Technology Overview
CircuLite is developing disruptive solutions to improve the treatment of chronic heart failure. The Company’s minimally invasive circulatory support systems are intended to work in conjunction with the heart to enhance clinical outcomes and improve quality of life for patients and their families.
Synergy®, CircuLite’s lead product, is designed to offer a new treatment option for patients with chronic heart failure who are not responding to standard medical care. Currently in a CE Mark clinical trial, Synergy features the world’s smallest surgically-implanted blood pump intended for long-term partial circulatory support and is targeted for use in patients diagnosed with NYHA Class IIIb/early Class IV (INTERMACS 4-6) heart failure.
Based on the positive data reported thus far from the Synergy CE Mark trial, CircuLite is pursuing the expansion of its micro-pump technology platform with next-generation circulatory support systems that address additional patient populations and broaden the commercial opportunity. The Company is advancing an endovascular system that is approaching clinical evaluation in Europe. CircuLite was also awarded a National Institutes of Health grant and is collaborating with the University of Maryland School of Medicine for the development of a pediatric circulatory support system for children and infants, and has also received a private grant from the Cardiovascular Medical Research and Education Fund, Inc. (CMREF) to support the development of a system for patients with right-heart failure. Finally, CircuLite is developing an all-support system that will be designed to accommodate the complete spectrum of a patient’s circulatory support needs from partial support through full support. CircuLite is also developing a fully auto-regulated circulatory support system under a European Union grant. The objective of the EU grant activity is to utilize flow and pressure sensors to automatically control the pump flow rates to meet patient cardiac demand.
CircuLite’s circulatory support systems are designed with unique attributes, which include:
- World's smallest implantable blood pump (the size of a AA battery and weighing 25g)
- First superficially implanted micro-pump, designed to be placed without cardiopulmonary bypass or sternotomy
- Small percutaneous lead
- Designed to supplement native cardiac output
- Designed for long-term support
- Magnetically and hydrodynamically stabilized rotor design
- Lightweight, rechargeable dual battery pack system (average power 6-8 hours)
These design attributes confer important potential advantages. The small size and minimally invasive procedures offer the potential for earlier, elective treatment for patients diagnosed with NYHA Class IIIb/early Class IV (INTERMACS 4-6) heart failure, and offer the potential for physicians to treat a larger proportion of heart failure patients. This approach with the Synergy surgical system has been shown to increase total cardiac output and to offload the heart1, allowing it to rest and potentially enable beneficial recovery of heart function. Additionally, clinical trials with the Synergy system have demonstrated improvements in quality of life and hemodynamic function1,2. CircuLite believes that its micro-pump technology can be adapted to fulfill a range of clinical needs and that these benefits may also help pediatric patients and patients with right-heart failure.
1Meyns B, Simon A, Klotz S, Wittwer T., Schlensak C. Rega F, Burkhoff D. Clinical benefits of partial circulatory support in New York Heart Association Class IIIb and Early Class IV patients. European Journal of Cardio-thoracic Surgery, 39 (2011) 693-698.
2Data on file, CircuLite, Inc. Clinical Flyer August 2011.