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Henry Schein Medical and MindChild Medical Announce an Exclusive Distribution and Supply Agreement for the MERIDIAN M110 Fetal Monitoring System

System Uses Surface Electrodes to Monitor Highly Accurate, Non-Invasive Fetal and Maternal Heart Rate and Uterine Contraction

MELVILLE, N.Y.--(BUSINESS WIRE)--Apr. 25, 2019-- Henry Schein Medical, the U.S. Medical business of Henry Schein, Inc., and MindChild Medical, Inc. today announced the signing of an exclusive distribution and supply agreement for the MERIDIAN™ M110 Fetal Monitoring System. The MERIDIAN M110, currently available to Henry Schein customers, is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). As part of the agreement, Henry Schein Medical will distribute the monitor to its obstetricians and pediatric cardiologist customers in the U.S.

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Henry Schein Medical signs an exclusive distribution and supply agreement for MindChild's MERIDIAN™  ...

Henry Schein Medical signs an exclusive distribution and supply agreement for MindChild's MERIDIAN™ M110 Fetal Monitoring System. (Photo: Business Wire)

William Edelman, Chief Executive Officer, MindChild stated, “We are thrilled to enter into this agreement with Henry Schein Medical, one of the preeminent distributors of medical devices and leading solutions companies for health care professionals in the U.S. We look forward to supporting Henry Schein, as they bring the MERIDIAN Fetal Monitoring System to the labor and delivery market.”

In a labor and delivery (L&D) setting, the MERIDIAN M110 derives these vital signs from maternal and fetal electrocardiogram (ECG) and uterine contraction signals captured via electrodes on the surface of a mother’s abdomen. These vital signs are then displayed on existing primary fetal monitors. The MERIDIAN M110 is indicated for use on women who are at ≥37 weeks into their pregnancy, in labor, and is intended for use only by health care professionals in a clinical setting, such as an L&D Department or birthing center.

“This is a great milestone for MindChild and Henry Schein and, more importantly, will result in excellent care to millions of women and newborns,” said Brad Connett, President, U.S. Medical Group for Henry Schein. “MindChild’s unique ability to monitor both fetal and maternal heart rates at the same time fits well with Henry Schein’s commitment to offering the finest solutions customers can rely on to deliver critical patient care.”

Adam Wolfberg, M.D., Chief Medical Officer, MindChild added, “The ability to monitor accurate fetal heart rate by extracting ECG information while simultaneously monitoring maternal heart rate, as well as uterine contraction, is a tremendous achievement. As the MERIDIAN M110 enters the labor and delivery market, new diagnostic capabilities will undoubtedly emerge, providing insight into fetal management not currently available.”

Dr. Wolfberg continued, “In the coming months and years, MindChild will build on this technology to improve the safety of obstetrics, and provide a new diagnostic device to obstetricians and pediatric cardiologists.”

England & Company served as financial and strategic advisor to MindChild relating to the exclusive distribution and supply agreement.

On January 17, 2017, MindChild Medical, Inc. announced the clearance of its 510(k) Pre‐Marketing Notification Application with the U.S. Food and Drug Administration for the MERIDIAN™ M110 Line of Non‐Invasive Fetal Heart Rate Monitors.

For more information, or to order MindChild products, please contact a Henry Schein sales consultant at (800) 772-4346.

About Henry Schein, Inc.

Henry Schein, Inc. (Nasdaq: HSIC) is a solutions company for health care professionals powered by a network of people and technology. With more than 18,000 Team Schein Members worldwide, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that improve operational success and clinical outcomes. Our Business, Clinical, Technology, and Supply Chain solutions help office-based dental and medical practitioners work more efficiently so they can provide quality care more effectively. These solutions also support dental laboratoriesgovernment and institutional health care clinics, as well as other alternate care sites.

Henry Schein operates through a centralized and automated distribution network, with a selection of more than 120,000 branded products and Henry Schein private-brand products in stock, as well as more than 180,000 additional products available as special-order items.

A FORTUNE 500 Company and a member of the S&P 500® and the Nasdaq 100® indexes, Henry Schein is headquartered in Melville, N.Y., and has operations or affiliates in 31 countries. The Company's sales from continuing operations reached $9.4 billion in 2018, and have grown at a compound annual rate of approximately 13 percent since Henry Schein became a public company in 1995.

For more information, visit Henry Schein at www.henryschein.com, Facebook.com/HenrySchein, and @HenrySchein on Twitter.

About MindChild Medical, Inc.

MindChild Medical, Inc., is a privately funded medical device company founded in 2008. MindChild’s principal technology platform, the MERIDIAN M110 non-invasive fetal electrocardiograph (fECG), maternal heart rate (MHR) and uterine contractions (UA) monitor, is designed to report fetal heart rate data equivalent to the gold standard fetal scalp electrode, report uterine contraction data equivalent to the gold standard intrauterine pressure cathode, as well as 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 Interim Chair, Associate Professor, Biomedical Informatics (Emory University)), James Robertson, President and CEO, and Jay Ward, Executive Vice President, both of E-TROLZ, Inc. MindChild has exclusively licensed intellectual property from MIT, 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.

About England & Company

With offices in New York, Houston and Washington, DC, England & Company is an independent investment banking and advisory firm dedicated to the middle market. Since the founding of England in 2003, the firm has provided honest and effective advice on mergers and acquisitions, private capital raising, financial restructuring, fairness opinions and valuations, and strategic advisory to the executive teams, boards of directors, and financial sponsors of public and private companies.

About the MERIDIAN M110 Non-Invasive Fetal Heart Rate Monitor

MERIDIAN M110 is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and uterine contractions (UA). MERIDIAN acquires and displays the FHR and MHR from abdominal surface electrodes that detect the fetal ECG signal (fECG), maternal ECG and uterine muscle contraction signals. MERIDIAN M110 is designed for women who are at term (≥ 37 completed weeks), in labor, with singleton pregnancies. MERIDIAN M110 is intended for use only by healthcare professionals in a clinical setting.

About the Fetal Heart Monitoring Market

Over 85%1 of the 4,000,0002 live births 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 movement3. Fetal Scalp Electrodes (FSE) that connect directly to the fetus during the later stages of labor and delivery are invasive devices associated with increased risk of maternal/fetal infection4. There are an estimated 28,000 fetal monitors spread over 3,400 hospitals in the US5, representing an investment of over $700,000,0006. MERIDIAN has been developed to provide uninterruptible fECG data while addressing the deficiencies in both Doppler and FSE via innovative non-invasive monitoring technology.

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1 "ACOG Refines Fetal Heart Rate Monitoring Guidelines", 6/22/2009 The American College of Obstetricians and Gynecologists Press Release

2 http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_03.pdf

3 Journal of Midwifery. Vol 18, No, 7: 424-428. July 2010
4 American Family Physician, 1992 Feb;45(2):579-82

5 http://www.aha.org/aha/resource-center/Statistics-and-Studies/fast-facts.html

6 Company estimates.

Source: Henry Schein, Inc.

Ann Marie Gothard
Vice President, Corporate Media Relations
Henry Schein, Inc.
Annmarie.gothard@henryschein.com
(631) 390-8169

Bill Edelman
Chief Executive Officer
MindChild Medical, Inc.
bill.edelman@mindchild.com
(978) 975-1160 x213