Swedish Medical Products Agency requires no additional clinical studies for RescueFlow

Swedish Medical Products Agency requires no additional clinical studies for RescueFlow®. Registration expected later this autumn. BioPhausia has received the evaluation of its registration application for RescueFlow®, which was submitted in January. No further documentation in the form of animal studies or clinical studies is required. Some points regarding the documentation of production processes need to be clarified. This work has already begun in cooperation with the contract manufacturer. The earlier estimate - that RescueFlow® will receive initial approval during the autumn - remains valid. Company President Stellan Lind comments: "It is really gratifying to be able to report that the Medical Products Agency's evaluation did not demand any additional clinical or preclinical studies. The issues relating to production technology will be resolved in the near future." Uppsala, August 10, 1998. Based on its contact network and know-how, primarily in connective tissue biology, BioPhausia is developing products for licensing to well-established pharmaceutical companies with strong marketing organizations. The project portfolio includes RescueFlow®, a resuscitation solution (registration phase), Krillase® for the debridement of chronic wounds (clinical phase III), and preclinical projects in the tumor and trauma treatment areas. For further information, please contact: Stellan Lind, President Tel. +46 (0)18-34 99 00