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Medical device combining viscosupplementation with pharmacological active molecule to regenerate cartilage in degenerative or traumatic osteoarthritis.

Periodic Reporting for period 1 - REGHA (Medical device combining viscosupplementation with pharmacological active molecule to regenerate cartilage in degenerative or traumatic osteoarthritis.)

Reporting period: 2015-05-01 to 2015-10-31

Regulaxis is a French biotech company developing a regenerative innovative medicine : Reg-O3,
providing a new hope for patients affected by OsteoArthritis (OA), with a First in Class Mechanism of Action.

H2020 SME Phase 1 granting allowed us to significantly accelerate several developments:
- better position to attract top European industrial partnerships
- excellent H2020 coaching to get a better understanding of patients and rheumatologists unmet needs
- financing of a worldwide market study of the exact targeted markets
and potential established players that would be interested in sourcing and in-licencing Reg O3 ready to be used prefilled syringe
"- Several face to face meetings and conference calls with our H2020 coach and selected H2020 expert
allowed us in particular to finalize the design of items and questions to be clarified
across a communication campaign with a much wider range of rheumatologists than our existing Key Opinion Leaders,
regarding their current OA treatments practices and their unmet needs,
including databases and European macroeconomic data about such practitioners.
(""Dear Doctor Questionnaire"")

- In depth forecasts analysis of various therapeutic protocols up to 2023 on a country by country basis
of current reference treatments for moderate OsteoArthritis, with exact same administration route and prescription habits as selected for Reg O3,
allow us, instead of relying on less accurate prevalence / incidence scenarios,
to consider in our commercial scale projections the exact number of patients diagnosed and treated.

Such analysis has been performed over Europe, with a specific focus on France, Germany, Italy, Spain and UK,
as well as USA, Japan, China, India, South Korea and Brazil to pave the ground for our international licencing strategies.
A summary of our results has been communicated in Report Core PDF.

- Horizon 2020 SME Phase 1 recognition also allowed us to be in a better position to engage the discussions
with top European and foreign industrial partners.
Selection of the most appropriate and competent industrial partners for both of our Active Pharmaceutical Ingredients
has been finalized and 2 out of 2 Letters of Intent have already been executed (cf Report Core PDF).

- All expected results are already finalized
* Such Dear Doctor Questionnaire is operational and will be engaged at the multinational EU level along 2016.
* Market analysis has been integrated in our development model and is being challenged along all our communications with established market players

- Impact on finished prefilled syringe design
The next identified bottleneck is the finalisation of the design of the intraarticular prefilled syringe medical device itself,
where many aspects have been elevated due to human use requirements, including in terms of sterilization processes.

Extended discussions with R&D departments of our industrial partners for key active pharmaceutical ingredients GMP manufacturing
also allowed to finalize Reg-O3 exact specifications to match expectations of European and international Regulatory Bodies
and be fully operational for Pharmaceutical Product Marketing Authorization registrations before even we start human clinical trials.

We expect to significantly reduce the burden for European population affected by OsteoArthritis by
* reducing the multi annual requirement to receive intraarticular injections (and its corresponding costs for Healthcare payers)
* improving quality of patients cartilage versus existing therapies, therefore overall well being of the 853 900 European concerned citizens in 2023,
as well as its severe side impact in terms of non working days for EU society.

We clearly benefited a great deal from H2020 SME Phase 1 program, and cannot wait to engage the next rounds of H2020 programs.