Sernova Corp: Achieving International Status

Richard (Rick) Mills
Ahead of the Herd

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

Regenerative medicine is slated to provide the next generation of therapeutics and for those companies and investors willing to successfully pave the way of the future, the rewards will be enormous. These therapies have the ability to not only treat diseases in a much better way than traditional drugs, but could significantly improve the quality of patient’s lives, reduce disease side effects and reduce the cost of healthcare.

The ultimate goal of regenerative medicine for technologies that produce proteins or hormones as therapeutics, is to develop an unlimited supply of safe and efficacious therapeutic cells placed, in a simple procedure, within the body in a cell friendly and retrievable medical device, while being protected from immune system attack.

“Sernova Corp (TSX.V – SVA; OTCQB – SEOVF) is a clinical stage regenerative medicine company developing medical technologies for the treatment of chronic debilitating metabolic diseases such as diabetes, blood disorders including hemophilia and other diseases treated through replacement of proteins or hormones missing or in short supply within the body.  Sernova is developing the Cell Pouch(TM), an implantable therapeutic medical device and immune protected therapeutic cells (donor, xenogeneic or stem cell derived therapeutic cells) which then release proteins and/or hormones for the treatment of disease.”

For the past 25 years, scientific laboratories around the world with specialty trained experts in cell technologies were learning the processes for how the body turns starting generalized stem cells into the mature functional cells. The recent scientific advances have turned these scientists towards developing therapeutic cells to treat diseases such as diabetes with the replacement of cells that have been lost in the body and if successful these technologies have the ability to treat millions of patients unlike the currently available donor cells. 

Knowing the importance of these developments, back in 2009, Sernova began working on and patented a proprietary, scalable, implantable medical device (Cell Pouch System™) that creates a natural environment for the survival and function of these therapeutic cells. When the time came, Sernova was determined to be in the forefront of such technologies with strong proof of concept on their therapeutic device with donor 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 (proteins, hormones or factors).

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.

Sernova Corp. is the first to demonstrate that the subcutaneous space (under the skin) can be successfully altered using the biopolymers of their implanted medical device, the Cell PouchTM, to generate and maintain a blood vessel rich, ideal tissue environment for therapeutic cells. With years of validation, Sernova’s device is unique in its function and its position in the marketplace. 

As part of their Cell Pouch™ technology, Sernova uses the concept of a space-holding polymer plug, whose length and number can be varied, which is temporarily placed under the skin around which develops the microvessel rich tissue environment to support therapeutic cells. The plug is then removed forming a void space for the transplantation of therapeutic cells which integrate into the microvessel rich environment. This ideal environment is supported long-term by the outer portion of polymer device which remains in place.

Sernova’s device for cell transplantation has three major functions:

• First, it provides a natural organ-like environment for therapeutic cells to be housed. Without a device, cells are not contained in a defined and removable location.

• Second, the Cell Pouch™ provides a sustainable micro-vessel rich environment for those cells to survive and release their product. The tissue supporting the cells, including microvessels, may eventually become absorbed without the ongoing presence of the polymer device. Loss of the tissue structures and blood vessels may result in the transplant eventually dying. As proof of this, biodegradable devices containing therapeutic cells placed under the skin failed over time and the concept was abandoned by a major pharmaceutical company.

• Third, while the Cell Pouch™ provides an ideal environment for therapeutic cells, Sernova’s other technologies provide protection of the cells from an immune system attack locally within its chambers. Interestingly, I believe Sernova is unique in its approach in separating the function of the device from their local immune protection technologies.

Sernova has demonstrated in long term studies that their device provides a stable, microvessel rich environment for therapeutic cells.

Market

Chronic debilitating metabolic diseases such as diabetes and blood disorders can be treated with SVA’s technology

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.

Sernova is currently concentrating on diabetes. The market for patients with diabetes that require an improved treatment like Sernova’s technologies (within our patented countries) is over 25 million patients.

Through business modeling, approximately 1% of the market has been estimated to be valued at a billion dollars a year revenue for Sernova even if they charged the equivalent to standard diabetes treatments.

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.

Competition

Sernova’s unique technology, with patents filed around the world since 2009, has proven successful over the years stimulating interest in this novel approach.

Companies are entering this cell therapy field because business leaders are seeing the enormous market and product potential of this field. This is driving up company valuations and thus, this ‘competition’ is a very good thing both from an investor perspective and corporate perspective.

Competitor devices developed to date have taken a very different approach from Sernova’s – using macro-devices that are protected from the immune system by walling off the cells from the body. Under this circumstance they do not bring vascularized tissue to the cells or allow the cells to survive in tissue chambers within a tissue matrix.

In your author’s opinion there is nothing new or revolutionary in this approach while Sernova’s device approach is unique in creating blood vessel lined tissue chambers and the fact local immune protection occurs within the device.