SAN CLEMENTE, CA, ROX Medical announced the closing of a financing round totaling $6M. The financing will be used to initiate an international trial of the ROX FLOW procedure for the treatment of resistant hypertension.
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ROX Medical announced the closing of a financing round totaling $6M. The financing will be used to initiate an international trial of the ROX FLOW procedure for the treatment of resistant hypertension (high blood pressure). Previously, ROX has successfully evaluated the FLOW procedure in pilot studies: "The very encouraging results from our pilot hypertension trial was the basis for this investment, enabling us to pursue a more comprehensive, randomized study using the FLOW procedure," said CEO Rodney Brenneman.
According to the Centers for Disease Control, 68 million people in the US have high blood pressure and 1.2 billion people worldwide. Of those, 50% of patients experience hypertension that remains uncontrolled (blood pressure above 140/90) and 15-20% have resistant form of hypertension. According to the American Heart Association, a 5 mmHg reduction in systolic blood pressure results in a 14% decrease in stroke, a 9% decrease in heart disease and a 7% decrease in overall mortality.
ROX Medical's FLOW procedure is a short, minimally invasive, catheter-based procedure whereby Interventional Cardiologists, Radiologists or Endovascular Specialists place a stent-like connection between the artery and vein in the upper leg. The procedure is intended to reduce peripheral vascular resistance, thereby holding the promise of a meaningful long-term reduction in hypertension. Uniquely, the FLOW procedure only involves the vascular structure, has an immediate effect; and is fully reversible.
To-date, ROX Medical has raised approximately $50M for its FLOW system, initially for studies and early commercialization of the FLOW procedure for COPD (pulmonary) treatment. The prior successful studies on COPD patients also demonstrated a significant lowering of blood pressure in hypertensive patients. "Hypertension physicians were encouraged by this response in our COPD patients, and pushed us to pursue this therapy separately for resistant hypertension patients as well. We're excited to move forward with a randomized controlled trial," Brenneman said. Pilot results with the ROX FLOW procedure in resistant hypertensive patients have shown reductions in systolic and diastolic blood pressure on par with those for device therapies like renal denervation.
The ROX FLOW procedure for hypertension is not approved for use in the U.S.
Investors in the latest round of funding include continuing investors Domain Associates and Versant Ventures.