Axena Health
Axena Health is a private medical device company commercializing the Leva Pelvic Health System, an FDA-cleared prescription digital therapeutic combining an intravaginal motion sensor with a smartphone app for at-home treatment of urinary and fecal incontinence in women.
- Company typePrivate
- Founded2017
- HeadquartersNewton, United States
- Headcount51–100
- GTM typeB2B and B2C
- OfferingHardware or Manufacturing
What Axena Health does
Axena Health, Inc. is a private, women-led medical device company headquartered in Newton, Massachusetts that commercializes the Leva Pelvic Health System, a prescription-only digital therapeutic for urinary incontinence (UI) and chronic fecal incontinence (FI) in women. The Leva System combines an FDA-cleared intravaginal motion sensor with a smartphone application that delivers a 12-week, five-minute-per-day pelvic floor muscle training (PFMT) program with real-time biofeedback visualization, clinician-monitored progress tracking, and integrated educational content including content from Mayo Clinic. Axena holds FDA Breakthrough Device Designation for chronic FI and is the first femtech product in the Digital Therapeutics Alliance product library.
The company operates a multi-channel prescription distribution model: federal healthcare via the VA Federal Supply Schedule, GSA Advantage, and DoD DAPA through SDVOSB partner Lovell Government Services; direct-to-consumer telehealth via UpScriptHealth (pharmacy distribution partner since March 2023); and commercial insurance reimbursement billed under HCPCS Level II code S9002, with named payer coverage including Cigna Healthcare. Reimbursement economics are supported by a 2025 Budget Impact Model in the Journal of Medical Economics demonstrating $1.07 PMPM cost savings over 24 months for a 1-million-member commercial health plan. The company has accumulated 11 peer-reviewed studies including RCTs and the largest real-world evidence base for an at-home FDA-cleared incontinence treatment, and is expanding an AI-integrated care pathway platform in collaboration with Mayo Clinic.
Axena has raised approximately $34.4M in venture funding (a $25M Series A led by AXA IM Alts in February 2023, plus ~$9.4M in 2024 with Cross-Border Impact Ventures, Avestria Ventures, Catalio Capital Management, and KOFA Healthcare) and is led by CEO Randy Pritchard (appointed October 2024), with Dr. Samantha Pulliam serving as Chief Medical Officer and Whitney Parachek as Chief Commercial Officer. Revenue is not publicly disclosed, but recent distribution wins, NIH PFDN TULIP trial inclusion, and global health feasibility work in Nigeria indicate an early-stage commercial company building toward institutional scale.
Axena Health firmographics
Firmographics- Name
- Axena Health
- Legal name
- Axena Health, Inc.
- Website
- https://axenahealth.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Axena Health is a private medical device company commercializing the Leva Pelvic Health System, an FDA-cleared prescription digital therapeutic combining an intravaginal motion sensor with a smartphone app for at-home treatment of urinary and fecal incontinence in women.
- Ownership category
- akta.pro rank
Axena Health industry classification
Industry- Product category
- Women's Pelvic Health Medical Devices
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Sexual & Pelvic Health Telehealth (STI care, pelvic pain, endometriosis/PCOS support) (HLALAHAJ)
Keywords
Where Axena Health is headquartered
LocationHeadquarters
- HQ city
- Newton
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Axena Health business model
Business model- GTM type
- B2B and B2C
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Marketing or Sales, Personnel, Operations
Revenue model
- Leva Pelvic Health System Device and Software: The Leva Pelvic Health System is sold as a prescription medical device combining an FDA-cleared vaginal motion sensor with integrated smartphone software. The system is available by prescription only and is reimbursed via healthcare insurance plans (HCPCS Level II code S9002) as well as government channels including the VA Federal Supply Schedule. The commercial model includes physician engagement throughout the patient treatment journey.
- Insurance Reimbursement and Payer Coverage: The Leva System is covered by commercial health plans including Cigna Healthcare and federal healthcare systems (VHA, CCN, MHS). A Budget Impact Model published in the Journal of Medical Economics demonstrated $1.07 PMPM cost savings to health plans, supporting payer coverage decisions. Total estimated 24-month cost per treated patient is $10,447 including $2,100 intervention cost.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | One time/ perpetual license | Leva Pelvic Health System - Prescription Digital Therapeutic |
Go-to-market motion3 records
Distribution channels3 records
Marketing channels6 records
Axena Health product offering
Product offeringCore offering
Axena Health develops and sells the Leva Pelvic Health System, a prescription digital therapeutic combining an FDA-cleared intravaginal motion sensor with a paired smartphone application. The system provides at-home, clinician-supervised pelvic floor muscle training (PFMT) for the first-line treatment of female urinary incontinence and chronic fecal incontinence.
Product overview
Axena Health offers a single flagship product, the Leva Pelvic Health System, which is a prescription digital therapeutic for pelvic floor disorders in women. The system consists of an FDA-cleared vaginal motion sensor (intra-vaginal probe with motion sensors) paired with the Leva smartphone application. The sensor and app work together to guide users through a 12-week at-home pelvic floor muscle training program in five minutes daily, providing real-time visualization, coaching, progress tracking, and physician oversight. The company also maintains additional companion apps (Leva and your Leva) referenced in its privacy policy. The portfolio is unified under the Leva brand, with educational and AI integration collaborations enhancing the app experience.
Differentiator
Problem solved
Functional benefit
Brands
- Leva Pelvic Health System: FDA-cleared digital therapeutic device combining a small vaginal motion sensor with a smartphone app to provide at-home guided pelvic floor muscle training for urinary and fecal incontinence treatment.
Products and services
- Leva Pelvic Health System A prescription digital therapeutic for women combining an FDA-cleared intravaginal motion sensor with a smartphone application. It provides at-home guided pelvic floor muscle training (PFMT) with real-time biofeedback and progress tracking for treatment of urinary incontinence and chronic fecal incontinence in adult women.
- Leva Mobile Application The smartphone companion application paired with the Leva Pelvic Health System sensor. Delivers guided 12-week pelvic floor muscle training, personalized coaching, educational content (including Mayo Clinic overactive bladder material), and remote progress tracking used by both patients and prescribing clinicians.
Quantifiable outcome
- Up to 80% reduction in bladder leakage with 12-week Leva treatment program, with relief lasting at least two years
- +5 more outcomes
Companies that use Axena Health
Customer profileNamed customers6 records
Segments5 records
Ideal customer profiles4 records
Axena Health technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Axena Health partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered core and minor.
- University of Wisconsin–MadisoncoreConducted a single-blind randomized controlled trial (RCT) in Urogynecology demonstrating the Leva Pelvic Health System's efficacy in treating fecal incontinence in women. The study enrolled 38 participants and showed equivalence between 8-week and 16-week treatment arms, with 63% sustained improvement at 24-week follow-up and 75% mean treatment adherence. Results were published in Urogynecology, the official journal of the American Urogynecologic Society (AUGS).
- Mayo CliniccoreExpanded collaboration with Mayo Clinic from initial February 2025 partnership to develop an AI-integrated solution for women with pelvic floor disorders. The new platform will analyze patient data to create personalized care pathways designed to reduce high treatment dropout rates. The development program initially focuses on urinary incontinence and overactive bladder, with plans to expand to additional pelvic floor treatment pathways. Mayo Clinic made an investment to further Axena's pelvic health efforts.
- University of Abuja Teaching HospitalminorNigeria-based clinical partner in feasibility study evaluating clinic-based pelvic floor muscle training using motion-based biofeedback technology combined with a digital home program for Nigerian women. The 60-woman study ran from November 2024 to June 2025, with results presented at FIGO 2025 World Congress in Cape Town.
- Lagos State University Teaching HospitalminorNigeria-based clinical partner in feasibility study evaluating clinic-based pelvic floor muscle training using motion-based biofeedback technology combined with a digital home program for Nigerian women. The 60-woman study ran from November 2024 to June 2025, with results presented at FIGO 2025 World Congress in Cape Town.
- Lovell Government ServicescoreService-Disabled Veteran-Owned Small Business (SDVOSB) vendor partnership enabling Axena Health to make the Leva Pelvic Health System available on the Department of Veterans Affairs' Federal Supply Schedule (FSS), GSA Advantage, and Department of Defense's Distribution and Pricing Agreement (DAPA). This enables female veterans to access Leva through VHA, VA Community Care Network, and Military Health System.
- National Institutes of Health (NIH) Pelvic Floor Disorders NetworkcoreNIH Pelvic Floor Disorders Network (PFDN), funded by NICHD, included the Leva Pelvic Health System in the TULIP multi-center clinical trial comparing three first-line treatments for postpartum urinary incontinence. Axena provides 72 Leva devices, technical support, and coaching sessions. Six leading clinical research sites participate: Duke, UC San Diego/Kaiser Permanente, U Chicago, UT Southwestern, UPenn, and Women and Infants Hospital (Brown).
- UpScriptHealthcorePartnership with direct-to-consumer telehealth company UpScriptHealth to offer consultation and treatment for women with urinary incontinence symptoms through the FDA-cleared Leva Pelvic Health System. The telehealth platform enables women to complete a medical history questionnaire, have an online consultation for a prescription, and access the device providing pelvic floor muscle training at home. UpScriptHealth has served as Axena's pharmacy distributor since March 2023.
- ThinkPlaceminorGlobal Design, Strategy & Innovation firm collaborating with Axena Health on large-scale research to investigate burdens of incontinence on women in low- and middle-income countries. The partnership examines how women could access treatment within local healthcare delivery systems and in a manner that accommodates cultural norms. ThinkPlace has worked with organizations including Johns Hopkins University, Bill and Melinda Gates Foundation, UNICEF, and J&J.
Scale indicators10 records
Recent moves6 records
Expansion highlights7 records
Axena Health competitors and assessment
Company assessmentDirect peers
- Elidah (ELITONE): Elidah's ELITONE is a non-invasive, FDA-cleared external pelvic floor muscle stimulation device for stress urinary incontinence in women. Directly comparable to Leva as an at-home, prescription-capable, consumer-facing incontinence treatment, with overlapping patient segments and competing biofeedback/EMS mechanism of action.
- Atlantic Therapeutics (Innovo): Atlantic Therapeutics markets the Innovo device, an FDA-cleared, non-invasive external pelvic floor stimulator for stress urinary incontinence. Directly comparable to Leva in target condition (female UI), delivery model (prescription or OTC at-home therapy), and clinical positioning as a first-line conservative treatment.
Emerging players
- Perifit: Perifit offers a connected Kegel trainer with biofeedback via a smartphone app targeting postpartum recovery and pelvic floor strengthening. Comparable consumer-facing, app-based pelvic floor strengthening model, though focused on wellness/fitness positioning rather than FDA-cleared incontinence treatment.
- Caldera Medical: Caldera Medical develops medical devices for the treatment of female pelvic floor disorders including stress urinary incontinence and pelvic organ prolapse. Comparable niche women's pelvic health medical device focus, though with a stronger surgical mesh/implant portfolio rather than digital therapeutics.
- Materna Medical: Materna Medical is an emerging women's health medical device company developing devices to reduce pelvic floor injury during childbirth and related pelvic floor indications. Comparable early-stage femtech medical device company with overlapping clinical specialty focus (urogynecology/FPMRS) and similar FDA pathway strategy.
Broad incumbents
- Hologic: Hologic is a large publicly-traded women's health medical device leader with broad diagnostics and surgical portfolios. Relevant as a broader incumbent in women's pelvic and gynecological health with established commercial channels; several Axena executives (CCO, VP) previously led businesses at Hologic.
- CooperSurgical (CooperCompanies): CooperSurgical is a large established women's health medical device and fertility company with adjacent offerings in pelvic floor and gynecological health. A broader incumbent that could expand into digital pelvic floor therapeutics or partner with Axena given its commercial footprint.
- Laborie Medical Technologies: Laborie is a global medical technology company focused on pelvic health diagnostics and therapeutics, including urodynamics and incontinence treatment products. Comparable target patient population (women with pelvic floor disorders) and overlapping clinical specialty channels (urogynecology).
- Boston Scientific (Pelvic Health): Boston Scientific has a dedicated Pelvic Health franchise offering mid-urethral slings and other surgical interventions for stress urinary incontinence and pelvic organ prolapse. A broad incumbent serving the same patient population via later-line surgical interventions, representing both competitive threat and potential M&A interest.
Others
- Renovia Inc. Renovia was the original developer of the Leva Pelvic Health System technology; Axena Health acquired the Leva technology and related assets. Functions as a predecessor entity in the same technology lineage and remains linked via the Renovia.com URL still listed in Axena's privacy policy.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights7 records
Customer concentration
Axena Health social profiles
Digital presenceAxena Health financial estimates
Financial estimateRevenue estimate
Valuation estimate
Axena Health leadership team
Management profileNumber of profiles
Profiles7 records
Axena Health funding detail
Funding detailFunding overview
Funding rounds4 records
Investors5 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Axena Health M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Axena Health
What does Axena Health do?
Axena Health develops and sells the Leva Pelvic Health System, a prescription digital therapeutic combining an FDA-cleared intravaginal motion sensor with a paired smartphone application. The system provides at-home, clinician-supervised pelvic floor muscle training (PFMT) for the first-line treatment of female urinary incontinence and chronic fecal incontinence.
Is Axena Health a public or private company?
Axena Health is a private company. It is classified as venture growth investor backed and is currently operating.
When was Axena Health founded?
Axena Health was founded in 2017. It employs 51 to 100 people.
Where is Axena Health based?
Axena Health is headquartered in Newton, United States, in the North America region.
How does Axena Health make money?
Two revenue lines are on record. Leva Pelvic Health System Device and Software is the primary driver. The others are insurance Reimbursement and Payer Coverage.
Who are Axena Health's main competitors?
Direct peers on record are Elidah (ELITONE) and Atlantic Therapeutics (Innovo). Emerging players are Perifit, Caldera Medical and Materna Medical. Broad incumbents are Hologic, CooperSurgical (CooperCompanies), Laborie Medical Technologies and Boston Scientific (Pelvic Health). Renovia Inc. is listed as an others.
Does Axena Health have an API?
No public API is recorded for Axena Health.
What industry is Axena Health in?
Axena Health's product category is Women's Pelvic Health Medical Devices. Its primary akta.pro industry code is HLALAHAJ, Sexual & Pelvic Health Telehealth (STI care, pelvic pain, endometriosis/PCOS support). Its NAICS code is 334510 and its SIC code is 3845.