Latest news with #DeNovoClassificationRequest
Yahoo
08-05-2025
- Business
- Yahoo
SS Innovations to Submit De Novo Application to the FDA for the SSi Mantra 3 Surgical Robotic System for Multiple Indications
All Clinical Data Validated by Leading Third-Party CRO for Safety, Feasibility and Efficacy FORT LAUDERDALE, Fla., May 08, 2025 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the 'Company' or 'SS Innovations') (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that the Company is planning to submit a De Novo Classification Request to the U.S. Food and Drug Administration (the 'FDA') for the SSi Mantra 3 surgical robotic system (the 'SSi Mantra 3') in July 2025. If approved by the FDA, the SSi Mantra 3 would be cleared to market in the United States. Submission of the De Novo Classification Request does not guarantee FDA approval. Since the Company began the sale of its system in August 2022 it has installed a total of 80 SSi Mantra robotic surgical systems in 75 hospitals and over 3,800 surgeries have been performed, including over 200 robotic cardiac surgeries. The SSi Mantra 3 version was launched in June 2024, and the Company has already installed 37 systems that have been utilized to perform more than 750 multispecialty robotic surgical procedures, including 70 cardiac cases, with no device related mortality, injury or complications. Real world clinical data, validated by a leading contract research organization ('CRO'), supports the ability of the SSi Mantra 3 to safely perform a wide variety of surgical procedures. The planned submission of the SSi Mantra 3 to the FDA will include an application for multispecialty indications including urology, gynecology, general surgery, and thoracic and cardiac surgery. Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, 'We currently have approval to market our SSi Mantra surgical robotic system in six countries and continue to advance our global expansion. We are taking important steps, including the planned De Novo application to the FDA, to introduce our empowering, cost-effective surgical robotic technology to the U.S. market. In parallel, we are pursuing European Union CE Mark approval for our SSi Mantra surgical robotic system and look forward to our future with great confidence.' About SS Innovations SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company's product range includes its proprietary 'SSi Mantra' surgical robotic system and its comprehensive suite of 'SSi Mudra' surgical instruments, which support a variety of surgical procedures including robotic cardiac surgery. An American company headquartered in India, SS Innovations plans to expand the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company's website at or LinkedIn for more information and updates. About the SSi Mantra The SSi Mantra Surgical Robotic System is a user-friendly, modular, multi-arm system with many advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information display, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery. The SSi Mantra has been clinically validated in India in more than 100 different types of surgical procedures. Forward Looking StatementsThis press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words 'anticipate,' 'assume,' 'believe,' 'estimate,' 'expect,' 'will,' 'intend,' 'may,' 'plan,' 'project,' 'should,' 'could,' 'seek,' 'designed,' 'potential,' 'forecast,' 'target,' 'objective,' 'goal,' or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations International's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Investor Contact:The Equity Group Kalle Ahl, CFA T: (303) 953-9878 kahl@ Devin Sullivan, Managing Director T: (212) 836-9608dsullivan@ Media Contact:press@ T: (212) 739-0300Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
22-04-2025
- Health
- Business Wire
Click Therapeutics Announces FDA Marketing Authorization for CT-132, the First Prescription Digital Therapeutic for the Preventive Treatment of Episodic Migraine in the United States
NEW YORK--(BUSINESS WIRE)--Click Therapeutics, Inc., ('Click') a leader in prescription medical treatments as both prescription digital therapeutics and software-enhanced drug™ therapies, has obtained FDA marketing authorization for the first prescription digital therapeutic for the preventive treatment of episodic migraine. FDA granted the De Novo Classification Request for the company's prescription digital therapeutic, CT-132, for the preventive treatment of episodic migraine in patients 18 years of age and older. It is intended for adjunctive use alongside acute and/or other preventive treatments for migraine. The marketing authorization for CT-132 is based on data from the ReMMi-D (Re duction in M onthly Mi graine D ays, NCT05853900) study in patients taking standard-of-care prescription migraine medications (acute, preventive first-line, and preventive second-line), where CT-132 met its primary endpoint. Clinical results from the ReMMiD-C bridging study (NCT06004388), which showed that CT-132 performed similarly in patients taking calcitonin gene-related peptide (CGRP) inhibitors, were also submitted in the De Novo and included in the product's FDA premarket review. 'This marks a significant milestone for the more than 37 million adults in the US who live with migraine,' said Shaheen Lakhan, MD, PhD, FAAN, chief medical and scientific officer of Click Therapeutics. 'As a groundbreaking digital therapeutic for migraine prevention, CT-132 offers eligible patients a new path to reducing the burden caused by migraine, one they can access anywhere via an evidence-based mobile application on their smartphone, significantly improving accessibility and expanding care to patients.' Click Therapeutics recently presented CT-132 pivotal study results at the American Academy of Neurology Annual Meeting, where co-investigator Stewart J. Tepper, MD, Vice President of the New England Institute for Neurology and Headache and scientific advisor to Click shared in a post-conference Medscape article, 'I think this is very exciting as a clinician who takes care of patients because we don't have anything like this in our migraine armamentarium. We know that behavioral techniques are helpful adjunctively, but large areas of the country just don't have access to them.' 'With this landmark, first-in-class FDA authorization in episodic migraine, Click's interventions have now demonstrated clinically meaningful benefit across three unique therapeutic areas, including psychiatry, cardiometabolic disease and now neurology,' said David Benshoof Klein, chief executive officer of Click Therapeutics. 'As the first authorization in our neurology pipeline, and the first of our PDTs to target and successfully treat a pain-related condition, it confirms the power of Click's platform to deliver meaningful outcomes across therapeutic areas.' Built on Click's industry-leading AI-enabled platform, CT-132 combines scientifically proven therapies with proprietary mechanisms of action to deliver clinically-meaningful interventions for patients with episodic migraine. Click Therapeutics designs patient-centric applications like CT-132 by incorporating storytelling, user research, and elements of consumer technology to increase engagement and drive improved clinical outcomes, with the goal of delivering personalized treatment for effective migraine management. Intended for adjunctive use alongside other treatments for migraine, CT-132 demonstrated in clinical testing the ability to add clinically meaningful benefit on top of background pharmacotherapy. CT-132 is thus well-positioned for further development in the future as a software-enhanced drug™ therapy. Click's software-enhanced drug therapies combine software with pharmacotherapy to create software-enhanced drug™ treatment options, targeting the unique needs of a specific medication to deliver added clinical benefit to patients. Click launched its new product offering, Click SE™, in October 2024 to pioneer this new therapeutic category in response to increasing interest in the U.S. Food and Drug Administration (FDA) draft guidance on Prescription Drug-Use Related Software (PDURS). This marketing authorization announcement follows Click's recent Series C funding round news, announced in March 2025. Indication: The CT-132 prescription digital therapeutic is indicated for the preventive treatment of episodic migraine in patients 18 years of age and older. It is intended for adjunctive use alongside acute and / or other preventive treatments for migraine. Safety Information: There are no contraindications to using CT-132. CT-132 is not intended to be used as a standalone therapy. CT-132 does not replace or substitute other migraine treatments, including medication for migraine. Patients should continue their current treatment as directed. About the ReMMi-D Pivotal Study and ReMMiD-C Bridging study The indications for use for CT-132 are supported by the results from two double-blind decentralized randomized controlled trials, a pivotal study (ReMMi-D) and a bridging study (ReMMiD-C). The pivotal ReMMi-D study evaluated the effectiveness and safety of CT-132 for the prevention of episodic migraine in patients 18 years and older, compared to a sham digital control and included patients (n=558) on the most commonly prescribed migraine medications. ReMMiD-C was designed identically to ReMMi-D but required that participants (n=110) be taking at least one calcitonin gene-related peptide (CGRP) inhibitor, though participants were also permitted use of non–migraine-specific acute or preventive medications. The study designs mirrored those of contemporary randomized control trials for migraine drugs. However, unlike in drug studies, patients continued their existing migraine medications without any washout period, so the additive treatment effect of CT-132 on top of background pharmacotherapy could be evaluated. Both studies demonstrated that CT-132 reduced monthly migraine days (MMDs) compared to a sham digital control in patients already using acute and preventive migraine medications, with no device-related adverse events reported. At the completion of the pivotal ReMMi-D study, CT-132 demonstrated a statistically significant reduction in monthly migraine days (MMDs) after 12 weeks of treatment compared to the sham digital control (n=568, ITT population; treatment difference: –0.9 MMDs; p =0.005). Participants in the treatment arm experienced a mean reduction of –3.04 MMDs by the end of the intervention. Further, migraine related quality of life, assessed by the Migraine-Specific Quality-of-Life Questionnaire (MSQ, revealed a difference between the CT-132 and sham digital control arms from as early as 4 weeks and through weeks 8 and 12. Migraine disability, as measured by the Migraine Disability Assessment (MIDAS) score, improved more in the CT-132 arm than in the sham arm at the end of treatment. Note that the analysis of secondary effectiveness endpoints did not include multiplicity adjustment or formal hypothesis testing. Engagement and adherence were high and sustained over the full 12-week duration of the treatment, with a median of 81 daily lessons out of 84 completed by those receiving the sham digital control and a median of 84 completed by those receiving CT-132. CT-132 was well-tolerated, with no discontinuations due to treatment-emergent adverse events (TEAEs). The ReMMiD-C bridging study provided supportive information, also evaluated versus a sham digital control but without formal hypothesis testing, that demonstrated similar performance of CT-132 in patients taking the new-class of migraine-specific medications, CGRP inhibitors. About Migraine Migraine is a complex and debilitating condition that affects more than 37 million adults and is the second leading cause of disability in the United States. 1,2 It is characterized by episodes of moderate-to-severe headache and is generally associated with nausea and increased sensitivity to light and sound. 3 For those living with migraine, attacks unfold over hours to days and negatively impact key domains of life including employment, educational attainment, and relationships. 4 Despite the availability of preventive migraine medications, there remains a significant unmet need in migraine management. Many patients continue to experience frequent and debilitating attacks, even when using these drugs as prescribed. 5 About Prescription Digital Therapeutics Prescription Digital Therapeutics (PDTs) deliver evidence-based treatments directly to a patient via their smartphone in the form of a mobile app. With PDTs, the software is the treatment. PDTs are prescribed by a physician to treat a disease or condition, and as such are clinically validated and FDA-regulated. PDTs can be used independently or in combination with traditional pharmaceutical treatments. About Click Therapeutics Click Therapeutics, Inc. develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. We are expanding the possibilities of medicine with Digital Therapeutics™ that combine clinical science with the power of software to create a new way to treat disease. Operating at the intersection of biology and technology, we use a proprietary platform-based approach to therapeutic development that leverages patient-centric design principles and innovative AI-based technologies to deliver a unique combination of engagement and clinical outcomes, consistently. Digital therapeutics on Click's platform are regulated, clinically validated prescription mobile applications that are being developed to address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. In 2024, in response to FDA guidance on prescription drug use-related software (PDURS) and building off the capabilities of our platform, we launched Click SE™ to extend our digital therapeutics platform and expertise to the development of software-enhanced drug™ therapies that combine software with pharmacotherapy to offer added clinically meaningful benefit to patients. To date, three Click Therapeutics devices have received FDA marketing authorizations. The company's self-developed CT-132, a first-in-class prescription digital therapeutic for preventing episodic migraine, was granted De Novo classification by the FDA. Click Therapeutics, in collaboration with Otsuka, developed Rejoyn™, which became the first prescription digital therapeutic authorized by the FDA for the adjunctive treatment of major depressive disorder symptoms. Additionally, the company expanded its portfolio into cardiometabolic disease with AspyreRx, which received FDA marketing authorization for the treatment of type 2 diabetes. Our commitment to advancing digital medicine means we continually improve our platform technologies, ensuring we stay at the forefront of cognitive, behavioral, and neuromodulatory therapeutic innovation, to achieve the best possible outcomes for patients. Our diverse team of innovators—spanning clinicians, researchers, technologists, designers and more—works together to create cutting-edge digital therapeutics, united in the mission to transform patient care. For more information, visit and connect with us on LinkedIn. References
