The next-generation leva pelvic digital therapeutic will help treat stress, mixed and mild to moderate urgency urinary incontinence in women
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
Renovia has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its next-generation leva pelvic digital therapeutic.
The new leva pelvic digital therapeutic will help strengthen pelvic floor muscles, as well as treat stress, mixed and mild to moderate urgency urinary incontinence (UI) in women.
By using the company’s patented movement-based sensor and app technology, the next-generation leva offers real-time feedback to the women when they perform their pelvic floor muscle exercises.
Renovia chief medical officer Dr Samantha Pulliam said: “FDA clearance of the next generation of the leva Digital Therapeutic is one of many milestones that we believe will allow us to improve care for the millions of women who experience UI and other pelvic floor disorders.”
Renovia’s new digital therapeutic is based on the same mechanism found in current-generation leva digital therapeutic
Renovia’s new digital therapeutic is said to be based on the same mechanism of action and sensor technology found in the current-generation leva digital therapeutic that was demonstrated to offer statistically significant improvement in objective pelvic floor muscle (PFM) performance measures, patient-reported UI symptom severity and condition-specific quality of life.
The company already completed a multi-centre, pilot randomised controlled trial (RCT) using the next-generation leva digital therapeutic device. The trial comprised of 60 subjects, with the control group carrying out traditional Kegel exercises.
According to the company, the study demonstrated statistically better results among leva users, despite being a 60 subject pilot study.
Renovia plans to introduce the next-generation leva digital therapeutic in the spring of 2020, while the current-generation leva digital therapeutic continues to available in the US.
Renovia co-founder, chairman and CEO Marc Beer said: “Over the past two years, the Renovia team has taken the peer-reviewed mechanism of action of the existing leva device and completely reimagined it in a patient-centric form factor.
“The next-generation leva combines our clinically-established and patented technology with a new discreet form factor and a completely redesigned app interface.”
In August 2018, Renovia raised $42.3m financing to speed up clinical research, development and new digital therapeutic device launches targeted at pelvic floor disorders.