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Advancing Technologies Open New Pathways for Medical Care

FinancialBuzz.com News Commentary

As technology evolves to increase productivity and eliminate or reduce human error, several major industries are expected to undergo significant changes. The medical device industry, for example, is expected to enter a new phase thanks to several advancements such as the Internet of Things (IoT), big data analytics, augmented reality devices and other technologies that are only now reaching maturity or will promptly. Overall, the medical technology industry encompasses numerous segments such as instruments, apparatuses, and machines that are used in the prevention, diagnosis or treatment of illness or disease. Moreover, such devices can help in detecting, measuring, restoring, correcting, or modifying the structure or function of the body for some health resolutions. Additionally, internet-connected devices, ranging from hospital imaging equipment to implantable pacemakers and infusion pumps, help healthcare providers and patients in a variety of tasks, such as monitoring vitals, improving diagnostics, regulating dosages, and more. According to Synopsys, a computer integrated systems design company, U.S. hospitals have an average of 10-15 connected medical devices per bed. As such, the global medical devices market reached a value nearly USD 423.8 Billion in 2018, having grown at a compound annual growth rate (CAGR) of 5.28% since 2014. Furthermore, it is expected to grow at a CAGR of 5.33% to nearly USD 521.64 Billion by 2022, according to data published by Research and Markets. Endonovo Therapeutics, Inc., Zimmer Biomet Holdings, Inc., Baxter International Inc., NuVasive, Inc. , Medtronic plc.

The orthopedic medical devices segment is a growing and vibrant section of the medical devices industry. High prevalence of orthopedic conditions such as degenerative bone disease coupled with a rising geriatric population and a number of road accidents are anticipated to drive the market. Additionally, early onset of musculoskeletal conditions triggered by obesity and sedentary lifestyle are expected to boost its growth as well. On the basis of products, the market is categorized into accessories and surgical devices. The surgical device segment is further divided into drill guide, custom clamps, guide tubes, screw drivers, and distracters, among others. The accessories segment covers products such as braces, arthroscopes, and other consumables. Currently available trauma management techniques are incapable of restoring body parts successfully due to the lack of efficient surgical tools. As a result, manufacturers are investing significantly in Research and Development (R&D) to develop innovative and efficient devices. Overall, the global orthopedic devices market size was valued at USD 36.1 Billion in 2017. It is anticipated to expand at a CAGR of 3.1% over the forecast period of 2018 – 2026, according to Grand View Research.

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Endonovo Therapeutics, Inc. announced today that their, “SofPulse device is being evaluated at major universities for orthopedic surgeries.”

SofPulse is Endonovo’s FDA-Cleared, non-invasive device utilized for the reduction of postoperative pain and edema. SofPulse represents a low-cost drug-free solution for reducing opioid usage, accelerating patient recovery and preventing opioid addiction following surgical procedures. This non-invasive and non-pharmacologic therapy has no known side effects and presents no potential for overdose or dependency as SofPulse is not reliant on any narcotic to produce pain and edema reduction. SofPulse has been effectively utilized and studied extensively in soft tissue postoperative pain management showing significant clinically proven results for the reduction of postoperative pain and edema.

Endonovo Therapeutics CEO Alan Collier stated, ‘We are pleased to announce SofPulse is now being evaluated at major medical universities. We believe this is a unique opportunity for SofPulse® to be evaluated, and upon completion and approval, be used as a standard of healthcare moving forward. We are also optimistic SofPulse® can be used by professors as a standard medical device which can be implemented in the educational process for all medical professionals. Although we are in the early stages, the university administrators and professors are expediting the evaluation process.’

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About Endonovo Therapeutics Inc: Endonovo Therapeutics 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..”

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Zimmer Biomet Holdings, Inc. announced back in September the FDA 510(k) clearance for the Persona® Revision Knee System for revision knee replacement procedures. The Company expects to launch the system for patients in the United States over the coming weeks. This revision system offers anatomic components designed to match a patient’s anatomy for a personalized fit. Available with a modern, intuitive instrumentation platform, the Persona Revision Knee System enables surgeons to take a personalized approach to addressing simple to complex revision procedures by offering the flexibility to utilize their preferred surgical approach. “Persona Revision completes Zimmer Biomet’s flagship Persona knee system and enhances our ecosystem of customer-centric solutions that address the needs of our customers and improve patient outcomes,” said Ivan Tornos, Zimmer Biomet’s Group President of Global Orthopedics. “The highly-anticipated release of Persona Revision provides surgeons with a full portfolio for the continuum of knee arthroplasty care and the ability to truly tailor an implant solution based on each patient’s unique requirements.”

Baxter International Inc. and Spectral Medical Inc., a late stage theranostic company advancing therapeutic options for sepsis and septic shock, announced last week a distribution agreement for TORAYMYXIN™ PMX-20R (PMX), a hemoperfusion filter, and the Endotoxin Activity Assay (EAA), an on-market companion diagnostic tool that aids in the risk assessment of ICU patients for progression to severe sepsis. PMX is an investigational device in the U.S. that removes endotoxin, which contributes to sepsis, from the bloodstream. “Spectral believes that Baxter is the best industry partner to commercialize the PMX product within the U.S. and Canada,” said Dr. Paul Walker, CEO of Spectral. “This agreement provides Spectral access to Baxter’s large installed base of critical care devices in hospitals across the U.S. and Canada, and Spectral believes this partnership significantly accelerates the company’s commercialization efforts for PMX.”

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NuVasive, Inc. announced recently that the Company had received U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded indications for the CoRoent Small Interlock™ system. The expanded indication allows for on-label use of the device at multiple contiguous levels from C2-T1 for anterior cervical discectomy and fusion (ACDF) procedures, compared to other systems on the market cleared for only one- or two-level use. ACDF is a commonly performed surgery to address cervical disc degeneration or spinal instability. “NuVasive’s expanded indications for use of the CoRoent Small Interlock system represents the first interfixated cervical implant on the market to be cleared for use in more than two level procedures,” said Matt Link, President of NuVasive. “This first-of-its-kind clearance reflects NuVasive’s efforts to further penetrate the cervical market and deliver solutions that address a broader range of spine care.”

Medtronic plc announced last week that it will begin enrollment in a pilot study evaluating the safety and efficacy of the Symplicity Spyral renal denervation (RDN) system using a targeted procedural approach with a reduced number of radio frequency (RF) ablations. Set to enroll 50 patients at up to 15 sites in the U.S. and Europe, the single-arm study is designed to focus on ablating the distal main renal artery and primary branches to lower blood pressure utilizing a simplified procedural approach. “In depth anatomical study indicates the renal nerves are closer to the renal artery in the distal renal artery and branches. Focusing the procedure on these targeted locations may help us understand if we can achieve meaningful blood pressure reductions more efficiently,” said Andrew Sharp, M.D., Interventional Cardiologist at the University Hospital of Wales, in Cardiff, United Kingdom, and co-principal investigator of the SPYRAL DYSTAL study. “Early evidence using this modified approach has been encouraging and we intend to build on that data with the DYSTAL study.”

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