Palm Beach, FL – March 21, 2019 – A recent article in a medical device industry periodical, INN, said that: “2018 has been an important year for the medical device industry as M&A, technology and regulatory catalysts have impacted the market. Following these trends, 2019 is expected to be an even bigger year for the market. US Food and Drug Administration (FDA) fees, cybersecurity and the FDA’s 510(k) submission are catalysts that could move the market next year.” Late last year, FORBES had described the medical device market as: “… A disruptive market of $410 billion until 2023… The INN report said that the faster path the FDA has promoted for approval of medical devises, will be a key reason for the market’s continuing surge. It said: “In November, the FDA announced another update to its Medical Device Safety action plan. The agency said it is “pursuing these changes to help keep pace with the increasing complexity of rapidly evolving technology. By doing this, the organization will “modernize” its 510(k) clearance pathway, which will affect medical devices. The changes are meant to create a safer product for patients while holding companies accountable for any safety discrepancies, all while holding on to the FDA’s “gold standard for safety.” Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), Nevro Corp. (NYSE: NVRO), PAVmed Inc. (NASDAQ: PAVM), Motif Bio plc (NASDAQ: MTFB), Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX).
The agency intends to follow up with these goals in early 2019 by cementing an alternative 510(k) pathway. In the statement, the agency also says it believes this will promote greater transparency and post-market surveillance for medical devices. The FDA says this 510(k) upgrade pathway will also account for new advances in “material science” such as digital health, 3D printing and other technologies.
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 that it has filed for 510(k) premarket clearance with the U.S. Food and Drug Administration (“FDA”) for its first generation Rapid Acoustic Pulse (“RAP”) tattoo removal device. The device is indicated as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal on the arms, legs and torso in Fitzpatrick Skin Type I-III individuals. Clinical trials 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, resulting in accelerated fading in comparison to stand-alone laser treatment. The current standard of care for tattoo removal is to use a Q-switched (pulsed) laser to ablate the tattoo ink particles into pieces small enough for the body’s natural processes to remove them. Unfortunately, this current method is highly inefficient, requiring up to 10 or more office visits to achieve acceptable results. A clinical trial has demonstrated that using our Rapid Acoustic Pulse (“RAP”) device in conjunction with a Q-switched laser has the potential to produce similar results in just 2 to 3 office visits.
Dr. Christopher Capelli, president and CEO of Soliton, said, “The submission of our 510(k) application for premarket clearance of our RAP device represents an important step in the commercialization of our products. We will be operating in a large industry segment that seeks the solutions our technology offers in terms of speed of tattoo removal and the potential for higher operating margins for the professional practices that adopt the RAP technology.”
“Our strategy is a razor/razorblade model with consumable products for single-use applications, generating recurring revenue that should allow Soliton to share in the volume growth that is expected in the coming years,” continued Dr. Capelli. “We believe this business model will serve the Company and our shareholders well as we enter into the tattoo removal segment – estimated to be approximately $4.8 billion annually by 2023 – and eventually into additional aesthetics markets. We are excited about the prospects for expanding the use of our RAP technology to address new markets and other aesthetic issues.” Read this and more news for SOLY at: https://financialnewsmedia.com/news-soly/
Other recent developments in the healthcare, biotech industries:
Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, recently announced that D. Keith Grossman has been appointed President and Chief Executive Officer of Nevro and a member of the Board of Directors (the “Board”), effective today. Mr. Grossman succeeds Rami Elghandour, who has stepped down as President, CEO and a director of the Company. Nevro also appointed two new independent directors, Elizabeth (“Bess”) Weatherman and Kevin O’Boyle, effective immediately, and accepted the resignation of Ali Behbahani as a director. The leadership appointments follow constructive engagement with Broadfin Capital, LLC (“Broadfin”), a significant Nevro stockholder.
“On behalf of the Board and our entire company, I am excited to welcome Keith Grossman to the Nevro team,” said Michael DeMane, Chairman of the Nevro Board. “Keith brings over 30 years of experience in leading innovative medical technology companies through periods of strategic change to deliver growth and enhanced value for stockholders. As we look to the future, I am confident that under Keith’s direction, Nevro will be well positioned to capture a burgeoning market opportunity with its pioneering spinal cord stimulation (SCS) technology to treat chronic pain.”
PAVmed Inc. (NASDAQ: PAVM) a highly differentiated, multiproduct medical device company, recently announced that its NextFlo™ Infusion System (“NextFlo”) achieved a key milestone in its quest to eliminate the need for complex and expensive electronic infusion pumps for most of the estimated 1 million infusions of fluids, medications and other substances delivered each day in hospitals and outpatient settings in the United States.
NextFlo is a completely disposable intravenous (IV) infusion set designed to deliver highly-accurate gravity-driven infusions independent of the height of the IV bag. It maintains constant flow by incorporating a proprietary, passive, pressure-dependent variable flow-resistor consisting entirely of inexpensive, easy-to-manufacture disposable mechanical parts.
Motif Bio plc (NASDAQ: MTFB) recently announced that the U.S. Food & Drug Administration (FDA) has granted the Company’s request for a Type A meeting to discuss the points raised in the Complete Response Letter received from the FDA related to the New Drug Application (NDA) for iclaprim for the treatment of acute bacterial skin and skin structure infections. The meeting is scheduled to take place on May 3, 2019.
Graham Lumsden, Chief Executive Officer of Motif Bio, said: “We are pleased that the FDA has granted our meeting request and that critical personnel from the FDA have been invited to attend the upcoming meeting with our internal and external experts. We look forward to a collaborative meeting and to discussing with the Agency the best way to move iclaprim towards marketing approval.”
Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX) recently reported financial results for the fourth quarter and year-ended December 31, 2018 and provided a corporate update. “2018 was a transformational year for Catalyst with the approval of Firdapse® (amifampridine phosphate) tablets, the first and only evidence-based, FDA approved treatment for patients with Lambert-Eaton myasthenic syndrome or LEMS. With this approval, all adult LEMS patients will now have affordable access to Firdapse,” said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst Pharmaceuticals. “We are pleased with the robust momentum that we have seen since the launch of Firdapse, including patient enrollment forms, the breadth of prescribers, and positive reimbursement trends. In 2019, we will remain laser-focused on the commercial launch of Firdapse, as well as on our efforts in the clinic to evaluate Firdapse as a potential therapy to treat other rare neuromuscular diseases.”
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