Magnetecs Receives Grants Totaling $626,000 for Remote Navigation Systems
Inglewood, CA – Magnetecs Corporation, a designer and manufacturer of robotic systems for minimally invasive surgical procedures, today reported that the Company has received two grants to date for a total of $626,000 for the development of remote magnetic navigation systems.
The Company recently received a grant of $244,000 from The United States Internal Revenue Service Therapeutic Discovery Project Program, which was created by the Affordable Care Act. This grant is provided to US companies that have development projects showing significant potential to produce new cost-saving therapies, create U.S. jobs, and increase U.S. competitiveness.
Magnetecs has received a grant of up to $382,000 from the Israel-U.S. Binational Industrial Research and Development (BIRD) Foundation for a joint development project with Given Imaging Ltd, a world-leading company from Israel in the field of gastroenterology, for a Magnetically Guided Capsule Endoscope.
“These grants represent confirmation of our vision to fulfill the promise of robotic surgery by increasing the efficacy, safety, and efficiency of a wide range of minimally invasive procedures,” said Josh Shachar, CEO of Magnetecs Corporation. “As Magnetecs moves into the certification and pre-commercialization phase of our Robotic Catheter Guidance Control and Imaging system for electrophysiology, we are pleased to receive government and foundation support for this application and for our next application in gastroenterology.”
CGCI HUMAN STUDIES ONGOING IN MADRID
CGCI EP Suite at La Paz Hospital
Human studies using CGCI for patients with irregular heartbeat began on October 7, 2010, at Hospital General Universitario La Paz in Madrid, Spain. The studies are being conducted by Dr. Jose Merino, Director of the Arrhythmia & Electrophysiology Research Unit of the hospital. The Principal Investigator for the studies is Dr. Vivek Reddy, Professor of Medicine and Director, Cardiac Arrhythmia Service, Mount Sinai School of Medicine, in New York City. The studies will also be conducted by Dr. Eli Gang, Chief Medical Officer of Magnetecs, Clinical Professor of Medicine, Geffen School of Medicine at UCLA, who has also served as Director of the Clinical Electrophysiology Laboratory at Cedars-Sinai Medical Center in Los Angeles.
To date, 15 patients have participated in the first 20-patient study in which a highly detailed map of the heart is created using the CGCI system’s magnetically guided catheter. The primary outcome of the study measures intracardiac anatomic site target acquisition and repetition of acquisition. Successful outcomes have been achieved in all 15 patients thus far participating in the study. A description of the study can be found on theClincalTrials.govsite.
The first mapping study is expected to be completed by the end of 2010 and will be followed by an additional mapping study of 20 patients. This second study is expected to be completed by the end of the first quarter of 2011. A subsequent study of 40 patients in which mapping and ablation procedures will be conducted using the CGCI system is expected to be completed in the second quarter of 2011.
CGCI SUBMISSION FOR CE MARK CERTIFICATION
CGCI uses eight electromagnets in a unique configuration to intelligently guide a magnetically-tipped catheter, enabling a physician to precisely and consistently control surgical tools in highly dynamic or previously inaccessible environments while enhancing both the physician’s dexterity and the patient’s safety. The first study in the mapping of the heart is a diagnostic procedure that is performed for patients who have an arrhythmia or irregular heartbeat. Magnetecs expects this study to lead to a CE Mark application for commercialization in Europe planned for the first half of 2011. Additional human studies for ablation are expected to lead to approval of the CGCI system for therapeutic procedures used to correct heart arrhythmia.
CGCI INSTALLATIONS PLANNED IN LONDON, NEW YORK CITY AND PRAGUE
Additional installations in Europe and the US will support the Company’s program to receive FDA 510(k) certification. Magnetecs is currently in the initial stages of planning human studies in the US at Mount Sinai Medical Center in New York City under the direction of Dr. Reddy and Dr. Andre d’Avila, and in the UK at St. Mary’s Hospital in London under the direction of Dr. Nicholas Peters and Dr. Wyn Davies. CGCI installations and studies are also currently being planned at Na Homolce Hospital in Prague, Czech Republic.