Edwards Lifesciences is continuing its M&A run with two more major deals. The cardiac device company announced yesterday evening that it will spend $1.2 billion to acquire two companies: JenaValve Technology and Endotronix. The news came at the same time that the cardiac device company reported a second-quarter revenue miss and reduced TAVR guidance. As […]
Endotronix Inc.
Endotronix has positive pulmonary artery sensor data
Endotronix announced positive six-month results from a pivotal trial evaluating its Cordella pulmonary artery (PA) sensor. Naperville, Illinois-based Endotronix designed Cordella to enable proactive, data-driven heart failure (HF) management. It aims to engage patients, reduce and prevent congestion and improve outcomes. The PROACTIVE-HF trial evaluates Cordella in NYHA Class III HF patients at risk of […]
Endotronix submits pulmonary artery sensor for FDA premarket approval
Endotronix announced today that it submitted a premarket approval (PMA) application to the FDA for its Cordella system. Cordella, a pulmonary artery (PA) sensor system, enables proactive, data-driven heart failure (HF) management. It engages patients, reduces and prevents congestion and improves outcomes. The Cordella system delivers proactive PA pressure data and non-invasive vital health data […]
Endotronix wins FDA IDE for Cordella pressure-guided therapy trial
Endotronix announced today that the FDA granted it investigational device exemption (IDE) to conduct a study for its Cordella sensor. The study evaluates the use of Cordella in pulmonary artery (PA) pressure-guided therapy. PROACTIVE-HF 2, a prospective, dual-arm trial, aims to expand access for heart failure patients. Endotronix seeks to support efficient and scalable remote […]
Endotronix completes enrollment in pulmonary artery sensor trial
Endotronix announced today that it completed enrollment for a trial evaluating its Cordella pulmonary artery (PA) sensor. Lisle, Illinois-based Endotronix plans for results from the Proactive-HF pivotal study to support its application for FDA premarket approval. Cordella, an investigational device, enables proactive, data-driven heart failure (HF) management. It engages patients, reduces and prevents congestion and […]
Endotronix expands U.S. headquarters in Illinois
Endotronix today announced plans to relocate and expand its headquarters in Naperville, Illinois to support a commercial launch of its heart failure treatment devices. The company’s new building will significantly increase its manufacturing and operating capacity to grow its workforce by 30%. The new location also allows for continued expansion for its Cordella heart failure […]
Endotronix expands Series D to $70m
Endotronix said today that it added $35 million to the Series D round it first closed a year ago for the Cordella cardiovascular monitoring technology it’s developing. The Lisle, Ill.-based company initially closed the Series D at $45 million on Sept. 14, 2018, earmarking the proceeds for CE Mark approval in the European Union and […]
FDA approves Endotronix trial for Cordella PA pressure sensor
Endotronix last week announced that it received FDA approval to begin its multi-center Proactive-HF trial of the Cordella Pulmonary Artery Pressure Sensor System. The trial is designed to help the Cordella Sensor reach pre-market approval faster and will begin enrollment in the third quarter of 2019. “We are excited to begin enrollment in this groundbreaking […]
Former Rotation Medical CEO Shadan joins Miach Ortho | Personnel Moves – January 3, 2019
Early stage medtech firm Miach Orthopaedics said today that it named former Rotation Medical CEO and medtech vet Martha Shadan as its new prez and chief executive officer. Shadan has held numerous leadership positions at medtech firms, including Zimmer Biomet (NYSE:ZBH), Covidien, Bristol Myers Squibb and Merck, Westborough, Mass.-based Miach said. Prior to joining Miach, Shadan […]
Endotronix closes $45m Series D
Endotronix said today that it closed on a $45 million Series D round for the Cordella cardiovascular monitoring technology it’s developing. The Lisle, Ill.-based company said its latest raise was led by LSP and included Aperture Venture Partners, BioVentures Investors, Lumira Ventures, OSF Ventures, Seroba Life Sciences, SV Health Investors, Wanxiang Healthcare Investments and an unnamed […]
Biolase CEO Flynn steps down | Personnel Moves – April 13, 2018
Biolase (NSDQ:BIOL) said this week its CEO Harold Flynn has resigned from the company to pursue other interests, and that current CFO John Beaver will step in to act as interim CEO. The transition will be made immediately, the Irvine, Calif.-based company said. “I would like to thank Harold for the leadership and commitment he has […]
