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Fiagon AG secures patent license agreement with GE and receives notice of 510(k) clearance from FDA

GE Healthcare and Fiagon AG Announce a Patent License Agreement

 

Fiagon AG today announced that it has entered into an agreement with GE Healthcare. Under the terms of the agreement, Fiagon will acquire a patent license to several of GE Healthcare´s ENT and Cranial navigation technologies. This will help Fiagon surround and back up the 35 issued patents and substantial intellectual property of Fiagon, resulting in greater protection from competitive interference by other companies.

 

 

This agreement is further evidence of Fiagon´s commitment to seek to enhance innovation in surgical navigation and to maintain technological leadership. Recently developed instruments for ENT surgery include the first bendable navigated instrument, the FlexPointer for precise sinus applications and the navigated FinePointer for applications onto the Laterobase. Both products using the Fiagon unique „chip on the tip“ technology for navigation.

 

 

The GE Healthcare patent license agreement was acquired by Fiagon for an undisclosed cash payment.

 

 

Regulatory Approval in the USA and China

 

Fiagon today also announced that it has received US FDA 510(k) clearance on April 30, 2014 to market its proprietary surgical navigation system in the United States. This FDA clearance comes shortly after the recent China CFDA regulatory clearance.  Fiagon is anticipating substantial initial orders for the navigation system through master distributor agreements in China and the USA.

 

 

The navigated FlexPointer, has been very well received in Europe as an instrument that permits surgical sinus intervention without the need of exchange during the surgery. The Pointer is inserted endoscopically assisted and indicates the current position. The unique FlexPointer is navigated at the tip of the instrument and can be intraoperatively adjusted by bending it.

 

 

The navigated FinePointer is designed to support skull base surgery for ENT access. The very thin FinePointer is the navigated at the tip and permits less invasive approaches in keyhole surgery resulting in less pain and more rapid recovery for the patient.

 

 

Dr. Timo Krueger, chief executive officer of Fiagon AG, said, “We are excited about the excellent acceptance of our technology in Europe, and are looking forward to the penetration of the USA and China markets in the coming years. Our patent portfolio has been significantly strengthened by the GE license agreement, and coupled with our regulatory clearance, we are ready to move rapidly to expand our sales to the USA and to China“

 

 

Amanda Baccarini, Chief Marketing Officer of GE Healthcare Surgery, said, “At GE Healthcare, we believe in the benefits of surgical navigation and are pleased to license technology to Fiagon AG in order to advance minimally invasive procedures in the ENT and Cranial fields.“

 

About Fiagon

 

Fiagon AG Medical Technologies, a private investor owned company based near Berlin, Germany, is the parent company of Fiagon GmbH Holding. Fiagon develops and manufactures innovative surgical navigation systems of the latest generation with its proprietary „chip on the tip“ technology. In the last 4 years Fiagon, along with world-renowned physicians, has changed the standard in ENT navigation with its proprietary navigation technology.  And this unique technology is expected to also be very useful in oral and maxillofacial surgery, neurosurgery, spine, and dental surgery.

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