NuVue Therapeutics, Inc. Receives 510(k) Approval
Fairfax, VA, March 8, 2011 – NuVue Therapeutics, Inc. has received FDA “510(k)” approval for its first ColorMark™ Biopsy Needles, the company announced today.
The first needles, the ColorMarkTM-A, are for use in fine needle aspiration biopsies, during which the exact position of the tip of the needle can be extremely difficult to determine. According to NuVue’s founder and Chief Executive Officer, Roger Kolasinski, the tip of the ColorMarkTM-A biopsy needle oscillates in an orbital motion, causing it to show up brightly in real time on the screen of a color ultrasound. As a result, the operator can clearly see the instrument, even at relatively deep locations and steep angles of insertion, permitting accurate withdrawal of tissue from the suspect mass for biopsy.
Mr. Kolasinski said the ColorMark needles meet an important unmet medical need: “Because of the difficulty in seeing the fine needles under ultrasound, 16-18% of FNA biopsies must be repeated, often under costly MRI or CT imaging. More importantly, there are untold numbers of missed diagnoses, preventing early discovery when cancers are most treatable.”
NuVue will follow the fine needles with a line of core biopsy needles, and a complementary product, the BrightMarkTM tissue markers. When a biopsy is performed, a tissue site marker is often left behind to locate the tumor for monitoring via ultrasound or subsequent biopsy. Tissue site markers currently on the market typically consist of metal clips that tend to migrate within soft tissue, making accurate location of the tumor difficult or impossible. NuVue’s BrightMarkTM tissue site markers, however, consist of contrast agents encapsulated into microcapsules using technology the company has licensed from NASA. Unlike metal clips, these microcapsules lodge in the interstitial spaces of the tissue and do not migrate.
NuVue also is developing a new, targeted drug delivery system that dramatically eases the adverse toxic side effects of standard chemotherapy when treating soft tissue cancers. NuVue’s system uses the ColorMark visualization capabilities to deliver precisely controlled amounts of free or encapsulated chemotherapy drugs directly into tumors in soft tissue organs such as the liver, pancreas, breast, prostate, lung, thyroid, ovary, bladder, and kidney. According to Mr. Kolasinski, this technique permits use of as little as 1/500th to 1/200th of the normal dose of chemotherapy, substantially eliminating most adverse side effects, ultimately saving the patient’s immune system and giving the patient a better quality of life both during and after their regimen of therapies.
For further information, contact: Mr. Roger S. Kolasinski, CEO, NuVue Therapeutics, Inc., 11135 Sedgefield Road, Fairfax, Virginia 22030: Tel: 703 477-3000 (Cell Phone) /703 591-1691 (Land Line) rskolasinski@nuvuetherapeutics.com.
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