Western Research Park

Sernova’s Cell Pouch Regenerative Medicine Clinical Trial for Patients with Type 1 Diabetes Supported with Continuous Glucose Monitoring Systems

Continuous Glucose Monitoring System (CGM) to provide sensitive tracking of key efficacy measures in patients at important time points throughout the study

LONDON, Ontario, Feb. 22, 2018 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX-V:SVA) (OTCQB:SEOVF)
(FSE:PSH), a clinical stage company developing regenerative medicine technologies for the treatment
of chronic diseases including diabetes and hemophilia, is pleased to announce continuous glucose
monitoring systems (CGM (Medtronic Minimed, Northridge, CA)) will be provided to patients in
Sernova’s US regenerative medicine clinical trial of its Cell Pouch(TM). CGM will be used to track
the function of the transplanted cells in the measurement of key efficacy measures at multiple time
points following transplantation of the therapeutic cells into the Cell Pouch.

Glucose variability and hypoglycemia duration can be determined using CGM. CGM involves the
subcutaneous placement of a glucose sensor connected to a pager-sized monitoring device that stores
glucose data over a 6-day period. Data from each period will be analyzed for mean glucose
concentration, mean glucose variability, number and duration of hyper- and hypo- glycemic episodes,
and total duration of hypoglycemia.

“We believe continuous glucose monitoring of patients may be an important and sensitive method to
closely track the function of the transplanted therapeutic cells within the Cell Pouch,” said Dr.
Philip Toleikis, Sernova’s President and CEO. “We are pleased with our collaborators in this study
who have shown the foresight to support Type 1 diabetes patients seeking treatment via
next-generation regenerative medicine technologies.”

Sernova has recently received US Food and Drug Administration (FDA) notice of allowance for its IND
for a new human clinical trial with the Cell Pouch System (CPS) in the United States. Sernova is
taking final steps to begin enrollment of patients in the new clinical trial under this US IND to
investigate the Cell Pouch for treatment of type 1 diabetes (T1D) in individuals with hypoglycemia
unawareness. The trial is a Phase I/II prospective single arm study of islets transplanted into the
subcutaneously implanted Cell Pouch. The primary objective of the study is to demonstrate safety
and tolerability of islet transplantation into the Cell Pouch and the secondary objective is to
assess efficacy through a series of defined measures.

About the Trial
The study is a Phase I/II single site, single arm, Company sponsored trial. Following approval by
the Institutional Review Board, patients with hypoglycemia unawareness will be enrolled into the
study under informed consent. Patients will then be implanted with the Cell Pouch including
sentinel devices. Following vascularized tissue development, a dose of purified islets under
strict release criteria will be transplanted into the Cell Pouch and patients followed for safety
and efficacy measures for approximately six months. At this point a decision will be made whether
to transplant a second islet dose with subsequent safety and efficacy follow up. Patients will then
be further followed for one year. CGM is planned to provide a sensitive and accurate tracking
method to follow important efficacy measures at various time points throughout the study.

About Sernova’s Cell Pouch
The Cell Pouch is a novel, proprietary, scalable, implantable macroencapsulation device 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 with 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 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 treated through replacement of proteins or hormones missing or in
short supply within the body. For more information, please visit www.sernova.com.
Source: Sernova Corp

For further information contact:
Philip Toleikis, Ph.D., President and CEO Tel: (604) 961-2939
philip.toleikis@sernova.com
www.sernova.com