Sernova Announces Peer-Reviewed Publication Demonstrating Positive Preclinical Indicators of Safety and Efficacy of Its Novel Cell Pouch System(TM) Therapeutic Approach for the Treatment of Thyroid Diseases


Sernova prepares for a clinical trial of a new treatment for postoperative hypothyroidism

LONDON, ONTARIO – TheNewswire – January 27, 2022 – Sernova Corp. (TSXV:SVA) (OTC:SEOVF) (FSE/XETRA:PSH), a clinical-stage regenerative medicine and cell therapy company developing a potential “working cure” for chronic diseases, including type 1 diabetes (T1D ) is pleased to announce the publication of a peer-reviewed preclinical study demonstrating the positive results of a novel Cell Pouch System™ cell therapy approach to treat hypothyroidism and potentially avoid lifelong addiction to thyroid medication after surgical removal of the thyroid gland.

The journal article titled Subcutaneous Transplantation of Human Thyroid Tissue in a Prevascularized Cell Pouch™ Device in a Mus musculus Model: Evidence for Thyroid Transplant Viability and Function“, by lead author, Dr. Sam M. Wiseman has been published in the prestigious scientific journal, PLOS ONEJanuary 20, 2022. In this study, thyroid tissue from patients undergoing surgery for the treatment of mild disease was transplanted into Sernova cell packets that had been previously implanted into laboratory mice. The objective of the study was to investigate the long-term survival of human thyroid tissue in the cell pocket and to assess the ability of these thyroid transplants to release thyroid hormones into the bloodstream. The study confirmed that human thyroid tissue transplanted into the Cell Pouch survived and released human thyroglobulin into the bloodstream with no adverse effects during the three months of the study. Thyroglobulin was used as a biomarker efficacy measure in this study because it is the precursor to thyroid hormones.

“I am very excited about this study as it represents a crucial first step towards a future where we can offer our patients a treatment option that helps preserve their thyroid function by avoiding postoperative hypothyroidism, its many associated morbidities and lifespan addiction to thyroid medication,” commented Sam M. Wiseman BSc, MD, FRCSC, FACS.

Dr. Philip Toleikis, President and CEO of Sernova Corp, said: “For hypothyroid disease, these data support the potential of our Cell Pouch to enable recovery of the natural thyroid hormone feedback system after thyroidectomy, restoring thyroid hormone levels without the risks and side effects associated with replacement medications. hormonal. This could provide life-changing options for the more than 150,000 patients who undergo thyroidectomy in the United States alone each year. These preclinical data are consistent with our findings on the use of the Cell Pouch in the treatment of T1D and hemophilia A. We believe that the therapeutic approach of the Sernova Cell Pouch System could provide “functional cure” to millions of patients who suffer from conditions caused by the absence of systemic proteins or hormones.

Sernova Corp., with Dr. Wiseman as clinical investigator, is preparing regulatory documents to proceed with a Phase 1/2 human clinical trial in subjects undergoing thyroid surgery. In this study, subjects will be implanted with the cell pocket to create the vascularized tissue environment several weeks prior to the transplant of their healthy thyroid tissue. The objective of the study is to assess the safety and the efficacy of the transplanted Cell Pouch tissue, the efficacy being measured by the recovery of thyroid hormone from the blood. The Company expects to submit a clinical trial application by 2022.

The thyroid gland produces hormones that regulate metabolism within a narrow functional range. Thyroid hormone replacement medications are frequently used to treat insufficient or absent thyroid activity. Optimizing thyroid hormone replacement medications can be challenging with dose adjustments requiring frequent lab testing to achieve appropriate levels. Thyroid hormone replacement therapy is associated with several side effects, including impaired cognition, lethargy, and weight gain, resulting in decreased quality of life and incurring significant ongoing costs to the patient and the healthcare system.


Surgical removal of the thyroid gland, or thyroidectomy, is commonly performed for the management of thyroid cancers and for the treatment of benign (non-cancerous) conditions such as nodules, goiter, and hyperthyroidism. It is estimated that approximately 150,000 thyroidectomies are performed in the United States each year, with most people having thyroid surgery eventually being diagnosed with benign conditions. Some patients undergoing partial thyroidectomy and all patients undergoing total thyroidectomy require lifelong oral postoperative hormone replacement therapy.


Sernova develops regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and immunoprotected therapeutic cells/tissues (i.e. human donor cells, corrected human cells and stem cell-derived cells) to improve the treatment and quality of life for people with metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, thyroid disease and other diseases treated by cellular production of proteins or missing or insufficient hormones in the body. For more information, please visit


The Cell Pouch, as part of the Cell Pouch System, is a novel, scalable, proprietary implantable macro-encapsulation device solution designed for the survival and long-term functioning of therapeutic cells. Upon implantation, the device is designed to embed itself into tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells, which then release proteins and hormones as needed to treat the disease.

The Cell Pouch, along with Cell Therapeutics, has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans. Sernova is currently conducting a phase 1/2 study at the University of Chicago. The first positive results were presented at several international scientific conferences.


Christopher Barnes

Vice President, Investor Relations

Sernova Corp.

[email protected]

Tel: 519-902-7923

Corey Davis, Ph.D.

LifeScience Advisors, LLC

[email protected]

Tel: 212-915-2577


This press release contains statements which, to the extent that they are not recitals of historical fact, may constitute “forward-looking statements” that involve various risks, uncertainties and assumptions, including, without limitation, statements regarding prospects, plans and objectives of the company. Whenever possible, but not always, words such as “anticipates”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “could”, “might” or “should” occur are used to identify forward-looking statements. These statements reflect management’s beliefs regarding future events and are based on information currently available to management as of the date such statements were made. Many factors could cause Sernova’s actual results, performance or achievements not to be those anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this press release. These factors could include, but are not limited to, the Company’s ability to obtain additional financing and license agreements on reasonable terms, if at all; ability to conduct all preclinical and clinical studies required for the Company’s Cell Pouch System and/or related technologies, including the timing and results of such trials; ability to obtain all necessary or timely regulatory approvals; the ability to license additional complementary technologies; its ability to implement its business strategy and compete successfully in the marketplace; and the inherent risks associated with the development of combination biotechnology products generally. Many factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors are encouraged to consult the Company’s quarterly and annual filings available at for additional information on the risks and uncertainties associated with forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.


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