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“Regenerative
medicine research translates fundamental knowledge in biology, chemistry and
physics into materials, devices, systems and a variety of therapeutic
strategies, which augment, repair, replace or regenerate organs and tissue.
 Cell-based therapies represent the most mature
sub-sector of regenerative medicine, and at this point, hundreds of thousands
of patients around the world have been treated with these therapies. As the
standard-of-care has now evolved to include FDA approved cell therapies, new
frontiers are also opening. Exciting breakthroughs in cell-based immune
therapy and gene therapy have opened new avenues to transform patient care.
The
promise of our field is to deliver cost-effective, lifesaving or
life-enhancing medicines which target the underlying disease, rather than the
symptoms.
The
majority of regenerative medicine companies are therapeutically focused and
developing a variety of technologies including cell-based therapies, small
molecule and biologic based therapies, gene therapies, tissue-engineered
biomaterials and scaffolds and implantable devices.
The
second largest group of regenerative medicine companies are developing tools
such as stem cells for drug discovery and toxicity testing, as well as
clinical tools, bio-processing tools and platforms that include equipment,
consumables, reagents and storage systems to support commercialization and
clinical applications.
Large
pharmaceutical and large–cap biotech companies are closely monitoring both
preclinical and clinical stage technologies and 40% of these companies are in
active pursuit of therapeutic opportunities. In addition to having some level
of investment in the industry, a recurring message that echoes throughout the
industry is that big pharma does not want to miss this opportunity; they are
monitoring the space diligently and methodically assessing the key questions
to commercialize and bring these products to market.” anon
BUT
What is
truly required to take these discoveries to the market?
 With all the recent
media coverage regarding these amazing discoveries and small to mid-size
biotech companies quickly jumping into the regenerative medicine field hoping
to take advantage of the enormous opportunities, Sernova Corp (TSX.V – SVA))
has been steadily and diligently working, since 2009, developing and testing
its products for regenerative medicine in preparation for this wave of
discoveries.
Sernova’s
products are uniquely focused on those diseases in which a protein, hormone
or factor, missing or in short supply in the body, could be replaced by
therapeutic cells which release those factors into the bloodstream.
Diabetes,
hemophilia and thyroid disease are but three of the multibillion dollar
market opportunities where such treatments could lead to:
- A significant improvement in the quality of
patient’s lives
- Reducing health care costs
- Potentially reduce the devastating side effects
of disease
While
other scientific laboratories around the world were advancing stem cell
technologies which, if successful, would provide sources of therapeutic cells
for various clinical applications, Sernova was in parallel working on a
proprietary, scalable, implantable medical device (Cell Pouch System™) that
creates a natural environment for the survival and function of these therapeutic
cells so that when the time came, Sernova would be in the forefront of such
technologies with strong proof of concept on their therapeutic device with
therapeutic cells within.
 Sernova
scientists designed and contract manufactured its scalable device suitable
for implantation under the skin. Its scientists studied the needs of cells
and designed the device around those needs.
Cells
need to live in a tissue matrix, a sort of nourishing scaffold, and they need
to be supplied by a rich source of micro-vessels for the exchange of
nutrients, wastes and of course the released therapeutic (protein, hormone or
factor).
With
the micro-vessels in place therapeutic cells can thrive, a good comparison
would be to the highways of a city - bringing in essential supplies and
shipping out products. Without these highways, the micro-vessels, the
therapeutic cells eventually succumb to a lack of oxygen/nutrients and die.
Following
manufacture of the device in a number of sizes, Sernova then proceeded to
conduct multiple studies to:
- Prove the device’s biocompatibility
- Prove the ability of the device to integrate
with surrounding tissue
- Prove the device does not cause inflammation
On the
heels of these successful studies, multiple preclinical efficacy studies were
conducted using donor islets (the cells that regulate blood sugar) in various
transplantation models of diabetes. Not only did they conduct mouse studies,
but they also successfully tested human scaled devices in multiple large
animal models of diabetes.
Sernova’s
determination to build a very strong scientific platform, based on multiple
scientific studies, proving the safety and efficacy of the Cell Pouch™ did
not go unnoticed.
Sernova’s
results were presented at international transplantation conferences under
peer scrutiny and the phenomenal amount of background work is now paying off.
The
company entered clinical trials with its device housing therapeutic cells in
severely diabetic patients. Test results have shown biocompatibility, and
safety, of the device in a cohort of human patients with insulin producing
islets transplanted into the device in a first in world study of such a
device with therapeutic cells.
In all of
the studies so far, from small animals to humans, the islets (therapeutic
cells) within the device have been proven to be surviving in a tissue matrix
with the islets intimately associated with micro-vessels, a hallmark of
islets found within the pancreas.
The
islets have also been shown to be able to make the hormones that regulate
blood sugar, indicating that the multiple cell types found in the islets are
surviving and functioning, again a significant advancement in the
regenerative field.
With
these promising results, while the clinical work with donor islets is
ongoing, Sernova is now focused on the even bigger goal of obtaining an
unlimited supply of cells for the treatment of millions of patients, and
expanding into other clinical applications.
The
timing of this work is ideal, a number of stem cell technologies are in need
of a medical device in which to survive, engraft and produce the factors to
treat disease. With years of validation Sernova’s device is unique in its
function and its position in the marketplace.
In
fact, a combination of the implantable medical device (Sernova’s Cell
Pouch™), local immune protection and a virtually unlimited supply of cells
places Sernova with the potential ultimate solution to treat
insulin-dependent diabetes, an approach that the Juvenile Diabetes Research
Foundation endorses and one which could benefit millions of type-1 and type-2
suffers of diabetes.
Regenerative
medicine was a hot topic at the recent annual healthcare investor conferences
in San Francisco this past January and Sernova had its roster full with
business development meetings.
 It isn’t
surprising to your author that interest in Sernova’s technologies is building
by pharmaceutical companies and other technology companies with regenerative
medicine products that fit together with Sernova’s technologies.
And SVA
is not sitting idle, while some companies would be content with a focus
entirely on diabetes Sernova is going several steps further. By pursuing its
platform technologies into the Hemophilia A market and other indications such
as thyroid disease the company is intent on providing increased depth and
more opportunities for potential partnering deals with large pharmaceutical
companies.
Conclusion
Since
2009, Sernova has made enormous strides forward in anticipation of the
blossoming of the regenerative medicine field and investors stand to
significantly gain from management’s foresight. It is anticipated that with
all the ongoing activities, 2015 may well be a pivotal year for Sernova.
Sernova
Corp. TSX.V – SVA, with its disruptive technologies potentially providing the
ultimate treatment for chronic diseases, is in a perfect position for
investors as the Company progresses to the international “dance floor” with
the introduction of its technologies to the world.
In
1908, Russian scientist Alexander Maximow proposed a groundbreaking
scientific theory. Maximow theorized that all blood cells came from a common
parent cell found in bone marrow - he called them ‘stem’ cells.
When I
think about Sernova and its potential I keep circling around to the fact that
WE, AS IN SERNOVA, DESPITE 0VER 100
YEARS OF RESEARCH AND BILLIONS OF DOLLARS POURED INTO THE FIELD OVER THE LAST
20 OR SO YEARS, HAVE THE ONLY MANUFACTURED, PROVEN SAFE TO BE IN HUMANS HOME
FOR THERAPEUTIC STEM CELLS. Nobody else has anything even
remotely close to the commercial stage Sernova’s Cell Pouch(TM)is at.
“Sernova
has achieved a major milestone with its first-in-human testing. Our
respective scientific teams are moving ahead to accelerate the pace of
innovation, and believe the Cell Pouch(TM) is a highly promising vehicle for
transplantation of future stem cell therapies.” Dr.
James Shapiro of the Edmonton Protocol, Sernova’s Principal Investigator for
the diabetes study
Sernova’s
Cell Pouch™, local immune protection technologies and years of solid
background supportive work positions the company far ahead of the herd as the
regenerative medicine field transitions from research to product development.
How many companies are out there right now saying to themselves 'Hey, we have this amazing stem cell technology but we
do not have an approved, safe, bio-compatible way to put them in a
human that will keep them alive to function and really make a
difference.'
Your
author believes there’s a whole host of companies looking to update their ‘do
not have’ relationship status.
Is a
valuation event for SVA on your radar screen?
If not,
it should be.
 Richard
lives with his family on a 160 acre ranch in northern British Columbia. He invests
in the resource and biotechnology/pharmaceutical sectors and is the owner of
Aheadoftheherd.com. His articles have been published on over 400 websites,
including:
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***
Legal
Notice / Disclaimer
This
document is not and should not be construed as an offer to sell or the
solicitation of an offer to purchase or subscribe for any investment.
Richard
Mills has based this document on information obtained from sources he
believes to be reliable but which has not been independently verified.
Richard
Mills makes no guarantee, representation or warranty and accepts no
responsibility or liability as to its accuracy or completeness. Expressions
of opinion are those of Richard Mills only and are subject to change without
notice. Richard Mills assumes no warranty, liability or guarantee for the
current relevance, correctness or completeness of any information provided
within this Report and will not be held liable for the consequence of
reliance upon any opinion or statement contained herein or any omission.
Furthermore,
I, Richard Mills, assume no liability for any direct or indirect loss or
damage or, in particular, for lost profit, which you may incur as a result of
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Richard
owns shares of Sernova Corp. TSX.V - SVA.
Sernova
Corp. is a paid sponsor of Richard’s site aheadoftheherd.com
This
article is not paid for content.
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