Medical Devices Embrace Exciting Technological Breakthroughs

NEW YORK, Feb. 13, 2020 /PRNewswire/ -- The medical device industry is seeing growth across its global markets thanks to new technologies that push the industry to new highs in the developed world. Additionally, thanks to emerging economies, healthcare infrastructure is now being properly established. And perhaps not surprisingly, by 2022, more than 30% of the global healthcare expenditure is expected to arise from emerging economies. In developing countries, medical device companies leverage low manufacturing and labor costs to generate significant profit margins for investors. As a result, the medical device market is projected to grow by USD 134.2 Billion during the period of 2020-2024 and at a CAGR of over 5%, according to Technavio. In the meantime, technology is transforming the medical device market with features such the Internet of Things (IoT), machine learning and advanced 3D printing. For instance, IoT in healthcare is increasingly used to promote active patient engagement and patient-centric service delivery through advanced devices that constantly connected with each other. And despite global growth, the United States is still the largest medical device market, with a value of USD 156 Billion, which accounted for 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, estimates that by 2023, the medical device market is expected to grow to USD 208 Billion. Endonovo Therapeutics, Inc. (OTC: ENDV), Johnson & Johnson (NYSE: JNJ), Integra LifeSciences Holdings Corp. (NASDAQ: IART), Medtronic plc (NYSE: MDT), Colfax Corporation (NYSE: CFX) 

Some of the most promising, high growth opportunity segments in the medical device market by application include surgical and infection control devices, general medical devices, cardiovascular devices, orthopedic devices and home healthcare devices. Among them, new innovations in the orthopedic medical devices segment have helped create new market value. Orthopedic devices are intended to stabilize body posture, treat deformities and restore normal skeletal function either by replacing or reinforcing the damaged part. The global orthopedic devices market has evolved from conventional surgical procedures to the use of modern prosthetic and fixation devices. And, coupled with these innovations modern diagnostic techniques have significantly reduced the need of complex surgical procedures. In addition, the high occurrence of orthopedic conditions, such as degenerative bone disease, coupled with a rising geriatric population, is anticipated to drive the market. Overall, the Global Orthopedic Devices Market is estimated to witness a CAGR of 5.69% during the forecast period 2017–2023, according to Kenneth Research.

Endonovo Therapeutics, Inc. (OTCQB: ENDV) announced today that it is, "collaborating with a Stanford University sponsored Orthopedic Shoulder and Knee Study to determine benefits of Endonovo's tPEMF SofPulse^® on pain, medication levels, and physical function post-operatively.

The Stanford University study official title is 'A Pilot Prospective, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Pulsed Electromagnetic Field (PEMF) Therapy in Decreasing Post-Operative Pain Following Orthopedic Surgery'. The Orthopedic focused study will evaluate 76 patients with Active and Sham Comparator groups, measured by visual analog scale (VAS), at 10 days after, and will allow surgeons to determine the efficacy of Endonovo's SofPulse^® tPEMF portable device postoperatively. Board certified Orthopedic surgeon, Dr. Geoffrey D. Abrams, is the key investigator and will be conducting the study.

Endonovo's SofPulse^® tPEMF portable device is FDA cleared, non-invasive, drug-free, non-opioid treatment for postoperative pain and edema that is presently being adopted for use in major hospitals and clinics nationwide. Endonovo Therapeutics collaboration and participation on multiple efficacy studies, clinical evaluations, and adaption by nationwide hospitals will further show the efficacy and effectiveness on PEMF SofPulse^® treatments and therapy. 

Endonovo CMO, Dr. Nev Zubcevik DO, 'The study will allow surgeons to determine if PEMF SofPulse^® therapy is beneficial in reducing patient-reported post-operative pain. Surgeons will be able to make observations on the amount of pain medication taken daily and the physical function outcome scores after surgery and PEMF treatment.'. Results of the study will be published as detailed on https://clinicaltrials.gov/ct2/show/NCT04109638. Dr. Zubcevik continued 'Past published clinical efficacy studies for tPEMF SofPulse^® have shown 2.2X reduction of post-op use of narcotics at 48 hours, 300% reduction of pain scores which relates to nearly a three times faster reduction in the need for pain medication post-op and 275% reduction in inflammation and swelling at 18 hours postoperatively.'

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. www.endonovo.com."

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Johnson & Johnson (NYSE: JNJ) subsidiary Johnson & Johnson Medical Devices Companies announced last September that DePuy Synthes (DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.) will launch the ATTUNE Cementless Knee in a rotating platform option in select markets around the world. This launch combines the proprietary technologies of the ATTUNE Knee designed to provide stability while the knee is in motion with DePuy Synthes' extensive heritage in rotating platform knees and cementless technology. "The ATTUNE Cementless Knee has the same great kinematic features of the cemented ATTUNE Knee, but I feel the cementless technology is a better alternative for my younger and more active patients who have healthy, strong bone," said Ryan M. Nunley, MD, Associate Professor and Fellowship Director at Washington University Orthopedics, Barnes Jewish Hospital. "These patients have the potential to remain active for many decades, and I think the evidence3 is growing that cementless knees have good long-term durability. I've implanted more than 400 ATTUNE Cementless Knees in my practice with excellent early results."

Integra LifeSciences Holdings Corp. (NASDAQ: IART), a leading global medical technology company, announced last year that it has acquired Rebound Therapeutics, developers of single-use medical devices that enable minimally invasive access, using optics and illumination, for visualization, diagnostic and therapeutic use in neurosurgery. Rebound's minimally invasive surgical (MIS) technology features integrated optics and illumination capable of interfacing with existing operating room monitors.  "The acquisition of Rebound Therapeutics reflects Integra's ongoing commitment to developing innovative products to address unmet needs in neurosurgery," said Dan Reuvers, corporate vice president and president of Integra LifeSciences' Codman Specialty Surgical division. "Rebound's MIS technological platform is a natural addition to our portfolio of neurosurgical products and will expand our therapeutic-focused offerings. We are eager to further develop Rebound's cutting-edge MIS technologies to help surgeons improve the standard of care for neurosurgery patients."

Medtronic plc (NYSE: MDT) announced last month, it has received U.S. Food and Drug Administration (FDA) approval of Micra™ AV, the world's smallest pacemaker with atrioventricular (AV) synchrony. Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired. Medtronic now offers the first and only FDA-approved leadless pacemaker portfolio, expanding the number of potential candidates for this groundbreaking technology in the U.S.  "With the approval of Micra AV, more pacemaker patients qualify for a new treatment option that offers the advantages of leadless pacing – including a minimally invasive implant procedure and a cosmetically invisible device," said Larry Chinitz, M.D., cardiac electrophysiologist and director of NYU Langone's Heart Rhythm Center in New York City. "Although complications with traditional pacemakers are infrequent, when they occur, they're expensive to treat and can be invasive for the patient. Real-world use of Micra has shown a 63% reduction in major complications compared to traditional pacemakers."  Historically, patients with AV block have been treated with traditional dual-chamber pacemakers which are implanted in the upper chest, under the skin below the collar bone, and connected to the heart using thin wires called "leads." Identical in size and shape to the original Micra Transcatheter Pacing System (TPS), Micra AV has several additional internal atrial sensing algorithms which detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium, providing "AV synchronous" pacing therapy to patients with AV block.

Colfax Corporation (NYSE: CFX) subsidiary DJO Global, Inc., leading provider of medical technologies designed to get and keep people moving, introduced last summer, the AltiVate Reverse^® Short Stem, the first fully-convertible, inlay, short stem shoulder arthroplasty system available in the United States. The AltiVate Reverse^® Short Stem was designed by DJO, a market leader in shoulder arthroplasty systems, using principles based on a design with minimum 10-years of clinical follow-up1. The AltiVate Reverse Short Stem received FDA 510(k) clearance in April 2019 for use in anatomic, reverse, and partial shoulder arthroplasty.  "The AltiVate Reverse Short Stem is truly the first-of-its-kind technology: a short, convertible stem based on the philosophy of an inlay humeral stem," said Jeff McCaulley, Global President of DJO Surgical^®. "With the first inlay short stem addition to our market-leading AltiVate Reverse, we are continuing DJO's history of innovation by developing products that are different by design which allows us to continue our long history of leading innovation and creating the future of shoulder arthroplasty." The AltiVate Reverse^® Short Stem is designed for easy conversion from anatomic to reverse without overstuffing the joint, while its 135° neck-shaft angle allows for a more anatomic humeral reconstruction in both anatomic and reverse shoulder arthroplasty. The short stem is also more bone-sparing than a standard-length stem, allowing for implant positioning independent of the humeral canal.

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