Oncoustics

Oncoustics is a medical device company operating from Toronto and San Francisco, focused on creating artificial intelligence-based solutions for non-invasive disease diagnostics. The firm was founded in 2018, spinning out of quantitative ultrasound imaging research conducted by co-founder Ahmed El Kaffas in 2014 at Sunnybrook Research Institute, which is affiliated with the University of Toronto. El Kaffas, a medical physicist and engineer with extensive experience in ultrasound and AI, laid the foundational technology for the company. The leadership was later strengthened by Beth Rogozinski, a serial entrepreneur with a significant background in health and technology, who joined as CEO in late 2019. Rogozinski's journey into healthcare was driven by the realization that the system was ill-equipped for chronic conditions. Her prior experience includes serving as Chief Product Officer at Pear Therapeutics, where she was instrumental in the development of reSET, the first prescription digital therapeutic cleared by the FDA.

The company's core business revolves around a hardware-agnostic, AI-powered software-as-a-medical-device (SaMD) platform that enhances standard ultrasound devices. By applying machine learning algorithms to the raw sound signals—data typically discarded by conventional ultrasound systems—Oncoustics can detect unique acoustic biomarkers. This allows for the characterization and differentiation of healthy versus diseased tissues, essentially creating a "virtual biopsy". This approach aims to reduce or eliminate the need for expensive, high-end imaging and painful, invasive biopsies. The business model targets healthcare providers, initially focusing on hepatology and endocrinology clinics, with future expansion into primary care. Oncoustics also collaborates with pharmaceutical companies, using its technology to support clinical trials and drug development.

Oncoustics' initial product, the OnX Liver Assessment Solution, addresses the significant unmet need in diagnosing and managing chronic liver disease, a market valued at over $30 billion globally. This solution is designed to detect conditions like fibrosis (scarring) and steatosis (fatty build-up) at the point of care within minutes. The system is engineered for use by a wide range of healthcare professionals, not just specialist sonographers, thanks to acquisition guidance features. Having amassed a large proprietary dataset of over 4 million RF signals, the company is pursuing regulatory clearance from the FDA, Health Canada, and CE Mark in Europe. Beyond liver disease, the company's technology has potential applications for other organs, including the prostate, kidney, breast, and thyroid.

Keywords: medical device, artificial intelligence, ultrasound diagnostics, non-invasive diagnostics, virtual biopsy, liver disease, tissue characterization, SaMD, point-of-care, health-tech, chronic disease management, machine learning in healthcare, fibrosis detection, steatosis measurement, digital health, FDA clearance, medical imaging AI, acoustic biomarkers, preventative care, clinical trial support