COVID-19 Pandemic Still Fueling Need For Increased Supplies & New Technology In PPE Markets

Palm Beach, FL – March 23, 2021 – Personal protective equipment (PPE) is critical to protect healthcare workers (HCWs) from highly infectious diseases such as COVID-19. PPE may include aprons, gowns, or coveralls, masks or respirators, and goggles. However, hospitals have been at risk of running out of the safe and effective PPE including personal protective clothing needed to treat patients with COVID-19, due to unprecedented global demand. In addition, there are only limited manufacturing facilities of such clothing available worldwide, due to a lack of available knowledge about relevant technologies, ineffective supply chains, and stringent regulatory requirements. Therefore, there remains a clear unmet need for coordinating the actions and efforts from scientists, engineers, manufacturers, suppliers, and regulatory bodies to develop and produce safe and effective protective clothing using the technologies that are locally available around the world. In pandemics of highly infectious diseases such as COVID-19, the risk of healthcare workers (HCWs) being infected is much greater than the general population, as they are in direct contact with patients. Personal protective equipment (PPE) is considered to be a critical component that can be used to protect HCWs from droplets from coughs, sneezes, and aerosol-generating procedures in addition to other contaminated body fluids and surfaces from infected patients.  Active biotech companies in the market this week include Dyadic International, Inc. (NASDAQ: DYAI), Maitri Health Technologies Corp. (OTCPK: MHTCF) (CSE: MTEC), Oramed Pharmaceuticals Inc. (NASDAQ: ORMP), Dynavax Technologies Corporation (NASDAQ: DVAX), INOVIO, (NASDAQ: INO).


An article in ACS Publications said that: “The supplies of safe and effective protective clothing needed to treat COVID-19 patients have been severely depleted due to the unprecedented global demand. In addition, in some cases, the standard of PPE has not been of the required quality for medical uses, thus adding to delay and waste. A recent survey by Nursing Times showed that ∼73% of National Health Services (NHS) nurses were without long-sleeved disposable gowns, eye protection, and FFP3 respirators. In addition, ∼63% did not have fluid-repellent face masks due to the current crisis…  Furthermore, PPE needs to be “donned” and “doffed” correctly, and it may be uncomfortable to wear. Although there have been many advisory publications from various organizations and regulatory bodies such as the World Health Organization (WHO), the NHS in the U.K., and the Centre for Disease Control and Prevention (CDC) in the USA about the specification and use of PPE, there remains the unmet need for safer and more effective PPE for HCWs around the world and a clear understanding and knowledge about the regulatory standards for such equipment.”


Maitri Health Technologies Corp. (OTCPK: MHTCF) (CSE: MTEC) BREAKING NEWS:  Former Johnson & Johnson Executive Joins Advisory Board at Maitri Health TechnologiesMaitri Health Technologies Corp. (“Maitri”), a global platform for healthcare supply security, today announced the appointment of Bridget Ross to its Advisory Board.  Ms. Ross is currently CEO of ChroniSense Medical, Ltd., a U.S. HealthTech company and maker of wearable, medical-grade disease management devices. Over three decades, she held several executive roles at the world’s largest broadly based healthcare company, Johnson & Johnson (NYSE: JNJ), leading a number of medical divisions.


“Bridget brings an unmatched level of experience and success to Maitri’s extended team,” said Andrew Morton, CEO of Maitri. “Maitri is uniquely positioned to modernize healthcare systems for governments, healthcare systems and businesses to function well beyond the pandemic. Bridget’s counsel and insights on product development will be invaluable as we continue to evolve and execute our integrated PPE and technology strategy.”


Ms. Ross was previously President of the Global Medical Group at Henry Schein, where she led the growth strategy for a US$2.4 billion global business. At J&J, she was appointed Vice President, Commercial Operations of its Medical Device Sector, after previous roles as Global President at two J&J subsidiaries, leading product innovation and sales.


A graduate of the University of Alberta, Ms. Ross also previously served as a Health Sector Advisory Council Member at Duke University in North Carolina.  She joins a Maitri Advisory Board that includes a former Canadian Minister of Health, a former chief digital office of Bayer Inc., one of the world’s foremost specialists in infectious diseases and an internationally recognized expert in healthcare supply systems.  Continued…. Read this full release and more news for Maitri Health Technologies at:    


Other recent developments in the healthcare industry with regards to Covid include:


Dyadic International, Inc. (NASDAQ: DYAI), a global biotechnology company focused on further improving, applying and deploying its proprietary C1-cell protein production platform to accelerate development, lower production costs and improve the performance of biologic vaccines and therapeutics at flexible commercial scales, recently announced that the Company is expanding its partnership with South Korea’s Medytox, Inc. (“Medytox”), a global biopharmaceutical company with sales in approximately 60 countries. Dyadic and Medytox will co-develop C1 manufactured COVID-19 vaccines and/or boosters, which will, if successful, be used to immunize people against two or more of the current and future COVID-19 variants. This project can provide dedicated local supply, to help combat COVID-19, in this region of the world.


Dr. Gi-Hyeok Yang, Sr, Executive Vice President and Head of Research and Development at Medytox stated, “We are very excited to extend our collaboration with Dyadic and their C1 technology platform to partner in the co-development of C1 manufactured COVID-19 vaccines. Dr. Yang continued “We have been working closely with Dyadic since July 2020, when we obtained access to their C1 expression platform and experienced the remarkable versatility and high productivity of the C1 platform. Based on our experience and comparing the C1 technology platform against several other expression platforms such as CHO and insect cells, we believe that the fungi-derived C1 expression system is the most realistic technology to develop and manufacture multi-valent (i.e., tri-valent, and tetra-valent) vaccines, rapidly and affordably, against COVID-19 mutant viruses without the need for a large-scale bioreactor facility.


Oramed Pharmaceuticals Inc. (NASDAQ: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, recently announced that it has entered into definitive agreements to form a joint venture focused on the development of novel oral COVID-19 vaccines. The new company, Oravax Medical Inc., is based on Oramed’s proprietary POD™ oral delivery technology and Premas Biotech Pvt. Ltd.’s novel vaccine technology.


Oravax’s COVID-19 vaccine candidate benefits from being a virus like particle (VLP) triple antigen vaccine that targets three structural proteins, which should make it a better candidate for protection across emerging mutations of the coronavirus. The oral delivery of the vaccine should allow for widescale inoculation and easier distribution of the vaccine without requiring an injection.


Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, recently announced that the European Commission (EC) has granted Marketing Authorization for HEPLISAV B (Hepatitis B Vaccine (Recombinant), Adjuvanted) for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The approval was issued following the Euroean Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion on the company’s Marketing Authorization Application. The approval and CHMP recommendation were based on the positive benefit-risk for HEPLISAV B as demonstrated by the safety and immunogenicity results of three Phase 3 clinical trials.


INOVIO, (NASDAQ: INO) recently announced it met primary and secondary endpoints among all evaluable subjects for the REVEAL 1 trial. This trial is one of two ongoing pivotal, randomized, double-blind, multi-center, placebo-controlled, Phase 3 trials (REVEAL 1 and REVEAL 2) evaluating the safety, tolerability and efficacy of VGX-3100 to treat HPV-16/18-associated cervical high-grade squamous intraepithelial lesions (HSIL) using the company’s proprietary CELLECTRA® 5PSP device.


The trial protocol-defined modified intention to treat (mITT) population (N=193) includes all subjects with endpoint data. For the primary endpoint of histopathological regression of HSIL combined with virologic clearance of HPV-16 and/or HPV-18 at week 36, the percentage of responders was 23.7% (31/131) in the treatment group, versus 11.3% (7/62) in the placebo group (p=0.022; 12.4% difference in percentage, 95%CI: 0.4,22.5), thus achieving statistical significance. All secondary efficacy endpoints were achieved. These endpoints were: a) regression of cervical HSIL to normal tissue combined with HPV-16/18 viral clearance, b) regression of cervical HSIL alone, c) regression of cervical HSIL to normal tissue, and d) HPV-16/18 viral clearance alone.


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