Sernova Reveals Promising Cell Pouch System™ Data for Hypothyroidism Treatment at ATA 2023

At the 2023 American Thyroid Association (ATA) Annual Meeting in Washington, D.C., Sernova Corp. SVA SEOVF (FSE/XETRA:PSH), a pioneer in clinical-stage cell therapeutics, unveiled new preclinical findings for its Cell Pouch System™. This innovative platform is showing promise as a potential remedy for post-operative hypothyroidism, a condition that often necessitates life-long synthetic hormone replacement following thyroidectomy.

Groundbreaking Preclinical Outcomes

The presented data highlighted the potential of the Cell Pouch System™ to restore normal thyroid hormone levels after total thyroidectomy. By transplanting the patient's thyroid tissue into a uniquely pre-vascularized environment provided by the Cell Pouch™, key hormones such as free thyroxine (FT4) and triiodothyronine (T3) returned to baseline levels. Moreover, thyroid stimulating hormone (TSH) levels initially spiked after the surgery, but a noticeable reduction began five weeks post re-implantation, indicating successful reactivation of the body's natural thyroid feedback system.

Further assessments using radio-isotope uptake imaging and histology six months after the procedure confirmed that the transplanted thyroid tissues remained healthy and functional within the Cell Pouch™. This breakthrough could shift the paradigm in hypothyroidism management by alleviating the lifelong reliance on hormone therapy along with its accompanying side effects such as weight gain, depression, and cognitive issues.

Sernova's Therapeutic Ambitions and Market Potential

Sernova's immediate strategy involves leveraging tissue from the patient's own gland, which is typically removed during benign thyroid surgeries. This first-generation approach eliminates the need for immunosuppressive medications, while a second-generation solution is being explored using stem cell-derived technologies to potentially benefit a larger population of hypothyroid patients.

With approximately 150,000 thyroidectomies conducted yearly in the U.S. alone, the market for such an innovative treatment is substantial. The Cell Pouch System™ also extends beyond hypothyroidism, having demonstrated encouraging results as a functional cure for Type 1 diabetes in clinical studies at the University of Chicago. This device, persisting operational for lengthy periods exceeding four years, fosters a vascularized habitat for therapeutic cells, potentially freeing patients from daily insulin injections.

In alignment with their forward-looking agenda, Sernova Corp. has entered a strategic partnership with Evotec to develop an off-the-shelf cell therapy for insulin-dependent diabetes, utilizing induced pluripotent stem cells (iPSC). This collaboration holds the promise of mass-producing insulin-producing cells, catering to the needs of millions worldwide.

Sernova, CellPouch, Hypothyroidism