Palm Beach, FL – October 8, 2019 – 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. While the global market is projected to continue its rapid growth, it is the U.S. that has the largest share of the global market at approximately 40% of the worldwide revenues. An article in MEDTECHDIVE said that Fitch Solutions forecasted that: “… the U.S. medical device market will achieve a compound annual growth rate of 4.9% over the coming years, leading to its value to top $200 billion in 2023… Fitch’s forecast that the medical device market will outpace the broader economy is based on certain demographic trends and regulatory changes — including faster review times and the suspension of the 2.3% medical device excise tax — that the group predicts will fuel growth.” Most investors are concerned about the short and maybe long term effect of tariffs and creates uncertainty but Fitch’s: “… analysts think the sector is better placed to weather the choppy conditions than the broader economy.” Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), Akcea Therapeutics, Inc. (NASDAQ: AKCA), Livongo Health, Inc. (NASDAQ: LVGO), Pfenex Inc. (NYSE: PFNX), Gilead Sciences, Inc. (NASDAQ: GILD).
Medtech continued: “Population growth, aging of the baby boomers and the rising prevalence of chronic diseases will provide tailwinds for the medical device industry through to 2023, according to Fitch. The analysts also expect FDA’s proposed Software as a Medical Device framework to benefit companies by cutting the time it takes to update and improve products.” In light of those trends, Fitch expects the U.S. medical device industry to grow in size from about $164 billion in 2018 to $208 billion in 2023. The analysts predict all segments of the device industry will contribute to the increase. Fitch expects medical device manufacturers to achieve those growth figures both by reaching more patients and increasing per capita sales. By 2023, the medical device industry is expected to make about $615 per person in the U.S., up from $502 in 2018.
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 the Company’s preliminary proof of concept study results using its Rapid Acoustic Pulse (RAP) Device for the treatment of fibrotic (keloid and hypertrophic) scars has been selected for presentation via abstract at the American Society for Dermatologic Surgery (“ASDS”) Annual Meeting on October 24, 2019. The ASDS Annual Meeting is taking place on October 24-27, 2019 in Chicago, IL.
“We are pleased to be presenting the results from our initial follow-up visit to attendees at this important dermatology conference,” stated Christopher Capelli, MD, founder, President and CEO of Soliton. “We look forward to being able to share these results with our shareholders and all interested parties as quickly as possible after the conference. We view this proof-of-concept trial as the starting point for demonstrating that our technology could impact other fibrotic disorders. The same mechanism of action at work to reduce keloid and hypertrophic scars could likely extend to such indications as capsular contraction, Peyrone’s Disease, and even liver fibrosis.”
Fibrotic scars, such as keloid and hypertrophic scars, represent wound healing gone awry. Existing published research suggests that factors relating to the wound-healing environment (including tension at the boundary of the scar) can cause fibroblasts to become stuck in a hyper-productive loop, unable to stop the production of collagen that leads to the thickened, raised and dense structures often associated with these fibrotic scars.
The American Osteopathic College of Dermatology estimates that keloids affect around 10 percent of people, whereas hypertrophic scars are more common. Keloid scars are more prevalent among populations with darker pigmentation. Hypertrophic scars affect men and women from any racial group equally, although people between the ages of 10 and 30 years old are more likely to be affected. Read this and more news for SOLY at: https://www.financialnewsmedia.com/news-soly/
Recent developments in the healthcare, biotech industries:
Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc. and Pfizer Inc, recently announced that the companies have entered into a worldwide exclusive licensing agreement for AKCEA-ANGPTL3-LRx, an investigational antisense therapy being developed to treat patients with certain cardiovascular and metabolic diseases.
AKCEA-ANGPTL3-LRx is designed to reduce the production of angiopoietin-like 3 (ANGPTL3) protein in the liver, a key regulator of triglycerides, cholesterol, glucose and energy metabolism. AKCEA-ANGPTL3-LRx is currently being evaluated in a Phase 2 study in patients with Type 2 diabetes, hypertriglyceridemia and non-alcoholic fatty liver disease (NAFLD).
“AKCEA-ANGPTL3-LRx has the potential to treat people suffering from certain cardiovascular and metabolic diseases. Given the unmet medical need for this patient population and the broad market potential, we believe Pfizer’s expertise and breadth of experience in cardiovascular and metabolic diseases makes it well suited to accelerate clinical development of AKCEA-ANGPTL3-LRx, and to deliver it to patients in need of additional therapies for these life threatening diseases,” said Damien McDevitt, Ph.D., interim chief executive officer at Akcea.
Livongo Health, Inc. (NASDAQ: LVGO) a leading Applied Health Signals company empowering people with chronic conditions to live better and healthier lives, recently announced it was awarded a contract to provide the Livongo for Diabetes solution to eligible members covered by the Federal Employees Health Benefits Program (FEHBP) who are living with Type 1 or Type 2 diabetes under one health plan covering 5.3 million federal employees, retirees, and their families out of the nearly 8 million people who receive their benefits through the FEHBP.
Livongo signed a two-year agreement which will launch the Livongo for Diabetes program starting on January 1, 2020 and expects a nine to twelve-month deployment period to those eligible members living with diabetes. Livongo expects that this agreement will add approximately 25,000 Livongo for Diabetes Members in 2020, growing to approximately 45,000 Members in 2021. This is larger than the expectation of 20,000 to 30,000 total Members previously disclosed by Livongo. Based on this updated expected enrollment, we anticipate this agreement will account for $20-25 million in revenue in 2020 and $30-35 million in revenue for 2021, or a total of $50-60 million including both years.
Pfenex Inc. (NYSE: PFNX) recently announced that the U.S. Food and Drug Administration (FDA) has approved the new drug application (“NDA”) for PF708 submitted under the 505(b)(2) regulatory pathway, with Forteo® (teriparatide injection) as the reference drug. Like Forteo, the FDA-approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk for fracture.
“The FDA’s approval of PF708 marks a major milestone in Pfenex’s history as our first approved commercial product and further validates our Pfēnex Expression Technology platform. We look forward to continuing to work with our commercialization partner Alvogen to launch PF708 in the U.S. We believe PF708 has the potential to significantly enhance patient access to an important therapy as a cost-effective alternative to Forteo, which had $1.6 billion in global sales in 2018,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex.
Gilead Sciences, Inc. (NASDAQ: GILD) recently announced that the U.S. Food and Drug Administration (FDA) approved a pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF). Descovy for PrEP
is indicated to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are HIV-negative and at-risk for sexually acquired HIV, excluding individuals at-risk from receptive vaginal sex.
“Descovy for PrEP provides a new HIV prevention option that matches Truvada’s high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “This is a reflection of Gilead’s continued commitment to addressing the evolving needs of people living with or at risk for HIV and to driving innovation across the HIV care continuum.”
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