Biotech Brief: Why 2019 is Projected To Be Strong For Medical Device Market

Palm Beach, FL –June 4, 2019 – The aging of the worldwide population yearly creates a larger market for the medical device industry. It fuels the expansion of the global and U.S. medical device markets. The World Health Organization, according to an article in Todays Medical Developments, an industry source, said that: “… the geriatric population will reach 1.5 billion by 2050; 16% of the total world population – and as chronic and lifestyle disease increases, demand for medical devices, advanced technology grows.”  SelectUSA (a U.S. Department of Commerce program) has stated that the U.S., the world’s largest medical device market, represents about 40% of the global industry with exports surpassing $41 billion. Todays Medical Developments article added that the global medical technology market is “… is estimated to reach $409.5 billion by 2023 with a compound annual growth rate (CAGR) of 4.5%, according to ResearchandMarkets forecast. If you are looking for more opportunity, Evaluate Medtech’s analysts suggest the global medical device market will grow at 5.6% CAGR to reach $595 billion by 2024. Medical device manufacturing remains a strong market, driven by technological developments, an aging population, and increases in chronic and lifestyle diseases – trends that expand healthcare spending.”    Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), Novartis AG (NYSE: NVS), Amgen Inc. (NASDAQ: AMGN), Medtronic plc (NYSE: MDT), Baxter International Inc. (NYSE: BAX).


The expansion also creates jobs in the market. The article showed that: “Direct and indirect employment accounts for nearly 2 million jobs – medtech directly accounts more than 500,000 – and while 80% of medical device companies in the United States consist of fewer than 50 employees, the medtech industry employs people in all 50 states.”  It concluded that medical technology devices: “… must be produced better, safer, faster, and more economically to have the best chance for market acceptance, so early-stage collaboration requires a design for manufacturability (DFM) approach. Enabling proactive designing of products to optimize manufacturing: machining, fabrication, assembly, test, procurement, shipping, delivery, service, and repair, DFM addresses aspects that will deliver the best cost, quality, reliability, regulatory compliance, safety, time-to-market, and customer satisfaction.”


Soliton, Inc. (NASDAQ: SOLY) BREAKING NEWS:  Soliton, a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center (“MD Anderson”), today announced results of preclinical studies of the use of a new version of its acoustic pulse technology which reveal its RAP device appears to be capable of selective disruption of the fibrotic septa that contribute to the appearance of cellulite.  The new discovery, referred to as “acoustic subcision,” helps explain the recent proof-of-concept trial results showing an improvement in the appearance of cellulite following use of the Company’s RAP device.  Together with the device’s demonstrated ability to stimulate new collagen production in animal models, this represents what the Company believes is a potentially important new way to treat cellulite and improve the appearance of the skin.  The RAP device for the treatment of cellulite is investigational and not available for sale in the United States.


“While the proof-of-concept clinical trial results we have recently announced regarding the improvement in the appearance of cellulite have been very encouraging,” commented Dr. Chris Capelli, President and CEO of Soliton, “Understanding the basic science and biology behind these results is very important.  We believe the discovery we are outlining here helps explain the promising results we saw from this trial, as well as setting the foundation for a platform technology that may have potential in a number of aesthetic indications.”


The term ‘subcision’ normally refers to a surgical procedure used to sever the fibrotic septa using a special hypodermic needle, punctured through the skin, in order to allow the dimpled skin associated with cellulite to return to a flatter, smoother state. This procedure is typically painful enough that anesthesia is required. Futhermore, this surgical procedure can result in extensive bruising, bleeding or post-treatment discomfort and downtime.  Our use of the term ‘acoustic subcision’ describes the apparent ability of our RAP technology to do this without ever breaking the skin.  What’s more, the procedure should require no anesthesia and importantly, as seen in our clinical trial, there should be no bruising, bleeding or post-treatment discomfort or downtime.  See Illustrations and Read this entire release along with more news for SOLY at:   


Other recent developments in the healthcare, biotech industries:


Novartis AG (NYSE: NVS) recently announced new data and clinical trial updates in NSCLC at the ASCO 2019 Annual Meeting. This includes primary efficacy results from the GEOMETRY mono-1 Phase II clinical trial demonstrating that investigational MET inhibitor capmatinib (INC280) shows promise as a potential treatment option for patients with locally advanced or metastatic NSCLC that harbor MET exon-14 skipping mutation. There are currently no approved targeted therapies to treat this particularly aggressive form of NSCLC. Results of the Phase II study will be presented at an oral session today at ASCO, June 3, 2019, at 8:00 a.m. CDT (Abstract #9004).


“New lung cancer treatment options are critical, as this deadly disease affects more than 2 million new patients around the world each year,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. “The GEOMETRY mono-1results are encouraging, and we look forward to discussing these results with health authorities with the hope of bringing this targeted treatment option to people with this aggressive type of lung cancer.”


Amgen Inc. (NASDAQ: AMGN) recently announced the first clinical results from a Phase 1 study evaluating investigational AMG 510, the first KRASG12C inhibitor to reach the clinical stage. In the trial, there were no dose-limiting toxicities at tested dose levels. AMG 510 showed anti-tumor activity when administered as a monotherapy in patients with locally-advanced or metastatic KRASG12Cmutant solid tumors. These data are being presented during an oral session at the 55thAnnual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.


“KRAS has been a target of active exploration in cancer research since it was identified as one of the first oncogenes more than 30 years ago, but it remained undruggable due to a lack of traditional small molecule binding pockets on the protein. AMG 510 seeks to crack the KRAS code by exploiting a previously hidden groove on the protein surface,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “By irreversibly binding to cysteine 12 on the mutated KRAS protein, AMG 510 is designed to lock it into an inactive state. With high selectivity for KRASG12C, we believe investigational AMG 510 has high potential as both a monotherapy and in combination with other targeted and immune therapies.”


Medtronic plc (NYSE: MDT) recently announced U.S. Food and Drug Administration (FDA) clearance and commercial launch for the SelectSite(TM) C304-HIS deflectable catheter system for use in procedures involving His-bundle pacing (HBP).


The SelectSite C304-HIS deflectable catheter system features a deflectable, out-of-plane curve to reach the bundle of His and is designed to enable enhanced range maneuverability, fixation and implant success for a wider range of patient anatomies. Its adjustable form helps accommodate and secure the pacing lead in more challenging anatomies, including patients with a large right atrium.


Baxter International Inc. (NYSE: BAX) a global leader in acute care therapies, recently announced that the peer-reviewed journal Blood Purification published a supplemental issue sponsored by Baxter that features real-world clinical experience with the company’s Oxiris filter, which can be used simultaneously in continuous renal replacement therapy (CRRT) and in the removal of cytokines and endotoxin to aide in the management of acute kidney injury (AKI) patients with sepsis. The studies, which are being highlighted at the 37th Vicenza Course on AKI and CRRT in Italy this week, add to the body of scientific knowledge around the use of extracorporeal (outside the body) blood purification (EBP) to address critical conditions.


The use of EBP to remove cytokines and endotoxin from the blood represents a promising approach to treat patients with conditions where excessive levels of those inflammatory mediators are often seen including sepsis, a serious medical condition that affects up to 40 percent of critically ill patients in the ICU.1-7 While EBP continues to be studied for its potential to help address sepsis and other conditions, clinical research is particularly challenging in this setting. In fact, many clinical trials that explored the effect of EBP have failed to demonstrate consistent results due to the complexity of patient cases, among other factors. To help address these limitations, Baxter intends to support the creation of the OxirisNet registry with several Italian hospitals to track key treatment data for patients who receive a treatment with the Oxiris filter. The new registry will use a web-based platform specifically designed for research purposes and will be fed by clinical data that are prospectively collected.


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