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Phillips-Medisize announces FDA approval of myBETApp and BETACONNECT Navigator

Phillips-Medisize, LLC (Phillips-Medisize) is honoured to announce Bayer’s recent approval from the U.S. Food and Drug Administration (FDA) for the myBETAapp™ and BETACONNECT™ Navigator. Phillips-Medisize designed and developed the BETACONNECT autoinjector, myBETAapp and the BETACONNECT Navigator via its Medicom device strategy and design services group.

With this software in relapsing-remitting multiple sclerosis, people using the electronic BETACONNECT autoinjector to administer BETASERON® (interferon beta-1b) can use Bluetooth® technology to connect their current autoinjector to the new myBETAapp on their mobile device or computer. Patients have the opportunity to share their injection data with their BETA Nurse and healthcare team. Viewing this data through the BETACONNECT Navigator may be a useful tool for the healthcare team to gain insights into patients’ injection history and provide support to those taking BETASERON.

"Since introducing the first FDA approved treatment option for relapsing remitting multiple sclerosis patients more than two decades ago, we’ve listened closely to the community to understand their needs and how we can support them," said Mark Rametta, D.O., FACOI, FACP, Bayer’s medical director for Neurology. "The myBETAapp and BETACONNECT Navigator add to the services that we’ve developed based on patient feedback, including 24/7 access to nurse support and the first and only electronic autoinjector for patients taking BETASERON."

"Connected health is more than a buzz word at Phillips-Medisize. It is a strategy that includes the offering of device strategy and design services (via Medicom) to medical and pharmaceutical companies helping them deliver to their patients a connected health device solution. We are proud of the BETACONNECT, myBETAapp and BETACONNECT Navigator Phillips-Medisize developed (via Medicom) for Bayer. Our broad capabilities and technologies enable Phillips-Medisize to provide a turn-key connected health solution, which few companies can match," comments Matt Jennings, chairman and chief executive officer, Phillips-Medisize.

"The FDA’s approval of myBETAapp and BETACONNECT Navigator work cohesively with the already approved BETACONNECT autoinjector and Bayer’s BETASERON® drug. This endorses our view that drug delivery devices, combined with mobile apps, provide support for patients and customers," comments Bill Welch, chief technology officer, Phillips-Medisize.

For full prescribing information visit: http://labeling.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf

For BETACONNECT Instructions for Use please visit: http://labeling.bayerhealthcare.com/html/products/Betaconnect_IFU.pdf

For myBETAapp Instructions for Use please visit: http://labeling.bayerhealthcare.com/html/products/mybetaapp_IFU.pdf