MindChild Medical, Inc. Announces Receipt of Certificate of Registration by BSI Group America Inc., Under the International Organization for Standardization (ISO) 13485:2003 for the Design, Development and Manufacturing of the MERIDIAN™…

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MERIDIAN M110 Provides Continuous Non‐Invasive Fetal and Maternal
Monitoring Using Surface Electrodes That Detect Fetal ECG (fECG), Fetal
Heart Rate (FHR), Maternal Heart Rate (MHR), and Uterine Contractions
(UA)

NORTH ANDOVER, Mass.–(BUSINESS WIRE)–MindChild Medical, Inc. Announces Receipt of Certificate of
Registration by BSI Group America Inc., Under the International
Organization for Standardization (ISO) 13485:2003 for the Design,
Development and Manufacturing of the MERIDIAN™ Line of Non‐Invasive
Fetal Monitors

MindChild Medical, Inc. today announced that it has received ISO
13485:2003 certification for the design, development and manufacturing
of its MERIDIAN family of non-invasive Fetal Monitors1,2,3,4.
ISO 13485:2003 certification precedes European pre-marketing submission
of a Technical File submission5, enabling European
commercialization of the MERIDAN family of Fetal Monitors. MindChild
previously announced 510(k) pre-marketing clearance of the MERIDIAN M100
Fetal Monitor. MindChild anticipates entering the US market with the
MERIDIAN family of Fetal Monitor products following the FDA
pre‐marketing clearance of the current 510(k) notification. Additional
pre‐market regulatory filings are anticipated during 2016.

The MindChild Medical Meridian M110 Fetal Monitor is an intrapartum
fetal monitor that non-invasively measures and displays fetal heart rate
(FHR), maternal heart rate (MHR), and uterine contractions (UA). The
MindChild Meridian acquires and displays the FHR, MHR and UA from
abdominal surface electrodes that detect the fetal ECG signals, maternal
ECG signals, and of uterine muscle contraction signals. Tracings of FHR
and UA are displayed onto a primary fetal monitor.

The MindChild Meridian M110 is indicated for use on women who are at >
36 completed weeks, in labor, with singleton pregnancies, using surface
electrodes on the maternal abdomen. The MindChild Meridian is intended
for use by healthcare professionals in a clinical setting.

The Meridian M100 and M110 Fetal Heart Monitors6 are intended
to be compatible with qualified fetal monitoring systems, facilitating
rapid adoption by clinicians where MERIDIAN is commercially available.
The Meridian M110 and M100 Fetal Heart Monitors are designed for women
who are at > 36 completed weeks, in labor, with singleton pregnancies,
using surface electrodes on the maternal abdomen.

Previous Announcements

On November 16, 2015, MindChild Medical, Inc. announced filing of a
510(k) Pre‐Marketing Notification Application with the US Food and Drug
Administration for the MERIDIAN™ M110 Line of Non‐Invasive Fetal Heart
Rate Monitors

On April 19, 2015, MindChild Medical, Inc. announced clearance of a
510(k) Pre‐Marketing Notification Application with the US Food and Drug
Administration for the MERIDIAN™ M100 Line of Non‐Invasive Fetal Heart
Rate Monitors

On November 11, 2014, MindChild Medical, Inc., announced the filing of a
510(k) Pre‐Marketing Notification Application with the US Food and Drug
Administration for the MERIDIAN™ M100 Line of Non‐Invasive Fetal Heart
Rate Monitors

On April 8, 2014, MindChild Medical, Inc., announced the 1,000th
successful non‐invasive fetal heart monitoring session utilizing the
MERIDIAN™ Fetal Heart Monitor

On May 1, 2013, MindChild Medical, Inc., presented the MERIDIAN™
Non‐Invasive Fetal Heart Rate Monitor at the 61st Annual Meeting for the
American College of Obstetricians and Gynecologists (ACOG) in New
Orleans.

On February 13, 2013, MindChild Medical, Inc., presented the MERIDIAN™
Non‐Invasive Fetal Heart Rate Monitor at the 33rd Annual Meeting for the
Society for Maternal Fetal Medicine (SMFM) in San Francisco, CA.

On November 5, 2012, MindChild Medical, Inc., and The University of
Oxford announced a Sponsored Research Agreement for the Development of
Innovative Signal Processing Software for Fetal and Maternal Monitor
with the MERIDIAN™ Non‐Invasive Fetal Heart Rate Monitor.

On September 25, 2012, MindChild announced clearance of a 510(k)
Pre‐Marketing Notification with the US Food and Drug Administration
(FDA) for the MERIDIAN™ M1000 Non‐Invasive Fetal Heart Rate Monitor.

On June 18, 2012, MindChild announced the appointment Thomas Garite,
M.D. to the Clinical Advisory Board for the MERIDIAN Line of
Non‐Invasive Fetal Heart Rate Monitors.

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 M110 and M100 Non‐Invasive Fetal Heart Rate Monitor

The MindChild Medical Meridian M110 Fetal Heart Rate Monitor is
an intrapartum fetal monitor that non-invasively measures and displays
fetal heart rate (FHR), maternal heart rate (MHR), and uterine
contractions (UA). The MindChild Meridian acquires and displays the FHR,
MHR and UA from abdominal surface electrodes that detect the fetal ECG
signals, maternal ECG signals, and of uterine muscle contraction
signals. Tracings of FHR and UA are displayed onto a primary fetal
monitor. The MindChild Medical Meridian M110 Fetal Heart Rate Monitor is
an intrapartum fetal monitor that externally measures and displays fetal
heart rate (FHR). The MindChild Meridian M100 acquires and
displays the FHR tracing from abdominal surface electrodes that detect
the fetal ECG signal (fECG). FHR tracings are displayed onto a primary
fetal monitor. In addition, the M100 synchronizes the TOCO transducer
signal which is also displayed to the primary fetal monitor. MERIDIAN
M100 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%7 of the 4,000,0008 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 movement9.
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 infection10. There are an estimated
28,000 fetal monitors spread over 3,400 hospitals in the US11,
representing an investment of over $700,000,00012. MERIDIAN
has been developed to provide uninterruptible fECG data while addressing
the deficiencies in both Doppler and FSE via innovative non‐invasive
monitoring technology.

1 MindChild received 510(k) pre‐marketing clearance for the
MERIDIAN M1000 Fetal Heart Monitor September 19, 2012. MERIDIAN M1000 is
a stand‐alone Fetal Heart Rate Monitor.

2 MERIDIAN Fetal Heart Monitor is protected by patents, both
issued and pending.

3 MERIDIAN 100 Fetal Heart Monitor received 510(k)
pre‐marketing clearance April 17, 2015.

4 MindChild announced November 16, 2015 filing a 510(k)
pre-marketing notification with the US Food and Drug Administration
(FDA) for its MERIDIAN Model M110 non‐invasive Fetal Heart Monitor

5 European pre-market clearance requires the Conformité
Européenne, or “European Conformity” (“CE”) registration process.

6 MERIDIAN is supplied with single‐use proprietary electrodes
designed to monitor fetal heart rate.

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

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

9 Journal of Midwifery. Vol 18, No, 7: 424‐428. July 2010

10 American Family Physician, 1992 Feb;45(2):579‐82

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

12 Company estimates.

Contacts

MindChild Medical, Inc.
Bill Edelman, 978-975-1160 x22
bill.edelman@mindchild.com