Avails Medical announces the commencement of U.S. Pivotal Clinical Trials for eQUANT™

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MENLO PARK, Calif., Aug. 15, 2022 /PRNewswire/ -- Avails Medical, a pioneer in rapid, automated and fully electrical antibiotic susceptibility testing (eAST) announced today the commencement of U.S. pivotal clinical trials for its eQUANTsystem, which will be used to support a submission for FDA clearance.

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Monday, August 15, 2022
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FDA, Laboratory, AST, CEO, Technology, Animal Drug Availability Act 1996, East, Microbiology, Department, University Hospitals Cleveland Medical Center, Doctor of Philosophy, Equant, Workflow, Physician, MD, Medical microbiology, Time, McFarland, Blood culture, Adoption, Pharmaceutical industry
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AVAILS MEDICAL, INC.
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  • MENLO PARK, Calif., Aug. 15, 2022 /PRNewswire/ -- Avails Medical, a pioneer in rapid, automated and fully electrical antibiotic susceptibility testing (eAST) announced today the commencement of U.S. pivotal clinical trials for its eQUANTsystem, which will be used to support a submission for FDA clearance.
  • In a recent clinical pilot study Avails demonstrated highly accurate AST results when using the eQUANT McFarland output.
  • "Our modular, cost-efficient eQUANT system features a small footprint and straight-forward user interface, making it well suited for widespread adoption from clinical laboratories to community hospitals.
  • Avails Medical, Inc., a privately held company, was founded to help fight one of today's biggest global health threats - antibiotic resistance.


Avails Medical announces the commencement of U.S. Pivotal Clinical Trials for eQUANT™

MENLO PARK, Calif. , Aug. 15, 2022 /PRNewswire/ -- Avails Medical, a pioneer in rapid, automated and fully electrical antibiotic susceptibility testing (eAST™) announced today the commencement of U.S. pivotal clinical trials for its eQUANT system, which will be used to support a submission for FDA clearance.

Avails' eQUANT system provides a standardized inoculum (0.5 McFarland equivalent) directly from a positive blood culture in as fast as 40 minutes that can be used with traditional automated AST systems and with disk diffusion, accelerating AST turnaround times by as much as one day.

"eQUANT addresses the critical need for faster bloodstream infection diagnostics to enable physicians to optimize antibiotic therapy early, either by broadening it to overcome resistance to empiric agents used or to narrow it to minimize unnecessary use of broad-spectrum agents.  Also facing a general staff shortage across microbiology laboratories, automating and accelerating the preparation of standardized organism suspensions for antimicrobial susceptibility testing of positive blood cultures using the eQUANT system will result in improved workflow and faster turn-around times", said Michael R. Jacobs, MD, PhD, Professor Emeritus, Department of Pathology, Case Western Reserve University and Director Emeritus, Clinical Microbiology, University Hospitals Cleveland Medical Center.

In a recent clinical pilot study Avails demonstrated highly accurate AST results when using the eQUANT McFarland output. With eQUANT, AST results were available at least 22 hours faster compared to conventional methods.

"Our modular, cost-efficient eQUANT system features a small footprint and straight-forward user interface, making it well suited for widespread adoption from clinical laboratories to community hospitals. The technology is designed to fit seamlessly into the existing workflow of laboratories of all sizes and enable timely and accurate AST results", said Dr. Oren Knopfmacher, CEO of Avails Medical.

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About Avails Medical Inc.
Avails Medical, Inc., a privately held company, was founded to help fight one of today's biggest global health threats - antibiotic resistance. The Avails all-electrical technology platform is designed to significantly reduce the amount of time required to obtain the reliable antibiotic susceptibility data, which is necessary to enable accurate therapy decisions. Avails' electronic biosensor technology is designed to improve speed and accuracy in pathogen quantification and susceptibility testing directly from human specimens by eliminating crude, time-consuming and manual specimen culturing steps. www.availsmedical.com

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SOURCE Avails Medical, Inc.

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