Israeli medical device start-up Olive Diagnostics has completed a successful clinical trial of the company’s KG, the world’s first hands-free, non-invasive, artificial intelligence (AI)-based optical device for 100% passive and seamless urinalysis. The device mounts to any toilet, and the company plans to eventually bring it to most of the world’s toilets. The trial at the Hadassah Ein Kerem Medical Center in Jerusalem was conducted by TechnoSTAT Clinical Services, an international clinical trial management and monitoring company. Olive Diagnostics’ device can be used at any home or clinic in the world to accurately detect biomarkers for prominent medical conditions and diseases that include certain types of cancers related to the prostate, ovaries, and kidneys; heart failure; dehydration; kidney stones; inflammation in the urinary bladder, and other conditions.
Olive Diagnostics will be working through assisted living facilities, outpatient facilities, and telemedicine providers in Europe to reduce their operating costs by reducing hospitalization while providing them the opportunity to deliver a differentiated value-added service. KG can also provide family members and caretakers medical information to detect the risk of conditions such as dehydration and provide insights regarding bowel movements.
The company has also completed its ISO 13485 certification, a critical milestone necessary for CE certification, which will enable Olive Diagnostics to commercialize its technology and commence sales in the European Union. Olive Diagnostics is also in the FDA pre-submission phase for the United States.
Olive Diagnostics’ KG is an affordable Internet of Medical Things (IoMT) device that mounts to any toilet. It detects urine’s molecular composition and generates secure and personalized diagnostic data in real-time. The system generates information on factors that include molecules such as red blood cells, protein, ketone, creatinine, etc., as well as other urine characteristics such as volume, pressure, color, and frequency. If any issues require immediate attention or the onset of symptoms is detected, KG sends an alert to the relevant caregiver.
The continuous monitoring nature of Olive Diagnostics’ device alerts users to pre-symptomatic issues, sometimes weeks before symptoms and the appearance of conditions including urinary tract infection (UTI) and kidney stones. When the risk of a condition like UTI is detected, prophylactics can be administered, a capability which may reduce the likelihood of hospitalizations. For men, kidney stones can be detected weeks before the onset of pains so that they can easily be treated before hospitalization is required. This makes the startup’s device a critically important tool for the elderly, where early detection can improve the quality of live and of care.
The clinical trial was designed to correctly check the system’s ability to detect protein in urine in more than 900 samples. TechnoSTAT performed third-party validation on its models.
On a single test designed to mimic the traditional urine stick method, KG delivered a sensitivity rating of 92.8%. Sensitivity means that the system positively identifies that the specific molecule is in the sample, and it turns out that this molecule exists in the sample. When it came to specificity, meaning that the system says that a specific molecule does not exist in the sample, and it turns out that this material does not exist in the sample, KG delivered 95.5% rating. According to the US National Institutes of Health (NIH), urine sticks have a sensitivity rating of 80% and a specificity rating of 95%.
However, the real value in Olive Diagnostics’ device is in its ability to monitor urinations continuously. TechnoSTAT found that KG achieved a sensitivity rating of 98.7% and a specificity rating of 100% on simulated five daily urinations. Therefore, the system is not only able to perform the tests passively with no user behavioral changes, but it is also more accurate than urine sticks that constitute the gold standard for home-based diagnosis. Olive’s KGs allows for continuous monitoring with all the advantages of early disease detection to allow for early intervention and increased quality of life.
“Olive Diagnostics delivers continuous home-based, medical-grade urine diagnostics that help monitor health changes. We are enabling the early detection and treatment of certain diseases to reduce the cost of healthcare in patients and improve their quality of life. The organization is gearing up to move the device into households and clinics worldwide with a potential market of every active toilet user wishing to monitor their health,” said Guy Goldman, CEO of Olive Diagnostics.
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The eHealth Ventures partnership is a leading investor in early-stage digital health companies.
It includes 2 VC funds and a technological incubator with an exclusive focus on digital health and significant government non-dilutive funding. Partners include Maccabi (a leading Israeli HMO), Amgen (global biotech giant), the Mayo Clinic, Medison Ventures, Arad Investments, and the Hadar Group. The team has reviewed over 1,650 companies to date and invested in a portfolio of 24 highly innovative companies (digital diagnostics, therapeutics, home care and Bioconvergence).