Second Heart Assist Announces an Impressive Successful Completion of a First-In-Human Case Study in Central America with its Whisper™ Device

SALT LAKE CITY, July 25, 2024 — Utah-based Second Heart Assist Inc., announced today the successful completion of the company’s first Central American case to evaluate the performance of its Whisper™ percutaneous mechanical circulatory device, designed to improve both cardiac function and renal perfusion in patients hospitalized with acute decompensated heart failure (ADHF). Second Heart Assist has already successfully performed FIH studies in Panama (South America) and other OUS countries for multiple indications.

A resident of Panama developed severe cardiomyopathy and progressive biventricular heart failure following a Covid infection several years earlier that led to multiple hospitalizations and three in past several months prior to the admission where the patient presented severe volume overload and cardiogenic shock as confirmed by hemodynamic monitoring (“terminal heart failure” as stated by the patient’s physician). Like previous admissions, initial treatment included another course of high dose IV diuretics for two days, with only modest success. Per protocol, hemodynamic monitoring was initiated that confirmed the cardiogenic shock with an initial cardiac index of 1.4 liters/min, (normal 2.4 liters/min), and very elevated left and right heart filling pressures that were both greater than 3 times the normal values. The Second Heart Assist Whisper™ device was easily and quickly inserted and was associated with an immediate and very large increase in urine output (over 400% over the previous hour) that persisted throughout the 25 hours of flawless device performance before planned and uneventful device removal. Despite the very significant diuresis during device use, there was an actual improvement in measured renal function (Creatinine) that persisted even after device removal. Hemodynamics returned to near normal within 24 hours and the patient was then converted to oral heart failure medications and discharged less than 48 hours after receiving therapy from the Whisper™ device, and only 5 days after the presentation in cardiogenic shock.

“I am immensely pleased with the outcomes of the recent case involving our device. Both the implantation and explantation processes were seamless and successful. The pump performed flawlessly, delivering significant and rapid improvements in hemodynamic parameters through high-volume diuresis. I am thrilled by the progress we are making at Second Heart Assist and am optimistic about the transformative potential of our device in treating heart failure,” said Dr. Leslie Miller, Chief Medical Officer of Second Heart Assist Inc.

This patient demonstrates both the power and safety of early initiation of the SHA device in the management of patients with advanced heart failure who present with severe volume overload that develop diuretic resistance and have persisting congestion.

About Second Heart Assist Inc.

Second Heart Assist Inc. (www.secondheartinc.com) is developing a temporary mechanical circulatory support (MCS) system that utilizes a stent cage fitted with a motorized impeller to aid in providing circulatory support throughout a patient’s body. The system is intended for use in patients hospitalized with acute decompensated heart failure (ADHF) and who develop diuretic resistance with persistent congestion (cardio-renal syndrome (CRS), and/or cardiogenic shock (CS), and those in need of prophylactic hemodynamic support during high-risk percutaneous coronary intervention (PCI).

Caution: the Whisper™ device is not approved and not for sale in any geography.

For more information, please contact Jeff Donofrio, CEO ([email protected]) or Dr. Leslie Miller, CMO ([email protected]).