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Endonovo Therapeutics

Stock Symbol: ENDV

Analyst Report

seethroughequitySeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced it has initiated coverage on Endonovo Therapeutics, Inc. (ENDV) with a price target of $1.15.

The report is available here: ENDV Initiation Report. SeeThruEquity is an approved equity research contributor on Thomson First Call, Capital IQ, FactSet, and Zack’s. The report will be available on these platforms. The firm also contributes its estimates to Thomson Estimates, the leading estimates platform on Wall Street.

Science_tab-optBased in Los Angeles, CA Endonovo is a biotechnology company focused on developing bioelectrical devices and therapies for regenerative medicine. Endonovo is developing two new platform technologies that utilize time-varying electromagnetic fields (TVEMF). These include the company’s Immunotronics™ Platform, a non-invasive medical device for the treatment and prevention of organ failure, and its Cytotronics™ Platform, an application of TVEMF to enhance and expand cells and potentially for the development of fully human biologics. Endonovo will initially develop therapies from these platforms addressing rare diseases, which should expedite development time if Endonovo can secure a Humanitarian th (1)Device Exemption for its Immunotronics™ device for acute liver failure, and an Orphan Drug Designation for its Cytotronics™ cell therapy for graft versus host disease (GVHD). However, we believe the company’s broader goal is to show that its Immunotronics technology has very large potential to change the way we treat inflammation and prevent organ failure. We view Endonovo as a speculative company in the biotechnology market with high risk and high growth potential from the large markets targeted by its intriguing and potentially disruptive Immunotronics™ and Cytotronics™ platforms.

“Endonovo is led by a committed management team with significant experience in the industry. The company is led by CEO and Chairman Alan Collier, who brings over 20 years of experience in corporate finance, technology and IP development. Collier joined the company in 2011. His previous roles include founding IP Resources International, where he developed a platform for licensing and acquiring technology for life sciences and technology companies. The company’s Chief Medical Officer is Leonard Makowka, MD, PhD. Dr. Makowka has been published over 400 times and is known in the medical community, having served as Executive Director at the Comprehensive Liver Disease Center at St. Vincent’s Medical Center as well as serving as a member of the Board of Directors at multiple publicly listed companies. Endonovo also benefits from the financial and operations experience of President Michael Scott Mann and COO Don Calabria, who joined the company in 2012 and 2011, respectively, and each bring Endonovo over 20 years of relevant leadership experience. We have included full bios of Endonovo’s top management on pages 10-11 of this report,” stated Ajay Tandon, CEO of SeeThruEquity. “We are initiating coverage with a 12-month price target of $1.15 per share.”

Additional highlights from the report are as follows:

Next 12-18 months a key time for Endonovo

Management-HomeWe see the next 12-18 months as being an important time for Endonovo. As of the end of 2015, Endonovo been funded with approximately $2.8mn of capital, and management is in the process of raising an additional round of $2mn – $5mn, which would be used to advance its platforms into clinical trials. Indeed, the company has several potential milestones in the next year. For the Immunotronics™ platform, these include the initiation of a rat liver trial, which is expected to commence in 2H16, as well as an application for an investigational device exemption (IDE) for acute liver failure (early 2017E).

history_home1For the Cytotronics™ Platform, the next key milestones that would be enabled by this funding would be the potential granting of an orphan drug designation (estimated 1H2017E) from the FDA for its next generation off-the-shelf treatment for GVHD. Assuming management is able to execute on these initiatives, we would expect this to set up another and potentially larger raise for 2017E. The purpose of this raise would be to fund human studies for the Immunotronics™ device, which would possibly done in conjunction with a reverse split and an attempt to list shares on a national exchange such as the NYSE MKT or NASDAQ.

Initiate coverage with a price target of $1.15

Company Overview

Endonovo_Logo_red_optEndonovo Therapeutics (ENDV) is 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 enhancing the biological and therapeutic properties of cells for the development of next-generation 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 and the treatment of Graft-Versus-Host Disease using its ex vivo expanded and enhanced stem cells.

Endonovo means to renew from within. Our mission is to save lives by treating and preventing vital organ failure.

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Key Investment Highlights

Endonovo Therapeutics (OTC:ENDV) Developing Next-Generation Cell Therapy for Acute and Chronic Graft-Versus-Host Disease Using Cell-Enhancing Cytotronics Platform

  • The Company believes that its development of next-generation cell therapies that have been enhanced ex vivo using its Cytotronics™ platform will be a major innovation in the regenerative medicine market, which is expected to increase from US$2.6 billion in 2012 to US$6.5 billion by 2019, according to Transparency Market Research.
  • “We are very excited to be a leader in the development of next-generation, ex vivo enhanced cells for regenerative medicine,” stated Endonovo CEO, Alan Collier. “We have seen several stem cell therapies fail in clinical trials over the last couple of years, which points to a critical need for the development of methods to increase the biological and therapeutic properties of stem cells.”
  • Endonovo is requesting the United States Food and Drug Administration (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.

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“We have taken our method of expanding a population of immune privileged stem cells from the human umbilical cord and combined it with our Cytotronics platform to create large quantities of optimized immuno-regulatory stem cells that can be used as an allogeneic, off-the-shelf therapy for the treatment of Graft-Versus-Host Disease,” commented Endonovo Chief Scientist, Dr. Donnie Rudd.

“Our Cytotronics platform is particularly suited to address many of the issues that have plagued stem cell therapies that have recently failed, such as their loss of potency and self-renewal when expanded ex vivo, their poor engraftment and their limited ability to survive when transplanted,” says Dr. Rudd.

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  • Time-Varying Electromagnetic Field (TVEMF) technology is fundamentally different from other magnetic pulse devices. TVEMF is based on the physics of electricity and magnetism as well as the physiology of cells and tissues.
  • Endonovo’s TVEMF device produces a patented square waveform, which was proven the most effective waveform to increase cell growth and the production of over 200 growth factors and cytokines.
  • history_home1The basis for Endonovo’s (OTC: ENDV) Time-Varying Electromagnetic Field (TVEMF) technology was created at NASA in conjunction with the development of cell therapies to treat injuries and diseases that astronauts might encounter during long term manned missions in outer space.
  • The original concept of TVEMF was developed when NASA realized that cellular growth  increased as the space shuttle crossed the earth’s magnetic poles. It took over eight years to define and develop a device that produced the same effect. This magnetic field device (TVEMF) was originally designed to enhance cellular expansion (growth) in NASA’s rotating wall bioreactor. After numerous experimental studies, the results were so significant with the bioreactor that a prototype was designed for use directly on the human body.
  • Cytotronics™ Platform Allows for the Large-Scale Expansion and Enhancement of Immuno-Regulatory Stem Cells With Enhanced Biological and Therapeutic Properties
  • Ex-Vivo-ModulationEndonovo Therapeutics (OTC: ENDV) Files Patent Application on Cell Therapy Created Using Its Proprietary Cell-Enhancing Cytotronics Platform
  • Therapeutic Represents the First Product to Be Created Using the Company’s Cytotronic™ Platform to Expand and Enhance the Therapeutic Properties of Stem Cells
  • The prospect of increasing the availability and safety of cord blood transplants has attracted the attention of large pharmaceutical companies, such as Swiss drug maker Novartis, which recently announced another $15 million investment in Israeli stem cell company, Gamida Cell.

“By combining the two technologies, we are addressing the problem from two sides,” stated Endonovo CEO, Alan Collier. “We are expanding the number of blood-forming stem cells and also enhancing the biological properties of these stem cells to create enhanced cell therapies.”

“Our competitors are primarily using genetic modification and/or pharmacological modulation to expand and/or enhance the therapeutic properties of stem cells, while we are simply using physical energy and a simulated stem cell environment, which we believe will result in safer and more effective therapies,” concluded Mr. Collier.

Technology

History

The basis for Endonovo’s (OTC: ENDV) Time-Varying Electromagnetic Field (TVEMF) technology was created at NASA in conjunction with the development of cell therapies to treat injuries and diseases that astronauts might encounter during long term manned missions in outer space.

The original concept of TVEMF was developed when NASA realized that cellular growth  increased as the space shuttle crossed the earth’s magnetic poles. It took over eight years to define and develop a device that produced the same effect. This magnetic field device (TVEMF) was originally designed to enhance cellular expansion (growth) in NASA’s rotating wall bioreactor. After numerous experimental studies, the results were so significant with the bioreactor that a prototype was designed for use directly on the human body.

Endonovo’s (OTC: ENDV) TVEMF device produces a patented square waveform, which was proven the most effective waveform to increase cell growth and the production of over 200 growth factors and cytokines.

TVEMF vs PEMF

Time-Varying Electromagnetic Field (TVEMF) technology is fundamentally different from other magnetic pulse devices. TVEMF is based on the physics of electricity and magnetism as well as the physiology of cells and tissues.

  • PEMF devices do not produce square waves, the optimal waveform for a tissue response.
  • PEMF devices do not produce enough intensity to stimulate a response; most do not even produce 1 Gauss of intensity.
  • PEMF devices do not produce a rate of induction (slew rate) that is quick enough to penetrate deep within tissues. TVEMF produces pulses that are only 0.0001 seconds wide.
  • Furthermore, TVEMF features repeating patterns of pulses that are selected based on known motor-neuron stimulation patterns of musculoskeletal tissues.

Why Square Waves?

Sine waves take too long to reach their peak intensity. The lower slew rate means that they are not effective in producing a cellular/tissue response.Triangle and sawtooth waves also suffer from a lower slew rate, meaning that they are not effective in producing a cellular/tissue response.

Endonovo’s TVEMF device produces a patented square waveform, which was proven the most effective waveform to increase cell growth and the production of over 200 growth factors and cytokines.

square waves

Products

Bioelectronics

Electromagnetic pulses are responsible for many of the activities in our bodies. They are an integral part of what keeps our hearts beating and brains functioning.The bioelectronics device is a portable Time-Varying Electromagnetic Field (TVEMF) system. The unit uses a sophisticated miniaturized circuit board that delivers the specifically designed and patented electromagnetic field to a designated area of the body through the use of antennas (coils).

Press Releases

Leadership

Management-HomeAlan Collier – Chairman & Chief Executive Officer
Mr. Collier has more than twenty years of experience in corporate finance, IP development, telecommunications and technology with a concentration in healthcare and technology over the last five years. Prior to his appointment as Endonovo’s CEO and chairman, Mr. Collier served as CEO and director of IP Resources International, Inc. where he was instrumental in developing a platform for for the licensing and acquisition of life science and technology companies.

Previously, Mr. Collier served as a Senior Managing Director at Mid-Market Securities, a FINRA-registered Broker-Dealer. Prior to joining Mid-Market Securities, Mr. Collier was a Managing Director at Mosaic capital and co-managed its Capital Markets Group. He was previously a Vice President at Corporate Capital Group and Managing Director and CEO of Greenbridge Capital Group.

Over the progression of his career, he has specialized in the development and financing of early stage, high growth, and acquisitive companies (public and private). He has structured, participated in, and completed numerous transactions including mergers and acquisitions, equity and debt placements, capital restructuring, joint venture development, and channel partner procurement. He has held numerous board and executive positions throughout his career in the telecommunications, technology, specialty finance, corporate finance and healthcare industries. Mr. Collier holds FINRA Series 7, 79, 63, and 24 Licenses.

Michael Scott Mann – President
Mr. Mann has over 30 years experience in merger and acquisitions and operational management. In 2008 Mr. Mann acquired the assets of Hanover Asset Management, now Endonovo Therapeutics, Inc,. and led the company to become listed on the OTCBB in 2012.

From January 2003 to April, 2011, Mr. Mann was the Founder, President and Chief Executive Officer of U.S. Debt Settlement, Inc. (USDS), a Frankfurt listed company, where he implemented a growth by acquisition strategy successfully acquiring numerous companies.

From January 2002 to July 2003, Mr. Mann was the Chief Executive Officer of Shared Vision Capital, a boutique investment banking firm that assisted emerging companies with early seed capital and bridge loans. Earlier still, from October 1998 to December 2001, Mr. Mann was the Vice President of Investor Relations for JuriSearch.com, an online legal research platform. During his tenure with JuriSearch.com, Mr. Mann was directly responsible for funding the company’s growth and development. In addition, Mr. Mann founded Universal Pacific Communications, a privately owned telecommunications company. Under his leadership as President, Universal Pacific developed a fiber optic disaster recovery telecommunications network, designed for and successfully marketed to Fortune 1000 companies.

Don Calabria – Chief Operating Officer
Mr. Calabria brings over seventeen years of leadership and experience in national business operations to emerging growth companies, mergers and acquisitions, finance, and business development. Mr. Calabria has a deep level of experience in analyzing companies, determining the operational efficiencies, and conducting operational due diligence on targeted acquisitions.
Previously, Mr. Calabria served as President of Gemini Consulting Group, Inc., a boutique consulting firm which specialized in providing consulting services to companies in multiple marker segments with a core focus directed towards capital structuring and investments, brand strategy and marketing, M&A activities, and operational efficiencies. Prior to this, Mr. Calabria was the VP of Operations for TrinTel Communications; the largest privately held Infrastructure Company in the wireless telecommunications industry. As part of the Company’s initial Senior Management team, which grew the company to a $350+ million valuation in under three years, Mr. Calabria specialized in managing joint venture agreements and strategic alliances as well as directing all subsidiary operations including regional sales, marketing, and business development practices. Prior to this, as the Director of Operations for Wireless Solutions, LLC, he helped facilitate the sale of the company to TrinTel Communications.
Mr. Calabria holds an MBA from the Graziadio School of Business and Management at Pepperdine University and a BS in Management from Arizona State University.

Leonard Makowka, M.D., Ph.D. – Chief Medical OfficerOver the past 30 years, Dr. Makowka has transitioned himself as a distinguished clinical and transplantation surgeon and medical researcher to a successful entrepreneur, advisor and board member in a wide range of industries. Since receiving his M.D. degree from the University of Toronto Medical School in 1977 and Ph.D. from the University of Toronto’s Department of Pathology in 1982, he has published over 400 articles and chapters in both clinical and basic scientific research.

Between 1989 and 1995, Dr. Makowka served as the Chairman of the Department of Surgery and Director of Transplantation Services at Cedars Sinai Medical Center in Los Angeles, California. During this time, he also served as Professor of Surgery at the UCLA School of Medicine. Dr. Makowka would later become Executive Director of the Comprehensive Liver Disease Center at St. Vincent’s Medical Center in Los Angeles, CA, where he created a multiple disciplinary approach to the treatment of liver disease.  He is currently the active Chairman of the Corporate Advisory Board of the UCLA School of Nursing. Dr. Makowka has since retired from the active practice of medicine and has experienced a successful career in developing investment and business strategies for companies in the healthcare, life sciences, finance, and other industries.

Dr. Makowka has served on the board of directors for various private and publicly traded companies in the healthcare and life science industries. From 1998 to 2003 he served on the Board of Directors of Hollis Eden Pharmaceuticals, (NASDAQ: HEPH) and served on the Board of Directors for Kinmed, Inc., a privately held biotech company. As an entrepreneur, Dr. Makowka has worked with several companies in a wide range of industries. He was a founding consultant for Ivivi Technologies, Inc. (NASDAQ: IVVI), a publicly traded medical technology company focusing on designing, developing, and commercializing proprietary electrotherapeutic technologies. In addition, Dr. Makowka founded Trillenium Medical Imaging Inc., a company engaged in the novel healthcare application of proprietary infrared imaging.

As Endonovo Therapeutics’ Chief Medical Officer, Dr. Makowka will be responsible for developing the company’s scientific advisory board, overseeing the company’s clinical research activities and will serve as a liaison between the company and the medical community.

Steven Barnes – Vice President of Investor RelationsSteven has over 18 years of extensive banking and corporate finance experience representing both the buy and sell side. His corporate, strategic and operational expertise includes public markets, private debt and equity, mergers, acquisitions, divestitures and strategic planning.  He spent 8 years in the securities industry as a licensed (series 7, 63 & 55) representative of a NASD (now FINRA) Beverly Hills/New York based trading firm where he worked as an institutional trader, financial analyst and money manager. In 2003 Steven founded and was the principal of Empire Financial, Inc., a full service investment banking and corporate advisory firm in Los Angeles, California.  He structured numerous private and public debt and equity offerings in many diverse sectors including biotechnology, healthcare, entertainment, and hardware/software technology companies.

Investor Relations:

Endonovo Therapeutics, Inc.
6320 Canoga Avenue, 15th Floor
Woodland Hills, CA 91367
Mr. Steven Barnes
Vice President of Investor Relations
(800) 701-1223, Ext. 108
Sbarnes@endonovo.com
www.endonovo.com

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