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Veran Medical receives CE Mark clearance for its next generation SPiN Thoracic Navigation System™ for lung cancer

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April 19th, 2018 – St Louis, MO

Veran Medical has received CE Mark clearance for its next generation ENB SPiN Thoracic Navigation System™ for lung cancer. The approval clears the way for Veran to accelerate commercialization efforts of its newest platform for lung specialists across Europe. Veran originally received CE Mark for its SPiN IR™ platform in 2011 for diagnosing and guiding treatment of suspected cancer in the liver, kidney and other soft tissue. In 2016, Veran received CE Mark clearance for an earlier generation SPiN Drive® platform for lung specialists.  Veran has also just received clearance for commercializing its SPiN Thoracic Navigation System™ in Taiwan.

“We are thrilled to provide physicians and patients in Europe and across the globe with access to this break-through care solution for lung cancer,” said Veran Medical CEO Jason Pesterfield. “At Veran, our mission is to provide physicians with the tools to access, sample and guide treatment of the smallest suspected cancer nodules so—together, we can stage shift lung cancer.”

The SPiN Thoracic Navigation System™ converts CT scans into precision 3D maps used to navigate the airways in the lungs. Veran’s Always-On Tip Tracked® sampling instruments contain small electromagnetic sensors in the tips to help guide physicians straight to the nodules. Veran’s proprietary SPiN Perc® technology gives physicians the ability to seamlessly transition to a navigated percutaneous approach to reach small nodules outside of airways. The software platform is available in English, French, Italian, German, and Spanish.

Lung cancer kills an estimated 1.6 million people a year worldwide. In Europe alone in 2017, it’s estimated that lung cancer killed 275,000 men and women. New lung cancer screening is helping identify patients earlier in the disease progression and has been proven to save lives.

“To stage shift cancer, physicians need the right tools to consistently reach and sample small nodules—wherever they are located. Unfortunately, to date, the clinical evidence is clear that legacy tools like conventional bronchoscopy, legacy ENB systems, and radial EBUS solutions just aren’t working. We believe Veran offers lung cancer physicians and their patients a better option,” said Pesterfield.

Bronchoscopy is commonly used for the diagnosis of suspicious pulmonary nodules discovered on computed tomographic (CT) imaging of the chest. However, multiple clinical trials have documented that traditional tools are failing physicians. In the large multi-center AQuIRE registry, diagnostic yields were as low as 38.5%.  Results presented at the American College of Chest Physician 2017 meeting in Toronto from a randomized clinical trial pitting Radial Endobronchial Ultrasound (R-EBUS) vs. standard bronchoscopy with fluoroscopic guidance, diagnostic yields were 48.7% and 26.8%, respectively.

 

About Veran Medical Technologies

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.

Media Inquiries: Please Contact TJ Meyer at tj.meyer@veranmedical.com

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