This financing supports the commercialization of the Cordella™ Heart Failure System (Cordella System) and clinical development of the Cordella™ Pulmonary Artery Sensor (Cordella Sensor) through CE Marking and FDA Premarket Approval (PMA). The product platform consists of a comprehensive remote patient management software solution coupled with a seamlessly integrated, next generation implantable pulmonary artery sensor to streamline heart failure care management and provide early detection of worsening heart failure.
"We are thrilled with the world-class leadership and support of LSP and our existing investor group as we launch into the next phase of our company," commented Harry Rowland, CEO of Endotronix. "This financing accelerates our U.S. and E.U. launch of the Cordella System and supports our upcoming landmark randomized, controlled clinical study, PROACTIVE-HF, to demonstrate the safety and effectiveness of proactive heart failure management."
The Cordella System is designed to address inefficiencies in heart failure management and promote guideline-based therapy so physicians can improve patient care and reduce re-hospitalizations with effective and scalable remote patient management. Over 26 million people worldwide suffer from heart failure and it is a leading cause of re-hospitalization for people over 651,2. With U.S. treatment costs reaching $31B per year, heart failure management remains a pressing unmet clinical need3.
"Endotronix is on the cusp of transforming heart failure management," stated Fouad Azzam. "Their scalable Cordella System enables streamlined and timely flow of clinical-level information that can improve patient outcomes and supports sustainable care delivery revenue for healthcare providers. We're excited to be part of the team to drive this transformation in the heart failure market."
This announcement builds on the earlier news of successful first-in-human use of the Cordella Sensor in Europe and first commercial use of the Cordella System at select U.S. sites.
About the Cordella™ Heart Failure System The Cordella Heart Failure System is a proactive heart failure management solution that brings patient management into the digital age and allows physicians to treat more patients with guideline-based therapy. The easy-to-use system extends clinical care into the home by collecting and securely transmitting daily patient data and insights to the heart failure clinician to guide therapy and optimal dosing. In the U.S. market, the system drives care delivery revenue using Medicare's existing Chronic Care Management Services to support proactive, high-quality heart failure care. For suitable patients, the system seamlessly integrates pulmonary artery pressure data with a next generation wireless, implantable sensor. Clinical studies have demonstrated that pulmonary artery pressure-guided management can reduce heart failure-related hospitalizations and reduce mortality.
About Endotronix, Inc. Endotronix, Inc., a digital health, medtech company, is developing an integrated platform to provide comprehensive, reimbursable health management tools for patients suffering from chronic heart failure. The company's comprehensive solution includes a cloud-based disease management data system and outpatient hemodynamic management with a breakthrough implantable wireless pulmonary artery sensor for early detection of worsening heart failure. Learn more at www.endotronix.com
About LSP LSP (Life Sciences Partners) is an independent European investment firm, providing financing for private and public life sciences companies. LSP's mission is to connect investors to inventors, focusing on unmet medical needs. Since the late 1980s, the LSP team has invested in about 100 innovative enterprises, many of which have grown to become leaders of the global life sciences industry. With over €1.7 billion ($2.0 billion) of investment capital raised to date and offices in Amsterdam, Munich and Boston, LSP is Europe's leading life sciences investor. The LSP Health Economics Fund 2 invests in innovative products that can increase the quality of health care, while reducing the cost of care. For more information, please visit: www.lspvc.com.
1 Ponikowski P et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure 2015;1:4–25
2 Mozzafarian D, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016
3 Joo H, et al. Cost on Informal Caregiving for Patients with Heart Failure. Am Heart J. 2015 Jan;169(1):142–48.e2.