Palm Beach, FL –May 14, 2019 – The U.S. is a global leader in technology. The U.S. is also historically where innovation is always at the forefront… so it is no surprise that the U.S. Medical Device market… a marriage of technology and innovation… is making the U.S. the global leader in medical devices. Typically, the purpose of a medical device is not achieved by pharmacological, immunological, or metabolic means… it is a technological solution. The medical device industry relies on several industries where the United States holds a competitive advantage, including microelectronics, telecommunications, instrumentation, biotechnology, and software development. Collaborations have led to recent advances… innovation fuels the medical device sector… (which) should continue growing at a positive rate in the future. Industry publications report that: “Compared to several other industries including automotive, defense, and telecommunications, the medical device industry invests a higher percentage of yearly revenues into product innovation, reflecting the competitive nature of the industry and constant innovation and improvement of existing technologies. Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), Medtronic plc (NYSE: MDT), Axsome Therapeutics, Inc. (NASDAQ: AXSM), Mylan N.V. (NASDAQ: MYL), Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX).
A recent FORBES article says this about the size of the medical device market and the importance of innovators: “A disruptive market of $410 billion until 2023, changes dramatically with the entrance of small and medium size players, many of them rising up from the startup community.” And the demand is also projected to rise according to a report from Grand View Research: “Rising prevalence of chronic diseases and increasing geriatric population in the country are among principal market drivers. According to the U.S. Census Bureau, 49 million or 15.0% of the population in the country belonged to the geriatric category in 2015. The bureau estimates that by 2023, geriatric population will account for 23.0% of the total U.S. population. The onset of chronic diseases is more commonly prevalent between the ages of 45 and 54. Thus, increase in geriatric population is primarily driving demand for medical device solutions globally.”
Soliton, Inc. (NASDAQ: SOLY) BREAKING NEWS: Soliton technology is looking to cash in on the rise of the cellulite removal market, which is set to be worth $1.4 billion dollars by 2026. Yahoo Finance talks to Wally Klemp, the Executive Chairman of Soliton, about the the company’s new acoustic shockwave technology that reduces cellulite.
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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 that the Japanese Patent Office has issued a notice of grant of patent Number 6503302, “Rapid Electrohydraulic Shockwave Generator”.
Clinical trials for tattoo removals have demonstrated that using the Company’s RAP device, in conjunction with a Q-Switched laser, allows for multiple passes of laser treatment in a single treatment session. The current standard of care for tattoo removal is to use a Q-Switched laser to ablate the tattoo ink particles into pieces small enough for the body’s natural processes to remove them. Independent studies have shown this standard treatment requires on average ten or more office visits to achieve acceptable results. In our own clinical trial using the RAP device in conjunction with a Q-Switched laser, patients experienced 75% to 100% removal of their tattoos in just three office visits.
Dr. Chris Capelli, President, CEO and Co-Founder of Soliton, said, “Our corporate patent portfolio continues to expand globally as a component of our overall intellectual property assets. This portfolio is essential to support the Company commercialization strategy which focuses both on domestic U.S. channels as well as aesthetic channels in a variety of international markets.” Dr. Capelli continued, “Additionally, clinical trials are under way to determine if our device may be effective at removing cellulite or accelerating current fat removal technologies.” Read this and more news for SOLY at: https://financialnewsmedia.com/news-soly/
Other recent developments in the healthcare, biotech industries:
Medtronic plc (NYSE: MDT) recently announced findings from a pilot study of its investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver lifesaving defibrillation and anti-tachycardia pacing therapy in one system, with a device the same size as traditional, transvenous ICDs. Results from the pilot study were presented during a late-breaking session at Heart Rhythm 2019, the Heart Rhythm Society`s 40th Annual Scientific Sessions.
The Extravascular ICD pilot study, which represents the first-in-human chronic (long-term) use of the investigational, first-generation system, showed that the new system can be implanted with no major complications, and can sense, pace and defibrillate the heart. The EV ICD system is investigational worldwide and not approved for sale or distribution.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) recently announced the acceleration of the timeline for reporting topline results from the MOMENTUM Phase 3 trial of AXS-07 (MoSEIC™ meloxicam and rizatriptan), Axsome’s novel, oral, investigational medicine with distinct dual mechanisms of action for the acute treatment of migraine. The trial is being conducted pursuant to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). The first patient was enrolled in the MOMENTUM trial in March 2019, and currently approximately 40% of the target number of patients have been randomized. Based on the faster-than-expected enrollment in this trial, topline results are now expected in the second half of 2019, versus previous guidance of the first quarter of 2020.
The MOMENTUM (Maximizing Outcomes in Treating Acute Migraine) Phase 3 trial is a randomized, double-blind, placebo- and active-controlled study of AXS-07 for the acute treatment of migraine, in which patients are randomized to treatment with AXS-07, rizatriptan, meloxicam, or placebo. Rizatriptan, the active comparator in the trial, is considered to be one of the most efficacious oral medications currently available for the acute treatment of migraine.
Mylan N.V. (NASDAQ: MYL) recently announced the U.S. launch of Erlotinib Hydrochloride Tablets, 25 mg, 100 mg and 150 mg, a generic version of Genentech’s Tarceva®. Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
Erlotinib Hydrochloride Tablets is indicated for the treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.
Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX) a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, recently reported financial results for the first quarter ended March 31, 2019 and provided a corporate update.
“The first quarter of this year was very critical for us, as we became a fully-integrated biopharmaceutical company with the commercial launch of Firdapse,” said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst Pharmaceuticals. “We are pleased that the Firdapse launch is off to an excellent start and while it is still early, with much work to be done, it is especially gratifying to see the number of patients that were previously naive to any form of amifampridine that are now being effectively treated with Firdapse. We continue to be motivated by the very positive response that we are receiving from patients and healthcare providers. Lastly, we continue to make progress in clinical development of our robust pipeline of other potential indications for Firdapse.”
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