Articles from Axena Health, Inc.

Axena Health, Inc. (Axena Health), a women’s health company redefining the standard of care for pelvic health conditions through clinically proven, non-invasive treatments, today announced female veterans now have access to the Leva Pelvic Health System through their federal healthcare providers, including the Veterans Health Administration (VHA), VA Community Care Network (CCN) and Military Health System (MHS).

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, today announced that researchers in Nigeria are enrolling women in a feasibility study examining a novel treatment modality for female incontinence. The study will assess a clinic-based treatment program at two research sites in Nigeria, which leverages Leva® Pelvic Health System technology coupled with a home-based, digital program of health education and instruction on pelvic floor muscle training (PFMT). ArcHealth Foundation, Inc., a 501(c)(3) public charity that supports equitable and affordable access to health technologies globally, issued a grant to support in-country data management by Helium Health, a leader in healthcare digitization across Africa who is accelerating the Continent’s transition to a technology and data driven healthcare sector.

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, today announced the appointment of Erica Rogers to its Board of Directors. Known for her transformative leadership in the medical device industry, Rogers brings over two decades of expertise, including her tenure as President and CEO of Silk Road Medical, where she guided the company from early stages through its IPO and commercial expansion, pioneering advancements in stroke prevention.

AUGS PFD Week 2024 booth 611—Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, announced that researchers have identified a potential machine learning model clinicians could use to create personalized treatments for female pelvic floor disorders. Based on an analysis of over 600 real-world patients, researchers from Massachusetts General Hospital, Massachusetts Institute of Technology, and Axena Health used machine learning to identify trends that may enable clinicians to personalize first-line treatment for female urinary incontinence and improve the identification of patients who may need advanced treatments such as sacral neuromodulation. The abstract authors will present the data in an oral abstract on Thursday October 24 at 3:55 pm at PFD Week 2023, the American Urogynecologic Society (AUGS) annual scientific meeting in Washington, DC. Researchers used the Leva® Pelvic Health System in the study.

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, today announced the appointment of Randy Pritchard as its new Chief Executive Officer, effective immediately. Pritchard brings nearly 25 years of experience in medical device and health technology, including leadership in driving commercial success, innovation, and strategic opportunities. His extensive background will be critical in advancing Axena Health’s mission to improve the lives of women affected by pelvic floor disorders such as urinary incontinence (UI) and fecal incontinence (FI).

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, announced today that the National Institutes of Health’s (NIH) Pelvic Floor Disorders Network (PFDN) will include the Leva® Pelvic Health System in a multi-center clinical study designed to compare treatment methods for first-time mothers experiencing urinary incontinence (UI). The study will enroll 216 women who will access one of three treatments for UI: “usual care” (i.e., patient education about Kegel exercises and other lifestyle changes at home), interventionist-guided pelvic floor muscle training (PFMT), and Leva-guided PFMT. Study results will provide valuable guidance to clinicians and women who want to access PFMT using a method that best supports their success.

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, is now offering the Leva® Pelvic Health System through www.levarx.com. In collaboration with UpScriptHealth, the new telehealth offering connects women with prescribing clinicians who can evaluate their incontinence symptoms and, if appropriate, prescribe the Leva System. With the U.S. experiencing a growing shortage of OB-GYNs, the new telehealth service will allow women to access effective first-line incontinence treatment quickly and easily, improving individual outcomes and decreasing overall costs for the healthcare system.

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, announced today that a new published study adds additional real-world evidence supporting women’s effective use of the Leva® Pelvic Health System to access pelvic floor muscle training (PFMT), which is first-line treatment for incontinence. The new Journal of Medical Internet Research: Formative Research study of 947 women concluded that the Leva System was safe, effective and delivered clinically significant symptom improvement for women suffering from urinary incontinence (UI) regardless of age, BMI and UI sub-type. The study follows a 2022 published review showing similar real-world evidence. Together, the studies represent the largest body of real-world evidence supporting an at-home, FDA-cleared treatment for female incontinence.

Please replace the release issued April 11, 2024 with the following corrected version due to multiple revisions.

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, has closed on an additional $9.4 million in its Series A fundraising. Cross-Border Impact Ventures (CBIV) coinvested alongside existing investors AXA IM Alts through its Global Healthcare Private Equity Strategy, KOFA Healthcare and Avestria Ventures. Donna Parr, managing director and partner at CBIV, is joining Axena Health’s board of directors as part of its investment.

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, announced today that Highmark Blue Cross Blue Shield (Highmark BCBS) and Blue Cross Blue Shield of North Dakota (BCBS of ND) have both added the Leva® Pelvic Health System as a covered benefit for their members suffering with urinary incontinence. Highmark BCBS is one of the largest Blue Cross Blue Shield Association plans, serving approximately seven million members across Pennsylvania, Delaware, New York and West Virginia. The Leva System was reviewed favorably by Highmark BCBS’s New Technology Assessment Committee. BCBS of ND is the largest Blue Cross Blue Shield plan in North Dakota, serving over 300,000 members. Both positive coverage decisions became effective on April 1, 2024.

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, unveiled the findings from a landmark study to understand the impact of urinary incontinence (UI) on women in sub-Saharan Africa. The first-of-its-kind study revealed a critical need for awareness, education, and access to evidence-based treatment. Available online, the study will inform the future development of treatment options based on the Leva® Pelvic Health System’s patented mechanism of action that will resonate with cultural norms and are accessible through local healthcare delivery systems.

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, welcomes the Centers for Medicare & Medicaid Services’ (CMS) new Healthcare Common Procedure Coding System (HCPCS) Level II code for the Leva® Pelvic Health System. The Leva System’s patented, motion-based technology allows women to treat urinary incontinence (UI) and fecal incontinence (FI) through pelvic floor muscle training, also known as Kegels, correctly and in the privacy of their home. Effective on April 1, 2024, the new code makes it easier for clinicians, distributors, payers and, most importantly patients, to access Leva System’s clinically validated, non-invasive treatment.

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, announced today that leading pelvic health researchers have published a new study demonstrating the Leva® Pelvic Health System’s long-term treatment efficacy for female urinary incontinence (UI). The new study published online in the International Urogynecology Journal on January 21, shows UI symptom relief lasts for at least two years following eight weeks of Leva System-assisted pelvic floor muscle training (PFMT), which is a first-line treatment for incontinence. The abstract was named “Best Overall Abstract Presentation,” from the International Urogynecological Association (IUGA) at its 2023 annual meeting.

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, has launched a study to examine the barriers women faced while seeking treatment for urinary incontinence (UI) and fecal incontinence (FI). The study is expected to include 500 real-world users of the Leva® Pelvic Health System and follows a pilot survey showing that most participants were unsuccessful trying pelvic floor muscle training (PFMT) on their own or with a physical therapist. Study results could help clinicians, payers and policy makers accelerate access to easy, effective first-line treatment for UI and FI.

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, has signed agreements with four leading distributors to streamline access to the Leva® Pelvic Health System. Byram Healthcare Centers, Inc. (“Byram Healthcare”), EVERSANA, J&B Medical and OneSource Medical Group, LLC, now offer the Leva System, recently named to AARP’s 2023 Medical Breakthroughs, making it easier for physicians, healthcare systems and patients to access safe and effective at-home treatment for incontinence supported by multiple clinical trials and published data.

AUGS PFD Week 2023— Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, commends leading researchers in women’s health, who presented data showing that urinary incontinence (UI) symptom relief is durable for two-years following eight-weeks of treatment with the Leva® Pelvic Health System. These researchers also presented data showing that the Leva System improved symptoms of early-stage pelvic organ prolapse, a pelvic floor disorder in which one or more of the pelvic organs drop or press into or out of the vagina due to a weak pelvic floor. The Leva System is a non-drug, non-surgical treatment that helps women strengthen their pelvic floor at home, on their own schedule, by guiding correct and consistent pelvic floor muscle training (PFMT). The researchers presented their data in two abstracts during PFD Week 2023, the American Urogynecologic Society’s (AUGS) annual scientific meeting held in Portland, Ore. Oct. 4-6, 2023.

Axena Health, Inc. (Axena Health), a women’s health medical device company focused on scalable treatments for female pelvic health, congratulates the researchers who received “Best Overall Abstract Presentation” from the International Urogynecological Association (IUGA) at its annual meeting in The Hague / The Netherlands on June 21-24, 2023. Lead Author Dr. Milena M. Weinstein of Massachusetts General Hospital, Harvard Medical School, presented the award-winning abstract, which showed that Leva® Pelvic Health System use provides durable and significantly greater improvement in urinary incontinence (UI) symptoms compared to home pelvic floor muscle training (PFMT) alone. Study authors concluded that for women choosing first-line care at home for stress and mixed UI, a motion-based device should be considered to optimize results.

Axena Health, Inc. (Axena Health), a FemTech medical device company focused on scalable treatments for female pelvic health, introduced today the Leva® Pelvic Health System for the first-line treatment of chronic fecal incontinence (FI), also called accidental bowel leakage (ABL), in women. The U.S. Food and Drug Administration (FDA) cleared the new indication in 2022 following Breakthrough Device Designation in 2021. New coaching and education support along with updates to the Leva System app combine to support its use for chronic FI, making access to first-line treatment easy and practical.

Axena Health, Inc. (Axena Health), a women’s health medical device company focused on scalable treatments for female pelvic health, announced today a large-scale study that will investigate the burdens of incontinence on women in low- and middle-income countries to support equitable access to treatment. The first-of-its-kind study will examine how women could access treatment within local healthcare delivery systems and in a manner that accommodates cultural norms. Study results will be available in late 2023 and will inform the development of new treatment options based on the Leva® Pelvic Health System, a digital health treatment for urinary incontinence (UI) with published studies supporting its effectiveness, including durable, long-term symptom relief.

Axena Health, Inc. (Axena Health), a medical device company relentlessly dedicated to women’s health, today announced that Cigna Healthcare (Cigna), one of the largest healthcare insurance providers in the United States with approximately 15 million members, has added the Leva Pelvic Health System as a covered treatment for stress, urgency and mixed urinary incontinence (UI) in women. The Leva Pelvic Health System is a prescription digital therapeutic (PDT) that guides women through pelvic floor muscle training (PFMT), offering an easy, convenient way for women to treat UI and chronic fecal incontinence (FI) by strengthening their pelvic floor muscles. The positive coverage decision from Cigna follows Axena Health’s recent $25 million Series A fundraising and a new Obstetrics and Gynecology study showing the Leva System’s long-term efficacy for female UI.

Axena Health, Inc. (Axena Health), a medical device company relentlessly dedicated to women’s health, today announced the results of a one-year longitudinal follow up to its pivotal randomized controlled superiority trial (RCT) of the Leva® Pelvic Health System as a treatment for urinary incontinence (UI) in women. The results, published in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG), showed that Leva-guided pelvic floor muscle training (PFMT) yielded significantly greater symptom improvement compared with PFMT practiced by Kegel exercises. The study measured outcomes at six and 12 months, making it one of the few studies to track long-term symptom improvement for a non-surgical intervention for UI.

Axena Health, Inc. (Axena Health), a newly-formed commercial-stage medical device company focused on women’s pelvic health, today announced a $25 million Series A investment from AXA IM Alts through its Global Healthcare Private Equity Strategy. The investment will support and expand access to the Leva® Pelvic Health System, a prescription digital therapeutic (PDT) that offers easy-to-use, at-home treatment for urinary incontinence (UI) and chronic fecal incontinence (FI) in women. The Leva System is cleared by the U.S. Food and Drug Administration (FDA) to treat stress, mixed and mild-to-moderate urgency UI (including overactive bladder) in women and for first-line treatment of chronic FI in women.