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Brainlab and Mobius Receive CE Mark Approval for Airo® Mobile Intraoperative CT

Global sales and CE Mark approval represent significant milestones for innovative system
Munich, Germany, April 1, 2014 – Brainlab, a global leader in medical technology and Mobius Imaging, developer of advanced imaging technologies, announced today CE Mark approval for Airo Mobile Intraoperative CT. The CE Mark allows Brainlab to begin installation of the systems sold in the European Union.

“In light of the enormous market response Airo has already experienced around the world, we are eager to begin installation and use in Europe,” said Stefan Vilsmeier, President and CEO at Brainlab. “We are dedicated to meeting the growing demand for real-time imaging in the O.R. to improve and expedite clinical decision-making which benefits both the patient and the surgical team. Airo surpasses this demand and we are pleased to now be able to provide our European customers with this advanced imaging system.”

Airo is a unique system that advances health care delivery by producing high-quality CT images that enhance surgical decision-making and support minimally invasive surgery. The portable scanner provides reproducible high-resolution images, thanks to its integrated O.R. table column by TRUMPF and 32-slice helical scan detector array. Airo boasts the largest gantry opening on the market, lending itself particularly to cranial, spine and trauma procedures. Airo also connects seamlessly and automatically with Curve™ Information Guided Surgery by Brainlab, allowing for immediate surgical navigation on newly acquired images in the O.R.

“Receiving CE Mark approval for our flagship product, Airo, is a significant milestone for Mobius Imaging,” said Gene Gregerson, CEO of Mobius Imaging. “We are proud of the extensive research and usability put into Airo that resulted in a Red Dot award-winning product design. Airo has been showcased at many European congresses and customers are excited to have the opportunity to bring the product’s benefits to their patients.”

The first European shipments of Airo are expected in April 2014.

About Brainlab

Brainlab, headquartered in Munich, develops, manufactures and markets software-driven medical technology, enabling access to and consistency of advanced, less invasive patient treatment.

Core products revolve around information-guided surgery, precision radiation therapy, and information and knowledge sharing that fosters interdisciplinary collaboration. Brainlab technology currently powers treatments in the fields of neurosurgery, radiosurgery/radiotherapy, orthopedics, ENT, CMF, spine, and trauma.

Privately held since its formation in 1989, Brainlab has more than 5,000 systems installed in about 95 countries. Brainlab employs 1,150 people in 17 offices worldwide, including 290 research & development engineers, who form a crucial part of the product development team.
To learn more, visit www.brainlab.com/airo.

About Mobius Imaging, LLC

Mobius Imaging develops, designs and manufactures advanced imaging technologies that fit seamlessly into existing medical workflows. The company’s approach to technology – Intelligent Imaging – is designed to give healthcare practitioners the crisp, clear images they want, whenever and wherever they want them, without adding time or complexity to the procedure. From the OR to the ER to clinical settings of all kinds, Intelligent Imaging expands possibilities. Founded in 2008, the company maintains a broad IP portfolio. Its first commercial product, the Airo Mobile Intraoperative CT System, is distributed under an exclusive sales and service agreement with Brainlab.
To learn more, visit www.mobiusimaging.com.