Neoprobe Launches First Cardiosonix Product; Provides Cardiosonix and Neoprobe Business Update.Business Editors/Health and Medical Writers DUBLIN, Ohio--(BUSINESS WIRE)--Nov. 20, 2002 Neoprobe Corporation (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :NEOP NEOP Neoprobe Corporation (stock symbol) NEOP Near Earth Object Program NEOP New England Order of Protection NEOP Nuclear Explosive Operating Procedure ), 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , 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 Cerebral blood flow, or CBF, is the blood supply to the brain in a given time.[1] In an adult, CBF is 750 mls/min or 15% of the cardiac output. On a weight basis, this is 50 to 54 milllitres/100grams/minute. ." 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 medica (māˑ·dē·k 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 ADBF Asian Dragon Boat Federation ADBF Adaptive Digital Beamforming technology, which uses a special application of digital Doppler ultrasound Doppler ultrasound An imaging technique using ultrasound that can detect moving liquids. Mentioned in: Priapism Doppler ultrasound methods to provide a direct non-invasive measurement of volume blood flow, as well as a range of additional hemodynamic he·mo·dy·nam·ics n. (used with a sing. verb) The study of the forces involved in the circulation of blood. he parameters. Clinical studies reported by some of the leading neurosurgery neurosurgery /neu·ro·sur·gery/ (noor´o-sur?jer-e) surgery of the nervous system. neu·ro·sur·ger·y n. Surgery on any part of the nervous system. 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 Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. , 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 sentinel node Sentinel lymph node, signal node of Virchow An isolated, enlarged often left-sided supraclavicular lymph node, classically associated with metastatic gastric CA which, when found, indicates that the malignancy is non-resectable. Cf Mary Joseph nodule. Congress meeting in Yokohama, Japan, researchers presented updated clinical data from the clinical studies involving Lymphoseek(TM). Lymphoseek is the radiopharmaceutical radiopharmaceutical /ra·dio·phar·ma·ceu·ti·cal/ (-fahr?mah-soo´ti-k'l) a radioactive pharmaceutical, nuclide, or other chemical used for diagnostic or therapeutic purposes. licensed by Neoprobe for the identification of the sentinel lymph node Sentinel lymph node The first lymph node to receive lymph fluid from a tumor. If the sentinel node is cancer-free, then it is likely that the cancerous cells have not metastasized. Mentioned in: Vulvar Cancer . The clinical results confirmed earlier findings demonstrating the improved clearance and nodal Having to do with nodes. See node. NODAL - Interpreted language implemented on Norsk Data's NORD-10 computers. Used by CERN and DESY high energy physics labs to control their accelerator hardware, PADAC and SEDAC. Included trackball input, graphics. detection properties of Lymphoseek as compared to the colloid colloid (kŏl`oid) [Gr.,=gluelike], a mixture in which one substance is divided into minute particles (called colloidal particles) and dispersed throughout a second substance. 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 lymphatic /lym·phat·ic/ (lim-fat´ik) 1. pertaining to lymph or to a lymphatic vessel. 2. a lymphatic vessel. lym·phat·ic adj. mapping (ILM), an emerging standard of care technology for breast cancer and melanoma. Neoprobe also holds significant interests in the development of related biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. 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. Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company's plans and strategies, expectations for future financial performance, new and existing products and technologies, and markets for the Company's products, are forward-looking statements. The words "believe," "expect," "anticipate," "estimate," "project," and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company's continuing operating losses, uncertainty of market acceptance, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and exclusive distributor, competition, limited marketing and manufacturing experience, and other risks detailed in the Company's most recent Annual Report on Form 10-KSB and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements. |
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