As a general rule, the most successful man in life is the man who has the best information
Sernova Corp. TSX.V – SVA has developed the subcutaneous Cell Pouch™ specifically designed to overcome the issues with previous implanted devices for cell transplantation. Sernova’s extensive Phase I/II clinical safety and efficacy studies have shown this device to be both safe and effective, while being sparing of islets, supporting its design and function.
Sernova’s Cell Pouch System™ is a versatile and scalable, first-in-class implantable medical device made entirely of FDA approved materials. The Cell Pouch System™ provides a natural “organ-like” environment rich in tissue matrix and micro-vessels. This is the ideal environment for therapeutic cells to thrive which then release the necessary proteins and/or hormones as required.
Sernova Corp. TSX.V - SVA is years ahead of everyone else in regards to having a proven, safe and compatible device for housing therapeutic cells in human’s.
A quiet summer is the perfect opportunity to build an ownership position in the company. At aheadoftheherd.com we anticipate a string of news releases, starting as early as September, regarding multiple different investigators using SVA’s Cell Pouch™ combined with their own stem cells for many different indications.
Interview
Today we’re sitting with Richard (Rick) Mills owner and host of aheadoftheherd.com
AOTH: What is unique about Sernova Corp’s (TSX.V – SVA) regenerative medicine technology approach where therapeutic cells such as glucose responsive islets can be successfully placed under the skin enabling them to survive and function when others have failed and why has Sernova’s approach generated so much recent interest from investigators?
Rick Mills: Those are important questions. First of all, researchers have been looking for ideal sites in the body as alternatives to the liver portal vein for placement of therapeutic cells including stem cell derived technologies and under the skin is such a site if the tissue could be adapted to provide an environment rich in blood vessels and tissue matrix to support therapeutic cells.
I believe Sernova is the first to demonstrate that the subcutaneous space (under the skin), among other sites, 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.
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 unique technology with patents filed around the world in 2009 has proven successful over the years stimulating interest in other investigators in this novel approach.
AOTH: I assume the interest is stimulated from the fact that Sernova has demonstrated safety and efficacy of their device using the therapeutic cells?
Rick M: Exactly. Sernova demonstrated successful safety and efficacy in small and large animal models of diabetes proving that their technology works and is also scalable for human therapeutic cell transplantation. They presented their ground breaking results at the highly esteemed International Islet Transplantation Conference soon after and re-opened the field involving the placement of therapeutic cells under the skin.
The fact that investigators are testing Sernova’s unique approach is a testament to SVA and demonstrates that SVA is on to something important, having solved a major problem for therapeutic cell transplantation that has not been previously achievable in many years.
AOTH: That’s exciting! Are shareholders protected from someone copying Sernova’s technology and selling their own product?
Rick: This is just my opinion, and I’m not a lawyer, but I think it’s a good thing investigators are doing their own research, independently supporting SVA’s findings. I have absolutely no problem with this because there are patents in place which were filed internationally designed to protect SVA’s technologies and commercial interests. Furthermore, SVA has over six years of design, contract manufacturing and testing, supporting their product.
AOTH: Why does Sernova believe the placement of such a medical device is important to create the appropriate environment for therapeutic cell transplantation that can produce proteins or hormones to treat chronic diseases?
Rick: Sernova's device for cell transplantation does at least three important things:
- First, it provides a location for therapeutic cells to be housed (i.e. we know where they are and if necessary the device can be removed).
- Second, the Cell Pouch™ provides a sustainable micro-vessel rich environment for those cells to survive and release their product (without a rich micro-vessel environment, the cells may not function or even die).
- Third, while the Cell Pouch™ provides an ideal environment for therapeutic cells, Sernova’s other technologies provide protection of the cells from 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.
Without a device, cells are not contained in a defined and removable location. We want to know where the transplanted cells are. Also, 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. On the other hand, Sernova has demonstrated in long term studies that their device provides a stable, microvessel rich environment for therapeutic cells.
AOTH: Alright, what else is unique about Sernova's approach?
Rick: As I alluded to earlier, Sernova’s Cell Pouch™ intentionally does not create a barrier from the immune system, rather it creates an ideal tissue environment for therapeutic cells. Sernova separated their local immune protection technologies from the Cell Pouch™ itself because they believe that combining immune protection within the walls of a macro-device defeats the ability to create an ideal tissue environment for therapeutic cells applicable for human use.
For example, an immune protected macro-device which literally walls off the therapeutic cells from the natural tissue environment:
- Prevents needed tissue matrix from interacting with cells and blood vessels from extremely close contact to them.
- Could be difficult to scale to humans because as the device gets bigger to contain enough cells for efficacy, the cells become further and further away from an oxygen supply and may lead to lack of function and/or cell death.
- Tissue cannot integrate into the device, preventing local healing and under this circumstance, the body tends to wall off the device with scar tissue.
AOTH: Then the cells can become asphyxiated?
Rick: That’s right. Over time, the cells wouldn’t be expected to get the oxygen and conduct the nutrient exchange they require to survive.
Providing local immune protection of cells through microencapsulation, or Sernova's other immune protection technologies, protects cells within the Cell Pouch™ while allowing these cells to live within a life-giving tissue matrix extremely close to micro-vessels. These are key features of cell survival and function.
As far as I know Sernova is the only group to have designed a scalable, implantable device that creates ideal micro-vessel, tissue lined chambers for the placement of therapeutic cells in which the cells have been proven to become well vascularized in multiple animal models and in humans with diabetes transplanted with islets.
AOTH: Where is Sernova going with its technologies?
Rick: It is my understanding that Sernova continues to be interested in expanding its human clinical work in islet transplantation in additional countries and is also actively exploring technologies that can provide unlimited sources of cells for the treatment of millions of patients. They are also working on additional clinical indications for the Cell Pouch™ such as haemophilia A, providing lots of opportunities.
AOTH: Any thoughts as to the future?
Rick: I envision a future where SVA’s products, their Cell Pouch™ with immune protected cell technologies being used for a number of different chronic diseases and eventually being available in virtually every hospital in the world.
AOTH: The therapeutic potential for patients and monetary implications for investors appear staggering.
Rick: Currently, there are about 25 million treatable patients who could use, and benefit from, SVA’s technologies in the field of diabetes alone.
AOTH: Anything you’d like to add?
Rick: I’d just like to emphasize, I believe Sernova's polymer device is the only such implantable medical device specifically designed to create natural tissue and micro-vessel lined chambers for the placement of therapeutic cells. These therapeutic cells, such as islets, have consistently been shown to survive within a tissue matrix and become vascularized in small and large animal models of diabetes in Sernova’s studies and in humans as proven in Sernova's clinical study with Dr. Shapiro.
Sernova's device is patented widely and recently among multiple other countries, a US patent has been issued on Sernova's device and cell technologies.
AOTH: Thank you Rick, as always a pleasure and very informative
Conclusion
The holy grail of Diabetes, Parkinson’s and Hemophilia A treatment is for patients not to have to take injections or infusions. Sernova Corp. (TSX.V-SVA), it’s Cell Pouch System™ and immune protection technology should be on everyone’s radar screen.
It’s definitely on mine. Is Sernova on yours?
If not, it should be.
Richard (Rick) Mills
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 the use and existence of the information provided within this Report.
Richard owns shares of Sernova Corp TSX.V – SVA
Sernova is a paid sponsor of Richard’s site aheadoftheherd.com