Why the U.S. Remains the Largest Market for Medical Devices

Palm Beach, FL – December 18, 2019 – Back in the end of 2018, a report from Moody’s said that 2019 should be a standout year for the medical device industry. They added that revenue growth for device companies would be driven through innovation for most companies and categories. They were right on both counts! The numbers through 2019 so far are estimated to be $475 billion in the US, increasing to $595 billion by 2024. The medical device industry is expected to grow at an expected rate of 5.6 percent CAGR until 2024. Another report says that this growth is fueled by new technology in powered devices. Medical device and technology development are an area in which U.S. companies are at the forefront. According to a SelectUSA.gov, the U.S. has the largest medical device market in the world… and it represented about 40 percent of the global medical device market in 2017 and beyond.  According to the report: “… one of the components fueling the growth includes electro-medical equipment, which includes a variety of powered devices such as pacemakers, patient-monitoring systems, MRI machines, diagnostic imaging equipment (including informatics equipment) and ultrasonic scanning devices.  Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), Alphatec Holdings, Inc. (NASDAQ: ATEC), Medtronic plc (NYSE: MDT), ImmunoGen, Inc. (NASDAQ: IMGN), Acasti Pharma Inc. (NASDAQ: ACST) (TSX-V: ACST).


The global medical device industry has demonstrated strong and sustainable growth in the recent past. Biotech companies are banking on an aging population, increasing incidence of chronic and lifestyle diseases and increasing adoption of innovative technology.  Many in the sector believe the industry appears to be in robust growth. The medical device industry’s global annual sales are forecast to rise more than 5 percent a year to reach nearly $800 billion by 2030.


Soliton, Inc. (NASDAQ: SOLY) BREAKING NEWSSoliton Announces Successful Completion of Safety Testing at SGS to Support FDA Filing for Second Generation Device – 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 its Rapid Acoustic Pulse (“RAP”) device successfully completed the IEC 60601 safety testing being conducted at SGS, the world’s leading inspection, verification, testing and certification company. The testing was led by a team at Sanmina Corporation, a leading electronics manufacturing services provider.


This safety testing is a requirement of the supplemental 510(k) filing for the Company’s RAP device for tattoo removal, improvement in the appearance of cellulite, keloid (scarring) and additional pipeline indications. The tests are intended to ensure that devices meet standard safety metrics to protect users and patients. The supplemental 510(k) filing will provide an update to Soliton’s current FDA 510(k) clearance, which was received in May 2019 for tattoo removal, with respect to the step changes made to the device to improve usability in the field.


Dr. Chris Capelli, Soliton’s President, CEO and co-founder, commented, “We are pleased, but not surprised by the safety testing results of our RAP device. The safety of our second generation device mirrors that of our first, and these results reinforce this. We look forward to submitting this safety data in early 2020, simultaneous with the Special 510k filing of our second generation RAP device. This step is an important one in our plans to commercialize the device being launched for tattoo removal to a select and limited number of dermatologists in mid-2020.”     Read this and more news for SOLY at:   https://financialnewsmedia.com/news-soly/


Recent developments in the healthcare, biotech industries:


Alphatec Holdings, Inc. (NASDAQ: ATEC) a medical device company dedicated to revolutionizing the approach to spine surgery, recently announced the commercial release of the SafeOp Neural InformatiX System (“SafeOp”), which has been designed to seamlessly integrate critical neural information into ATEC procedural solutions.


The commercial launch of the SafeOp System follows successful alpha evaluations that began earlier this year, and is the last of 12 planned commercial launches for 2019, delivering on ATEC’s commitment to accelerate growth through clinical distinction.


Medtronic plc (NYSE: MDT) the global leader in medical technology, recently announced it has completed the acquisition of Klue, a software company focused on behavior tracking that can provide real-time insights into when a person is consuming food. Klue’s technology is expected to be incorporated into the Medtronic Personalized Closed Loop (PCL) insulin pump system, currently in development. The PCL system is designed to automate insulin delivery in a way that is real-time, personalized and adapts to the user, with a goal of dramatically simplifying diabetes management for the patient. In addition, the Klue technology can be leveraged to enhance the company’s market-leading analytics and insights in their smart1 CGM technology to help people using multiple daily injections (MDI) stay ahead of high and low glucose events.


ImmunoGen, Inc. (NASDAQ: IMGN) recently announced that the U.S. Food and Drug Administration (FDA) has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine. Based on this guidance, the company will initiate SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin® (bevacizumab).


“We have engaged in constructive discussions with FDA and evaluated all avenues to bring mirvetuximab to patients more quickly,” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “Having aligned with the agency that women with FRα-high platinum-resistant ovarian cancer that has progressed after prior treatment with bevacizumab require better therapeutic options, we are pleased to advance mirvetuximab in this patient population with SORAYA, which, if successful, would enable us to submit an application for accelerated approval during the second half of 2021. We anticipate enrolling the first patient in SORAYA next quarter and expect top-line data from the study in mid-2021.”


Acasti Pharma Inc. (NASDAQ: ACST) (TSX-V: ACST) recently announced that the last patient completed their final visit in the Company’s TRILOGY 1 pivotal Phase 3 trial of CaPre last week. Topline results for TRILOGY 1 are expected to be reported as planned in December 2019. The Company also expects the last patient to complete their final visit in TRILOGY 2 in early January 2020, with topline results expected towards the end of January 2020.


Topline results will include a readout of the primary endpoint, which is intended to show CaPre’s overall impact on lowering triglycerides (TGs) after 12 weeks compared to placebo. Safety and tolerability (e.g. overall adverse events (AE) and serious AE rate, any discontinuation due to AEs, and AEs of special interest such as gastrointestinal events) will also be reported.


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