By: Hagay Levy
CEO
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Iluria

Iluria‘s groundbreaking tech for the management of ADD/ADHD treatments has successfully completed a clinical trial, operates with leading US and EU hospitals, and is targeting a huge initial market.

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Minimum investment: $10,000
Type:Equity   
Stage:Pre-seed
Category:Healthcare
  • Campaign Highlights
  • Pitch
  • Team
  • Financial data
  • The Deal
  • Documents
  • Disclosures
  • Updates

Campaign Highlights

Improving life quality for children and adolescence, while saving enormous medical costs

Today, about 10% of all children and adolescents in the world are diagnosed with ADD/ADHD, but this large population has to rely on pharmacological treatments, whose effectiveness is measured subjectively via "trial and error", based on manually filled question forms. In many cases, this outdated method leads to an incorrect clinical process, which also includes medication treatment which is not helpful to the patient, and also carries very high treatment costs. For both these patients and their clinicians, Iluria's tech is the first real breakthrough in the field, providing for the first time a continuous and objective analysis of medication treatment processes, relying on mathematical analysis of changes in physiological markers, measured using any smart wearable item or smartwatch.

An innovative solution for an international market estimated at billions $

Initially, Iluria's solution is aimed for the children and adolescents care industry in developed markets, valued at billions of dollars annually, with around 128 million children diagnosed between the ages of 5-19, out of a total of 257 million (!) people of all ages, diagnosed with ADD/ADHD worldwide. In the US alone, the annual cost of treatment is estimated at tens of thousands per patient, which is completely wasted in most cases on incorrect and ineffective treatment - both in medical resources, as well as costs not covered by insurance, which weigh heavily on the families of the patients, while also not actually improving childrens' health.

Clinical and business collaborations with leading medical centers worldwide

The system developed by the company has already been successfully validated in a clinical trial with Clalit HMO in Israel. In the US, the company has clinical and business collaboration with the Cincinnati Children's Hospital, one of the leading pediatric centers the US, and is also considered as the leader in ADD/ADHD. The company is also collaborating with other well-known European medical centers, including IRCCS MEDEA - Associazione La Nostra Famiglia (Italy), Central Institute of Mental Health (Germany) and University Medical Center Groningen (Netherlands).

Other medical centers the company is already in contact with include Mount Sinai in New York, Hasbro Children's Hospital in Rhode Island, Children's Health in Dallas as well as with a large number of other institutional and private health service providers. Moreover, the company was selected by Takeda, one of the largest pharmaceutical companies in the world, to participate in the Meet the Pharma program, for a future strategic collaboration.

Attractive and protected IP, on the FDA's fast approval track

Iluria's technological developments in the field of ADD/ADHD represent an attractive, registered and protected intellectual property (PCT / IB2020 / 050088 - 2773ILU-PCT) and the company has also filed a patent application aimed at protecting the use of its technology in the fields of Depression and Anxiety (Provisional Patent Number 63164673). Simultaneously, the company began a pre-submission process with the FDA, based on clinical trials with Clalit HMO and the Cincinnati Children's Hospital, in the "Decision Support Tool" rapid approval track.

Accelerator programs & capital raised via The Israeli Innovation Authority and other investors

Iluria has started a fund raising process to fund product development and commercialization, for institutional entities (clinical service providers and insurance companies) as well as for end users (as part of a consortium to build the ADHDmyway platform, led by Amazon Web Services). The clinical proceedings were funded with the assistance of the Innovation Authority, and the company has also completed pre-seed recruitment from Health Wildcatters (one of the top three US Healthcare acceleration programs). The current round of funding already includes additional investments, made by several "angel" investors who operate in the US Healthcare sector.

Pitch

The Idea

The problem

Up until not so long ago, children and adolescents who suffer from ADD/ADHD also had to suffer the accompanying stigma, that they are simply "impatient" or "just not good students" or in some cases even "problematic children", but now it is clear to both health and education systems, that Attention Deficit Hyperactivity Disorder (ADD and ADHD) is a real, chronic neurodevelopmental disorder, resulting from a lack of dopamine (a neurotransmitter).

In the short term, these attention disorders are related to patterns of inattention, hyperactivity and impulsivity, and if not treated properly, especially in the first years of the disorder’s appearance, may include long-term adverse effects - depression and other psychiatric disorders, inability to complete academic studies, increased crime rates, increased rates of unnatural mortality etc. In other words, the same unfair stigmatic marking, by the very systems that are supposed to help the child, unfortunately often turns into a "self-fulfilling prophecy".

Currently, about 128 million children and adolescents, between the ages of 5 and 19, are diagnosed with ADD/ADHD, and this population constitutes almost half of all people diagnosed, amounting in total to about 279 million people, worldwide.

Along with behavioral therapies, in most cases ADHD requires regular medication, in order to balance dopamine levels. The pharmacological treatments include a very wide range of drugs with different release mechanisms and dosages. Attention Deficit Hyperactivity Disorder is a very complex disorder to analyze, for the following reasons:

  • The effectiveness of pharmacological treatment is personal and also changes over time, along with the physiological changes in patients;
  • The disorder includes elements that are affected by the medication in an unrelated way - inattention, hyperactivity and impulsivity, and these three elements are not necessarily coordinated (for example, the medication may, in some cases, lower the level of hyperactivity, but not produce a sufficient improvement in the child's attention).

Current monitoring processes include manually filling out questionnaires. These processes are entirely manual and subjective, as clinicians rely on input given by teachers and parents, who do not necessarily possess the relevant skills needed to evaluate treatment effectiveness.

In fact, the entire monitoring process is carried out, to this day, by a method of trial-and-error, leading not only to clinical treatments that are not beneficial to patients, but also to enormous costs covered by the clinical service providers, insurance companies and HMOs. Annual care costs for a child with ADD/ADHD in the US are estimated at tens of thousands per year, with annual costs in Europe ranging similar amounts.

 

The Solution

Iluria's groundbreaking technological solution provides a continuous and objective analysis of medication treatment, by mathematical analysis of changes in physiological markers, measured using any smart wearable IoT product (e.g., smartwatch or smart wristband) used by users.

Through the analysis of proprietary ML (machine learning) based algorithms, the system analyzes the effectiveness of the medication throughout the day (the duration of effect and changes in intensity) and also provides long-term trends insights, maintaining a completely passive monitoring at all stages, without any patient involvement.


Iluria's software platform is designed to improve the quality of care and reduce ongoing treatment costs, by providing objective and ongoing monitoring, while complying with the global clinical standard - The Diagnostic and Statistical Guide for Mental Disorders, 5th Edition (DSM-5).
 

How does it work?

Iluria's software mathematically analyzes the daily changes in physiological markers (such markers have already been scientifically and clinically associated with ADD/ADHD), which change during the medication treatment processes (such markers include motility, angular motility, heart rate, heart rate variability, etc.). This physiological data is measured on a regular basis by using any smart wearable product (such as Fitbit, Apple Watch, etc.).

The changes in the physiological data are mathematically analyzed by the machine learning engine, which provides an ongoing analysis of the medical treatment effectiveness throughout the day, as well as an analysis of longer trends in the effectiveness of treatment. The various reports are provided to the relevant end-user (clinicians, patients, parents and institutional players) in order to provide an objective analysis, based on the passive measurement of patients.

The machine learning system, which is the central part of the platform, was validated in two initial clinical trials. The first clinical trial was successfully completed with Clalit Health Services, the world's 2nd largest HMO, and the second trial (in which the first phase of measurements has already been completed with great results) is conducted in collaboration with Cincinnati Children's Hospital, one of the top children's hospitals in the US and the leading US institute in the study and treatment of ADD/ADHD.

Beyond that, and as part of its product strategy, the company is working to upgrade its solution to also address ADD/ADHD in adults. For this purpose, the company was selected from a long list of nominees for collaboration with the Takeda pharmaceutical company, as part of the Meet the Pharma Startups program of the EIT Health organization (Click here for additional info).

In addition, as part of the product strategy for the upcoming years, to also treat additional behavioral disorders starting with Anxiety and Depression, the company has recently filed a provisional patent application covering the management and control of pharmacological treatments for these conditions.


Technology and IP

Iluria's ADD/ADHD technology is the first and only of its kind in the world, with the ability to provide continuous and objective monitoring, without external intervention, using existing technological infrastructures to measure physiological indicators (such as smart watches).

In a completed trial conducted in collaboration with Clalit Health Services, the company has developed its first product’s version, aimed at deciding whether medical treatments are effective or not, in compliance with the DMS-5 clinical diagnosis done by clinicians. In this trial, a group of patients underwent three different clinical diagnostic processes, to eliminate potential false and positive cases. In parallel, the patient's physiological markers were measured during these processes, and then various layers of the mathematical models were developed to automatically identify the effectiveness of the medication, relying only on measuring physiological elements using a smart wearable. The clinical trial results of the Clalit Health Services study were presented at the Israeli Clinical Pediatric Society annual convention in February 2021 (for more details about the publication click here).

In the planned follow-up testing to be carried out in the US and Europe, longer tests will be carried out for FDA and CE approvals, and the company has begun a process of pre-submission to the FDA, in order to ensure rapid regulatory approval, as a “decision support tool”.

In January 2019, the company filed a PCT application (Global Protection) for the protection of intellectual property related to applying it's technological solution in the field of ADD/ADHD. This application is currently in the National Phase (For more details click here).

In addition, in March 2021, Iluria has also filed a provisional patent application for the protection of its IP for use in cases of Anxiety and Depression, which are also characterized by "trial and error" in the monitoring of the effectiveness of pharmacological treatment. Application Number 63164673 (DIAGNOSIS AND MONITORING MEDICAL EFFECTIVENESS FOR ANXIETY AND DEPRESSION DISORDERS).


International Collaborations


Institutional medical service providers
In addition to its collaboration with Clalit Health Services, the company has a collaboration with the Cincinnati Children's Hospital, which is considered the largest and the leader in the field of attention disorders in the US. The collaboration includes a multi-year program for the development and commercialization of the product, while interfacing with the core system used by the organization to manage the treatment processes in the field of attention disorders (Cincinnati Children's Hospital Mehealth for ADHD - www.mehealth.com).

The company has also established a consortium for clinical and commercial collaboration with three leading medical centers in Europe: IRCCS MEDEA - Associazione La Nostra Famiglia (Italy), Central Institute of Mental Health (Germany) and University Medical Center Groningen (Netherlands).

Tech platforms for parents of children with ADHD

Iluria is a partner in a consortium led by Amazon Web Services, which was established in order to develop a holistic system for fully managing the processes which parents of children with ADHD face (ADHDMyWay). In this consortium, Iluria is in charge of adding the scientific/clinical component to the system.

In addition, Iluria has a partnership with Tiimo (www.tiimoapp.com), a Danish startup already in production that develops technologies for the daily management of ADD/ADHD. Tiimo's product currently serves over 12,000 end users.

Pharma companies

The company was selected for the Meet the Pharma program by the EIT Health organization, for future collaboration with Takeda, a leading international pharmaceutical company. As part of this collaboration, the company will expand its technology for use in adult ADD/ADHD patients.

Team

Hagay Levy
Co-Founder and CEO
Biography
Hagay has been a founding partner and CEO of Iluria since it was formed. Hagay has over 25 years of business c-level experience in various high tech companies in the B2B world, in the fields such as Fintech, Communications and Homeland Security. Hagay has held a wide range of management positions, such as CFO, Business Development Manager and Product Management. At the beginning of his professional career, Hagay gained extensive experience as a business analyst, specializing in corporate recovery. Hagay has a BA in economics and management and a master‘s degree in finance and accounting, both from Tel Aviv University.

  • Founder
Ido Friedlin
CTO
Biography
Ido is a Data Science expert with many years of experience in developing Machine Learning-based systems, in the fields of finance, healthcare and cyber. Ido founded Modelity Technologies (acquired by LPA GMBH) and served as its CEO for many years, in addition to a number of other senior technology and management positions in Israel and abroad, including as VP of Strategy for the Menora Mivtachim Group. Ido has a BA in mathematics and computer science and an MA in finance, both from Tel Aviv University.

Ran Yizraeli
VP Business Development
Biography
Ran has extensive experience in accompanying, maturing and leading technology companies at an early stage, mainly in the field of medical equipment and life sciences. Prior to joining Iluria Ran served for many years as an investment manager at an investment firm in the venture capital sector, during which time he accompanied companies such as Lithotech Medical (now owned by Nordson Medical) MediGuide Ltd. (now owned by Abbott) and Modelity Technologies. Ran has a BA in law (LL .B) from the Interdisciplinary Center in Herzliya.

Birkat Klimstein Levy
Co-Founder and director
Biography
Birkat is a founding partner of Hoshen Project Management, one of Israel‘s leading companies in the country in the fields of urban renewal, urban planning, infrastructure and structures. Birkat, who serves as a director at Iluria, founded the company together with her life-partner, Hagay Levy, based on many years of in-depth knowledge in the field of ADHD, as a mother of 4 children, 3 of whom are diagnosed with attention disorders. Birkat has a BA in landscape architecture from the Technion and a MA in business administration from Tel Aviv University.

  • Founder
  • Director
Professor Liran Carmel
Scientific Advisory Board
Biography
Prof. Liran Carmel is a world-renowned mathematician and scientist in the field of computational biology. Liran is the director of the Department of Genome Research at the Hebrew University and completed his postdoctoral research in the US at the National Health Institute, specializing in molecular evolution, genetics and RNA biology. In addition to his academic background, Liran has many years of experience in developing technologies for various industries. Liran accompanies Iluria since prior to its formal establishment and helps formulate and test the scientific and mathematical concept on which the technology is based. Liran has a BA degree in physics from Tel Aviv University, a MA in physics from the Technion, a doctorate in mathematics and computer science from the Weizmann Institute of Science, and a postdoctoral fellowship from the National Health Institution in the United States.

  • Advisor
Professor Itai Berger
Clinical Advisory Board
Biography
Prof. Itai Berger is an expert in pediatrics, pediatric neurology and child development, and is one of the leading experts in the country in the field of attention disorders. Itai currently manages the child neurology services in the pediatric ward at Assuta Ashdod Hospital. Itai studied medicine at Ben Gurion University, specialized in pediatrics at Shaare Zedek, then specialized in child neurology, at the Children‘s National Medical Center in Washington, D.C. and at Shaare Zedek Hospital. He also managed the child neurology unit at Hadassah Hospital.

  • Advisor
Dr. Venkat Reddy
Clinical Advisory Board (UK)
Biography
Dr. Venkat Reddy is an expert in pediatrics and child development, with about 30 years of experience in the British National Health Service (NHS) in the treatment of attention disorders, autism and other disabilities. Venkat currently serves as Senior Head of Child Development at Cambridge Medical Center (Cambridgeshire & Peterborough NHS) and also serves as Head of Clinical and Artificial Intelligence at Future Perfect, which deals with digital infrastructures for the medical world. In the past, among his many other activities, Venkat has served as a clinical leader at the NHS Innovation Institute.

  • Advisor

Financial data

The Deal

Documents

Disclosures

Updates

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