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Objective Assessment . Better Outcome
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Gee it’s so
PAINFUL
We all experience the world from our own perspective
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The Current Standard of Care
Today, Pain Assessment is Subjective
Personal motivation Communication ability Environmental factors Cultural differences
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is spent annually on healthcare for pain management 1
more than cancer and diabetes combined!
$600BIn the U.S.
is spent annually on healthcare for pain management 2
€450BIn Europe
SEVERAL FACTORS CONTINUE TO FUEL
THIS MARKET
Aging populations
Steady incidence of chronic diseases
Lack of treatment-efficacy measurement tools
Opioid epidemic3:~25% misuse prescribed opioids
~10% become addicted
PAIN IS THE #1 REASON FOR PHYSICIAN VISIT1
The Economic Burden of Pain Management
1. Institute of Medicine of the National Academies Report. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, 2011. The National Academies Press, Washington DC. 2. Breivik H et al., (2013) The individual and societal burden of chronic pain in Europe: the case for strategic prioritization and action to improve knowledge and availability of appropriate care. BMC Public Health, 13:12293. https://www.drugabuse.gov/drugs-abuse/opioids/opioid-crisis
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A call forCHANGE
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So Why to Measure Pain Response?Who Cares?
Standardization of Care, improved quality and
reduce costs
Medasense – Confidential and Proprietary information
Less exposure to pain and overdosing -less adverse events
Personalized analgesia, better clinical outcomes, shorter recovery and patient satisfaction
Patient
Payer Care Provider
Multiple Stakeholders
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Meet
AI analysis to capture thePhysiological Response to Pain
“Personalize the Pain TreatmentFor better outcomes”
Novel patented technology assessing thephysiological response to pain – the Nociception
NOLTM - - The Nociception Level
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NOL™ Technology: A Multi-Parameter Approach and AI Algorithms
A non-invasive finger probe acquires multiple pain-related physiological signals through 4 sensors.
Dozens of pain related physiological parametersand their derivatives are extracted.
Proprietary artificial intelligence algorithms identify the pain-related pattern to determine a patient’s individual, real-time and continuous “Physiological Signature of Pain”.
The OBJECTIVE pain index (NOLTM) is presented as a scale from 0 (no pain response) to 100 (extreme pain response) compare to patient’s baseline.
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Multiparameter ApproachMajor “Families” of Parameters
PULSE RATE
PULSE RATE VARIABILITY HIGH FREQUENCY (0.15-0.4 HZ)
PHOTOPLETHYSMOGRAPH (PPG) AMPLITUDE
PERIPHERAL TEMPERATURE (TEMP)
GALVANIC SKIN RESPONSE (GSR ): BASAL LEVEL AND PEAK FREQUENCY
MOVEMENT (ACCELEROMETER)
Galvanic Skin Response
Temperature
Accelerometer
Photoplethysmograph
Nociceptive Pain PathwaysConscious or unconscious - Pain response is there.
1. Painful stimuli activate specialized nerve cells (nociceptors), which send pain signals to the spinal cord.
2. Within the spinal cord, the signals are transmitted and passed up to the brain.
3. In the brain, the signals pass to the thalamus which acts as a sorting station and the autonomic nervous system is initiated (lower brain).
4. Certain parts of the brain generates signals that travel back down the spinal cord to inhibit or amplifythe pain signals.
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Activation of the sympathetic nervous system - resulting in a whole constellation of physiologic responses:
ANS Response to Nociception = Fight-or-Flight
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Normalized Per Patient
PULSE RATE
PULSE RATE VARIABILITY HIGH FREQUENCY (0.15-0.4 HZ)
PHOTOPLETHYSMOGRAPH (PPG) AMPLITUDE
PERIPHERAL TEMPERATURE (TEMP)
GALVANIC SKIN RESPONSE (GSR ): BASAL LEVEL AND PEAK FREQUENCY
MOVEMENT (ACCELEROMETER)
Each recording starts with baseline reading:
->
Each parameter is compared to the baseline
->
each patient is compared to his/her baseline
Medasense – Confidential and Proprietary information
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Clinically Validated 4 publications in the highest impact factor
journals in the field
15 abstracts in the most important conferences
in the field
88 citations including by the most important KOL
in the field
Over eight studies conducted worldwide (Israel, Europe, Canada, USA) with more than 500 patients indicated that the NOL™ index:
Discriminates between painful and non- painful stimuli
Grades different levels of painful stimuli
Correlates with the analgesic state
Demonstrates superiority over other technologies
Full list of publications can be found here
Clinically Validated
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The NOL™ Outperforms Commonly used Parameters(Heart Rate, Pulse Amplitude) and SPI (GE)
In this ROC analysis NOL™ outperforms other parameters and indices to discriminate between noxious andnon-noxious stimuli.AUC for NOL absolute values were the highest: 0.93
(N=58; ASA I – III; Ages 18-75; Entropy target <60; Elective surgery under general anesthesia)
Edry R1, Recea V, Dikust Y, Sessler DI ‘Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor” Anesthesiology , May 2016.
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NOL for Precision MedicineFrom Hospital ($3B) to Digital Health ($6B)
Home
Rehab
Pain Clinics, Orthopedics Physiotherapists
ER and General Ward
Intensive Care Units
Operating Rooms
Nursing Homes
Personalized Pain Treatment From
Hospital to Home
1st Target Market :Hospitals 2nd Target Market :Clinics and Home
NOLedge™: Prototype PMD-200™: Commercialized
Dentist
Pediatric
Objective, real-time, non-invasive, quantified pain response
Medasense Vision
Inpatient / Hospital:Bedside Monitor
Objective, Real-time, Non-invasiveassessment of pain
In hospitals, clinics and at home
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To facilitate end-user pain management through accurate and objective assessment of pain in all relevant settings and scenarios.
Outpatient: Mobile
Home : Wearable
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Our flagship product
Monitoring Nociceptionin Hospitals
PMD200(TM) pain monitoring device
Optimization of intraoperative analgesicsto reduce pain and opioid side effects
CE, Health Canada and AMAR(Israel) approved
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Non-optimized treatment: The consequences
Pain and Opioid adverse effects in surgical patients
of surgical patients suffer adverse events due topain relief medication 4
12% This translates into:
50% Increase $20B
$4,7003.4
in the readmission15.8% vs 9.4%
additional days of hospitalization
In additional cost perpatient (30% increase)
Estimated annual healthcare cost (US)
50%
of surgical patients suffer from moderate to severe
post-operative pain.1-3
1. Pain-out.med.uni-jena.de 2. “Incidence, patients satisfaction, and perceptions pf post-surgical pain: Results from a US national survey. “, GanTJ et al. , Current Medical Research and Opinion. 2014 3. “The burden of acute postoperative pain and the potential role of the COX-2-specific inhibitors” J. Stephens et al, Rheumatology 2003;42(Suppl. 3):iii40–iii52 4. 300,000 patients study “Effect of Opioid-Related Adverse Events on Outcomes in Selected Surgical Patients”, Oderda et al, Journal of Pain & Palliative Care,2013
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NOL™ Benefits Reported by Users:Personalization and Optimization of Analgesics
“Better controlled administration of
analgesia drugs” (Rennes MC, France)
“Reducing dose of intraoperatively used
opioids” (Bonn MC, Germany)
“Being able to titrate opioids to patient
needs”(Leiden MC, the Netherlands)
I truly believe in the NOL™ technology. I am convinced it will improve the quality of our
anesthesia and impact on patients' recovery
Professor Philippe RichebéMaisonneuve-Rosemont Hospital, University of Montreal, Quebec, Canada. PI and SAB
I believe that the NOL index may allow for more balanced anesthesia, as for the first time we are able to titrate analgesic medication to patients' needs.
Professor Albert DahanDepartment of Anaesthesiology at
Leiden University Medical Center, The Netherlands
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NOL indicates nociceptive response
Snapshot of NOL ™ Early Indication of Patient’s Nociceptive Response
Administration of Sufentanil
Patient moved, HR and BP increased
Patient was exposed unnecessarily to pain
NOL Interpretation during surgery stimulus:• NOL <10 : most likely
overdosing• 10<NOL<25 : adequate
analgesia• NOL >25: most likely under-
dosing
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NOL for Precision MedicineFor Digital Health ($6B)
Home
Rehab
Pain Clinics, Orthopedics Physiotherapists
Personalized Pain Treatment From Clinic to Home
2nd Target Market :Clinics and Home
NOLedge™: Prototype
Dentist
Pediatric
Objective, real-time, non-invasive, quantified pain response
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Pipeline product
Monitoring the effectiveness of pain treatment at home
and in clinics
NOLedge(TM)
Mobile pain monitoring
Currently for investigational use only
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NOLTM Mobile Pain Monitoring TechnologyWireless Sensor – Big Data Analytics
Sensing unitwirelessly collects
pain-related physiological parameters
Cloud processing and analysis
Patient interfaceTreatment engagement and
feedback system
Expert (Provider) interface Patients’ trends over time for
treatment efficacy
Medasense: Big Data AnalyticsTransforming data into insights
Medasense – Confidential and Proprietary information
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Specific example of
chronic pain:
Back Pain
#1
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$50billion
~50%
31million
Back pain is the #1 cause of disability worldwide
Americans have back pain at any given time
spend annually by Americans on back pain
of back pain surgeries are not effective
At least
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• Baseline - Quantifies patients’ initial pain response during the treatment period
• Follow-on - Promotes a continuum of care, from diagnosis to treatment follow up
• Engagement - Promotes patient engagement and compliance
• Value Based - Provides effectiveness measure for value-based reimbursement
• Titration: Provides clinicians a tool to evaluate and then optimize treatment
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Clinical Evidence – Chronic PainFeasibility trial, 33 subjects, Rambam MC, Israel, 2014
[1] American Academy of Pain Medicine Annual Meeting, March, 2014 [2] International Association for the Study of Pain Annual Meeting, Buenos Aires, Argentina, October, 2014
Results: Medasense Index differentiates between effective and non-effective intervention of patients with chronic pain1,2
Classification Accuracy:
82% (N=33)
NON-EFFECTIVEPAIN
TREATMENT
EFFECTIVEPAIN
TREATMENT
NON-EFFECTIVEPAIN
TREATMENT
EFFECTIVEPAIN
TREATMENT
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Clinical Evidence – Acute PainFeasibility trial, 58 awake volunteers, Rambam MC, Israel, 2010
“Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters”, Treister et al. PAIN®, June 2012
“Integrating data from a variety of sources should allow us to achieve a more accurate estimation of the pain experience “
Commentary review on Medasense article, PAIN®, 2012
Medasense Index response to pain
Time [sec]Meda
sens
e NoL
Time (sec)
No Pain
Low Pain
Medium Pain
High Pain
Results: Medasense Index strongly correlates with subjective pain assessment1,2
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Case studies – Awake , healthy 42yrs. Old male, pressure stimulation on the thumb area
Results: Medasense Index strongly correlates with subjective pain assessment1,2
Prostate carcinoma
56yo Male, BMI 26, ASA2 Laparoscopic prostatectomy
Prostate carcinoma
58yo Male, BMI 30.3, ASA2Laparoscopic prostatectomy
Common Practice NOL Guided
Duration HH:MM(from induction)
2:12 3:39
Total Remifentanil 2364(mg) 1273(mg)Norm. Remi (mg/kg/min) 0.121 0.066
Total Inadequate Anesthesia events
34 30
Pain Scores in PACUMax & AVG
8(6.4) 8 (5.6)
Morphine Consumptionin PACU
0.093 mg/kg 0.021 mg/kg
PACU readiness 2:14 1:01
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Morphine 10mg
NOL Guided analgesia↑ 134 mmHg
↓ 90 mmHg
↑ 90 bpm
↓ 46 bpm
↑ 20
↓ 10
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Common Practice analgesia
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Key TakeawaysObjective assessment of pain response is a major unmet need with a $9B TAM
Enables personalization and optimization of pain treatment, leading to improved clinical and economic outcomes
Validated, patented, superior technology, with supporting peer reviewed published clinical evidence
CE, Health Canada and AMAR(Israel) approvals
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