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Novel catheter to reduce Urinary Tract Infections (UTIs)

Periodic Reporting for period 1 - T-CONTROL (Novel catheter to reduce Urinary Tract Infections (UTIs))

Reporting period: 2018-08-01 to 2018-11-30

The aim of the action was to further evaluate technical, commercial and clinical aspects of our T-Control product, in order to design a successful and well-detailed business plan.
The actions carried can be summarised as:
i) Technical requirements established,
ii) Documentation for regulatory purposes detailed,
iii) Clinical necessities further concreted,
iv) The way of measuring the effectiveness and cost-effectiveness of the product designed and,
v) The economic necessities calculated.
The work was realized inhouse, but accounting with the support of several stakeholders (validation actions and surveys), advisors and with a significant contribution of the coaching services.
Both the team and the persons involved have contributed to widen and further specify our product and market positioning, creating a clear roadmap to commercialisation, assigning tasks and responsibilities in between.
By meeting the above-mentioned objectives, the company was able to reach the point where the Go/no-Go decision for all the future actions is basically an economic question. We eager to raise financial resources in order to cover the execution costs, so that the activities can start as soon as possible and as detailed in the present business plan.
Rethink Medical has further investigated the technical parameters and technological and regulatory requirements regarding product design and final manufacturing. The company evaluated several providers and selected one that with all the technological knowledge can meet price expectations and regulatory/quality requirements.
Rethink Medical has listed the regulatory steps for CE Mark notification, and we have started to work on the preparation of the technical filing procedures. A notifying body was in fact selected.
A Market research was conducted at a deeper level including clients, payers, insurers, hospitals... It included validation surveys, consultation of market reports/groups, and analysis of trends. We have seized the exercise to broaden our contacts list by healthcare professionals, hospitals, and potential licenses.
Based on the information gathered, a detailed commercial plan was prepared, paving special interest in Spain, where the company plans to start the commercialisation, with local agents. Several Spanish hospitals in our network have shown interest in using the product and participating in the clinical trials. At international level (EU at the cornerstone of the international expansion), potential license and/or distribution partners were analysed and contacted.
A Cost effectiveness study design started, confirming the pricing strategy.
An operative planning (production, warehousing, logistics and market access activities) has been envisaged.
The Go-to-market strategy was elaborated on a global level, with detailed Business Plan including scientific and commercial information.
Is important to highlight our Innovative purchasing model for the first years of operation. Exploitation, once the product is manufactured, can start without being registered. Such purchasing models offers financial support from the Administration and facilitates the organic growth of the company, with several advantages: 1. VC dilution can be avoided or at least diminished, 2. TTT (Time-To-Tomb) can be significantly broaden.
A Risk assessment was performed determining all the possible risk factors, contingency plans and analysis of the consequences.
An IP plan was updated: apart from the already approved patent, trademark registration was filed internationally (approved in the EU) in order to protect all the data published so far and in the future. Exclusivity agreements with specific providers are under discussion, aimed to create further barriers to competition.
With manufacturing during the first half of 2019, clinical trials can start in Sep ’19.
We expect to receive positive clinical outcomes from the clinical trials planned both in Spain and other countries.
T-control can contribute to:
- A significant decrease in infections,
- Improve the work effectiveness of the nursing staff
- Increase the quality of life of the patients, which has an effect on their physical, mental, social and professional life as well.
- The sustainability of the healthcare system by reducing costs, optimizing human resources (nursing staff) and reducing material usage.
The Spanish launch – if it happens before having a license/distribution partner for other countries- was planned and is expected to serve for demonstrating the potential of this business through the data received from customers.
As the project is under evaluation by possible license/distribution partners in other countries, any additional data (scientific, business or regulatory) is welcome and well appreciated, as it will help to reach satisfactory deals and enable T-Control to be launched in all EU countries, the US and possibly other markets.
With the preparation of the technical file and the already established relationship with the Notified Body, CE Mark approval is expected before Mid-2020, which is the deadline for the introduction of a new regulation.
After registration, we will have the possibility to amplify the data in order to meet the new requirements until 2025.
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