Otsuka has inked a deal to buy renal denervation player ReCor Medical. The takeover will give Otsuka an ultrasound ablation system that lowered the blood pressure of hypertension patients in a recent clinical trial.
ReCor’s device is designed to treat hypertension by downregulating the activity of the sympathetic nerves that run to and from the kidneys along renal arteries. The device does this through the use of ultrasound energy to interrupt nervous system signaling. Medtronic looked set to develop a device based on a similar idea around five years ago, only for it to fall short in the clinic.
Early data on ReCor’s device suggests it may be better equipped to succeed, although doubts remain. In a sham-controlled trial, the delivery of two or three seven-second ablations to each renal artery lowered blood pressure in some patients. The daytime ambulatory blood pressure of one-fifth of participants in the treatment arm fell to below the target. In the control arm, 3% of participants hit the target.
The data, and clearance to start a pivotal U.S. study, led Otsuka to strike a deal for ReCor.
“ReCor’s statistically-significant clinical results in the SOLO trial are convincing biological proof that renal denervation with ReCor’s ultrasound-based system is effective in reducing blood pressure in patients with hypertension,” Kazumichi Kobayashi, Otsuka’s renal denervation project leader, said in a statement (PDF). “We are excited to commercialize this technology, which has the potential to become one of the great technological advancements in hypertension treatment.”
The deal follows nine years in which ReCor was buffeted by external forces. Three years after ReCor was founded in 2009, renal denervation became a red-hot topic when Medtronic posted clinical data that suggested its device could achieve 30 mm Hg systolic blood pressure reductions. Talk of a 40% drop in the rate of heart attacks and strokes followed.
Then, in 2014, the field fell back to earth. In a larger sham-controlled clinical study, Medtronic’s renal denervation device failed to reduce blood pressure after six months. That prompted Medtronic and St Jude Medical to suspend their renal denervation trials.
The 2014 clinical trial marked the end of Medtronic’s first renal denervation device but the company returned with a revised offering. Early data on the second-generation device resurrected interest in the field, although expectations are considerably lower than they were pre-2014. An interim analysis of the new device linked it to a 5 mm Hg sham-adjusted reduction in 24-hour systolic blood pressure.
If that modest reduction is maintained as the trial progresses and is shown to improve outcomes, Medtronic may have a viable product on its hands. But the progress of ReCor and its likely takeover by Otsuka means Medtronic may face competition if it gets to market. Differences in the designs of the Medtronic and ReCor trials make it hard to compare the efficacy of their respective devices.