NEWTON, Mass.–(BUSINESS WIRE)–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.

“Pelvic floor disorders are typically progressive conditions and affect women globally”

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Proceeds from the fundraising will support Axena Health’s growth. In the United States, the company is focused on the continued commercial launch of its Leva® Pelvic Health System, an at-home treatment for urinary incontinence (UI) and chronic fecal incontinence (FI) in women. Outside the Unites States, Axena Health will accelerate its work developing scalable treatments in low- and middle-income countries.

“Over the past year since Axena Health’s founding, we’ve seen remarkable U.S. prescriber adoption and growth in payer coverage, leading to improved patient access. The demand for improved first-line treatment options for urinary incontinence and chronic fecal incontinence is clear and we’re thrilled to partner with CBIV and our existing investors to reach more women across the U.S.,” said Jim O’Connor, CFO and interim CEO of Axena Health. “CBIV’s focus on impacting women’s health globally also aligns perfectly with Axena Health’s ongoing work in sub-Saharan Africa to improve access to evidence-based treatments.”

“Pelvic floor disorders are typically progressive conditions and affect women globally,” said Ms. Parr. “Too often, women are left with the option of either suffering in silence or pursuing long-term medications or surgical solutions. In our view, neither of those treatments is accessible at scale – particularly not in low resource settings. The Leva® Pelvic Health System provides the opportunity to improve access and health outcomes so we couldn’t be more excited to partner on Axena Health’s growth.”

Dr. Zina Affas Besse, Deputy Head of Healthcare Private Equity at AXA IM Alts added, “AXA IM Alts is thrilled to have been Axena Health’s founding investor in 2023. We’re excited to partner with Donna and CBIV as the company works to improve treatment options for more women in the U.S. and globally, in line with our objectives of generating outcomes that benefit people and the planet, while meeting our clients’ financial objectives.”

About the Leva® Pelvic Health System

The Leva® Pelvic Health System offers an innovative, non-invasive, medication-free way for women to train and strengthen their pelvic floor muscles—at home in just five minutes a day—to treat urinary incontinence (UI) and chronic fecal incontinence (FI). Combining a small FDA-cleared vaginal motion sensor with integrated software, the Leva System offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active physician involvement, all of which support women’s success. Recognizing that level-one evidence shows pelvic floor muscle training is most effective when performed under the supervision of a skilled healthcare provider, the Leva System is available by prescription only, allowing physicians the opportunity to treat UI and chronic FI on a broad scale and with continued involvement in patient success. The Leva System has multiple clinical trials and published data from globally recognized medical centers supporting its efficacy in treating UI, including two studies in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG).

About Axena Health

Axena Health, Inc. is dedicated to improving the lives of women with pelvic floor disorders. Axena Health’s flagship product, the Leva® Pelvic Health System, offers a novel, effective, first-line treatment for urinary incontinence (UI) and chronic fecal incontinence (FI), underreported conditions affecting over 78 million and 12 million women in the U.S. alone. Axena Health’s technology enables non-invasive, drug-free treatment via precise visualization of movement in real time during pelvic floor muscle training, while monitoring usage and progress. For more information, please visit www.axenahealth.com or www.levatherapy.com and follow Axena Health on LinkedIn.

Important Indication and Other Information for the Leva® Pelvic Health System

The Leva® Pelvic Health System is intended for (1) strengthening of pelvic floor muscles, (2) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women and (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (>3-month uncontrolled passage of feces) in women. Treatment with the Leva System is by prescription and is not for everyone. Please talk to your prescriber to see if Leva System is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use Leva System while pregnant, or if you think you may be pregnant, unless authorized by your doctor. For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.levatherapy.com.