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Announcement just out.

"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."


Any thoughts?