December 17, 2014 9:47 PM ET

Healthcare Equipment and Supplies

Company Overview of CircuLite, Inc.

Company Overview

CircuLite, Inc. designs and develops minimally-invasive devices for long term partial circulatory support. It provides Synergy Pocket Micro-pump, an implantable blood pump. The company was founded in 2004 and is based in Saddle Brook, New Jersey. CircuLite, Inc. operates as a subsidiary of World Heart Corp.

250 Pehle Avenue

Plaza 1

4th Floor

Saddle Brook, NJ 07663

United States

Founded in 2004

Phone:

201-543-2430

Fax:

201-543-2015

Key Executives for CircuLite, Inc.

Chief Executive Officer
Age: 70
Managing Director of CircuLite GmbH
Chief Technology Officer
Technical Director of CircuLite GmbH
Director of Endovascular & Cannula Engineering
Compensation as of Fiscal Year 2014.

CircuLite, Inc. Key Developments

Heartware International Inc., CircuLite, Inc. - M&A Call

To discuss the Acquisition Of CircuLite(R), Inc. by Heartware International Inc

CircuLite, Inc. Receives Approval to Begin CE Mark Trial for SYNERGY(R) IC Circulatory Support System

CircuLite, Inc. announced that it has received approval from the Federal Agency for Medicines and Health Products in Belgium to commence the CE Mark trial of the SYNERGY(R) IC Circulatory Support System, the first mechanical support system that does not require major surgery. The SYNERGY IC System is based on the surgical SYNERGY(R) Circulatory Support System -- the world's smallest commercially available circulatory support pump - which is designed to treat ambulatory chronic heart failure patients (INTERMACS >=4). While the SYNERGY IC Circulatory Support System uses the same superficially placed micro-pump platform as the surgical system, it is the first implantable circulatory support system whose Inflow Cannula is designed to be implanted by a cardiologist using standard interventional techniques. The procedure is designed to further reduce the invasiveness of implantation, and thereby reduce the rate and severity of adverse events. The multi-center CE Mark trial will enroll up to 20 patients, starting in Belgium and expanding to two additional European clinical sites. Clinical status, end organ function, exercise tolerance, functional capacity and quality of life will be assessed post-implantation. Patient screening has commenced at the University Hospitals Leuven, Belgium.

CircuLite Inc. Announces 90-Day Results for its CE Mark Trial of the SYNERGY(R) Circulatory Support System

CircuLite Inc. announced 90-day results for the final 26 patients in its CE Mark Trial of the SYNERGY(R) Circulatory Support System, which were discussed in an oral presentation at the 33rd meeting of the International Society for Heart and Lung Transplantation. The patients were implanted with the final, commercial version of the SYNERGY System, which demonstrated clinically meaningful and sustained hemodynamic improvements, with a relatively low rate of adverse events when compared with larger support devices. The last 26 consecutive patients in the CE Mark Trial -- out of the total 63-patient trial set -- were treated with the optimized SYNERGY System. Ninety-day follow-up from these non-inotrope dependent INTERMACS >=4 patients showed significant hemodynamic improvements, including decreased pulmonary artery and pulmonary capillary wedge pressures, and increased cardiac output. Peak VO2, the six-minute walk test and the Minnesota Living with Heart Failure Questionnaire also demonstrated significantly improved functional status and quality of life. Major adverse events, such as bleeding, infection and stroke, trended lower than published studies of larger support devices. The SYNERGY System was also featured in one additional oral presentation and two poster presentations at ISHLT. The oral presentation and one poster featured animal studies of an investigational right heart application of the SYNERGY System to treat pulmonary arterial hypertension, which demonstrated that right ventricular support may improve both systemic and pulmonary hemodynamics. The other poster presentation reviewed an animal study of an investigational endovascular implantation of the SYNERGY System, which demonstrated the feasibility of deploying a novel Inflow Cannula transseptally, via venous access to the left atrium for implantation with no complications.

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