FDA Allows Expanded Use of Remote Devices to Monitor Patients' Vital Signs in Global COVID-19 Health Crisis

Financialnewsmedia.com News Commentary

PALM BEACH, Florida, April 7, 2020 /PRNewswire/ -- As the global health crisis quickly spreads in the United States, officials face the daunting task of treating patients in person and monitoring their progress. With quarantines increasing throughout the world, healthcare providers and governments must utilize solutions beyond their walls to monitor the crises and the state of their patients more than ever. Luckily, companies across the globe are already pivoting their technologies to help fight the spread of this deadly virus. Existing modern solutions in diagnostics and monitoring treatments are being repurposed and being used as powerful tools to help fight the current pandemic. These technologies can help identify outbreak hotspots, prevent infections, reduce the need for physical contact in diagnostics.  The FDA recently issued an update allowing certain remote diagnostic tools to be used in the fight. The update said: '"Today, as part of the U.S. Food and Drug Administration's ongoing efforts to address the coronavirus outbreak (COVID-19), the agency issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure.  Active healthcare stocks in news today include:  Biotricity Inc. (OTCQB: BTCY), CytoDyn Inc. (OTCQB: CYDY), Amazon.com, Inc. (NASDAQ: AMZN), The Clorox Company (NYSE: CLX), Sorrento Therapeutics, Inc. (NASDAQ: SRNE).

"Allowing these devices to be used remotely can help health care providers access information about a patient's vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus," said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. "This policy reflects the FDA's commitment to ease burdens on health care providers and facilities as they face this public health emergency. Such devices include technologies capable of enabling remote interactions to provide crucial information to be used as an adjunctive when health care providers diagnose or treat COVID-19 or co-existing conditions. During this public health emergency, it is imperative that the FDA provide regulatory relief and adapt as the situation warrants to act upon measures to save lives."

Biotricity Inc. (OTCQB: BTCY) BREAKING NEWS - Biotricity's Real-Time Monitoring Bioflux Device can Help Identify Life Threatening QT Prolongation in COVID-19 Patients - Biotricity, a medical diagnostic and consumer healthcare technology company, today announced that its Bioflux® units are designed for QT interval analysis, a section of the ECG, to identify serious risks like QT prolongation. QT prolongation is a measure of delayed ventricular repolarization, which can cause sudden cardiac death. QT is becoming an important factor for COVID-19 patients, as some of the drugs being used can cause QT prolongation as a side effect, leading to sudden cardiac death. Bioflux can be used to remotely monitor this.

"One of the key features that Bioflux has is the ability to record QT variability and ranges. This is particularly important since a known side effect of many drugs is QT prolongation which can lead to very serious arrhythmias. Drugs that are currently being studied to treat COVID-19 patients, such as hydroxychloroquine, have been known to cause QT prolongation. Because of this reason, I feel more comfortable knowing that Bioflux has the ability to detect this," said Dr. Afflu.

Drs. Patel and Nasif stated "An important aspect of Biotricity's technology that has made our practice long term customers is the detailed analysis from the data collected from the Bioflux, such as QTc and QT Prolongation. Our practice has been utilizing this aspect of the Bioflux as QT prolongation can be a side effect of many drugs."

Bioflux is an FDA approved advanced remote patient monitoring (RPM) technology that is engineered to assist diagnoses of heart conditions such as cardiovascular disease (CVD) and enhance patient outcomes. RPM technology supports the world's goal of promoting social-distancing and is the safest solution to help monitor patients during a pandemic while maintaining high quality patient care. Offering the combined benefits of highly precise data for accurate and speedy diagnosis, patients are actively monitored from the comfort of their homes, minimizing hospital visits and reducing the risk of potential infection.

Waqaas Al-Siddiq PhD, founder and CEO of Biotricity said: "The COVID-19 pandemic has underscored the desperate need to utilize remote patient monitoring and telehealth solutions to aid infection containment and make intervention and diagnosis faster. Social distancing is still a relatively new concept for our society to grapple with, but it is uniquely suited to a remote healthcare delivery model. Future epidemics will capitalize on telemedicine and remote patient monitoring to support social distancing while maintaining a high quality of patient care."

In other healthcare news of note:

CytoDyn Inc. (OTCQB: CYDY) recently announced that the first two COVID-19 patients have been treated with leronlimab under the Company's Phase 2 randomized clinical trial, which is for patients with mild-to-moderate indications. The Company anticipates that enrollment of more patients will accelerate this week at multiple clinical sites.

In addition, the Company's investigational new drug, leronlimab, has now been administered to 15 severely ill COVID-19 patients at four hospitals, 10 patients treated at a leading medical center in the New York City area and five patients at three other hospitals, all under an emergency investigational new drug (EIND), which were granted by the U.S. Food and Drug Administration (FDA) for each individual patient.

Amazon.com, Inc. (NASDAQ: AMZN) and Conduent Incorporated (CNDT), a business process services and solutions company, recently announced that its disease surveillance and outbreak management platform, Maven®, is now available on Amazon Web Services (AWS). Conduent's Maven solution was  recently refigured to help public health agencies securely engage patients, and track, manage and report on cases and potential exposures of coronavirus (COVID-19).

Given the critical need to stop the spread of COVID-19 in the U.S., where Maven is primarily used, Conduent is waiving the software license fee for the Maven COVID-19 module through June 30, 20201 for qualified state- and territorial-level public health agencies as a means to enable the agencies in the fight against COVID-19.

The Clorox Company (NYSE: CLX) recently announced a wide-ranging series of grants to three organizations on the front lines of fighting coronavirus: Direct Relief, Centers for Disease Control and Prevention Foundation's Emergency Response Fund and the American Red Cross. The donations, totaling $5 million, will directly go toward "care for the caregivers" — people who are working with these public health organizations on the front lines to support public health.

"We are humbled by the work being done by these organizations in the fight against the coronavirus and want to join them in providing aid to caregivers who are performing heroic acts during this time of need,"  said Benno Dorer, chair of The Clorox Company Foundation and chair and CEO of The Clorox Company. "The private sector needs to act, and these donations are part of our longstanding history of providing support to public health organizations. In addition, we're doing everything possible to get our disinfecting products to people and communities as quickly as possible. In this unprecedented time, we must all work together to battle this pandemic."

Sorrento Therapeutics, Inc. (NASDAQ: SRNE) recently announced it has initiated the next phase of its collaboration with Celularity, Inc., a Warren, New Jersey, based clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies derived from the postpartum human placenta. On April 2, 2020, Celularity announced that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for the use of its proprietary CYNK-001 in adults with COVID-19. Celularity also announced that it will immediately commence a Phase I/II clinical study including up to 86 patients with COVID-19.

The collaboration between Sorrento and Celularity reflects the longstanding relationship between the two companies dating to Celularity's inception. Celularity is preparing to launch CYNK-001 manufacturing at its new purpose-built cGMP/cGTP manufacturing facility in Florham Park, New Jersey. Sorrento will make available to Celularity current existing capacity in Sorrento's state-of-the-art cGMP cell therapy manufacturing facilities in San Diego, California. The addition of Sorrento's cGMP cell therapy manufacturing capacity is expected to facilitate the rapid scale-up and sustained production of Celularity's novel CYNK-001 cell therapy for use in its Phase I/II clinical study in COVID-19 infected adults, as well as its existing clinical programs in acute myeloid leukemia (AML), multiple myeloma (MM) and glioblastoma multiforme (GBM).  "We are confident that our strategic relationship with Sorrento will help assure our ability to meet the scale requirements for our efforts in COVID-19," said Celularity CEO Robert Hariri, M.D., Ph.D.

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