Ms. Cynthia Pussinen reports

SERNOVA PRESENTS COMPELLING NEW DATA ON THE CELL POUCH SYSTEM(TM) AS A PROMISING TREATMENT FOR POST-OPERATIVE HYPOTHYROIDISM AT THE 2023 AMERICAN THYROID ASSOCIATION ANNUAL MEETING

Sernova Corp. is discussing new preclinical data for its novel cell therapy platform, the Cell Pouch system, as a potential treatment for postoperative hypothyroidism at the 2023 American Thyroid Association (ATA) annual meeting being held in Washington, D.C., from Sept. 27 to Oct. 1, 2023.

Key insights from the poster:

• After total thyroidectomy, reimplantation of thyroid tissue into the prevascularized Cell Pouch resulted in the restoration of the two main thyroid hormones, that is, free thyroxine (FT4) and triiodothyronine (T3), to the baseline levels.
• Thyroid-stimulating hormone (TSH) levels had a significant peak immediately after thyroidectomy, with a gradual decline observed starting five weeks after the reimplantation of thyroid glands. This pattern underscores the re-establishment of the intrinsic thyroid feedback loop's impact.
• Newly reported radioisotope uptake imaging and histology assessments confirmed the presence of healthy and functional thyroid tissues within the Cell Pouch six months following reimplantation.

"Currently, thyroidectomy patients are bound to lifelong thyroid hormone replacement therapy. A significant subset of those patients grapple with persistent symptoms of thyroid dysfunction, including weight gain, fatigue, depression, memory and cognitive impairment, negatively impacting their quality of life," said Cynthia Pussinen, chief executive officer at Sernova. "With Sernova's Cell Pouch system, we aim to improve quality of life with a treatment for postoperative hypothyroidism. These new data replicate a human clinical scenario in which thyroid tissue is reimplanted into the patient, via the Cell Pouch, leading to the restoration of normal thyroid function. Sernova is assessing the commercial opportunity and pathways for accelerated development of the thyroid program."

Approximately 150,000 thyroidectomies are performed annually in the United States alone, representing a significant market opportunity. Sernova's potential first-generation product would utilize healthy tissue from the patient's own gland removed during thyroidectomy for benign disease. This therapeutic approach would negate the need for immune suppression medication. A second-generation stem-cell-derived technology could potentially be used to treat the broader population with hypothyroid disease.

Poster details:

Title: Auto-Transplantation of Rat Thyroid into a Pre-Vascularized Retrievable Cell Pouch Device for the Treatment of Post-Operative Hypothyroidism

Presenter: Dr. Arash Memarnejadian, senior research scientist, Sernova

Date and time: Sept. 29 from 9:50 a.m. to 12:40 p.m. Eastern Time

Poster No.: 323

About Sernova Corp.

Sernova is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease and blood disorders that include hemophilia A. Sernova is currently focused on developing a functional cure for insulin-dependent diabetes with its lead asset, the Cell Pouch system, a novel implantable and scalable medical device with immune-protected therapeutic cells. On implantation, the Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova's Cell Pouch system has demonstrated its potential to be a functional cure for people with Type 1 diabetes in a continuing phase 1/2 clinical study at the University of Chicago, with Cell Pouches implanted for periods of more than four years and counting.

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