Notice regarding the submission for new manufacturing process for haemostasic products in Europe
We are pleased to announce that on the 13th January 2022, our European subsidiary 3-D Matrix Europe SAS submitted an application to the European notified body for the approval of the CE-marked haemostatic products using a new manufacturing process developed by a new manufacturing partner in Europe.
Our group signed a global contract manufacturing and service agreement with Pharmpur GmbH, located in Augsburg, Germany (hereafter “Pharmpur”) on 16th December 2021. Under this contract, Pharmpur undertakes manufacturing, packaging, and delivery of the company's products for markets in Europe and other countries where the CE Mark is recognized, UK, US, Canada, and Japan. Pharmpur has already commenced the production of our haemostatic products for the US market.
The application which was made under MDR, includes all the existing CE-marked haemostatic products such as PuraStat and PuraBond, using the manufacturing process developed in partnership with Pharmpur.
Once approved, our group can manufacture the haemostatic products at the new manufacturing site in Europe, in addition to the existing manufacturing site in Japan. This is part of the company’s initiative for diversifying critical suppliers spread across different geographical regions.
The impact of this submission has not been factored into our financial results forecast for the current full-year nor the business revenues stated in the current Mid-Term Business plan. Prompt announcement will be made in the event status of the approval or other related matters affect our performance.