FinancialBuzz.com News Commentary

NEW YORK, March 18, 2020 /PRNewswire/ -- The number of cities and governments around the world ordering people to distance themselves over the coronavirus (COVID-19) pandemic is rising; as of Tuesday, health officials have encouraged everyone to limit interactions in order to avoid overwhelming the healthcare systems. In the United States, known cases of the coronavirus surpassed 5,000 as testing, which was limited for some time, has expanded. Innovative advanced testing is important for various reasons, one of which is the potential assistance a test can provide during vaccine development. Researchers at the Peter Doherty Institute for Infection and Immunity – a joint venture between the University of Melbourne and the Royal Melbourne hospital – were able to test blood samples at four different time points in an otherwise healthy woman in her 40s, who presented with COVID-19 and had mild-to-moderate symptoms requiring hospital admission. The team was able to dissect the immune response leading to successful recovery from COVID-19, which might be the secret to finding an effective vaccine. Professor Katherine Kedzierska, a laboratory head at the Doherty Institute explained that the results "showed that even though COVID-19 is caused by a new virus, in an otherwise healthy person, a robust immune response across different cell types was associated with clinical recovery, similar to what we see in influenza. This is an incredible step forward in understanding what drives recovery of COVID-19. People can use our methods to understand the immune responses in larger COVID-19 cohorts, and also understand what's lacking in those who have fatal outcomes." CHF Solutions, Inc. (NASDAQ: CHFS), Co-Diagnostics, Inc.  (NASDAQ: CODX), Opko Health, Inc. (NASDAQ: OPK), Novavax, Inc. (NASDAQ: NVAX), OpGen, Inc. (NASDAQ: OPGN)

In the meantime, a coordinated effort to combat the pandemic between the International Chamber of Commerce (ICC) and the World Health Organization (WHO) is underway, the two working closely to ensure the latest and most reliable information and tailored guidance reaches the global business community. According to a report by WHO, all businesses have a key role to play in minimizing the likelihood of transmission and impact on society. For instance, on Monday, the financial markets were in freefall after the Federal Reserve's Sunday announcement that it is slashing interest rates by a full percentage point and admission that it would buy USD 700 Billion in Treasury securities. Currently, the benchmark federal fund rate is at a range of 0 to 0.25 percent, down from a range of 1 to 1.25 percent. The cut essentially brings the nation's interest rate to zero. As such, this is an aggressive step to protect the U.S. economy from the COVID-19 pandemic. Additionally, the Trump administration announced that it is working on continually expanding testing and is preparing to ask Congress to infuse about USD 850 Billion in additional stimulus to help the economy deal with a system paralysis. The administration also announced that it favors making direct payments to citizens to help the public deal with the increasing social distancing. Thanks to these measures, the stock markets modestly recovered on Tuesday.

CHF Solutions, Inc. (NASDAQ: CHFS) just announced breaking news this morning that, "the key takeaways from its clinician webinar held yesterday, which stressed the importance of managing fluids administered to critically ill, COVID-19 patients to avoid potentially life-threatening complications.

Because COVID-19 patients are hemodynamically unstable, they need fluid replacement, which puts them at risk for developing volume overload, acute respiratory distress syndrome (ARDS), and other complications related to progressive congestion

The medical panel unanimously agreed that fluid stewardship is very important in patients with COVID-19 who become critically ill, and that ultrafiltration is an option for efficient fluid removal and rapid decongestion, and a way to optimize the volume status of these patients in a predictable way.

The physicians described the many benefits that portable ultrafiltration devices, like CHF Systems' Aquadex SmartFlow™, have over conventional renal replacement therapies, such as ease of use, and the speed with which therapy can be initiated in the ICU.  They also cited the low extracorporeal volume (35 mL) for patients with hemodynamic instability, and the low blood flow rate, which is not achievable with conventional dialysis machines.

The webinar panel was moderated by Dr. Amir Kazory, M.D., FASN (University of Florida, Gainesville), with Dr. Maria DeVita, M.D., FACP, FASN (Lenox Hill Hospital, NY, NY) and Dr. Mehdi Oloomi, M.D. (Mount Sinai Medical Center) serving as panelists.

The learning objectives for the webinar were:

-  Discuss the World Health Organization (WHO) protocol, published March 13, 2020, and the importance of identifying volume overload in COVID-19-infected patients because the risk of volume overload is very high1

-  Understand the risks associated with volume overload, importance of maintaining fluid balance, and benefits of using ultrafiltration in patients with volume overload

-  Discuss training and personnel required to quickly implement access to ultrafiltration

-  Listen to real-world critical care patient case studies

"We are pleased that the three physician panelists, who are experienced users of ultrafiltration technology in the critical care setting, were able to present a valuable solution for the treatment of critically ill COVID-19 patients," said John Erb, CEO of CHF Solutions. "The Aquadex SmartFlow system is designed to address the needs of critical care patients suffering from hypervolemia (volume overload) and we want to ensure that all patients are able to access this therapy."

An audio replay of the webcast, slides and a transcript are available at http://ir.chf-solutions.com/events.

About CHF Solutions - CHF Solutions, Inc. (Nasdaq: CHFS) is a medical device company dedicated to improving the lives of patients suffering from fluid overload with its novel ultrafiltration therapy system. The company is focused on developing, manufacturing and commercializing the Aquadex SmartFlow system for ultrafiltration therapy. CHF Solutions is headquartered in Minneapolis, Minn., with wholly-owned subsidiaries in Australia and Ireland. The company has been listed on the Nasdaq Capital Market since February 2012.

About the Aquadex SmartFlow System - The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies."

Co-Diagnostics, Inc. (NASDAQ: CODX) and PreCheck Health Services, Inc. a provider of medical screening devices which provide data to assist physicians in preventing and treating chronic diseases, through its Latin American Division, announced last week that PreCheck had entered into an exclusive agreement with Co-Diagnostics, Inc. to distribute Co-Diagnostic's Logix Smart™ Coronavirus COVID-19 Test in Ecuador, which has a population of 16 million. PreCheck has ordered an initial 30,000 COVID-19 tests and will be registering the product in Ecuador.

Opko Health, Inc. (NASDAQ: OPK) announced last week that it is now accepting specimens for testing of coronavirus disease 2019 (COVID-19) from healthcare providers, clinics and health systems throughout the United States. In addition, BioReference had announced a partnership with the New York State Department of Health to provide testing for the first public drive-through testing facility on the East Coast. The facility will be located in New Rochelle, NY, the epicenter for the New York State outbreak. BioReference, in partnership with the state of New York, also expects to begin offering up to 5,000 tests a day at additional satellite testing sites to be set up next week. "Cases of COVID-19 are increasing across the US, making access to testing a critical component in helping healthcare providers identify infected patients more quickly. BioReference has been working expeditiously to develop and offer this test that will yield high-quality and accurate results," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "I believe that the private sector should be part of the solution in controlling the COVID-19 outbreak and am proud that BioReference can assist Governor Cuomo as he leads New York State through this crisis."

Novavax, Inc. (NASDAQ: NVAX) announced last week the Coalition for Epidemic Preparedness (CEPI) awarded an initial funding of USD 4 Million to support Novavax' efforts to develop a COVID-19 vaccine. CEPI and Novavax are having ongoing discussions on additional funding from CEPI to address Novavax' costs through Phase 1. "This first stage of funding from CEPI is critical to enable ongoing development of our COVID-19 vaccine candidates," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We commend CEPI for its role as a vital partner to bridge the funding gap for innovative biotech companies like Novavax, which have robust vaccine technology platforms. Novavax is working tirelessly to create a vaccine against this growing epidemic." Novavax has produced and is currently assessing multiple recombinant nanoparticle vaccine candidates in animal models prior to advancing to clinical trials. Initiation of Phase1 clinical testing is expected in late spring of 2020.

OpGen, Inc. (NASDAQ: OPGN) reported yesterday an update on the business of Curetis GmbH ("Curetis"), the other party to the planned business combination with OpGen. Today, Curetis announced that it started offering a CE-IVD certified real-time PCR test kit for SARS-CoV2 (also known as 2019-nCov), the causal pathogen of Corona Virus Disease 2019 (Covid-19). The test kit was developed and is manufactured by Curetis' strategic partner BGI (Shenzhen, China) and was cleared by Chinese authorities in January 2020. In compliance with European regulations for in-vitro-diagnostics (IVD) tests, the test kit was CE-IVD certified on February 28, 2020.  The test kit is compatible with standard methods for extracting the virus' nucleic acid from the sample such as the QIAamp Viral RNA Mini Kit (QIAGEN) and can be performed on standard real-time PCR instruments such as the Applied Biosystems 7500 Real-Time PCR System (ThermoFisher Scientific) that are available in many molecular diagnostic laboratories in Europe. The test kit includes all necessary reagents and controls to test up to 48 patients in just a few hours.

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