Sernova - Primed For Prime Time

Richard (Rick) Mills

Ahead of the Herd

As a general rule, the most successful man in life is the man who has the best information

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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.