REPLICATE® System | Updates

By Lea Ellermeier & Rüdger Rubbert

FDA simplifies admission process for REPLICATE's US market entry!

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Public

Dear Companists,

First, we would like to thank our 1800+ Companists who invested more than EUR 2.9 million together with the co-investment. We are looking forward to start into the year 2018 alongside all of you. In this report, we would like bring you up to speed and inform you of exciting developments.

Our utmost priority at present is penetrating the US market. The US regulatory authority FDA has been pursuing a strategy they call the “Least Burdensome Approach.” Its aim is to facilitate and accelerate the approval of modern technology. A new guideline was recently published in December 2017:

The FDA is currently re-educating its employees for the new procedures. This process is 90% complete.

 

For the REPLICATE® system, this means that we are still preparing our application for US market admission and that we are adjusting the necessary documents according to the new regulations. We are working in close cooperation with our US partners, who are supervising our application process, and expect that the admittance process will become less susceptible to bureaucratic imponderables as a result of the new regulations. This means that the market launch planned for mid-2018 is very probable.

 

Replicate Dental Technologies

 

We have also started preparing our marketing for the US market entry. An important milestone was the renaming of our US subsidiary, Natural Dental Implants Inc., to REPLICATE Dental Technology Inc. The renaming is part of our marketing strategy of strengthening the protected product name REPLICATE. At the same time, the new name clearly identifies us as a high-tech company in the field of dental medicine. The tech company label is of particular importance for valuation during the expected initial public offering. We also plan on renaming the NDI AG by mid-year.

We are very pleased with the FDA’s current strategy and look forward to the upcoming US market launch.

 

Kind regards,

Lea und Rüdger



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