Renal Denervation is dead. Long Live Renal Denervation. So expects ReCor Medical as it has announced Series D investment of approximately $15M led by Otsuka Holdings Co., Ltd., and Sofinnova Partners.
It’s not much more than a year since all the expectation and buzz that characterized the nascent renal denervation technology was put on ice when Medtronic’s Symplicity III HTN study yielded disappointing results. Investment in renal denervation projects by the many protagonists at the time was either put on ice or, in the case of Covidien with its recently acquired OneShot, shelved completely.
More recently it would appear there’s been a significant amount of soul-searching as companies have re-examined the Symplicity data and sought their own explanations. One possible cause of the poor results was mooted as being the rather first generation feel of the original single electrode technology employed in the then extant Symplicity device.
If it is to be the technology that takes the blame, then ReCor might be in good shape, its system relying on ultrasound rather than radiofrequency energy to do the job, and also promising circumferential delivery of this therapeutic energy.
So to the present day, which sees ReCor planning to start a new 20-25 centre US/EU randomized study into the use of its Paradise system in hypertensive patients to demonstrate its effect on blood pressure in conjunction with, and in the absence of, hypertensive drug therapy. These things don’t come cheap, hence the welcome news of additional funding.
“The Series D investment led by Otsuka Holdings shows renewed interest in the renal denervation field and confidence in our ultrasound-based Paradise System,” commented Andrew M. Weiss, President and CEO of ReCor. “We are pleased to have attracted investment from one of Japan’s premier healthcare groups. This new relationship will support our upcoming US clinical studies and open new potential for our technology in Japan and greater Asia. We are pleased to be positioned alongside Boston Scientific and Medtronic, who have also recently announced new clinical trials in renal denervation for the treatment of hypertension.”
“ReCor believes that our Paradise technology may have a distinct advantage over competitive RF-based RDN systems by providing active vessel protection and 360 degree energy delivery. We believe that we can demonstrate an important clinical effect in hypertension patients with the Paradise system,” added Mano Iyer, ReCor COO and co-founder, “We are working with leading hypertension experts and interventionalists to finalize our clinical study design, and plan to begin enrollment in the second half of 2015.”
Source: PR Newswire