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MilliDrop Report Summary

Project ID: 781889

Periodic Reporting for period 1 - MilliDrop (New MilliDrop Analyzer: miniaturized and faster clinical microbiology testing in only one drop)

Reporting period: 2017-08-01 to 2018-01-31

Summary of the context and overall objectives of the project

The emergence of many multi-resistant bacteria threatens modern medicine in developed countries where surgeries and anti-cancer treatments depend on the effectiveness of antibiotics. Globally, in the absence of a change in practices, the World Health Organization (WHO) has announced that multi-resistant bacteria (MRB) infections could be responsible for 10 million deaths per year in 2050.
To respond to this threat, WHO recommends prevention, the search for new antibiotics and the development of diagnostic tools for better management of the arsenal of available antibiotics.
Bacteremia and sepsis are among the pathologies whose mortality rate is most aggravated by the emergence of MRB strains. In fact, the vital prognosis of the patient in sepsis depends on the success of the antibiotic treatment in the first 24 hours. Unfortunately, today, the antibiotic sensitivities of an infectious agent are determined more than 48 hours after blood collection. With the increase in MRB cases, it is increasingly difficult to prescribe the right antibiotic to the patient without the results of the antibiogram.
MilliDrop is an ambitious French innovative spin-off from the ESPCI Paris School. The company developed over the past 3 years a disruptive Microbiology analysis instrument with highly increased throughput and reduced tests volumes (~100nL).
The goal of the H2020 SME Instrument Phase 1 project is to assess the technical feasibility, business opportunities and regulatory pathways of an In Vitro Diagnostic (IVD) solution which would integrate all the laboratory workflow in a single automated instrument to deliver the result 30h earlier than the current methods.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

MilliDrop performed experimental demonstration and prepared a well-adapted business development strategy. The market study identified blood infections as the best adapted initial market segment and collected necessary information to prepare an advanced business plan for successful European market entry.
Feasibility study confirmed that innovative and powerful MilliDrop technology enables bacterial Detection, Isolation, Identification and Antibiotics Susceptibility Testing (AST) within 20h from the patient blood sample. In addition, regulatory requirements and Freedom to Operate (FTO) surveys gave critical inputs for the future IVD instrument development plan. Anticipating CE/IVD certification, MilliDrop prepared its quality management system according to the norm ISO13485. The FTO confirmed that MilliDrop’s solution does not depend on external patents, which helped to fill a new patent application.
SME Instrument Phase 1 feasibility study enabled MilliDrop to decide to pursue the further development to a medical device diagnostic solution and to prepare and submit the SME Instrument Phase 2 proposition. An advanced development and business plan is prepared to raise financial support to reach IVD market within 5 years.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The implemented action enabled to confirm that there is an appealing market opportunity for the MilliDrop In Vitro Diagnostic. This opportunity was greatly refined through the SME Instrument Phase 1 project.
Potential added value in time saving and integrated workflow was shown feasible through experimental work. These improvements were demonstrated to match the market needs according to global analysis and Lab interviews in Europe.
The first segment to address with the MilliDrop IVD solution was identified as blood infections or patients in sepsis because of the extreme urgency of getting AST results for those patients that are in life threatening situation and need adapted antibiotics treatment as early as possible.
Conditions of market access were better characterized. The first FTO analysis reported no IP barriers and high success chance for a new patent application. The certifications process and requirements are now anticipated with the quality management system in the company and software development methods.
The solution is not yet available for sales but, feasibility was demonstrated experimentally, and the technological assessment helped to build the development plan to achieve commercialization within 5 years and to anticipate funding needs.
All labs interviewed are enthusiastic at the solution. Pr Kempf from Frankfurt University Hospital said, “If what MilliDrop exposes here is really working as said, then this is exactly what we need!”. Dr Bercot from Saint Louis added “I will definitely save some room to put your analyzer in my lab”
With appropriate funding, the MilliDrop IVD solution will be successful in the clinical microbiology laboratory and disrupt the current standards. By cutting down the time to result by more than 30h, it will enable to dramatically reduce mortality and help fighting against multiresistant bacteria. In coming months, MilliDrop ambition is to raise 4 million euro through French national programs and Capital Ventures for R&D and prototype development. With these additional results and achievements MilliDrop will apply within the next 12 months for SME Instrument Phase 2 program.

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