Palm Beach, FL – March 27, 2019 – The U.S. markets are bullish on the future of the medical device markets. In addition to projections that postulate that: “In 2024, the total medical technology revenue globally is expected be nearly $600 billion U.S. dollars.” and that the: “… U.S. remains the largest medical device market in the world, with a market size of around $156 billion as well as representing about 40 percent of the global medical device market…” (https://www.selectusa.gov/medical-technology-industry-united-states) The markets, Moody’s in particular, are expecting this trend to continue. Recently an online journal focusing on the medical device industry seemed to echo this optimistic view of the industry publishing an article titled: “Moody’s: Outlook strong for medical devices in 2019. The article said: “The medical device industry should see a stand-out year in 2019, according to a Moody’s report on the industry, Medtech Dive reports. The financial services company predicts a positive outlook for medtech, with forecasted earnings before interest, tax, depreciation and amortization of between 4.5% and 5.5% for companies on an organic basis, according to the report. The positive outlook for medtech stands out from the rest of the healthcare field, with pharmaceuticals and U.S. for-profit hospitals only receiving a stable outlook, Medtech Dive reports. Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), Bio-Path Holdings, Inc. (NASDAQ: BPTH), Aldeyra Therapeutics, Inc. (NASDAQ: ALDX), Endo International plc (NASDAQ: ENDP), AbbVie Inc. (NYSE: ABBV).
Revenue growth for device companies will be driven through innovation for most companies and categories, with sales in emerging markets expected to grow more than 10%, according to the report. “The future isn’t entirely without challenges for medtech, however, with Moody’s noting rising trade tensions and the possible return of the medical device excise tax in 2020 as noted hurdles for the industry.”
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 its 510(k) application for premarket clearance filed with the U.S. Food and Drug Administration (“FDA”) for its first generation Rapid Acoustic Pulse (“RAP”) tattoo removal device has cleared the agency’s acceptance review. The application now moves to a substantive review. The device is indicated as an accessory to the 1064 nm Q-Switched (pulsed) 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. 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, that independent studies have shown require 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. Christopher Capelli, president and CEO of Soliton, said, “We are very pleased with the progress of our premarket notification through the FDA review process.” Dr. Capelli continued, “Having found that our submission contained all the necessary elements and information, we look forward to the substantive review and FDA clearance of the RAP device.”
“We are excited about the prospects for our RAP technology as we enter the tattoo removal segment—estimated to be approximately $4.8 billion annually by 2023. And, we expect our higher energy version of this new technology will eventually take us into additional, and potentially bigger aesthetics markets. Because our technology relies upon replaceable cartridges for each treatment, we believe our business model will benefit from recurring revenue, allowing Soliton to share in the volume growth in the aesthetic category expected in the coming years,” said Dr. Capelli. Read this and more news for SOLY at: https://financialnewsmedia.com/news-soly/
Other recent developments in the healthcare, biotech industries:
Bio-Path Holdings, Inc. (NASDAQ: BPTH) a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, recently announced its financial results for the full year ended December 31, 2018 and provided an update on recent corporate developments. “Throughout 2018, we made great progress in pursuit of our mission of bringing innovative new RNAi nanoparticle therapeutics to cancer patients with high unmet medical need,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. “This progress was highlighted by the recent updated interim analysis of our Phase 2 trial of prexigebersen in acute myeloid leukemia (AML). Of the 17 evaluable patients, 65% had a response, including 29% who achieved a complete response, one of which achieved a morphologic leukemia free state. With these interim results in hand, we are even more confident as we move this program forward in combination with venetoclax and decitabine.”
Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) recently announced positive results from the Phase 3 ALLEVIATE Trial of 0.25% and 0.5% reproxalap topical ophthalmic solution in patients with allergic conjunctivitis. The clinical trial met the primary endpoint and the key secondary endpoint for both concentrations of reproxalap.
“We are thrilled to announce positive results from ALLEVIATE, our first completed Phase 3 clinical trial,” commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Consistent with positive results from five prior Phase 2 clinical trials in ocular inflammation, today’s announcement confirms the potential of reproxalap as a novel and clinically meaningful approach for the treatment of allergic conjunctivitis. Given that approximately half of allergic conjunctivitis patients also suffer from ocular dryness, we believe the ALLEVIATE results highlight the relevance of reproxalap to our current Phase 3 program in dry eye disease.”
Endo International plc (NASDAQ: ENDP) recently announced the publication of Phase 2 data evaluating collagenase clostridium histolyticum (or “CCH”) for the treatment of cellulite in Dermatologic Surgery, the official journal of the American Society for Dermatologic Surgery. CCH is the first and only investigational injectable treatment designed specifically to reduce the appearance of cellulite by disrupting the collagen structure of fibrous septae, which cause dimpling of the skin.
Consistent with the recently released Phase 3 studies, the Phase 2 data recently published in the journal online, demonstrate that CCH delivered a clinically meaningful and statistically significant improvement as compared to placebo for all primary and secondary endpoints.
AbbVie Inc. (NYSE: ABBV) recently announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved SKYRIZI™ (risankizumab), an interleukin-23 (IL-23) inhibitor, for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies. This approval marks the first country approval in the world for SKYRIZI.
“With this first global approval of SKYRIZI, we are excited to bring a new treatment option to people living with psoriatic disease in Japan,” said Michael Severino, M.D., vice chairman and president, AbbVie. “SKYRIZI has the potential to improve the signs and symptoms of these chronic, immune-mediated diseases. We look forward to continuing to work with regulatory authorities to make this treatment available to more patients worldwide.”
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