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
IQM to Deliver Its First Quantum Computer in South America to Brazil’s Eldorado Research Institute17.9.2026 09:43:00 CEST | Press release
Eldorado will house an IQM Spark at their Campinas headquarters and will also access IQM's 54-qubit cloud-based system, pairing on-premises hardware with larger-scale capability via the cloud. This will enable innovation and growth to scale with their quantum knowledge development. This is the first quantum computer purchase by a private research institute in Brazil, which will enable researchers, engineers, universities, and industry partners to advance research and build capability locally. IQM and Eldorado aim to accelerate quantum adoption across Brazil and South America by building expertise locally and opening the system to Eldorado's network of universities, startups and industry partners. IQM Quantum Computers (Nasdaq: IQMX), a global leader in superconducting quantum computers, today announced a purchase agreement with the Eldorado Research Institute to deploy its first quantum computer in South America, marking IQM's entry into the region. This press release features multimed
Merz Therapeutics Receives EU/EEA Approval for XEOMIN® for the Treatment of Pediatric Spasticity Associated With Pes Equinus17.9.2026 08:00:00 CEST | Press release
Approval expands XEOMIN use to include the symptomatic treatment of spasticity associated with pes equinus in children and adolescents with cerebral palsy aged 2 to 17 years. Approval includes both children and adolescents who are able to walk and those who are non-ambulant, broadening the population eligible for XEOMIN treatment Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that it has received approval in the European Union (EU) / European Economic Area (EEA) for XEOMIN® (incobotulinumtoxinA) for the symptomatic treatment of spasticity associated with pes equinus, a condition in which tight calf muscles cause the foot to point downward, in ambulant and non-ambulant children and adolescents with cerebral palsy (CP) aged 2 to 17 years.1,2 This approval expands access to an established botulinum neurotoxin therapy for some of the youngest and most vulnerable patients across Europe. Spasticity is a common and often disruptive symptom in childr
Mediterranean Network for Haemoglobinopathies Launches in Rome, Connecting Clinical Experts and Patient Leaders to Advance Equitable Care17.9.2026 08:00:00 CEST | Press release
Founding members endorse a Declaration of Intent centred on practical collaboration, meaningful patient participation and evidence-based improvement. The Network will address shared challenges including blood supply, unequal access to specialist care and innovation, real-world evidence and European policy change. Avanzanite Bioscience becomes Founding Sponsor to support an independent platform designed to connect expertise, highlight unmet needs and help turn scientific and patient knowledge into practical collaboration. The Mediterranean Network for Haemoglobinopathies (MNfH) was recently launched at Palazzo Wedekind in Rome, bringing together leading clinicians and patient representatives from Cyprus, Greece, and Italy, with the Thalassaemia International Federation (TIF). Supported by Avanzanite Bioscience as Founding Sponsor, the independent regional platform will connect expertise across borders, strengthen the patient voice, and turn shared knowledge into practical initiatives th
IKI Advances Promotional Forecast Accuracy by More Than 10 Points With SymphonyAI17.9.2026 07:03:00 CEST | Press release
Lithuania's second-largest grocer brings AI-driven promotional planning to its network of 250 stores, with early results already showing double-digit gains in forecast accuracy SymphonyAI, a global leader in Vertical AI, today announced that IKI, one of Lithuania's largest grocery retailers, is implementing SymphonyAI's Promotional Evaluation and Promotional Planning solutions across its network of 250 stores, as part of its strategy to strengthen data-driven promotional planning. IKI continuously evaluates opportunities to strengthen its category management and promotional planning capabilities. As promotional programs become increasingly sophisticated, the retailer has invested in advanced analytics and AI-driven forecasting to support data-driven decision making across its business. In its initial work with SymphonyAI across select categories, IKI has seen promotional forecast accuracy improve by more than 10 percentage points, along with a reduction in stock-outs during promotional
Lattice Advances FPGA Design with New Leadership AI-Driven Development Tool, Lattice Prompt17.9.2026 04:00:00 CEST | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today introduced a new leadership AI-powered FPGA development tool for small and mid-range FPGAs that redefines how FPGA developers work across the full design flow. Lattice Prompt pairs with AI agentic tools developers already use, combining them with Lattice design tools, knowledge base, and documentation to turn natural language inputs into validated responses, dramatically accelerating FPGA development while optimizing design performance and capability. "Accelerating time-to-market demands and rising design complexity are putting mounting pressure on FPGA developers to do more with every design cycle," said Esam Elashmawi, Chief Strategy and Marketing Officer, Lattice Semiconductor. "Lattice Prompt gives developers AI-assisted access to the full design flow, grounded in Lattice's validated knowledge, so they can focus on what matters most: building differentiated systems." Lattice Prompt:
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