10:41 AM EST, 03/03/2025 (MT Newswires) -- Sernova Biotherapeutics (SVA.TO), a regenerative medicine company, was edging up on Monday after saying the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to evaluate its Cell Pouch with auto-transplanted thyroid cells in patients undergoing thyroid surgery for nodular thyroid disease.

Sernova's ( SEOVF ) Cell Pouch bio-hybrid organ, together 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", the statement said.

Preclinical studies have shown that re-implantation of thyroid tissue into the Cell Pouch 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, the statement said.

"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 ( SEOVF ). "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."

Sernova ( SEOVF ) was last seen up $0.005, to $0.205, on the Toronto Stock Exchange.