Sernova Corp. announced publication of a peer reviewed preclinical study demonstrating positive results of a novel Cell Pouch System cell therapy approach to treat hypothyroidism and potentially avoid lifelong dependence on thyroid medication following surgical removal of the thyroid gland. The journal article entitled "Subcutaneous transplantation of human thyroid tissue into a pre-vascularized Cell Pouch device in a Mus musculus model: Evidence of viability and function for thyroid transplantation," by lead author, Dr. Sam M. Wiseman was published in the prestigious scientific journal, PLOS ONE, January 20, 2022.

In this study, thyroid tissue from patients undergoing surgery for treatment of benign disease was transplanted into Sernova Cell Pouches that had been previously implanted into laboratory mice. The aim of the study was to investigate the long-term survival of human thyroid tissue in the Cell Pouch and evaluate the ability of these thyroid transplants to release thyroid hormones into the bloodstream. The study confirmed that the human thyroid tissue transplanted into the Cell Pouch survived and released human thyroglobulin into the bloodstream, with no adverse effects for the three-months duration of the study.

Thyroglobulin was used as a biomarker efficacy measure in this study as it is the precursor of thyroid 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, the subjects will be implanted with the Cell Pouch to create the vascularized tissue environment several weeks prior to transplant of their healthy thyroid tissue.

The objective of the study is to assess the safety and efficacy of the Cell Pouch transplanted tissue, with efficacy measured as recovery of thyroid hormone in the bloodstream. The Company expects to submit a clinical trial application within 2022. The thyroid gland produces hormones that regulate metabolism within a narrow functional range.

Thyroid hormone replacement drugs are frequently used to treat insufficient or absent thyroid activity. Optimization of thyroid hormone replacement medications can be difficult with dose adjustments requiring frequent lab tests to reach appropriate levels. Thyroid hormone replacement therapy is associated with several side-effects including impaired cognition, lethargy, and weight gain, leading to diminished quality of life, and incurring significant ongoing costs to the patient and healthcare system.