PALM BEACH, Florida, December 18, 2018 /PRNewswire/ --
Financialnewsmedia.com News Commentary
With long life expectancy and emerging economies' increasing expenditure on healthcare, there is an increased and growing demand for technologically superior medical devices. According to ResearchAndMarkets.com, the global medical device market is expected to reach an estimated $409.5 Billion by 2023, and it is forecast to grow at a CAGR of 4.5% from 2018 to 2023. Major factors for the growth in the industry are healthcare expenditure, technological development, aging population, and chronic diseases. The medical technology industry (commonly referred to as medical devices) consists of instruments, devices apparatuses, or machines that are used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for some health purpose. Active biotech, medical and pharma companies in the markets this week include Earth Science Tech, Inc. (OTCQB:ETST), Evofem Biosciences, Inc. (NASDAQ: EVFM), Novavax, Inc. (NASDAQ: NVAX), Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN).
Earth Science Tech, Inc. (OTCQB:ETST) BREAKING NEWS: Earth Science Tech, an innovative biotech company focused on the cannabidiol (CBD), nutraceutical and pharmaceutical fields, medical devices, and research and development, today announces the production of the first commercial production run of Hygee™, its new, original medical device to fight sexually transmitted infections (STIs). The official launch is scheduled for early 2019.
After numerous partnerships, tests, distribution agreements and prepping, ETST has officially ordered a first production run of Hygee™. Initial marketing will target North America, South America, Asia and Africa, and the Company will package Hygee™ in English, French, Portuguese, Spanish, Vietnamese and Arabic to reach an wide audience of consumers. These languages are mother tongues for 1.5 billion people, with many other ethnic groups using English as a second language. By offering Hygee™ in different languages, ETST can reach the majority of individuals globally, as well as those in the Company's current agreed distribution network, shared in November.
The Hygee™ self-sampling kit includes a discreet, wearable medical device that enables a woman to anonymously test for STIs such as chlamydia. Testing for this disease is particularly important for pregnant women, who must be screened for chlamydia infections to minimize the risk of transmission of the infection to their babies during childbirth. In any given year, approximately 8 million women give birth in the United States, Canada, Brazil, Mexico, Morocco, Djibouti, and Vietnam where Hygee™ will first be offered.
While this niche represents a considerable market for the Hygee™ medical device, opportunity exists well beyond pregnant women. The World Health Organization recommends that all sexually active women aged 15 to 25 get tested yearly for chlamydia, representing a market of about 500 million women worldwide.
Dr. Michel Aube, ETST's CEO and chief science officer, states, "No other existing method of collecting genital specimens from women is more convenient or more efficient than Hygee™. Through intentional design, Hygee™ is a 'mistake proof' medical device with extremely simple instructions that allow any woman, regardless of age or education the assurance of correctly using the kit on the first try. With roughly 130 million new chlamydia cases diagnosed yearly, according to the WHO, Hygee™ is dedicated to this area of women's health."
ETST's projections for Hygee™ anticipate strong sales growth in years two and three after product launch. As soon as year one, sales of Hygee™ and the associated in vitro molecular diagnoses should reach between $1.5 million and $2.5 million USD. Second year sales should reach $1 million monthly and up to $20 million yearly as early as the third year. Read this and more news for ETST at https://www.financialnewsmedia.com/news-etst
Other recent developments and happenings in the biotech industry include:
Evofem Biosciences, Inc. (NASDAQ: EVFM) this week announced that its Phase 3 clinical trial of Amphora® for the prevention of pregnancy, AMPOWER, successfully met its primary endpoint. AMPOWER assessed the efficacy, safety and subject satisfaction with Amphora in approximately 1,400 healthy women aged 18-35 years at 112 centers in the U.S. The primary endpoint of the study was the pregnancy rate over seven cycles of use (one cycle = 21-35 days) as assessed by the Kaplan-Meier statistical method. Top-line data analysis demonstrates a cumulative pregnancy rate of 14.0% over seven cycles of use (95% CI 10.0, 18.0). This corresponds to an 86.0% efficacy rate (referred to as typical use), which meets the pre-determined endpoint of this clinical trial. In women who correctly used Amphora per study protocol, the cumulative pregnancy rate was 1.3% over seven cycles of use (95% CI 0.4, 2.1). This corresponds to a 98.7% efficacy rate. The results demonstrate that when Amphora is used as directed, the efficacy in which women can have confidence is similar to other frequently used contraceptive methods.
Novavax, Inc. (NASDAQ: NVAX) recently announced the promotion of Jill Hoyt to Senior Vice President of Human Resources and Biegie Lee to Vice President of Information Technology. "I am thrilled to announce these two important management promotions; Jill and Biegie are vital parts of a seasoned executive team striving to accomplish our near and long-term corporate objectives," said Stanley Erck, President and Chief Executive Officer of Novavax, Inc. "Jill has been working with me and the senior leadership team to hire, develop and support employees of this company, which is consistently being recognized as one of the best in the biopharmaceutical industry. Biegie has been leading Novavax' efforts to preserve, protect and support our robust IT infrastructure, an important function given our needs around the ongoing management of enourmous amounts of data with complex information system tools."
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) this week announced positive topline results from the Phase IIIb FOCUS study that evaluated the efficacy and safety of fremanezumab for the preventive treatment of migraine in adult patients who previously experienced inadequate responses to two to four classes of preventive treatments. In the study of 838 patients, including those who suffer from either chronic or episodic migraine, patients treated with fremanezumab experienced highly significant reduction in the monthly average number of migraine days versus placebo (-0.6 days) over the 12 week assessment period, for both monthly (-4.1 days, p<0.0001) and quarterly (-3.7 days, p<0.0001) dosing regimens. In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both quarterly and monthly dosing regimens. There were no safety signals detected in the study.
Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body's ability to bring oxygen to the areas where it's needed most, announced this week that it has been awarded a patent for the use of its breakthrough drug, trans sodium crocetinate (TSC), in conjunction with Tissue Plasminogen Activator (tPA) for the treatment of stroke. Currently, tPA - a thrombolytic used to break down blood clots in patients suffering from ischemic stroke - is the only FDA-approved therapeutic stroke treatment. Worldwide, stroke is the second leading cause of death and is responsible for an estimated 6.2 million deaths per year. The granting of Diffusion's patent follows the recent news that the Company received FDA approval to enroll patients in an ambulance-based Phase 2 clinical trial testing TSC for the treatment of both ischemic and hemorrhagic stroke.
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