Germany-based medical technology company Fiagon has entered into an agreement with the US-based 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.
Fiagon’s 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 use Fiagon’s unique ‘chip on the tip’ technology for navigation.
The GE Healthcare patent license agreement was acquired by Fiagon for an undisclosed cash payment.
Fiagon has also announced that it has received US FDA 510(k) clearance on 30 April 2014 to market its proprietary surgical navigation system in the US.
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 US.
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 navigated at the tip and permits less invasive approaches in keyhole surgery, resulting in less pain and more rapid recovery for the patient.
Fiagon CEO Dr Timo Kruger said the company is excited about the excellent acceptance of its technology in Europe, and are looking forward to the penetration of the US 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 U.S. and to China," Dr Kruger added.