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Personalized cardiopulmonary resuscitation device for emergency teams

Periodic Reporting for period 1 - pCPR (Personalized cardiopulmonary resuscitation device for emergency teams)

Reporting period: 2016-12-01 to 2017-05-31

Sudden cardiac arrest strikes without warning and affects up to 1 million people in US and Europe per year (up to 4 million worldwide), being the leading cause of unexpected death in the world . Despite international medical efforts, 9 out of 10 people will die after a cardiac arrest (average survival rate 10.6%) and less than 3% will survive with no neurologic effects . In the European Union, cardiovascular diseases costs more than EUR 192 billion annually.

Emergency teams suffer the most with the extremely high mortality and morbidity rates due to cardiac arrest worldwide. One of the main reasons we only save 1 out of 10 people after a cardiac arrest it’s because emergency teams cannot obtain the right clinical information at the right time - the resuscitation golden time.

pCPR is a new portable medical device to properly assist emergency teams during sudden cardiac arrest emergencies. It consists of a thoracic pad with built-in sensors that doctors, nurses and paramedics apply directly to the patient linked to a new monitor display and defibrillator to support and guide their critical decision-making and personalized therapy.

On a conceptual basis, pCPR allows:
• A more accurate in-time clinical insight of the critically ill patient based on his physiology by non-invasive technologies assisting the emergency teams;
• Better quality of CPR performance, based on the previous status;
• Reduce mortality and better neurological outcomes through goal-directed therapies.

pCPR has been developed as a customer’s centered solution, both for emergency professional users and for health managers/emergency decision-makers:
• Offers added value on patient monitoring and timely therapeutics with the same previous training and logistics for in-hospital or out-of-hospital teams;
• Promotes quicker decision-making and deploy;
• Offers event data management that can be managed afterwards for quality and registry purposes;
• Is easily adaptable and scalable to different clinical settings of international markets;
• Offers public and scientific recognition on desired outcomes, namely survival rate after cardiac arrest;

Last June of 2017, pCPR project has been officially endorsed by the Portuguese Resuscitation Council, branch of the European Resuscitation Council (www.erc.edu) as an “ambitious, structured and undoubtedly relevant project in the resuscitation area” (Annex 10).
pCPR wants to be one of the leading assistive medical device for emergency teams worldwide in a 5-years’ time frame.
pCPR had an intense 2016 (INEO Start mentoring programme at IPN Incubator, selection for acceleration programme “Building Global Innovators 7th Batch” from MiT Portugal, nomination to InnoStars Award 2016 by EIT, selection as Alpha StartUp at WebSummit 2016, 1st Patent submission) culminating with the SME Instrument Phase I contract assignment.

Since December of 2016, here’s the key milestones achieved by pCPR project:

A. National Innovation Certification NP4457 by official body EiC;
B. IP Contract with Expert Company Patentree (Portugal);
C. Confirmed in-depth freedom-to-operate analysis;
D. Regular monthly meetings of the Advisory Board;
E. First Round of Investment – preparatory meetings with Portugal Ventures, BusyAngels and Joyn Ventures;
F. Technical Development Contract with reputed IPN-LAS for Lab development of pCPR proprietary regional cerebral oximetry sensors;
G. Technology transfer agreement of non-invasive cardiac output method with company BioBee (Spain);
H. Technical partnership agreement with Centre for Advanced Sensor Technology – University of Maryland (USA) concerning transcutaneous CO2;
I. Technical Development Contract with CITEVE (Portugal) concerning the thoracic pad development;
J. Marketing Plan partnership with Marketing Master PG Program of Nova Lisbon University (Portugal);
K. Regular technical feedback from a 16 Emergency Professionals Focus Group;
L. Letter of Interest from major Portuguese private Health Group concerning field Trials;
M. Letter of Support from the National Resuscitation Council, branch of the European Resuscitation Council;
N. National IP Report received confirming 1st Patent Claims;
O. 2nd Patent submission concerning cerebral regional oximetry and thoracic pad configuration;

During SME Instrument Phase 1 pCPR Team focused on the analysis and validation of pCPR in different perspectives: product technical feasibility, market and competition in-depth analysis, product feasibility from an economic point of view, alignment with legal and IP requirements and definition of pCPR commercialization strategy to ensure a rapid and sustainable market entry. So, aligned with the activities expected in the description of action, the following technical and business tasks were performed:
A. Refinement of the business model and go-to-market plan;
B. Engagement with new international strategic partners for product validation and commercialization support;
C. Creation of awareness about the gaps in the emergency medical services and its needs of introduction of new standards and technological innovation.
D. Refinement of product features to complete an operational prototype with cross development of technologies from different fields (medical, software, hardware, biomedicine, materials…) and technology transfer from national and international R&D entities and other companies;
E. A provisional patent regarding the thoracic pad was submitted and an Intellectual Property protection plan has been developed.

During the feasibility study (Q1+Q2 2017) Medsimlab has developed pCPR prototype, while validating its go-to-market strategy and defining an IP roadmap which will be the baseline for its dissemination strategy based on the submission of patent applications. In addition, important partnerships were established.

PCPR MAJOR TAKE-HOME MESSAGES FROM SME INSTRUMENT PHASE I:

 Expect stiff competition and a highly-regulated market on debut in 2018;
 Key competitors will be Cardiac Science, Physio-Control, Philips Healthcare and Zoll Medical;
 Submit additional patents and actively protect IP in target markets;
 Design-Measure-Learn at all stages of product development;
 Address Emergency Managers and not only Emergency Teams;
 Conduct Pilot Trials asap in Germany and UK;
 Enlarge Team competencies recruiting entrepreneurial attitude;
 Engage in all-levels of emergency networks;
 Find healthcare expert funding;
 Apply to SME Instrument Phase II;
 Work harder!
pCPR is a mind-changer market player belonging to Health 2.0 ecosystem. It aims to revolutionise the health market approach to emergent rescue of cardiac arrest, reaching the resuscitation gold-standard assistive device status in a 5-years’ time frame. pCPR goal is to be used by every emergency team rescuing cardiac arrest victims worldwide both at out-of-hospital and in-hospital settings, being directly involved in 1 to 6% reduction of cardiac arrest mortality (1% reduction means 4.000 lives saved per year in Europe).

pCPR has submitted 2 Patents applications (November 2016 and July 2017) concerning its innovative thoracic pad and the new regional cerebral oximetry sensor by near infrared spectroscopy. pCPR is involvev also in technology transfer of non-invasive technologies from other fields to healthcare medical devices industry.

On the completion of SME Instrument Phase 1, MEDSIMLAB reinforced its conviction that pCPR has unique benefits as an innovative medtech product that could reach European and international healthcare markets.

A combined fast-to-market niche strategy is crucial for pCPR success:

 Early market validation of design and technical features;
 Solid technical innovation and friendly usability;
 Credible pilot trials in developed European markets;
 Full IP protection and regulation compliance;
 Interdisciplinary focused Team;
 Health Experts as Investors;
 Channel distribution according to regional markets;
 Selection of Key Emergency Institutions as Early-Adopters;
 Internal R&D continuous achievements;
 Development of pCPR’s family of products;


Last June of 2017, pCPR project has been officially endorsed by the Portuguese Resuscitation Council, branch of the European Resuscitation Council (www.erc.edu) as an “ambitious, structured and undoubtedly relevant project in the resuscitation area”.