The Big Deal About Stem Cell Therapies and Regenerative Medicine

LAS VEGAS, July 28, 2017 /PRNewswire/ --

Stem cell therapies are a key component of the regenerative medicine field that promises to be a revolutionary approach to treating many degenerative conditions by repairing damaged tissue and harnessing the body's ability to heal itself. Biotech companies in focus include: Endonovo Therapeutics, Inc. (OTCQB: ENDV), Pulse Biosciences, Inc. (NASDAQ: PLSE), Pluristem Therapeutics, Inc. (NASDAQ: PSTI), Cytori Therapeutics, Inc. (NASDAQ: CYTX) and Capricor Therapeutics, Inc. (NASDAQ: CAPR).

However, when looking at this great promise in terms of return on investment, let us be completely honest, most early stage stem cell investors have lost their shirts. We are now more than twenty years removed from the earliest commercial stem cell companies that were founded in the late 1980's, went public in the late 1990's and who were once seen as an exciting investment opportunity, but ended up being a huge disappointment. 

So, should investors still be interested in regenerative medicine? After all, stem cells have largely produced failures and unregulated stem cell clinics marketing unproven therapies are taking over. The answer is a resounding yes, but the dot-com like era of regenerative medicine, which led investors to pour money into anything and anyone marketing a cell therapy is over. Investors will need to look at companies solving issues with stem cells or those taking a completely new approach.

One company that is looking to address many of the issues with stem cell therapies, as well as developing another approach to regenerative medicine is Endonovo Therapeutics, Inc. (OTCQB: ENDV). On the stem cell front, ENDV is using its Time Varying Electromagnetic Fields (TVEMF) technology, originally developed at the National Aeronautics and Space Administration (NASA) to expand and activate stem cells to produce more biologically potent cell therapies. However, more importantly, ENDV is developing a non-invasive medical device that would render many of the cell therapies currently under development obsolete. These devices, called Electroceuticals, harness the electrical signals that our cells and nerves use to control the immune and regenerative response to treat inflammatory and degenerative diseases. ENDV is developing this exciting technology for treating and preventing heart failure following a heart attack, to treat chronic kidney disease, peripheral artery disease and non-alcoholic steatohepatitis (NASH).

Another small biotech company like ENDV working on electric treatments for diseases is Pulse Biosciences (NASDAQ: PLSE), whose Nano-Pulse Stimulation (NPS) technology uses nano second electric pulses to illicit an immune response for the treatment of cancer. PLSE recently announced the treatment of its first patient in a study to evaluate the safety and efficacy of its novel NPS technology for seborrheic keratosis (SK) lesions. SK is one of the most common types of skin lesions, affecting more than 80 million patients in the United States. Additionally, PLSE announced that it will host its quarterly investor conference call on July 27, 2017, at 1:30 p.m. PDT / 4:30 p.m. EDT. The company will provide an update on the clinical advancement of the PulseTx^[TM] System, including progress of the clinical study evaluating NPS for the treatment of seborrheic keratosis (SK), as well as the status of the 510(k) submission from earlier this year.  

Another company seeking to address past pitfalls of stem cell therapies is Pluristem Therapeutics, Inc. (NASDAQ: PSTI) is a developer of placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions. Pluristem's products include PLX-PAD and PLX R18. The Company's PLX cells are adherent stromal cells (ASCs) that are expanded using a three dimensional (3D) process. The system utilizes a synthetic scaffold to create an artificial 3D environment where placental-derived stromal cells can grow. This process allows the cells to be expanded rapidly while remaining healthy and potent cells that can secrete therapeutic biomolecules. The Company's PLX products are administered using a standard needle and syringe. PSTI recently announced that Austria's regulatory health agency, the Austrian Agency for Health and Food Safety (AGES), had cleared Pluristem to begin enrollment in Austria for its pivotal Phase III trial of PLX-PAD cells to treat critical limb ischemia.

In other stem cell news:

Cytori Therapeutics, Inc. (NASDAQ: CYTX) recently announced that its STAR study assessing its Habeo Cell Therapy for the treatment of Scleroderma had failed to meet its primary endpoint at week 24 nor any of its secondary endpoints at week 24 or week 48. On the other hand, CYTX stated that there were 'clinically meaningful' improvements in both the primary and secondary endpoints of both hand function and scleroderma-associated functional disability compared to placebo in a subgroup of patients with diffuse cutaneous scleroderma, a more severe form of the disease. The company has stated that it will continue it analysis of the data before determining its next steps.

Capricor Therapeutics, Inc. (NASDAQ: CAPR) a biotechnology company developing biological therapies for Duchenne muscular dystrophy and other rare diseases, following news that Janssen Biotech, Inc. had decided not to exercise its option to exclusively license Capricor's lead candidate CAP-1002 for the development and commercialization in the field of cardiology, announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to CAP-1002, Capricor's development candidate for the treatment of Duchenne muscular dystrophy, a debilitating genetic disorder characterized by progressive weakness and chronic inflammation of skeletal, heart, and respiratory muscles. The Rare Pediatric Disease Designation, as well as the Orphan Drug Designation previously granted to CAP-1002 by the FDA, covers the broad treatment of DMD. Upon receiving market approval for CAP-1002 by the FDA, Capricor would be eligible to receive a Priority Review Voucher.    

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