FloSeal Granted Streamlined Review Status by the FDA; May Accelerate U.S. Approval.

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--April 27, 1999--

Fusion Medical Technologies Inc. (Nasdaq NM:FSON) Tuesday announced that its flagship bleeding-control product, FloSeal Matrix Hemostatic Sealant(TM), has been formally accepted for premarket approval (PMA) review and has been granted streamlined review status by the United States Food and Drug Administration (FDA).

According to the FDA, devices requiring a PMA filing that are very well understood by both the developer and the Agency may be included in the streamlined review track. For FloSeal, the FDA has determined that a panel review will not be required. Decisions on whether a device in the streamlined review track can be marketed will routinely be made 180 days from the time the PMA application has been filed by the FDA. However, because the streamlined review process is fairly new, the actual timing may vary. Fusion has requested a "100 day" meeting with the FDA to discuss any outstanding issues with respect to U.S. regulatory approval and expects that meeting to take place in June.

Fusion President and Chief Executive Officer Philip Sawyer commented, "The FloSeal PMA application was submitted to the FDA in February, and we are very encouraged to have received streamlined review status from the Agency. We believe that this and the recently announced CE Mark Certification of FloSeal in Europe reflect the quality of the product and the completeness of the FloSeal regulatory applications."

Fusion Medical Technologies is developing and commercializing proprietary bioresorbable devices for controlling bleeding in a variety of settings. Fusion's products in development are derived from its FloSeal(TM) Matrix technology, which is based on a bioresorbable combination of a proprietary collagen-based gel with thrombin. These products are designed for use as hemostatic sealants in a broad range of procedures. These include difficult applications in which conventional means of achieving hemostasis, such as sutures, staples, topical hemostats or fibrin glues do not generally work effectively.

FloSeal and the Company's other products under development have not been approved for sale in the United States by the United States Food and Drug Administration. Fusion Medical Technologies(TM), Fusion(TM), FloSeal(TM) and the stylized Fusion logo are trademarks of the company.

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that involve risks and uncertainties. The company's actual results may differ significantly from the results discussed in the forward-looking statement. Factors that might cause such a difference include those discussed in "Risk Factors," including, but not limited to, the sections titled, "If we do not successfully commercialize FloSeal our business will suffer" and "If we do not obtain FDA approval, we cannot sell FloSeal in the United States, which would significantly harm our business," as set forth in the company's Registration Statement on Form S-1, dated April 1, 1999.