Well-balanced shareholding structure
Emosis is a private company financed by a balanced mix of shares (Cap Innov'Est seed fund, founders, stakeholders), non-dilutive direct or indirect funding and loans obtained from a banking pool (BPI France, BNP Paribas, CIC).
Emosis shareholders are its founders, the seed fund Cap Innov’Est, some employees and other stakeholders (who joined them by exercising all or part of their stock options).
Non-dilutive co-financing has been obtained at regional (Grand Est), national and international levels, some of which come from financing programs for innovative projects (Eurostars from the European Commission; Nofar from the Israeli Innovation Authority).
Emosis Ltd is the Israeli subsidiary of Emosis SAS.
A rich ecosystem
Emosis has forged technological, academics, clinical and financial partnerships with a series of French and international stakeholders.
Clinical investigators
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Universities
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Local sponsors
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Funders
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Distributors
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Market outlook
The coagulation and hemostasis test market (including D-dimer) is estimated at $ 3.5 billion, or around 5% of the in vitro diagnostic market.
Emosis estimates that the market could be multiplied at least by 2 to 4 within 10 years, due to the continuation of current market growth (6 to 12%), linked in particular to the aging of populations and the increasing adoption of cytomolecular tests to meet currently unmet needs, for large populations of patients suffering in particular from cardiovascular disease or cancer.
As in the entire in vitro diagnostic industry, some large global players coexist with smaller companies addressing specific segments of the industry (e.g. reagents) or focused on a particular technology.
No actor is currently positioned specifically as Emosis on hemostasis and coagulation tests in flow cytometry for medical use.
Regulatory
- Europe
In vitro diagnostic tests fall under the European regulations on in vitro diagnostic medical devices (2017/746) published on May 5, 2017 in the Official Journal of the European Union (OJEU). This regulation (RDIV) will replace the Directive on MD in vitro diagnostics (89/79/EEC - DDIV) from May 26, 2022.
Market access according to the Directive was essentially conditioned by CE marking, the European framework of compulsory essential requirements.
The RDIV provides for new provisions, in particular concerning clinical evaluations and investigations.
- USA
Depending on whether or not there is a test for which market access has already been approved (clearance, approval), the authorization is subject to a 510k or PMA procedure.
The procedures include FDA inspections to ensure compliance with quality requirements (CFR 21, part 809 and part 820).
- Other countries
Except in special cases, other countries recognize, often with certain adjustments, one or the other regulation. Beyond regulatory authorization, registration of tests in the nomenclature and reimbursement may be necessary.