MEDISTIM HAS RECEIVED FDA CLEARANCE FOR VERIQC(TM)

MediStim has today received confirmation from the US
Food and Drug Administration (FDA) that the company's
new product VeriQC is cleared for sale in the USA.

VeriQC is MediStim's new generation of intraoperative
systems for quality assessment used during coronary
artery bypass grafting (CABG). The new system
combines state-of-art transit time blood flow
measurements (TTFM) with a new ultrasound imaging
modality. By using ultrasound imaging, it will
become easier for the surgeon to plan, optimize and
assess quality of the surgical procedure.
VeriQC is therefore a new tool that will contribute
to improved surgical precision and quality, which may
ultimately provide better outcomes to the patients.

In addition to CABG, the VeriQC may be applied in
other surgical areas, such as valve surgery,
transplantation surgery and during surgery of
congenital heart defects.

With this FDA clearance, the CE approval and the
clearance in Japan, MediStim is now positioned to
sell the VeriQC in all the largest markets.

The new product more than doubles MediStim's market
potential, both due to the new application areas, but
also because the value of this system increases
significantly compared with the VeriQ without the
imaging modality.

Globally, about 730 000 CABG procedures are being
performed every year. The largest market for
MediStim's products is the USA, constituting about
37% of the global market. USA represents a big
potential for MediStim, as equipment for quality
assessment is only being used in about 20% of the
procedures performed every year. It is expected that
a significant share of hospitals with VeriQ systems
will convert to VeriQC over time, and that the
introduction of imaging will accelerate the market's
acceptance for intraoperative quality assessment in
general.

With both TTFM and ultrasound imaging cleared by the
FDA, MediStim has taken an important step forward
towards our goal of becoming the standard of care
also in the American market.