During the project execution, we have carried out an extensive desk research (for objectives 1 and 2), discussed with Notified bodies and experts in the regulatory sector (for objective 1), and talked personally (at dissemination events or by visiting them in person) with several potential customers (for objectives 2 and 3).
Main results of objective 1:
The HyperCollar 3D is a class IIb medical device under the 2017-745 Medical Device Regulation (MDR). However, there is a minor risk that this will change to a class III, based on clarification of classification rule 11. In general, the current transition of the EU regulatory landscape from MDD towards MDR adds risks to the regulatory conformity process and therefore the time to market. This risk applies to the medical device industry as a whole, and not specifically to Sensius, but it still represents a risk for our commercial strategy.
A Quality Management System (QMS) will be set up that supports the above activities by starting with documenting the development process. After that, the QMS can be gradually extended.
Main results of objective 2:
• In all countries, respondents stated that purchasing this device was more likely than a leasing model, especially for larger hospitals
• The US is the largest and most attractive market, due to hospital’s extensive financial resources and existing reimbursement codes for other hyperthermia treatments. Among US hospitals there is a broader range of willingness-to-pay for innovative devices than in Germany and Switzerland.
• Germany and Switzerland are similar for the high willingness to pay, but lacks of broad reimbursement. In Germany, there is a scheme (Zusatzentgelte) that could be a bridge to permanent funding. In both countries, the engagement of Key Opinion Leaders is the key for commercial success.
• The two countries differ in a few aspects. Switzerland is obviously a smaller market, and only a few hospitals will have enough patients to warrant purchasing the device. However, in Switzerland, per patient fees were considered as an acceptable financing method, but administrators in Germany were resistant and saw it as an “extra” cost.
• Germany and Switzerland can be developed in a two-step approach: initially focus on larger university hospitals with an interest in the technology and reasonable capital endowment and once appropriate DRG & fee for service codes in place the market can be expanded to cover more hospitals.
• Large university hospitals in Switzerland and Germany will have the financial resources to purchase the device at the upper end of the range, or even above it depending on their interest in the technology
• Post-purchasing & marketing support offered by Sensius would be well-received
Main results of objective 3:
We have talked with six institutes (the list is in Sec. 2.4) and secured their support. Three of them are in the Netherlands (in addition to the Erasmus Medical Center, in which we are already active), one in Germany, one in Swizerland, and one in France (which is not among our tier-1 countries but it is still very relevant to our European commercialization strategy). Having letters of support signed has proved to be much harder than expected. We have received two new letters of support (in the annex) and we have 6 more signed in the recent past.
We also attended several events within the framework of the project (or the month before/after it). In particular they are:
• ESTRO 38, the annual conference of the "European Society for Radiotherapy and Oncology". Held in April 2018 in Milan and attended by Gerard van Rhoon & Martin Paulides, co-founders of Sensius. It was useful to make contacts that were used to achieve objectives 1 and 2 of the project.
• Startup OLÉ, event for European start-ups supported by the European Commission and Startup Europe. Held in April 2018 in Salamanca (Spain) and attended by Paul van den Biggelaar and Peter van Paassen, co-founders of Sensius. Over 10,000 people attended, and Sensius won the pitching award.
• ESHO 2018 – 32nd Annual Meeting of the European Society for Hyperthermic Oncology. Held in May 2018 in Berlin (Germany) and attended by Paul van den Biggelaar and Peter van Paassen, co-founders of Sensius. Sensius sponsored the event, and in particular the " 2nd Annual Young Investigators Award". The Phase 1 project had just started, and it was an ideal moment to draw the attention of a wide audience on it.
• EBAN Winter Summit, flagship event of the European Business Angels Network. Sensius has been invited to pitch as winner of the EBAN Scale-up of the month, May edition (special edition for the SME Instrument winners). We won the final pitch competition.
• Start JLM award. Start JLM gives entrepreneurs the opportunity to connect and benefit from interaction with prominent local tech leaders in Jerusalem in a 7-day immersive program, featuring interactive fireside chats and panels, specially designed how-to workshops, site visits at leading companies and exclusive networking meet-ups with the city’s start-up community.
During the execution of the Phase 1 project, and thanks to it, Sensius was awarded a very prestigious prize: the EBAN scale-up of the month in a special edition dedicated to the winners of the SME Instrument.
