MEDISTIM ANNOUNCES THAT FDA HAS INSPECTED THEIR FACILITY IN OSLO AND HORTEN
(Oslo, January 28 2011) MediStim (OSE: MEDI), a
Norwegian medical technology company operating in
cardiovascular and other fields of surgery, announces
that FDA has just completed a 4 day inspection of
their facilities in Oslo and Horten. It was confirmed
during the inspection that MediStims systems and
production facilities are compliant with FDA's rules
and regulations for Medical devices in the US.
The inspection was completed without any findings
that will affect the company's clearance for selling
its products in the US. MediStim had a similar
inspection in 2004 with the same result. MediStim has
a sales organization in the US and sell its products
directly in the US market. FDA is the governmental
regulating body in the US and all medical device
companies needs a clearance from FDA in order to
legally sell its products in the US. Once clearance
is obtained the FDA will conduct inspections to
ensure that the companies are in compliance with
their rules and regulations.
The result of the second inspection confirms that
MediStim is focusing on quality. MediStim has just
recently received clearance for its new product
VeriQC in the US (press release 29.12.2010). 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.
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.
The product is being launched in the US at the annual
meeting arranged by the Society of Thoracic Surgeons
(STS). The congress starts the 30th of January 2011
and I held in San Diego.
For further information, please contact:
President & CEO Kari E. Krogstad
Tel: + 47 918 38 110,
Email: kari.krogstad@medistim.com
CFO Thomas Jakobsen
Tel: + 47 906 59 940,
Email: thomas.jakobsen@medistim.com
About MediStim
MediStim is a Norwegian medical technology company
listed on the Oslo Stock Exchange (OSE: MEDI). The
company is the global leader within development,
manufacturing and sales of medical equipment for
quality assessment of cardiac- and vascular surgery.
Cardivascular disease is the most common cause of
death in the western world, and about 730.000
coronary artery bypass surgery procedures and about
600.000 peripheral vascular surgery procedures are
performed annually on a global basis.
MediStim has a track record of revenue growth and
profitability, and continues to invest in the
development of new products. The company is in
process of launching the VeriQC a new and
groundbreaking product combining transit time flow
measurement (TTFM) and ultrasound imaging in one
system, which is expected to become a new standard of
care within within intraoperative quality assessment.
The company has own sales organizations in Norway,
Germany and the USA, in addition to about 50
distributors in Asia, Europe, Middle East, Africa and
South America.
For more information about MediStim, visit our
website at www.medistim.com
This information is subject of the disclosure
requirements acc. to ยง5-12 vphl (Norwegian Securities
Trading Act)
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MediStim ASA