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NuVue BrightMark™ Tissue Site Markers The Company's second product system is the NuVue BrightMark™ line of Tissue Site Markers. These markers consist of contrast agents encapsulated into microcapsules using the Company’s platform microencapsulation technology. Unmet Clinical NeedPractitioners performing biopsies often leave behind an imageable “marker” to mark the site of the biopsy for purposes of monitoring the mass via ultrasound, for repeat biopsies, or for marking the site before and/or after surgery. Tissue Site Markers currently on the market typically consist of metal clips that tend to migrate within tissue, and so do not reliably mark the targeted tissue with accuracy over the long term. There is an unmet clinical need for tissue markers that are easy to use and reliably mark the procedural site after their deposition without migration, while also having the ability to biodegrade over an extended period of time. The NuVue Solution NuVue’s BrightMark™ line of Tissue Site Markers will meet this need. Unlike the metal clips in current use, the Company’s microcapsules lodge in the interstitial space of tissue without migration. And because the NASA/NuVue-developed microcapsules are so durable and biologically robust, they have the potential to endure in the tissue for long periods of time.
Preclinical shelf-life studies, still under investigation, indicate that these markers may survive in tissues for upwards of a year before they begin to bio-degrade. The Company’s tissue markers have achieved proof of concept in animal human tumor models, i.e. Xenographs, and will be developed for 510(k) approval and market introduction in April 2010, at the same time as the core biopsy needles. Like the ColorMark™ biopsy needles, the Company’s BrightMark™ Tissue Site Markers will increase practitioners' effectiveness in tumor diagnosis and follow-up of cancer. These products form the second leg of NuVue’s Site-Specific Regimen of Cancer Therapy™.
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