WhiteSwell Announces Six-month Outcomes After eLym System Treatment for Acute Decompensated Heart Failure Patients in its DELTA-HF Study

WhiteSwell, a company pioneering a new paradigm in the treatment of acute decompensated heart failure (ADHF), announced today positive six-month follow-up data on the initial nine patients treated in its ongoing DELTA-HF trial evaluating the WhiteSwell eLymtm System. The data were presented by William Abraham, M.D., professor of medicine, physiology, and cell biology at The Ohio State University Wexner Medical Center, at the Technology and Heart Failure Therapeutics (THT) conference today in Boston.

Nine hospitalized patients with ADHF received eLym therapy in conjunction with diuretic therapy and were followed for six months.

Summary of key findings:

• Reduced tissue congestion: A biomarker of tissue congestion, CA-125, decreased 77% from baseline to a median of 23 u/ml at 90 days.
• Reduced rehospitalizations: Comparing patients' clinical course before and after eLym therapy, in the six months prior to eLym therapy there were 13 heart failure related hospitalizations, while in the six months after eLym therapy there were just two heart failure hospitalizations and one heart failure related death, for a 77% reduction.

The minimally invasive catheter system was successfully deployed and removed in all patients, with a mean treatment time of 24 hours. At hospital discharge, acute decongestion was demonstrated by a mean weight loss of approximately 6 kg and the elimination of orthopnea and reduction of peripheral edema in all patients. Kidney function was preserved in all patients during treatment and out to 30 days. The treatment was safe with no serious procedure-, device- or therapy-related adverse events in eight out of nine patients.

"These data demonstrate that the eLym System is safe and, in conjunction with loop diuretics, can support consistent improvement of multiple markers of decongestion, all while preserving renal function," said William Abraham, M.D. "We were especially encouraged by the dramatic reductions in heart failure related events, which were reduced despite no up-titration of guideline-directed medical therapy. I look forward to additional clinical data building upon these findings."

Patients with acute decompensated heart failure who are discharged with persistent congestion tend to experience poor outcomes, including rehospitalization and death. In the DELTA-HF trial, patients are treated with the minimally invasive, catheter-based eLym System to facilitate fluid removal from the body's tissues and organs, concurrent with diuretic removal of excess vascular fluid. The eLym System works by targeting the body's largest lymphatic vessel, the thoracic duct, and creates pressure conditions that support the tissue drainage capabilities of the overwhelmed lymphatic system.

"We have patients with ADHF who are frequently hospitalized with congestion, and they are very challenging to treat," said George Khabeishvili, M.D., Principal Investigator, Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia. "The unique treatment approach with the eLym System involves a straightforward procedure. The therapy has helped my patients feel better and, importantly, helped keep them out of the hospital."

About the DELTA-HF Trial

The Decongestion of Excess Lymphatic Fluid via the Thoracic Duct in Acute Decompensated Heart Failure (DELTA-HF) trial is a non-randomized early feasibility trial evaluating the safety and performance of the eLym System, a unique approach for the treatment of fluid overload or congestion in patients with ADHF.

About the eLymtm System

The eLym System is a minimally invasive catheter-based system designed to facilitate the removal of excess fluid from tissues and organs (interstitial fluid) in patients with ADHF by supporting the overwhelmed lymphatic system's ability to actively drain fluid. The eLym System is deployed in the left internal jugular and innominate veins near where the lymphatic system's major highway, the thoracic duct, connects. It creates a low-pressure zone to facilitate fluid drainage in conjunction with intravenous diuretics.

About WhiteSwell

WhiteSwell is a patient-focused company dedicated to improving treatment of acute decompensated heart failure (ADHF), a primary cause of repeat hospitalization and emergency room visits. A privately held company, WhiteSwell is headquartered in Galway, Ireland. For more information visit www.whiteswell.com.