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Endonovo Therapeutics Inc (OTCMKTS:ENDV) Rockets Up The Charts

Endonovo Therapeutics Inc (OTCMKTS:ENDV) Rockets Up The Charts
Written by
Alex Carlson
Published on
April 5, 2016
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InsidrFinancial

Source: rejuvmedicalsw.com

Endonovo Therapeutics Inc (OTCMKTS:ENDV) has quickly emerged as one of the most exciting names on the OTC markets. ENDV has become a volume leader with a history of explosive moves for penny stock investors and traders. The latest surge higher has shorts scrambling to cover as we suspect the company is on the verge of receiving some major news.

Endonovo Therapeutics describes itself as "an innovative biotechnology company developing bioelectronic devices and therapies for regenerative medicine. Endonovo's Immunotronics platform is a non-invasive, non-implantable bioelectronic device for treating/preventing vital organ failure through the reduction of inflammation, cell death and the promotion of regeneration. Endonovo's Cytotronics platform provides for a method of expanding and manipulating cells using simulated microgravity and Time-Varying Electromagnetic Fields (TVEMF) for tissue engineering and cell therapies. The company's initial concentration is on the treatment of acute and chronic inflammatory conditions of the liver using its proprietary Immunotronics platform."

Just last week, ENDV announced that it had received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application entitled "Biological Molecules Produced by Electromagnetically Stimulating Living Mammalian Cells." The patent application covers the production of biological molecules, including growth factors and cytokines in adult stem cells using the company's proprietary technologies. This Notice of Allowance concludes substantive examination of the patent application and is expected to result in the issuance of a U.S. patent in the near future. ENDV has added this technology to its patent licensing program as it begins to pursue potential revenue producing applications of its portfolio of intellectual property.

In February, ENDV retained Holland & Knight to prepare and file the paperwork necessary to obtain an orphan drug designation for Endonovo's proprietary Cytotronics product. Endonovo is requesting the FDA grant an orphan drug designation to its next-generation, off-the-shelf treatment for Graft-Versus-Host Disease (GVHD) using Cytotronics expanded and ex vivo enhanced stem cells from the human umbilical cord.

GVHD is a rare complication following allogeneic tissue transplants, including bone marrow and cord blood transplants, wherein immune cells in the transplanted tissue (the graft) recognize the recipient (the host) as "foreign" and begin to attack the host's cells. Acute GVHD can result in significant damage to the liver, skin, mucosa and the gastrointestinal tract and is a major issue associated with high morbidity and mortality in transplants.

Orphan drug designation is a really big deal. It is granted by the FDA to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. The designation provides incentives for sponsors to develop products for rare diseases, which may include tax credits towards the cost of clinical trials. The orphan drug designation also would entitle Endonovo to a seven-year period of marketing exclusivity in the United States for the company's orphan indication should Endonovo receive FDA approval for the treatment of GVHD. Therapies with orphan drug status are also not subject to a prescription drug user fee for the orphan indication.

Once ENDV receives word from the FDA, it plans to demonstrate the safety and effectiveness of its Cytotronics product through adequate and well-controlled studies satisfying the FDA's requirements for Premarket Approval. CEO Alan Collier said:

"This is the first of many steps for Endonovo receiving FDA approval to market its Cytotronics product for the treatment of GVHD. Upon Premarket Approval we will expediently engage new studies to further illustrate our technology's capability in treating a wide-array of other conditions with our biologically potent, off-the-shelf, allogeneic treatment where currently human leukocyte antigen (HLA) markers prevent a recipient from obtaining a matching transplant (graft)."

Currently trading with a market cap of $83 million, ENDV is one of the most exciting stories among micro caps. ENDV recently repurchased $154,303 in convertible notes preventing additional shareholder dilution. The company has filed to withdraw its S-1 from registration of all the remaining shares under the Equity Purchase Agreement with Kodiak Capital, including 215,000 "Commitment Shares" issued to Kodiak Capital pursuant to the Equity Purchase Agreement. Furthermore, Endonovo has notified COR Clearing, LLC of its obligation to return to the company a total of 1.89 million unpaid shares from the Equity Purchase Agreement with Kodiak Capital. ENDV is protecting the interests of its stockholders and this is a rarity among penny stocks. We will be updating Insider Financial as soon as we know more. For continuing coverage on ENDV, sign up for our free newsletter today and get our next hot stock pick!

Disclosure: We have no position in ENDV and have not been compensated for this article.

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