World Diabetes Day 2024: BOYDSense advances breath-based glucose monitoring with EIC support and new financing

On 14 November 2024, World Diabetes Day highlighted the global need for better, more accessible diabetes care. In that context the European Innovation Council community spotlighted BOYDSense, an award winning medtech startup developing a non invasive breath glucose monitor. The company says its first product, called Lassie, will provide blood glucose values after a simple breath into the device and a smartphone app. BOYDSense frames the device as pain free, lower cost and less wasteful than conventional fingerstick or continuous glucose monitoring systems.

What BOYDSense is developing and why it matters

BOYDSense was founded in 2015 and has research and development activity in France and the United States. The company develops breath analysis technology intended to measure biomarkers in exhaled air. Its first application target is blood glucose monitoring for people with diabetes and pre diabetes. The company argues that non invasive monitoring could lower barriers created by pain, recurring consumable costs and environmental waste associated with test strips and lancets.

Clinical evidence so far

BOYDSense published a company update summarising the conclusion of a second clinical study run with Toulouse University Hospital. The trial enrolled 130 patients with type 2 diabetes and ran in two phases. During the first phase researchers collected data used to develop an embedded algorithm to infer blood glucose from breath signals. In a second phase the prototype device equipped with that algorithm was used by 30 patients to perform repeated glucose measurements.

According to the study sponsors BOYDSense and the Toulouse investigators, the trial met its objectives. Those objectives included establishing a functioning system under test conditions, confirming patient interest in a non invasive option, validating earlier developments and collecting additional data to improve algorithms. Principal investigator Prof. Pierre Gourdy described the approach as a potentially attractive alternative to capillary glycemic monitoring. BOYDSense CEO Ben Delhey said the data allowed the team to improve device performance and its smartphone application.

Funding, partnerships and EIC support

BOYDSense says it became an EIC Accelerator Blended Finance beneficiary with the project named Lassie. The EIC support reportedly helped BOYDSense generate clinical evidence and attracted follow on investors. In 2024 the company announced a 7 million euro capital increase in a financing round led by Swiss Diabetes Venture Fund, Bioserenity and the European Innovation Council Fund.

Technical and clinical challenges to watch

Breath based monitoring is scientifically promising but technically challenging. Breath composition varies with many external and physiological factors that can confound measurements. Detecting small changes in blood glucose requires highly sensitive sensors and algorithms able to generalise across populations. Clinical validation needs sufficiently large and diverse datasets including people with type 1 and type 2 diabetes, different age groups and varied comorbidities. Regulatory authorities require evidence of accuracy, repeatability and safety before market clearance and reimbursement decisions.

BOYDSense reports progress in miniaturising the hardware, improving bill of materials and initiating new clinical trials to refine algorithms. These are necessary steps but they do not guarantee eventual regulatory approval or commercial uptake. Large scale prospective studies, independent validation and cost effectiveness analysis will determine whether the device can compete with established fingerstick methods and continuous glucose monitors.

Regulatory and market outlook

The company said it is in discussions with regulators in the United States and Europe. For glucose monitoring devices regulators review analytical and clinical accuracy according to defined protocols and performance standards. Market access will also depend on pricing, reimbursement policies and how healthcare systems evaluate trade offs between non invasiveness and measurement accuracy. Even with successful trials and regulatory clearance, adoption commonly requires real world evidence, clinician endorsement and payer engagement.

Wider implications and caveats

If validated at scale, a reliable breath based glucose monitor could reduce pain and waste for people who need regular glucose checks. BOYDSense emphasizes environmental benefits from using fewer consumables. The company also projects future breath based applications in conditions such as sepsis, fatty liver disease and some cancers. Those claims point to a broader platform ambition rather than an imminent multi indication regulatory pathway.

Readers should note that public statements from startups and preliminary clinical announcements tend to present positive findings. Independent peer reviewed publications, regulatory decisions and post market performance remain the key milestones that determine whether a technology becomes a clinical standard. The EIC grant and the recent equity financing reduce some development risk but they do not eliminate the need for further evidence.

What to watch next

1. Publication of the full clinical results from the Toulouse CHU study in a peer reviewed journal. 2. Outcomes from any new, larger scale trials BOYDSense initiates to improve algorithm generalisability. 3. Progress on ISO 13485 certification and formal regulatory filings in the EU and US. 4. Technical details about sensor performance, calibration needs and the expected accuracy compared with standard fingerstick testing and continuous glucose monitors. 5. Reimbursement and distribution plans in target markets if regulatory clearance is achieved.

More information about BOYDSense and the Lassie project is available on the company website and on CORDIS for the EIC funded project. The European Innovation Council provides blended finance to de risk deep tech and help attract follow on investors but independent evaluation remains crucial for clinical adoption.