Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced that its Logix Smart™ Coronavirus COVID-19 Test has been approved for sale in Mexico by the Mexican Department of Epidemiology (“InDRE”) after InDRE successfully concluded an evaluation of the test’s sensitivity and specificity and its non-reactivity with other respiratory viruses. InDRE, which is analogous to the U.S. Centers for Disease Control and Prevention (CDC), is required to evaluate any test to detect the disease before the test may gain clearance to be sold into the Mexican healthcare market.

Co-Diagnostics also announced that CoSara, the Company’s joint venture for manufacturing in India, expects to now begin filling orders following the successful evaluation of CoSara’s Saragene™ COVID-19 RT-PCR test kit by the Indian Council of Medical Research (ICMR). The evaluation showed 100% sensitivity and 100% specificity without any cross reactivity with other respiratory viruses, and it has been cleared for sale to the Indian market.

CoSara has received a license from the Central Drugs Standards Control Organisation (CDSCO) to manufacture the Saragene COVID-19 test kits. The test approved by the CDSCO was the same as that originally designed by Co-Diagnostics, and will be manufactured in CoSara’s GMP manufacturing facility in Ranoli, India which is capable of large scale production.

Dwight Egan, Co-Diagnostics CEO, remarked “Orders for our Logix Smart COVID-19 test continue to be strong. We believe our continued growth is due to our ability to meet testing needs on a timely basis, with a high quality, cost-efficient, easy to process test. We are pleased that our technology is also being deployed in many areas in the United States, providing high-throughput diagnostic solutions to improve the quality of COVID-19 detection in those communities. The Company has participated in governmental and private initiatives designed to increase test availability.”

The Company’s Logix Smart COVID-19 test is currently available to all clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA), and is authorized to be used for the diagnosis of SARS-CoV-2, the virus that causes COVID-19.

About Co-Diagnostics, Inc.:

Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a new, state-of-the-art diagnostics technology. The Company’s technology is utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.

Liberate Medical announced that it has received FDA Emergency Use Authorization for its VentFree™ Respiratory Muscle Stimulator, intended to be used to reduce disuse atrophy of the abdominal wall muscles, which may reduce the number of days adult patients require mechanical ventilation, including those patients with COVID-19.

Reducing the time patients spend on mechanical ventilation may reduce the risks of prolonged mechanical ventilation, which include hospital acquired infections, deteriorated quality of life and death. Fewer days on ventilation may also increase the availability of ventilators during the COVID-19 pandemic.

Two pilot randomized controlled trials, recently completed in Europe and Australia, indicated that compared with placebo stimulation, the VentFree may reduce ventilation duration and ICU length of stay. Last year VentFree™ received FDA Breakthrough Device Designation and CE marking in the European Union.

“We are grateful to the FDA for recognizing the potential of VentFree and feel privileged to have the opportunity to help patients on mechanical ventilation during the COVID-19 pandemic” said Angus McLachlan PhD, co-founder and CEO of Liberate Medical.

Invasive mechanical ventilation commonly weakens the breathing muscles, increasing the need for further ventilator support. Current methods of respiratory muscle training cannot be used when patients are sedated or delirious, which is common among critically ill patients. The VentFree stimulator uses proprietary non-invasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation. These features enable treatment to begin from the early phase of mechanical ventilation, while patients are sedated or delirious, and continue until the patient is successfully weaned from mechanical ventilation.

Liberate Medical has been working with manufacturers in Minnesota, Ohio and Iowa to speed up production and distribution and expects VentFree™ devices to be immediately available to hospital ICUs nationwide.

About Emergency Use Authorization of VentFree

VentFree has neither been cleared or approved for the indication for use by health care providers to treat adult patients by reducing disuse atrophy of the abdominal wall muscles, which may reduce the number of days of ventilator support in patients who require mechanical ventilation in healthcare settings during the COVID-19 pandemic.

VentFree has been authorized for the above emergency use by FDA under an Emergency Use Authorization. VentFree has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About Liberate Medical

Liberate Medical is a clinical / commercial stage medical device company that develops neuromuscular electrical stimulation technology to improve the quality and reduce the cost of care for patients with pulmonary disorders.

The 13th edition of MEDICAL FAIR ASIA originally scheduled for 9-11 September 2020 will be postponed to the last quarter of the year; 9-11 December 2020. The region’s leading medical and healthcare trade fair focusing on Hospital, Diagnostic, Pharmaceutical, Medical & Rehabilitation Equipment & Supplies is organised by Messe Düsseldorf Asia.

Rescheduling the trade fair was necessary in view of the continuing fight against COVID-19 which includes ongoing travel restrictions, tighter social distancing measures; suspension of all events and mass gatherings and most recently, the extension of the circuit breaker measures in Singapore as announced by Singapore’s Multi-Ministry Taskforce.

Mr Gernot Ringling, Managing Director, Messe Düsseldorf Asia, said: “In close consultation with the MEDICAlliance global network of medical trade fairs – of which the exhibition is a part of – the decision to postpone MEDICAL FAIR ASIA was not one we have taken lightly as our partners, exhibitors and teams have worked extremely hard thus far. However, as we consider the latest developments globally and in Singapore, we feel it is in the best interest of all involved to move the exhibition to the end of the year, as this will allow for maximum participation from regional and international businesses.”

“We are extremely grateful for the support and understanding of our partners and exhibitors as we stay committed to take every possible measure to carry over the successful status of the trade fair to the new dates. We look forward to welcoming the industry in December with the same trusted MEDICAL FAIR ASIA brand they have come to know, with qualified business visitors and a top-quality sourcing, networking and thought-leadership platform.” he added.

The MEDICAL FAIR ASIA team will reach out to all industry partners, confirmed exhibitors and participants regarding event logistics and planning.

About Messe Düsseldorf Asia
Messe Düsseldorf Asia is a subsidiary of Messe Düsseldorf in Germany, one of the world’s leading trade fair organisers, responsible for organising more than 20 global No. 1 exhibitions in various industries including medicine and health, specifically MEDICA, COMPAMED and REHACARE INTERNATIONAL held in Düsseldorf, Germany. With extensive expertise in organising trade fairs in Southeast Asia, Messe Düsseldorf Asia has developed a portfolio of numerous trade fairs in the region since 1995.

Inspiren, a nurse-led technology company, deploys its flagship solution in the fight against COVID-19 to ensure staff are adequately protected at all times. The device, rapidly installed and wall mounted at the bedside, leverages computer vision to automate enhanced contact tracing. In the event of a confirmed source patient, Inspiren provides bed-level insight into all who entered that space, how long the visit lasted, the proximity to the source patient, and if PPE was secure at all times.

“Our mission has always been to protect patients and safeguard staff,” says Michael Wang RN, CEO of Inspiren. “The collective efforts of clinicians and technologists working side by side over the last few years have manifested this mission. It is an honor to be able to provide peace of mind to those who are selflessly putting themselves on the front lines to care for patients.”

In 2019, Inspiren received more than 20 international innovation awards for its hybrid sensing computer vision, IoT, and audio/video monitoring platform from organizations such as TIME, Edison, SXSW, Fast Company, and the American Nurses Association. The device, known as iN, has been utilized in the care environment to eliminate preventable harm such as pressure ulcers, reduce falls by up to 75%, and ensure front line clinical staff are recognized for their hard work through a robust gamification platform.

Since the outbreak, Inspiren’s founding nurses have been on the front lines working at hospitals in New York City and Central New Jersey. Through first-hand experience they have been identifying and documenting the critical front-line and administrative needs surfacing from the outbreak. As a result, Inspiren has reallocated 100% of its development efforts to where they are needed most—the fight against COVID-19. New algorithms have been created to alert staff in real time if PPE (mask, eye shield, gown) is not worn or secured properly. Additionally, to limit staff exposure, Inspiren developed a new remote monitoring solution that allows virtual visitation of patients in isolation rooms through live de-identified video and audio feed. Inspiren also repurposed its patient visit history functionality to enable fully automated contact tracing, which is critical in controlling infection and nearly impossible to achieve with existing infrastructure.

The platform communicates with hospital staff in real time via the device’s interactive LED display and through a suite of mobile and desktop applications.

“In a time of crisis, the risk of selecting disparate, non-integrated, technology solutions for various use cases, is exponentially magnified,” says Dr. Paul Coyne, President of Inspiren. “There is no other single solution that can simultaneously fulfill the multitude of needs of those on the front line during the current height of this pandemic, and beyond.”