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News Releases |
Luminetx News Release:
VeinViewer by Luminetx™ receives FDA Class I Exempt Certification
Friday, November 03, 2006
Memphis, Tenn. – Memphis-based Luminetx Corporation, which discovers, develops and commercializes bioscience technologies, today announced its premier product, VeinViewer by Luminetx™, a vascular imaging system, has received clearance from the FDA as a Class I Exempt Medical Device – thus commencing full commercial roll-out.
The VeinViewer allows physicians, nurses and other health care professionals to clearly see accessible vasculature (or lack thereof) in real time. The device uses a combination of near-infrared light and patented technologies to image vascular structures and project their location directly on the surface of the skin. This provides clinicians with a safe, non-invasive adjunct technology for clinical treatments and procedures including, but not limited to: IV insertions, PICC line insertions, routine venipuncture (blood sampling), blood and plasma donations and treatment for varicose and spider veins.
"The VeinViewer technology has transformed our ability to deliver compassionate care," said Joel A. Saltzman, M.D., medical director of anesthesia at Le Bonheur Children’s Medical Center. "With VeinViewer, we have reduced not only the number of sticks, but also the levels of stress associated with multiple sticks for the practitioner, the patient and the patient's family."
Venipuncture is commonly seen as one of the most painful and frequently performed invasive procedures by nurses1. According to an article in the Journal of Phlebotomy, an estimated 1 billion venipunctures are performed annually2. In one study in the Journal of Nursing, the number of penetrations for successful catheter placement ranged from one to at least 143.
"We are being told that the VeinViewer has significant applications beyond our initial expectations, said Jim Phillips, president and CEO at Luminetx. "It will be a new standard of care for anyone who requires vascular access, and we are launching initiatives to assure that patients from coast to coast can benefit from this innovation in medical care."
Phillips also announced today that the company raised approximately $15 million in capital during its most recent financing round, which just concluded this week.
Pilot product manufacturing began this spring. Among the leading institutions where VeinViewer is currently in use are Memphis-based Le Bonheur Children’s Medical Center and St. Jude Children's Research Hospital, Rainbow Babies & Children’s Hospital in Cleveland, University of Wisconsin Children’s Hospital, Anne Arundel Medical Center in Annapolis, Md, and Midwest Vein Center in the Chicago area, just to name a few.
"With the VeinViewer, we have been able to avoid expensive and traumatic visits to the operating room to obtain venous access," Saltzman said. "This translates into less risk to the patient and thousands of dollars saved. This also means more efficiency in the OR because we do not have to disrupt the schedule for this type of procedure."
By projecting real-time images of a patient's vasculature directly onto the skin, clinicians have the ability to visualize the location of the target area regardless of a patient’s age, body type or skin tone. During prototype development in December 2004, the device was recognized by Time magazine as "one of the most innovative medical inventions" of the year4.
Luminetx has partnered with Plexus Corporation to manufacture the VeinViewer in its 100,000 square foot Buffalo Grove facility in the Chicago area. "We understand the impact that the VeinViewer technology will have within the healthcare industry, and we are very pleased to have been selected to manufacture such a revolutionary product," said Dean Foate, president and CEO for Plexus Corporation. Plexus specializes in providing production and assembly services for industry-leading accounts, including many in the medical sector.
About Luminetx Corporation
Based in Memphis, Tenn., Luminetx Corporation discovers, develops and commercializes bioscience technologies. Luminetx was selected by Red Herring as one of its "Top 100" companies in North America in May of 2006. For more information, visit luminetx.com.
1Jacobson A. Intradermal normal saline solution, self-selected music, and insertion difficulty effects on intravenous insertion pain. Heart and Lung: The Journal of Acute and Critical Care 1999:28:114-122. 2Grable HO, Gill GW. Phlebotomy puncture juncture: preventing phlebotomy errors – potential for harming patients. Laboratory Medicine 2005; 36,7:420-33. 3LaRue GD. Efficacy of ultrasonography in peripheral venous cannulation. Journal of Intravenous Nursing 2000; 23:29-34. 4Time Magazine, "The Most Amazing Inventions of 2004", Nov. 29, 2004.
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