SAN CLEMENTE, Calif., Oct. 26, 2017 — ROX Medical Inc., a privately held medical device company pioneering an innovative interventional vascular therapy for uncontrolled hypertension, announced the publication of 12-month outcomes of the ROX CONTROL HTN study in the prestigious journal, Hypertension.
CONTROL HTN is a multi-center randomized controlled trial that enrolled patients with uncontrolled hypertension. In the study, at the 12-month follow-up, patients treated with the ROX Coupler had a sustained mean reduction of 25mmHg in in-office systolic blood pressure and a reduction of 13 mmHg in 24-hour ambulatory systolic BP vs. baseline. These results are consistent with 6-month clinical outcomes reported previously in The Lancet, which reported a mean drop of 27 and 13 mmHg in office and ambulatory pressures respectively.
"The magnitude of ambulatory blood pressure reduction at 12 months is striking and establishes a genuine, significant, and durable anti-hypertensive effect," said Dr. Melvin Lobo of the Barts NIHR Biomedical Research Centre and lead author of the Hypertension publication. "These compelling clinical benefits suggest that the ROX Coupler has the potential to be a major advance in the treatment of patients suffering from uncontrolled hypertension."
Rodney Brenneman, Chief Executive Officer of ROX Medical commented, "According to the CDC, more than five million patients in the US with stage 2 hypertension (> 160 mmHg) are not achieving acceptable blood pressure control on available medical therapies. Publication of the CONTROL HTN 12-month outcomes adds to the growing body of evidence for the ROX Coupler as an important new option for patients struggling with uncontrolled hypertension."
The 12-Month Control HTN data will be included in an oral presentation on the ROX Coupler by Dr. Krishna Rocha-Singh, at the TCT2017 meeting in Denver on Monday, November 30.
ROX Medical is currently enrolling the CONTROL HTN-2 Clinical study, a randomized, sham controlled pivotal trial designed to evaluate the safety and effectiveness of the ROX Coupler used to create an arterio-venous anastomosis in the iliac vessels, in patients with high blood pressure. Dr. Rocha-Singh is the principal investigator for the CONTROL HTN-2 clinical trial. For more information on the CONTROL HTN-2 study, please visit www.controlhtn2.com.
About ROX Medical, Inc.,
ROX Medical is a privately held medical device company pioneering an innovative interventional vascular therapy for Uncontrolled Hypertension. ROX Medical has developed a simple, minimally invasive and reversible procedure that may be performed in under one hour without sedation in a standard vascular catheterization lab. More than 67 million Americans are living with high blood pressure, and 16 million know they have high blood pressure and are receiving medication for it but still don't have their pressure under control. ROX Medical is conducting additional studies in hypertension and is available commercially in Europe under CE mark.