2010 Press Releases Communiqués de presse
Prominent Transplant Surgeon, Dr. Steven Paraskevas, Joins Sernova Scientific Advisory Board
Sernova Provides Corporate Update And Announces Closing Of Private Placement
Sernova Completes $1,000,000 Private Placement, Grants Options
Sernova Expands Scientific Advisory Board
Sernova Corp Announces Private Placement and $570,000 First Closing
Pioneer in Islet Transplantation, Dr. James Shapiro, Joins Sernova Scientific Advisory Board
Sernova Awarded $275,000 Financial Contribution From NRC-IRAP To Support Research And Development
Ontario's Minister Goodyear Announces $45 Million Investment in Innovation and Job Creation Through NRC-IRAP at Sernova Corp.
Sernova Announces Positive Results of its Proprietary Cell Pouch System(tm) in Preclinical Diabetes Model
Sernova Completes Second Closing Of Private Placement
Sernova Presents Cell Pouch System Preclinical Results At The American Society Of Internal Artificial Organs
Appointment Of Stephen Nagler To The Sernova Business Advisory Board
Sernova Announces $1.2M Private Placement And $400,000 First Closing
Sernova To Present At Biofinance Canada Conference
Sernova Announces Interim Results from Key Preclincal Study With its Proprietary Cell Pouch System(tm)
Sernova Advances Cell Pouch System(tm) Into Non-Human Primate Studies
Sernova To Present At Biopartnering North America Conference
Press Release Communiqué de presse - December 16, 2010 16 December, 2010
Prominent Transplant Surgeon, Dr. Steven Paraskevas, Joins Sernova Scientific Advisory Board
Source: Sernova Corp
FOR RELEASE
December 16, 2010, 6:00 a.m. EDT
LONDON, ONTARIO--(Marketwire -- December
16, 2010)
- Sernova Corp. (TSX-V: SVA), is pleased to
announce the
appointment of Dr. Steven Paraskevas, MD,
Ph.D., to the
Corporation's Scientific Advisory Board. Dr.
Paraskevas is
transplant surgeon at McGill University Health
Centre and
Director of the Pancreas and Islet Transplant
Program and
of the Human Islet Isolation Laboratory at McGill.
"Dr. Paraskevas is highly respected in the islet
transplant
field and will be an excellent addition to
Sernova's clinical
development team working on the Cell
Pouch(TM)," said
Dr. James Shapiro, MD, Ph.D. FRCS (Eng.)
FRCSC,
Director of the Clinical Islet Transplantation
Program at the
University of Alberta and member of Sernova's
scientific
advisory board.
"The new islet transplantation program at McGill
University headed by Dr. Paraskevas is the third
such
centre in Canada and provides the potential to
significantly
increase the number of diabetic patients that can
be
treated with donor islets. This advancement will
not only
benefit diabetic patients but will be
advantageous to
Sernova as it prepares for clinical development
of the Cell
Pouch(TM)," noted Dr. Philip Toleikis, President &
CEO of
Sernova Corp.
Dr Paraskevas earned a BA in Biology at
Harvard
University in 1988, and obtained his MD and
completed
General Surgery residency at McGill. During that
time, he
also studied mechanisms of cell death in
transplanted
human islets, completing a PhD in Experimental
Surgery
at McGill in 2003. Based on this work, he earned
the
Scientific Trainee Award of the Canadian
Diabetes
Association in 1997. After residency, he
completed a two-
year fellowship in abdominal solid-organ
transplantation at
the University of Minnesota, where he was also
involved
in the clinical islet transplant program under Dr
Bernhard
Hering. He returned to McGill in 2002 and is
currently
Associate Professor in Surgery and member of
the multi-
organ transplant program.
His current research focuses on methods to
improve islet
survival of human islets, paralleling the focus of
Sernova's
proprietary technologies. He is a Councillor-at-
large of the
Canadian Society of Transplantation and Chair of
the Cell
Transplant Committee of the American Society of
Transplant Surgeons.
"Sernova is developing an eminent team of
clinicians to
lead the clinical evaluation of the Cell Pouch(TM)
and we
are thrilled to have Dr. Paraskevas as a member
of that
team, added Dr. David White, Chairman of
Sernova's
Scientific Advisory Board.
Sernova's Cell Pouch System(tm) is a scalable
medical
device providing a natural "organ-like"
environment for
therapeutic cells. Once implanted under the skin,
it
develops into a tissue-engineered pancreas
when infused
with islets. The natural environment established
by the
Cell Pouch System(tm) is expected to conserve
cell
number, and promote natural function thereby
increasing
cell survival, while significantly increasing the
number of
treatable patients beyond those with severe
disease.
About Sernova
Sernova Corp. is a Canadian-based, health-
sciences
company focused on commercializing medical
technologies. Sernova is currently developing a
platform
technology for a number of serious disease
indications,
starting with a novel treatment for insulin-
dependent
diabetes, using the novel Cell Pouch System(TM)
and its
patented Sertolin(TM) cell technology. According
to the
American Diabetes Association approximately 9
million
Americans require insulin injections and it is the
sixth
leading cause of death in the United States. One
out of
every 8 dollars spent on health care in the
United States is
spent on treating diabetes and its complications.
Worldwide expenditures on insulin alone are
estimated to
be $15 billion annually and growing.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities -- that could cause actual results to
differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - December 07, 2010 7 December, 2010
Sernova Provides Corporate Update And Announces Closing Of Private Placement
*** Sernova Now Has Financial Resources to
Start Clinical
Trials in 2011 ***
THIS NEWS RELEASE IS NOT FOR
DISTRIBUTION TO
U.S. NEWSWIRE SERVICES OR FOR
DISSEMINATION
IN THE UNITED STATES
Source: Sernova Corp
Tuesday, December 7, 2010, 6:00 a.m. EDT
LONDON, ONTARIO--(Marketwire -- December
7, 2010) -
Sernova Corp. ("Sernova" or the "Company")
(TSX
VENTURE:SVA - News) is pleased to provide an
update
on activities and plans for 2011 and the closing
of private
placement.
Private Placement
The Company has completed a non-brokered
private
placement of 1,400,000 Units at a price of $0.16
per Unit
raising gross proceeds of $224,000. Each Unit
issued
consisted of one common share of the Company
(a
"Share") and one-half of a share purchase
warrant (a
"Warrant"). Each whole Warrant entitles the
holder thereof
to acquire one Share at a price of $0.20 for a
period of 24
months. All of the securities issued in the private
placement are subject to a four month hold
period that
expires on April 3, 2011.
Dr. Philip Toleikis, Sernova's President & CEO,
stated:
"This and previous private placements have
positioned
Sernova with the financial resources to continue
to build
value through the accomplishment of several
milestones
during the coming year." Proceeds of the
offering will be
used to fund ongoing development of Sernova's
proprietary Cell Pouch System(TM), including
cGMP
manufacturing, pre-clinical studies required by
regulatory
authorities to support a future Phase I/II human
clinical
study of insulin-dependent diabetes, and for
general
working capital.
Corporate Update
During 2010, we achieved a number of key
milestones
including:
- Refocusing our strategy around the
commercialization of our Cell Pouch System(TM).
- The augmentation of our Scientific Advisory
Board
with the additions of Dr. James Shapiro and Dr.
David
Sutherland.
- Prepared for initiation of human clinical trials
with the
Cell Pouch System(TM) by completing a
significant
preclinical study demonstrating long-term
glucose control
in an industry-standard model of diabetes.
The Cell Pouch System(TM) is a proprietary
medical
device which may offer a revolutionary
improvement over
the current practice of injecting therapeutic cells
into blood
vessels. Based on previous pre-clinical research,
the Cell
Pouch System(tm) becomes a vascularised
organ-like
structure when placed in the body, providing the
microcirculation thought to be essential to early
function
and long-term survival of therapeutic cells.
During the coming year, Sernova plans to build
shareholder value by continuing to advance the
Cell
Pouch System(TM) into human clinical trials by:
-establishing a relationship with an ISO13485
compliant
manufacturer to produce our US-FDA GMP-
compliant Cell
Pouch Systems(TM);
- preparing documentation to support regulatory
filings
required to begin human clinical trials in 2011for
patients
to receive donor islets;
- continuing to establish relationships with
leaders in the
medical community by presenting at leading
transplantation conferences including: The
Canadian
Society of Transplantation, and World Congress
of
International Pancreas and Islet Transplant
Association;
- presenting the validation study of the Cell
Pouch
System(TM) in non-human primates, assessing
tissue
incorporation and angiogenesis, which was
conducted in
collaboration with the University of Illinois at
Chicago's
Transplant Biology Research Laboratory; and
- presenting key results from ongoing studies of
the Cell
Pouch System(TM) in autograft and islet-sparing
allograft
porcine studies.
Another important aspect of Sernova's
commercialization
strategy, is establishing collaborative
relationships with
companies working in the cell therapy field.
Based on
research to date, the Cell Pouch System(TM) has
the
potential for a wide range of uses in cell therapy
including
the treatment of diabetes, haemophilia, spinal
cord injury,
Parkinson's disease and other chronic
debilitating
diseases.
"Now that we have demonstrated strong efficacy
in
diabetes with the Cell Pouch(TM) we are hoping
to
establish one or more collaborations to
demonstrate the
expanded utility of the Cell Pouch System(TM)
for other
therapeutic cells during 2011," added Dr.
Toleikis.
As always, we wish to thank our shareholders
for their
continued support of our vision to build a
successful and
profitable health-sciences company.
Dr. Philip Toleikis, President & CEO Sernova
Corp
About Sernova
Sernova Corp. is a Canadian-based, health-
sciences
company focused on commercializing medical
technologies. Sernova is currently developing a
platform
technology for a number of serious disease
indications,
starting with a novel treatment for insulin-
dependent
diabetes, using the novel Cell Pouch System(TM)
and its
patented Sertolin(TM) cell technology. According
to the
American Diabetes Association approximately 9
million
Americans require insulin injections and it is the
sixth
leading cause of death in the United States. One
out of
every 8 dollars spent on health care in the
United States is
spent on treating diabetes and its complications.
Worldwide expenditures on insulin alone are
estimated to
be $15 billion annually and growing.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities -- that could cause actual results to
differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - November 05, 2010 5 November, 2010
Sernova Completes $1,000,000 Private Placement, Grants Options
THIS NEWS RELEASE IS NOT FOR
DISTRIBUTION TO
U.S. NEWSWIRE SERVICES OR FOR
DISSEMINATION
IN THE UNITED STATES
Source: Sernova Corp
Friday, November 5, 2010, 6:00 a.m. EDT
LONDON, ONTARIO - (Marketwire - November
5, 2010) -
Sernova Corp. ("Sernova" or the "Company")
(TSX
VENTURE: SVA - News) is pleased to announce
that it
has completed a non-brokered private
placement of
6,666,667 units (the "Units") at a price of $0.15
per Unit
raising gross proceeds of $1,000,000. The
private
placement, which was previously announced as
an
offering of up to $750,000 in the Company's
news release
of October 18, 2010, was increased by $250,000
to
accommodate oversubscriptions.
The Company completed the private placement
in two
closings: 2,866,667 Units were issued in the
second
closing on November 4, 2010 and 3,800,000
Units were
issued in the first closing on October 17, 2010.
Each Unit
issued consisted of one common share of the
Company (a
"Share") and one-half of a share purchase
warrant (a
"Warrant"). Each whole Warrant entitles the
holder thereof
to acquire one Share at a price of $0.20 for a
period of 24
months. In connection with the second closing,
the
Company paid $11,150.16 to finders and issued
21,000
finder warrants (such finder warrants having the
same
terms as the Warrants).
Proceeds of the offering will be used to fund
ongoing
development of Sernova's proprietary Cell
Pouch
System(TM), including cGMP manufacturing,
pre-clinical
studies required by regulatory authorities to
support a
future Phase I/II human clinical study of insulin-
dependent
diabetes, and for general working capital.
The terms of the private placement are subject to
final
acceptance by the TSX Venture Exchange. All of
the
securities issued in connection with the closings
of the
private placement are subject to resale
restrictions,
including a four month hold period.
Sernova also reports that it has granted
incentive stock
options to officers, directors and consultants to
purchase
up to an aggregate of 1,488,333 common shares
at $0.15
per share and 250,000 common shares at $0.20
per share
for a period of 5 years expiring October 28,
2015.
About Sernova
Sernova Corp. is a Canadian-based, health-
sciences
company focused on commercializing medical
technologies. Sernova is currently developing a
platform
technology for a number of serious disease
indications,
starting with a novel treatment for insulin-
dependent
diabetes, using the novel Cell Pouch System(TM)
and its
patented Sertolin(TM) cell technology. According
to the
American Diabetes Association approximately 9
million
Americans require insulin injections and it is the
sixth
leading cause of death in the United States. One
out of
every 8 dollars spent on health care in the
United States is
spent on treating diabetes and its complications.
Worldwide expenditures on insulin alone are
estimated to
be $15 billion annually and growing.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
Press Release Communiqué de presse - October 19, 2010 19 October, 2010
Sernova Expands Scientific Advisory Board
Dr. David E.R. Sutherland M.D., Ph.D., Pioneer
In Islet
Autograft Transplantation, Joins Sernova
Scientific
Advisory Board
Source: Sernova Corp
LONDON, ONTARIO - (Marketwire - October 19,
2010) -
Sernova Corp. (TSX-V: SVA), is pleased to
announce the
appointment of Dr. David Sutherland, MD, Ph.D.
to the
Corporation's Scientific Advisory Board.
"Dr. Sutherland joining our Scientific Advisory
Board
follows the Company's recent announcement of
Dr. David
Shapiro's appointment and represents another
key
component in our strategy of advancing
Sernova's Cell
Pouch System(TM) into Human Clinical Trials,"
stated Dr.
Philip Toleikis, Sernova's President & CEO.
Dr. Sutherland, M.D., Ph.D. is a Professor,
Transplantation
Scientist and Clinician in the Division of
Transplantation,
Director of the Schulze Diabetes Institute and
Dobbs
Diabetes Research Chair within the Department
of Surgery
at the University of Minnesota where he
oversees the
largest clinical islet autotransplant program in the
world.
In 1974, Dr. Surtherland pioneered islet
transplantation by
performing the world's first clinical islet
transplant.
Dr. Sutherland is a member of the executive
committee of
the Collaborative Islet Transplant Registry (CITR)
and has
served as president of the International
Transplantation
Society, the American Society of Transplant
Surgeons, the
Cell Transplant Society, and the International
Pancreas
and Islet Transplant Association. He is author or
co-author
on over 1500 publications.
"Sernova's Cell Pouch System(TM) represents a
potential
opportunity to significantly optimize and simplify
islet
transplantation. In addition, the potential islet-
sparing
effect is highly attractive. I look forward to
working with
Sernova to advance the Cell Pouch System(TM)
into
human clinical trials," Said Dr. Sutherland.
Sernova's Cell Pouch System(TM) is a scalable
medical
device providing a natural "organ-like"
environment for
therapeutic cells. Once implanted under the skin,
it
develops into a tissue-engineered pancreas-like
endocrine
"organ" when infused with islets. The natural
environment
established by the Cell Pouch System(TM) is
expected to
conserve cell number, and promote natural
function
thereby increasing cell survival, while
significantly
increasing the number of treatable patients
beyond those
with severe disease.
Dr. Toleikis added, "Having both the pioneer of
islet
autograft transplant in Dr. Sutherland and the
pioneer of
the Edmonton Protocol in Dr. Shapiro associated
with our
company provides significant validation to our
platform to
deliver therapeutic cells through the Cell Pouch
System(TM). We anticipate that their
involvement with our
Scientific Advisory Board will streamline the
clinical
development and commercialization of this
important
product."
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities - that could cause actual results to differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - October 18, 2010 18 October, 2010
Sernova Corp Announces Private Placement and $570,000 First Closing
THIS NEWS RELEASE IS NOT FOR
DISTRIBUTION TO
U.S. NEWSWIRE SERVICES OR FOR
DISSEMINATION
IN THE UNITED STATES
Source: Sernova Corp
Monday, October 18, 2010, 6:00 a.m. EDT
LONDON, ONTARIO - (Marketwire - October 18,
2010) -
Sernova Corp. ("Sernova" or the "Company")
(TSX
VENTURE: SVA - News) is pleased to announce
that it is
offering on a non-brokered private placement
basis up to
5.0 million units (the "Units") at a price of $0.15
per Unit to
raise proceeds up to $750,000. The Company
completed
a first closing in the amount of $570,000 on
October 15,
2010.
Proceeds of the offering will be used to fund
ongoing
development of Sernova's proprietary Cell
Pouch
System(TM), including pre-clinical studies
required by
regulatory authorities to support a future Phase
I/II human
clinical study of insulin-dependent diabetes, and
for
general working capital.
Each of the Units consists of one common share
of the
Company (a "Share") and one-half share
purchase
warrant (a "Warrant"). Each whole Warrant
entitles the
holder thereof to acquire one Share at a price of
$0.20 for
a period of 24 months from closing. In
connection with the
placement, the Company may pay cash fees or
issue
warrants (having the same terms as the
Warrants) to
finders in accordance with the policies of the TSX
Venture
Exchange.
In the first closing, the Company issued
3,800,000 Units
and 37,333 finder warrants and paid $2,800 to
finders.
The terms of the private placement are subject to
final
acceptance by the TSX Venture Exchange. All of
the
securities issued in connection with a closing of
the private
placement will be subject to resale restrictions,
including a
four month hold period.
About Sernova
Sernova Corp. is a Canadian-based, health-
sciences
company focused on commercializing medical
technologies. Sernova is currently developing a
platform
technology for a number of serious disease
indications,
starting with a novel treatment for insulin-
dependent
diabetes, using the novel Cell Pouch System(TM)
and its
patented Sertolin(TM) cell technology. According
to the
American Diabetes Association approximately 9
million
Americans require insulin injections and it is the
sixth
leading cause of death in the United States. One
out of
every 8 dollars spent on health care in the
United States is
spent on treating diabetes and its complications.
Worldwide expenditures on insulin alone are
estimated to
be $15 billion annually and growing.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities - that could cause actual results to differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - September 21, 2010 21 September, 2010
Pioneer in Islet Transplantation, Dr. James Shapiro, Joins Sernova Scientific Advisory Board
LONDON, ONTARIO--(Marketwire --
September 21,
2010) - Sernova Corp. (TSX-V: SVA), is pleased
to
announce the appointment of Dr. James Shapiro,
MD,
Ph.D. FRCS (Eng.) FRCSC, to the Corporation's
Scientific
Advisory Board. In 2000, Dr. Shapiro led the
team
responsible for developing the Edmonton
Protocol which
was a major advancement in the treatment of
insulin-
dependent diabetes and now the current
standard of care
for Islet Transplantation.
"The experience and clinical expertise of Dr.
Shapiro will
be invaluable to Sernova as it continues to plan
its clinical
trials program." noted Dr. Philip Toleikis,
President & CEO
of Sernova Corp.
Dr. Shapiro, a world-renowned transplantation
scientist
and clinician is Director of the Clinical Islet
Transplantation
Program at the University of Alberta where he
oversees
the largest clinical islet transplant program in the
world.
Dr. Shapiro's research contributions have been
principally
focused on improving outcomes of clinical islet
transplantation. Under his leadership, an
extensive
network of international collaborations has been
developed to study islet function, and to monitor
for
tolerance and autoimmune reactivity in the islet
recipients
receiving immunosuppression. He is Principle
Investigator
on a number of US National Institutes for Health
(NIH) and
Juvenile Diabetes Research Foundation (JDRF)-
funded
clinical trials, including clinical testing of co-
stimulation
blockade in islet transplantation and he led an
international
multicentre trial of the Edmonton Protocol.
"I am very impressed with the preclinical
assessment of
Sernova's Cell Pouch System(tm) and look
forward to its
clinical application," Said Dr. Shapiro.
Dr. Shapiro has been the recipient of many
awards,
including a Hunterian Medal from the Royal
College of
Surgeons of England, the Gold Medal in Surgery
from the
Royal College of Physicians and Surgeons of
Canada, and
the Governor General's Gold Medal. He is a
recipient of
the Meritorious Service Medal from the
Governor General
of Canada.
He sits on the Editorial Board of the journal
Transplantation and Diabetes Therapeutics and
Technology, and is an active reviewer for
several journals
including Nature Medicine, Transplantation, and
The
British Journal of Surgery.
"The Sernova team is honored by this enormous
opportunity to work with such an eminent
scientist and
leader in the islet transplant field. We are looking
forward
to having Dr. Shapiro's involvement in the
ongoing
development of our clinical and regulatory
strategy for the
Cell Pouch System(tm), added Dr. David White,
Chairman
of Sernova's Scientific Advisory Board.
Sernova's Cell Pouch System(tm) is a scalable
medical
device providing a natural "organ-like"
environment for
therapeutic cells. Once implanted under the skin,
it
develops into a tissue-engineered pancreas
when infused
with islets. The natural environment established
by the
Cell Pouch System(tm) is expected to conserve
cell
number, and promote natural function thereby
increasing
cell survival, while significantly increasing the
number of
treatable patients beyond those with severe
disease.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities -- that could cause actual results to
differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - September 13, 2010 13 September, 2010
Sernova Awarded $275,000 Financial Contribution From NRC-IRAP To Support Research And Development
Source: Sernova Corp
FOR RELEASE
September 13, 2010, 6:00 a.m. EDT
LONDON, ONTARIO--(Marketwire - September
13, 2010)
- Sernova Corp. (TSX-V: SVA) announced it has
been
awarded a second non-refundable financial
contribution of
up to $275,000 from the National Research
Council of
Canada Industrial Research Assistance Program
(NRC-
IRAP).
This award will bring IRAP's total contribution to
Sernova's
research and development programs to
$761,000 since
July 2009.The new funding will be used to
support study
of the potential islet-sparing effect and optimal
dose of
islets to provide a long-term treatment for
diabetic patients
using Sernova's novel Cell Pouch System(TM) in
a pre-
clinical allograft model of diabetes.
The Cell Pouch System(TM), a proprietary
medical device,
is Sernova's lead product which is implanted
under the
skin rapidly forming into a tissue-engineered,
organ-like
structure that provides a natural environment for
the
survival and function of therapeutic cells.
Dr. Philip Toleikis said, "This IRAP contribution
enables
Sernova to accelerate the commercialization of
the Cell
Pouch System(TM) into the allograft market.
Findings from
this study could revolutionize the way donor
islets are
transplanted into patients and greatly increase
the
potential clinical utility of the Cell Pouch
System(TM) for
the treatment of diabetes worldwide."
Under the current standard of care, known as
the
Edmonton Protocol, donor islets are injected
directly into
the portal vein of the liver. This process causes
an instant
blood-mediated reaction (IBMIR) which destroys
insulin-
producing islets and leads to further side effects
for
patients. Sernova's previous results in an
autograft
setting, also supported by NRC-IRAP, suggest
the cells
implanted using the Cell Pouch System(TM)
avoid IBMIR
thereby providing efficacy with far fewer islets
than
required for the Edmonton Protocol.
"The potential islet-sparing of Sernova's
approach would
mean that islet transplantation could become a
viable
treatment option for millions of patients suffering
from
diabetes worldwide," added Toleikis.
The new study supported by the NRC-IRAP
program will
transplant diabetic animals with various doses of
donor
insulin-producing islets into Sernova's Cell Pouch
System(TM) and will be completed within 12
months.
Positive interim results are expected to be used
to support
a future clinical study in allograft patients, the
largest
segment of patients currently receiving donor
islets.
Findings from this study could revolutionize the
way islet
transplantation is conducted if it is possible to
treat multiple
patients with a single donor pancreas.
Dr. Philip Toleikis, President and CEO of Sernova
said
"We are grateful to NRC-IRAP for their continued
support
of the commercialization of the Cell Pouch
System(TM).
The financial support along with technical and
business-
oriented advisory services, provide a distinct
competitive
advantage for Sernova. We look forward to
commercializing our technology into multiple
disease
indications and major markets worldwide."
Sernova also announced the granting of
incentive stock
options to non-employee directors to purchase
up to an
aggregate of 330,000 common shares at $0.12
per share
for a period of 5 years expiring September 9,
2015.
About NRC-IRAP
The National Research Council-Industrial
Research
Assistance Program (NRC-IRAP) is Canada's
premier
innovation assistance program for small and
medium-
sized enterprises (SMEs). It is a vital component
of the
NRC, a cornerstone in Canada's innovation
system,
regarded world-wide as one of the best
programs of its
kind.
Further information can be found at
http://www.nrc-
cnrc.gc.ca/eng/ibp/irap/about/index.html
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities -- that could cause actual results to
differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - July 29, 2010 29 July, 2010
Ontario's Minister Goodyear Announces $45 Million Investment in Innovation and Job Creation Through NRC-IRAP at Sernova Corp.
Source: Sernova Corp
FOR IMMEDIATE RELEASE
July 29, 2010
LONDON, ONTARIO--(Marketwire -- July 29,
2010) -
Sernova Corp. (TSX VENTURE:SVA) is pleased
that the
Hon. Gary Goodyear, Minister of State for
FedDev
Ontario, while speaking at Sernova today,
announced that
as part of Canada's Economic Action Plan,
FedDev
Ontario will provide $45 million through the
National
Research Council's Industrial Research
Assistance
Program (NRC-IRAP) to eligible small and
medium sized
businesses in southern Ontario to boost their
research and
development capacities, increase innovation,
create jobs
and bring their ideas from the lab to the
marketplace.
Sernova Corp. was awarded a financial
contribution of
$486,000 from the National Research Council of
Canada
Industrial Research Assistance Program (NRC-
IRAP) for
2009-2010. This non-repayable contribution,
along with
technical and business oriented advisory
services
provided by NRC-IRAP, is being used by
Sernova to
complete an important pre-clinical study to
validate and
optimize Sernova's novel Cell Pouch
System(TM) device
for cell transplantation into diabetic patients.
"I am very proud that our government is
supporting the
work of innovative businesses here in London,"
said Ed
Holder, Member of Parliament for London West.
"With our
support, London companies are conducting more
research
and bringing new ideas into the marketplace that
benefits
Canadian businesses, workers and
communities."
"Providing financial assistance to small and
medium-sized
enterprises demonstrates the National Research
Council
of Canada's commitment to turn knowledge into
innovation," said NRC President John R.
McDougall.
"Sernova Corporation's entrepreneurship and
dedication
to developing industry-leading and
internationally-
recognized products is exactly the kind of drive
we look for
when partnering with innovative Canadian
firms."
The Cell Pouch System(TM) is a proprietary
device which
has been developed for eventual human use
and is a key
component of Sernova's platform technology.
The Cell
Pouch System(TM) will be used initially for
treatment of
insulin-dependent diabetes and has the potential
for use in
additional cell transplantation therapies including
haemophilia, spinal cord injury, Parkinson's
disease and
other chronic debilitating diseases.
Dr. Philip Toleikis, Sernova's President & CEO,
noted "Our
Cell Pouch System(TM) is a proprietary medical
device
developed for human use which is implanted
under the
skin and rapidly forms into a tissue-engineered,
organ-like
structure that provides a natural environment for
the
survival and function of therapeutic cells. The
NRC-IRAP
sponsored study showed very encouraging
positive long-
term results in which daily insulin injections were
eliminated representing a significant
achievement as a
possible alternative to the current practice of
injecting
islets directly into the portal vein of the liver. In
addition,
there was a significant reduction in the number
of insulin-
producing islets used to achieve this efficacy
relative to
the current standard of care for islet
transplantation
suggesting that the device may be islet-sparing.
The
financial contribution from NRC-IRAP was a key
component enabling us to employ highly skilled
scientists
to conduct the study towards developing our
products for
the international market pending regulatory
approval."
Based on these encouraging results, the
Company is
taking steps towards clinical evaluation of its Cell
Pouch
System(TM).
According to the American Diabetes Association
approximately 9 million Americans require insulin
injections and it is the sixth leading cause of
death in the
United States. One out of every eight dollars
spent on
health care in the United States is spent on
treating
diabetes and its complications. Worldwide
expenditures on
insulin alone are estimated to be $15 billion
annually and
growing.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities - that could cause actual results to differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - July 12, 2010 12 July, 2010
Sernova Announces Positive Results of its Proprietary Cell Pouch System(tm) in Preclinical Diabetes Model
Source: Sernova Corp
July 12, 2010, 6:00 a.m. EDT
LONDON, ONTARIO--(Marketwire -- July 12,
2010) -
Sernova Corp. (TSX VENTURE:SVA) is pleased
to report
positive results from a long-term study
evaluating the
safety and efficacy of the Cell Pouch System(TM)
in a pre-
clinical model of diabetes.
Detailed data will be presented at the 23rd
International
Conference of the Transplant Society,
Vancouver, British
Columbia, Canada, August 15th-19th in a
presentation
entitled, "A novel Cell Pouch(TM), an alternative
to
intrahepatic islet transplantation."
Dr. Philip Toleikis, Sernova's President & CEO,
noted "Our
Cell Pouch System(TM) is a proprietary medical
device
implanted under the skin rapidly forming into a
tissue-
engineered, organ-like structure that provides a
natural
environment for the survival and function of
therapeutic
cells. These long-term results represent a
significant
achievement as a possible alternative to the
current
practice of injecting islets directly into the portal
vein of the
liver."
"Our data are profound because they suggest
the
potential to reduce side-effects associated with
the current
standard of care and achieve glucose control
with
significantly fewer islets than normally required,"
said
Toleikis.
On March 16, 2010, Sernova reported initial
results
demonstrating that the Cell Pouch System(TM)
becomes
rapidly vascularised and achieved initial glucose
control in
subject animals.
The following summarizes important new
findings reported
today:
Long-term insulin independence was
successfully
achieved with significantly fewer islets than the
current
standard of care, requiring only about 10% of
insulin-
producing islets normally used for the Edmonton
Protocol.
Animals in the study achieved long-term glucose
normalization throughout the course of the study.
Standard laboratory tests demonstrated
transplanted islets
produced insulin and responded similarly to non-
diabetic
animals to provide control of glucose.
No adverse events related to the Cell Pouch
System(TM)
occurred during the study.
About the Study
The Cell Pouch System(TM) was implanted in
pigs which
were then made diabetic through removing the
pancreas
and chemical induction. The animal's own islets
(Autograft)
isolated from the pancreas were transplanted
into the
device. Standard measures of efficacy including
fasting
and non-fasting glucose levels, glucose
tolerance tests
(IVGTT), and C-peptide were taken up to 72 days
post-
transplant. At the end of the study period, the
device
containing the islets was removed and the
animals
returned to a diabetic state.
Following transplantation, a substantial number
of study
animals maintained glucose levels within the
normal
range, showed glucose tolerance tests (IVGTT)
similar to
non-diabetic animals and were C-peptide
positive, an
important confirmation of insulin-producing islet
function.
Microscopic fluorescence analysis of the device
revealed
both microvessels and insulin associated with
islets.
Upon removal of the Cell Pouch System(TM)
containing
islets, fasting glucose levels returned to the
diabetic range
and animals required daily insulin injections to
maintain
normal glucose levels. The animals return to the
diabetic
state was further confirmed by IVGTT and C-
peptide
analysis.
From a safety perspective, no adverse events
occurred
related to the Cell Pouch(TM) throughout the
study
following implantation of over 40 devices for up
to 5
months. The devices were well-incorporated with
collagen
at all time points and yet were not visible under
the skin,
an important consideration for patients.
Dr. David White, Chair of Sernova's Scientific
Advisory
Board stated, "I am particularly enthusiastic
about these
results and the potential clinical relevance to
patients
suffering from diabetes. These new data suggest
that the
Cell Pouch System(TM) represent a possible
clinically
relevant alternative to injection of islets into the
portal vein
of the liver and may reduce the side effects of
transplantation including the instant blood-
mediated
reaction (IBMR). The indication that our device
achieves
glucose control with a reduction in the number of
islets
normally required is also of profound clinical
importance
as it may increase the availability of life-changing
islet
transplantation to many diabetic patients."
Sernova believes that the Cell Pouch
System(TM) has the
potential for a wide range of uses in cell therapy
including
the treatment of diabetes, haemophilia, and
other chronic
debilitating diseases. Based on these
encouraging results,
the Company is taking steps towards clinical
evaluation of
its Cell Pouch System(TM).
According to the American Diabetes Association
approximately 9 million Americans require insulin
injections and it is the sixth leading cause of
death in the
United States. One out of every eight dollars
spent on
health care in the United States is spent on
treating
diabetes and its complications. Worldwide
expenditures on
insulin alone are estimated to be $15 billion
annually and
growing.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities - that could cause actual results to differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - June 08, 2010 8 June, 2010
Sernova Completes Second Closing Of Private Placement
THIS NEWS RELEASE IS NOT FOR
DISTRIBUTION TO
U.S. NEWSWIRE SERVICES OR FOR
DISSEMINATION
IN THE UNITED STATES
Source: Sernova Corp
Tuesday, June 8, 2010, 6:00 a.m. EDT
LONDON, ONTARIO - (Marketwire - June 8,
2010) -
Sernova Corp. ("Sernova" or the "Company")
(TSX
VENTURE: SVA - News) is pleased to announce
that is
has completed a second closing of its previously
announced private placement offering of units
(the "Units")
at a price of $0.15 per Unit. The Company raised
gross
proceeds of $150,720 in the second closing and
has
raised gross proceeds of $555,970 from the two
closings.
Proceeds of the offering will be used to fund
ongoing
development of Sernova's proprietary Cell
Pouch
System(TM), including pre-clinical studies
required by the
FDA to support a future Phase I/II human clinical
study of
insulin-dependent diabetes, and for general
working
capital.
The Company issued 1,004,800 Units in the
second
closing, each Unit consisting of one common
share of the
Company (a "Share") and one-half share
purchase
warrant (a "Warrant"). Each whole Warrant
entitles the
holder thereof to acquire one Share at a price of
$0.20 for
a period of 24 months.
In connection with the second closing, the
Company
issued 33,880 finders' warrants ("Finders'
Warrant") and
approximately $5,000 was paid to finders. Each
Finders'
Warrant entitles the holder thereof to purchase
one Share
at $0.15 per Share for a period of 24 months
from closing.
All of the securities issued in connection with the
second
closing are subject to four month hold period that
expires
on October 5, 2010. The offering is subject to
acceptance
by the TSX Venture Exchange.
About Sernova
Sernova Corp. is a Canadian-based, health-
sciences
company focused on commercializing medical
technologies. Sernova is currently developing a
platform
technology for a number of serious disease
indications,
starting with a novel treatment for insulin-
dependent
diabetes, using the novel Cell Pouch System(TM)
and its
patented Sertolin(TM) cell technology. According
to the
American Diabetes Association approximately 9
million
Americans require insulin injections and it is the
sixth
leading cause of death in the United States. One
out of
every 8 dollars spent on health care in the
United States is
spent on treating diabetes and its complications.
Worldwide expenditures on insulin alone are
estimated to
be $15 billion annually and growing.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities - that could cause actual results to differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - May 28, 2010 28 May, 2010
Sernova Presents Cell Pouch System Preclinical Results At The American Society Of Internal Artificial Organs
Source: Sernova Corp.
Friday, May 28, 2010, 6:00 a.m. EDT
LONDON, ONTARIO - (Marketwire - May 28,
2010)
Sernova Corp. (TSX VENTURE:SVA) is pleased
to
announce that Dr. David White, chair of
Sernova's
Scientific Advisory Board, is presenting results
from a key
porcine diabetes study evaluating the safety and
efficacy
of the Cell Pouch System(TM).
Dr. White's podium presentation entitled
"Development of
a Cell Pouch to Form an Artificial Pancreas" is
being
presented in the "Artificial Organ Development
Session" at
the American Society of Artificial Internal Organs
(ASAIO)
56th Annual Conference, Baltimore, MD, May
28th at 3:45
p.m.
The Cell Pouch System(TM) establishes a
biological
environment capable of preserving the
functionality of
therapeutic cells, allows for safe and long-term
efficacious
cell-based therapy and may offer a revolutionary
improvement over the current practice of
injecting
therapeutic cells into blood vessels.
The Cell Pouch System(TM) is a proprietary
medical
device, implanted below the skin, allowing for
incorporation of tissue and microvasculature to
form a
subcutaneous tissue-engineered pancreas,
establishing
an environment for the survival and functionality
of insulin-
producing islets and other therapeutic cells.
The study supported by a $486,000 financial
contribution
from the National Research Council of Canada
Industrial
Research Assistance Program (NRC-IRAP) which
involves
implantation of Sernova's novel medical device
into
diabetic pigs to establish device parameters and
optimize
performance will be used as part of the
regulatory
documentation in support of a future Phase I/II
human
clinical study.
Sernova believes that the Cell Pouch
System(TM) has the
potential for a wide range of uses in cell therapy
including
the treatment of diabetes, haemophilia, spinal
cord injury,
Parkinson's disease and other chronic
debilitating
diseases.
According to the American Diabetes Association
approximately 9 million Americans require insulin
injections and it is the sixth leading cause of
death in the
United States. One out of every eight dollars
spent on
health care in the United States is spent on
treating
diabetes and its complications. Worldwide
expenditures on
insulin alone are estimated to be $15 billion
annually and
growing.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities - that could cause actual results to differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - May 26, 2010 26 May, 2010
Appointment Of Stephen Nagler To The Sernova Business Advisory Board
Source: Sernova Corp.
Wednesday, May 26, 2010, 6:00 a.m. EDT
LONDON, ONTARIO - (Marketwire - May 26,
2010) -
Sernova Corp. (TSX-V:SVA), a company focused
on
product development and commercialization of
innovative
medical technologies for cell therapies, is
pleased to
announce the appointment of Mr. Stephen
Nagler, LLB to
the Corporation's Business Advisory Board.
Mr. Nagler is Partner (Business and Finance
International),
Eaton Van Winkle LLC, New York. Mr. Nagler is
a venture
partner in Frontier Ventures, an emerging
venture capital
fund focused on Canadian life science
companies and
Chair of Tristate Ventures LLC, a leading New
York City
based angel investor group focused on
investments in
microcap companies, mostly in the healthcare
sector,
which he founded in 1999. Mr. Nagler is on the
Advisory
Board of BioContact and Chair of the
International Finance
program. Mr. Nagler is a graduate of the City
College of
New York and NYU Law School.
Dr. Philip Toleikis, President and CEO said "I am
pleased
to welcome Stephen to the Sernova team. He
has been
instrumental in assisting his numerous corporate
clients to
access capital through his extensive network of
investment bankers, venture capitalists, and
private equity
groups. He has assisted his clients to raise more
than
$250 million in financings over the past four
years and his
wealth of international finance experience will be
of
significant benefit to the company as we
progress toward
our goal of becoming an internationally
recognized clinical-
stage product development organization."
About Sernova
Sernova Corp. is a Canadian-based, health-
sciences
company focused on commercializing medical
technologies. Sernova is currently developing a
platform
technology for a number of serious disease
indications,
starting with a novel treatment for insulin-
dependent
diabetes, using the novel Cell Pouch System(TM)
and its
patented Sertolin(TM) cell technology. According
to the
American Diabetes Association approximately 9
million
Americans require insulin injections and it is the
sixth
leading cause of death in the United States. One
out of
every 8 dollars spent on health care in the
United States is
spent on treating diabetes and its complications.
Worldwide expenditures on insulin alone are
estimated to
be $15 billion annually and growing.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities -- that could cause actual results to
differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - April 29, 2010 29 April, 2010
Sernova Announces $1.2M Private Placement And $400,000 First Closing
THIS NEWS RELEASE IS NOT FOR
DISTRIBUTION
TO U.S. NEWSWIRE SERVICES OR FOR
DISSEMINATION IN THE UNITED STATES
Source: Sernova Corp
Thursday, April 29, 2010, 6:00 a.m. EDT
LONDON, ONTARIO - (Marketwire - April 29,
2010) -
Sernova Corp. ("Sernova" or the "Company")
(TSX
VENTURE: SVA - News) is pleased to announce
that it is
offering on a non-brokered private placement
basis up to
8.0 million units (the "Units") at a price of $0.15
per Unit to
raise proceeds up to $1.2 million. The Company
completed the first closing of the offering on April
28,
2010, raising $405,250 through the issuance of
2,701,666
Units.
Proceeds of the offering will be used to fund
ongoing
development of Sernova's proprietary Cell
Pouch
System(TM), including pre-clinical studies
required by the
FDA to support a future Phase I/II human clinical
study of
insulin-dependent diabetes, and for general
working
capital.
Each of the Units consists of one common share
of the
Company (a "Share") and one-half share
purchase
warrant (a "Warrant"). Each whole Warrant
entitles the
holder thereof to acquire one Share at a price of
$0.20 for
a period of 24 months from closing.
In connection with the first closing, the Company
issued
46,923 finders' warrants ("Finders' Warrant")
and
approximately $7,000 was paid to finders. Each
Finders'
Warrant entitles the holder thereof to purchase
one Share
at $0.15 per Share for a period of 24 months
from closing.
All of the securities issued in connection with the
first
closing are subject to four month hold period that
expires
on August 29, 2010. The offering is subject to
acceptance
by the TSX Venture Exchange.
About Sernova
Sernova Corp. is a Canadian-based, health-
sciences
company focused on commercializing medical
technologies. Sernova is currently developing a
platform
technology for a number of serious disease
indications,
starting with a novel treatment for insulin-
dependent
diabetes, using the novel Cell Pouch System(TM)
and its
patented Sertolin(TM) cell technology. According
to the
American Diabetes Association approximately 9
million
Americans require insulin injections and it is the
sixth
leading cause of death in the United States. One
out of
every 8 dollars spent on health care in the
United States is
spent on treating diabetes and its complications.
Worldwide expenditures on insulin alone are
estimated to
be $15 billion annually and growing.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities -- that could cause actual results to
differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - April 07, 2010 7 April, 2010
Sernova To Present At Biofinance Canada Conference
Source: Sernova Corp.
Wednesday, April 7, 2010, 6:00 a.m. EDT
LONDON, ONTARIO--(Marketwire - April 7,
2010) -
Sernova Corp. (TSX-V:SVA), a company focused
on
product development and commercialization of
innovative
medical technologies for cell therapies,
announced that its
President & Chief Executive Officer will present
an
overview of the company's technology to a
select group
of biotech industry investors at the BioFinance
Conference
in Toronto, Ontario, Canada. Sernova's
presentation is
scheduled for 4:00 p.m. April 7, 2010.
The proprietary Cell Pouch System(TM),
Sernova's lead
technology is a novel, matchbook size medical
device that
is placed under the skin in a simple procedure.
Once
implanted, the device becomes a vascularised
organ-like
structure and provides the microcirculation
essential to
early function and long-term survival of
transplanted
therapeutic cells. Sernova believes the Cell
Pouch
System(TM) offers a valuable potential
improvement to
the current practise of injecting therapeutic cells
directly
into the bloodstream. Sernova's first application
is in
support of islet transplantation for treatment of
insulin-
dependent diabetes, where the Cell Pouch
System(TM) is
expected to prevent the instant blood-mediated
inflammatory reaction (IBMIR) believed to rapidly
destroy
up to an estimated 90% of the transplanted islets
and in
addition eliminate serious complications such as
islet-
induced blood clotting and liver thrombosis. The
reduction
in islet loss, once verified, could lead to improved
safety
and efficacy of islet transplantation and the
potential of
treating multiple patients from a single pancreas
donation.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities -- that could cause actual results to
differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - March 16, 2010 16 March, 2010
Sernova Announces Interim Results from Key Preclincal Study With its Proprietary Cell Pouch System(tm)
LONDON, ONTARIO--(Marketwire -- March
16,
2010) - Sernova Corp. (TSX VENTURE:SVA)
today
reported interim results from a key porcine
diabetes study
evaluating the safety and efficacy of the Cell
Pouch
System(TM).
Interim results, to be presented at the American
Society of
Artificial Internal Organs 56th Annual
Conference,
Baltimore, MD, May 27th-29th in a podium
presentation,
confirm that the Cell Pouch System(TM)
establishes a
biological environment capable of preserving the
functionality of therapeutic cells. The results also
confirm
the Cell Pouch System(TM) allows for safe and
efficacious
cell-based therapy and may offer a revolutionary
improvement over the current practice of
injecting
therapeutic cells into blood vessels.
The Cell Pouch System(TM) is a proprietary
medical
device, implanted below the skin, allowing for
incorporation of tissue and microvasculature to
form an
organ-like structure, establishing an environment
for the
survival and functionality of therapeutic cells.
The study supported by a $486,000 financial
contribution
from the National Research Council of Canada
Industrial
Research Assistance Program (NRC-IRAP)
involves
implantation of Sernova's novel medical device
into
diabetic pigs to establish device parameters and
optimize
performance.
Dr. Philip Toleikis, Sernova's President & CEO
stated,
"These promising interim results are being used
to finalize
the device design and manufacture for the
pivotal pre-
clinical studies required by the FDA, in support of
a future
Phase I/II human clinical study."
In this study Sernova's proprietary Cell Pouch
System(TM)
was implanted under the skin of eight week old
Yorkshire-
Landrace pigs and evaluated for tissue
incorporation and
microvasculature development for various time
periods up
to eight weeks. Animals were then made diabetic
using a
stringent method with a combination of
pancreatectomy
and streptozotocin. The animal's own islets
(Autograft)
were isolated from the pancreas and following
functional
assessment, transplanted into the chambers of
the Cell
Pouch(TM). At intervals, various efficacy
measures
including fasting and non-fasting glucose levels
were
recorded as well as glucose tolerance tests
(IVGTT)
performed. After up to three months following
islet
transplantation, pouches were removed and
efficacy
measures repeated.
From an efficacy perspective, all transplant
recipients
showed graft function demonstrated by a
reduction in
blood glucose and glycemic control (IVGTT and
glucose
area under curve (AUC) measures). Following
removal of
the transplanted Cell Pouch(TM) up to the three
month
time point there was a significant reduction in
glucose
disappearance rate and glucose AUC indicating
a loss of
graft function. Importantly, functionality was
achieved
using 5% - 10% of the equivalent number of
functional
adult islets normally transplanted using the
Edmonton
Protocol procedure.
From a safety perspective, no adverse events
occurred
related to the Cell Pouch(TM) throughout the
study
following implantation of the device. The devices
were
well-incorporated with collagen at all time points
and yet
were not visible under the skin, an important
consideration
for patients. Quantitative blinded analysis of
blood vessel
growth showed significant microvasculature
development
in the pouches at all time points assessed.
Specific
differences between the device configurations
will enable
selection of the final device design.
"These interim results represent a significant
achievement
of the Cell Pouch System(TM) as a possible
clinically
relevant viable alternative to injection of islets
into the
portal vein of the liver and may reduce the side
effects of
such transplantation such as the instant blood-
mediated
reaction (IBMR)," said Dr. David White, Chair of
Sernova's
Scientific Advisory Board. "The potential that our
device
may also achieve functionality with a reduction in
the
number of islets normally required is also of
profound
clinical importance."
Sernova believes that the Cell Pouch
System(TM) has the
potential for a wide range of uses in cell therapy
including
the treatment of diabetes, haemophilia, spinal
cord injury,
Parkinson's disease and other chronic
debilitating
diseases.
According to the American Diabetes Association
approximately 9 million Americans require insulin
injections and it is the sixth leading cause of
death in the
United States. One out of every eight dollars
spent on
health care in the United States is spent on
treating
diabetes and its complications. Worldwide
expenditures on
insulin alone are estimated to be $15 billion
annually and
growing.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities -- that could cause actual results to
differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - March 02, 2010 2 March, 2010
Sernova Advances Cell Pouch System(tm) Into Non-Human Primate Studies
RESEARCH TO BE CONDUCTED IN
COLLABORATION
WITH LEADING U.S. TRANSPLANT CENTER
LONDON, ONTARIO--(Marketwire -- March 2,
2010) -
Sernova Corp. (TSX VENTURE:SVA) today
announced
that it has entered into a research agreement
with the
University of Illinois at Chicago's Transplant
Biology
Research Laboratory to conduct studies with its
proprietary Cell Pouch System(TM) in non-
human
primates. Initial studies in the collaboration will
evaluate
the pouches sized for humans which were
previously
shown to form "organ-like" networks of
microvessels and
tissue incorporation in porcine models and
represents a
key validation step toward the initiation of future
human
clinical trials. "We are excited to be involved in
the pre-
clinical evaluation and advancement of
Sernova's Cell
Pouch System(TM)," said Dr. Amelia
Bartholomew, Chief
of Translational Research at UIC.
"UIC is a leading research and clinical centre for
organ
transplantation including islet transplantation for
diabetes
and it can conduct GLP-quality preclinical studies
to
support our future regulatory filings in
preparation for
clinical studies," said Dr. David White, Chair of
Sernova's
Scientific Advisory Board.
The Cell Pouch System(TM) is a proprietary
medical
device which may offer a revolutionary
improvement over
the current practice of injecting therapeutic cells
into blood
vessels. Based on previous pre-clinical research,
the Cell
Pouch System(TM) becomes a vascularised
organ-like
structure when placed in the body, providing the
microcirculation thought to be essential to early
function
and long-term survival of therapeutic cells.
Sernova
believes that the Cell Pouch System(TM) has the
potential
for a wide range of uses in cell therapy including
the
treatment of diabetes, haemophilia, spinal cord
injury,
Parkinson's disease and other chronic
debilitating
diseases.
"Establishing this first premier collaboration
represents a
key milestone in our strategy to work closely
with leading
transplant centers worldwide for the validation
and
commercialization of the Cell Pouch
System(TM)," said Dr.
Philip Toleikis, President & CEO of Sernova Corp.
According to the American Diabetes Association
approximately 9 million Americans require insulin
injections and it is the sixth leading cause of
death in the
United States. One out of every 8 dollars spent
on health
care in the United States is spent on treating
diabetes and
its complications. Worldwide expenditures on
insulin alone
are estimated to be $15 billion annually and
growing.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(TM), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
Neither the TSX Venture Exchange nor its
Regulation
Services Provider (as that term is defined in the
policies of
the TSX Venture Exchange) accepts
responsibility for the
adequacy or accuracy of this release.
The securities offered have not been, and will
not be,
registered under the United States Securities Act
of 1933,
as amended, and may not be offered or sold in
the United
States absent registration or any applicable
exemption
from the registration requirement of such Act.
This press
release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be
any sale of
these securities in any jurisdiction in which such
offer,
solicitation or sale would be unlawful.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities -- that could cause actual results to
differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.
Press Release Communiqué de presse - January 25, 2010 25 January, 2010
Sernova To Present At Biopartnering North America Conference
Source: Sernova Corp.
Monday, January 25, 2010, 6:00 a.m. EDT
LONDON, ONTARIO - (Marketwire - Jan. 25,
2010) -
Sernova Corp. (TSX-V:SVA), a company focused
on
product development and commercialization of
innovative
medical technologies for cell therapies,
announced that its
President & Chief Executive Officer will present
an
overview of the company's technology and
milestones for
2010 to a select group of biotech industry
investors and
potential alliance partners at the BioPartnering
North
America Conference in Vancouver, British
Columbia.
Sernova's presentation is scheduled for 9:30
a.m. January
26, 2010.
Last year, Sernova:
Appointed Dr. Philip Toleikis as President & CEO
and
under his leadership,
Transformed and advanced its corporate
strategy around
its proprietary Cell Pouch System(tm) to position
the
company as a leader in enabling cell therapies,
Successfully raised CDN$1.4 million to support
this
strategy through a combination of equity
financings and a
financial contribution from the National Research
Council
of Canada (NRC),
Recruited key scientific staff to execute the
strategic plan
and several internationally recognized leaders in
the
business of cell therapy for Sernova's Board of
Directors
and Business Advisory Board,
Demonstrated long-term safety and efficacy of
the
prototype Cell Pouch System(TM) in a small
animal model
of diabetes as reported at the International Islet
Transplant
Conference in Venice,
Designed, manufactured and filed patents on the
human-
scaled Cell Pouch System(TM),
And initiated an NRC-sponsored key proof of
concept
study in a large animal model of diabetes to
optimize and
assess the safety and efficacy of the human-
scaled Cell
Pouch System (TM).
The proprietary Cell Pouch System(TM),
Sernova's lead
technology is a novel, matchbook size medical
device that
is placed under the skin in a simple procedure.
Once
implanted, the device becomes a vascularised
organ-like
structure and provides the microcirculation
essential to
early function and long-term survival of
transplanted
therapeutic cells. Sernova believes the Cell
Pouch
System(tm) offers a valuable potential
improvement to the
current practise of injecting therapeutic cells
directly into
the bloodstream. Sernova's first application is
diabetes,
where the Cell Pouch System(tm) is expected to
prevent
the instant blood-mediated inflammatory reaction
(IBMIR)
believed to rapidly destroy up to an estimated
90% of the
transplanted islets and in addition eliminate
serious
complications such as islet-induced blood clotting
and liver
thrombosis. These improvements, once verified,
could
lead to the treatment of multiple patients from a
single
pancreas donation and improved safety and
efficacy for
islet transplantation.
During 2010, Sernova will seek to continue to
build
corporate value by advancing its core
technologies toward
human clinical trials and commercialization. Key
objectives
targeted for the upcoming year are:
To establish research collaborations with one or
more
leading transplant centres to conduct non-human
primate
studies of the Cell Pouch System(tm). Sernova is
in the
process of establishing relationships with groups
who can
conduct GLP-quality preclinical studies as
requested by
Health Canada and the US-FDA. Such clinical
centres also
currently perform the "Edmonton-protocol"
transplantations and are aware of IBMIR and
other
complications with this procedure.
To complete the current large animal study
which is
funded by a financial contribution of up to
$486,000 from
the National Research Council of Canada
Industrial
Research Assistance Program (NRC-IRAP). The
study
involves the implantation of Sernova's novel
medical
device followed by islets into diabetic pigs to
establish
device parameters and optimize performance.
The study
commenced in August, 2009 and is expected to
be
completed in Q3 2010 and will generate data in
part to
support regulatory filings in support of a future
Phase I/II
human clinical study. Sernova anticipates
reporting interim
results during Q1 2010.
To continue to seek partnerships with leaders in
the cell
therapy field to enhance their technology
platforms using
Sernova's Cell Pouch System(tm). Such
partnerships
would potentially enable Sernova to capture the
value of
its intellectual property beyond its current focus
in
diabetes.
To continue to increase Sernova's access to
industry
leaders and technical expertise by expanding the
Company's business and scientific advisory
boards.
To ensure the Company has adequate financial
resources
to achieve its goals through further equity
financings,
strategic investments and grant funding.
About Sernova
Sernova Corp. is a Canadian-based health
sciences
company focused on product development and
commercialization of innovative proprietary
platform
medical technologies in the cell therapy arena
such as the
Cell Pouch System(TM) to provide a safe and
efficacious
environment for therapeutic cells and
Sertolin(tm), a
technology which, when combined with cell
therapy, may
protect therapeutic cells without the need for
patients to
take anti-rejection drugs.
For further information contact:
Philip Toleikis, Ph.D., President and CEO
Tel: (604) 961-2939
info@sernova.com
www.sernova.com
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responsibility for the
adequacy or accuracy of this release.
This news release contains forward-looking
information,
which involves known and unknown risks,
uncertainties
and other factors that may cause actual events
to differ
materially from current expectation. Important
factors -
including availability of funds, the results of
financing
efforts, the results of research and product
development
activities - that could cause actual results to differ
materially from Sernova's expectations are
disclosed in
Sernova's documents filed from time to time on
SEDAR
(see www.sedar.com). Readers are cautioned
not to place
undue reliance on these forward-looking
statements,
which speak only as of the date of this press
release. The
company disclaims any intention or obligation,
except to
the extent required by law, to update or revise
any
forward-looking statements, whether as a result
of new
information, future events or otherwise.