BactoByte is developing a conceptually new laboratory system that will process a line of assays, delivering clinical-grade results in medical (blood, urine, swabs, spinal fluid), environmental, and food applications in 1 hour total turnaround. The bioconvergence technology enforces caregivers with quick and precise diagnostics and antibiotic screening to improve outcomes, reduce misdiagnosis, shorten hospital length of stay, and save hospital-acquired infections and readmission-attributed costs.
“…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.” Dr Margaret Chan, Director Of WHO.
BactoByte has had a successful first clinical validation for unitary tract infection testing and they’re now looking to begin clinical validation studies for bloodstream infections (BSI) in Hadassah Medical Center in Jerusalem. Early data from this study shows over 90% of agreement with standard testing methods.
“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’s market is ~13,000 hospitals and urgency care centers servicing laboratories in the US, scaling with a pipeline of additional syndromic panels.
The founding team of BactoByte is a group of seasoned professionals and serial entrepreneurs who invented and significantly de-risk a complex platform technology quickly. The BOD chair, Mr. Dan Wolterman, is a former President and CEO of Memorial Herman Health System and has over 40 years of experience in the healthcare industry and a long history of community involvement. He is currently serving as Chair of the NuVasive, Inc. and on Vizient, Inc. and Altamont-backed Intuitive Health boards.
Next, the Company plans to start the FDA trial for the device and first Acute Bloodstream Infection assay in the US in Q4 of 2022. The preliminary analysis has shown the high potential to receive FDA Breakthrough classification, enabling fast-track approval track and go-to-market in 2023.
These days, BactoByte is accelerating product development, clinical validation, and FDA 510 (K) pre-submission activities toward Series A funding planned in Q2 2022.
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 $3.5 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. In addition, 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 submitting the first FDA application.
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