(OTCBB:NEOP), a diversified developer of innovative oncology and
cardiovascular surgical and diagnostic products, today announced that
it had received notification that its special 510(k) application for
the revised and enhanced Quantix/OR(TM) blood flow measurement had
been accepted by FDA. In addition, Neoprobe has completed the
necessary regulatory steps to begin marketing the product in the EU.
With the completion of the regulatory clearances, Neoprobe
reintroduced the Quantix/OR at a joint meeting of the German, Austrian
and Swiss cardiovascular surgical society meeting in Hamburg this past
weekend. The Quantix/OR received a favorable response from the
surgeons in attendance at the meeting and evaluations of the revised
product have begun.
Neoprobe's Vice President of Marketing, Douglas Rash, said, "the
Quantix/OR has been revised to enhance visual ergonomics and to
facilitate surgeon use. The flexible probe configuration will permit
surgeons to access vessels for measurement during both on- and
off-pump by-pass procedures. We were pleased with the response of the
physicians in Hamburg who were able to preview the product and we
believe the changes that have been made to the Quantix/OR will be well
received by the surgical community. Over the coming weeks, we will be
working with our product distributors in the United States and Europe
for a full product re-introduction at the American Association for
Thoracic Surgery annual meeting in early April."