Healight (TM) Safety Study in Critically Ill COVID-19 Patients

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madman

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December 28, 2020​



First Safety Study Utilizing Ultraviolet A Light Catheter as a Prospective Anti-Infective in Critically Ill, Intubated SARS-Cov-2 Patients

ENGLEWOOD, CO / ACCESSWIRE / December 28, 2020 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company (the "Company") focused on commercializing novel products that address significant patient needs announced the completion of the safety study evaluating the Healight™ ultraviolet A light catheter technology. This single-center, U.S.-based study evaluated the safety and proof of principle of the Healight device in newly intubated critically ill patients on mechanical ventilation diagnosed with COVID-19.

The data collected from this clinical investigational-use-only study will be presented to the U.S. Food & Drug Administration (FDA) as part of the review process for Healight as a COVID-19 treatment. The results of this study will also be submitted for publication.


Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "This is an important milestone, and we look forward to continuing discussions with the FDA on the advancement of the Healight technology."

The Healight technology platform employs proprietary methods of administering intermittent ultraviolet (UV) A light via a novel respiratory tract device. Pre-clinical findings indicate the technology's significant impact on reducing a wide range of viral and bacterial loads, including the coronavirus HCoV-229E, which is associated with the common cold. Recently published pre-clinical data have been the basis of discussions with the FDA for a path to enable human use for the potential treatment of SARS-CoV-2 in intubated patients in the intensive care unit (ICU).
 
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This is a single-center, open-label, pilot study. 5 adult patients, aged over 18, who are confirmed positive with SARS-CoV-2 and are newly intubated, will receive UV light treatment to reduce SARS-CoV-2 viral load.
 
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