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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - MOWOOT (Integral Intestinal Transit Management System for chronic constipation)

Teaser

Summary

Up to 15% of the EU and USA population suffers from Chronic Constipation. The most affected collectives are women, elderly people and patients with Neurogenic Bowel disorders related to Spinal cord injury, Parkinson and multiple Sclerosis. Constipation causes painful evacuation, faecal impaction and incontinence, which have a big negative impact on the quality of life of these patients.
usMIMA S.L., offered MOWoOT as a non-pharmacological, non-invasive solution to relieve chronical 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 series of actuators. A pilot study with chronically constipated patients has already shown that the daily use of MOWoOT ameliorates idiopathic chronic constipation.
usMIMA wants to target a 90B Mâ‚¬ market of 150 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 has to prioritize the following activities during this phase 2:
â€¢ Conducting a larger clinical study as a marketing strategy to build confidence in the medical sector and promote MOWoOT prescriptions and reimbursement
â€¢ Upgrading MOWoOT 1.0 prototype to MOWoOT 2.0 product, by adding cloud and smart services and other features required by users
â€¢ Reducing costs (below current 500â‚¬) through scaling the manufacturing process
MOWoOT is expected to produce a big impact on usMIMA by:
â€¢ Generating 3.5 Mâ‚¬ of EBITDA by 2021
â€¢ Incorporating five new specialized employees to complement current staff profiles
â€¢ Introducing MOWoOT products in EU and USA markets by 2020
Moreover, MOWoOT will empower patients and elderly people, enhance well-being among the society, increase autonomy and reduce the increasing health care expenses due to aging population and the derived.

Work performed

Mowoot project has a favourable development, the management flow was created and applied through stablished management protocols and quality management measures and procedures.
During this first period, the efforts related with WP2 were focused on the design of MOWOoT 2.0 and its cost reduction, preparing the device for MP with new moulding and features. The electronics has also been redesigned, achieving as a result one single PCB helping not only space in the device, but also the initial investment required for mass production set up and tooling.
Regarding the HW developped specifications were defined based on the functionalities and user cases defined for the MOWoOT 2.0 version to serve as a guide for the hardware design. The development of the FW has been supported by the PCB designed. A first version has been developed integrating basic functionality and remote communication, including the communications protocol definition with the actions that the device can perform. The redesigns impacts on the cost reduction taking into consideration mass production goals, which is part of the WP3 planned for the second perdiod of the project. This made us modify the focus in WP2 from the initial proposal, where the effort was supposed to be dedicated on electronics and software development and we went a step further and start designing the required moulds. Several parts of the prototype have been built in order to validate the proposed solutions and also to help the decision making processes during the design stage.
Furthermore, contacts with mould manufacturers have been established to request budgets for the production of the first final product case.
SW specifications were defined and aligned with the electronics hardware design restrictions. A draft of the data architecture for the cloud platform was made. However, the architecture is prone to be adjusted once the cloud and APP development begin and first communication and functional tests are performed.
A control panel art design has been defined and redesigned according to the new moulds. Control panel suppliers have been contacted in order to get budgets for the production of the full functional prototypes and to evaluate the feasibility of the design for MP of the final device. This step also corresponds to WP3 but has been advanced and integrated into the design stage of WP2.
Electromagnetic and electrical safety compliance laboratories have been contacted in order to evaluate the best candidate to conduct the tests.

Regarding the work performed and achieved so far related to WP4 (clinical trial):
- The negotiation of the contract and signature of the agreement with the previously contacted centres has been achieved (GCU, CST, HUMT)
- The selection of a CRO; negotiation of the contract and signature of the agreement with PKTejeda S.L was achieved
- The design of the clinical trial protocol has been performed
- The elaboration of all the documents needed to perform the clinical trial have been done: protocol, annexes, scales, bowel diaries, informed consents, data management plan
- The protocol has been submitted to IRBâ€™s (Spain and UK)
- The amendments to protocol requested by IRBâ€™s have been done
- An electronic database has been designed
- Two liability insurance policies have been contracted, one for each country
- On-site initial visits and training of IPâ€™s and support staff in the three centres have been carried out
- The clinical trial has started in the three centres (Jan 2018)
- As of now, the patients included are N=32 (GCU= 17, CST= 8, HUMT= 7)
- A first-site monitoring visit in two of the centres (GCU and CST) was carried out
- On-site initial visits and training of IPâ€™s and support staff in the three centres have been carried out

And regarding WP5, everything has gone smoothly, performing the scheduled tasks regarding the IPR protection, data management and dissemination activities for this first period.

Final results

Launching this product to the market, is already a step beyond the state of the art per se. MOWOoT 2.0 is the first Automated Exo-Peristalsis (AEP) device, is a novel way to treat chronic constipation. Traditional approaches include laxatives and enemas, which are expensive and have side effects and massage treatment was to difficult to administer daily.
MOWOoT 2.0 is democratizing this individual, non-invasive, non-pharma treatment for the over 15% of the population that suffer chronic constipation, leading to a new gold standard of care.
MOWOoT 2.0 will be a IoT device, connected to the cloud, which will allow having the patient and doctor in touch, making massages libraries accessible and changing the massage parameters regarding the doctor prescription, tracking and recording data to adjust the massage selection, timings and paces.
With MOWOoTt project, the 1st clinical trial for automated colon massage ever will be performed. If the hypothesized results are materialized, we will obtain a scientific publication that will make official that it is a safe treatment, without adverse effects and full of advantages for the patient.
usMIMA decided to commercialize the primary and very basic version without IoT services to evaluate the market, obtaining real feedback on pricing sales channels, KOL support in sales, etc.) Thanks to this decision, we were able to gain more visibility, prepare a marketing and sales strategy for MOWoOT 2.0 that is rooted in real-life feedback and confirm first partnerships with international KOL and distributors.Meanwhile, MOWoOT 2.0 product was under development.