In the recent past, children and adolescents with ADHD faced the burden of stigma, being referred to as "having ants in their pants." They were often considered poor students, and sometimes even labeled as "problematic." Today, the health and education systems recognize that attention deficit disorder (ADD and ADHD) is a genuine and chronic neurodevelopmental condition resulting from dopamine deficiency, and is unrelated to a student's intelligence or cognitive abilities.
The attention disorder manifests in short-term symptoms of inattention, hyperactivity, and impulsivity. Improperly treated attention disorders, particularly during the early stages, can lead to long-term negative consequences, including:
Essentially, the very systems meant to aid these children often contribute to a "self-fulfilling prophecy" through unfair labeling.
Presently, approximately 128 million individuals aged 5 to 19 worldwide are diagnosed with attention deficit disorder, accounting for nearly half of the total diagnosed population of around 250 million people.
Behavioral treatment alone is insufficient for most ADHD cases and typically necessitates regular medication to balance dopamine levels. There is a wide variety of drug treatments, with different release mechanisms, doses, and more. Analyzing ADHD is challenging for the following reasons:
• Treatment begins with physicians prescribing the lowest available dose of a chosen drug, which may be adjusted or changed over several months or even years.
• The effectiveness of drug treatment varies individually and evolves alongside physiological changes in patients.
• The disorder encompasses distinct aspects - inattention, hyperactivity, and impulsivity - which respond differently to drug treatment. For instance, while hyperactivity levels may decrease with medication, the child's attention may not improve significantly.
Current monitoring processes rely on manual questionnaires. These subjective methods involve input from teachers and parents, who may lack the relevant skills to assess treatment efficacy. As a result, the monitoring process remains trial and error-based, leading to suboptimal clinical outcomes, low engagement rates (less than 50% within the first two years), and substantial costs borne by clinical service providers and insurance companies. Annual treatment expenses for a child with ADHD in the US reach tens of thousands of dollars, similar to the costs level in Europe. Furthermore, parents spend additional non-covered costs, exceeding one thousand dollars per patient.
Iluria's software introduces a revolutionary technological solution that offers a constant and objective evaluation of drug treatment safety and efficacy. This is achieved through mathematical analysis of physiological indicators recorded by any wearable IoT device or smartwatch owned by users.
Using machine learning-based algorithms, the system assesses the physiological impact of drug treatment throughout the day, including duration and intensity, while also providing long-term trends. The monitoring process is entirely passive and non-invasive, requiring no active participation from the patient.
The goal of Iluria's software platform is to enhance treatment quality, foster patient commitment and adherence, and reduce ongoing treatment expenses. It achieves this by delivering objective and continuous monitoring in accordance with the recognized clinical standard, the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
On June 1, 2023, the company secured a patent for their ADHD solution in the American market. Similar processes are underway for other regions such as Europe, China, India, and more.
How it Works
Iluria's software utilizes mathematical analysis of daily fluctuations in physiological markers, which have already been scientifically and medically established to be associated with ADHD. These markers undergo changes during the course of drug treatment processes, including movement, angular movement, heart rate, heart rate variability, and more. Physiological data is routinely collected using various intelligent wearable devices such as Fitbit or Apple Watch. The initial product version employed Samsung Galaxy watches for pilot programs conducted in medical institutions, with plans to incorporate additional smartwatch and wristband platforms.
The mathematical analysis of physiological data is performed by the machine learning engine, which delivers a continuous evaluation of the therapeutic impact throughout the day. This includes identifying risk factors like abnormal heart rate increases and assessing long-term treatment trends. Objective reports generated through passive patient monitoring are provided to relevant stakeholders, including clinicians, patients, and parents.
The core component of the system, the machine learning technology, underwent testing in two completed clinical trials conducted by the company. The first trial was successfully conducted in collaboration with Clalit Health Services, while the second study, involving two measurement stages, partnered with the Cincinnati Children's Hospital. Cincinnati Children's is one of the leading pediatric medical facilities in the United States and a world leader in ADHD research and treatment. Additionally, the company initiated another clinical trial in Italy in March 2023, collaborating with IRCCS Eugenio Medea - Associazione La Nostra Famiglia, a leading Italian children's hospital. Furthermore, the company is initiating additional field trials (pilots) in the United States, England, and Europe.
Selected from a pool of companies, Iluria secured a partnership with Takeda Pharmaceutical, through the Meet the Pharma Startups program organized by EIT Health. Additionally, the company had the opportunity to present its solution to Takeda UK's management, exploring potential collaboration in the British market.
Looking ahead, the company is actively working on expanding the solution to address ADHD in adults as part of its product strategy. In that regard, the company is starting a pilot with Tel Aviv University to measure treatment impact on the student population. Moreover, in line with the future product roadmap aimed at treating other behavioral disorders such as anxiety and depression, the company recently submitted a patent application covering the management and control of drug treatments in these areas.
Technology and intellectual property
The company's technology being developed for attention deficit hyperactivity disorder (ADHD) is unparalleled worldwide, providing continuous and unbiased monitoring through existing technological infrastructures, such as smartwatches, without the need for external intervention.
In collaboration with Clalit Health Services, the company conducted an experiment to develop the initial version of the product. This version enables the identification of treatment-related situations based on clinical diagnosis and medical factors. To avoid biasing of misdiagnosed cases, a group of patients underwent three DSM-V compliant clinical diagnostic processes, with and without drug treatment. Simultaneously, the mathematical models' different layers were developed to automatically assess the effectiveness of drug treatment solely through physiological measurements using smartwatches. The results of this successful clinical trial were presented at the annual conference of the Israeli Society for Clinical Pediatrics (for more information, click here).
In the United States, a successful clinical trial was conducted with Cincinnati Children's Hospital. This trial involved the expansion of the technology into a multi-day analysis of drug treatment tailored to each individual patient.
On March 2023 the company launched another clinical trial with the Italian base IRCCS Eugenio Medea - Associazione La Nostra Famiglia, with the goal to provide additional data to enhance the models.
In January 2019, the company submitted a PCT (global protection) application to safeguard intellectual property in the ADHD field. The application is currently in the National Phase (for more details, click here). On June 1, 2023, the US Patent Office confirmed the approval of the patent for the USA. Additional territories are expected to grant final approvals in the upcoming year.
Furthermore, in March 2021, the company submitted a PCT application to protect intellectual property in the domains of anxiety and depression. These areas also involve a trial and error process in monitoring the effectiveness of drug treatment (for more details, click here).
Institutional medical service providers
Alongside the collaboration with Clalit Health Services, the company has partnered with Cincinnati Children's Hospital, renowned as the foremost institution in the United States specializing in attention disorders. This collaboration includes a multi-year plan for product development and commercialization, integrating with the organization's core system for managing treatment processes in the field of attention disorders,the Cincinnati Children's Hospital Mehealth for ADHD center (www.mehealth.com).
In the UK, the company collaborates with a medical center affiliated with the English Health Authority (NHS) - Rotherham Doncaster and South Humber NHS Foundation Trust. The collaboration involves various stages, including a product pilot and support for regulatory (CE-UK) and commercial (UK Reimbursement) processes. Given the relatively favorable regulatory environment in England, the company is considering an initial launch of the medical product in the U.K. market before expanding to the U.S. market.
Pilots and additional clinical trials: As mentioned, the company initiated a field pilot in partnership with a prominent medical center in Budapest, Hungary - Bethesda Children's Hospital. Concurrently, an expanded clinical trial is being conducted with one of Italy's leading medical centers, IRCCS Eugenio Medea - Associazione La Nostra Famiglia.
Simultaneously, the company formed a consortium for clinical and commercial collaboration with several leading medical centers in Europe, including the aforementioned centers in Italy and Hungary, as well as the Central Institute of Mental Health (Germany) and University Medical Center Groningen (Netherlands). The consortium aims to jointly pursue grants from the European Union and carry out additional pilots.
To establish the future infrastructure for analyzing the effects of drug treatment in adult patients, the company initiated a clinical trial with Tel Aviv University. This trial focuses on analyzing the treatment's effectiveness for young adult (students), with the primary objective of preventing unnecessary overuse of various drugs as a means to enhance concentration.
Technological platforms for parents of children with ADHD
While evaluating direct-to-consumer activities, the company has established collaborations with various companies, including:
- A partnership with Tiimo (www.tiimoapp.com), a Copenhagen-based company specializing in developing technologies for the daily management of ADHD. Tiimo's product presently caters to over 50,000 end users.
- Collaboration with Neuro-solutions (www.neurosolutionsgroup.com), a Canadian company that created a video game targeting behavior regulation in ADHD patients. The company serves approximately 50,000 end users.
- Iluria serves as a partner in the consortium led by Amazon Web Services. This consortium aims to create a comprehensive system, named ADHDMyWay, to fully support parents of children with ADHD in managing their unique challenges. Within this framework, Iluria's role focuses on incorporating the scientific and clinical components into the system.
- The company was chosen to participate in the Meet the Pharma program organized by the EIT Health organization, paving the way for potential collaboration with Takeda, a global pharmaceutical company. Currently, we are exploring opportunities to join forces with Takeda UK in our endeavors within the English market.
- Furthermore, the company maintains ongoing communication with other pharmaceutical companies, including Otsuka, to explore potential partnerships and collaborations.
Iluria in the media