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© 2016 Advanced Maternity Innovations, LP - All Rights Reserved
American Medical Technologies, Improving
Pregnancy Management
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
 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 Outdated, inaccurate technology leads to significantly higher costs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
 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
 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
 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
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
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
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®
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.
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®
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®
 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
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®
 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
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
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?
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
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
1770 ST. JAMES PLACE, SUITE 600, HOUSTON, TEXAS 77056
Tel: 713-680-0200
Fax: 713-680-0299
advancedmaternityinnovations.com
info@innovalp.com
If are interested in investing with Advanced
Maternity Innovations, please follow the
I’m Interested link.
Thank You for Your
Interest

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AMI Solution Presentation

  • 1. © 2016 Advanced Maternity Innovations, LP - All Rights Reserved American Medical Technologies, Improving Pregnancy Management
  • 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 If are interested in investing with Advanced Maternity Innovations, please follow the I’m Interested link. Thank You for Your Interest