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Sernova Announces University of Chicago Institutional Review Board (IRB) Approval of the FDA-cleared Therapeutic Cell Pouch Clinical Study

IRB Approval Signals ‘Green Light’ for Sernova’s Clinical Protocol to Proceed

LONDON, Ontario, May 14, 2018 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF) 
(FSE:PSH), announces today it has received University of Chicago Institutional Review Board (IRB) 
approval to begin a new clinical protocol for the FDA-cleared human clinical trial to investigate 
the Cell Pouch™ for treatment of type 1 diabetes (T1D) in individuals with hypoglycemia 

The University of Chicago Institutional Review Board (IRB) is a committee established to review and 
approve research involving human subjects. The purpose of the IRB is to ensure that all human 
subject research is conducted in accordance with all federal, institutional, and ethical 
guidelines. The primary goal of an IRB is to safeguard the rights, safety and welfare of 
participants in research studies.

"The approval of our clinical protocol by the University of Chicago IRB represents a significant 
milestone enabling the company to expand the clinical testing of our Cell Pouch System to the US. 
Patient selection and enrollment can now proceed," said Dr. Philip Toleikis, Sernova President and 

The approved protocol is a Phase I/II non-randomized, unblinded, single arm, company-sponsored 
trial, where diabetic subjects with hypoglycemia unawareness will be enrolled into the study under 
informed consent. Subjects will then be implanted with Cell Pouches. Following development of 
vascularized tissue chambers within the Cell Pouch, subjects will then be stabilized on 
immunosuppression and a dose of purified islets under strict release criteria will be transplanted 
into the Cell Pouch.

A sentinel pouch, also transplanted with islets, will be removed for an early assessment of the 
islet transplant. Subjects will be followed for safety and efficacy measures for approximately six 
months. At this point, a decision will be made with regards to the transplant of a second islet 
dose with subsequent safety and efficacy follow up. Patients will then be further followed for one 
year. The primary objective of the study is to demonstrate safety and tolerability of islet 
transplantation into the Cell Pouch™. The secondary objective is to assess efficacy through a 
series of defined measures.

About Sernova’s Cell Pouch™ Technologies
The Cell Pouch™ is a novel, proprietary, scalable, implantable macroencapsulation device designed 
to prevent device fibrosis for the long- term survival and function of therapeutic cells (donor, 
stem cell-derived cells and xenogeneic cells) which then release proteins and/or hormones as 
required to treat disease. The device is designed upon implantation to incorporate with tissue, 
forming highly vascularized tissue chambers for the transplantation and function of therapeutic 
cells. The device 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 Diabetes
T1D is a life-threatening disease, affecting more than 3.3 million individuals in Canada and US, in 
which the body's immune system mistakenly attacks and kills the pancreatic cells that produce 
insulin a hormone that is essential for life because of its role to help the body use glucose. The 
existing standard of care for patients with TID is suboptimal. To date, there is no cure for T1D, 
and people living with the disease are dependent on exogenous insulin therapy to help keep their 
blood-sugar levels from spiking too high, which can lead to long- term complications such as kidney 
and heart diseases or an acute, potentially deadly health crisis. Present-day insulin therapy is, 
however, an imperfect treatment method that requires people with T1D to carefully monitor their 
blood sugar throughout the day and take multiple, calculated doses of insulin based on food intake, 
exercise, stress, illness and other factors. A miscalculation or unexpected variable leading to 
high or low blood sugar episodes are daily threats, and only a third of people with T1D achieve 
their long-term blood glucose targets, placing them at risk for T1D-related health complications.

About Sernova Corp
Sernova Corp is developing disruptive regenerative medical technologies using a medical device and 
immune protected therapeutic 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. For more information, please visit www.sernova.com

For further information contact:
Philip Toleikis, Ph.D., President and CEO 
Tel: (604) 961-2939;