May 11, 2006
Nashville, May 11, 2006 – Veran Medical Technologies announced today that it received marketing clearance from the U.S. Food and Drug Administration (FDA) for the SPiN IR™ System, an image guidance system indicated for the treatment of traditionally CT guided soft tissue biopsy and ablation procedures. “The SPiN IR™ System represents a categorically new approach to therapy delivery in a broad range of oncology areas,” said Jerome R Edwards, Veran president and chief executive officer. Veran is very excited about the clearance of its first major product as it advances our strategy of enhancing therapy delivery in areas such as lung, liver, and kidney,” The SPiN IR™ System is the first system of its kind to import multiple 3D scans and provide four dimensional (4D) real time data to physicians so they can accurately deliver therapy. Along with the system, Veran also delivers a broad range of instruments that universally adapt existing biopsy needles and ablation device plus plan to deliver their own line of integrated navigated instruments.
Veran is a privately held medical device company headquartered in St. Louis, MO. The company’s mission is to empower physicians to diagnose cancer earlier and to enable precision therapy to save lives. In the United States, lung cancer kills more people each year than breast, prostate, pancreatic and colon cancers combined.
Veran has developed and commercialized an FDA cleared, next generation electromagnetic thoracic navigation platform called the SPiN Thoracic Navigation System™. Veran’s breakthrough technology has been adopted by leading cancer centers throughout the United States. Veran provides physicians with a full line of bronchoscopic brushes, needles, forceps and steerable catheters with tiny electromagnetic sensors embedded in the tips for precise navigation. The combination of these proprietary Always-On Tip Tracked® instruments and Veran’s exclusive patient respiratory gating technology enables physicians to accurately access lung nodules by accounting for nodule movement during patient breathing, a common challenge for lung specialists.
Another challenge lung specialists face is that approximately 40% of lung nodules lie outside of an airway, making them very difficult to reach endobronchially, and traditionally requiring an additional procedure. Veran’s SPiN Thoracic Navigation System™ is the first and only FDA cleared technology that enables Pulmonologists or Thoracic Surgeons to safely and accurately access lung nodules outside of an airway using SPiN Perc™, a navigated transthoracic needle. With SPiN Perc™, Veran combines endobronchial navigation with percutaneous navigation, allowing physicians to access all lung nodules in a single procedure, regardless of nodule size or location. This eliminates the cost and risk of unnecessary procedures and empowers physicians to provide a same day diagnosis for their patients. The early diagnosis and treatment of lung cancer has been proven to save lives.