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Biotech Brief: Optimistic Outlook Growing for Multi-billion Dollar Medical Device Industry

PALM BEACH, Florida, April 23, 2019 /PRNewswire/ -- A recent industry article reported on an optimistic overview concerning the Medical Device Industry. It 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." In addition, another publication added more details from the Moody's report saying: "The outlook for the U.S. medical device industry in 2019 is positive, according to a report released Thursday by Moody's Investors Service. The credit ratings agency said industry success will be aided by earnings growth from new products and solid demand in emerging markets, which is expected to see a double-digit percentage increase. The forecast for earnings before interest, tax, depreciation and amortization is for growth of 4.5% to 5.5% for companies on an organic basis, the credit ratings agency said in the report. Moody's sees the U.S. medical device industry as a bright spot in healthcare in the year ahead. Medical device makers will see mid-single-digit revenue growth driven by product innovation across most companies and categories, the agency said. Sales in emerging markets will continue to grow more than 10%." Active Healthcare companies in the markets this week include: Soliton, Inc. (NASDAQ: SOLY), Moleculin Biotech, Inc. (NASDAQ: MBRX), Baxter International Inc. (NYSE: BAX), Mustang Bio, Inc. (NASDAQ: MBIO), Integra LifeSciences Holdings Corporation (NASDAQ: IART).

IbisWorld.com also recently reported: "the outlook for medical device companies appears positive. The medical device industry is poised for steady growth, with global annual sales forecast to rise by over 5 percent a year and reach nearly US$800 Billion by 2030 . These projections reflect increasing demand for innovative new devices (like wearables) and services (like health data), as lifestyle diseases become more prevalent, and economic development unlocks the huge potential in emerging markets – particularly China and India.  Medical device companies will ultimately seek to play a larger role in the value chain and get closer to customers, patients and consumers. Done right, this will not only add new revenue streams for them, but also contribute to shorter, cheaper, and fewer hospital visits – and thus lower healthcare costs.

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 development team has completed final testing of the Company's second generation rapid acoustic pulse ("Gen 2 RAP") device at Sanmina, Inc., the Company's global manufacturing partner.

The Gen 2 RAP device is intended to be used in Company's upcoming pivotal registration clinical trial to submit to the FDA for 510(k) clearance of the device.  This new device is designed to be capable of functioning both as the Gen 1 device does for the acceleration of tattoo removal, and as a stand-alone device for potential reduction of cellulite and other future indications. In this second model, the Gen 2 RAP should be capable of delivering higher-powered acoustic pulses at greater depths, making it a platform device with a wide range of potential future uses. This device has not been cleared by the FDA.

The treatment head of the Gen 2 RAP device is automated to allow continuous feeding of electrode material enabling the electrohydraulic pulse generator to operate for longer treatment times at higher and more consistent peak acoustic pressures. As well, the treatment head can now accommodate varying reflector designs to allow for treatment depths that are optimized for addressing the fibrotic structures that contribute to cellulite.

"Given the excitement surrounding the proof of concept cellulite trial results that are about to be presented to the scientific community," commented Dr. Chris Capelli, President and CEO of Soliton, "we needed to be ready to launch an expanded clinical trial for the cellulite indication. The Gen 2 RAP device is the key to being able to start this expanded trial and seek FDA clearance." Dr. Capelli continued: "The Gen 2 RAP device represents the kind of multi-indication platform potential that we believe may make our RAP system an indispensable tool for clinicians." Read this and more news for SOLY at:https://www.financialnewsmedia.com/news-soly/

Other recent developments in the healthcare, biotech industries:

Moleculin Biotech, Inc. (NASDAQ: MBRX) a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, recently announced it will host a conference call to discuss its significant discovery for lung cancer, FDA Fast Track Designation and recent corporate events. The call will be at 4:30 p.m. ET on Wednesday, April 24, 2019.

Participants can dial (800) 860-2442 or (412) 858-4600 to access the conference call, or can listen via a live webcast, which is available in the Investor Relations section of the Company's website at www.moleculin.com. The Company will field live questions from equity analysts in a Q&A segment of this call. Participants may submit questions in advance for the Company to address in the Q&A segment by sending them to info@moleculin.com. A webcast replay will be available in the Investors section of the Company's website at www.moleculin.com for 90 days. A teleconference replay will be available at (877) 344-7529 or (412) 317-0088, confirmation code 10130980, through May 1, 2019.

Baxter International Inc. (NYSE: BAX) a global leader in advancing surgical innovation, recently announced that it has received U.S. Food and Drug Administration (FDA) approval for faster preparation of its leading hemostatic product, Floseal Hemostatic Matrix, at the 2019 Association of perioperative Registered Nurses (AORN) Global Surgical Conference and Expo. This next generation of Floseal has 20 percent fewer components and steps to prepare, making it easier and faster for operating room (OR) nurses to get Floseal in the hands of surgeons to help stop bleeding during procedures. The new design will be on display at Baxter's AORN booth #1624.

"We are focused on advancing the art of healing in the operating room with our innovative and dependable surgical products that address intraoperative bleeding," said Wil Boren, president of Baxter's Advanced Surgery business. "When creating the next generation of Floseal, we had OR nurses in mind. We listened to their feedback so that we could deliver on our promise of customer-inspired innovation."

Mustang Bio, Inc. (NASDAQ: MBIO) a clinical-stage biopharmaceutical company focused on translating today's medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, recently announced that the New England Journal of Medicine has published data from St. Jude Children's Research Hospital ("St. Jude"), the nation's leading hospital dedicated to understanding, treating and curing childhood cancer and other life-threatening diseases. The data comes from a Phase 1/2 clinical trial of a lentiviral gene therapy for the treatment of newly diagnosed infants under two years old with XSCID, also referred to as SCID-X1 and commonly known as bubble boy disease. Under a licensing agreement with St. Jude, Mustang will develop the lentiviral gene therapy for commercial use as MB-107.

The multi-center Phase 1/2 clinical trial is evaluating the safety and efficacy of a lentiviral vector to transfer a normal copy of the IL2RG gene to bone marrow stem cells in newly diagnosed infants under the age of two with XSCID, preceded by low exposure-targeted busulfan conditioning. A total of 10 infants have received the therapy to date in this clinical trial. The published data covers eight infants with XSCID who were treated at St. Jude and at UCSF Benioff Children's Hospital and followed for a median of 16.4 months.

Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, recently announced that it will release first quarter 2019 financial results on Wednesday, April 24, 2019, prior to market open. In conjunction with the earnings release, Integra will host a conference call at 8:30 a.m. ET.

Peter J. Arduini, president and chief executive officer, and Glenn Coleman, chief financial officer and corporate vice-president of International, will review first quarter 2019 results during the call. The live call is accessible by dialing (855) 719-5012 and using the passcode 1392893. A simultaneous webcast of the call will be available via the Company's website at www.integralife.com. A webcast replay of the call can be accessed through the Investor Relations homepage of Integra's website at www.integralife.com. A replay of the call will be available through April 29, 2019 by dialing (888) 203-1112 and using the passcode 1392893.

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