The Non-Invasive Advantage of Endonovo Therapeutics' (ENDV)

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The Non-Invasive Advantage of Endonovo Therapeutics' (ENDV) Electroceuticals

By RYAN ALLWAY
October 27, 2016 8:49 pm ET

Starting with the advent of the pacemaker and cochlear implants, physicians have for decades been using small jolts of electricity within the human body to stimulate activity. Though this method of treatment is clearly successful, the technology necessary to take “electroceuticals” to the next level simply wasn’t there until the recent advancements in technology.

Some of the more well known electroceutical devices approved by the FDA in recent years include a device that is implanted in the body in order to stimulate airway muscles to treat sleep apnea, and another that is an implanted weight control device that stimulates the vagus nerve in order to make a person feel full. Kristoffer Famm, head of the bioelectronics unit at GlaxoSmithKline (NYSE: GSK), predicts an endless array of devices to come. “The nervous system is crisscrossing our viscera to control many aspects of our organ function,” he states. “Rather than targeting cells with a drug, treatments could send an electrical pulse to a major nerve to alter the commands an organ receives, and thereby control its function.” No small player in the healthcare industry, GSK recently joined forces with Verily Life Sciences to form Galvani Bioelectronics “to enable the research, development, and commercialization of bioelectronics medicines.”

The idea is that miniature devices can be used to trigger biochemical processes that are typically manipulated by pharmaceutical drugs, which often times have far reaching side-effects well beyond treating the issue at hand. The ability to miniaturize these devices allows the reduction of procedure times, patient complications, and post-surgical pain.

But, what if, instead of implanting devices into the body, the same effect could be achieved through 100% non-invasive treatments?

This is where Endonovo Therapeutics (OTC: ENDV), a company focused on developing a bioelectronic approach to regenerative medicine, differs from the above-mentioned examples, as their Immunotronics™ platform is non-invasive.

Endonovo Therapeutics Research And Development

While many micro-cap technology companies have grand plans, they have to compete with much larger companies to attract the capital necessary to conduct their research. That is why it is all the more impressive that Endonovo, with a market cap of only $15 million, was able to recently secure an agreement with an institutional investor for up to $10 million in aggregate financing. This funding is allowing the company to move ahead with its own pre-clinical studies 2017.

The focus of these studies will be to evaluate “the effectiveness of its Immunotronics™ technology in accelerating regeneration of the liver and treating inflammatory conditions such as ischemia/reperfusion injury.” Non-Alcoholic Steatohepatitis (NASH), an inflammation of the liver caused by a buildup of fat, currently has no approved treatments and is an estimated $5 - $10 billion/year market. Endonovo aims to target NASH by using electrical stimulation to reduce inflammation in the organ, as NASH is classified as an “inflammatory disorder of the liver."

Additionally, Endonovo is currently studying the effects of its Cytotronics™ platform, using their Time-Varying Electromagnetic Field (TVEMF) technology to enhance the potential therapeutic properties of stems cells for use in cell therapies. Instead of using genetic modification and pharmacological modulation to alter/enhance the biological properties of cells, the company is using bioelectronics to create, ex vivo, modulated cells “with enhanced biological and therapeutic properties." This is a markedly different approach that allows for cells to be created with higher levels of key genes and proteins. As an example, Cytotronic™ expansion of peripheral blood stem cells resulted in an over 80-fold expansion of CD34+ cells in as few as 6 days.

The origins of this work actually go back to NASA, who at the time was trying to develop technologies to keep astronauts healthy during extended periods of time in microgravity and to expand stem cells. Scientists now better understand the complexity of stem cells and have realized that much of their therapeutic effect is achieved by secreting proteins to reduce inflammation and promote tissue healing. It is in this context that Endonovo is using its Cytotronics™ platform to validate the potential of injecting “trained” stem cells into a patient. The idea is not only to replace damaged or lost cells, but to also simultaneously deliver a cocktail of therapeutic proteins to those in need.

On August 10th, the company made further progress with the filing of a patent titled “Methods and Compositions for Treating Chemical and Radiation Injuries”, in which Alan Collier (CEO) commented “Now that we have an issued patent covering our proprietary process, which effectively trains cells to secrete therapeutic proteins, such as G-CSF, GM-CSF, EPO and IL-2, we can begin pursuing several indications using our Cytotronics platform.

"Many of the biomolecules that we can train cells to produce are used to promote the growth of specific blood cells, including, blood-forming stem cells, infection-fighting white blood cells and oxygen carrying red blood cells.”

Summary

With multiple platform technologies and funding to move ahead with pre-clinical trials, Endonovo Therapeutics appears to be well positioned for 2017. The company has an exceptional management team that not only consists of physicians and scientists, but also includes corporate finance professionals that can navigate the complex raises necessary to bring in the required funding for clinical trials. This experience is already evident in the recent $10 million raise and plans for uplisting to a national stock exchange.

For investors interested in non-invasive electroceuticals and bioelectronic applications in cell therapies, Endonovo Therapeutics unique approach and modest $15 million valuation is worthy of further consideration.


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