|ReCor's Paradise System--Courtesy of ReCor|
Otsuka has given renal denervation to treat hypertension another vote of confidence. It's signed a distribution deal for certain Asian companies with startup ReCor Medical, as well as making an additional investment in the company.
Renal denervation to treat hypertension had a major setback in 2014 with a failed clinical trial for Medtronic ($MDT). However, the medical device giant, as well as competitors Boston Scientific ($BSX) and St. Jude Medical ($STJ) and ReCor, of course, are plowing ahead with their clinical trial programs in the field.
The latest Otsuka infusion is for an undisclosed amount; the biopharma led a $15 million Series D for the company in April 2015 with participation from Sofinnova Partners.
"We highly value Otsuka's development and marketing capabilities in Asia--one of the most important potential markets for our Paradise technology," said ReCor President and CEO Andrew Weiss in a statement. "This latest investment is designed to fund our RADIANCE-HTN study, which we hope will demonstrate the blood-pressure-lowering effect of the Paradise System in patients with hypertension."
The cash will go to backing ReCor Medical's ongoing clinical trial that's aimed to support an FDA submission. The blinded, randomized and sham-controlled U.S. and European trial started this spring and is slated to enroll up 292 patients.
The trial is in patients with hypertension who are on up to two medications. Some patients in a treatment-resistant cohort will have at least 3 antihypertensive medications. All subjects will be hypertensive without medication or despite it. It's slated to have final primary outcome data in August 2017, according to the trial record on Clinicaltrials.gov.
In April 2015, Boston Scientific started a trial to support FDA submission to get its renal denervation device for hypertension. It's slated to have final primary endpoint data in November. Medtronic has continued on with a simplified version of its device--it's got more than a half-dozen open clinical trials related to renal denervation and hypertension, as does St. Jude.
Otsuka will conduct its own clinical trial of the ReCor Paradise ultrasound-based renal denervation system in Japan for treatment-resistant hypertension. The distribution deal covers for Japan, China, Korea and other Asian countries.
"This collaboration demonstrates Otsuka's strategy of leveraging our expertise in select disease areas for the development of medical device-based solutions with the potential to address medical needs that cannot be met by pharmaceutical treatment alone," said Otsuka President Tatsuo Higuchi.