SEC Clears Hemopurifier Device for Cancer Study in Indian Patients
New Delhi: In a step toward advancing medical device-based cancer care, the Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control Organisation (CDSCO) has granted permission to conduct a pilot clinical investigation of the Hemopurifier device in India.
The proposal, submitted by Qualtran Consulting, was reviewed during the 19th SEC (Oncology) meeting held on 5th June 2025 at CDSCO headquarters, New Delhi.
The firm presented Study Protocol No. AEMD-2024-01-Oncology-India, dated 24th May 2024, a proposal for grant of permission to conduct Pilot Clinical Investigation on proposed medical device Hemopurifier in the country on Indian population before the committee.
After detailed deliberation the committee recommended for;
"The grant of permission to conduct of Pilot Clinical Investigation to prove safety and feasibility of the device in removing circulating exosomes of individuals with solid malignancies on Indian Population as per Study Protocol no. AEMD-2024-01-Oncology-India dated 24.05.2024."
The Hemopurifier is a blood filtration medical device designed to selectively remove circulating exosomes and tumor-derived particles from the bloodstream. These components are known to play a role in tumor progression, immune evasion, and resistance to cancer therapies.
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