- Announces Series C Preferred Stock Offering
- Updates Status of Clinical Pipeline in Central Nervous System Disorders
LOS ANGELES, CA, Jan. 16, 2018 (GLOBE 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.