that BlueWind is building out.
• Medtronic: Markets the InterStim sacral neuromodulation system for OAB and UUI. Directly competes with BlueWind's Revi in the same urology call point, though Medtronic's technology is sacral (not tibial) and uses a traditional implanted battery and lead.
• Cogentix Medical (now part of Laborie): Markets the Urgent PC percutaneous tibial neuromodulation system for OAB. The most direct non-implantable competitor to Revi in tibial neuromodulation, addressing the same patient population with a non-implant approach.

Others

• Convatec: Wound, ostomy, continence and infusion care company that participated in BlueWind's 2022 $64M financing round and whose executive Evy Douglas sits on BlueWind's board. Ecosystem/investor peer with adjacent continence-care commercial overlap.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xtwitter.com/bluewindinc
• LinkedInlinkedin.com/company/2243132

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Subsidiaries2 records

Funding overview

Funding rounds4 records

Investors2 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 BlueWind Medical