StemCell Therapy

Vancouver, British Columbia--(Newsfile Corp. - October 17, 2019) - Sernova Corp. (TSXV: SVA) (OTCQB: SEOVF) (FSE: PSH), a clinical stage regenerative medicine company, has reported findings that further validate Cell Pouch and therapeutic cell performance in Type-1 diabetes. The Cell Pouch is a novel implantable device, that is transplanted with therapeutic cells such as insulin producing islets.

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The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release proteins and hormones as required to treat disease. The Cell Pouch, along with therapeutic cells, 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 reported the detection of enduring levels of C-peptide, measured up to 30 days and ongoing, in the bloodstream of a fasting patient in its ongoing Phase I/II Cell Pouch US clinical study of type-1 diabetes. This is an important step forward and evidence of ongoing islet engraftment within the Cell Pouch, as patients enrolled in Sernova's clinical trial have been incapable of producing C-peptide, prior to implantation of Sernova's Cell Pouch and therapeutic cells.

Dr. Piotr Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago and study principal investigator, stated: "Along with the preliminary safety and early indicators of efficacy, I am excited that we are observing C-peptide levels in the patient's bloodstream after recent transplant, not only following stimulation with a meal but also when the patient is fasting. These findings represent progress in clinical outcomes and evidence of enduring islet survival and function within Sernova's Cell Pouch. We look forward to reporting ongoing results in additional patients as the trial progresses."

The entry criteria of Sernova's clinical study require patients to be C-peptide negative upon enrolment. C-peptide, a biomarker of insulin and widely used as a measure of insulin production by islet cells, is typically measured following overnight fasting and during a glucose tolerance test. Together these measures provide an index of the patient's ability to control blood glucose through their production of insulin.

With the goal of improved blood glucose control and stabilization of fluctuating blood sugar levels commonly experienced in people with type-1 diabetes, a normalizing response can also decrease the likelihood of life threatening hypoglycemic unaware events, a key efficacy measure in the Sernova trial.

Sernova's clinical trial is continuing active recruitment and enrollment of study participants and further results will continue to be reported as the study progresses.

For more information on this clinical trial, please visit http://www.clinicaltrials.gov/ct2/show/NCT03513939. For more information on enrollment and recruitment details please visit http://www.pwitkowski.org/sernova.

Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells, such as human donor cells, corrected human cells and stem-cell derived cells, to improve the treatment and quality of life of people with chronic metabolic diseases. These diseases include insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body.

For more information, please visit the company's website http://www.sernova.com, contact Dominic Gray, Corporate Communications, at 519-858-5126 or email dominic.gray@sernova.com.

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