Flometrica

Until now, all diagnostic tests related to the evaluation of urinary system function were conducted in hospitals or specialized clinics. Flometrica is the world's first company to develop a home diagnostic product for diagnosing urological problems associated with the lower urinary system (LUTS).

The need
Over 50% of the population at the age of 50 will suffer at least one-time in the life from various urological problems that related to Lower Urinary Tract (LUTS) and Beinan Hiper Plasia (BPH) diseases, including: leaks, urinary urgency, urinary incontinence, irritable bladder, prostate cancer, prostatitis, and more. These problems are diagnosed by Urodynamic related tests which reflects a Total Available Market of $3 Billion. Currently, these diseases are diagnosed in hospitals or urological clinics. Uroflowmetry and Voiding Diary tests have been the primary tests used by urologists to make initial diagnoses for decades. However, these tests are cumbersome and require large and expensive equipment, as well as medical personnel to maintain and perform them. Additionally, it is not possible to continuously monitor patients throughout the day or collect enough information for insights and predictions.

These challenges result in delays in diagnosis and treatment since patients often cannot complete the test on time due to difficulties urinating caused by unpreparedness or environmental factors that create psychological pressure. Moreover, some medical issues occur at specific times, such as during the night or early morning, making it difficult to conduct a comprehensive and accurate test that matches the patient's urination profile.

The solution
Flometrica has developed a "digital measuring cup" that makes a revolution in the field of urodynamic tests in the field of urology. The Flometrica cup enables patients to comfortably perform tests at home, without pressure, saving significant time and resources while ensuring high-quality and efficient testing.

Flometrica eliminates the long wait for hospital appointments. Using this unique platform, doctors can guide patients to perform tests in different situations and at different times throughout the day and for several days, based on their symptoms. Compared to tests conducted in hospitals today, this solution offers greater value in understanding the patient's clinical condition and monitoring them during and after treatment. Additionally, the use of Flometrica's digital cup reduces medical expenses for the healthcare system and health insurance funds, which sometimes result from unnecessary and costly follow-up tests. It also significantly shortens waiting times and saves time for medical staff.

The company plans to launch a second product in the second half of 2023: a digital solution for the voiding diary. Currently, this test is done manually by patients for three days, and it helps doctors diagnose problems such as nocturia (nighttime urination), urinary incontinence, and urgency in urination. These issues greatly impact the elderly, causing sleep disturbances and posing health risks. In the future, the company intends to develop more products to complete the full set of urodynamic tests (including residual urine measurement) and provide monitoring capabilities for chronic patients with kidney stones and recurrent urinary tract infections. Additionally, the company is working on an AI (artificial intelligence) and ML (machine learning) algorithm system to analyze patient results based on Big Data, which will serve as an advanced diagnostic tool for doctors.

The technology
The technology behind the digital cup is based on the principle of electrical capacitance, which serves as a sensor continuously measuring volume over time. Integrated with additional sensors for movement, position, and pressure, it forms a technological platform from which various diagnostic and monitoring products for urinary tract problems can be derived. Flometrica's technology enables the combination of AI and ML algorithms.

Performing a remote test
The patient can now perform multiple tests at their home or office or at the doctor's clinic, instead of having to undergo tests in the hospital. These tests can be done at any time of the day when the patient experiences symptoms. The test results are transferred to a cloud-based server through a smartphone application. The cloud service collects and processes this information using unique algorithms to provide real-time information to the therapist for immediate diagnosis and monitoring of the patient's problem.

In addition to the convenience and undisturbed environment in which the tests can be performed, the digital cup allows the doctor to access a large number of results from the same patient, enabling more accurate diagnoses. The doctor may also request additional tests during or after drug treatment to assess the patient's response. For surgical treatments, the digital cup enables the monitoring of the patient's recovery and improvement over time.

(Conference of urologists, Eilat, December 2022)

The Opportunity
For several decades, the medical field has been seeking ways to outsource tests from hospitals to patients' homes to enable continuous or long-term monitoring based on individual needs. The COVID-19 pandemic has further highlighted the importance of remote medicine, especially for diagnostic tests and patient monitoring, eliminating the need for hospital visits for diagnostic purposes.

Intellectual Property
The "digital cup" is protected by a patent and is equipped with sensors that automatically perform urinalysis measurements. The patent was drafted and filed by Luzzatto and Luzzatto - Patent Attorney, one of the leading patent offices in Israel. It is registered and accepted in major markets such as the USA, Europe, Israel, Canada, Australia, China, and India. The first uroflowmetric product is approved by the FDA (American Regulatory Authority) and the Israeli Ministry of Health AMR (Medical Devices and Devices), allowing it to be marketed and sold in the USA and Israel. The company is also in the advanced stages of obtaining the European CE Mark. Flometrica has developed two algorithms in its cloud platform for analyzing the collected information and generating highly accurate results comparable to standard hospital devices, regardless of the user's proficiency.

Cooperation Agreements
Flometrica has distribution agreements with distributors in Israel, the USA, and Europe. The company has also established a collaboration with Asuta Ashdod (Maccabi) for usability testing of the product in a community medicine setting. The experiment involves testing approximately 100 male patients with urinary system problems, comparing the results obtained from the smart cup to those from hospital and clinic systems to highlight the advantages of home-based testing and diagnosis. Additionally, the company is in talks with the Kupat Holim Meuhedet for a pilot plan to provide answers to patients in a urology clinic, which could lead to continued product orders.

Flometrica was selected by the Mayo Clinic hospital in the USA from numerous Israeli companies for collaboration. The parties are working on cooperation agreements to utilize the smart cup for performing both types of tests simultaneously, as well as joint development of an innovative service that leverages collected patient data and a database built in collaboration with Mayo Clinic. This service will provide doctors with advanced diagnostic tools based on artificial intelligence, representing a significant breakthrough in urology diagnostics.

Target Audience
Flometrica's target audience includes insurance companies, health funds, urologists, and hospital managers who aim to provide optimal treatment using the company's digital cup. Private urology doctors and clinics also form part of the target audience, as they strive to integrate advanced technologies that enhance patient service and allow for efficient work and availability around the clock. Flometrica anticipates that exposure to its products among urologists, family doctors, and nurses will stimulate demand from users, leading to increased insurance coverage and patient interest in purchasing the products.