Avails Medical Announces FDA Clearance of its eQUANT™ System to Accelerate Workflow for Antibiotic Susceptibility Testing

MENLO PARK, Calif., Feb. 20, 2024 /PRNewswire/ -- Avails Medical, Inc., a leader in the development of rapid, automated and fully electrical antibiotic susceptibility testing (AST) technologies, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking eQUANT^TM system. The eQUANT system is a leap forward in combatting antibiotic resistance, providing a standardized inoculum (0.5 McFarland equivalent) directly from positive blood cultures. The clinical data submitted to FDA demonstrated eQUANT's potential to reduce routine AST turnaround times by up to one day, meeting the high hurdle of over 95% correlation to standard of care methods.

"To address the growing problem of antibiotic resistance, enhancing diagnostic speed in labs is vital and can save lives. In the trial, we found the eQUANT technology cut the time to find effective antibiotics by nearly a day, potentially enabling a quicker shift from broad-spectrum antibiotics to targeted treatments," said Dr. Stefan Riedel, Associate Medical Director at Beth Israel Deaconess Medical Center, and clinical study investigator.

The eQUANT system is differentiated by its compact design, intuitive interface, and cost-effectiveness, qualities that position it well for broad adoption across a range of healthcare environments, including community hospitals.

"Our team has worked diligently to bring the eQUANT system to the market to meet a critical demand in clinical microbiology: accelerating the existing workflow to actionable AST results to improve patient care. Commercializing the eQUANT system is our first step towards achieving our mission of making rapid AST testing both affordable and accessible in all healthcare settings, significantly improving patient care and saving lives," stated Dr. Oren Knopfmacher, CEO and co-founder of Avails Medical.

Avails Medical also announced the appointment of Michael Blitz as Executive Vice President for Commercialization and Business Development. Mr. Blitz has more than 20 years of experience in the infectious disease IVD space bringing novel technologies to the market. He recently helped commercialize the Karius test and previously held commercial leadership positions at GenePOC, Nanosphere and Meridian Bioscience. "We are pleased to welcome Mike to our executive team at this important juncture and looking forward to accelerating our entry into the AST market", said Dr. Knopfmacher.

Contacts:
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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 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. For more information on Avails Medical and the eQUANT system, visit www.availsmedical.com.

© 2024 Avails Medical, Inc. All rights reserved. eQUANT is a registered trademark of Avails Medical, Inc. Any unauthorized use is expressly prohibited.

SOURCE Avails Medical, Inc.