Rox Medical Inc. has shifted its business model as it seeks to lower the pressure—and possibly lure a buyer.
The San Clemente-based medical device maker will submit an application to the Food and Drug Administration in April for a pivotal trial of its Rox Coupler for treating high blood pressure, according to Rodney Brenneman, its cofounder and chief executive.
He said he expects conditional approval to start a Rox trial by the fourth quarter.
“They have to judge whether it’s a reasonable exposure for the American people to try a new device,” Brenneman said in an interview last week.
The Rox Coupler is implanted through a catheter to create and maintain a passageway between an artery and a vein in the hip. That passageway allows a calibrated flow of blood between the vessels, which leads to lower blood pressure.
“You put a device into an artery and a vein, and the cascade of events that happens is more drug-like,” Brenneman said in a 2010 interview.
The Rox Coupler was originally developed to treat chronic obstructive pulmonary disease, a combination of chronic bronchitis and emphysema.
Clinical trials found that the device lowered patients’ blood pressure, Brenneman said.
“We finished that pilot trial in the U.S., and frankly, we found that hypertension was starting to take off and we actually had patients who showed benefit in that indication,” he said.
Rox “ultimately made the strategic decision as a board that we were going to go after [high blood pressure] rather than push farther with COPD,” Brenneman said, adding that Rox has not done a pivotal trial for its device in COPD.
Changing focus also is expected to attract potential buyers, Brenneman said.
“We really decided it would be much more motivating for big companies that we’re trying to attract to jump into this hypertension market.”
Brenneman said potential Rox acquirers include Natick, Mass.-based Boston Scientific Corp.; Abbott Laboratories in Chicago; St. Paul, Minn.-based St. Jude Medical Inc.; C.R. Bard Inc. in Murray Hill, N.J.; the Cordis unit of New Brunswick, N.J.-based Johnson & Johnson; and Medtronic PLC, which is based in Ireland but operates from suburban Minneapolis.
He estimates that Rox Coupler could be used in some 1.6 million Americans who have uncontrolled high blood pressure. He called the Rox Coupler an “additive therapy” to approaches that larger companies are looking at for treating hypertension.
Rox will be looking to raise money as it pushes on with the trial.
Potential avenues for funding include an acquisition, an equity investment from a larger company, or if it doesn’t get that, more venture capital.
Some Rox investors include Versant Ventures, a Menlo Park-based firm with a Newport Beach office, as well as Domain Associates, a San Diego firm that started out in Laguna Niguel.
Rox previously had about 25 workers but downsized to six full-time employees and six part-time consultants after it shifted its focus, according to Brenneman.
The company is still a few years away from domestic commercialization.
Brenneman anticipates U.S. clinical trial enrollment to be done in late 2017, with FDA approval by late 2018.
Rox has what he called “modest sales” in Europe, primarily to its clinical trial centers. He said he could not disclose specific numbers.
“There will probably be only what I’d called measured use of the device until the U.S. trial is done,” he said, referring to a failed trial in 2014 by Medtronic for its Symplicity HTN-3 device.
Brenneman cofounded Rox with Keegan Harper, a serial healthcare entrepreneur.
