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| ReCor Medical's Paradise catheter--Courtesy of ReCor Medical |
California's ReCor Medical is forging ahead with its renal denervation efforts as more med tech outfits jump back into the field, roping in $15 million in financing and planning to launch a study aimed at FDA approval for its related device.
Otsuka Holdings led the Series D round with Sofinnova Partners contributing additional funding. Palo Alto, CA-based ReCor also revealed that it met with the FDA to discuss a new, randomized control trial of its Paradise Renal Denervation (RDN) System in hypertensive patients. The company will conduct the study at 20 to 25 sites in the U.S. and EU, positioning it alongside competitors Boston Scientific ($BSX) and Medtronic ($MDT) as they launch new clinical trials for renal denervation devices, CEO Andrew Weiss said in a statement.
"The Series D investment led by Otsuka Holding shows renewed interest in the renal denervation field and confidence in our ultrasound-based Paradise System," Weiss said in a statement. "This new relationship will support our upcoming U.S. clinical studies and open new potential for our technology in Japan and greater Asia."
The latest funding and new trial come as big names such as St. Jude Medical ($STJ), Boston Scientific and Medtronic refocus their attention on renal denervation despite a series of setbacks. Last year, Medtronic's market-leading renal denervation device Symplicity failed to meet its primary endpoint in a pivotal trial, sparking industrywide fallout. Boston Scientific temporarily delayed the start of its own U.S. renal denervation study and Covidien abandoned its program altogether.
But the companies are diving back into the field with new plans for growth. In April 2014, Medtronic announced that it would launch a new, smaller trial for its Symplicity device. And in July, St. Jude CEO Daniel Starks told investors in a Q2 earnings call that renal denervation deserves "high priority" and hypertension is the company's "sweet spot" for future R&D. Starks remained mum on specific plans, but alluded to a competitor's failed trial and said the company would build on promising clinical data to develop the therapy.
In the meantime, smaller med tech outfits like ReCor could give big name competitors a run for their money by offering alternatives to traditional renal denervation devices. Unlike Medtronic's Symplicity, ReCor's Paradise system eschews catheter-delivered radiofrequency energy and instead uses ultrasound blasts to ablate renal nerves and lower blood pressure. Michigan startup Ablative Solutions is also getting in on the effort, raising $9.5 million last year for its perivascular renal denervation system that delivers chemical treatment, rather than energy, to the outer layer of the renal arteries.
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