March 5, 2019 PR-M03-19-NI-011
PALM BEACH, Florida /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), Bio-Path Holdings, Inc. (NASDAQ: BPTH), TG Therapeutics, Inc. (NASDAQ: TGTX), Puma Biotechnology, Inc. (NASDAQ: PBYI), Amarin Corporation plc (NASDAQ: AMRN).
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 M.D. on behalf of the MD Anderson Cancer Center ("MD Anderson"), today announced that it has received notice from the U.S. Food and Drug Administration ("FDA") that the Company has qualified for the "Small Business" designation under the Medical Device User Fee Amendments ("MDUFA"). As a Small Business under the MDUFA, Soliton qualifies for a reduce or waived fee for medical device submissions made during the fiscal year 2019. Join our more than 208K fans here to follow the Company: https://soly-investors.com.
Dr. Christopher Capelli, president and CEO of Soliton, said, "We are pleased to have qualified for Small Business status allowing us to receive reduced or waived fees for our FDA submissions. We appreciate the opportunity to submit device applications for review and approval at more favorable rates. In certain submissions, the savings could be dramatic. This helps us to operate more efficiently. Our plan is to is to submit our Rapid Acoustic Pulse ("RAP") device for tattoo removal for premarket clearance with the FDA under our new status in the near future."
The MDUFA rates cover a number of submissions that are routinely made to the FDA for review and approval. The rate table assigns fees for the fiscal year – which ends on September 30, 2019 – for the application type submitted for review along with the Standard Fee and the Small Business fee for companies that qualify for the designation. Read this and more news for SOLY at: https://www.financialnewsmedia.com/news-soly/
Other recent developments in the healthcare, biotech industries:
Bio-Path Holdings, Inc. (NASDAQ: BPTH) On February 28, the company, a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, announced an upcoming poster presentation at the 2019 American Association for Cancer Research (AACR) Annual Meeting, taking place from March 29 – April 3, 2019 in Atlanta, GA.
Details for the poster presentation are as follows:
Date: Wednesday, April 3, 2019
Presentation Time: 8:00 am – 12:00 pm Eastern Time
Location: Georgia World Congress Center, Exhibit Hall B
Session: Gene- and Vector-Based Therapy, Poster Section 12
TG Therapeutics, Inc. (NASDAQ: TGTX) recently announced approximately $85 million in equity and debt financing. The Company priced a public offering of its common stock for gross proceeds of approximately $25.2 million, before deducting underwriting discounts and commissions and offering expenses payable by the Company. In addition, the Company granted the underwriters a 30-day option to purchase $3.8 million of additional shares of common stock. All of the shares in the offering are being sold by the Company. The Company anticipates using the net proceeds from the offering to fund the ongoing development of ublituximab and umbralisib, for research and development activities and for general corporate purposes. The offering is expected to close on March 5, 2019 subject to customary closing conditions.
Puma Biotechnology, Inc. (NASDAQ: PBYI) recently announced fourth-quarter results and 2019 guidance Thursday that were ahead of expectations, boosting confidence in Nerlynx achieving a global product revenue estimate of $683 million in 2023, according to Cantor Fitzgerald. Cantor Fitzgerald's Alethia Young maintained an Overweight rating on Puma Biotechnology and raised the price target to $57.
The LA-based pharmaceutical company reported strong fourth-quarter results, with U.S. Nerlynx sales of $61 millionhandsomely beating the consensus expectation of $53 million. Puma Biotechnology guided to 2019 U.S. Nerlynx sales of $255-$280 million, exceeding the consensus estimate of $238 million.
Amarin Corporation plc (NASDAQ: AMRN) recently announced that John F. Thero, Amarin's president and chief executive officer, presented a general company update at the 8th Annual SVB Leerink Global Healthcare Conference on Thursday, February 28, 2019, at 9:30 a.m. Eastern Time in New York City.
A live audio webcast of the presentation will be available at: http://www.amarincorp.com, and will be accessible at the same link for 30 days.
Amarin Corporation plc. is a rapidly growing, innovative pharmaceutical company focused on developing therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in polyunsaturated fatty acids and lipid science. Vascepa® (icosapent ethyl) is Amarin's first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates. Amarin's commercial partners are pursuing additional regulatory approvals for Vascepa in Canada, China and the Middle East.
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