DORAL, Florida, Nov. 15, 2018 (GLOBE NEWSWIRE)
Earth Science Tech LTD (OTCQB: ETST) (“ETST” or the “Company”), an innovative biotech company focused on the cannabidiol (CBD), nutraceutical and pharmaceutical fields, medical devices, and research and development, today announces a new partnership with Dermagate of Québec, Canada, to manufacture Hygee™, ETST’s new medical device designed to test women for sexually transmitted infections (STIs). Dermagate (http://www.dermagate.com/) and Pharmagate Group already hold an ISO 13485:2013 certification and has all the necessary knowledge, experience and manufacturing equipment to begin the industrial production of Hygee™.
Based on this partnership, ETST has begun the process of qualifying for Medical Device Single Audit Program (MDSAP) accreditation (https://www.fda.gov/medicaldevices/internationalprograms/mdsappilot/). MDSAP is a new certification that will shortly replace the ISO 13485 in five industrialized countries: Australia, Brazil, Canada, Japan and the United States. In addition, the European community and many other countries are looking to adopt this new accreditation in order to facilitate the commercialization of medical devices. Unlike the old ISO standard, companies will only have to earn the MDSAP once for all participating countries, instead of once for each individual company. This is excellent news for Hygee™ and ETST because those five big markets are part of the company’s target market, and sexually transmitted infections are a worldwide problem.
Combined with ETST’s recent agreement with Groupe Opmedic (https://www.otcmarkets.com/stock/ETST/news/Earth-Science-Tech-Inc-ETST-Partners-with-Groupe-Opmedic-for-Lab-Results-of-Hygee-Medical-Device?id=207061 ) for in vitro analyses and the development of new applications for Hygee™, ETST will shortly be able to start wide prevalence studies for chlamydia. This is the widest-spread of the bacterial sexually transmitted infections. Chlamydia affects two women for each man, and the goal of the product is to reduce its overall spread and to help young women around the world avoid the dangerous complications related to this silent infection.
This new strategic partnership will also give ETST access to other medical devices that can be distributed alongside Hygee™ and Nanoderm™. The portfolio of medical devices that ETST owns or distributes will increase greatly in 2019.
“I am very happy to see the progress we have made with Hygee™,” stated Nickolas S. Tabraue, chairman of ETST. “With the expected certification of our marvelous Hygee™ device in Canada Q1 2019 and in many countries in the middle of 2019, and the two new nutraceutical products that will be launched in 2019. Next year is shaping up very well and we intend to deliver everything we have projected.”
Following the agreement with Earth Science Tech LTD, Mr. Gaétan Houle President & CEO of PharmaGate Group Inc. and « DERMAGATE™ » was enthusiastic to announce that HYGEE™ will be manufactured in their facilities in La Prairie, Quebec Canada among several other products related to women’s Health. Mr. Houle was happy to talk about additional products in their « Pipeline » including a product aimed at reducing the side effects of the treatments of breast cancer patient thus increasing their quality of life.
Mr. Houle, is extremely optimistic about Hygee™. “The volume of first-year sales for Hygee™ will probably be far more than anticipated,” he said. “I was excited by Hygee™ from my first meeting with Dr. Aubé about few years ago, and I was sure that his medical device had tremendous potential. When we recently applied for the new MDSAP certification for all our products, we included Hygee ™ to accelerate its speed-to-market. This is why the certification audit for Hygee™ manufacturing will take place as soon as January 2019.”
“We are not afraid of success,” Houle concluded. “We are able to scale the production to any level needed to meet the worldwide market needs.”
“The team at Dermagate is fantastic,” said Dr. Michel Aubé, ETST CEO and chief science officer. “Their president has the same vision as we do, including a great concern for the health women everywhere. (https://www.otcmarkets.com/stock/ETST/news/Earth-Science-Tech-Inc-Targets-Breast-Cancer-and-Other-Womens-Health-Issues-in-New-Cannabis-CBD-Based-Pharmaceutical-Dru?id=155635) We are more engaged than ever in this important work.”
Both Tabraue and Aubé are excited that Health Canada will, as of January 1, 2019, no longer accept the old standard and will require the new MDSAP certification from manufacturers. The consensus of opinion is that this will spread to other countries and that many smaller manufacturers will close up shop, unable to meet the new standard. That would mean many existing products would need new manufacturers and distributors, which would constitute another major opportunity for ETST to expand its product catalogue.
Background on the Medical Device Single Audit Program (MDSAP) from the U.S. FDA:
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements. The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. The program’s main mission is to “…jointly leverage regulatory resources to manage an efficient, effective, and sustainable single audit program focused on the oversight of medical device manufacturers.”
DERMAGATE™ is a company specialized in the Manufacturing of Dermatology & Wound care products. One of their main product line is an antimicrobial bandages made under the form of garments & gloves for topical use in dermatology for common skin problems such as eczema & other skin infections. Many of DERMAGATE™ products are made out of technical textiles applied to health care including wound dressings, antimicrobial bandages, scar gel sheets, Ostomy and Hernia belts, Post Surgical compression garments & Gloves.
DERMAGATE™ is setting up for fast growth, they recently announced the acquisition of « Albuca Inc. » ( http://www.albuca.com ). Albuca’s laboratory specializes in the manufacturing of strong, non-invasive dental materials. Its main product, Endocal 10, marks a crucial breakthrough in endodontics.
To learn more, please visit: www.dermagate.com