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Integral Intestinal Transit Management System for chronic constipation

Periodic Reporting for period 3 - MOWOOT (Integral Intestinal Transit Management System for chronic constipation)

Reporting period: 2019-04-01 to 2019-11-30

Up to 24% of the EU and USA population suffer from Chronic Constipation. The most affected collectives are women, aging elderly people and patients with Neurogenic Bowel disorders related to Spinal Cord Injury, Parkinson and Multiple Sclerosis. Constipation causes a painful evacuation, fecal impaction and fecal incontinence, which have a big negative impact on the quality of life of these patients.
USMIMA S.L. created in 2014, offers MOWOOT, a non-pharmacological, non-invasive solution to relieve chronic constipation, without side-effects, in form of a wearable class II medical device that automatically emulates the abdominal massage techniques of professional therapists via a number series of actuators.
A pilot study with chronically constipated patients had already shown that the daily use of MOWOOT ameliorates idiopathic chronic constipation.
USMIMA wants to target a 90B M€ market of 250 million people with chronic constipation identified.
A feasibility study showed that, in order to target this market and increase the influence on target clients, USMIMA had to prioritize the following activities during the project:
• Conduct a larger clinical study as a marketing strategy to build confidence in the medical sector and promote MOWOOT prescriptions and reimbursement
• Reduce costs (below current 500€) through re-design and preparation of scaling the manufacturing process
• Upgrade Mowoot 1.0 prototype to Mowoot 2.0 product, by adding cloud and smart services and other features required by users and professionals
MOWOOT will empower patients and elderly people, enhance well-being among the society, increase autonomy of the treatment and reduce the increasing health care expenses due to aging population and the derived long-term cares.
-QMS:
• Successfull transition to the new applicable standard regarding the QMS (ISO 13485:2016 & EN ISO 13485:2016)
• Successful annual internal assessment audit (ISO 13485:2016)

-Mowoot 2.0 Design and development:
• Mowoot 2.0 design finished.
• Mowoot 2.0 prototypes built during the design stage as part of the iterative product development lifecycle.
• Mowoot 2.0 FW built and deployed in functional prototypes.
• Core of the Mowoot 2.0 Cloud Platform was developed and a functional version was deployed.
• Stress Testing tool was developed, built and validated as part of the preparation of Mowoot 2.0 MP processes, specifically for quality control assessments.
• Pre-lab testing has been conducted to assess the stability and robustness of Mowoot 2.0 design in front of electrical hazards.
• Regulatory documentation for Mowoot 2.0 has been developed to prepare market entry process.
• 1st short batch of Mowoot 2.0 has been produced to further conduct user validations and Technical testing.

-Clinical Study MOW-01-2017:
• Closing of executive phase of the study on 1st April 2019.
• Initiation of “analysis of results” phase with the data cleaning & definition of different populations for the statistical analysis: SAF n= 92, ITT n=92 and PP n=65.
• Design & Execution of the statistical analysis plan (SAP).
• Final discussion and interpretation of the results with lead investigators
• Nov-Dec2019 the manuscript is been written.
• Submission of the manuscript of the results of the Clinical Study for publication as an original article in a peer-reviewed scientific journal is planned for the 1st trimester of 2020.
• Brief summary of results:
the hypotheses of the clinical trial have been proven
the results of the study clearly demonstrate the medical benefits of the MOWOOT system in the treatment of home care patients suffering from chronic constipation.

-Dissemination:
• Transition of the dissemination activities to local distribution partners has been initiated to ensure scalability and international reach.
• Submission of preliminary report of the results of the Clinical Study to the GKV Spitzenverband Germany to support the entry of the MOWOOT device into public healthcare reimbursement
• Manuscript of the results of the Clinical Study “MOW-01-2017”

-BD:
• Signature with a distribution partner for Germany and initiate negotiations with further EU distribution partners.
• Public healthcare reimbursement (core part of business model):
Application for public healthcare reimbursement in Germany (“Hilfsmittelkatalog”) in collaboration with the German GKV Spitzenverband. Acceptance is expected in Germany during 2020.
The application process for public healthcare reimbursement in the UK has been initiated.
• Initiation of negotiations for a worldwide licensing deal.
• Preparation of series A financing round.
This period lead to important deliverables which takes the company closer to the goal of establishing the MOWOOT treatment as the new standard of care for slow intestinal transit chronic constipation as well as attracting further (private/VC) funding and distribution partners.
Impacts generated:

The IPR protection carried out within this project has a positive impact as entry barrier for competitor products and securing of product positioning. Furthermore IPR protection is an essential pre-requisite for attracting further private funding for the commercialization phase of the product.

Important milestones have been reached within the latest period to lower the cost of production and therefore create a viable business model for the product. Furthermore the connectivity component developed helps to enhance the value proposition and prepare the product for a sustained market presence in the ecosystem of digital and connected health that will gain more importance in the future. Main impacts will be driven by the following features:
• Reduction in the cost of production
• Design prepared for market shortage events of crucial parts
• Product readiness for the different demands of public healthcare reimbursement market via modular design
• Preparedness for future market requirements via connectivity & cloud services.
• Optimized treatment: the treatment by MOWOOT 2.0 has been optimized based on the results of early prototype testing to give the best possible clinical results.

The results of the clinical study support the beneficial effects of the MOWOOT medical device on chronic constipation. These positive clinical results provide the high quality evidence needed for entering public healthcare reimbursement in EU markets & gaining professional acceptance.
So far the biggest direct impact of our study has been made in the German market, where the application to public healthcare reimbursement (GKV Spitzenverband/Hilfsmittelverzeichnis) has been submitted in November 2019, including the results of the clinical trial. In addition, MOWOOT treatment is positively mentioned in the official medical guidelines to manage constipation in neurological patients in Germany (Deutschsprachige medizinische Gesellschaft für Paraplegiologie, August 2019 “Leitlinie Neurogene Darmfunktionsstörung bei Querschnittlähmung”, p15).
Currently the company is working on the same goals in the UK, where the public healthcare reimbursement process has been initiated in collaboration with the NHS.

In QM, Medical device company are obliged by law to comply with a strict quality management. ISO13485 certification, maintainance and audits state the foundation for the business of the company. Furthermore MOWOOT 2.0 documentation has been prepared to especially address the demands for the new Medical Devices Regulation (MDR 2017/745).
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