The Business of Biofabrication

Sernova Biotherapeutics has received clearance from the U.S. Food and Drug Administration for its Investigational New Drug application. The clearance enables the company to evaluate its Cell Pouch bio-hybrid organ, integrated with autologous thyroid cells, in patients undergoing thyroid surgery for nodular thyroid disease—a condition that often leads to hypothyroidism due to reduced thyroid hormone production.

Hypothyroidism affects millions worldwide and is especially common following thyroid surgery. Sernova’s innovative approach involves implanting thyroid tissue into a pre-vascularized Cell Pouch, a procedure that has shown promising preclinical results. Studies indicate that re-implantation of thyroid tissue within the pouch successfully restores key thyroid hormones to levels comparable to those before surgery, without requiring hormone replacement therapy or immune suppression. Radio-isotope imaging and histological analyses have confirmed the presence of healthy, functioning thyroid tissue up to five months after implantation.

As a clinical-stage regenerative medicine company, Sernova is focused on developing bio-hybrid organs to treat chronic diseases. Its technology, initially targeting type 1 diabetes, is now expanding into thyroid disorders, potentially offering a more natural and long-term solution for patients. The FDA clearance is a significant milestone that will broaden the scope of the company’s clinical trials and supports its strategy to diversify therapeutic applications in chronic conditions.

About Sernova Biotherapeutics
Sernova Biotherapeutics is a clinical-stage regenerative medicine company focused on developing innovative bio-hybrid organ technologies to address chronic diseases. By combining its proprietary Cell Pouch with human donor cells or stem cell-derived therapies, the company creates functional bio-hybrid organs designed to restore and enhance compromised organ functions. Initially targeting conditions such as type 1 diabetes and thyroid disorders, Sernova’s approach offers the potential for durable, physiological solutions that reduce or eliminate the need for lifelong medication.