Gravity Medical Launches Landmark Stroke Trial in India to Evaluate Cutting-Edge Supernova Stent-Retriever

Gravity Medical Technology has announced the launch of the GRASSROOT Trial, a landmark clinical study in India across 16 leading hospitals.

Lake Forest, California--(Newsfile Corp. - September 26, 2024) - Gravity Medical Technology, a leading innovator in stroke treatment technology, announces the launch of the GRASSROOT (Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial) Trial in India. The trial aims to enroll 60 patients to study the safety and efficacy of the Supernova Stent-retriever.

Gravity Medical Launches Landmark Stroke Trial in India to Evaluate Cutting-Edge Supernova Stent-Retriever

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As India faces a growing stroke burden, innovative solutions like the Supernova Stent-Retriever are essential to improving outcomes. "For India to realize its demographic dividend, we must preserve health - especially in the realm of stroke and its consequences," says Dr. Shashvat Desai MD, Chief of R&D at Gravity. Successful trial enrollment sets a path for clinical use in stroke care in India.

Gravity makes the Supernova, which is an innovative medical device known as a stent-retriever. The Supernova can remove blood clots from the arteries of the brain that cause stroke.

Gravity is a global medical device company dedicated to expanding access to advanced stroke treatment through innovative technologies. By supporting research and development in emerging markets and prioritizing ethical practices, Gravity aims to make life-saving stroke care accessible to patients worldwide.

Gravity has developed and successfully commercialized the most advanced and accessible devices for mechanical thrombectomy in South East Asia. India, the world's most populous nation with 1.45 billion people, has extremely low access to mechanical thrombectomy. Of the 375,000 Indians who qualify for stroke intervention annually, only 4,500 receive this life-saving treatment.

As part of Gravity's mission to expand stroke care in India, the company is pursuing a two-fold strategy. First, it aims to strengthen national capacity by conducting large, multicenter stroke thrombectomy trials in both public and private hospitals throughout the country. Second, Gravity is leveraging this collaborative, stakeholder-driven approach to secure regulatory approval in India using local clinical data. The ultimate goal is to make advanced and accessible stroke treatment devices available to patients across India, addressing the country's urgent need for life-saving medical technology.

The Supernova stent-retriever is a next-generation mechanical thrombectomy device. It overcomes current limitations of existing devices- specifically designed to treat all types of clots- soft and tough. This is especially important in India, South and East Asian, Middle Eastern, and African populations.

The study went live in India on August 15th 2024 which is India's Independence Day.

The first patient was successfully enrolled, treated, and discharged from AIIMS, New Delhi, under the leadership of Dr. Shailesh Gaikwad and Dr. Deepti Vibha. Commenting on this milestone, Dr. Kunakorn Atchaneeyasakul, MD, MPH, CEO of Gravity Mission, said, "We are confident that the first treatment in India with the Supernova Stent will begin a ripple effect of better stroke care for the world." This marks a significant achievement in the GRASSROOT Trial and sets the stage for improved stroke care both in India and globally.

This is a landmark moment for India and Indian stroke care. The GRASSROOT Trial is the first stroke thrombectomy trial generating novel clinical data to improve understanding of pathophysiology of stroke patients in India.

A groundbreaking clinical trial has been launched across 16 hospitals in India to assess the safety and efficacy of the Supernova Stent-Retriever, a device designed to treat ischemic stroke patients. This multi-center trial includes participation from several prestigious public institutions, including:

• All India Institute of Medical Sciences (AIIMS), New Delhi
• Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry
• Postgraduate Institute of Medical Education and Research (PGI), Chandigarh

The trial aims to enroll 60 patients, providing crucial data on the performance of the Supernova Stent-Retriever in real-world clinical settings. The full details and progress of the study are available on ClinicalTrials.gov (ID: NCT06249776).

About Gravity Medical Technology

Gravity Medical Technology, born from the Gravity Mission, is a physician-scientist-led organization with global expertise. Committed to democratizing stroke care, Gravity Medical develops customizable and personalized stroke treatment technologies to ensure better access and outcomes worldwide. The company was founded to improve stroke care for all and is the brainchild of a collective of stroke and neurointervention experts from around the globe. Gravity Medical is uniquely positioned to understand clinical needs and develop life-saving, innovative technology that is accessible to all.

For more information, please visit https://www.gravitymedtech.com/.

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