CorWave has announced successful completion of a six-month chronic in vivo study for its novel implantable heart pump, marking the final stage of preclinical development before advancing to human clinical trials.
The French medical device company, focused on developing solutions for heart failure patients, reported that its Left Ventricular Assist Device (LVAD) demonstrated successful operation for up to six months in preclinical studies. Additionally, nine chronic ovine implants were conducted for 60 days without chronic anticoagulant therapy, with no device failures or signs of thrombosis at explant.
Breakthrough Wave Membrane Technology
CorWave's LVAD is powered by the company's proprietary wave membrane pump technology, representing a significant departure from conventional rotary blood pumps that have dominated the market since the late 1990s. This innovative pumping mechanism operates in a pulsatile mode, synchronizing with the native heart rate.
"This technology has the potential to shape the future of long term mechanical circulatory support. It can overcome current limitations of rotary blood pumps and create real smart and adaptive circulatory support," commented Dr. Martin Strueber, a cardiac surgeon who supported the company during preclinical development.
The device's unique design, combined with a smart algorithm, enables the pump to adapt its flow to patients' activity levels and preserve physiological balance. This adaptive capability aims to reduce adverse events commonly associated with current LVADs and improve quality of life for heart failure patients.
Promising Preclinical Results
The preclinical studies demonstrated several key advantages of CorWave's technology. The device showed excellent thromboresistance even without chronic anticoagulation, a significant advancement considering thrombotic complications remain a major concern with current LVADs.
Dr. Sebastian Schulte Eistrup, a cardiac surgeon involved in the in vivo studies, noted, "CorWave's novel self-adaptive, smart LVAD has demonstrated excellent preclinical results, with no device-related failures and complications. Surgical implantations were uneventful and intuitive."
The control algorithm allowed for synchronous support in either co-pulsation or counter-pulsation mode and operated reliably throughout the study period. This ability to synchronize with natural cardiac rhythms could potentially provide more physiological support than current continuous-flow devices.
Path to Clinical Implementation
With these preclinical milestones achieved, CorWave is actively preparing for its First-in-Human study. The company has already scaled up to industrial production levels with the inauguration of its urban factory in Clichy, France in October 2023. The facility is equipped with state-of-the-art technology and designed to produce up to 1,000 pumps annually, representing a potential revenue of approximately €100 million.
Louis de Lillers, CEO of CorWave, stated, "These results not only meet the highest standards in the LVAD industry but also indicate potential clinical advantages over rotary blood pumps. Following these significant milestones, the team is now actively preparing for the clinical introduction of the device."
Addressing an Unmet Medical Need
Heart failure represents a significant global health burden, with millions of patients progressing to advanced stages despite optimal medical therapy. Current LVADs have improved survival for end-stage heart failure patients but are associated with significant complications including thrombosis, bleeding, and infection.
CorWave's technology aims to address these limitations by mimicking natural cardiac function more closely. By producing pulsatile flow similar to a healthy heart, the device may reduce the risk of adverse events while providing effective circulatory support.
Founded in 2012, CorWave has secured over €80 million in equity capital from investors including Bpifrance, EIC Fund, Financière Arbevel, M&L Healthcare, Novo Holdings, Seventure Partners, Sofinnova Partners, Ysios Capital, and Vlerick Group. The company employs more than 80 people and continues to advance its mission of improving outcomes for heart failure patients through innovative medical technology.
As the company transitions from preclinical to clinical development, the medical community will be watching closely to see if CorWave's novel approach can deliver on its promise to transform mechanical circulatory support for heart failure patients.
