FDA approval of INJEX systems.

Business/Health Editors & Medical Writers

BERLIN--(BUSINESS WIRE)--Sept. 30, 2002

Roesch AG Medizintechnik (SIN 529 140) announces that it has received the approval (510 K) of the U.S. Food and Drug Administration (FDA) for its needle free injection systems.

This approval allows Roesch AG to market its reusable injection system INJEX and its single used injection system ROJEX for needle free, subcutaneous drug application in the U.S. market.

"Of course we are very proud of having received the FDA approval for our INJEX and ROJEX system," said Prof. Weidler, CEO of Roesch AG. "Now there is no additional regulatory clearance needed to start the marketing of our INJEX system in the United States."

In consequence of this clearance INJEX will now also be launched in the USA in the indication of growth hormone application via a cooperation partner, who already sells INJEX in this indication in Europe.

"The acceptance of our needle free INJEX technology through the FDA will make it easier to get regulatory approval also in other countries who are traditionally closely related to the FDA procedure like the Middle East, India, Asia, Australia and South Africa. This clearance will in addition suport FDA approvals of Roesch's new developments (to be filed) like INJEX OneWay and INJEX All-in- one," Prof. Weidler stated.