While the surprise flop of Medtronic's ($MDT) market-leading renal denervation device spurred a domino effect on other players in the field, California startup ReCor Medical has no plans to delay its program, affirming its commitment to a device that takes a different approach to lowering blood pressure.
Earlier this month, Medtronic shocked the industry when it unveiled that its Symplicity device failed to meet its efficacy endpoint in a sham-controlled pivotal trial, after which competitors Boston Scientific ($BSX) and Covidien ($COV) put their programs on hold.
But ReCor's Paradise system is unlike Symplicity and its relatives, avoiding catheter-delivered radiofrequency energy and instead using ultrasound blasts to ablate renal nerves and lower blood pressure. And that difference gives the company's technology a different safety and efficacy profile, CEO Andrew Weiss said.
"Following the recent publication of negative results from one of the RDN clinical trials, some competitors have announced that they are either delaying, reducing or abandoning efforts to commercialize their RF-based RDN products," Weiss said in a statement. "Having reviewed our own clinical results and spoken to clinicians who have collectively treated hundreds of patients with resistant hypertension using different RDN systems, ReCor is convinced that our product is well-differentiated from these RF-based approaches."
And so the venture-backed company is moving forward with its device, which is CE marked and on the market overseas. In 6-month data from an earlier trial, Paradise lowered systolic blood pressure by 33 mmHg in patients with drug-resistant hypertension, ReCor said, results that compare well with offerings from Medtronic and St. Jude Medical ($STJ). Notably, however, ReCor's technology has not been submitted to the kind of sham-controlled study that imperiled Symplicity, and the company has announced no plans to change that.
ReCor is backed by European investor giant Sofinnova Partners.
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Special Report: Renal denervation: Medtronic, St. Jude vie for lion's share of billions