Magnetecs Engages Dr. Alexander Fleming for US Regulatory Affairs
Magnetecs Corporation, a designer and manufacturer of robotic catheterization control systems for minimally invasive surgical procedures, today reported the engagement of Dr. Alexander Fleming, President and CEO of Kinexum LLC, to support the U.S. Food and Drug Administration (FDA) clearance of the Company’s Catheter Guidance Control and Imaging (CGCI) Robotic System.
Dr. Fleming has held senior positions in the US healthcare industry and at the FDA. He is a leading authority on regulatory policy and communications and brings extensive experience and insight for successfully advancing regulatory clearance. He served as Chief Medical Officer, Boston Medical Technologies and Chief Scientific Officer, Ingenix Pharmaceutical Services--A UnitedHealth Group Company. He helped shape regulatory policy, review process, and reviewer professionalism for over a decade as reviewer, leader, and innovator at the FDA. He is a board certified endocrinologist with medical and research training at Emory, Vanderbilt, and National Institutes of Health.
“As Magnetecs continues human clinical trials of our CGCI system at La Paz Hospital in Madrid, we have concurrent US clinical trials planned in summer 2011 at Utah Valley Regional Medical Center and subsequently at Mount Sinai Medical Center in New York City for 510k submission,” said Josh Shachar, Chief Executive Officer and Chief Technology Officer of Magnetecs Corporation. “This key development stage of our Company necessitates an efficient US regulatory process, and Dr. Fleming’s Kinexum organization clearly emerged as the best choice to effectively enable our US regulatory clearance.”
Dr. Fleming’s regulatory and technical expertise has been requested in numerous international settings including the World Health Organization, where he was assigned during 1991-92. He was a member of the expert working groups on Good Clinical Practices and General Considerations for Clinical Trials of the International Conference on Harmonization (ICH) and participated on other ICH committees including the Common Technical Document working group. While serving at FDA's Center for Drug Evaluation and Research (CDER), Dr. Fleming was also the founder and editor in chief of the Virtual Journal of Drug Evaluation, a major contributor to FDA's Good Review Practice (GRP) initiative, and chair of the committee responsible for education and training at CDER. He conceived and led the first FDA pilot project to utilize the internet for regulatory communication.
Dr. Fleming is lead author of the book, “Optimizing Development of Therapies for Diabetes. He serves on numerous scientific advisory boards, expert committees, and corporate boards. He founded the Leigh Thompson Renaissance Conference, a forum for promoting dialogue and creativity within the community of therapeutic developers. Dr. Fleming has served as invited editorialist to The New England Journal of Medicine and as a commentator on National Public Radio.
Dr. Fleming founded Kinexum in 2003 to provide services to the healthcare industry to support cost effective regulatory and clinical development strategies. Kinexum (www.kinexum.com) accelerates health product development and commercialization by supporting both new and mature companies with high value scientific, clinical, regulatory, and business expertise. Involvement ranges across pharmaceuticals, medical devices, diagnostics, nutrition, and health informatics. Recognized for leadership in the Washington DC health and governmental policy arena and the Minnesota bio-business community, Kinexum is committed to innovative products and processes that improve the health of people and the companies that serve them.
CGCI provides a unified system for robotic guidance, control and imaging of electrophysiology and other procedures. Previous magnetic guidance systems use large, independent magnets which emit a substantial, continuous magnetic field, have limited control capabilities, and require shielding. In contrast, Magnetecs’ CGCI system creates an electromagnetic field that is largely contained in the electromagnetic array and focused in an area no larger than the patient’s chest. CGCI emits a magnetic field only when in use and can dynamically adjust and manipulate this field to achieve unprecedented three-dimensional catheter-guidance precision and responsiveness, all with safety and reliability. The CGCI system is integrated with sophisticated cardiac mapping and navigation technologies, including X-ray, intracardiac echocardiography (ICE) and other advanced electrophysiology lab technologies and equipment. Magnetecs is planning additional applications of the Company’s electromagnetic technology in the fields of interventional cardiology, gastroenterology, neurology, and gynecology.
Magnetecs Corporation designs and manufactures a unique and highly efficient robotic catheterization control system for minimally invasive surgical procedures and the advanced specialized tools used in these procedures. The Company believes that its proprietary Catheter Guidance Control and Imaging (CGCI) system will greatly improve the efficacy, safety and cost efficiency of many common minimally invasive surgeries. Magnetecs has established advanced electrophysiology surgical suites for CGCI development and testing at the Company’s headquarters facility in Inglewood, California. For additional information on CGCI and Magnetecs Corporation, please visit the Company’s website at www.magnetecs.com.
Daniel Saks, Senior Vice President, Corporate Affairs
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