2. This presentation and the related materials include “forward-looking
statements”. The opinions, forecasts, projections, or other statements
(“statements”) other than statements of historical fact, are forward-looking
statements. Although Advanced Maternity Innovations, LP (“AMI”) believes
that the expectations reflected in such forward-looking statements are
reasonable, it is highly likely that actual results and timing will vary, and may
vary substantially, from plans and projections shown. Many of the factors which
will determine actual results are not within the control of AMI. A high degree of
risk and uncertainty is inherent in the development of the AMI business,
technology systems and other product applications.
An investment in AMI is subject to substantial risks. No person should invest in
AMI who is not in a position to hold the investment indefinitely or sustain the
loss of his/her entire investment. Please review this information carefully and
request from AMI any additional information deemed to be necessary to fully
evaluate the risks and the merits of an investment in AMI. Many of the factors
which will determine actual results are not within the control of the general
partner. This investment is suitable only for persons who have substantial
financial resources. No liquidity event may occur and there may not be
distributions.
IMPORTANT NOTICE
3.
4. Pregnancy monitoring/management hasn’t evolved since the 1970’s
Existing monitoring products have legacy of performance/safety
issues
Outdated, inaccurate technology leads to significantly higher costs
for the patient, providers and payers
Unnecessary hospital/clinic visits for “false labor” - 50% of patients
admitted for preterm labor are not in true labor
20% of symptomatic patients diagnosed as not being in true preterm
labor will delivery prematurely
No monitoring products available to lower cost venues such as the
home
Increasing incidence of obesity in pregnant population driving the
demand for monitoring technology that is accurate for obese
patients
Patient discomfort – Tight straps and frequent sensor relocation
Improving Pregnancy Management Leads to
the Solution of These Problems
5. FDA cleared SureCALL® Labor Monitor® – pregnancy management
through the accurate and objective monitoring of uterine
contractions
Well-established, safe, accurate, noninvasive, and readily
understood electromyography
Accurately assess uterine electrical activity in real time
Comfortable - No tight straps, No repositioning
Disposable electrodes applied to the surface of the patient’s
abdomen
Integrated Fetal Heart Monitor and Maternal Heart Monitors
AMI’s CLINICAL SOLUTION
SureCALL® Clinic Model
6. Accurately and objectively monitor obese patients
Identifies true labor versus false labor – studies show up to 100% accuracy
Predicts the onset of delivery – studies show up to 100% accuracy up to 14
days in advance
Identifies and manages high risk pregnancy patients as early as 100 days out
Assists in the determination for Cesarean delivery
Accurate and cost-effective remote monitoring through wireless telemetry
and cellular technology providing patient monitoring at home
Produces cost savings and integrable Into electronic medical record systems
Short learning curve
Over 1,700 Patient Recordings, Over 60 Published peer-reviewed technical
articles and book chapters, Over 120 technical abstracts and
professional society presentations
SureCALL® Labor Monitor®
SureCALL® Clinic Model Wearable Remote Model
7. Offers the precision and accuracy of the clinic model in a handheld-
sized wearable package
Designed to expand the telemedicine capabilities in obstetrical care
Will play a key part in alleviating the pressure on overburdened
healthcare systems by cutting down on unnecessary hospital
visits
Allow consumers and practitioners access to reliable precision
uterine monitor nearly anywhere with nearly instantaneous
results
Reliably capture a mother’s labor contractions in an easy to use and
completely non-invasive fashion
Recordings are pushed to a proprietary cellular phone app via the
cloud where it is then stored and analyzed by the AMI web
application
Practitioners, monitoring services, medical record systems, and
patients can access the monitoring results
SureCALL® Wearable Remote Monitor
8. Couples Wirelessly to
a Cell Phone,
Transmitting Data
Light, Portable,
Wearable, Comfortable
and Non-invasive
Immediate Opportunity
to Expand Monitoring
to Home Market,
Reducing Hospital
Visits (Costs)
Transmits to Clinic,
Hospital, Monitoring
Station or Directly to
Doctor
Empowers Home Care
Monitoring and
Telemedicine
Significantly Lower the
Cost of Monitoring
High Risk Patients
SureCALL® Wearable Remote Monitor
SureCALL® WEARABLE
REMOTE MODEL
9. Patient at Home,
Hospital or Clinic
Cellular
Phone
Wearable
Device
Storage
Server
Doctor
Monitoring Station
Hospital / Clinic /
Monitor ServiceElectronic Medical
Records
SureCALL® Wearable Remote Monitor
10. Category SureCALL Toco IUPC
PREGNANCY MANAGEMENT
Identify True Labor vs. False Labor Yes No No
Predict Delivery / Onset of True Labor Yes No No
Identify High Risk Pregnancies Yes No No
Predict Delivery Yes No No
Manage C-section Deliveries Yes No No
Compensate for Patient Movement Yes No Yes
Measure Obese Patients Yes No Yes
Display Voluntary “Push” to Involuntary Contractions Yes No No
Preterm Applications Yes Limited No
Term Applications Yes Yes Yes
SAFETY/RISK
Invasive Yes No Yes
Infection Risk Yes No Yes
COMFORT
Surface Electrodes and Beltless Yes No No
Pressure Gauge – Tight Belt No Yes No
CONVENIENCE
Home Care Use Yes Yes No
Ambulatory Use Yes No No
Superior and More Cost-Effective Technology Replaces
Tocodynamometer and Intrauterine Pressure Catheter
SureCALL® Labor Monitor®
11. USES AND POTENTIAL BENEFITS OF THE
SureCALL® LABOR MONITOR®
Clinical Condition Clinical Use Potential Benefits
Antepartum Predict preterm delivery Prevent preterm
delivery and improve
perinatal outcome.
Early Labor Differentiate between Prevent unnecessary
false and true labor. admissions.
Preterm Contractions Determine need for Prevent unnecessary
tocolysis. use of tocolytics and
decrease cost.
Cervical Rule out the presence of Better define Incompetence
subclinical uterine candidates for post-
electrical activity. cerclage tocolysis.
Better understanding
of etiologies.
12. Induction of Labor Predict success of Prevent unnecessary
induction. prolonged inductions.
More objective and
accurate analysis of
uterine activity.
Augmentation of Labor More objective and Decrease numbers of
accurate analysis of cesarean sections due
uterine activity. to inappropriate use of
oxytocin.
Better way to monitor
and adjust oxytocin
infusion.
Failure to Progress More objective and Decrease numbers of
accurate analysis of cesarean sections due to
uterine activity. inappropriate use of
oxytocin.
Clinical Condition Clinical Use Potential Benefits
USES AND POTENTIAL BENEFITS OF THE
SureCALL® LABOR MONITOR®
13. Clinical Condition Clinical Use Potential Benefits
Tocolysis Predict success of Prevent complications
tocolysis. from tocolytics.
More objective and Decrease time on
accurate analysis of tocolytics.
uterine activity.
Improved method to Predict response
monitor and adjust augmentation
tocolytic therapy.
Labor Decreased need for Decreased risk of
invasive monitoring. maternal infection.
Decreased risk of
vaginal infection.
Improved response
time with
dysfunctional
labor.
USES AND POTENTIAL BENEFITS OF THE
SureCALL® LABOR MONITOR®
14. Invented and Initially Developed at
University of Texas Medical Branch - Galveston
Starting 2004, Development Advanced by AMI
Non-invasive EMG Signals Acquired from Abdominal Surface
Electrodes
Comfortable for Patients
Accuracy of Contraction Frequency, Duration, and Intensity – 100%
Accurately and Objectively Monitor Obese Patients
Predict Delivery – Up to 14 Days in Advance
Over 1,700 Patient Studies Completed
Multiple Patents Issued & Pending – USA & International
Cleared to Market by FDA for Term Patients
Enables Replacement of Existing Uterine Monitors
Short Learning Curve
SureCALL® Technology
15.
16. As a patient approaches delivery, the cervix needs to soften and
become more distensible, a process called Cervical Ripening.
The SureCALL Collascope® induces the autofluorescence of the
cervical collagen then measures the intensity to accurately determine
the amount of collagen and thus, Cervical Ripening in the patient.
SureTOUCH Collascope®
17. Designed for both normal and high risk pregnancy
management
UV Light through fiber optics fluoresces Cervical Collagen
Objectively monitor the condition (ripening) of the cervix
throughout gestation
Objectively monitor induced labor and pharmacological
treatment
Early detection of preterm deliveries
Quantitative replacement for subjective – digital exam
Replacement for Fetal Fibronectin test
>500 patient clinical patient recordings completed
Received 513(g) letter from FDA designating as a non-
significant risk, Class II device
Competition – No competitive instrument
SureTOUCH Collascope® Technology
18. Superior Pregnancy
Management Through
Improved Uterine
Monitoring
Makes existing technology obsolete
1,700 SureCALL® patient trials ~ up to 100% accuracy
FDA cleared for term labor
FDA application in process for preterm labor
$1 Billion
Annual Global Market
Approximately 100% of USA patients are monitored
Expanding market with new, advanced applications
Compelling Consumables
Driven Economic Model
Favorable margins on disposables
Favorable margins on hardware
Direct Path to
Commercialization in
Multiple End Markets
Replaces existing technology - hospital and clinic
market
Expands market with addition of new applications
Expands existing home monitoring market
Open new markets – ambulatory, EMS, urgent care
Significantly Lower Cost of
Today’s “Standard of Care”
Reduce hospital/doctor visits for “false labor”
Accurate monitoring of high risk patients at home via
wireless remote cellular technology
Commercialization
Marketing has been initiated – commercial acceptance
validated
INVESTMENT HIGHLIGHTS
19. MANAGEMENT EXPERIENCE: In Technology, Startups And Operations
TECHNOLOGY ADVANTAGE:
• Platform Technology
• Clinically Proven – Over 2,200 Patient Studies From Multiple Institutions
• Term Labor - SureCALL® FDA Cleared
• Preterm Labor – SureCALL® Studies Completed Ready For FDA Filing
on Safety Study Competition – Q3 2016
• Wearable Remote – SureCALL® Clinically Proven – FDA Filing Q3 2016
• Development Of Advanced Technical Applications in the Pipeline
INTELLECTUAL PROPERTY PROTECTED: Multiple Patents, Issued and Applied,
Protecting Priority Technology in the USA and Globally
FINANCIAL PERFORMANCE EXCELLENCE:
• Instruments with Multiple Applications, Multiple Markets
• Consumables, Service Contracts
• Opportunities for – Leasing, Financing, Service Center Operation
• High ROI
AMI HAS INITIATED LIMITED COMMERCIAL SALES
WHY INVEST?
20. I. Technologies – Continuous
Upgrade
II. Captures Existing
Markets
III. Product Development
IV. Develop New Markets
V. Profitability
• Proven Superior
• Replace 1970’s Technology
- Technical Superiority
- Cost-Effective
- Patient Friendly
• Develop Pipeline
• Develop Technology Platform
• Expanded Applications
• Remote Wireless/Home Care
• High Margins
• Premium ROI
Business Plan
21. WE ARE RAPIDLY IMPROVING THE STANDARD OF CARE
FOR PREGNANCY MANAGEMENT THROUGH ADVANCED,
COST- EFFECTIVE TECHNOLOGY, BENEFITING ALL MAJOR
STAKEHOLDERS
PATIENTS – MOTHER AND BABY
IMPROVED OUTCOMES AND REDUCED COSTS
PROVIDERS – HOSPITAL AND DOCTOR
IMPROVED PATIENT CARE, SAFETY AND REDUCED
COSTS
PAYORS AND SOCIETY – SIGNIFICANTLY REDUCED COSTS
HEALTHCARE COSTS AND SOCIETAL BURDEN
PARTNERS / INVESTORS – PREMIUM ROI
IN SUMMARY
PRODUCING A WIN – WIN – WIN – WIN
22. 1770 ST. JAMES PLACE, SUITE 600, HOUSTON, TEXAS 77056
Tel: 713-680-0200
Fax: 713-680-0299
advancedmaternityinnovations.com
info@innovalp.com
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Maternity Innovations, please follow the
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Interest