ATLANTIC-THERAPEUTICS
6.2.2020 15:02:14 CET | Business Wire | Press release
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
Samsung Bioepis Announces Positive Preliminary Phase 1 Data for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)6.5.2026 01:00:00 CEST | Press release
Phase 1 study has demonstrated pharmacokinetics (PK) equivalence between SB27 and KeytrudaPhase 1 and Phase 3 studies expected to be completed within 2026 Samsung Bioepis Co., Ltd. announced today that the Phase 1 study on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), has met its primary pharmacokinetics (PK) endpoints. The randomized, double-blind, three-arm, parallel group, multicenter clinical trial demonstrated pharmacokinetic bioequivalence of SB27 (pembrolizumab) to the reference product Keytruda. Initiated in January 2024, Phase 1 study is being conducted in four countries, and is expected to be completed by November 2026.2 The study assessed pharmacokinetics, efficacy, safety, and immunogenicity of SB27, EU-sourced Keytruda, and US-sourced Keytruda in patients with stage II or IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy. 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sour
Megaport Launches Built-In DDoS Protection Enabling On-Demand Network Resilience6.5.2026 00:00:00 CEST | Press release
Megaport DDoS Protection removes the trade-off between security, performance, and cost, offering rapid enterprise-grade mitigation. Megaport Limited (ASX: MP1) (“Megaport”), a leading global automated infrastructure platform, today announced the launch of Megaport DDoS Protection. This new, built-in security capability for Megaport Internet allows customers to filter malicious traffic directly within the Megaport network rather than routing it through a separate or external service, for mission-critical uptime without introducing additional latency or routing complexity. As enterprises increasingly migrate to distributed cloud environments, traditional DDoS mitigation has struggled to keep pace with cloud and distributed infrastructure adoption. Standard ISP solutions often resort to dropping all traffic and taking the service offline to protect the network, while external third-party providers force a "security detour" that reroutes traffic through public infrastructure, introducing s
IFF Reports First Quarter 2026 Results5.5.2026 22:23:00 CEST | Press release
Delivered solid top and bottom line Q1 resultsProgressing disciplined sale process for Food Ingredients businessReaffirms Full Year 2026 Financial Guidance IFF (NYSE: IFF) reported financial results for the first quarter ended March 31, 2026. First Quarter 2026 Consolidated Summary: Management Commentary “IFF is off to a solid start in 2026, with first quarter results that reflect the customer focus and operational execution we’ve been building across the company,” said Erik Fyrwald, CEO of IFF. “We delivered volume growth in all four segments, improved profitability, and generated strong cash flow in the first quarter. As we look ahead, we are maintaining a disciplined approach to how we are planning the balance of the year as the current operating environment remains unsettled. We remained focused on advancing our commercial and innovation pipelines, driving productivity, and working with customers to offset inflation. This – when combined with our solid start to the year – derisks t
Logitech Announces Q4 and Full Fiscal Year 2026 Results5.5.2026 22:06:00 CEST | Press release
Strong FY 2026 Demonstrates Strategy and Operating Principles Are Delivering SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the fourth quarter and full Fiscal Year 2026. For Fiscal Year 2026: Sales were $4.84 billion, up 6 percent in US dollars and 4 percent in constant currency compared to the prior year. GAAP operating income was $775 million, up 18 percent compared to the prior year. Non-GAAP operating income was $911 million, up 18 percent compared to the prior year. GAAP earnings per share was $4.80, up 16 percent compared to the prior year. Non-GAAP EPS was $5.78, up 19 percent compared to the prior year. Cash flow from operations was $1.04 billion. The year-ending cash balance was $1.7 billion. The Company returned $768 million of cash to shareholders through its annual dividend payment and share repurchases. For Q4 Fiscal Year 2026: Sales were $1.09 billion, up 7 percent in
Sentinel Midstream Advances Texas GulfLink Deepwater Port5.5.2026 22:00:00 CEST | Press release
Marks Historic Milestone for U.S. Energy Export Infrastructure under the U.S.-Japan Trade Deal Sentinel Midstream LLC (Sentinel) today announced the commencement of its Texas GulfLink deepwater port (Texas GulfLink or the Project), marking a significant milestone enabled by funding received pursuant to the U.S.—Japan Trade Agreement. The project advances in coordination with the U.S. Department of Commerce and the Government of Japan and reflects the shared commitment to strengthening global energy security and expanding U.S. export infrastructure. Sentinel will lead the development of Texas GulfLink, overseeing construction, commercial operations, and long-term management of the terminal. Funding provided under the U.S.—Japan Trade Agreement, pursuant to Executive Order 14345 signed on September 4, 2025, underscores continued international confidence in U.S. energy infrastructure and supports the expansion of American crude oil exports to global markets. Upon this commencement, Texas
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