Biotech Brief: U.S. Medical Device Market Reaches $156 Billion Mark

PALM BEACH, Florida, April 9, 2019 /PRNewswire/ -- Medical technology is an area where the U.S. companies are at the forefront. In fact, according to recent industry publication 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 last year alone. 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. 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 including neuro-stimulators, stent technologies, biomarkers, robotic assistance, and implantable electronic devices. Since innovation fuels the medical device sector's ongoing quest for better ways to treat and diagnose medical conditions, when coupled with patient life expectancy increasing and aging populations globally, the medical device sector should continue growing at a positive rate in the future." Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), T2 Biosystems, Inc. (NASDAQ: TTOO), Sangamo Therapeutics, Inc. (NASDAQ: SGMO), Pfizer, Inc. (NYSE: PFE), Melinta Therapeutics, Inc. (NASDAQ: MLNT).

FORBES calls the medical device market a: "A disruptive market of $410 billion until 2023… Software plays a big part in this shift as a differentiator in medical devices as well as the manufacturing  of portable devices used by the end user."

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 it has completed the first evaluation timepoint for its proof of concept clinical trial for the treatment of cellulite. Results for a single acoustic shockwave treatment are being assessed by a blinded group of clinicians.

The study, conducted by Dr. Michael Kaminer at SkinCare Physicians in Boston, MA, in collaboration with Dr. Elizabeth Tanzi of Capital Laser and Skin Care, concluded evaluation of safety and efficacy for all patients through the initial 12-week time point.  The study is designed to evaluate results at both the 12-week and 26-week timepoints from initial treatment in order to assess both near-term and long-term effects.

"We are pleased with how quickly this trial has progressed," commented Dr. Chris Capelli, Soliton's President and CEO. "We look forward to disclosing the independent assessment of the data from this trial in the near future.  We believe the opportunity in the treatment of cellulite could be very significant for Soliton."

Dr. Michael Kaminer of SkinCare Physicians added: "Having led the clinical development of Cellfina, the only treatment with FDA clearance for producing long-term reduction of cellulite, I am particularly aware of the unmet need in the treatment of cellulite.  Having a non-invasive alternative treatment could provide a real benefit for patients while also expanding the breadth of services offered by clinicians."    Read this and more news for SOLY at:  https://www.financialnewsmedia.com/news-soly/   

Other recent developments in the healthcare, biotech industries:

T2 Biosystems, Inc. (NASDAQ: TTOO) a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, recently announced that on March 15, 2019 it issued inducement awards to seven new employees and on April 3, 2019 it issued inducement awards to four new employees.   

These awards were made under T2 Biosystems' Inducement Award Plan (the "Inducement Plan"), which was adopted by the company's Board of Directors on March 1, 2018 and amended and restated on February 21, 2019 and provides for the granting of equity awards to new employees of T2 Biosystems.

Sangamo Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine company, and Pfizer, Inc. (NYSE: PFE) recently announced interim data from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy for severe hemophilia A. Data indicate that SB-525 was generally well-tolerated and demonstrated a dose-dependent increase in Factor VIII (FVIII) levels across the four dosage cohorts. Eight patients total were dosed. Based on these results, the Safety Monitoring Committee (SMC) recommended cohort expansion at the 3e13 vg/kg dose. Further details will be disclosed during Sangamo's conference call and webcast scheduled for 8:00 a.m. ET today, which can be accessed on the Sangamo website.

"The interim data from the first eight patients with hemophilia A treated with SB-525 gene therapy in the Alta study are encouraging and demonstrate a dose-dependent relationship, evidence of sustained factor levels, and low variability, both within each patient and within each cohort," said Edward Conner, MD, Chief Medical Officer of Sangamo. "These interim results suggest that SB-525 may be well-tolerated and may prove to have the predictability and sustained treatment effect that can bring clinical benefit in patients with hemophilia A. We need to continue observing how the data mature and how additional patients in the expansion cohort respond to SB-525. We look forward to working with Pfizer to potentially advance SB-525 into a registrational study."

The Phase 1/2 interim data include eight patients treated across four ascending dosage cohorts (9e11 vg/kg, 2e12 vg/kg, 1e13 vg/kg and 3e13 vg/kg, with two patients per cohort). Patients demonstrated a dose-dependent increase in FVIII levels, achieving clinically relevant increases in FVIII activity in the higher dosage cohorts and normal FVIII levels in the 3e13 vg/kg dose cohort (normal range: 50-150%). At week 6 post infusion, the two fourth dose cohort patients reached 140% and 94% of normal (as measured by one-stage clotting assay) and 93% and 65% (as measured by chromogenic assay). A dose-dependent reduction in the use of Factor VIII replacement therapy was also observed, with patients in the highest dose cohort not requiring factor replacement therapy after initial use of prophylactic factor and experiencing no bleeding events to date. SB-525 was generally well-tolerated, with one patient (treated with the 3e13 vg/kg dose) reporting a treatment-related serious adverse event of hypotension and fever, which occurred following vector infusion and resolved with treatment within 24 hours of completion of vector infusion. 

Melinta Therapeutics, Inc. (NASDAQ: MLNT) a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, recently announced that researchers are scheduled to present multiple scientific data presentations with data from its antibiotic portfolio at this year's 29^th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), April 13-16 in Amsterdam, Netherlands.

"The body of data presented at ECCMID represents an important step in the global fight against antimicrobial resistance and delivering anti-infective solutions to patients," said Sue Cammarata, M.D., chief medical officer of Melinta. "We are pleased that these data will be shared within the infectious disease community to further elucidate the value and utility of these anti-infective agents."

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