MOUNTAIN VIEW, California, August 22, 2017 /PRNewswire/ --
Vascular Dynamics, a medical device company currently developing an innovative treatment for hypertension and one of the leading principals of the Rainbow Medical Investment Cluster, announced that the Food and Drug Administration (FDA) approved the company's plans to initiate conclusive and pivotal trial experimentation to investigate the effectiveness of its flagship product, MobiusHD, in the treatment of chronic hypertension.
Vascular Dynamics was chosen by the FDA to participate in an accelerated EAP (Expedited Access Pathway) program, the objective of which is to catalyze innovative and life-saving experimental treatments, as a means of bringing them to clinical use among patients as soon as possible. In addition, the company is one of nine companies chosen for participation in an IDE (Investigational Device Exemptions) pilot program, to enable the execution of experiments on a smaller scale and an expedited pathway to FDA marketing approval.
The Solution to Reducing Drug Resistant Hypertension
MobiusHD, a miniature invasive implant, changes the way by which patients who do not respond to medications for reducing hypertension are treated. The implant is inserted by means of a catheter and placed in the carotid, in a location containing baroreceptor nerves that regulate the heart's output, thereby regulating the body's blood pressure. Whenever these sensors are damaged, the brain receives erroneous commands that cause the increase in blood pressure. The implant developed by Vascular Dynamics enhances the sensors' signals and improves blood pressure regulation.
Efi Cohen-Arazi, CEO of Rainbow Medical, said, "We are pleased to have received such a meaningful expression of faith from the FDA for the Vascular Dynamics solution. Experimenting within the EAP framework emphasizes the medical need and recognition of the innovative solution we have developed. This pathway can significantly shorten the product's time to market and bring relief to millions of patients worldwide coping with chronic hypertension and drug resistance."
The pivotal study, CALM 2 (Controlling and Lowering Blood Pressure with MobiusHD), taking place in the United States and for the first time in Europe, is intended to examine the effectiveness of MobiusHD in controlling, regulating and lowering high blood pressure in chronically ill patients who, although they have received multiple hypertension medications, saw no improvement in their condition. It is one of the most common phenomena in medicine yet to find a sufficient pharmaceutical or technological response.
Dr. Gregg Stone, Primary Researcher and Director of Cardiovascular Research and Education at Columbia University Medical Center, said:
"Around the world we are coping on a daily basis with repeated cases of patients suffering from chronic hypertension who do not respond to various medications or modifications in the patient's lifestyle. The MobiusHD experiment is a critical and highly important step in finding additional therapeutic alternatives for a giant market that has yet to find a solution in modern medicine".
"The experiment is an extremely important milestone, in which we will be able to confirm the latent potential in our technology for the treatment of this enormous global population, and prove that MobiusHD is capable of changing and saving lives," added Robert Stern, President and CEO of Vascular Dynamics. "Thanks to our participation in the unique FDA program designed to advance our trial experimentation, we are capable of assuring a quick, effective and safe research study of the highest standards."
What is Chronic Hypertension?
Chronic hypertension is one of the more serious issues facing modern medicine. The body proves incapable of responding to countermeasures given the body to reduce its blood pressure. Ongoing high blood pressure is liable to lead to severe vascular and organ damages, reflecting a significant danger to the patient.
About Vascular Dynamics
The company is part of the Rainbow Medical Investment Group corporate cluster. Vascular Dynamics is developing catheter-delivered technologies to bring a better quality of life to patients who are resistant to conventional treatments for hypertension. The company is conducting controlled and multi-center human clinical trials in the US and Europe in order to evaluate the safety and performance of the MobiusHD device. In December 2015, the MobiusHD system was awarded the EU's trademark certification, the CE.
About Rainbow Medical
Rainbow Medical is an Israeli research, development and investment company specializing in the establishment and development of breakthrough products and companies in the medical device field. The company maintains an extensive reservoir of intellectual properties, based upon the patents registered by its co-founding entrepreneur, Yossi Gross.
In its current portfolio the company has holdings in companies engaged in developing products and treatments for a variety of chronic indicators, such as heart disease, diabetes, hypertension, restoring vision to the blind, uterine fibroids and chronic neuropathic pain, among others.
The company was founded by Glenrock Israel, an investment company owned by Leon Recanati, Yossi Gross, one of the world's premier medical device entrepreneurs and Efi Cohen-Arazi, one of the most admired managers in Israel's life sciences industry.
For additional details,
Tali Karasik Regev
+972-54-5901474
Extra Mind PR
