"Is the Berlin Heart meant for permanent use?"

Berlin Heart develops, produces and trades innovative devices for the mechanical support of the heart. Our products INCOR®, EXCOR® and EXCOR® Pediatric cover the whole range of medical indication for all ages, from the newborn to the adult. For this the international Berlin Heart is the market leader in Germany and Europe.

--------------------------



In June 2002 the worldwide first implantation of the INCOR® device took place in the German Heart Centre DHZB. The CE approval for Berlin Heart INCOR® was granted after 9 months of clinical testing on March 21st 2003.During the ISRBP Congress (International Society for Rotary Blood Pumps) which took place in Bad Oeynhausen, our INCOR® device was awarded with the ICMT-Award (International Centre for Medical Technologies) for being the most innovative product.

By July 2005 no less than 200 INCOR® devices had been already implanted. In September 2005, Berlin Heart AG could report another milestone with regard to long term therapy of VAD INCOR® – one patient is living with the device for 3 years.

Berlin Heart AG plies its trade in two plants. The headquarters in Wiesenweg 10 hosts the administration, research and development, marketing and sales and the manufacturing of INCOR®, EXCOR® cannulas and driving units. The production of the EXCOR® blood pumps is effected in the plant in Usedomer Strasse in the district Berlin Wedding.

Berlin Heart Inc., a wholly owned subsidiary of Berlin Heart AG, was founded in October 2005. A US team is in place to support entry into the US market. The on-site presence ensures optimal support of the US clinics in emergency cases and allows close cooperation with the FDA.

Originally founded as a private equity company, Berlin Heart was acquired in October 2006 by Syscore GmbH, a long-term investor concentrating on the medical technology sector. With this New investor Berlin Heart seeks to accelerate the growth of its INCOR® and EXCOR® business and further build on the position in the US market. The University of Alberta Hospital/ Stollery Children's Hospital will be a training and reference center for the US and Canadian market. The longstanding successful cooperation with the German Heart Institute in Berlin will be continued.

As part of the transaction, Berlin Heart's legal structure was changed from an AG to a GmbH, thus enabling a faster and more flexible response to market developments.

The left ventricular assist device INCOR® is meant to be designed for patients, who suffer from chronicle heart insufficiency. The heart has weakened to that extent that the only help is either heart transplantation or the implantation of a ventricular assist device. For this, there are two certain categories of patients to be considered:
Patients, who require an assist of the pump function for a limited time while they are waiting for a heart transplant.
Patients, who cannot be transplanted for particular reasons and therefore require a permanent use of the assist device INCOR®. It does happen that the heart of a patient recovers while connected to the INCOR® device and is able to take over the pumping function on its own again. The device is then explanted.