Even in the global pandemic situation, South Korea’s successful response and protocol to COVID-19 is highly regarded, and interest in Korean disinfection and protection products is increasing significantly.

In this regard, CAREMILLE INT, a Korea-based company, is a leading firm with more than 20 years experience in the medical device industry, announced that it launched a new protective suit, ‘Pro Guard’ and a surgical gown, ‘Pro Guard S1 & S2’ in May of 2020.

Pro Guard is approved as Type 4 by the Korea Occupational Safety & Health Agency meeting all criteria level of virus and nuclear fallout protection. It consists of a full body suit with a hood and non-slip shoe covers. This product can be used for both industrial and medical purposes.

Pro Guard protective suit is made of 100% polypropylene with advanced hard coat offering advantages of lighter weight and increased durability and strength. The most important factor being which 100% of the Pro Guard products are made in Korea.

Moreover, the Pro Guard S1 & S2 are personal protective garments intended to be worn by health care personnel during surgical or high-risk pandemic situations to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter. In accordance to the AAMI classification, the S1 & S2 are registered as Level 3 moderate to high risk gown with the purpose to be used in conditions such as arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases.

In the midst of this pandemic, CAREMILLE INT takes seriously its commitment to help medical professionals manage the impact of the COVID-19 outbreak worldwide. CAREMILLE INT also intends to fulfill its commitment by providing its PPE at a below market rate specifically for those seeking to purchase PPE for donation purposes.

In addition to the PPE, CAREMILLE INT is also an authorized distributor for many COVID-19 related products such as, but not limited to, COVID-19 RT-PCR and rapid kits to Universal Transport Mediums (UTM).

Kilkenny based life sciences company MyBio has has signed an exclusive distribution agreement in Ireland with German manufacturer MöLab GmbH for its highly accurate COVID-19 antibody diagnostic test kit.

The potentially game-changing test kit provides nearly perfect diagnostic specificity (99.5% IgG, and 99.2% IgM) – a measurement of how likely the test will tell you whether the antibodies are in your system. This makes it the most accurate antibody test of its kind available in Ireland.

MyBio believe the test can play a crucial role as the lockdown eases and more people return to work. “We anticipate strong demand for this kit from corporations, businesses, professional laboratories, and other life science companies and institutes across the country”, said Dan Dilks, the company’s head of sales and business development. “If offered by their employer, this test kit will provide an important and simple pre-screening service for employees in Ireland, which will prove an invaluable tool in the fight against COVID-19 in the coming months as people return to work and desire to know if they have been exposed”.

Currently available for professional use, the test kit provides a quick, on-the-spot result in 10 minutes. It’s easy to use, needing only a finger-prick sample much like a blood glucose test. The test can also be run with serum or plasma samples.

Unlike the test to determine if somebody is currently carrying the virus, antibody testing determines if a person has had the infection in the past. This is done by detecting the presence of antibodies produced by the immune system against COVID-19.

A recent study in Heinsberg, Germany has suggested that the coronavirus infection rate could be much higher than initially thought. The research showed that close to a quarter of those tested were asymptomatic – showing no signs of having caught the virus. MyBio’s test kit will help diagnose such cases, on-site and quickly.

Commenting on the announcement, Linda Nolan, chief executive said: “We’re delighted to partner with MöLab in providing an antibody test kit with the highest specificity and sensitivity to the market here”.

“Companies and Institutions are looking for ways to reopen while taking every step to reduce the risk of coronavirus exposure. Ensuring employees feel safe returning to work is crucial in this process and this kit, which is affordable and easy to use, is another weapon in the fight against COVID-19.”

As a result of the new partnership, MyBio Ltd will provide marketing, sales, customer service and technical support for the sale of MöLab`s Covid-19 antibody diagnostic kit. The kit is currently being sold in the UK and across the EU.

Vapotherm, Inc., a global medical technology company focused on the development and commercialization of its proprietary Hi-VNI® Technology products that are used to treat patients suffering from respiratory distress, announced a major expansion in its capital equipment manufacturing capabilities. This expansion is expected to enable the company to increase production of its Precision Flow® systems by up to 20X above pre-COVID-19 pandemic levels.

At maximum capacity, Vapotherm’s manufacturing increase would create up to an additional 350 manufacturing jobs at its New Hampshire facility. This scaling up is in response to a potential increase in demand for the company’s Precision Flow Hi-VNI® system in the event of additional waves of COVID-19. The Precision Flow Hi-VNI system is an advanced high-flow nasal cannula (HFNC) system using high velocity to treat the respiratory distress experienced by COVID-19 patients.

“The COVID-19 pandemic has greatly accelerated a process we were already seeing of respiratory experts recognizing the benefits of our Precision Flow Hi-VNI system for treating patients with all types of respiratory distress,” commented Joe Army, CEO of Vapotherm. “As hospitals and governments across the United States and around the world prepare for potential future waves of COVID-19 patients and subsequent pandemics involving respiratory disease, we are expanding our manufacturing capabilities to be in a position to meet the needs of hospitals and patients for our therapy. The expansion also provides us with optionality and flexibility when thinking about our ability to bring new products to market faster.”

Since the outbreak of the COVID-19 pandemic, a growing number of public health authorities and medical specialty societies in the United States and around the world have expressed support for the use of HFNC as a first line therapy for treating the respiratory distress experienced by hospitalized COVID-19 patients over early intubation and mechanical ventilation. For example, the Center for Disease Control (CDC), the National Institutes of Health (NIH), the Society of Critical Care Medicine (SCCM), and the American College of Emergency Physicians (ACEP) recommended HFNC over early invasive mechanical ventilation when possible. Additionally, SCCM further suggests HFNC is preferable to non-invasive positive pressure ventilation (NiPPV) in the management of COVID-19 respiratory distress.

The Company is also seeing expressions of interest from domestic and foreign governments, including a $9.9 million blanket purchase agreement (BPA) from the Department of Defense (DoD) that was awarded on May 22, 2020 to support the acquisition of Precision Flow units by the country’s 51 DoD hospitals. Vapotherm is the only HFNC company eligible under this BPA. DoD hospitals have the option to seek funding, and if approved, place orders against the BPA’s $9.9 million cap to acquire Precision Flow devices for up to one year from the date of issuance.

Michael McQueen, M.D., Vice President of Medical Affairs at Vapotherm, commented, “The U.S. medical community did a phenomenal job of quickly recognizing the limitations and possible issues of early intubation and mechanical ventilation in the management of COVID-19 patients. Along with working tirelessly on the front lines, they were continually communicating, sharing information, and adapting real time to changing management paradigms. One of the most visible examples of that has been the complete U-turn from the initial management recommendations of avoiding HFNC and proceeding with early intubation, to the current standards suggesting the opposite – avoid intubation and mechanical ventilation if possible, and utilize HFNC aggressively early in the course of treatment.”

Vapotherm invented HFNC and now sells an advanced form of HFNC that provides high flow at a high velocity, rapidly flushing the dead space in the limited time between breaths when respiratory rates are elevated. The Precision Flow Hi-VNI system also offers a number of additional benefits relative to other conventional HFNC systems, including:

COVID-19 respiratory distress is characterized in particular by patients needing more oxygen. Vapotherm’s Precision Flow Hi-VNI system provides more precise control over the amount of oxygen being delivered to patients than conventional HFNC systems, as the Vapotherm Precision Flow Hi-VNI allows flow rates and oxygen concentrations to be titrated independent of each other. This is vital in treatment of the respiratory distress experienced by COVID-19 patients as published data on critical care patients has suggested that the delivery of either too much or too little oxygen can lead to increased mortality rates.

Vapotherm’s Precision Flow Hi-VNI system, which is clinically proven to treat both Type 1 (hypoxic) and Type II (hypercapnic) respiratory distress, is the only HFNC product listed under the United States Food and Drug Administration’s QAV product code, which was included by the FDA at the outset of the COVID-19 pandemic on a list of devices used to provide ventilation and ventilatory support to patients with respiratory failure or respiratory insufficiency during the COVID-19 public health emergency.

Vapotherm’s proprietary Precision Flow Hi-VNI system provides optimal humidification of the delivered oxygen. This humidification is important to maintain the integrity and mucous-clearance capacity of the patient’s airways.

The Vapotherm Precision Flow Hi-VNI system allows for rapid disinfection between patients – less than five minutes, while other conventional HFNC systems may take up to an hour.

Vapotherm’s Precision Flow Hi-VNI system uses a disposable patient circuit to deliver the humidified oxygen to the patient, with a new circuit being used for each patient, an important characteristic when treating respiratory distress from an infectious cause.

Vapotherm, Inc. is a publicly traded developer and manufacturer of advanced respiratory technology based in Exeter, New Hampshire, USA. The company develops innovative, comfortable, non-invasive technologies for respiratory support of patients with chronic or acute breathing disorders. Over 2.2 million patients have been treated with Vapotherm Hi-VNI Technology.

Allegheny General Hospital (AGH), part of Allegheny Health Network (AHN), is among 20 academic health centers nationwide participating in a new study examining the best ways to reduce the risk of COVID-19 infection among front line health care workers in hospital emergency departments.

Supported by a $3.7 million grant from the Centers for Disease Control and Prevention (CDC), the COVID-19 Evaluation of Risk in Emergency Departments (COVERED) Project is a

12-week study involving 1,600 emergency department personnel in 20 academic health care institutions across the country. It includes physicians, nurses, and staff such as clerks, social workers or case managers.

The goal of the study is to determine what practices and personal protective equipment (PPE) most effectively prevent exposure to COVID-19 in an emergency setting, where incoming patients may or may not have the virus, and emergency procedures can increase the risk of spreading the virus through the air. PPE includes face masks, face shields, gowns, and gloves, among other equipment.

The study will enroll both emergency physicians who do and do not typically perform endotracheal intubation (inserting a breathing tube) in suspected COVID-19 patients, as well as emergency department nurses and non-clinical staff.

The study team chose to track endotracheal intubation procedures because these are aerosol-generating procedures that have been shown in past SARS and MERS epidemics to increase the risk of virus transmission to health care workers.

Emergency department staff enrolled in the study will be followed for three months and undergo screenings and biweekly blood tests and nasal swabs to evaluate for COVID-19 exposure. Questionnaires also will be completed weekly so that procedural practices are documented.

At AHN, the study is led by principal investigator Jestin Carlson, MD, an emergency physician at the Network’s Saint Vincent Hospital and co-investigator Arvind Venkat, MD, an emergency physician at AGH.

“We are thrilled to be participating in this study aimed at finding the most effective ways to prevent transmission of COVID-19 in the emergency environment,” Dr. Carlson said. “We believe its benefits will extend beyond this current COVID-19 pandemic, but also serve to protect health care workers and the public in any future pandemics or epidemics.”

National co-principal investigators are Nicholas Mohr, MD, associate professor of emergency medicine and vice chair for research in the Department of Emergency Medicine at the University of Iowa Carver College of Medicine, and David Talan, MD, professor of emergency medicine and infectious diseases at the David Geffen School of Medicine at UCLA.

The COVERED project is a collaboration between EMERGEncy ID NET, a network of 12 US emergency departments funded by the CDC to study emerging infectious diseases and led by Dr. Talan, and the National Emergency Airway Registry (NEAR).

For more information about the COVERED study and a list of participating institutions, visit http://www.covered-study.org.

About the Allegheny Health Network:
Allegheny Health Network (AHN.org), a Highmark Health company, is an integrated healthcare delivery system serving the greater Western Pennsylvania region. The Network is composed of 12 hospitals, ambulatory surgery centers, Health + Wellness Pavilions, multiple employed physician organizations, home and community-based health services, a research institute, and a group purchasing organization. The Network provides patients with access to a complete spectrum of advanced medical services, including nationally recognized programs for primary and emergency care, trauma care, cardiovascular disease, organ transplantation, cancer care, orthopedic surgery, neurology and neurosurgery, women’s health, diabetes, autoimmune disease and more. AHN employs approximately 21,000 people, has more than 2,500 physicians on its medical staff and serves as a clinical campus for Drexel University College of Medicine, Temple University School of Medicine, and the Lake Erie College of Osteopathic Medicine.