BactoByte has appointed Mr. Dan Wolterman, Former President and CEO of Memorial Hermann Health System, as a Board Chair. With more than 40 years of experience in the healthcare industry and a long history of community involvement, Mr. Dan Wolterman currently serves as a Chair of the board of NuVasive, Inc., and on board of Vizient, Inc., in addition to serving on the board of Altamont-backed Intuitive Health. He previously served on Volcano Corporation’s board, acquired by Royal Philips in 2015, and Invuity, Inc., acquired by Stryker Corp. in 2018.
BactoByte has developed a revolutionary method of rapid testing for microbial contamination. This novel antibiotic screening enables caregivers to administer one-hour bacterial diagnostics while improving outcomes, reducing misdiagnosis, and lowering health care costs.
“While traditional methods of testing performing slow, and existing alternatives are limited, BactoByte develops a fundamentally new and universal approach of single-cell precise testing of bacterial contamination and antimicrobial susceptibility, “ says Dr Vladimir Glukhman, PhD., Chief Technology Officer and co-founder of BactoByte. “The synergy of biochemistry, machine learning, and complex algorithms of image analysis in one system creates the unique ability of BactoByte core technology and products.”
BactoByte is focusing on the development of its first product – the Laboratory Analyser and Disposable Kits. The Second-generation PoC (Point-of-Care) systems and disposable units will start development while the laboratory system will go into trial. BactoByte hopes to start the FDA 510(K) DeNovo trials in the US in 2022. The FDA added the DeNovo pathway for device marketing rights to address novel devices of low to moderate risk that do not have a valid predicate device.
“…Today, antibiotics are rarely prescribed based on a definitive diagnosis. Diagnostic tests can show whether or not an antibiotic is actually needed, and which one. Having rapid, low-cost, and readily available diagnostics is an essential part of the solution to this urgent problem,” quoting Dr Margaret Chan, former Director-General of the World Health Organization (WHO).
The first assay – Blood Stream Infection (BSI) will include the first-line antimicrobials identification recommended for systemic inflammatory syndrome (SIRS) treatment. Bloodstream infections (BSI) are life-threatening sepsis triggered by microorganisms circulating in the bloodstream. Quick diagnostics are critical for the successful treatment of such conditions as there is a 7% rise in mortality rates for every hour of delay of treatment. BactoByte test is much quicker than existing hospital tests, which can take up to 72 hour to process.
BactoByte‘s first market is ~13,000 hospitals and emergency medical care centers servicing laboratories in the US. Next, the Company plans to address the primary care offices and companion veterinary practices with the second-generation system worldwide. The global clinical microbiology market was estimated to be $ 7.8 billion in 2020, with the laboratory instrument segment growing with a CAGR of 8.6%. This market is expected to reach a value of $ 11.2 billion by 2025!
“Whereas data suggest that early initiation of appropriate antibiotic therapy is associated with better patient outcome, antimicrobial resistance is currently jeopardizing effective treatment worldwide. Therefore, strategies to improve rapid pathogen identification and antimicrobial susceptibility testing (AST) are urgently needed,” commented Prof Jacob Strahilevitz, MD, Head, Department of Clinical Microbiology and Infectious Diseases of Hadassah Medical Center of Jerusalem. “Bactobyte’s unique method of rapid and specific bacteria identification and AST is appealing in its simplicity as a point of care application.”
In 2020, Red Herring choose BactoByte as a winner in their top 100 European startups, in the field of medical devices. https://www.redherring.com/events/red-herring-europe/2020-red-herring-top-100-europe-winners/ The Red Herring Top 100 award highlights each year the most exciting startups from Asia, Europe and the Americas. Hundreds of companies from each region are reviewed in a rigorous 3-step process that looks at all aspects of the company.
Founded in 2017, BactoByte is a Jerusalem-based startups that seeks to empower caregivers with one-hour bacterial diagnostics and antibiotic screening capability to improve outcomes, reduce misdiagnoses, and lower healthcare costs. To date, BactoByte has raised $2 million at the seed stage, developed product prototypes, accomplished proof of concepts for urine, bloodstream, and swabs, and achieved over 90% of categorical agreement in its first clinical validation. BactoByte works closely with leading medical centers such as Hadassah Medical Center and Shaarei Medical Center of Jerusalem.
These days, BactoByte is working on its Series A funding round and invites potential investors to contact for additional information. The Series A funding is for completing the BactoByte system development, doing the 510(k) DeNovo clinical trial and submit the first FDA application.
For further information:
Miron Krokhmal, CEO, BactoByte
miron AT bactobyte.com
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