Data-Driven Healthcare:

In today’s world of data-driven, AI-powered healthcare, real-time clinical insights are gold - and we’re mining them everywhere…  except one place.

Home health tech has revolutionized monitoring from heartbeats to glucose. Yet, stool-based monitoring remains the forgotten frontier.

Packed with biomarkers, for inflammation, disease, and microbiome health, these samples hold - untapped medical treasure. But we literally - flush away one of the richest sources of health data every single day.

Why? Simple - the 'ick factor' - the inconvenience, aversion and lack of convenient home monitoring devices.

This gap creates a significant opportunity: whoever finds a way to overcome these challenges and access this hidden data, will unlock new levels of predictive care, real-time disease tracking, and personalized medicine for more effective treatment.

That’s exactly what HARP Diagnostics is doing - turning the 'ick factor' into an 'X factor' with the world’s first automated, hygienic, and user-friendly solution for stool-based remote patient monitoring, for at-home use or at the clinic.

Our initial focus: inflammatory bowel diseases (IBD) such as Crohn’s Disease and Ulcerative Colitis, where accurate and frequent monitoring can make a life-changing difference.

The Medical Need

Inflammatory Bowel Disease (IBD) – widely known as Crohn’s Disease and Ulcerative Colitis -is a chronic, life-altering condition affecting over 7 million people worldwide. It is a life-long journey (typically diagnosed at a young age), marked by repetitive episodes of flare-ups and remission. During flares, patients often experience debilitating symptoms like abdominal pain, fatigue, frequent and irregular bowel movements, anxiety and more. These episodes severely impact daily life, productivity, and emotional well-being.

While IBD has no cure, timely intervention through regular monitoring and early detection of flare-ups can significantly reduce suffering, extend remission, improve quality of life and prevent complications.

But the current monitoring options are uncomfortable, messy, complicated, and patients’ adherence is challenging and therefore low:

1. Conventional monitoring options (such as colonoscopy) are often too invasive, inconvenient and expensive.

2. Non-invasive biomarkers of inflammation are considered a more convenient and cost-effective monitoring option. Fecal calprotectin (FC) is the leading non-invasive biomarker for early detection of inflammation - often revealing signs of inflammation up to three months before symptoms arise.

• Yet despite its clinical value, regular monitoring is rare. Current tests require unpleasant stool collection and lab submission, leading to poor patient adherence.
• As a result, many patients avoid or postpone testing, often creating a snowball effect of disease progression, leading to significant complications and surgeries, such as bowel obstructions, perforations, colon removal, increased risk for colon cancer and more.
• Some at-home FC stool tests have been introduced in recent years (only outside the US) trying to bridge the gap, but they are very user dependent, error-prone, complicated to use, and often unreliable - studies show up to 15% of test results are invalid due to user mistakes and technical issues.

Therefore, to-date none of these home FC tests have been approved for use in the US.

This highlights a critical unmet need: a simple, accurate, and user-friendly home monitoring solution that enables early detection and better disease control.

In a Nutshell:

• IBD is chronic and cyclical.
• Ongoing periodical monitoring can detect early flare-up - key to preventing complications.
• Current tests are unpleasant and complex, leading to poor patient adherence.
• Stool tests provide vital clinical data - but are rarely performed due to sample collection and test handling burden.
• No FDA-cleared home solution exists in the U.S.
• Some European at-home test kits exist, but they are too inconvenient and user-dependant.

The Solution

HARP Diagnostics developed the world’s first automated, user-friendly, and rapid home stool test platform. The patented portable device can be used by the patients from the comfort of their home, or by the healthcare provider at the doctor’s office (point-of-care) - with no mess, no user error, and no direct contact with the sample. It’s designed to be user-friendly and fail-safe even for people with no training, ensuring more patients test themselves regularly and easily.

The device provides results within minutes and sends the data to doctors through a cloud-connected system, helping them make better, real-time data-driven decisions about treatment adjustments, dramatically improving continuity of care and long-term outcomes.

The system is designed specifically for chronic disease monitoring. The first test on the platform measures fecal calprotectin (FC), the most widely used biomarker for monitoring IBD activity.  This will allow for frequent, reliable testing that supports early flare detection and better disease management.

In the future, HARP’s platform will be used for other GI conditions, like irritable bowel syndrome (IBS), colon cancer (occult blood), and more.

Highlights:

• Professional-grade home test for IBD — no lab or user training needed.
• Concealed sample collection — no mess, no contact.
• Reader device runs the full test at the push of a button.
• Fast, accurate results sent directly to the doctor, for decision support.
• Digital platform for data tracking, personalized care, and basis for AI prediction.
• For use at home or clinic — no skilled staff required.

The Technology

HARP has developed a groundbreaking multidisciplinary platform for performing complex biological testing in a fully automated, accurate, and user-friendly way that requires no user expertise. Every step of the process – from sample collection to result delivery – has been redesigned from the ground up to enable true clinical-grade home monitoring without requiring a professional lab, whether used by a patient at home or by a non-clinical assistant in a clinic (medical assistant).

System Components:

• Unique Seamless Collection Tool (Patent Pending): A single-use stool collection unit that easily attaches to a toilet, and designed to collect a tiny sample in a new fully clean, intuitive and seamless sample collection method (“No See, No Touch, No Smell”). The collection process is automated, concealed, and precise.
• Single-Use Test Kit:
  • Smart Tube (Patent Pending): After collection, the sample is easily inserted into an easy-to-use tube with an innovative mechanism that seamlessly integrates with the test device.
  • Biochemical Test Cartridge: Detects a key biomarker of intestinal inflammation.
• HARP Reader (Patent Granted): A fully automated electromechanical device that processes the entire testing sequence at the push of a button. After inserting the sample tube and test cartridge, the system confirms component integrity, executes the test and analyzes it algorithmically to provide an accurate numerical result.
• Smartphone App: Functions as the digital "brain," guiding the user, alerting to errors, providing troubleshooting, and delivering results to the doctor. It also collects patient-reported data to create a full clinical profile, which contributes to the growing dataset used for future AI-based predictions and analysis.
• Cloud-Based Physician Dashboard: All test results and patient data are stored securely in the cloud, accessible to physicians. The platform enables trend analysis, personalized treatment optimization, and long-term disease tracking. It will also serve as the foundation for AI-powered flare prediction, at a later stage.

Key Technological Advantages:

• Fully automated, hands-free process: From sample insertion to accurate result.
• Built-in safety and control mechanisms: Reduces user error through validated technologies and strict checks.
• Three patent layers: Automation system, collection tool, and smart tube – creating strong IP barriers and enabling a compact, affordable, user-friendly home product.
• Intuitive UX with fail-safe design: Alerts and guides the user to ensure proper function by non-professionals.
• Expandable platform: Designed for future tests (e.g., occult blood, IBS, etc.) using the same infrastructure.

Major Advantage: Big Data Collection & AI-Driven Insight

Beyond immediate clinical benefits, HARP's system establishes a unique infrastructure for real-time, continuous clinical Big Data collection directly from patients.

The platform stores all test results, patient-reported outcomes, and other relevant data in the cloud, enabling:

• Personal trend analysis: Detecting early changes before symptoms appear
• Personalized treatment plans: Data-driven precision medicine
• Decision support tools: Empowering physicians with dynamic dashboards to optimize care and monitor disease effectively