Precardia Inc. received some good news from the U.S. FDA, which has granted the company's catheter-based system for treating volume overload in patients with acutely decompensated heart failure (ADHF) breakthrough device designation.

The device is intended to quickly reduce congestion in the venous system, known as cardiac preload, with an eye toward improving overall cardio-renal function. Currently, it is being assessed in the VENUS-HF early feasibility study.

Citing statistics from a study in the American Journal of Epidemiology the company says 1.8 million patients are admitted to hospitals with ADHF in the U.S. each year. And these patients face challenges.

Last summer, Navin Kapur, director of the acute circulatory support program at Tufts Medical Center and chief medical advisor and chair of the company's scientific advisory board, noted that current approaches are suboptimal. Further, there had not been any treatment advances in the last 20 years. He expressed optimism with Precardia’s minimally invasive approach.

Improving on the gold standard

“The gold standard in-hospital treatments for ADHF include intravenous diuretics, vasodilators, and inotropic agents,” Lisa Wipperman Heine, the company’s president and CEO, told BioWorld. “These drugs are designed to improve symptoms and heart function by reducing fluid overload and cardiac filling pressures.”

Despite that, diuretics can take time to work and prove ineffective in those with advanced heart failure, severe venous congestion or renal insufficiency. “Patients who do not respond to diuretics do not have access to a primary therapeutic tool designed to relieve ADHF-related pulmonary and systemic congestion, and as a result are at dramatically increased risk of mortality,” she added.

Those hospitalized with ADHF face tough odds in terms of readmission and post-discharge death. Mortality rates are roughly 37% in the first year after discharge, and 78% within five years.

“A device-based therapy to limit fluid overload may quickly improve symptoms and cardio-renal function in patients with ADHF who are not responding adequately to diuretics, however there are no FDA-approved devices that treat this clinical condition.”

The company is hoping to change that with its system, which works by transiently occluding venous blood flow in the superior vena cava. It is hoped that can alleviate heart failure symptoms and improve renal function. “Importantly, the Precardia system is able to treat patients who are not responding adequately to diuretics, providing a viable treatment option to a uniquely vulnerable patient population that currently has no proven safe and effective option,” she concluded.

As a result of this designation, the St. Paul, Minn.-based company will have priority engagement with the agency. In addition, CMS has created an alternative new technology add-on payment pathway for technologies gaining this designation.

Precardia’s news comes roughly a year after Houston-based Procyrion Inc. said it had secured the same designation for its Aortix system. Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for ADHF with worsening renal function.

Not long before securing this designation, the startup completed a $30 million series D financing led by Bluebird Ventures to advance development of the system. Proceeds were earmarked for supporting a pilot study of the device and subsequent submission of an IDE application for an FDA-approved pivotal clinical trial.

At the time, the company said initial indications for the system focused on treating diuretic-resistant ADHF patients – a market worth potentially $4 billion.

For its part, in late 2018, Whiteswell, which has a presence in Galway, Ireland, Palo Alto, Calif., and Israel, scooped up a $30 million series B funding round led by Ra Capital Management and an Incube Ventures syndicate, with participation from other investors. The funds were earmarked for product development and a pivotal study of the company's minimally invasive, catheter-based approach to help ADHF patients.

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