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NuVue ColorMark™ Needles
Unmet Clinical Need Each year, medical practitioners in the U.S. and abroad conduct millions of percutaneous biopsy procedures, in which a sample of tissue is extracted from a suspicious body mass to determine whether it is cancerous. In “fine needle aspiration” or “FNA” biopsy procedures, a small-diameter needle is used to extract interstitial fluids and cellular components from an abnormal area of tissue by suction into a syringe. Many of these biopsies are conducted under ultrasound to locate the needle in the targeted tissue. The small size (gauge) of the FNA needle makes FNA a far less painful procedure, while ensuring fewer complications, such as hematoma, bleeding and infection. However, the small size and the flexibility of the needles make them difficult to control under palpation, and difficult to “see” under ultrasound: depending upon the skill and experience of the practitioner, as many as 16-18% of fine needle aspiration biopsies must be repeated. These shortcomings led to a trend towards “core needle biopsy” (“CNB”), in which a large, hollow needle is used for acquiring multiple solid cores of tissue. However, CNB may be painful and can cause extensive complications including infection, i.e. peritonitis with abdominal tissue extraction and even “seeding” cancerous cells as the needle is withdrawn, due to its size. For these reasons, there is an unmet clinical need for biopsy needles that are minimally invasive but accurate, cost efficient, and can be used with minimally invasive imaging techniques such as Doppler ultrasound. The NuVue Solution: Fine Needle Aspiration Biopsy NeedlesTo meet this need, NuVue has developed the ColorMark™ line of biopsy needles for use in fine needle aspiration biopsy procedures. The needles’ patent-pending design consists of a state-of-the-art biopsy needle integral to a handle containing a battery-powered signal generator.
With these advantages, NuVue’s ColorMark™ FNA needles have the potential to capture a large portion of the biopsy needle market. Core Needle Biopsy NeedlesThe Company recognizes that, even with the availability of its new FNA needles, core needle samples will still be indicated in many cases, and that smaller-diameter core needles also can be difficult to visualize under Doppler Ultrasound. The Company therefore will introduce the ColorMark™-C line of core biopsy needles. These disposable, single-use needles will use the same enhanced ultrasound guided visualization technology as the ColorMark™-A, causing a state-of-the-art core biopsy needle to vibrate and show up brightly under ultrasound. In addition to the needle and signal generator, the product will include a reusable, sterilizable cassette handle for firing the core retrieval mechanism. As with the fine needles, the product can be used with any color Doppler ultrasound machine. The Company’s enhanced Ultrasound Guided Visualization (UGV™) biopsy needles will increase practitioners' effectiveness in diagnosing and following cancer. These products form the first leg of NuVue’s Site-Specific Regimen of Cancer Therapy™.
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The Company’s first product system is the NuVue
The signal generator causes the needle to oscillate in an orbital motion, making the needle show up brightly on the screen of the color ultrasound, all the time, in real time, during a procedure. As a result, the operator can clearly see the instrument, even at relatively deep locations and steep angles of insertion, permitting an accurate withdrawal of tissue or cellular components from the suspect mass, which can also be readily visualized, in real time. The needle and handle comprise a single-use, disposable product.