Therapnea: Novel Therapy to treat Obstructive Sleep Apnea based on Thomas Oro-Pharyngeal Stent

Project Information

Therapnea

Grant agreement ID: 782483

DOI

10.3030/782483

Project closed

EC signature date 1 August 2017

Start date 1 September 2017

End date 28 February 2018

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

THERAPNEA LABS LTD
Israel

Periodic Reporting for period 1 - Therapnea (Therapnea: Novel Therapy to treat Obstructive Sleep Apnea based on Thomas Oro-Pharyngeal Stent)

Reporting period: 2017-09-01 to 2018-02-28

Summary of the context and overall objectives of the project

Obstructive sleep apnea is the most common organic sleep disorder in which the respiratory path becomes occluded during sleep, usually due to collapse of the upper airways, causing the patient to stop breathing, with severe co-morbidity issues.
Although there are several known therapies for apnea (behavioural, devices or surgery), none is as successful and effective as using compressed air respiratory support to keep the airways open during sleep, making CPAP (Continuous Positive Airway Pressure) the most common treatment of choice. Unfortunately, it still has many limitations regarding patient’s compliance, and it is ONLY SUCCESSFUL FOR 50% OF PATIENTS.
According to the World Health Organisation (WHO), over 100 Million people worldwide suffer sleep apnea and its related morbidity and mortality risks. Tens of millions are unable to adhere or abandon current therapies, with CPAP as the first line of treatment. Low CPAP compliance, mainly due to major discomfort, is recognized as the major issue, and many companies are investigating ways to improve it. Sleep apnea devices market size is worth USD 8.8 billion by 2023, with 7.7% CAGR from 2016 to 2023.
We at Thomas Medical Ltd. have been working on the development of a disruptive solution to respond to the unmet needs of patients that can’t adhere current therapies. The invention is an upper airway stenting device intended for the treatment of adult obstructive sleep apnea. The device, Therapnea™, operates by providing mechanical support to the walls of the pharynx and the back of the tongue, thereby preventing their collapse and eliminating partial or complete airway obstruction during sleep. We aim to provide effective therapy to the tens of millions of sleep apnea patients who can’t be helped with current CPAP devices or surgeries, and thus become the first line of treatment in the long term.
The overarching objective of the feasibility study was to collect clinical data and evidences in a sleep lab demo regarding the acceptance, effectiveness, impact on sleep architecture and many other parameters. The aim of the study was to understand and enable the successful continuation of the development of the product, help assess the risks associated with the planned industrialization and scalability, and reduce the risks associated with the commercialization of the solution.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The overarching objective of the feasibility study was to collect clinical data and evidences in a sleep lab demo regarding the acceptance, effectiveness, impact on sleep architecture and many other parameters. The aim of the study was to understand and enable the successful continuation of the development of the product, help assess the risks associated with the planned industrialization and scalability, and reduce the risks associated with the commercialization of the solution. All this has been carried out successfully, confirming we can continue investing in the product to make it market ready and introduce it in the target countries and segments defined.
Besides the clinical study, during the project we carried out deeper market analysis, stakeholders identification and engagement, technological roadmap, IPR analysis and financial forecasts.

Hence, during the period of the project, the CEO of Thomas Medical had met with sevral experts in field of sleep disorders. In Beijing, China, with one sleep lab and two potential distributors in the sleep disorders, selling CPAPs and also three potential investors. In Hong Kong, with one sleep lab and one distributor and one potential investor. In Singapore, with one potential distributor and one potential investor. In San Francisco with three potential investors. In Israel with two sleep labs, one potential distributor and and five potential investors. We had also met in Israel with four propfessionals in the sleep disorders, and experts in regulations. The purpose of the meetings where to collect professionals’ opinion on our device, to find out their interest distributing our device, once it is ready and to find out interest investing in our project. ALL professional we have met expressed high level of interest in the project and the device and showed interest getting involved in the future, some for investing and some for distributing, subject to positive results of the “Proof of Concept” clinical study. There were no sleep disorders congresses during the period of the project. We do plan to visit the “Sleep” congress in Baltimore, 2-6 June 2018.

The clinical study done in a sleep lab, in Mumbai, India, in January 2018, as main objective of the SME-1 project, we have proved our system is working successfully, stopping apnea, and snoring. We have also learnt, from the clinical study, how we should design the final product and where and how to start to sell it. This work has already began.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The proposed therapy methodology and device bring a totally new concept in sleep apnea therapy: the ability to deploy stenting therapy to sleep apnea. This is not only new to Europe, but world-wide. If this therapy is found safe, compliance and effective, it will improve the health and wellbeing of tens of millions of sleep apnea patients who can’t adhere CPAP therapy. Clinical studies show that the health-resources utilization of a sleep apnea patient are halved after therapy is initiated. Additionally, treating sleep apnea leads to significant reduction is road and work accidents caused by excessive sleepiness. These savings will clearly contribute the European and global challenges in the areas of healthcare, quality of life, reduction of health costs and competitiveness in the health market. Additionally, the ability to collect physiological Big Data from patients will create the first of its kind database, which will be very valuable to researchers and industry, benefiting the all aspects of society.

Patient with the beta-version of Therapnea device