Dassault Systèmes Intensifies the MEDIDATA Commitment to Patient Experience With Investment in Click Therapeutics for Digital Therapeutics Beyond Clinical Trials

Dassault Systèmes (Euronext Paris: FR0014003TT8, DSY.PA) today announced its investment in Click Therapeutics, a leader in prescription digital therapeutics and software-enhanced drug therapies. The transaction advances Dassault Systèmes’ transformation of the patient experience in life sciences and healthcare through end-to-end technology solutions used across the healthcare ecosystem.

The transaction strengthens the existing relationship between Dassault Systèmes’ MEDIDATA brand and Click Therapeutics, helping to improve patient engagement - post-trial through commercialization - and advancing the Patient Experience to deliver end-to-end technology solutions across the healthcare ecosystem. The continued relationship and subsequent investment will set a gold standard and unified offering for digital and pharmaceutical clinical trials' design and execution, providing a path to Prescription Digital Therapeutics (PDTs) and Software-Enhanced (SE) product approvals, expanded labels for existing therapeutics, and, ultimately, a novel pipeline for long-term, real-world evidence generation.

MEDIDATA has virtualized clinical research, creating a unified patient experience with integrated technology solutions. This foundation, built on running over 8,000 active studies annually, allows MEDIDATA, together with Click Therapeutics, to extend their commitment to patients into real-world care, fostering improved coordination and outcomes between patients, physicians, caregivers, and life science manufacturers. Click Therapeutics will gain access to Dassault Systèmes’ global presence and expertise, while both companies will provide unparalleled support for developing PDTs and SE products, making them available to patients.

“Digital therapeutics are beginning to transform the way customers think about their future clinical development programs and are providing demonstrable therapeutic benefits over drugs alone in many cases,” said Anthony Costello, CEO, Medidata. “Today’s investment in Click Therapeutics reflects our commitment to this exciting technology, and our partnership with them will enable our customers to take the fastest, most reliable path to bringing digital therapeutics to patients, helping to build a direct connection to patients over a life-long healthcare journey.”

“Since the FDA shared its latest thinking on Prescription Drug Use-Related Software in guidance, we have experienced a surge in interest in how software can add to the benefits of medication. Now is the time to expand treatment options for patients through software as medicine,” said David Benshoof Klein, CEO, Click Therapeutics. “The investment from Dassault Systèmes, the foremost leader in virtualizing the life sciences and healthcare industry, will enable us to continue to expand the boundaries of medicine and develop new, cutting-edge patient solutions to advance care.”

FOR MORE INFORMATION

Digital Therapeutics (DTx) are evidence-based software interventions designed to prevent, manage, or treat medical conditions, used independently or alongside traditional treatments. Prescription Digital Therapeutics (PDTs) are a subset of DTx that offer clinically validated treatment benefits. As such, they are regulated as medical devices, reviewed by regulatory authorities for safety and effectiveness, and require a healthcare provider’s prescription.

Software-enhanced (SE) drugs are drug-software combination products designed to enhance the value of a specific drug, built on the rigor and principles of PDTs. Software-enhanced drugs co-package a branded medication with a digital therapeutic that targets the unique needs of the medication and its patient population to deliver added clinical benefit compared to the medication alone. This creates an “SE” formulation of the drug that offers combined therapeutic benefits in one prescription for ease of use and optimal patient access.

About Medidata: Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 35,000 trials and 11 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across approximately 2,300 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

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 can address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases.

Click Therapeutics, in collaboration with Otsuka, developed the first prescription digital therapeutic authorized by the FDA for the adjunctive treatment of major depressive disorder symptoms, Rejoyn™. In October 2024, in response to FDA guidance on prescription drug use-related software (PDURS), 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.

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 www.clicktherapeutics.com and connect with us on LinkedIn.

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ABOUT DASSAULT SYSTÈMES

Dassault Systèmes is a catalyst for human progress. Since 1981, the company has pioneered virtual worlds to improve real life for consumers, patients and citizens. With Dassault Systèmes’ 3DEXPERIENCE platform, 370,000 customers of all sizes, in all industries, can collaborate, imagine and create sustainable innovations that drive meaningful impact. For more information, visit: www.3ds.com.

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