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Sernova Biotherapeutics Receives FDA Clearance for IND Application for its Cell Pouch Bio-hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism
LONDON, Ontario and BOSTON, March 03, 2025 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics, (TSX: SVA...
About this update from Sernova Biotherapeutics Inc
[{"type":"text","content":"Sernova Biotherapeutics Receives FDA Clearance for IND Application for its Cell Pouch Bio-hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism\n\n\n\n LONDON, Ontario and BOSTON, March 03, 2025 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics, (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a leading regenerative medicine company focused on developing it’s Cell Pouch bio-hybrid organ as a functional cure for type 1 diabetes, today announced that the U.S. Food and Drug Administration (FDA) has cleared it’s Investigational New Drug (IND) application to evaluate the Company’s Cell Pouch with auto-transplanted thyroid cells in patients undergoing thyroid surgery for nodular thyroid disease.\n \n\n Hypothyroidism, a condition resulting from insufficient thyroid hormone production, affects millions worldwide and can significantly impact quality of life. It is especially prevalent among patients after thyroid surgery. Sernova’s Cell Pouch bio-hybrid organ, in combination with autologous thyroid cell therapy, is designed to restore natural thyroid function by providing a stable, long-term, and physiological solution without the need for thyroid hormone replacement medications or immune suppression therapy.\n \n\n \"The FDA’s clearance of our IND application to investigate our Cell Pouch bio-hybrid organ in an additional indication is great progress,\" said Jonathan Rigby, CEO of Sernova. \"This further demonstrates that our technology has the potential to play an important role in advancing cell therapies that improve the quality of life for patients suffering from chronic illnesses.\"\n \n\n Preclinical studies have demonstrated that re-implantation of thyroid tissue into the pre-vascularized Cell Pouch, without immune suppression, successfully restored the primary thyroid hormones, thyroxine (T4) and triiodothyronine (T3), to pre-thyroidectomy levels without hormone supplementation. Radio-isotope imaging and histological analysis confirmed the presence of healthy, functional thyroid tissue within the Cell Pouch up to five months post-implantation. Receipt of FDA clearance provides Sernova with the ability to diversify its clinical trial activity in chronic conditions as the Company strengthens its financial resources.\n \n\n\n ABOUT SERNOVA BIOTHERAPEUTICS\n \n\n\n Sernova Biotherapeutics...