Atlantic Therapeutics Announces FDA Clearance for Over-the-Counter Use of INNOVO®

The Company is Well Positioned to Drive its Next Phase of Global Expansion and Growth

Atlantic Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter (OTC) clearance to INNOVO®, a non-invasive, clinically proven and wearable device for the treatment of stress urinary incontinence (SUI) in adult females.

This approval represents a major milestone that will be a key value driver for Atlantic Therapeutics. This achievement as well as the previous funding rounds position the company to enter its next phase of growth, driven by geographic expansion within the U.S., accelerated sales in other geographies, further development of its existing product portfolio and expansion into new clinical applications.

INNOVO® is the first transcutaneous electrical stimulation continence device to be cleared by the FDA, following positive results from two clinical trials. The clinical trials demonstrated that 80%1 of INNOVO® users experienced significant improvements after four weeks and 87%2 were considered “dry” or “near dry” after three months.

“With INNOVO® now approved for over-the-counter use in the U.S., women suffering from urinary incontinence, a common but stigmatized condition, have easy access to this convenient, effective and safe product, which is backed by science,” said Steve Atkinson, Chief Executive Officer of Atlantic Therapeutics. “No longer requiring a prescription for INNOVO® means women can take back control of their personal health in the safest and most convenient way possible with this effective at-home treatment. They no longer need to suffer in silence and make do with temporary fixes, such as pads, to manage their condition.”

“We are encouraged by the over-the-counter clearance of INNOVO® and believe it unlocks substantial value for Atlantic Therapeutics,” said Anne Portwich, Partner at LSP and investor in Atlantic Therapeutics. “This is an exciting time to be supporting the global expansion and growth of Atlantic Therapeutics.”

An estimated one third of all U.S. females are affected by SUI3, representing a significant market opportunity for INNOVO®. INNOVO® has an excellent safety record to date, with over 3.5 million therapy sessions delivered by INNOVO® worldwide with no reported device-related complications. INNOVO ® can be purchased without a prescription at www.myinnovo.com starting February 6, 2020.

 

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy

Exit mobile version