NORTH ANDOVER, Mass.--(BUSINESS WIRE)--MindChild Medical, Inc. today announced appointment of Thomas Garite, M.D. to the Clinical Advisory Board (CAB) for its MERIDIAN non-invasive fetal heart monitor. The CAB will meet periodically to assess the development strategies for the Meridian Monitor and advise the company on the state of the fetal monitoring market.
Dr. Adam Wolfberg, MindChild’s Chief Medical Officer and Chairman of the CAB, commented, “Dr. Garite is a world leader in obstetrics and will bring tremendous experience to the CAB as we continue the development of the MERIDIAN system. The world-class clinical capabilities and real-life experiences represented by this CAB in fetal monitoring make this group uniquely suited to support the ongoing development of MindChild’s non-invasive fetal monitoring technology.”
Thomas J. Garite, M.D., is the Director of Research and Education for the Obstetrix Medical Group, and is Editor In Chief of the American Journal of Obstetricians and Gynecology. Prior to joining Obstetrix, he was Professor of Obstetrics and Gynecology at the University of California Irvine, and served for 16 years as the Department’s Chairman. He now serves as Professor Emeritus. Dr. Garite has authored more than 180 journal articles and five textbooks. Dr. Garite’s research has focused on intrapartum and antepartum fetal assessment through fetal heart rate monitoring and pulse oximetry, general prematurity, premature rupture of membranes and the infectious etiology of prematurity, and the management of labor. Dr. Garite has received several awards from distinguished societies, including teaching awards and most notably the Career Achievement Award from the Society of Maternal Fetal Medicine and the National Teaching Award from the Association of Professors of Obstetrics and Gynecology/Council on Residency Education in Obstetrics and Gynecology.
Dr. Garite said, “I am excited to join the Clinical Advisory Board for MindChild. Throughout my career, fetal monitoring has been a cornerstone of my research and focus. Accurate acquisition of the signal for the fetal heart rate is critical to this process. Chronic increases in maternal obesity/Body-Mass-Index have created new challenges for existing non-invasive fetal heart rate monitoring technologies. An accurate external EKG is also critical in the testing of patients before labor and in the decision making process of whether early delivery is necessary for impending fetal compromise and this technology cannot help but to improve our ability to make these decisions. MindChild's Meridian non-invasive fetal monitoring technology may hold the promise of such an advance.”
Dr. Garite joins Aaron B Caughey, MD, PhD, Emily F. Hamilton, MDCM, Gary Hankins, MD, Michelle L. Murray, PhD, RNC-OB, and Michael Ross, MD, MPH, on the Clinical Advisory Board.
Previous Announcements
On June 11, 2012, MindChild announced Results of National Fetal Monitoring Market Survey
On February 22, 2012, MindChild reported formation of a Clinical Advisory Board for the MERIDIAN™ Line of Non-Invasive Fetal Heart Rate Monitors
On February 6, 2012, MindChild reported filing of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the MERIDIAN™ Line of Non-Invasive Fetal Heart Rate Monitors
About the MERIDIAN Non-Invasive Fetal Heart Rate Monitor
MERIDIAN is a fetal monitor that non-invasively measures and displays fetal heart rate (FHR). MERIDIAN acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). MERIDIAN may also be used to measure and display fetal heart rate using direct ECG (DECG) with a Fetal Scalp Electrode (FSE). MERIDIAN is designed for women who are at term (> 36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. MERIDIAN is intended for use by healthcare professionals in a clinical setting.
About the Fetal Heart Monitoring Market
Over 85%2 of the 4,0000,0003 live births occurring in the US during 2011 required fetal monitoring during labor and delivery. Current non-invasive Doppler, employing ultrasound to detect FHR is subject to loss of fetal heart rate due to maternal/fetal movement4. Fetal Scalp Electrodes (FSE) that connect directly to the fetus during the later stages of labor and delivery are associated with increased risk of maternal/fetal infection5. There are an estimated 28,000 fetal monitors spread over 3,400 hospitals in the US6, representing an investment of over $700,000,0007. MERIDIAN has been developed to provide uninterruptible fECG data while addressing the deficiencies in both Doppler and FSE via innovative non-invasive monitoring technology.
About MindChild Medical, Inc.
MindChild Medical, Inc. is a privately funded medical device company founded in 2008. MindChild’s principal technology platform, the MERIDIAN non-invasive fetal electrocardiograph (fECG) monitor, is designed to report fetal heart rate data equivalent to the gold standard fetal scalp electrode in addition to novel ECG metrics intended to provide obstetricians a deeper understanding of fetal/maternal health and management.
MindChild was co-founded by Adam Wolfberg, MD, Assistant Professor, Tufts Medical Center, Gari Clifford, PhD, previously Principal Research Scientist at Harvard-MIT Division of Health and Science Technology (currently on the faculty at the University of Oxford in the Department of Engineering Science), James Robertson, President and CEO, and Jay Ward, Executive Vice President, both of E-TROLZ, Inc. MindChild has exclusively licensed intellectual property from the Massachusetts Institute of Technology, Tufts Medical Center and E-TROLZ, Inc., a Massachusetts technology company that develops and commercializes breakthrough physiologic monitoring platforms for a wide variety of applications.
For more information, please visit www.mindchild.com.
1 Meridian Fetal Monitor is not available in the United States. Pending 510(k) clearance.
2 "ACOG Refines Fetal Heart Rate Monitoring Guidelines", 6/22/2009 The American College of Obstetricians and Gynecologists Press Release
3 http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_03.pdf
4 Journal of Midwifery. Vol 18, No, 7: 424-428. July 2010
5 American Family Physician, 1992 Feb;45(2):579-82
6 http://www.aha.org/aha/resource-center/Statistics-and-Studies/fast-facts.html
7 Company estimates.