Axena is focused on women's pelvic health treatments. 32% of adult women in the United States have at least one pelvic floor disorder, but the go-to first line of treatment - pelvic floor muscle exercises, like Kegels - are often done incorrectly or not at all. Axena offers an alternative first-line treatment - the Leva® Pelvic Health System. Leva® is a FDA-cleared and insurance-reimbursed treatment for urinary and fecal incontinence. It utilizes a motion sensor device, real-time patient biofeedback, data delivery to the supervising clinician, and patient coaching to help women perform their pelvic floor muscle exercise correctly, and, in the process, overcome any ineffectiveness and the subsequent emotional, psychological, and social challenges of a pelvic floor disorder, such as incontinence. 

CEO: Eileen Maus

Headquarters: Newton, MA

Year Founded: 2023

Year Avestria First Invested: 2023 (Fund II)

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Recent Press:

March 8, 2024: This profile from Medtech Insight highlights CEO Eileen Maus. In it, she describes the focus of Axena’s Leva®, sharing that about 60% of U.S women had at least some symptoms and incontinence is the second most popular reason as to why women are admitted to nursing homes. But, her work goes beyond just addressing urinary incontinence - it is about generating strong data to help company, clinicians, patients, and providers, encouraging women to advocate for themselves and their healthcare, and going beyond expectations, even in the face of adversity.

March 8, 2024: In conjecture with ThinkPlace Kenya, Axena has published a report focusing on urinary incontinence in women in Sub-Saharan Africa. The report also covers the experiences of healthcare professionals involved in the care of urinary incontinence. The aims of this report are multifold: to inform product development work, to document the burden of incontinence in target markets, to advocate for treatment funding for incontinence and other pelvic floor disorders, and to encourage others to engage in pelvic floor disorder-related research in Africa. (Read the corresponding press release here.)

March 4, 2024: The Centers for Medicare & Medicaid Services’ (CMS) new Healthcare Common Procedure Coding System (HCPCS) Level II code covers the Leva® Pelvic Health System. Clinicians, distributors, payors, and patients now have another way to access Leva® as a treatment option: either through the HCPCS code or though Leva®’s previously established pharmacy code.

January 23, 2024: In this press release, Axena commended the publication of Leva®’s results in the International Urogynceology Journal. As the Lead Author, Milena M. Weinstein, MD, FACOG, FACS, shared, there is sparse data regarding the use of pelvic floor muscle training for urinary incontinence. This study’s publication, thus, not only demonstrates the benefits of Leva but also may encourage additional research into pelvic floor muscle training and urinary incontinence in general.

January 22, 2024: While Kegels, one of the most common treatments for pelvic floor weaknesses and disorders, are accessible, they tend to be ineffective for many women. Meanwhile, urinary incontinence patients tend to skip treatment such as medications or surgeries. Axena’s new study aims to understand the journey for urinary incontinence patients and the barriers they face. The Axena team also hopes the findings from this study will continue to convince payors and providers to support women’s access to first-line treatments, like Leva®.

January 21, 2024: The longitudinal analysis of Leva®-assisted therapy was published in International Urogynecology Journal. The study found that those who completed eight weeks of pelvic floor muscle training (PFMT) guided by Leva showed durable and significantly greater urinary incontinence symptom improvement than those who completed a standard at-home program over 24 months. Even after the first group stopped their guided pelvic floor muscle training, they still saw symptom relief for up to two years afterwards. The study is the second longitudinal analysis of an original randomized controlled clinical trial (RCT) published in Obstetrics and Gynecology (The Green Journal) in April 2022, and the abstract for this study was named “Best Overall Abstract Presentation,” from the International Urogynecological Association (IUGA) at its 2023 annual meeting.

January 9, 2024: Axena has partnered with four new distributors for its Leva® Pelvic Health System. Byram Healthcare, EVERSANA, J&B Medical and OneSource Medical Group, LLC now offer Leva®, which is a prescription device. This partnerships allow an increased number of women to access Leva® and its benefits: effective, non-invasive, and medication-free first-line treatment for urinary and fecal incontinence.

December 6, 2023: In this article for MedCity News, Axena’s Chief Medical Officer, Dr. Samantha Pulliam, argues that female incontinence is now a public health crisis. Fetal and urinary incontinence affect over 90 million women around the world, and the prevalence is only rising. But, because of the stigma associated with fetal and/or urinary incontinence, only one in nine women with self-reported urinary incontinence receive treatment. Naming incontinence as a public health crisis, she concludes, will not only help raise awareness but also support improved access to screenings and treatment.

December 5, 2023: Silicon Valley Bank (SVB)’s inaugural “Innovation in Women’s Health 2023” puts the spotlight on women’s health: on both its need for funding and R&D and on the founders and companies heading innovations in the space. Axena was featured as a notable deal in devices, one of the largest women’s health-focused deals in 2023, and one of the companies serving women in their later years. Antiva Biosciences, AOA, Madorra, Mae, and Midi - five other Avestria portfolio companies - were also mentioned throughout the report.

October 7, 2023: Eight weeks of treatment with the Leva® Pelvic Health System can lead to urinary incontinence symptom relief for two years according to the latest research on Axena Health’s device. Presented at PFD Week 2023- the American Urogynecologic Society’s (AUGS) annual scientific meeting - this data also showed that Leva® improved symptoms of early-stage pelvic organ prolapse and provided “durable and significantly greater improvement” in urinary incontinence symptoms compared to a home-based program of pelvic floor muscle training alone (which doesn’t offer the same guidance and feedback as Leva®). These results were consistent even if the women didn’t continue using Leva® past the eight week trial period.

October 2, 2023: AARP, formerly the American Association of Retired Persons, listed Axena’s Leva® Pelvic Health System as one of its top five breakthroughs in women’s health in 2023. The article titled Leva® “high-tech help for incontinence” and shared that patients using Leva® reported significantly greater improvement in incontinence than those exercising on their own.

August 15, 2023: In its mid-year 2023 healthcare report, Silicon Valley Bank (SVB) named women’s health as the sector to watch, writing “Now more than ever, it is evident that investment into this space can bring impressive returns for multiple players, including investors, providers and payers.” The report also included a market map of women’s health subsectors that have raised the most amount of funds from venture capital investors since 2015, and Axena’s Leva® Pelvic Health System was included in the “Pelvic Health” subsector. Antiva Biosciences, AOA, Curio, Madorra, and Midi - five other Avestria portfolio companies - also made the market map across subsectors.

June 22, 2023: The researchers who presented a study showing the benefits of Leva® won the “Best Overall Abstract Presentation” from the International Urogynecological Association (IUGA). Lead author Dr. Milena M. Weinstein of Massachusetts General Hospital, Harvard Medical School, presented the abstract at the International Urogynecological Association (IUGA)’s annual meeting in The Netherlands in mid-June.

June 20, 2023: Axena’s Leva® Pelvic Health System is now available to treat both urinary and fecal incontinence. Leva originally received FDA 510(k) clearance to treat stress, mixed, and mild-to-moderate urinary incontinence (UI) in 2022. Following further indication clearance by the FDA, Leva® can now also treat fetal incontinence: a condition that, like urinary incontinence, can be improved by pelvic muscle floor training, but also goes unreported and untreated due to the stigma around it.

May 17, 2023: Axena Health has begun a global study into women’s urinary and fecal incontinence, specifically looking at the burden of these health conditions in low- and middle-income countries to support global and equitable access to treatment. The study will follow women in Nigeria and Kenya and will encompass their accessibility to treatment options and the culture around these health conditions and their treatments. The second phase of the research will cover additional African countries as well as those in South Asia.

March 22, 2023: Cigna Healthcare announced that the Leva® Pelvic Health System is a covered treatment for stress, urgency and mixed urinary incontinence (UI) in women. Cigna recently published a study that said that only 25% of women perform pelvic floor muscle training (PFMT) - which is an established treatment option for urinary and fetal incontinence - adequately. Leva can help women strengthen their pelvic floor muscles correctly while in the comfort of their own in just around five minutes a day. Cigna currently has has over 115 million members in the United States.

March 1, 2023: The one-year longitudinal follow up to Axena’s pivotal randomized controlled superiority trial has been published in Obstetrics and Gynecology. The study found that pelvic floor muscle training (PFMT) guided by Axena’s Leva® Pelvic Health System yielded significantly greater symptom improvement for urinary incontinence (UI) and fecal incontinence (FI) than PFMT practiced by Kegel exercises. The study, which is one of the first to track symptom improvement for non-surgical UI and FI interventions, also measured outcomes at both six months and 12 months and follows up on “Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial,” which Obstetrics and Gynecology published in April 2022.

February 20, 2023: Axena Health announced a $25 million dollar Series A raise to support its pelvic floor digital therapeutic: the Leva® Pelvic Health System. Axena acquired the Leva system from Renovia, which received FDA 510(k) clearance for it in 2022. The Leva® system includes a vaginal motion sensor that connects through an app and guides women through pelvic floor exercises that can help reduce urinary and fecal incontinence.

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