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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. (OTC: ETST), TransEnterix, Inc. (NYSE: TRXC), Cerus Corporation (NASDAQ: CERS), Puma Biotechnology, Inc. (NASDAQ: PBYI), Johnson & Johnson (NYSE: JNJ).

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 a 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:

TransEnterix, Inc. (NYSE: TRXC) was up slighly in early trading on Tuesday at $2.79 trading just over 340,000 shares by 10:00am Est. TransEnterix, a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, recently announced its naming to Deloitte's 2018 Technology Fast 500TM, an annual ranking of the fastest growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors. "We're thrilled to be recognized as one of Deloitte's 2018 Technology Fast 500 companies," said Todd M. Pope, TransEnterix president and CEO. "TransEnterix's mission is to advance minimally invasive surgical capabilities through digital laparoscopy with the SenhanceTM Surgical System.

Cerus Corporation (NASDAQ: CERS) today announced that it has filed for CE Mark registration for the Company's INTERCEPT red blood cell (RBC) system. "The INTERCEPT RBC CE Mark submission is a major milestone in the Company's history and represents the culmination of years of effort to complete the full INTERCEPT portfolio of products to help ensure that patients have access to safe blood transfusions," said William 'Obi' Greenman, the Company's president and chief executive officer. "Red blood cell transfusions are one of the most common hospital procedures globally, and there are more than 25 million red blood cell units transfused in Europe, Middle East and Africa (EMEA) annually. The INTERCEPT red blood cell system is designed to reduce the risk of transfusion transmitted infections and other potential complications such as transfusion-associated graft-versus host disease."

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, this week announced top line results from the Phase III NALA trial of the Company's lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease) in the setting of metastatic disease. The Phase III NALA trial is a randomized controlled trial of neratinib plus capecitabine versus Tykerb® (lapatinib) plus capecitabine in patients with third-line HER2-positive metastatic breast cancer. The trial enrolled 621 patients who were randomized (1:1) to receive either neratinib plus capecitabine or lapatinib plus capecitabine. The trial was conducted globally at sites in North America, Europe, Asia-Pacific and South America. The co-primary endpoints of the trial are centrally confirmed progression free survival (PFS) and overall survival (OS). An alpha level of 1% was allocated to the PFS and 4% allocated to OS.

Johnson & Johnson (NYSE: JNJ) was up over 2% in early trading on today at $131.43 trading over 5.3 Million shares by 10:00am EST.  JNJ this week announced that the Board of Directors has authorized the repurchase of up to $5 billion of the company's common stock.  "Based on our continued strong performance and, more importantly, the confidence we have in our business going forward, the Board of Directors and management team believe that the company's shares are an attractive investment opportunity," said Alex Gorsky, Chairman and Chief Executive Officer.  "Our strong cash flow enables us to simultaneously return value to shareholders through our regular quarterly dividend and share repurchases, while at the same time continuing to deploy capital that will further strengthen our robust enterprise pipeline and drive long-term growth."

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