MAY 9TH, 2018 Endonovo Therapeutics Signs Dis
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MAY 9TH, 2018
Endonovo Therapeutics Signs Distribution Agreement with Plagens Medical Consultants for its Pain Relief Electroceutical(TM) SofPulse(R)
1:30 pm ET May 9, 2018 (Globe Newswire) Print
Endonovo Therapeutics, Inc. (OTCQB: ENDV) ("Endonovo" or the "Company" , a commercial-stage developer of Electroceutical(TM) Therapies, today announced a distribution agreement with Plagens Medical Consultants for the distribution of SofPulse(TM), its non-invasive Electroceutical(TM) Therapy for post-operative pain relief and reduction of swelling.
SofPulse(TM) is the Company's FDA-Cleared Electroceutical(TM) System for the palliative treatment of post-operative pain and edema in superficial soft tissues. SofPulse(TM) is an easy-to-place, non-invasive device delivering targeted MicroCurrent Therapy (tMCT) to enhance post-surgical recovery. tMCT is an innovative process using proprietary technology to reduce pain and swelling. The therapy is non-invasive and non-pharmacologic, with no known side effects and no potential for overdose or dependency. SofPulse(TM) has been used effectively and studied extensively in soft tissue post-operative management. The low levels of microcurrent are completely safe and, in fact, are 1000 times lower than those emitted by a mobile phone.
The Company's Electroceutical(TM) Therapy has been evaluated in 5 randomized, double-blind controlled clinical trials demonstrating:
-- 300% decrease in mean pain scores at 5 hours post-surgery;
-- 2.2-fold reduction in narcotic use post-surgery in active users; and
-- 275% lower mean IL-1 beta (inflammatory biomarker) in the wound exudates of active users following surgery
Endonovo's non-invasive pain relief therapy, SofPulse(R), represents a low-cost, drug free solution to the over use of opioids following surgical procedures. Following surgery, many patients will head home with prescriptions for 30 or more opioid painkillers, which is enough to trigger addiction. However, the American Society of Anesthesiologists recommends using prescription painkillers sparingly, if at all, after surgery. Post-surgical prescription practices have played a role in the opioid epidemic and despite the risk of dependence, many surgery patients receive opioid prescriptions for a month's supply or more. Furthermore, about 6 percent of surgery patients are still using opioid painkillers three months or longer after their surgery, according to a study published last year in JAMA Surgery.
Non-invasive electrotherapies, such as Endonovo's SofPulse(R), are believed to modulate pain signaling through activation of peripheral endogenous opioids and opioid receptors; making these non-pharmacological devices an extremely safe and economical alternative to prescription painkillers.
Alan Collier, Endonovo Chief Executive Officer, stated, "We are pleased to establish this partnership with Plagens Medical Consultants and I look forward to collaborating with their team to bring SofPulse to a national level. Plagens is a great partner for the SofPulse brand, possessing the scale, infrastructure, reputation, clinical experience and complementary product portfolio to make SofPulse a market leader in post-surgical pain management, recovery and rehabilitation. We are excited Plagens recognized the quality, robustness, innovation and design quality of SofPulse."
"Plagens Medical Consultants, a medical device company established in 1978 and with over 65 years of combined leadership experience, is proud to announce its partnership with Endonovo. Plagens is confident Endonovo's SofPulse will effectively address the opioid problems associated with orthopedic injuries and surgical recovery while providing a non-pharmaceutical option for patients. The feedback we have received on SofPulse from Physicians and other providers has been remarkable. Plagens is anxious to bring this to market in Michigan and the surrounding Great Lakes area." - Jason Walters, Senior Shareholder / Partner, Plagens Medical Consultants.
The distribution agreement may be expanded with additional products and territories in the future. Financial terms of the agreement were not disclosed.
About Plagens Medical Consultants
Since 1978, Plagens has specialized in supplying a diverse range of musculoskeletal devices to hospitals and healthcare providers in Michigan and the surrounding Great Lakes area. In 2013, Plagens expanded its distribution to include products for surgical and non-surgical pain management as well as recovery and rehabilitation. www.plagens.com
About Endonovo Therapeutics
Endonovo Therapeutics, Inc. is a commercial-stage developer of non-invasive wearable Electroceuticals(TM) Therapies. The Company's current portfolio of commercial and clinical-stage wearable Electroceuticals(TM) Therapies addresseses wound healing, pain, post-surgical pain and edema, cardiovascular disease, chronic kidney disease, and Central Nervous System (CNS) dDisorders, including traumatic brain injury (TBI), acute concussions, post-concussion syndrome and multiple sclerosis. The Company's non-invasive Electroceutical(TM) System device , SofPulse(R), using pulsed short-wave radiofrequency at 27.12 MHz has been FDA-Cleared and CE Marked for the palliative treatment of soft tissue injuries and post-operative pain and edema, and has CMS National Coverage for the treatment of chronic wounds. The Company's current portfolio of pre-clinical stage Electroceuticalss(TM) addresses chronic kidney disease, liver diseasenon-alcoholic steatohepatitis (NASH), cardiovascular and peripheral artery disease (PAD), and ischemic stroke. The Company's non-invasive, wearable Electroceuticals(TM) work by restoring key electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing to occur. www.endonovo.com
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.
Investor Relations Contact:
Endonovo Therapeutics, Inc.
Mr. Andrew Barwicki
516-662-9461
Andrew@barwicki.com
www.endonovo.com
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MAY 3rd, 22018
Biotechnology Companies Making Major Announcements
10:00 am ET May 3, 2018 (PR Newswire) Print
FN Media Group Presents Microcapspeculators.com News Commentary
The Nasdaq Biotechnology Index has is approximately 25% off of its all time high from back in July of 2015. With all of the incredible breakthroughs in biotechnology over the last few years, it is a very exciting time for those involved in biotech companies.
On the heels of CVS Health's (CVS) big announcement that it plans to focus on kidney care and dialysis to improve patient outcomes and reduce costs, some other biotechnology companies that have made major announcements recently include: Endonovo Therapeutics, Inc. (OTC:ENDV), Heat Biologics, Inc. (NASDAQ:HTBX), Neovasc, Inc. (NASDAQ:NVCN), PTC Therapeutics, Inc. (NASDAQ TCT) and Akers Biosciences, Inc. (NASDAQ:AKER)
Endonovo Therapeutics, Inc. (QTCQB: ENDV)
Market Cap: $10.5M, current share price: $0.031
ENDV, a commercial stage developer of wearable non-invasive Electroceutical(TM) therapies targeting post-operative pain and edema, chronic wounds, cardiovascular disease, renal disease and central nervous system disorders, recently highlighted positive results from an early feasibility study of its Electroceutical(TM) Therapy in reducing Proteinuria in 4 patients with chronic kidney disease (CKD). The Company is now planning to conduct a larger clinical trial in CKD.
The Company's Electroceutical(TM) therapy, SofPulse(TM), is an easy-to-place, non-invasive device that delivers targeted MicroCurrent Therapy (tMCT) to enhance post-surgical recovery. The Company's non-invasive Electroceutical(TM) therapy using pulsed short-wave radiofrequency at 27.12 MHz has been FDA-Cleared and CE Marked for the palliative treatment of soft tissue injuries and post-operative pain and edema, and has CMS National Coverage for the treatment of chronic wounds. ENDV recently stated that it is pursuing several sales and distribution channels in its 10-k annual report. The Company's strategy for commercialization centers on establishing SofPulse(TM) as standard care for post-surgical healing for the more than 850,000 cosmetic procedures performed each year in the US. Additionally, ENDV is establishing sales and distribution channels to target the Veteran's Affairs medical facilities and the more than 15,000 skilled nursing facilities in the United States.
Heat Biologics, Inc. (NASDAQ: HTBX)
Market Cap: $23.6M, current share price: $4.17
HTBX is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer using of CD8+ "Killer" T-cells. Our T-Cell Activation Platform (TCAP) produces therapies designed to turn "cold" tumors "hot" and be administered in combination with checkpoint therapies and other immuno-modulators to increase their effectiveness. HS-110 is our first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells to attack cancer. HTBX has almost doubled in share price following the announcement of positive interim Phase 2 results for HS-110 in non-small cell lung cancer (NSCLC) and guidance on upcoming clinical milestones for HS-110, its ComPACT(TM) platform and PTX-35, a co-stimulator antibody being developed by its subsidiary, Pelican Therapeutics. An anticipated $6.9M grant from the Cancer Prevention Research Institute of Texas and multiple upcoming clinical milestones means investors should keep a close eye on HTBX.
Neovasc, Inc. (NASDAQ: NVCN)
Market Cap: $67.2M, current share price: $0.04
NVCN is a leader in the development of minimally invasive transcatheter mitral valve replacement technologies. Its products include the Reducer, for the treatment of refractory angina, which is not currently available in the United States and has been available in Europe since 2015, and the Tiara, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada and Europe. The company recently provided a general corporate update, concurrent with filing its Annual Report on Form 20-F, to highlight the Company's progress over the last month and to confirm the date of the earnings call where these matters will be discussed further. The drastic drop in NCVN's share price has resulted in its future-priced warrants and notes being even more dilutive than previously estimated. The Company will also be seeking shareholder approval at the next Annual and Special General Meeting, scheduled for June 4, 2018, to carry out a share consolidation at an appropriate time.
PTC Therapeutics, Inc. (NASDAQ: PTCT)
Market Cap: $1.407B, current share price: $30.33
PTCT plans to host a webcast conference call to report it's first quarter financial results and provide a business update on May 9th, 2018 at 4:30 p.m. (ET). The company also is going to be participating in an upcoming Investor Conference, the Bank of America Merrill Lynch 2018 Health Care Conference, on Tuesday, May 15th. Today the company's security finished daily trading up nearly 4%, and is quickly approaching the company's 52 week high.
Akers Biosciences, Inc. (NASDAQ: AKER)
Market Cap: $54.4M, current share price: $0.53
AKER develops, manufactures, and supplies rapid screening and testing products designed to deliver quicker and more cost-effective healthcare information to healthcare providers and consumers. The Company has advanced the science of diagnostics while responding to major shifts in healthcare through the development of several proprietary platform technologies. The Company's state-of-the-art rapid diagnostic assays can be performed virtually anywhere in minutes when time is of the essence. The Company has aligned with major healthcare companies and high volume medical product distributors to maximize product offerings, and to be a major worldwide competitor in diagnostics. The Company recently announced the engagement of two leading Independent Sales Representative (ISR) organizations to increase US sales and marketing capabilities for the Company's rapid test for heparin-induced thrombocytopenia (HIT). Investors should keep close watch on AKER to see if the added sales capabilities can result in a share price increase to avoid a potential reverse stock split.
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MAY 1st, 2018
Endonovo Therapeutics Highlights Feasibility Study Results of Its Electroceutical Therapy in Reducing Proteinuria in Chronic Kidney Disease Patients
7:35 am ET May 1, 2018 (Globe Newswire) Print
Company to Conduct Larger Clinical Study to Evaluate Its Electroceutical(TM) Therapy in Chronic Kidney Disease
Endonovo Therapeutics, Inc. (OTCQB: ENDV) ("Endonovo" or the "Company" , a commercial-stage developer of non-invasive Electroceutical(TM) therapies, today announced that it is targeting the treatment of chronic kidney disease (CKD) using its non-invasive Electroceutical(TM) Therapy and is currently planning a follow-up clinical study to evaluate its Electroceutical(TM) Therapy for reducing Proteinuria in CKD patients. Additionally, the Company highlighted positive results from an early feasibility study of its Electroceutical(TM) Therapy in reducing Proteinuria in 4 patients with CKD. The abstract of the early feasibility study was published in the American Journal of Kidney Diseases and has been posted by the Company on the Presentationssection of its Investor Relations website.
The feasibility study investigated the effectiveness of PEMF during a 2-week trial on reducing Proteinuria (P) in subjects with CKD, evaluating for synergy between Pulsed Electromagnetic Field Therapy (PEMF) and angiotensin receptor blockers (ARBs). Four volunteers with progressive poteinuric nephropathies applied PEMF to their lower-thoracic spine, allowing electromagnetic energy to pulse over both kidneys for 30 min, 3 times a day for 2 weeks. All medications were continued without change, including previously prescribed ARB's. Urinary spot collections were analyzed for protein to creatinine ratio's, expressed in grams per day.
During a two-week observational trial, the application of PEMF demonstrated reductions in protein to creatinine ratios expressed on urinary spot collections. Students paired t- test demonstrated in the four subjects, p = 0.06. There were no significant changes in the glomerular filtration rate (MDRD) or mean arterial pressures. No adverse events were reported. The reduction in proteinuria over 2 weeks was arithmetically, but not statistically significant due to small population size. This reduction in proteinuria warrants further study to determine long term effectiveness and possible synergy with RAS blockade.
Alan Collier, CEO of Endonovo Therapeutics, commented, "Proteinuria is the abnormally high presence of protein in the urine and is often a sign of chronic kidney disease. Furthermore, Proteinuria is another predictor of increased cardiovascular risk and numerous studies have shown that treating patients with diabetic/nondiabetic CKD and Proteinuria reduces Proteinuria and slows the progression of renal disease, and the greater the reduction in Proteinuria, the greater the benefit."
"Our Electroceutical Therapies may represent a clinically-meaningful option to treat or delay the progression of kidney disease in dialysis and pre-dialysis patients. Reducing Proteinuria is important because its existence can continue to confer the well-known inflammatory, catabolic, thrombotic, and toxic effects on the endothelium during the pre-dialysis period," concluded Mr. Collier.
The device used in this study was not the device currently marketed by the Company for treatment of post-operative pain and edema. There would be no expectation of getting similar results with the currently marketed device. FDA Approval for the device used in the feasibility study would be necessary to secure an appropriate indication for Endonovo to market such device.
About Chronic Kidney Disease:
Nearly 700,000 Americans have End Stage Renal Disease (ESRD), with approximately 500,000 of these patients on active dialysis and more than 120,000 new ESRD cases diagnosed each year. Financially, CKD represents a huge cost burden, costing Medicare nearly $65 billion a year for chronic kidney disease care, and another $34 billion directly related to dialysis patient care. Despite this high level of spending, outcomes for Medicare patients treated with in-center hemodialysis are poor with mortality rates up to 10 times higher than among the general Medicare population.
About Endonovo Therapeutics
Endonovo Therapeutics, Inc. is a commercial-stage developer of non-invasive wearable Electroceuticals(TM). The Company's current portfolio of commercial and clinical-stage wearable Electroceuticals(TM) addresses wound healing, pain, post-operative edema and Central Nervous System (CNS) Disorders, including traumatic brain injury (TBI), acute concussions, post-concussion syndrome and multiple sclerosis. The Company's non-invasive Electroceutical(TM) device using pulsed short-wave radiofrequency at 27.12 MHz has been FDA-Cleared and CE Marked for the palliative treatment of soft tissue injuries and post-operative pain and edema, and has CMS National Coverage for the treatment of chronic wounds. The Company's current portfolio of pre-clinical stage Electroceuticals(TM) addresses chronic kidney disease, liver disease, cardiovascular and peripheral artery disease. The Company's non-invasive, wearable Electroceuticals(TM) work by restoring key electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing to occur.
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.
Investors: Sign Up for Email Alerts on Endonovo
Investor Relations Contact:
Endonovo Therapeutics, Inc.
Mr. Andrew Barwicki
516-662-9461
Andrew@barwicki.com
www.endonovo.com
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