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Innovative Therapeutic Agents Grant Patients New Treatment Options

NEW YORK, Jan. 27, 2020 /PRNewswire/ -- The medical technology industry includes various segments such as instruments, apparatuses, and machines that are used in the prevention, diagnosis or treatment of illness or disease. Additionally, they can also aid in detecting, measuring, restoring, correcting, or modifying the structure or function of the body for some health purposes. The medical device industry often operates in conjunction with several other industries such as microelectronics, telecommunications, instrumentation, biotechnology, and software development. These cross industrial collaborations have led to significant technological advances in recent years, including neuro-stimulators, stent technologies, biomarkers, robotic assistance, and implantable electronic devices. Innovation fuels the medical device market, therefore, major investment in Research and Development is part of the formula for many companies involved; as discovering better ways to treat and diagnose medical conditions is key to success, especially when considering patient life expectancy and the increasing aging populations globally.

And according to data, the United States is still the largest medical device market, with a value of USD 156 Billion, which is 40% of the global industry in 2017. Research provided by SelectUSA, a U.S. government-wide program led by the U.S. Department of Commerce, projects that by 2023, the medical device market is expected to grow to USD 208 Billion. Endonovo Therapeutics, Inc. (OTC: ENDV), Medtronic plc (NYSE: MDT), Boston Scientific Corporation (NYSE: BSX), Nevro Corp. (NASDAQ: NVRO), LivaNova PLC (NASDAQ: LIVN)

An example of the innovative progress in the medical devices market can be seen in the subsector of Electroceuticals, a new category of therapeutic agents which act by targeting the neural circuits of organs. Electroceutical therapy works by mapping the neural circuitry and delivering neural impulses to these specific targets. The impulse is administered via an implantable device. ScienceDirect describes Electroceuticals is a recently coined term that broadly encompasses all bioelectronic medicine. It includes any type of electrical stimulation to affect and modify functions of the body; neural implants such as cochlear implants, retinal implants or spinal cord stimulators for pain relief but also cardiac pacemakers and implantable defibrillators. Recently, the field has expanded to include deep brain stimulation and the electrical stimulation of the vagus nerve, historically cited as the pneumogastric nerve, which interfaces with the parasympathetic control of the heart, lungs, and digestive tract. Increasing investments in the development of advanced bioelectric medicine is a major factor supporting the growth of the electroceuticals market. And the global electroceuticals/bioelectric medicine market size is expected to reach USD 28.5 Billion by 2026 while expanding at a CAGR of 7.4% according to a report by Grand View Research, Inc.

Endonovo Therapeutics, Inc. (OTCQB: ENDV) announced breaking news this morning that; initial sales of SofPulse® units into a VA hospital in Texas. SofPulse® is Endonovo's FDA-Cleared non-invasive device for reduction of postoperative pain and edema. SofPulse® represents a low-cost, drug-free solution to reduce use of opioids following surgical procedures and help prevent addiction. The therapy is non-invasive and non-pharmacologic, with no known side effects and no potential for overdose or dependency. SofPulse™ has been used effectively and studied extensively in soft tissue post-operative pain management. Learn more at

The Department of Veterans Affairs is a recognized leader utilizing proven strategies in pain management and opioid safety, and its success in reducing the use of opioids has been recognized by other health systems.

The Veterans Affairs Texas hospital is one of the department's largest hospitals, serving 27 Counties in Texas, and offers state of the art treatment for complex surgical conditions while at the same time promoting a multimodal approach for the treatment of postoperative pain aimed at reducing narcotics, which now includes SofPulse®.

Endonovo CEO Alan Collier stated, "I am extremely proud of our team and the effort to reach such a major milestone. Serving the veterans is an honor and privilege. Although the process was long and to become an approved vendor was a major accomplishment, we believe serving this VA Medical Center will open the doors for us to serve many other VA centers and assist with the VHA commitment in reducing opioid use."

About Endonovo Therapeutics Endonovo Therapeutics, Inc. is a commercial-stage developer of noninvasive wearable Electroceuticals® therapeutic devices. The Company's current portfolio of commercial and clinical-stage wearable Electroceuticals® therapeutic devices addresses wound healing, pain, post-surgical pain and edema, cardiovascular disease, chronic kidney disease, and central nervous system (CNS) disorders, including traumatic brain injury (TBI), acute concussions, post-concussion syndrome and multiple sclerosis. The Company's noninvasive Electroceutical® therapeutic device, SofPulse®, which uses 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 preclinical-stage Electroceuticals® therapeutic devices addresses chronic kidney disease, liver disease non-alcoholic steatohepatitis (NASH), cardiovascular and peripheral artery disease (PAD), and ischemic stroke. The Company's noninvasive, wearable Electroceuticals® therapeutic devices work by restoring key electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing to occur.

Medtronic plc (NYSE: MDT) announced recently that it had received approval from the U.S. Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate the safety and effectiveness of the PulseSelect™ Pulsed Field Ablation (PFA) System, a new technology that uses pulsed electric fields to treat atrial fibrillation. First procedures in the trial were performed in December 2019 by Bradley Wilsmore, M.D., at John Hunter Hospital, New Lambton Heights, NSW, Australia and in January by Atul Verma, M.D., the principal investigator (PI) for the study, at Southlake Regional Health Centre in Newmarket, Canada. PFA uses pulsed electric fields to ablate or create lesions and scar tissue to interrupt irregular electrical pathways in the heart and the triggers of atrial fibrillation. However, unlike traditional methods of ablation that heat the tissue (radio frequency) or cool the tissue (cryo) to ablate, PFA is non-thermal and selectively targets cardiomyocytes (heart muscle cells) while avoiding other types of tissue. "This study will evaluate a new energy source that may treat atrial fibrillation and potentially address the risks that have been associated with other ablation technologies, such as unintended tissue damage," said Verma. "The rigorous pre-clinical research to get us to these first procedures has been impressive and we are excited to support the development of more clinical evidence."

Boston Scientific Corporation (NYSE: BSX) announced earlier in December the U.S. Food and Drug Administration (FDA) 510(k) clearance of the EXALT™ Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D Duodenoscope is the first and only FDA cleared single-use (disposable) duodenoscope on the market and was granted Breakthrough Device Designation from the FDA to ensure patients and healthcare providers have timely access to this device. This device has been developed as an alternative to reusable duodenoscopes, eliminating the need for duodenoscope reprocessing and repairs, and allowing physicians to use a new, sterile device for every procedure. "The EXALT Model D Duodenoscope was developed to support clinicians in their mission to deliver the highest quality patient care," said Art Butcher, Senior Vice President and President, Endoscopy, Boston Scientific. "As a leading industry partner committed to advancing the care of pancreaticobiliary diseases for over 30 years, helping to ensure the integrity of ERCP is inherent in our mission to advance science for life and transform patient lives. This device, which was granted Breakthrough Device Designation by the FDA, builds on our legacy of delivering meaningful innovation that improves clinical outcomes."

Nevro Corp. (NASDAQ: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain conditions, announced earlier last year that it had completed patient enrollment in its prospective, multicenter Randomized Controlled Trial (RCT) for the treatment of chronic pain for patients who suffer from Painful Diabetic Neuropathy (PDN). "This is an important step in the evaluation of Nevro's Senza HF10 therapy for this very large and often undertreated patient population," said D. Keith Grossman, Nevro's Chairman, CEO and President. "Diabetes affects nearly one in ten adults in the United States and can damage peripheral nerves, resulting in severe pain and numbness in the hands and feet. According to published literature, there are approximately 4 million diabetic patients suffering from painful diabetic neuropathy in the U.S. alone. The SENZA-PDN study compares HF10 therapy plus Conventional Medical Management (CMM) to CMM alone in 216 patients at 18 centers in the United States. The primary endpoint of the study is the difference in proportion of treatment responders at 3-month follow-up and the study will collect outcomes out to 24 months. This RCT is designed to provide safety and efficacy data, which will be used to support customer adoption and efforts to ensure adequate payor coverage of this procedure. We thank Dr. Erika Petersen, Director of Functional and Restorative Neurosurgery at UAMS, for serving as the lead Principal Investigator for this study."

LivaNova PLC (NASDAQ: LIVN), announced back in September the first patient enrolled in "A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression" (RECOVER). The study will evaluate Vagus Nerve Stimulation Therapy (VNS Therapy) for Treatment-Resistant Depression (TRD) in accordance with the U.S. Centers for Medicare & Medicaid Services (CMS) National Coverage Determination as part of its Coverage with Evidence Development Program. "Through the RECOVER study, we have the ability to help patients with TRD across the United States gain access to a potentially meaningful treatment option to improve depressive symptoms and their quality of life," said Dr. Malik, President and Chief Medical Officer for CenterPointe Behavioural Health Systems; Chairman and Chief Executive Officer of Psych Care; and Clinical Associate Professor of Psychiatry at St. Louis University. "I have had positive results treating depressed patients with VNS Therapy in the past. I look forward to gaining a greater understanding of TRD and evaluating how patients respond to VNS Therapy as an adjunctive treatment during this study."

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