- Announces Series C Preferred Stock Offering
- Updates Status of Clinical Pipeline in Central Nervous
System Disorders
Los Angeles, CA -- January 16, 2018 -- InvestorsHub
NewsWire -- - Endonovo Therapeutics,
Inc. (OTCQB: ENDV) ("Endonovo" or the "Company"), a
clinical-stage developer of non-invasive electroceutical devices
for the treatment of central nervous system (CNS) disorders, has
provided a corporate update and outlook for 2018.
Plans to Complete Clinical Trial to Study Effects of
tPEMF in Patients with Brain Injury
Endonovo plans to complete a single center, prospective,
controlled, clinical trial of tPEMF to evaluate the effects of
tPEMF in patients with brain injury and external ventricular drain
(EVD) in an intensive care unit (ICU) setting. This clinical study
is an extension of a safety trial and will be open to all patients
who have or are fitted with an external ventricular drain (EVD) to
remove excess cerebrospinal fluid (CSF).
Redesign tPEMF Products for Use in Central Nervous
System Disorders
Endonovo plans to redesign tPEMF products for use in CNS
disorders in order to make its tPEMF therapy easier to use and
increase patient compliance. Endonovo believes that industrial
design and engineering of non-invasive electroceutical devices will
be a critical component to the precise stimulation of areas in the
CNS that require treatment and allow patients to use the therapy in
an in-home setting.
Initiate Previously Planned Studies of tPEMF in
Post-Concussion Syndrome and Acute Concussions
Endonovo plans to initiate previously planned clinical trials to
study the effects of tPEMF in patients with Post-Concussion
Syndrome (PCS) and Acute Sports-related Concussions upon the
redesign of its tPEMF devices for use in CNS disorders.
Initiate Previously Planned Feasibility Study for
Use of tPEMF In Patients with Multiple Sclerosis
Endonovo plans to initiate an open-label study of tPEMF
treatment in patients with multiple sclerosis (MS) that will be
used to assess feasibility and tolerability of tPEMF therapy and to
generate preliminary data on clinically relevant outcomes.
Pursuing Licensing, Distribution, and Partnership
Opportunities for FDA-Cleared Devices
Endonovo plans to commercialize its CE-Marked and FDA-Cleared
Electroceutical™ therapy in China, Japan, Korea and other
international markets. Endonovo has already initiated dialogue with
potential licensees, distributors and joint venture partners in
Asia. Endonovo will further look to establish distribution
agreements and licenses in the Unites States for cosmetic surgery
and orthopedic indications or explore the establishment of its own
sales and marketing channels.
Announces Series C Preferred Stock
Offering
Endonovo has announced a Senior Secured Series C Preferred Stock
Offering (the "Series C Stock") to raise up to $8 million in
funding. The Series C Stock is a fixed-price redeemable preferred
stock that accrues an 8% dividend per annum paid in quarterly
installments. The Series C Stock contains two year warrants to
purchase common shares, the number of warrants will be such number
as to have an aggregate exercise price equal to 20% of the purchase
price of the Series C Stock. The exercise price of the warrants
will be the closing price of Endonovo's common stock on the date
Endonovo receives fully executed closing documents from purchasers
of the Series C Stock and the subscription amount. To date,
Endonovo has raised approximately $1 million of the Series C Stock.
For more information on the Series C Stock, interested parties can
find the Company contact information below.
Management Commentary
"2017 was a pivotal year for Endonovo, which saw the company
position itself as a clinical stage developer of non-invasive
Electroceutical therapies by acquiring a portfolio of intellectual
property, a clinical pipeline in central nervous system disorders,
and FDA-Cleared and CE Marked products," said Alan Collier,
Co-Founder and CEO of Endonovo Therapeutics.
"Now having completed this acquisition, we are looking to
position the company for continued growth by redeeming our
outstanding convertible notes and uplisting the company onto a
national stock exchange where we can increase shareholder value."
"As we prepare restarting and completing a previously on-going
clinical trial to evaluate our non-invasive medical devices in
brain injury, we will also work to initiate several previously
planned clinical trials to evaluate our Electroceuticals in other
CNS disorders."
"The market for CNS therapies currently lacks effective
treatments for many CNS disorders, such as traumatic brain injuries
and stroke because of the difficulty in delivering efficacious
amounts of drugs to the brain. However, our highly differentiated
and non-invasive approach is not limited by the blood-brain barrier
to deliver our therapy to the central nervous system, which
presents a significant opportunity for Endonovo to capture a
significant share of the CNS therapeutics market estimated to be
worth $128.9 billion by 2025."
2018 Expected Milestones
· Restart clinical
trial for tPEMF treatment in patients with brain injury and
external ventricular drain (EVD)
· Initiate clinical
trial for tPEMF treatment in patients with Post-Concussion
Syndrome
· Initiate clinical
trial for tPEMF treatment in patients with acute sports-related
concussions
· Initiate pilot
clinical trial for tPEMF treatment in patients with relapsing forms
of multiple sclerosis
· 1-2 license
agreements to be signed by the end of 2018
· Uplist the Company's
common stock onto a national stock exchange
About Targeted-Pulsed Electromagnetic Fields
(tPEMF)
Targeted-Pulsed Electromagnetic Fields (tPEMF) use
radiofrequency waves at 27.12 MHz to deliver electromagnetic energy
to tissues. The Company's tPEMF technology works by restoring key
electrochemical process that initiate the anti-inflammatory and
growth factor cascades necessary for healing to occur. tPEMF
technology has been shown to accelerate the production of the
endogenous constitutive nitric oxide synthase systems (cNOS): the
anti-inflammatory system, resulting in increased blood and lymph
flow, and decreased pain and edema.
The Company's tPEMF technology has been evaluated in 5
randomized controlled clinical trials and has demonstrated
significant reductions in pain, edema and use of pain
medication.
In pre-clinical studies of neuroinflammation and brain injury,
the Company's tPEMF technology has demonstrated significant
reduction of neuroinflammation, including a 5-fold reduction of
IL-1 beta, a master regulator of neuroinflammation, when compared
to untreated animals. Furthermore, in pre-clinical studies of
angiogenesis (promotion of new blood vessels), the Company's tPEMF
technology demonstrated a 500 percent increase in angiogenesis at 8
weeks.
An Overview of the Company's tPEMF Technology can be
found in the presentations page on the Investor Section of the
Company's website.
About Endonovo Therapeutics
Endonovo Therapeutics, Inc. is a clinical-stage developer of
non-invasive electroceuticals for the treatment of Central Nervous
System (CNS) Disorders, including traumatic brain injury and
multiple sclerosis. The Company's non-invasive electroceuticals use
targeted-Pulsed Electromagnetic Fields (tPEMF) to induce
micro-currents in tissues to target proinflammatory, fibrogenic and
regenerative signaling pathways for the treatment of cardiovascular
and cerebrovascular diseases, as well as for the treatment of
chronic kidney and liver disease. Endonovo Therapeutics' is
developing a pipeline of electroceutical-based therapies for the
treatment of cardiovascular disease, cerebrovascular disease,
peripheral artery disease, chronic kidney disease, and
non-alcoholic steatohepatitis (NASH). The Company's tPEMF
technology using short wave radiofrequency at 27.12 MHz has been
FDA-cleared and has a CE Mark for the treatment of soft tissue
injuries and post-operative pain and edema, as well as CMS National
Coverage for the treatment of chronic wounds. Endonovo is
developing a clinical pipeline using tPEMF for the treatment of
central nervous system (CNS) disorders, including post-concussion
syndrome, mild traumatic brain injury (mTBI), acute sports-related
concussions and multiple sclerosis.
Safe Harbor Statement
This press release contains information that constitutes
forward-looking statements made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
All statements, trends, analysis, and other information contained
in this press release including words such as "anticipate,"
"believe," "plan," "estimate," "expect," "intend," and other
similar expressions of opinion, constitute forward-looking
statements. Any such forward-looking statements involve risks and
uncertainties that could cause actual results to differ materially
from any future results described within the forward-looking
statements. Risk factors that could contribute to such differences
include those matters more fully disclosed in the Company's reports
filed with the Securities and Exchange Commission. The
forward-looking information provided herein represents the
Company's estimates as of the date of the press release, and
subsequent events and developments may cause the Company's
estimates to change. The Company specifically disclaims any
obligation to update the forward-looking information in the future.
Therefore, this forward-looking information should not be relied
upon as representing the Company's estimates of its future
financial performance as of any date subsequent to the date of this
press release.
Endonovo Therapeutics, Inc.Mr. Michael MannPresident (800) 701-1223, Ext. 100mmann@endonovo.com www.endonovo.com Investor Relations Contact: Endonovo Therapeutics, Inc. Mr. Steven BarnesSenior Vice President of Investor Relations (800) 701-1223, Ext. 108S barnes@endonovo.com www.endonovo.com Source: Endonovo Therapeutics, Inc. Investors: Sign Up for Email Alerts on Endonovo