18-10-2020
BioWorld: Olive Diagnostics Emerges from Stealth with AI-Assisted Home Urinalysis Device

By Meg Bryant 

Israeli startup Olive Diagnostics Pvt. Ltd. is aiming to disrupt at-home urinalysis testing with a hands-free, noninvasive, artificial intelligence (AI)-based solution that provides remote diagnostics by detecting urine’s molecular composition. K2, as the device is called, attaches easily to the toilet rim to generate secure, personalized diagnostic data that directly links to a mobile app.

The company has raised nearly $2 million in seed money from the Israeli Innovation Authority, eHealth Ventures and private European and American investors, and is planning to raise $5 million more in a convertible loan.

The cloud-based, built-for-purpose spectrometer works with ultraviolet, visible and noninfrared light zones to capture the pathway that light passes through the molecular structures within urine. “All this is happening at incredibly fast speeds in order to capture urine in motion,” Guy Goldman, Olive Diagnostics’ co-founder and CEO, told BioWorld.

Meanwhile, a sensor, connects to the home Wi-Fi or mobile phone and communicates with the user via an app. Based on AI algorithms, the system generates information on factors such as baseline urine profile, red blood cells, protein, electrolytes, bacteria and concentration – alerting users to issues that require immediate attention, such dehydration, as well as predicting symptom outbursts, such as a Gout flair-up or urinary tract infection.

 

Continuously calibrates

“We’re calibrating the system on a continuous basis, millions of times a minute,” Goldman said, adding this increases the signal to noise ratio.

The app alerts users to conditions and predictions about their health and makes lifestyle suggestions. Users can also ask questions and enter information on the app, such as a doctor visit or symptom outbreak.

The device is powered by a battery that needs to be charged once every four months.

Olive Diagnostics is targeting a number of markets – from disease and wellness monitoring to medication compliance and clinical trials – with a phased approach based on regulatory requirements.

The company has a working prototype of K2 and plans to go into beta mode with up to 500 units in Europe in mid-2021.

“Urine is central to medicinal, health monitoring. Current solutions are cumbersome, limiting tracking analysis or medical history,” said Joseph Rosenblum, medical director at Maccabi Enterprise. “People want convenient, at-home health care solutions, passive diagnostic tools, disease prevention, early detection and accurate intervention, especially with rising health care costs and COVID-19.”

So far, the company has validated the technology on more than 300 people by putting their urine through its system and checking it against U.S. FDA-approved urine dip sticks. “We are currently clocking in at 98% accuracy for detecting protein and blood in urine over a 24-hour period, given that a person urinates at least three times a day,” Goldman said. The results were also validated by Technostat, a local contract research organization, and a hospital in northern Israel.

 

Regulatory roadmap and series A

The goal is to get CE marking and an approved FDA roadmap in the latter half of 2021, Goldman said, adding FDA clearance will require a de novo classification and further validation. He hopes to introduce the device in the U.S. with a limited, FDA-exempt feature set in May 2022, followed by FDA clearance toward the end of the year and a full U.S and European launch in 2023.

Based in Jerusalem with an office in Menlo Park, Calif., Olive Diagnostics grew out of Goldman’s frustration with remotely monitoring options when his mother was diagnosed with cancer and he was living and working in the U.K. “In the end … she died from dehydration and pneumonia, two things that we could have easily diagnosed and alerted on early,” he said. “She was at home, and we had no way of knowing of these conditions.”

The $5 million convertible loan will be used to develop the product for manufacturing, complete the Beta test, get CE certification and the FDA roadmap and release the product to the public.

The company will raise a series A financing once it secures initial revenues from its initial product launch at the end of 2021, Goldman said. Those funds will be earmarked for additional testing and commercialization.

In an age of increasing telehealth and remote monitoring, Olive Diagnostics’ is hoping its HIPAA- and GDPR-compliant K2 device will find a ready market. It anticipates retailing the device for about $100 and making money via a software-as-a-service-model with levels such as free, monitoring and coaching.

The company will also be looking potential partners. “Amgen is extremely interested in working with us on drug development and clinical trials,” Goldman said. For those projects, K2 will need FDA clearance.

For more information: guy.goldman@olive.earth

 

Israeli startup Olive Diagnostics Pvt. Ltd. is aiming to disrupt at-home urinalysis testing with a hands-free, noninvasive, artificial intelligence (AI)-based solution that provides remote diagnostics by detecting urine’s molecular composition. K2, as the device is called, attaches easily to the toilet rim to generate secure, personalized diagnostic data that directly links to a mobile app.

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