MindChild Medical · USSN 61/550,019, Filed 10/21/11 “Method and Device For Filtering, ... 2/6/12...

MindChild Medical New Investor Information Conference Call

June 12, 2013

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Agenda

• Market drivers for MindChild • Current status of MERIDIAN™ product

development • Current fetal monitoring multi-center clinical

results MindChild has achieved • Our accomplishments with FDA clearances and

our next steps • Our overall go-to-market business strategy • Strategic exit strategy • Our current financing requirements

Market Drivers for MindChild 1/2

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National Fetal Monitoring Market Survey1 • Respondents employ a fetal heart (FHR) monitor in 99.2% of deliveries • Over 75% of deliveries utilize some form of non-invasive FHR monitoring • Invasive FHR monitoring occurs in approximately 25% of all labor episodes • Respondents reported that in over 20% of deliveries, an unreliable non-

invasive FHR tracing leads to use of a Fetal Scalp Electrode (FSE) to monitor the fetus’s heart rate

• The vast majority of respondents reported an observed increase in BMI for admitted delivering mothers over the past 5 years

• Respondents reported that nearly 40% of deliveries are to mothers with a BMI greater than 30kg/m2

• Respondents noted that nearly 30% of delivering mothers are at, or above, a BMI that they feel adversely affects accurate FHR monitoring

Market Drivers for MindChild 2/2

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Current status of Meridian product development 1/6 Product Capabilities Development/

FDA Status

MERIDIAN™ 1000 Fetal Heart Rate 1. Clinical trials 2. FDA 510(k) Cleared

MERIDIAN™ 1010

1. Fetal Heart Rate 2. GE/Phillips

interconnectivity 3. Maternal monitoring 4. Fetal ECG display

1. Under development 2. IRB use for clinical

research

MERIDIAN™ 100

1. Fetal Heart Rate 2. Uterine contraction sync 3. GE/Phillips

interconnectivity

1. Under development 2. 510(k) planned for

Q3/2013

MERIDIAN™ 110 1. MERIDIAN™ + Uterine contraction

1. 510(k) planned for Q1/2014

MERIDIAN™ ELECTRODES

1. Single use 2. Fetal Heart Rate + Uterine

Contraction Monitoring

1. Under development 2. No-file 510(k) planned for

Q3/2013

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Current status of Meridian product development 2/6

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MERIDIAN™ 10001

MERIDIAN™ 10102 • Fetal Heart Rate3

• GE/Phillips interconnectivity

• Maternal monitoring • Fetal ECG display

1FDA 510(k) cleared 2IRB research platform 3MERIDIAN 1000 single feature


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MERIDIAN™ 1001

MERIDIAN™ 1102

• Fetal Heart Rate • Uterine contraction

• MERIDAN™ 100 – pass-through

• MERIDIAN™ 110 - integrated

• GE/Phillips interconnectivity

1FDA 510(k) filing planned Q3/2013 2FDA 510(k) filing planned Q1/2014


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MERIDIAN™ Electrode • +4M potential

uses/yr • Single use • Fetal Heart Rate +

Uterine Contraction Monitoring

• Major value driver due to high ASAP and +55% GP


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Licensed IP1 MindChild Filed IP

“Fetal monitoring system” USSN: 61/045,055, Filed: 4/15/08

“Non-invasive Detection of Fetal or Maternal Illness” USSN 61/550,019, Filed 10/21/11

“Method and Device For Filtering, Segmenting, Compressing and Classifying Oscillatory Signals” USSN: 11/470,506, Filed: 9/6/06

“Non-invasive Fetal Monitoring” USSN 61/550,024, Filed: 10/21/11

“Real-time data interface” USSN: 61/128,101, Filed: 5/19/08

“Extraction of fetal monitoring signals” USSN: 61/116,870, Filed: 11/21/08

“Fetal ECG monitoring” USP 7,949,389, Issued 5/24/11

1 Licensors: Tufts Medical Center, Inc., Massachusetts Institute of Technology, E-Trolz, Inc.


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Future Applications: ECG signal analysis → translational medical impact • Example: QT segment analysis → screening for maternal Rx (i.e., anti-

depressants)1

Advocacy for Meridian QT Analysis Capabilities

Zoloft Side Effect Law Firm http://www.zoloftbirthdefectslawyers.com

Baby With Birth Defect? - Birth Defect From Anti-Depressants? http://www.yourbirthdefectlawyer.com

The Importance of Proper Dosing of Antidepressants during Pregnancy

http://www.womensmentalhealth.org/posts/the-importance-of-proper-dosing-of-antidepressants-during-pregnancy/

Women Fearful of Effects of Antidepressants During Pregnancy http://www.medscape.com/viewarticle/723121

Antidepressants During Pregnancy Pose Dilemma for Women

http://www.wingofmadness.com/antidepressants-during-pregnancy-pose-dilemma-for-women-depression-treatment-postpartum-depression-my-health-news-daily-1354

1 Strategic buy side expands to include Rx sector

Current fetal monitoring multi-center clinical results MindChild has achieved 1/2

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R² = 0.9526

120

125

130

135

140

145

150

155

120 125 130 135 140 145 150 155

Min

dChi

ld H

R

Mea

sure

men

t

FSE HR Measurement

FSE vs. Meridian

Current fetal monitoring multi-center clinical results MindChild has achieved 2/2

MERIDIAN Clinical Center Number of Patients Enrolled

Tufts Medical Center 322

Brigham and Women’s 304

Akron Summa 48

Cleveland Fairview 40

TOTAL: 714

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Our accomplishments with FDA clearances and our next steps

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Our overall go-to-market business strategy 1/2

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Controlled MERIDIAN™ 100/110 rollout to select centers

• Diligence Objectives re Strategic Buyers – Demonstrate MERIDIAN™ adoption – Demonstrate electrode acceptance – Validate survey results (i.e., equipment

acquisition process, etc.) – Demonstrate integration w/ GE/Phillips

Our overall go-to-market business strategy 2/2

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CCF/Akron/RP

BW

Duke Emory

CS

JM

Illustrative target institutions Mindchild Key Opinion Leader (KOL) support

$400k required to initiate MERIDIAN™ 100/110 market seeding Target ASP: $8k/MERIDIAN™ $100/Electrode

Strategic exit strategy 1/4

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2012 Accomplishments


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Date Mindchild News Flow – Building Awareness

5/1/13 MindChild Medical, Inc. To Present MERIDIAN™ Fetal Monitor at the 61st Annual Meeting for the American College of Obstetricians and Gynecologists (ACOG)

2/4/13

MindChild Medical, Inc. to Present MERIDIAN™ Fetal Monitor, at the 33rd Annual Meeting for the Society for Maternal Fetal Medicine

1/5/13 MindChild Medical Inc. Announces Sponsored Research with Oxford University

9/25/12 MindChild Medical Inc. Announces FDA 510(k) Clearance for MERIDIAN™ Monitor

6/18/12 MindChild Medical, Inc. Announces Appointment of Thomas Garite, M.D. to the Clinical Advisory Board

6/11/12 MindChild Medical, Inc. Announces Results of National Fetal Monitoring Market Survey

2/22/12 MindChild Medical, Inc. Announces Formation of a Clinical Advisory Board

2/6/12 MindChild Medical, Inc. Announces Filing of a 510(k) Application for MERIDIAN™


• Analyst communication plan • I-Banker interviews • 1st Tier M&A target communications

• GE/Phillips/Covidien/Hologic

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Strategic exit strategy 4/4 • Model - Market Share Movement via Strategic Buyer • Electrode revenue drives valuation/CAPEX can be discounted w/o NPV impact

DCF 15% 20% 25% Period

NPV $92MM $78MM $67MM 2015-2019

1 Assumed Buyer investment of $9.1M: $4.8M (product development), $4.3M (market development)

Assumed share of new EFM installations by strategic buyer drives MindChild NPV

Post - Acquisition Activity by Buyer ($’000s) 2015 2016 2017 2018 2019 2020 2021 New EFM Installations/yr 4,384 4,427 4,472 4,516 4,562 4,607 4,653

Share of New EFM Installations

5% 10% 15% 25% 30% 30% 30%

EFM Units 219 443 671 1,129 1,368 1,382 1,396 EFM Installed Base Units 219 662 1,333 2,462 3,830 5,212 6,608

Total GP $5,685 $14,977 $27,389 $49,516 $73,236 $94,958 $116,897 Buyer Investment1 $(2,750) $(4,000) $(1,000) $(450) $(300) $(300) $(300)

Cash Flow $2,935 $10,977 $26,389 $49,066 $72,936 $94,658 $116,597

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Our current financing requirements 1/3

• Valuation Growth – PPS growth: $0.90 (2010) → $1.80 (2012) – Post Valuation $4.6M (2010) → $12.4M

(2012) • Budget Management - ± $100k to 2010

spend plan • $1M required to b/e (2014)

– $600k for FDA clearance – $400k for MERIDIAN™ market seeding

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21

$319,320

$100,333

$198,611

$92,000

$26,556

$113,300

$84,903

$201,570

$-

$200,000

$400,000

$600,000

$800,000

$1,000,000

$1,200,000

Spending 4/13-4/14

Marketing/Management

SGA

IP

Corp

FDA

Clinical evaluation

Electrodes

MERIDIAN

Units Placed During Market Seeding

MERIDIAN™ ELECTRODES

12 700


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Development FDA 2 Phase M&A Phase Apr 2013 May 2013 Jun 2013 Jul 2013 Aug 2013 Sep 2013 Oct 2013 Nov 2013 Dec 2013 Jan 2014 Feb 2014 Mar 2014 Apr 2014

Revenue $- $- $- $ - $ - $- $ - $- $ - $ 35,000 $ 40,000 $ 45,000 $ 50,000

GP $- $- $- $ - $ - $- $ - $ (200,000) $ (175,000) $ 30,000 $ 35,000 $ 40,000 $ 45,000

Product Development

MERIDIAN $ 48,320 $ 55,000 $ 55,000 $ 50,000 $ 47,000 $22,000 $ 12,000 $ 5,000 $ 5,000 $ 5,000 $ 5,000 $5,000 $5,000

Electrodes $ 1,833 $2,500 $ 43,000 $ 7,500 $ 43,000 $2,500 $ - $- $ - $- $ - $- $-

Clinical/FDA

Clinical evaluation $ 25,711 $ 30,400 $- $ 42,500 $ - $15,000 $ 27,500 $ 15,000 $ - $ 42,500 $ - $- $-

FDA $- $- $3,000 $ 23,000 $ 23,000 $3,000 $ - $ 40,000 $ - $- $ - $- $-

Legal

Corp $ 2,556 $2,000 $2,000 $ 2,000 $ 2,000 $2,000 $ 2,000 $ 2,000 $ 2,000 $ 2,000 $ 2,000 $2,000 $2,000

IP $ 300 $4,000 $3,000 $ 2,000 $ 2,000 $2,000 $ 2,000 $ 2,000 $ 42,000 $ 5,000 $ 5,000 $ 42,000 $2,000

SGA $ 2,503 $ 16,000 $2,300 $ 2,300 $ 15,300 $2,300 $ 1,400 $ 14,400 $ 1,400 $ 5,000 $ 16,000 $3,000 $3,000

Marketing/Management $ 13,570 $ 27,500 $ 27,500 $ 14,500 $ 14,500 $14,500 $ 14,500 $ 12,500 $ 12,500 $ 12,500 $ 12,500 $ 12,500 $ 12,500

Monthly $(94,793) $(137,400) $(135,800) $ (143,800) $ (146,800) $(63,300) $ (59,400) $(90,900) $ (62,900) $(72,000) $ (40,500) $(64,500) $(24,500)

CASH $ 329,026 $ 191,626 $ 55,826 $ (87,974) $(234,774) $(298,074) $(357,474) $ (648,374) $(886,274) $ (928,274) $(933,774) $(958,274) $(937,774)

Capitalization Summary • Financing History – Total Cash In: $3,342k as of 5/2013

– $225k Convertible Note (2009) • Converted to Series A at 10% discount

– $1,138k Series A (2010/2011) – $244k IRS Grant (2010) – Non-Dilutive – $767k Series A1 (2011) – $1,212k Series A2 (2012)

Class Shares Options Fully Diluted

Founders 3,360,081 3,360,081 47.8%

Investors 3,070,419 3,070,419 43.7%

Option Holders 541,000 541,000 7.7% Outstanding Options 59,000 59,000 0.8%

6,430,500 600,000 7,030,500 100.0%

1 $0.90/share, pre-money valuation ~$3.5m 23

MindChild Medical · USSN 61/550,019, Filed 10/21/11 “Method and Device For Filtering, ... 2/6/12...

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Transcript of MindChild Medical · USSN 61/550,019, Filed 10/21/11 “Method and Device For Filtering, ... 2/6/12...