Harp Diagnostics

Market position

Positions itself as offering the first automated, hygienic and user-friendly solution for stool-based remote patient monitoring, contrasting with colonoscopy (invasive and costly) and with existing European at-home fecal calprotectin kits that it describes as user-dependent and unreliable; it notes that no home fecal calprotectin test has been approved for use in the United States.

Automation and hygiene of the sample-collection and testing workflow — no direct contact with the sample, no required user expertise, and built-in error safeguards — aimed at the compliance and invalid-result problems attributed to existing home stool tests.

Technology

Harp 360 is a patented, fully automated end-to-end stool-testing platform: a user-friendly collector that avoids direct contact with the sample feeds an intuitive, cloud-connected automated testing system with built-in safeguards intended to eliminate human error. Initial focus is on non-invasive inflammation biomarkers, with fecal calprotectin cited as the leading marker. The company reports an IP portfolio of three patents, with the first granted and two additional applications at PCT stage, and plans to layer an AI-based flare-prediction model on routinely collected real-time clinical data combined with partner health-system data.

Go-to-market

The company was founded in collaboration with, and cites partnerships involving, The Trendlines Group, Boston Scientific and Clalit Health Services, Israel's largest HMO. It has engaged the FDA through a pre-submission meeting and used competition wins and Israel Innovation Authority grants to build visibility, while raising pre-seed capital through the ExitValley crowdfunding platform.

Patients with inflammatory bowel disease — Crohn's disease and ulcerative colitis, described as affecting over 7 million people worldwide — and their treating gastroenterologists, who use the results as a disease-management and decision-support tool; the system is also intended for point-of-care clinic settings.

Geography

Headquartered at the Trendlines Building, Misgav Business Park, 17 T'chelet Street, M.P. Misgav, Israel, with a stated regulatory focus on the United States market.

History

The company has developed working prototypes of the Harp 360 system and reports completed laboratory testing, initial clinical validation on patient samples and usability testing. It has received multiple grants from the Israel Innovation Authority and held a pre-submission meeting with the FDA that it describes as yielding positive feedback. In 2025 it won the IBD Innovate Shark Tank competition run by the American Crohn's & Colitis Foundation, took first place in the annual Crohn's & Colitis Association competition, and was named a top-five finalist in ASPER HUJI's "Rising Startup of the Year" competition. In the same period it ran a convertible-note pre-seed campaign on the ExitValley platform, in which The Trendlines Group also participated as an investor.

Risks & controversies

The product is pre-commercial: no home fecal calprotectin test has been cleared by the FDA in the United States, and Harp's own regulatory engagement is at the pre-submission stage. The company remains at pre-seed stage with a headcount in the 1-10 range, and its AI flare-prediction capability is described as a later-stage plan rather than an existing product.