Sernova Biotherapeutics Receives FDA Clearance for IND Application for its Cell Pouch Bio-hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism

/EIN News/ -- 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.

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.

"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."

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.

ABOUT SERNOVA BIOTHERAPEUTICS

Sernova Biotherapeutics is a clinical-stage company developing regenerative medicine therapeutics combining its Cell Pouch with human donor cells or stem cell-derived cell therapies to create bio-hybrid organs to treat chronic diseases. A bio-hybrid organ is comprised of non-biomaterials, such as the Cell Pouch, integrated with living tissues to restore or enhance the function of a compromised organ. This innovative approach aims to deliver a potentially revolutionary treatment for patients with chronic diseases, initially focusing on type 1 diabetes and thyroid disorders.

FOR FURTHER INFORMATION, PLEASE CONTACT:

David Burke VP, Investor Relations (917) 751-5713 Email: David.Burke@sernova.com Website: https://sernova.com/ 

The TSX has not reviewed this news release and does not accept responsibility for the accuracy or adequacy of this news release.

FORWARD-LOOKING INFORMATION

This press release contains forward-looking statements within the meaning of applicable Canadian securities laws. Forward-looking statements in this press release include our plan to consider the initiation of a clinical trial in patients undergoing thyroidectomy for benign nodular thyroid disease. With respect to the forward-looking statements contained in this press release, Sernova has made numerous assumptions regarding, among other things: the company’s ability to secure additional financing on reasonable terms, or at all; and the ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch, including the timing and results of those trials. A more complete discussion of the risks and uncertainties facing Sernova appears in Sernova’s Annual Information Form for the year ended October 31, 2024, filed with Canadian securities authorities and available at www.sedarplus.ca, as updated by Sernova’s continuous disclosure filings, which are available at www.sedarplus.ca. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Sernova disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.