© 2009 PeriGen -Proprietary and Confidential 1 © 2011 PeriGen - Proprietary and Confidential 1 PeriCALM ™ Software for Display and Real-time Analysis of Fetal Heart Rates and Uterine Contractions MKT-PPT-0034, rev ,

© 2009 PeriGen -Proprietary and Confidential 2 © 2011 PeriGen - Proprietary and Confidential 2 Participants Tina Armstrong RN, Clinical Specialist Vicki A. Lucas, RNC, BSN, MNEd, Ph.D. Chief Nursing Officer Emily Hamilton MD, SVP Clinical Research

© 2009 PeriGen -Proprietary and Confidential 3 © 2011 PeriGen - Proprietary and Confidential 3 Presentation Outline Role of Bedside Software in Electronic Fetal Monitoring and Labor Assessment Perspective from clinicians and administrators

© 2009 PeriGen -Proprietary and Confidential 4 © 2011 PeriGen - Proprietary and Confidential 4 Actions Communication Recognition Basic Sequence in Clinical Care Fix it Say it “I am concerned” See it

© 2009 PeriGen -Proprietary and Confidential 5 © 2011 PeriGen - Proprietary and Confidential 5 Problem Assessment of labor and EFM required in all labors. CS rates high variation Delayed recognition of EFM problem causing injury Limitation Inconsistent assessments caused by fatigue, distractions, inexperience Not to be confused with incompetence, or knowledge gaps Solution Computerized method to consistent analyze Labor progress and EFM patterns Safety net to complement clinical judgement What is the Relevance? Specialized Pattern Recognition Software

© 2009 PeriGen -Proprietary and Confidential 6 © 2011 PeriGen - Proprietary and Confidential 6 Key Clinical Objectives PeriCALM Tracings and Patterns 1.Standardize the analysis of EFM tracings Why: Even NICHD/ACOG definitions are open to interpretation 2.Standardize the assessment of labor Why : multiple factors affect labor progress and giving rise to large variation in clinical assessment 3.Enhance Situational Awareness Why: Fatigue, distractions, inexperience known to impair situational awareness

© 2009 PeriGen -Proprietary and Confidential 7 © 2011 PeriGen - Proprietary and Confidential 7 What is PeriCALM Tracings? Specialized Software for Displaying and Storing EFM 1.Collects and Displays Tracings from fetal monitors 2. Mechanism for annotating the strip 3.Posts Vital signs from the fetal monitor 4.Printing and Archiving capabilities

© 2009 PeriGen -Proprietary and Confidential 8 © 2011 PeriGen - Proprietary and Confidential 8 What is The PeriCALM Curve? Computerised assessment of labor progression 1.Graphical display of dilation(black) and descent(green) taken from pelvic exam entries 2.Superimposed blue lines show how the expected “average” dilation as well as a range 3. Blue line are adjusted at each exam for 6 factors including changes in contraction frequency, cervical dilation and effacement.

© 2009 PeriGen -Proprietary and Confidential 9 © 2011 PeriGen - Proprietary and Confidential 9 What is PeriCALM Patterns? Specialized Pattern Recognition Software 1.Analyzes fetal heart rate and uterine contraction records 2.Uses terminology based on NICHD definitions 3.Displays both a long-term overview to display trends and a close up detailed view with pattern measurements 4.Does not save markings in the electronic medical record

© 2009 PeriGen -Proprietary and Confidential 10 © 2011 PeriGen - Proprietary and Confidential 10 Demonstration

© 2009 PeriGen -Proprietary and Confidential 11 © 2011 PeriGen - Proprietary and Confidential 11 Perspective from Physicians: PeriCALM Patterns Facilitates Clear Communication and Better Situational Awareness Incomplete “handover” and miscommunication about the tracing leads can lead to delayed recognition of a problem and consequently little time for effective intervention.

© 2009 PeriGen -Proprietary and Confidential 12 © 2011 PeriGen - Proprietary and Confidential 12 Perspective From Nurses: PeriCALM Patterns Helps to Consistently Evaluate Both the Degree of Tracing Abnormality as Well as Trends Over Time Inconsistency in tracing assessment must be expected with inexperienced staff, distractions or fatigue. Criticism about tracing interpretation “in retrospect when outcome is known ” is often demoralizing and unproductive Escalating through a “chain of command” is naturally difficult

© 2009 PeriGen -Proprietary and Confidential 13 © 2011 PeriGen - Proprietary and Confidential 13 The Perspective from a Patient Safety Officer PeriCALM Patterns Provides a Safety Net to Complement Clinical Reasoning Litigation Costs by Clinical Category Inappropriate use of medications affecting uterine contractions in 47% Delayed recognition and intervention for problem tracings in 40-90% Oxytocin misuse is indefensible and avoidable. “Safe” medical devices provide users with warnings when unsafe conditions exist. PeriCALM Patterns identifies uterine tachysystole when it occurs so that clinicians can intervene early rather than try and explain their inaction after the fact.

© 2009 PeriGen -Proprietary and Confidential 14 © 2011 PeriGen - Proprietary and Confidential 14 Experience and Perspective From Rural Hospitals: Doctors often far from Hospital thus need to anticipate problems before emergencies occur Support clinical confidence with lower experience from low volume Connectivity so all who need to know can see the tracing

© 2009 PeriGen -Proprietary and Confidential 15 © 2011 PeriGen - Proprietary and Confidential 15 Common Clinical Questions 1.What does ACOG think about this? No formal opinion, agrees that computerization can analyze more consistently 2.What if I disagree with PeriCALM patterns? Same thing as when you disagree with another clinician/nurse today 3.Can a plaintiff lawyer get this application? No, it’s not saved 4.Are there any peer reviewed publications on this application? Yes, 17 5.Will my nurses forget how to read tracings? On the contrary, they receive continuous feedback, which is the one of the most effective mechanisms of adult learning.

© 2009 PeriGen -Proprietary and Confidential 16 © 2011 PeriGen - Proprietary and Confidential 16

© 2009 PeriGen -Proprietary and Confidential 17 © 2011 PeriGen - Proprietary and Confidential 17 Overview Detailed 17-minute view Compressed 2-hour overview Movable selecting Slider Window

© 2009 PeriGen -Proprietary and Confidential 18 © 2011 PeriGen - Proprietary and Confidential 18 FHR Information Baseline Accelerations Labels and Measurements Decelerations Window SummaryAnalysis Controls

© 2009 PeriGen -Proprietary and Confidential 19 © 2011 PeriGen - Proprietary and Confidential 19 Contraction Information Contraction detection Running graph - count/10 min with visual indicators when threshold is exceeded Mean Frequency Mean Montevideo units

© 2009 PeriGen -Proprietary and Confidential 20 © 2011 PeriGen - Proprietary and Confidential 20 Rapidity of Analysis ●What is the Baseline? ●What is the Variability? ●Contraction Frequency or count /10 minutes? ●Montevideo Units?

© 2009 PeriGen -Proprietary and Confidential 21 © 2011 PeriGen - Proprietary and Confidential 21 ●Mean Contraction Interval: Q1.7 min ●Mean Baseline: 137 bpm ●Mean Baseline Variability: 13.3 ●Mean Montevideo Units: 321 per 10 min Rapidity of Analysis

© 2009 PeriGen -Proprietary and Confidential 22 © 2011 PeriGen - Proprietary and Confidential 22 Short-Term Trends

© 2009 PeriGen -Proprietary and Confidential 23 © 2011 PeriGen - Proprietary and Confidential 23 Long-Term Trends

© 2009 PeriGen -Proprietary and Confidential 24 © 2011 PeriGen - Proprietary and Confidential 24 Up to 12-Hour Overview