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MENLO PARK, Calif., June 12, 2023 /PRNewswire/ — Avails Medical, a pioneer in rapid, automated and fully electrical antibiotic susceptibility testing (AST) solutions announced today the submission of its eQUANT^™ system for FDA 510(k) clearance.

The eQUANT system provides a standardized inoculum (0.5 McFarland equivalent) directly from a positive blood culture, which is designed to be used with traditional automated AST systems and Disk Diffusion, accelerating routine AST turnaround times by up to one day.

“The global emergence of superbugs and rise in antimicrobial resistance is a leading public health concern. Providing clinical laboratories with rapid diagnostics is key to address this important challenge. eQUANT could have the potential to enable physicians to de-escalate from costly empiric, broad-spectrum antibiotics to an effective and lower cost therapy, a real game changer for patients,” said Dr. Banaei, Professor of Pathology and Medicine and Medical Director, Stanford Health Care Clinical Microbiology Laboratory and investigator in the clinical study.

The eQUANT system’s unique features include a very small footprint, easy-to-use user interface and affordable economics, making it well suited for widespread adoption. In a previous pilot study completed at two world-renowned clinical laboratories, the eQUANT system achieved >98% correlation when compared to the subculture gold standard.

“We are delighted to announce the important company milestone of FDA submission of the highly anticipated eQUANT system”’ said Dr. Knopfmacher, CEO of Avails Medical. “This is an important first step towards commercializing eQUANT in the U.S. and other countries. eQUANT can provide any clinical laboratory with a simple and powerful tool that is designed to fit seamlessly into the routine clinical laboratory’s workflow, accelerating traditional AST turnaround times by up to one day.”  Avails Medical will showcase the eQUANT System as well as the eAST™ System at the upcoming ASM conference in Houston in June.

In addition to FDA submission, Avails Medical also announced today an additional $5.4M million in non-dilutive funding from CARB-X for its rapid eAST system, after successfully achieving additional gating milestones. The Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), is a global non-profit partnership based at Boston University dedicated to funding the development of new antibiotics, vaccines, diagnostics, and other products to address the rising global threat of antibiotic-resistant bacteria.

Contacts:
press@availsmedical.com

About Avails Medical, Inc.

Avails Medical was founded to address one of our greatest global health threats: antibiotic resistance. The Avails all-electrical technology is designed to significantly reduce the amount of time required to obtain the reliable antibiotic susceptibility data required to enable accurate therapy decisions. www.availsmedical.com

Acknowledgement and disclaimer
Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), and the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF) funded by the UK Government Department of Health and Social Care (DHSC). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.

MENLO PARK, Calif., Sept. 1, 2022 /PRNewswire/ —

Avails Medical, a pioneer in rapid, automated, and fully electrical antibiotic susceptibility testing (eAST^™) announced today the transition to the next phase of its CARB-X grant. Avails was awarded an additional $1.7 million in non-dilutive funding from CARB-X, the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator. CARB-X is a global non-profit partnership based at Boston University School of Law and dedicated to funding the development of new antibiotics, vaccines, diagnostics and other products to address the rising global threat of antibiotic-resistant bacteria.

Funds will support the accelerated development of the Avails Medical eAST system, a fully electrical antibiotic susceptibility testing device that reduces the time-to-results to an average of five hours. The Avails platform will enable health care providers to more efficiently determine the most effective antibiotic treatment for patients with severe bloodstream infections, particularly those involving multidrug-resistant pathogens.

“We are delighted to support the important work of Avails Medical”, said Erin Duffy, Ph.D., Chief of Research and Development of CARB-X. “The Avails eAST diagnostic platform offers a very practical solution to reducing time to actionable AST results, which is critical in guiding antibiotic therapy decisions, especially in hospital centers that are human-resource constrained.”

“Every hour counts for a patient with sepsis. Avails’ unique rapid eAST technology presents a meaningful opportunity to improve patient care by shortening the time to effective antibiotics at an affordable cost, “said Eszter Deak, Ph.D., Director of Scientific and Medical Affairs at Avails Medical. “We are honored and pleased that CARB-X continues to recognize the value of Avails Medical’s eAST system and supports us in our endeavor to significantly improve therapy decision support for bloodstream infections,” said Oren Knopfmacher, CEO of Avails Medical.

Avails could be eligible for additional funding from CARB-X upon successful completion of milestones.

Contact:
Avails Medical:
press@availsmedical.com

Acknowledgement and disclaimer:
Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is sponsored by Federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; Antibacterials Branch under agreement number: 75A50122C00028, and by awards from Wellcome (WT224842), and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.

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 required 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 culturing steps.

About CARB-X

Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services, Wellcome, a global charity working to improve health worldwide, Germany’s Federal Ministry of Education and Research (BMBF), the U.K. Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). CARB-X supports the world’s largest and most innovative pipeline of preclinical and early-stage development products against antibiotic-resistant infections. CARB-X is headquartered at Boston University School of Law. For more information, view a fact sheet on CARB-X’s first five years and the 2020-2021 annual report. Visit carb-x.org and follow CARB-X on Twitter @CARB_X.

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.

Contact:
press@availsmedical.com

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

MENLO PARK, Calif., June 1, 2021 /PRNewswire/ – Avails Medical, a pioneer in rapid, automated and fully electrical antibiotic susceptibility testing (AST) announced today the publication of a new peer-reviewed paper on its eQUANT^TM system and technology in Scientific Reports.

The eQUANT^TM – a novel instrument utilizing electrical biosensors – produces a standardized inoculum equivalent to a 0.5 McFarland directly from positive blood cultures. The proof-of-concept study demonstrates that eQUANT^TM inocula prepared from clinically significant species of Enterobacterales were comparable to 0.5 McFarland inocula generated from bacterial colonies in both CFU/ml concentration and performance in antimicrobial susceptibility testing, with ≧95% essential and categorical agreement for VITEK2 and disk diffusion. The eQUANT^TM, combined with a rapid, direct from positive blood culture identification technique, can allow the clinical laboratory to begin antimicrobial susceptibility testing using a standardized inoculum approximately 2-3 hours after a blood culture flags positive. This has the potential to improve clinical practice by accelerating conventional antimicrobial susceptibility testing and the resulting targeted antibiotic therapy.

“eQUANT^TM will eliminate the current need for time consuming 18-24 hour bacterial Petri dish cultures and enable standard AST to be initiated one day earlier”, said Meike Herget, PhD, CTO of Avails Medical.

“Accelerating antibiotic susceptibility testing for blood stream infections is key to reduce patient mortality and to de-escalate antibiotic therapy from a costly broad spectrum and empiric one to a targeted and lower cost therapy. With eQUANT^TM we are addressing the holy grail of timely blood stream infection diagnosis by allowing AST directly from a patient positive blood culture, saving time and lives. We are excited to be providing clinical laboratories with a simple though powerful new device that will fit seamlessly within a clinical lab’s workflow and enable timely and highly accurate AST results. Avails will be challenging the technology in our upcoming clinical study trials”, said Dr. Herget.

About eQUANT^TM

Avails eQUANT^TM technology will enable a single-step automated 0.5 McFarland preparation (in as fast as 40 minutes) directly from positive blood culture (PBC), removing 18+ hours from workflow by eliminating the need for subcultures. eQUANT^TM will enable legacy AST systems to be used directly from PBC. In addition eQUANT^TM will also allow for direct-from-PBC disk diffusion. The eQUANT^TM system is currently being evaluated in clinical studies.

Citation

Putney, S., Theiss, A.H., Rajan, N.K. et al. Novel electronic biosensor for automated inoculum preparation to accelerate antimicrobial susceptibility testing. Sci Rep 11, 11360 (2021). https://doi.org/10.1038/s41598-021-90830-2

About Avails Medical Inc.

Avails Medical, Inc., a privately held company, was founded in 2013 to help fight one of today’s biggest global health threats – antibiotic resistance. Founded by a team of Stanford University alums, the Avails all-electrical technology platform is designed to significantly reduce the amount of time required to obtain the reliable antibiotic susceptibility data required 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 culturing steps.

CONTACT:
Avails Medical
press@availsmedical.com