"CE Marking Progress Biomedical company, Tissue Therapies Limited (ASX: TIS) advises that it will provide additional information to the Notified Body assessing the Company’s application for CE Marking of its initial product, VitroGro® ECM. Tissue Therapies CEO, Dr Steven Mercer said that the Company had planned for requests for additional data in a range of critical areas, particularly manufacturing and compliance with the essential requirements for devices sold in the EU. “After making recent enquiries of the Notified Body assessing the application for CE Marking of VitroGro® ECM, we have been informed that the reviewers will request additional information” he said. “Additional requests for information during the CE Mark review process are considered routine and are not surprising to us or our regulatory advisors. “In anticipation of this type of request we have completed additional work to ensure we could promptly respond to likely enquiries during the examination process.” “We remain confident that CE Mark will be granted in time for the planned start of sales in the UK and Europe at the end of June 2012.” Dr Mercer said that the CE Mark submission was based on the strong clinical results of the pivotal EU study in hard-to-heal wounds, primarily venous leg ulcers, as well as validation of manufacturing processes. He also said that the nature of the additional information required indicated that significant progress had been made to bring VitroGro? ECM to market and that the review was moving to the final phase."
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TIS Price at posting:
51.0¢ Sentiment: Hold Disclosure: Held