Sernova Biotherapeutics has received FDA clearance for its Investigational New Drug (IND) application.
This clearance allows them to evaluate their Cell Pouch bio-hybrid organ, combined with autograft thyroid cells, in patients with hypothyroidism undergoing thyroid surgery.
The Cell Pouch aims to restore natural thyroid function, eliminating the need for hormone replacement therapy.
Preclinical studies showed successful restoration of thyroid hormones without immune suppression.
Sernova views this as an advancement of cell therapies and an opportunity to expand clinical trials for chronic conditions.
The company is focused on developing regenerative medicine therapeutics for chronic diseases like type 1 diabetes and thyroid disorders.
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