Company Announcements

ROX Medical Inc. Announces Sustained Improvements in Patients with Uncontrolled Hypertension Treated with the ROX Coupler

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CONTROL HTN 12-Month Data Published in Hypertension and to be presented at TCT 2017

SAN CLEMENTE, Calif., October 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.
For more information, visit www.roxmedical.com.

roxmedicalusROX Medical Inc. Announces Sustained Improvements in Patients with Uncontrolled Hypertension Treated with the ROX Coupler
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ROX Medical CONTROL HTN-2 Clinical Trial; First Procedure Performed

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SAN CLEMENTE, Calif., October 3, 2017 – ROX Medical Inc. A privately held medical device company pioneering an innovative interventional vascular therapy for Uncontrolled Hypertension, announced today that the first patient was treated in the CONTROL HyperTeNsion (HTN)-2 clinical study, the Company’s pivotal study 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.

The CONTROL HTN-2 study is a large, multi-center trial that will include up to 30 study sites in the U.S. The first procedure was performed at Brookwood Baptist Health PRINCETON BAPTIST MEDICAL CENTER in Birmingham, Alabama by Dr. Farrell O. Mendelsohn, Physician Partner at Cardiology, P.C. “Our entire research team at Cardiology, P.C. is excited about implementing this research study for our patients as the ROX Coupler technology may offer an alternative option to treat the global problem of uncontrolled hypertension” said Dr. Mendelsohn, the principal investigator for the research protocol.

Prior to CONTROL HTN-2, ROX Medical conducted a multi-center randomized trial in Europe. Patients treated with the ROX Coupler experienced a mean drop in blood pressure of 27 mmHg which was sustained out to 6 months. A manuscript has been recently accepted for publication confirming a significant and durable pressure drop at one year.

The ROX Coupler and FLOW procedure creates a passage between an artery and a vein in the upper thigh, which redirects a measured amount of arterial blood to the veins. This therapy is intended to reduce peripheral vascular resistance and add a compliant venous element to the arterial system through creation of a therapeutic arteriovenous anastomosis with the ROX Coupler.

Rodney Brenneman, Chief Executive Officer of ROX Medical, Inc., said, “starting the ROX CONTROL HTN-2 study is a crucial milestone in our efforts to help the millions of patients living with uncontrolled high blood pressure manage their disease. We congratulate our colleagues at Brookwood Baptist Health PRINCETON BAPTIST MEDICAL CENTER on being the first to enroll in this important study”.

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. For more information, visit www.roxmedical.com.

About Cardiology, P.C.,
For over forty years, the physician specialists at Cardiology, P.C. in Birmingham, Alabama have provided the most advanced diagnostic and treatment methods for managing heart and vascular disease and are at the cutting edge of clinical research. For more information, visit www.cardiologypc.com

roxmedicalusROX Medical CONTROL HTN-2 Clinical Trial; First Procedure Performed
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ROX Medical presents positive data for CONTROL-HTN resistant hypertension trial

ROX Medical presented positive results from the CONTROL-HTN trial, an international multi-center, prospective, randomized, controlled, blinded endpoint study of the ROX Coupler for the treatment of arterial hypertension, at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in Washington, DC. The CONTROL-HTN trial, NCT01642498, evaluated the safety and efficacy of a percutaneous procedure creating a fixed connection between a central artery and vein in the upper leg – for the treatment of hypertension. The primary outcomes are reduction of blood ambulatory blood pressure and office pressure at 6 months post procedure as well as the safety and efficacy of the ROX Coupler.

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roxmedicalusROX Medical presents positive data for CONTROL-HTN resistant hypertension trial
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ROX Medical completes enrollment in CONTROL-HTN trial

ROX Medical announced it has completed enrollment for CONTROL-HTN trial, an international multi center, prospective, randomized, controlled, blinded endpoint trial of the ROX Coupler for the treatment of arterial hypertension. The CONTROL-HTN trial, NCT01642498, is evaluating the safety and efficacy of a percutaneous procedure creating a fixed connection between a central artery and vein in the upper leg – for the treatment of hypertension. The primary outcomes are the safety and efficacy of the ROX Coupler in reduction of ambulatory and office blood pressure at 6 month’s post procedure. Paul A. Sobotka, MD, Chief Scientific Officer of ROX Medical, anticipates that last data obtained and results to be presented in the fall of 2014.

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roxmedicalusROX Medical completes enrollment in CONTROL-HTN trial
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ROX Medical adds 15th Clinical site, in Netherlands, to CONTROL-HTN randomized study

ROX Medical this week received confirmation of Ethics Committee approval at St. Antonius Hospital, Netherlands making it the 15th clinical center in the ROX CONTROL-HTN randomized study. St. Antonius will join centers across the UK, Belgium, Ireland, Germany, Poland and Greece. The CONTROL-HTN randomized study is a 100-patient trial to evaluate the ROX arterio-venous Coupler used along with standard drug therapy to treat resistant hypertension. The study is over 25% enrolled and is projected to complete enrollment before year-end.

roxmedicalusROX Medical adds 15th Clinical site, in Netherlands, to CONTROL-HTN randomized study
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ROX Medical Enrolls First Patient in Randomized Controlled Hypertension Trial of AV-Coupler

ROX Medical announced the first patient enrollment in the CONTROL-HTN international randomized controlled trial of the ROX FLOW procedure for the treatment of resistant hypertension (high blood pressure). The first patient was enrolled at the Universitair Ziekenhuis Brussel (University Hospital of Brussels) Brussels, Belgium by Professor Danny Schoors and Dr Sofie Brouwers.

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roxmedicalusROX Medical Enrolls First Patient in Randomized Controlled Hypertension Trial of AV-Coupler
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Dr. Sofie Brouwers presents the ROX COPD/HTN data at Austin Doyle Award Session at ISH 2012, Sydney, Australia

Dr. Sofie Brouwers from UZ Brussel, Belgium was selected to present at the prestigious Austin Doyle Award Session during the 2012 International Symposium of Hypertension (ISH) in Sydney, Australia. Dr. Brouwers presented the 12-month data from the ROX Medical US IDE and German Multicenter study on patients with concomitant COPD and Hypertension. The resulting data explored the associated blood pressure reduction after the creation of an iliofemoral fistula. The data showed that the creation of a calibrated iliofemoral AVF significantly reduced blood pressure after 3 and 6 months and that the reduction was maintained at 12 months.

Read the abstract here:  2012 ISH Austin Doyle Award Session

roxmedicalusDr. Sofie Brouwers presents the ROX COPD/HTN data at Austin Doyle Award Session at ISH 2012, Sydney, Australia
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ROX Medical Announces First Clinical Use of the ROX FLOW Procedure for the Treatment of High Blood Pressure in Resistant Hypertension Patients

ROX Medical, Inc. today announced the first clinical use of the ROX COUPLER TM at the Universitair Ziekenhuis Brussel (University Hospital of Brussels) to treat resistant hypertension. “We are pleased to have performed the first ever ROX FLOW Procedure for this new approach to hypertension, the acute impact on the patients’ blood pressure was greater than we expected and we look forward to understanding how much these patients benefit from the treatment over time.”

roxmedicalusROX Medical Announces First Clinical Use of the ROX FLOW Procedure for the Treatment of High Blood Pressure in Resistant Hypertension Patients
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