G...i think the rekindled interest in NEOP has to do with this PR on 11/20...looks like concrete progress:
B: Neoprobe Launches First Cardiosonix Product; Provides Cardio
B: Neoprobe Launches First Cardiosonix Product; Provides Cardiosonix and
Neoprobe Business Update
DUBLIN, Ohio, Nov 20, 2002 (BUSINESS WIRE) -- Neoprobe Corporation
(OTCBB:NEOP), a diversified developer of innovative oncology and cardiovascular
surgical and diagnostic products, announced today the commercial launch of the
first product in its Cardiosonix portfolio of blood flow measurement products
called the Quantix(TM) devices.
David Bupp, Neoprobe's president & CEO, said "We have launched the Cardiosonix
Quantix/ND(TM) in Germany, the United Kingdom and Switzerland. The Quantix/ND
received CE Mark clearance in August and received clearance under a special
510(k) application in the United States last week. The Quantix/ND is a
non-invasive bedside blood flow measurement system that easily and accurately
measures cerebral blood flow."
Neoprobe provided a summary of the Quantix product milestones achieved in the
past few months:
-- Receipt of clearance for marketing in Europe for Quantix/ND
through CE Mark certification;
-- Receipt of clearance for marketing in the U.S. for Quantix/ND
based on a special 510(k) submission to the U.S. FDA;
-- Completion of marketing agreements for the distribution of
Cardiosonix' Quantix/ND product in the United Kingdom and
Switzerland;
-- Presentation of promising results from clinical evaluations of
Cardiosonix' neurosurgery Quantix/ND product at the sixth
International Neurotrauma Symposium in Tampa, Florida, which
compared the blood flow measurement product to more invasive
technology; and,
-- Introduction of the Quantix-OR(TM) product, the intraoperative
measurement of blood flow, at the meeting of the European
Association for Cardio-thoracic Surgery.
Bupp continued, "Since we acquired Cardiosonix, our primary objectives were to
develop a suite of diagnostic products and to begin commercial sale of the first
product by year end. I am pleased that we have achieved both objectives. We will
be meeting with additional distributor candidates for the Quantix/ND and
Quantix/OR during the Medica meeting in Dusseldorf, Germany, which began this
week. Following the discussions at Medica, we expect to announce additional
distribution agreements in the coming weeks and months."
"The Quantix/ND is an angle-independent ultrasound probe that is designed to
allow neurosurgeons, neurologists, intensive care units, and emergency room
physicians to non-invasively measure cerebral blood flow in real time. In
addition, it can be used for blood flow measurement in vascular labs. The
Quantix/ND is based on Cardiosonix' proprietary ADBF technology, which uses a
special application of digital Doppler ultrasound methods to provide a direct
non-invasive measurement of volume blood flow, as well as a range of additional
hemodynamic parameters. Clinical studies reported by some of the leading
neurosurgery institutions in Europe and the United States have confirmed the
innovative breakthrough of the ADBF technology. The Quantix/OR employs the same
ADBF technology and has a variety of intraoperative probes that permit the
measurement of blood flow in large and small blood vessels, without the need for
vessel isolation. With the satisfactory review of the technical file for the
Quantix/OR, we have clearly taken the first step towards CE Mark clearance. We
expect the CE Mark clearance process for the Quantix/OR will be completed by the
end of this year, and we will submit an application for 510(k) marketing
clearance shortly thereafter."
Bupp also stated, "Development efforts have not been confined to the Quantix
products. Last week at the World Sentinel Node Congress meeting in Yokohama,
Japan, researchers presented updated clinical data from the clinical studies
involving Lymphoseek(TM). Lymphoseek is the radiopharmaceutical licensed by
Neoprobe for the identification of the sentinel lymph node. The clinical results
confirmed earlier findings demonstrating the improved clearance and nodal
detection properties of Lymphoseek as compared to the colloid agents currently
used by physicians. We expect to have additional information in the near future
regarding the activities associated with additional clinical evaluation of
Lymphoseek."
Neoprobe also announced the following upcoming milestones:
-- Commencement of commercial production of the Quantix/OR;
-- Completion of United States and additional foreign
distribution agreements for the Quantix/ND and foreign and
United States distribution of the Quantix/OR products; and,
-- Marketing clearance for the Quantix/OR in both the United
States and Europe.
About Neoprobe
Neoprobe develops and provides innovative surgical and diagnostic products that
enhance patient care by meeting the critical decision making needs of healthcare
professionals. Neoprobe's current line of gamma detection systems is widely used
for intraoperative lymphatic mapping (ILM), an emerging standard of care
technology for breast cancer and melanoma. Neoprobe also holds significant
interests in the development of related biomedical systems and agents. The
Company's strategy is to deliver superior growth and shareholder return by
maximizing its strong position in gamma detection technologies and diversifying
into new, synergistic biomedical markets through continued investment and
selective acquisitions. With the December 31, 2001 acquisition of Cardiosonix
Ltd., Neoprobe has expanded its product portfolio to include blood flow
measurement products. Cardiosonix is a development stage company that is in the
process of obtaining regulatory clearance to begin the clinical evaluation and
commercial sale of products. Cardiosonix' products are designed to be used by
neurosurgeons, cardiovascular surgeons and critical care physicians. |
