BTG and Mirada Medical announce CE Mark Certification for Simplicit90Y dosimetry software in Europe
BTG plc (LSE: BTG), an international specialist healthcare company, with Mirada Medical Ltd, a leading global brand in medical imaging software, today announced CE Mark certification for Simplicit90Y™ dosimetrysoftware, designed to optimise the planning of 90Y selective internal radiation therapy (SIRT) and facilitate personalised treatment for patients with liver cancer. CE Mark certification follows approval for Simplicit90Y™ in Canada.
BTG, in collaboration with Mirada Medical, have developed Simplicit90Y™ to be a customised, easy-to-use, dosimetry software developed for rapid 90Y SIRT workflow. Simplicit90Y™ provides digital processing, review and reporting of medical images with unique options for data display, quality control, image manipulation and quantification analysis. Together, these features allow for more standardised and consistent dosimetry planning and post-treatment validation, and the ability to personalise treatment for each patient.
“Simplicit90Y™ represents an important advance in providing patients and healthcare providers with added value beyond our products and we are pleased it has received CE Mark certification,” commented Zillah Moore, Director Commercial Operations EMEA. “It will ensure 90Y therapies, such as TheraSphere®, can be specifically tailored to individual patient needs, facilitating personalised treatments. Simplicit90Y™ will help us offer interventional oncology teams more power to personalise and optimise 90Y SIRT for their patients. We’re delighted Simplicit90Y™ is now available for physicians to use.”
“Dosimetry can be a time intensive and complex process and Simplicit90Y™simplifies both dosimetry planning and post-treatment validation,” said Etienne Garin, MD, PhD, Chair professor of Nuclear Medicine, Cancer Institute, Centre Eugene Marquis Rennes, France. “Knowing you can use this intuitive software to help deliver a more personalised treatment for each patient, achieving the best dose of 90Y radiation to the tumour while minimising exposure to healthy tissue, gives physicians more confidence.”
Matthieu Leclerc-Chalvet, Mirada Medical, Managing Director commented, “We designed this software to simplify the dosimetry workflow for SIRTand enhance consistency and efficiency. Mirada Medical supports 90Y treatment quality by incorporating advanced image processing tools that facilitate the clinician’s use of multi-modal images to plan 90Y SIRT treatment. Leveraging combined expertise from across the industry helped meet both the physician’s and patient’s needs and Simplicit90Y™ is a clear demonstration of that success.”
BTG and Mirada Medical will be at the 29th Annual EANM Congress in Barcelona, Spain, 15th – 19th of October, 2016. Information regarding Simplicit90Y™ will be available via the BTG booth (#62 & 76) and Mirada Medical booth (#65 & 66) in the main exhibition hall. For more information on Simplicit90Y™ please visit www.btg-im.com/Simplicit90Y and register your interest.
Simplicit90YTM is a standalone software device intended for use by Nuclear Medicine (NM) or Radiology practitioners for display, processing and reporting of data, including planar scans (Static, Whole Body) and tomographic scans acquired by gamma cameras or PET scanners. Physicians can use the system for viewing and assessing image data for general clinical diagnostic purposes with additional features and optimised workflow for yttrium-90 (90Y) dosimetry.
TheraSphere® 90Y glass microspheres are specifically engineered to carry far greater power than any other 90Y liver-directed cancer therapy.TheraSphere® works predominantly through radiation, with minimal embolic effect1 which allows the microspheres to lodge deeper inside the tumor, achieving a high absorbed dose. The result is a powerful, targeted and well-tolerated therapy that may lead to patients becoming eligible for curative therapies.
In the EU, Singapore, South Korea and Canada, TheraSphere® is approved for the treatment of hepatic neoplasia. TheraSphere® is commercially available in Hong Kong and Malaysia. In the US, TheraSphere® is approved under a Humanitarian Device Exemption (HDE) for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters. TheraSphere® is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion, when clinical evaluation warrants the treatment. The effectiveness of TheraSphere® for this use in the US has not been demonstrated. For full instructions for use and important safety information, please visit www.therasphere.com.
About BTG Interventional Medicine
BTG Interventional Medicine is part of BTG plc, a growing international specialist healthcare company. As medicine moves from major surgery to minor procedure, from the systemic to the local, no company endeavors to do more than BTG Interventional Medicine to help doctors in their quest to see more, reach further and treat smarter. Our growing portfolio of Interventional Medicine products is designed to advance the treatment of cancer tumors, advanced emphysema, severe blood clots, and varicose veins. To learn more about BTG Interventional Medicine, please visit: www.btg-im.com.
About Mirada Medical Ltd
Mirada Medical is a leading international brand in medical imaging. The company develops advanced software applications which help healthcare professionals use medical images more effectively and efficiently to improve cancer care. Mirada’s products are used across diagnostic radiology, molecular imaging, radiation oncology, medical oncology, tumour board and elsewhere. Mirada Medical was originally spun out of the University of Oxford. The company’s technologies and products continue to be developed by their team of specialists, engineers and world-renowned scientists at Mirada’s world headquarters in Oxford, England. For more information about Mirada Medical products visit: www.mirada-medical.com.
For further information contact:
Chris Sampson, Corporate Communications Director
+44 20 7575 1595; Mobile: +44 7773 251 178
+44 20 8618 2755; Mobile: +44 7725 925 841
Mirada Medical Ltd
Annamaria Albano, Marketing Programmes Manager
+44 1865 261 410
Pellerin O, et al. Cancer Biother Radiopharm 2013;28(6):459–65.