Endotronix Presents Positive PROACTIVE-HF Clinical Trial Results for its Cordella Pulmonary Artery Sensor

• The trial met primary safety and efficacy endpoints, demonstrating a markedly low rate of heart failure hospitalizations for NYHA class III HF patients.
• The results support the company's pre-market approval (PMA) application for U.S. market access, which is under review with the U.S. Food and Drug Administration (FDA).

NAPERVILLE, Ill., March 5, 2024 /PRNewswire/ -- Endotronix, Inc., a privately held company dedicated to advancing the treatment of heart failure (HF) at the intersection of digital health and medtech, presented 6-month results from its PROACTIVE-HF pivotal trial. PROACTIVE-HF evaluated the company's investigational Cordella Pulmonary Artery (PA) Sensor in New York Heart Association (NYHA) class III HF patients at risk of congestion. The trial met primary safety and efficacy endpoints and demonstrated a markedly low rate of HF hospitalizations in addition to showing a clinically significant improvement in patient quality of life, increased physical activity, and improvement in the NYHA functional class. The company previously announced the submission of its PMA application, which included the trial results. Dr. Liviu Klein presented the results today during a late-breaking session at Cardiovascular Research Foundation's Technology and Heart Failure Therapeutics (THT) conference in Boston MA.

To read the full PROACTIVE-HF trial results, click here.

"These results are very encouraging and provide strong evidence in favor of HF management using PA pressure-guided therapy, along with vital sign data, to remotely optimize guideline-directed medical therapy and improve heart failure outcomes," stated Dr. Klein, Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco and national principal investigator of the PROACTIVE-HF trial. "Cordella offers a novel patient-friendly system that includes a handheld PA pressure reader and allows patient visibility to health data. In my opinion, these key differentiators helped drive high levels of engagement for patients and supported them to make healthy lifestyle choices. Combined with the clinicians' targeted medication adjustments using the system's comprehensive view of patient health status, we achieved great patient outcomes overall and when compared to the same period before sensor implant."

The multi-center, prospective trial implanted 528 NYHA class III HF patients across 75 U.S. and European sites. Over half of the implanters were heart failure specialists and the trial showed high rates of patient compliance (>6 avg Cordella submissions/week) and clinician engagement (>2 avg reviews/week). The 6-month single-arm results met primary safety and efficacy endpoints as well as several clinically significant secondary efficacy endpoints.

• 99.2% Freedom from Device or System-related Complications (DSRC)
• 99.8% Freedom from PA Sensor Failure
• A low 0.15 rate of HF hospitalization/all-cause mortality at 6 months compared to a performance goal of 0.43 based on previous PA pressure-guided HF management trials (p<0.0001)
  • Met primary efficacy across all sub-groups of PA pressure-guided HF management (p<0.0001)
• Clinically significant improvement in patient quality of life metrics and key health metrics
  • 5-point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) (p<0.0001)
  • 23 meter improvement in 6-minute walk test (6MWT) (p=0.001)
  • 144 patients improved their NYHA class designation (p<0.0001)
  • 2.4 mmHg decrease in seated mean PA pressure from baseline for congested patients (p=0.001)
  • 5.9 mmHg decrease in-office systolic blood pressure from baseline (p<0.0001)
  • 2.2 lb decrease in at-home weight (p=0.001)

The PROACTIVE-HF results are consistent with previously reported clinical data for the Cordella PA Sensor, including the published 12-month results from the SIRONA 2 trial.

"These results are the culmination of many years of hard work and dedication by the Endotronix team and our clinical partners as we strive to provide best-in-class care for heart failure patients," commented Harry Rowland, CEO and co-founder of Endotronix. "We believe proactive, comprehensive care with Cordella improves the lives of patients living with heart failure and PROACTIVE-HF provides compelling evidence to support this new approach to impactful remote care delivery. With commercial launch expected later this year, we look forward to supporting clinicians in helping heart failure patients lead more full and active lives."

In addition, Endotronix continues to extend its evidence-based clinical foundation for Cordella with the market-expanding PROACTIVE-HF 2 clinical trial, which is enrolling patients.

About Endotronix
Endotronix innovates at the intersection of Medtech & Digital Health to improve care for people living with heart failure (HF). The comprehensive Cordella solution enables proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The Cordella Sensor is an implantable pulmonary artery (PA) pressure sensor that directly measures the leading indicator of congestion, allowing early, targeted therapy. The Cordella HF System is a patient health management platform, which combines comprehensive vital sign data from non-invasive devices to support patient-clinician engagement and care decisions. Combining trended insights, the versatile and scalable Cordella enhances current clinical practice and supports guideline-based care across the entire HF continuum. Learn more at www.endotronix.com.

The Cordella Pulmonary Artery Sensor System is an investigational device and is not currently approved for clinical use in any geography. CAUTION ? Investigational Device. Limited by Federal (or United States) Law to Investigational Use. Exclusively for Clinical Investigation. The Cordella HF System, without the sensor, is available for commercial use in the U.S. and E.U.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain predictions, estimates, or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

SOURCE Endotronix, Inc.