DORAL, Florida, Nov. 15, 2018 (GLOBE NEWSWIRE) -- Earth Science Tech, Inc. (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 Hygeeâ„¢ and Nanodermâ„¢. 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 Hygeeâ„¢,†stated Nickolas S. Tabraue, chairman of ETST. “With the expected certification of our marvelous Hygeeâ„¢ 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.â€
Following the agreement with Earth Science Tech, Inc. 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 Hygeeâ„¢. “The volume of first-year sales for Hygeeâ„¢ will probably be far more than anticipated,†he said. “I was excited by Hygeeâ„¢ 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 â„¢ to accelerate its speed-to-market. This is why the certification audit for Hygeeâ„¢ manufacturing will take place as soon as January 2019.â€
“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.â€
“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.â€
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:
https://www.fda.gov/downloads/medicaldevices/internationalprograms/mdsappilot/ucm430563.pdf
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.â€
About DERMAGATEâ„¢
DERMAGATEâ„¢ 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 DERMAGATEâ„¢ 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
About Earth Science Tech, Inc. (ETST)
Earth Science Tech, Inc. (“ETSTâ€) offers the highest purity and quality high-grade full spectrum cannabinoid oil on the market. There are positive results in studies on breast cancer and immune cells through the University of Central Oklahoma, in addition to studies through DV Biologics that prove the Company’s CBD oil formulation lowers cortisol and functions as a neuro-protectant, with positive result case studies through key health organizations. ETST formulates, markets and distributes the CBD oil used for its studies to the public, offering the most effective quality of CBD on the market.
To learn more, please visit: www.EarthScienceTech.com
ETST currently has four wholly owned subsidiaries focused on developing its role as a world leader in the CBD space and expanding its work in the pharmaceutical and medical device sectors::
Earth Science Pharmaceutical, Inc.
Earth Science Pharmaceutical ("ESP") is a wholly
owned subsidiary of Earth Science Tech), committed to the
development of low cost, noninvasive diagnostic tools, medical
devices, testing processes and vaccines for sexually transmitted
infections and/or diseases. ESP's CEO and chief science officer,
Dr. Michel Aubé, is leading the company’s research and development
efforts. The company’s first medical device, MSN-2, is a home kit
designed for the detection of STIs, such as chlamydia, from a
self-obtained gynecological specimen. ESP is working to develop and
bring to market medical devices and vaccines that meet the specific
needs of women. To learn more please visit: www.EarthSciencePharmaceutical.com
Cannabis Therapeutics, Inc.
Cannabis Therapeutics (“CTIâ€) is a wholly owned
subsidiary of Earth Science TechTich i poised to take a leadership
role in the development of new, leading-edge cannabinoid-based
pharmaceutical and nutraceutical products. CTI is invested in
research and development to explore and harness the medicinal power
of cannabidiol. The company holds three provisional application
patents for a CBD product that is focused on developing treatments
for breast and ovarian cancers, as well as two generic CBD based
pharmaceutical drugs. To learn more please visit: www.CannabisThera.com
KannaBidioiD, Inc.
KannaBidioiD (“KBDâ€) is a wholly owned subsidiary
of Earth Science TechB that provides a wide variety of products
geared toward the recreational space of cannabis. KBD’s unique
Kanna and CBD formulation is sold and distributed in CBD-infused
vapes/e-liquids products. Kanna and CBD synergistically enhance one
another, providing optimal relaxation, an uplifting sensation,
enhanced focus and the added benefit of assisting with nicotine
reduction therapy. To learn more please visit: www.KannaBidioiDInc.com
Earth Science Foundation, Inc.
Earth Science Foundation. (“ESFâ€) is a wholly
owned subsidiary of Earth Science Tech. ESF is in the process of
becoming a nonprofit organization to accept grants and donations to
conduct further studies and help donate Earth Science Tech's
effective CBD products to those in need. To learn more please
visit: www.ETSTFoundtion.org