ATLANTIC-THERAPEUTICS
Atlantic Therapeutics, a global medical device manufacturer, 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.
About Atlantic Therapeutics
Atlantic Therapeutics develops professional and consumer medical devices, related software, apps and connected health technologies to treat all types of incontinence, sexual health dysfunctions, and other associated disorders by strengthening muscles and modulating nerves of the pelvic floor. INNOVO® from Atlantic Therapeutics is an FDA-cleared, externally applied, patented CE device that delivers a safe, clinically effective and comfortable therapy to treat reversible clinical conditions associated with pelvic floor weakness in the comfort of the user's own home. Learn more at: www.myinnovo.com .
- Soeder S, et al, A randomised, controlled, double-blind, clinical study to compare two neuromuscular stimulator devices in female stress urinary incontinence: Effects on symptoms and quality of life. IUGA Conference 2018
- Dmochowski R, Lynch CM, Efros M, Cardozo L. External electrical stimulation compared with intravaginal electrical stimulation for the treatment of stress urinary incontinence in women: A randomized controlled noninferiority trial. Neurourol Urodyn. 2019 Sep;38(7):1834-1843. doi: 10.1002/nau.24066. Epub 2019 Jul 3
- The Urology Care Foundation (2018) Available at: [http://www.urologyhealth.org/ ] (Accessed: 24th August 2018)
View source version on businesswire.com: https://www.businesswire.com/news/home/20200206005128/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Audiencerate Achieves Google Customer Match Partner Status, strengthening its role as a Global Data Provider10.12.2025 22:40:00 CET | Press release
Audiencerate, an international technology company specializing in data activation solutions and platforms within the AdTech and MarTech sectors, has been officially awarded by Google as a Customer Match Upload Partner. This certification is granted to a restricted number of global operators (https://support.google.com/google-ads/answer/7361372?hl=en) authorized to manage and onboard first-party data into the Google Ads and DV360 ecosystem. The company strengthen its strategic partnership with Google by adding the Customer Match Upload Partner accreditation to its existing status as a certified Google Data Provider. This new credential enables Audiencerate to seamlessly integrate proprietary audience segments and data into Google’s advertising platforms. The combination of these two accreditations represents an exceptionalsituation in the international landscape and solidifies Audiencerate's position in the digital advertising market, which is increasingly reliant on first-party data. T
Defence, Security and Resilience Bank (DSRB) Development Group – Official Statement10.12.2025 21:06:00 CET | Press release
On 8 September 2025, the Defence, Security and Resilience Bank (DSRB) Development Group convened a high-level meeting in the City of London with representatives from 37 nations, including all G7 members, alongside the European Commission, NATO, European Parliament, Global Banks, and Ratings Agencies to discuss the DSRB. A number of countries have now indicated their intention to begin the formal steps required to bring the DSRB into existence. This phased pattern of engagement is standard in the creation of international financial institutions, which typically begin with a core group of anchor nations and expand as additional members join through charter negotiations and subsequent capital rounds. The DSRB is designed to complement the European Union’s SAFE initiative, offering a broader multilateral platform that brings together NATO and Indo-Pacific nations and mobilises global capital to build the balance-sheet capacity required to finance nations’ defence spending and long-term res
ClickUp 4.0's Craft & Quality is Available Today, Maximizing Human Productivity10.12.2025 19:26:00 CET | Press release
Hand-crafted to deliver the most polished, powerful ClickUp experience ever created ClickUp today announced the launch of ClickUp 4.0, a groundbreaking release designed to end the chaos of work sprawl and usher in a new era of work. With a bold vision for the convergence of software, people, and AI, ClickUp 4.0 delivers a suite of powerful new features that empower teams to do their best work in one converged workspace. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251210712132/en/ A new era of ClickUp For years, organizations have struggled with fragmented workflows, siloed tools, and the constant friction of context switching. ClickUp 4.0 is the answer: a single, beautifully crafted workspace that brings together tasks, docs, goals, chat, and AI-powered automation. The result is a platform that not only saves time but also sparks creativity and collaboration at every level. “Software is converging - we always knew it woul
United First Partners Serves as Introducing Broker on Mayflower IPO, a UK Listed Acquisition Vehicle and Among the Largest Primary New Issues in London in 2025, Highlighting UFP’s Increasing Presence Across ECM10.12.2025 18:42:00 CET | Press release
United First Partners (“UFP”) is pleased to announce its role as Introducing Broker on Mayflower Acquisition Limited (“Mayflower”), which completed its IPO today, raising USD 500 million. The size of the capital raised places Mayflower among the largest London acquisition vehicles of recent years. The offering represents an important development for UFP’s expanding capital markets platform and reflects the firm’s increasing activity within Equity Capital Markets (ECM). About Mayflower Acquisition Limited Mayflower is a UK Listed Acquisition Vehicle, sponsored by TOMS Capital and JRJ Group, incorporated to unlock exits across a closely-held company universe, including long-held private equity assets and large family-owned businesses. Mayflower’s structure provides guaranteed capital to asset owners, offering a flexible liquidity solution and higher potential for transaction success, and highly aligned economics to investors, with a significant Sponsor commitment of USD 75m. Mayflower wa
Abu Dhabi Launches FIDA Cluster to Shape the Next Generation of Financial and Investment Solutions10.12.2025 18:21:00 CET | Press release
Abu Dhabi has launched the FinTech, Insurance, Digital and Alternative Assets (FIDA) cluster to accelerate the development of next-generation financial and investment solutions and expand the emirate’s role as a global capital hub. Spearheaded by the Abu Dhabi Department of Economic Development (ADDED) and the Abu Dhabi Investment Office (ADIO), the cluster is a core pillar of Abu Dhabi’s long-term economic diversification agenda. By 2045, FIDA is projected to contribute an additional USD 15.2 billion to Abu Dhabi’s direct GDP, generate 8,000 skilled jobs and attract at least USD 4.6 billion in investment, cementing the emirate’s position as a destination for innovative and resilient financial systems. FIDA brings together high-growth areas where technology, regulation and capital intersect, including fintech, digital assets, insurance, reinsurance and alternative investments. It aims to position Abu Dhabi as a preferred jurisdiction for global firms seeking to design, test and scale n
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom