LONDON and ONTARIO, California, Oct. 24, 2019 /PRNewswire/ — Sernova Corp. (SVA.V) (SEOVF) (PSH.F), a clinical-stage regenerative medicine company, is pleased to announce that Mr. David Swetlow, CPA, CA, has joined Sernova as Chief Financial Officer.
Mr. Swetlow is a veteran of the high tech and life sciences industries with over 20 years in various senior management, board, and advisory roles for start-up, acceleration, and high-growth stage companies, including multiple TSX and Nasdaq listed biotech companies amongst them QLT Inc. and Protox Therapeutics Inc.
“Mr. Swetlow’s extensive financial and business experience with high-growth stage and public companies will bolster Sernova’s Management Team. Adding a full-time CFO at this inflection point for the company with our recent announcement of initial positive early efficacy indicators for our Cell Pouch(TM) Phase I/II US clinical trial for type-1 diabetes and ongoing business development activities will accelerate execution of the company’s financial, business and capital markets goals and strategies,” said Dr. Philip Toleikis, President and CEO of Sernova.
Sernova’s outgoing CFO, Mr. Sean Hodgins, will assist with the transition as he continues to provide contract CFO services to his technology company clients. Sernova would like to thank Mr. Hodgins for his contribution and wishes him well in his future endeavors.
In connection with Mr. Swetlow’s appointment, Sernova has granted an aggregate of 750,000 stock options on October 23, 2019 each such option being exercisable into one common share at a price of $0.21 per share. The options will vest over 36 months and expire after 10 years.
ABOUT SERNOVA’S CLINICAL TRIAL
Sernova is conducting a Phase I/II non-randomized, unblinded, single-arm, company-sponsored trial to assess the safety and tolerability of islet transplantation into the company’s patented Cell Pouch in participants with diabetes and hypoglycemia unawareness. The secondary objective is to assess efficacy through a series of defined measures. Importantly, patients enrolled in Sernova’s clinical trial are incapable of producing C-peptide prior to implantation of Sernova’s Cell Pouch and therapeutic cells.
Eligible subjects are implanted with Cell Pouches. Following the development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression and a dose of purified islets, under strict release criteria, transplanted into the Cell Pouch.
A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for additional safety and efficacy measures for approximately six months. At this point, a decision is made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will be then further followed for one year to assess longer-term safety and efficacy.
For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more information on enrollment and recruitment details, please visit www.pwitkowski.org/sernova.
ABOUT SERNOVA’S CELL POUCH
The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the long- term survival and function of therapeutic cells. 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 device, 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.
ABOUT SERNOVA CORP.
Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e., 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 such as 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 www.sernova.com
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although Sernova believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Sernova’s management on the date such statements were made, which include our beliefs about the conduct and outcome of clinical trials. The information disclosed represents results from one patient and may not be representative of all study patients or of the final study results. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
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