Lactate measurement using a novel non-invasive device

The National Institute of General Medical Sciences awarded Cambridge Medical Technologies LLC $1,010,698 on September 5, 2026, under the Biomedical Research and Research Training program (CFDA 93.859) to develop a noninvasive biosensor for measurement and serial monitoring of lactate levels using interstitial fluid extraction.

Cambridge Medical Technologies will improve device hardware and software for clinical use and perform in vitro experiments to optimize electrochemical measurement accuracy for lactate detection. The biosensor operates by using small current pulses to temporarily disrupt the stratum corneum epidermal barrier, allowing extraction of interstitial fluid from beneath the skin layer. The extracted sample flows into a micro chamber within the device where electrochemical reaction measures lactate concentration. The company will validate whether interstitial fluid lactate levels correlate with blood lactate levels, which would enable noninvasive serial monitoring in sepsis and other critical illnesses where lactate serves as a key biomarker for tissue hypoxia, shock, and mortality prediction.

Beth Israel Deaconess Medical Center serves as a sub-recipient partner, contributing clinical research expertise in sepsis and critical illness. Work is performed in Derwood, Maryland, with a period of performance through August 31, 2028. This Phase II SBIR award builds on Cambridge Medical Technologies' prior development of the ISF extraction technique and hardware architecture for alcohol and glucose biosensors.

Abstract

This is a phase II sbir award by cambridge medical technologies (CMT), LLC to further develop a noninvasive biosensor for measurement and serial monitoring of lactate levels using interstitial fluid (ISF). Lactate is a key biomarker in sepsis, a common and deadly illness that affects more than 1.7 million adults in the united states with mortality as high as 30% in severe cases. Elevated lactate is a marker of tissue hypoxia and shock, and early assessment of lactate levels enables prognostication and mortality prediction in patients with sepsis. CMT has developed a novel biosensor device that noninvasively samples ISF and measures the level of analyte of interest. The device works by temporarily disrupting the stratum corneum epidermal barrier using small current pulses, which allows for extraction of a small volume of ISF from just underneath the skin layer. The ISF sample flows into a micro chamber within the CMT biosensor device and performs electrochemical reaction to measure the lactate level. CMT has developed the hardware and ISF extraction technique during prior work on alcohol and glucose biosensors. The current project will extend the technique to lactate monitoring. As part of the project, the CMT will partner with a team from beth israel deaconess medical center (bidmc) who have extensive experience in clinical research, especially within sepsis and other critical illnesses where lactate is a key biomarker. The broad aim of the project is to determine whether the CMT lactate biosensor holds promise to noninvasively measure ISF lactate levels; and, if these levels will correlate with blood lactate levels, leading to clinical and commercial success. The specific aims of the study are to: 1) improve device hardware and software for clinical use, 2) perform in vitro experiments to optimize underlying electrochemistry for improved lactate measurement accuracy, freedom from interferent molecules, and increased product stability, and 3) perform early in vivo testing in emergency department patients as part of a clinical study to enable rapid iterative device development. The CMT team will make hardware and software device improvements, and perform in vitro testing to improve the product. After initial improvements, the bidmc team will use the CMT lactate biosensor to perform in vivo testing in emergency department patients with suspected sepsis who are undergoing clinical lactate measurement and compare the results. Achieving the proposed aims will position CMT to conduct FDA pivotal testing during its path to commercialization. The research plan will use an iterative approach by which CMT will develop and improve the device and bidmc will test IT in a real clinical environment across a broad range of human subjects and a clinically relevant range of lactate levels. Full exchange of the data will permit rapid adjustments to the prototypes so that modified versions of the device are tested in a timely and iterative manner.