|Placing the InterAtrial Shunt Device using a catheter and guidewire--Courtesy of Corvia Medical|
Corvia Medical has scooped up a potential buyer with a purchase option deal, but the Massachusetts-based startup is remaining hush-hush on the identity of the strategic partner and the deal terms. The deal likely hinges on the outcome of an upcoming trial for its transcatheter InterAtrial Shunt Device (IASD) to treat heart failure, or the subsequent FDA approval for which it's expected to provide the basis.
This mystery strategic partner is hardly the only major device player backing minimally invasive heart failure options. In late 2014, Edwards Lifesciences ($EW) made a similar option purchase agreement as part of a $50 million financing for Menlo Park, CA-based CardioKinetix, which also has a transcatheter heart failure treatment device that is in pivotal testing. And early this year, Johnson & Johnson's venture arm participated in a $28 million round for Israeli heart failure startup V-Wave that is developing a transvenously placed interatrial shunt to treat heart failure.
The FDA signed recently gave Corvia the go-ahead for the study, dubbed REDUCE LAP-HF I--it's slated to be substantial spanning up to 20 sites in the U.S. with an additional 8 ex-U.S. sites. The prospective, randomized, controlled trial will test the IASD System to reduce elevated left atrial pressure in patients with heart failure with preserved ejection fraction, also known as diastolic heart failure.
The company hasn't yet revealed how many patients the trial will enroll or what treatment the control group will receive; and Clinicaltrials.gov hasn't yet posted any public details on it.
"Treating heart failure patients, especially those with preserved ejection fraction, continues to be a challenge as current pharmacological treatments are ineffective," commented Dr. Martin Leon, Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center in New York and chair of the company's Scientific Advisory Group, said in a statement.
He continued, "We expect the results of the REDUCE LAP-HF I randomized study to confirm the significant clinical benefits demonstrated in the observational studies and will show clinically meaningful improvements in NYHA (New York Heart Association) functional class, exercise capacity and quality of life for this patient population."
Primary endpoint data were due last December from the prior REDUCE LAP-HF trial that was slated to be in 100 patients. The trial started in September 2013. The trial is in primary heart failure patients over age 40 with a 6-month primary endpoint of major adverse cardiac and cerebrovascular events (MACCE) defined as death, stroke or myocardial infarction or a systemic embolic event, excluding pulmonary thromboembolism.
Although the company hasn't yet publicly detailed the study results, Corvia must have some positive data in order to get an FDA greenlight on the forthcoming pivotal trial.
The Corvia Atrial Decompression System is the first transcatheter device designed to treat heart failure with preserved ejection fraction (HFpEF), the company noted. The Corvia implant is deployed via a small opening in the atrial septum. It forms a passage between the left and right atria that allows the left atrium to decompress in order to lower left atrial pressure. By offering continuous dynamic decompression of the left atrium, the system aims at improving heart failure symptoms and quality of life, as well as decreasing heart failure hospitalization rates and the associated costs of care.
Corvia Medical was previously known as DC Devices. Its most recent cash infusion was a $34 million Series D round in July 2014 from investors including Accelmed, Third Rock Ventures, General Catalyst Partners, Lumira Capital and an undisclosed strategic investor. The financing was said to be sufficient to complete the clinical program for its transcatheter heart failure device.
"The IDE approval and strategic funding solidify our commitment to advancing our breakthrough therapy for patients suffering from chronic heart failure," said Corvia President and CEO George Fazio, in a statement. "We look forward to providing physicians a technology that is designed to facilitate continuous and dynamic decompression of the left atrium and address the debilitating symptoms of heart failure."
He added, "We are especially pleased to have the support of a strategic partner with best-in-class global resources as we move this novel treatment toward international commercialization."
Fazio was at St. Jude Medical ($STJ) for about 17 years, holding various executive spots. He joined Corvia in 2010, shortly after it was founded the prior year. A prominent life sciences venture capital player, Third Rock's Mark Levin, sits on the Corvia board.
- here is the option deal and trial start announcement