Vocxi Health, a medical technology company developing the next generation of breath-based diagnostics, has partnered with Forj Medical to transform its MyBreathPrint™ device from a desktop prototype into a compact, handheld diagnostic platform designed for real-world use. The collaboration dramatically advanced the device’s performance and manufacturability, positioning it to revolutionize early disease detection through a simple, noninvasive breath test.

MyBreathPrint™ uses graphene-based nano sensors and machine learning based algorithms to detect volatile organic compounds (VOCs) produced by the body in a person’s breath that correspond with specific diseases, including lung cancer, the world’s leading cause of cancer death. The device’s ultra-sensitive sensors can detect compounds at parts-per-billion concentration, a thousand times more sensitive than conventional medical gas sensors. Combined with AI/ML based algorithm, the system delivers accurate, near-instant results in seconds, potentially enabling widespread screening in clinics — and ultimately, in homes.

Vocxi partnered with Forj Medical to translate its breakthrough science into a manufacturable, market-ready device. Forj Medical engineers employed design-for-manufacturability (DFM) principles and advanced miniaturization techniques to reduce the device’s size from that of a toaster to a handheld unit roughly the size of a deck of cards, without compromising precision or sensitivity.

“Early detection is the key to saving lives, and the ability to identify cancer and other diseases from a simple breath test to increase compliance has been a long-standing goal in medicine,” said Ping Yeh, CEO of Vocxi. “Forj Medical’s engineering ingenuity allowed us to take our vision from a concept on the bench to a manufacturable device ready for clinical deployment. Together, we’ve created something that could make early cancer detection accessible to millions.”

Forj Medical’s team solved multiple technical challenges in collaboration with Vocxi and its digital health partner S3 Connected Health. One of the most significant was maintaining clear electrical signals in concert with ultra-sensitive graphene sensors. The team identified and eliminated the noise sources through hardware design, custom algorithms, and more than 1,500 custom diagnostic tests conducted in rapid succession. The engineers also innovatively solved the challenge of humidity – a breakthrough in breath-detection devices.

Forj Medical then built a foundation for scalable manufacturing. The team condensed hundreds of electronic components onto a single printed circuit board, developed automated testing and data analysis systems, and created packaging and labeling protocols for direct shipment to healthcare providers.

“This collaboration exemplifies the early and close integration between the innovation and useability engineers in complex first-of-their-kind devices,” said Darren Gilmer, senior engineering manager, product development, at Forj Medical. “Vocxi’s sensor technology was exceptionally advanced, and our job was to make it manufacturable, reliable, and ready to scale. We achieved that by working side by side with Vocxi’s scientists to iterate, test, and refine every aspect of the original design.” The proximity of core team members in Minnesota’s Medical Alley facilitated rapid iteration and hands-on collaboration – literally delivering samples back and forth during testing and iteration – and gaining input from teams across the globe over a 24/7 timeline.

Gilmer added a key process step was precise engineering that allowed software to “talk” to the hardware, which is particularly complex in devices that gather and decipher biometric data. 

Throughout the 18-month project, the partnership between Vocxi, Forj Medical, and S3 Connected Health resulted in three joint patents, a working prototype, and first production run of 500 units which performed well in clinical testing. 

The MyBreathPrint™ system’s compact form, cloud connectivity, and affordability make it a promising solution for large-scale cancer screening and early detection of multiple diseases, with potential to save countless lives and dramatically reduce healthcare costs.