SAN DIEGO, CA--(Marketwired - Jul 15, 2013) - Naviscan, the manufacturer of a High-Resolution PET Scanner, announced today that its Japanese distributor, SCETI, has received notification of reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its high-resolution, organ-specific PET scanner used in breast applications (also known as Positron Emission Mammography or PEM) effective July 1, 2013. SCETI expects that this approval will open the market substantially for the future and will allow them to build on their installed base of clinical systems in Japan. The reimbursement criterion is based on the additional resolution and specificity obtained on PEM that cannot be determined in a typical whole body PET/CT exam.
High-resolution breast PET has an index lesion sensitivity of 93-96% with a sensitivity for secondary lesion detection comparable to MRI but with a 91% specificity, significantly better than MRI (p=0.032). This results in a measure of accuracy referred to as positive predictive value (PPV) for PEM prompted biopsies of 66%, again significantly better than MRI (p=0.016). The third advantage is PEM guided biopsy can be done on the same day and same dose of isotope, streamlining patient care.
Naviscan's CEO Paul J. Mirabella said, "SCETI has proven itself to be a formidable and extremely competent supplier of clinical solutions. We have been pleased with their performance to date and look forward to working with them to bring improved breast cancer management to the Japanese market."
Fabien Reyjal, SCETI's President said, "We are delighted to obtain a reimbursement approval from the Japanese MLHW which demonstrates PEM's clinical advantages and market acceptance. While the Japanese breast imaging market is evolving, we look forward to working with the local breast physicians and imaging specialists to provide patients across the country with access to the tremendous benefits of PEM."
About Naviscan PEM Scanner
The Naviscan PEM scanner is compact, mobile and easy-to-use for precisely characterizing breast cancer, enhancing surgical planning, monitoring patient response to chemotherapy and evaluating suspected recurrence. It is designed to show the metabolic phase of a lesion allowing for early breast cancer diagnosis and assisting physicians in making optimal care decisions by providing an ability to distinguish between benign and malignant lesions.
A pioneer among foreign companies in Japan, SCETI was established in Tokyo in 1925, before it joined Denis Group in 1958. In its early years, the company served as agent for major French Heavy Industry companies. Along the way, SCETI became gradually involved in nuclear medicine, strengthening its portfolio in quantum equipment, isotopes, reagents and diagnostics. Meanwhile, it diversified its activities into Life Sciences importing advanced functional ingredients for food, health food, cosmetics and pharmaceuticals manufacturing. Lately, the company ventured into medical imaging distributing high-end systems, equipment & services used in medical diagnosis and treatment. SCETI markets innovative Health Science solutions focusing on Life Sciences, Medical and Bio-Medical. It works as importer, distributor and licensor operating under QMS compliance. It serves the Industrial, Medical, Clinical, Pharmaceutical and Research networks in Japan and export markets.
About Naviscan, Inc.
Naviscan, founded in 1995, develops and markets compact, high-resolution PET scanners and the Stereo Navigator® Biopsy Accessory intended to provide organ-specific molecular imaging and guide radiological and surgical procedures. The Naviscan PET scanner is currently installed and available in breast and imaging centers throughout the world with global distribution in 34 countries. The Company is headquartered in San Diego, California and is the first to obtain FDA clearance and CE Mark for a high-resolution PET scanner designed to image small body parts and for breast biopsy image guidance. For more information, visit http://www.naviscan.com/