Pain Monitor by niusheng11

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									             Pain Monitor
    A Direct Way to Measure Pain

            Inventing Breakthroughs and Commercializing Science
                           Harvard Business School


    TEAM: Beth Leeman1, Melanie Pogach1, Koit Saarevet2, Kelly Yedinak2
AFFILIATIONS: 1Harvard Medical School , 2Massachusetts Institute of Technology
                  INVENTORS: David Borsook, Lino Becerra
                            What Is It?

Near Infrared Spectroscopy (NIRS) is a
noninvasive, safe optical method that can be
used to assess oxygenation in brain pain
center
 Full NIRS system for measuring pain

                                     Patient head cap
                          Computer interface with user
                                    Signal processing


                           Top view of patient’s head with prototype cap

                           Light sources (row)
                           Detectors (row)

   Pain Monitor - A Direct Way to Measure Acute Pain
                    What Does It Do?
                         How the technology works

The Pain Monitor solution provides two important functions:
1. An objective determination of patient pain level
2. Enables improved anesthesia/analgesia delivery


Tactile sensation (brush)      Pain sensation (heat, 46˚C)    Software converts
                                                              the result into a
                 single peak                    double peak   validated scale




   Pain Monitor - A Direct Way to Measure Acute Pain
                                    Who Needs It?
                                                  The Markets

  “There are (currently) no diagnostic tests that can determine the quality
  or intensity of an individual's pain”*
               Current method: subjective scale - patient judgment of their own pain
               level, or vital sign assessment


                                             Diagnostic Markets
                     Market                    Potential Market Size                  Potential Impact
         1 Clinical Trials                          $20 Million                     >8,000 NIH pain studies
         2 Chronic Pain                             $760 Million                       50 million people
         3 Veterinary Medicine                      $240 Million                       >27,000 Practices


                                   Analgesic Monitoring Markets
                    Market                     Potential Market Size                      Potential Impact
         4 OR, PACU, and ICU**                    $8 - $17 Billion                        >27 million people
         5 Military Hospitals                       $290 Million                            60 Hospitals


* Frost & Sullivan report on U.S. Pain Management Pharmaceuticals Markets, Nov 1, 2002
** Operating Room (OR), Post Anesthesia Care Unit (PACU), and Intensive Care Unit (ICU)
                                   Steps To Market
           Remaining Proofs of Concept and Major Milestones*

                                                                                    (6) Multicenter Study

                                                       (4 & 5) Efficacy & Outcome

                            (3) Scale Definition

               (2) POC Baseline Pain


               (1) POC

Now



            Proof of                      Correlate               Demonstrate                       Develop
       effectiveness with                 change in              decreased ICU                      universal
           analgesia                      spectra to               and PACU                       norms across
                                            clear                 stays and/or                      multiple
      Determine baseline pain             numerical               prevention of                      patient
       level without stimulus               scale                 chronic pain                     populations



  * These steps do not include those required for veterinary medicine

      Pain Monitor - A Direct Way to Measure Acute Pain
        Pain Monitor Funding Profile

                                                                                           (6) Multicenter Study

                                                    (4 & 5) Efficacy & Outcome
                                                                                                              Analgesia market
                                                                                                                sales begin
                       (3) Scale Definition

            (2) POC Baseline Pain
                                                  Diagnostic market
                                                     sales begin
            (1) POC      Ready for VC funding

Now


  Currently funded                                Funding Timeline                                           $1,218,000
                                                                                 $1,091,000     $1,091,000



                                                     $641,000     $641,000

                         $428,000      $437,000
            $356,000
               2009




                            2010




                                          2011




                                                        2012




                                                                      2013




                                                                                    2014




                                                                                                   2015




                                                                                                                   2016
 Other Relevant Success Factors

FDA Regulatory pathway  STRONG, no barriers foreseen

   NIRS is an FDA approved technology, no exemption required

   Less regulated markets may be quicker/easier (Military, Veterinary, Clinical Trials)

IP  STRONG, from 2 positions
   Lack of known infringement concerns

   Strong patents:
       Dec 2000 US Patent (broad)
       December 2005 International patent (specific) application has been submitted

Reimbursement  POSSIBLE

   Cost savings to hospitals  still need to demonstrate

   Incorporate into guidelines to be reimbursable by 3rd party payers  goal

 Pain Monitor - A Direct Way to Measure Acute Pain
  Summary and Recommendations

  The Pain Monitor has very good market potential however it is not
  recommended to be licensed or incorporated as a start-up YET
  1.A start-up currently appears preferable to licensing after Proof of Concept
  (POC) #2*
              •   Low development costs (primarily software)
  2.Once all POCs and clinical trials are completed, licensing or a joint
  venture are advisable
              •   There will be a large initial non-recurring engineering (NRE) cost to
                  produce the product at high volumes




* POC #2 is recommended to be completed with grants and seed money: NIH, DOD, JHACO, ATP
(tech grants)

    Pain Monitor - A Direct Way to Measure Acute Pain
Background Slides
A Guide To The Background Slides
   Slides 11-23 provide calculations and assumptions
    for market and funding figures

   Slides 24-40 provide background data

   Slides 41-44 provide a summary of published
    studies

   Slides 45-46 provide an overview of IP

   Slides 47-58 provide an overview of interviews
Pain Monitor - A Direct Way to Measure Acute Pain
      Summary Of Market Feasibility
                                             Diagnostic Markets
                                            Competitive       Ease of     Regulatory        Overall Market
          Market         Market Value    IP Advantage     Reimbursement     Ease            Attractiveness
                                                                                       Low total revenue but
1 Clinical Trials             1          4       5              5             5        clear need demonstrated
                                                                                       Attractive market with
2 Chronic Pain                4          4       5              3             5        low investment
                                                                                       Attractive market but
                                                                                       technology & IP are weak
3 Veterinary Medicine         2          1       3              4             5        here

                                        Analgesic Monitoring Markets
                                            Competitive       Ease of     Regulatory         Overall Market
          Market         Market Value    IP Advantage     Reimbursement     Ease             Attractiveness
                                                                                       Very attractive market
                                                                                       but effectiveness will be
4 OR, PACU, and ICU*          5          4       1              1             3        difficult to prove
                                                                                       Attractive and also
                                                                                       provides a potential
6 Military Hospitals          3          4       3              5             5        funding source



                             1                                                  5
                        Weak Position                                     Strong Position

                          Pain Monitor - A Direct Way to Measure Acute Pain
Market Calculations
                         Diagnostic Markets (US)
                                             Pain Pharma
               Clinical Trials                Companies                Devices Per Center        Base Price per Device
     Revenue             $20,000,000=            100                           1                      $200,000



                                        Frost & Sullivan, U.S. Pain
                                               Management
                                         Pharmaceuticals Markets            Assumption                 TechEn Co.



                                         # of New Phase III
                                         Trials Re. Pain Per           Cost of a Phase III Reduction in Trial Time
                                                 Year                    Trial Per Year     and Cost (% of 1 yr)
     Impact             $28,500,000=              15                     $19,000,000               10%

                                             clinicaltrials.gov       Federal Trade Commission        Assumption


               Chronic Pain             # Pain Mgmt Centers            Devices Per Center          Price per Device
     Revenue          $760,000,000=            3,800                           1                       $200,000
                                          Medtech Insight, LLC
               Source                           (2006)                      Assumption                 TechEn Co.


                                        # of Practices (large
               Veterinary Medicine         animals only)      Devices per Practice                 Price per Device
     Revenue          $243,800,000=            1,219                   1                               $200,000
                                           American Veterinary
                                           Medical Association              Assumption                 TechEn Co.



Pain Monitor - A Direct Way to Measure Acute Pain
                            Market Calculations
                      Analgesic Monitoring Markets (US)

Market: OR, PACU, ICU
ICU Total Revenue $8B - $17.5B
  ICU*                                                       Avg Stay
                            Patients/Year                     (Days)        Cost Per Day Stay Reduction
ICU Impact $21,875,000,000= 25,000,000                          5             $3,500          5%
                                JM Dutton and Associates,                  Dr. Wiley Hall, Director of
             Source                       LLC                www.cdc.gov   Neurocritical Care, UMass     Assumption
                                                            Devices per         Price per
                                  Total # Beds                 Bed               Device
   ICU
 Revenue     $17,480,000,000=         87,400                      1            $200,000
                                M D'Esopo, JB Nuzzo.
                                Biosecurity and
                                Bioterrorism. 2006, 4(1):
             Source             87-88                         Assumption          TechEn Co.
                                                            Devices per         Price per
                                  Total # Beds                 Bed               Device
  PACU
 Revenue     $12,000,000,000=         60,000                      1            $200,000
                                Morgan et al. Clinical
             Source             Anesthesiology (2005)         Assumption          TechEn Co.
                                                            Devices per        Price per
                              Total # Beds                     Bed              Device
OR Revenue    $8,000,000,000=    40,000                          1             $200,000
                                Advance for Health
                                Information Executives;
                                JM Dutton and Associates,
                                LLC; The Financial Times
             Source             (2000)                        Assumption          TechEn Co.
    Market Calculations

              Military                  Number of              Beds Per           Devices per    Price per
              Hospitals                 Hospitals              Hospital              Bed          Device

  Revenue      $288,000,000=                  60                    24                  1        $200,000
                                     www.tioh.hqda.pentagon.
                                     mil/MedVet/CombatSupp     RDD USA Military
              Source                 ortHosp.htm                  Supplier          Assumption    TechEn Co.




NB: Average time for hospital to recoup fixed costs of devices = 4 years
    Inflation rates 2-3% not included
    Average 10% in maintenance costs/year not included

     Pain Monitor - A Direct Way to Measure Acute Pain
  Market potential--customers

    Operating room
     One local university hospital performed > 1200 OR cases in 2007
     Particular populationstrauma, obstetric, cardiac surgery


    Intensive care unit
     Oversedation and analgesia leads to prolonged time on ventilators
     and increased morbidity and mortality in the ICU
     Underanalgesia and undersedation contributes to PTSD and
     significant patient morbidity
     30% acute care hospital costs
     $180 billion per year health care spending
                               (American Hospital Association)



Pain Monitor - A Direct Way to Measure Acute Pain
Market potential--customers

   Veterinary medicine
            ● Large market

            ● Trial in rats planned



         Clinical Trials
           ●   Objective outcome measure
                      to assess efficacy of new drugs

         Military Hospitals
           ●  Large numbers of acute trauma, surgery
           ● For use in transport and monitoring
           ● Is a setting with less direct nursing care/available staff for the
                wounded
           ● More automated method for detecting pain would

             improve patient care


Pain Monitor - A Direct Way to Measure Acute Pain
    Market potential--customers

Additional consumers:
   Neuro-intensive care
   Nonverbal patientsstroke, dementia,
    vegetative, locked-in, autism
   Dentistry
   Death row
Use of same system across domains –
 increases options for funding

Pain Monitor - A Direct Way to Measure Acute Pain
OR Monitoring Market
   Nearest market category for envisioned
    application
     Yearly revenues of $140 million
     Less than 2% growth

     Average unit price of roughly $20K (similar to the
      Aspect Medical BIS system)


   The NIRS system is at least an order of
    magnitude more expensive per unit!

Pain Monitor - A Direct Way to Measure Acute Pain
OR Monitoring Market
   Improbable but not impossible
     Need      to show ability to reimburse cost
       Bill   to patients & insurance
     Show      clear ability to improve patient care


   Other markets may be more promising!
       ICU
       Pain  Clinics
       Life Science & Pharmaceuticals Research



Pain Monitor - A Direct Way to Measure Acute Pain
Potential Reimbursement
Regulatory processes
 FDA
 Insurance



Non-regulatory processes
 Veterinary   markets
 Clinical trials




Pain Monitor - A Direct Way to Measure Acute Pain
Potential Partners/Licensees

       Major Players (Market Share 2008)

                               Johnson & Johnson                        (13.7%)

                               General Electric Co.                     (10.0%)

                               Medtronic, Inc.                          (8.5%)

                               Baxter International, Inc.               (7.1%)

                               Covidien Ltd.                            (6.4%)

                               Other                                    (54.3%)
                                e.g. Boston Scientific, T2 Biosystems


                           [Adapted from IBISWorld Industry Report, June 2008]

 Pain Monitor - A Direct Way to Measure Acute Pain
                      Projected Medical Device Industry Growth


                 8
                 7
                 6
Percent Growth




                                                                            2008        -0.1%
                 5                                                          2009        5.3%
                                                                            2010        6.8%
                 4
                                                                            2011        4.5%
                 3                                                          2012        4.7%
                 2
                 1
                 0
                 -1     2008    2009       2010      2011      2012

                                          Year                        [Integra Information, Dec. 2008]

                           Pain Monitor - A Direct Way to Measure Acute Pain
    Guidelines

    New JHACO Guidelines                           VA Guidelines
         January, 2000
   All accredited facilities must provide        The ―fifth vital sign‖
    appropriate pain assessment tools

   Assessment of pain must be
    documented

   If a facility does not have the tools to
    adequately manage a patient’s pain,
    the patient must be transferred to
    another hospital

   Institutions graded on pain
    assessment for accreditation


                                                          Medtech Insight, LLC (2006)

Pain Monitor - A Direct Way to Measure Acute Pain
  A direct way to measure acute pain

     Near infrared spectroscopy
         Noninvasive
         No injections
         No radiation

     Moves beyond current subjective methods of pain
      monitoring

     Uses in operating/recovery rooms, intensive care
      units, veterinary medicine facilities
         Benefits patients
         Reduce health care spending
             For acute care
                 Avoid under- and over-analgesia
                 Decrease PACU and ICU length of stay
             By reduction of chronic pain due to improved acute pain management

Pain Monitor - A Direct Way to Measure Acute Pain
                                           Pain

The estimated economic impact of pain in the U.S. = $100 billion
  annually
   Money spent on various forms of pain management
    projected to by 4-14.5% per year

   Most common reason for seeking medical care
              ~50% of office visits in the U.S.
              Longer duration of stay
              Longer recovery times
              Poorer outcomes

   80-85% of those >65 years have health problems that predispose to pain


                                                         Medtech Insight, LLC (2006)

     Pain Monitor - A Direct Way to Measure Acute Pain
Acute Pain
25 million people per year experience acute pain
due to injury/surgery
                                                    Medtech Insight, LLC (2006)

Acute post-operative pain leads to chronic pain in
10-50% of patients
     After common operations, e.g. CABG, hernia repair
     Severe in 2-10%
                                                    Kehlet et al. (2006)


   50% acute pain is undertreated



Pain Monitor - A Direct Way to Measure Acute Pain
      Chronic Pain
   >50 million people suffer from chronic pain in U.S.

   3,800 pain management programs/practitioners in
    the U.S. in 2006

   >50% of those who develop chronic pain become
    disabled
           25% leads to anxiety/depression

   ~14% of workforce have absences due to pain
                                                        Medtech Insight, LLC (2006)

    Pain Monitor - A Direct Way to Measure Acute Pain
Analgesic Monitoring Device
Estimated economic impact of pain in the U.S.  $100 billion
 25 million people per year experience acute pain due to injury/surgery
 After common surgeries, acute post-operative pain is followed by
 persistent (chronic neuropathic) pain in 10-50% (Kehlet et al., Lancet 2006)
 ~14% of workforce have absences due to pain
 VA Guidelines  ”Pain is the fifth vital sign”
 JHACO Guidelines, 2000 All accredited facilities must provide
 appropriate pain assessment tools
 [Medtech Insight, LLC (2006)]

 The problem:
          Currently  no way to objectively measure pain


                   The proposal:
                     An objective way to measure acute pain
                    Noninvasive
                    Near infrared spectroscopy
                    Assess change in blood oxygen level in brain pain centers
                              Analgesic Monitoring Device


Steps to market
1. Fills unmet need?
2. Proof of concept
How long/expensive?
Will end result be qualitative or quantitative?
How validated are the end points?
3. Regulatory pathways
                                                     $=     funding, investors

4. IP
5. How reimbursed/source of
payment for services




                                    Determine the Business plan
                                           Licensing vs. Start-up?
                            NIRS Pain Monitor

2. Proof of concept  INCOMPLETE
   Does this technology work? YES
     Can distinguished pain from other stimuli
     Data correlates to fMRI
 What more still needed?
   Market specific proof of concept
    Demonstrate absence of/change in pain spectra with analgesia
    Trials in OR (pending), ICU, veterinary medicine
   Technical issues remain
    Real time assessment (underway)
    Correlate change in spectra to clear numerical scale or image (children)
    Determine “baseline” pain level without stimulus
    Universal norms (specific age groups; populations, i.e. chronic pain)
   Demonstrate efficacy and outcomes
    Decrease ICU and PACU stays, lower costs, prevent chronic pain/costs




             $=       funding seed money, grants, investors
                                  NIRS Pain Monitor

3. Regulatory pathway  STRONG, no barriers foreseen
        NIRS is an FDA approved technology
        Need approval for proposed application
       Initial discussions with FDA  Class 1 device, no investigational
       device exemption (IDE) needed for studies

4. IP  STRONG
   Patent search yielded
      No direct competition for proposed application of NIRS
   (2002-present, international)
      Dec. 2000 U.S. patent  broad, sets precedent
      Dec. 2005 International application is specific


5. How reimbursed  CHALLENGE
   Cost savings to hospitals still need to demonstrate
   Benefit to patient  decrease over/under sedation, reduce frequency of chronic pain
   Reduce costs on medications, ventilator time, ICU and PACU time
   Costs of chronic pain
   To be reimbursable by 3rd party payers should be goal
   Support from societies/ guideline of societies
      Critical care, Surgery, Anesthesia, Veterinary medicine, JHACO support
   Non-FDA regulated markets
   Pharma, military, veterinary
              NIRS Pain Monitor

Summary / Recommendations
     Unmet clinical need
      Large size and multiple markets
      Difficult to quantify monetarily
         Reduced ventilator time, PACU stay
         Reduce patient morbidity
         Reduce frequency of chronic pain
         Improve quality of care
      No existing competitive market
      Strong IP
      Regulatory pathway smooth
      Nonregulatory market alternatives
      Much work remains on POC, technology
                            Timeline
1. Analgesia POC: evaluate pain in adults in OR based on multiple types of
   anesthesia (Funded) Jan 2009 – Jan 2010
          Concurrent technical issues:
          Making machine smaller, fewer sensors with real-time data presentation
2. Baseline pain w/o stimulus POC: includes a second machine (in order to do in
   parallel) – Resources: tech, pilot study ~20 subjects, IRB approval, $300K price tag
   (Unfunded) Jan 2009 – Jan 2011
3. Define a clear scale for level of pain in healthy population, correlate with existing
   methods of measurement (vital signs, etc.) with larger sample size ~150 subjects
   (possible to include in step 1) Jun 2009 – Jan 2012
4. Proof of efficacy: show ability to adjust analgesia based on a numerical pain level,
   small single center study of 20 – 50 subjects, FDA support needed (Unfunded) Jan
   2012 – Jun 2013
5. Show outcome effect: ability to reduce time in ICU, PACU, improve patient care,
   small single center study of 20 – 50 subjects (Unfunded) Extension of previous
   study Jul 2013 – Jan 2014
6. Multicenter study: get universal norms based on large sample, demonstrate
   outcome effect on a large scale 500 – 1000 subjects (Unfunded) Jan 2014 – Jan
   2017

Pain Monitor - A Direct Way to Measure Acute Pain
                         Timeline

Instructions for 3
Part 1: Record patient NIRS information throughout an OR procedure (pre-
   anesthesia through recovery) without stimulus



Instructions for 4
Part 1: Awake patient not in pain or sedated: Record NIRS pain level
   between VAS 3 and 7 with recorded level of stimulus
Part 2: Give anesthesia/analgesia, apply recorded levels of stimulus that
   correlate to previous VAS 3 and 7, and record new VAS levels. Should
   show reduction in VAS levels with same level of stimulus




Pain Monitor - A Direct Way to Measure Acute Pain
How device works
   Measures changes in total/ratio of oxy to deoxy
    hemoglobin levels in the brain

   Pain perception is converted into a digital scale

   A graph/AUC of absorption spectra correlates with a
    digital read out representing pain level

   Amount of anesthesia or analgesia adjusted for goal
    level < 3

   Transportable and affordable

Pain Monitor - A Direct Way to Measure Acute Pain
                            1.    Physical sensation =
                                  increased activity in brain

                            2.    Increased activity = need
                                  for more oxygen

                            3.    Body sends in fresh, oxygen-
                                  rich blood

                            4.    NIRS can detect oxygen
                                  levels in blood
Pain Monitor - A Direct Way to Measure Acute Pain
              690 nm: HbR
              830 nm: HbO




(Slide adapted from Lino Becerra, PhD)


    Pain Monitor - A Direct Way to Measure Acute Pain
                                 How device works

                                     Tactile sensation                                                                        Pain sensation




                                                                                             )
                                                                                                                              (heat, 46˚C); double peak
)




                                     (brush); single peak




                                                                                             ( µ M
( µ M




                                                                                             C o n c e n t r a t i o n
                                             1                                                                                               1
C o n c e n t r a t i o n




                                         0 .         5                                                                                   0 .         5




                                             0                                       T i m              e                    ( s )           0                                 T i m   e
                             -   5               0           5     1 0   1 5   2 0                                       -    5                  0           5   1 0   1 5   2 0




                                     -       0 .         5                                                                           -       0 .         5




                                         -       1                                                                                       -       1



                                                                 Somatosensory cortex
                                                                 (average, 10 subjects)

                            Pain Monitor - A Direct Way to Measure Acute Pain
VAS (visual analog scale) pain scale

 Validated pain scale
Pain scores ≥ 7  significant pain
Pain scores ≤ 3  acceptable/tolerable level

   With NIRS device, spectra loses second peak
   when VAS score ≤ 3
Preliminary data
  Group results robust
  Individual results– give multiple stimuli, use
  averaging phenomena

Pain Monitor - A Direct Way to Measure Acute Pain
How it works: Loss of second peak (contralateral side)
when VAS score 3 compared to 7


      Contralateral side                                       Ipsilateral side
                                    VAS 7
                                    VAS 3




                                                                         VAS7I
                   VAS7C




                                                                  0.2
             0.2


                                                                 0.15
           0.15


                                                                  0.1
             0.1



                                                                 0.05
           0.05



                                                                    0                               A
               0                                      A
                                                          -5               0     5   10   15   20
      -5             0     5   10           15   20

                                                                 -0.05
           -0.05



            -0.1                                                  -0.1




           -0.15                                                 -0.15




            -0.2                                                  -0.2




 Red = 7/10
 Blue = 3/10               Pain sensation (heat, avg 3 subjects)

  Pain Monitor - A Direct Way to Measure Acute Pain
CAN NIRS DISTINGUISH BETWEEN PAIN
AND NON-PAINFUL STIMULI?

Slater et al. (2006)
      ◦ Heel lance in infants elicits NIRS response
      ◦ No response to non-painful stimuli
      ◦ Greater response when awake
      ◦ Response increases with age

Becerra et al. (2008)
     ◦ Brush vs. noxious heat in adults
     ◦ NIRS detects single peak for non-painful
       stimuli and double peak for painful stimuli

  Pain Monitor - A Direct Way to Measure Acute Pain
SENSITIVE TO TREATMENT OF PAIN?
FOR USE IN CLINICAL TRIALS?


Bucher et al. (1995)
      ◦ Sucrose shown to reduce crying after heel lance in
        infants

        ◦ Cerebral blood volume measured by NIRS
          decreased in 5/14 infants after sucrose and in 6 /14
          infants after placebo BUT not clear that sucrose was
          effective treatment




 Pain Monitor - A Direct Way to Measure Acute Pain
CAN SIGNAL BE OBTAINED IN THE OR?

Kussman et al. (2005)
     ◦ Infants undergoing cardiac surgery
     ◦ Cerebral oxygen saturation measured with NIRS:
            After induction of anesthesia
            Before, during and after CP bypass
            With deep hypothermic circulatory arrest

Lee et al. (2008)
       ◦ Adults undergoing spinal surgery
       ◦ Cerebral NIRS significant predictor of plasma Hgb


 Pain Monitor - A Direct Way to Measure Acute Pain
DOES THE RESPONSE CORRELATE WITH
OTHER MEASURES OF PAIN?


Slater et al. (2008)
      ◦ Heel lance in infants
      ◦ NIRS measures correlate with:
      ◦ Infant pain profile (PIPP) score r=.57, p=0.001
      ◦ Facial expression r=.74, p<0.0001

Becerra et al. (2008)
     ◦ NIRS response similar to that seen with fMRI


  Pain Monitor - A Direct Way to Measure Acute Pain
IP – Patents and Applications
   US Patent 6,907,280. Method and apparatus for objectively measuring
    pain, pain treatment and other related techniques. Filed Dec 2000, issued
    Jun 2005
    Broad coverage of the technology.

   International Patent Application WO 2006/071891 A2. Evaluating Central
    Nervous System. Filed 12/23/2005.
    Specific, detailed coverage of the technology.

   US Patent Application 20060074298. CNS assay for prediction of
    therapeutic efficacy for neuropathic pain and other functional illnesses.
    Filed Sep 2005.
    Specific coverage for drug efficacy testing application.

   International search for patents owned by third parties yielded no signs of
    direct competition, thus, we consider IP strong.

   Coverage through 2025 - 8 years after clinical trials completed.
Pain Monitor - A Direct Way to Measure Acute Pain
Patent Application WO 2006/071891 A2 Claims

   Claims 1-11: measuring central nervous system (CNS)
    activity in a subject experiencing pain

   Claims 12-23: identifying therapeutic interventions for
    neurological conditions (incl. testing efficacy of pain
    treatment drug candidates)

   Claims 24-41, 65-69: using the measurement results to adjust
    the amount of medication, both for acute and chronic pain
    treatment

   Claims 47-64: evaluating pain or analgesia

Pain Monitor - A Direct Way to Measure Acute Pain
Interviews:




Pain Monitor - A Direct Way to Measure Acute Pain
Arthur ―Buzz‖ Dimartino
TechEn

   Prototype cost is $170K

   The TechEn NIRS system is ―custom made‖
       Potentially high NRE tooling cost to go to large
        scale production


   Savings of roughly 30% can be achieved with
    quantity, but overhead and distribution costs
    would roughly equal that

Pain Monitor - A Direct Way to Measure Acute Pain
 Peter Clardy, M.D.
 Director, Medical Intensive Care Unit,
 Beth Israel Deaconess Medical Center, Boston



     ―How we currently assess pain remains rather
      primitive despite use of validated tools and
      scales—we still often under and over dose‖
     ―Clinical need for such a device exists‖
     ―Ideally would be noninvasive, no interference
      with other equipment‖
     Would need FDA approval/IRB approval for use
     ―If could assess consciousness and pain
      together would be even more useful‖

Pain Monitor - A Direct Way to Measure Acute Pain
Wiley Hall, MD
Director, Neurocritical Care
University of Massachusetts, Worcester

    ―To assess pain, we look at vital signs. NIRS would be useful.‖

    ―Patients in the ICU are intubated, they don’t speak, so you don’t
     really know if they are in pain.‖

    ―Would use it for surgical patients as they have bigger pain
     issues.‖

 Use of NIRS may allow for better management of vital signs:

    In SAH: ―Because they are in pain and good analgesia would
     make blood pressure easier to control‖

    In the OR: ―If there’s not enough analgesia in the OR, and they
     need more sedation, and then blood pressure is harder to
     control‖

Pain Monitor - A Direct Way to Measure Acute Pain
Edward George, MD, Ph.D.
Department of Anesthesia
Massachusetts General Hospital, Boston



     ―The recovery room costs $1000 per hour.
      If there’s increased pain, the patient stays
      there.‖

     ―You want to decrease costs by decreasing
      time in the OR‖ – if better pain control, can
      use less sedating drugs

     ―…Use for high risk [cases]: 1. trauma 2.
      cardio-pulmonary bypass 3. obstetrics‖
Pain Monitor - A Direct Way to Measure Acute Pain
Adam Muzikant
Inotek Pharmaceuticals


   ―Starting with a prototype idea, must build proof
    of concept‖
   Most companies want answers to such
    questions—
       ―Is there real unmet need? Talk to end users.‖
       ―Is the use reimbursable? How long and how expensive to obtain POC, mechanism in
        humans‖
       ―Is the end point qualitative or quantitative?‖
       ―How validated will the end points be?‖
       ―Assess IP.‖

   ―Would need more POC studies in humans,
    which leads to significant increase in product
    value.‖
Pain Monitor - A Direct Way to Measure Acute Pain
Kevin L. Ohashi,
The Vertical Group
Device Venture Company


   Regarding how advanced the technology must be before a VC
    would consider investing depends on the VC firm. Some
    focus on early stage technology, like this company.

   Considerations for potential interest include—showing a clear
    unmet clinical need, identifying initial beach heads, assessing
    hurdles, i.e. business, regulatory pathways, management of
    founding teams.
   ―How will the diagnostic device get reimbursed? If it is just to
    save money—need to prove this3rd party reimbursement
    potential is superior.‖

   ―Device has a wide spectra of applications, need to demonstrate
    savings to customers, and ideally be reimbursable by 3rd party
    payers.‖


Pain Monitor - A Direct Way to Measure Acute Pain
Zaffer Syed
Clinical marketing group for Pain Management Boston
Scientific

    Clinical marketing group for Pain Management at Boston Scientific
      Targeted specifically at a spinal treatment for chronic pain


    His challenge: ―Assessing the mitigation of pain‖ is subjective
      Its difficult to prove the validity of a treatment without an objective
        measurement
      An objective measurement could ―further increase adoption of the therapy‖


    His customers are neuroscientists and pain clinicians.

    It is very much an interest of Boston Scientific to support clinical research

    Boston Scientific bought the start up company that is now their Pain
     Management group

    He sees an opportunity for this system to become a ―standard of care‖
      Could either replace or supplement the subjective VAS method



Pain Monitor - A Direct Way to Measure Acute Pain
  Wolf Sapirstein, MD, MPH,FACS
  Medical Officer, FDA
  Division of Cardiovascular Devices, Office of Device Evaluation
  Center for Devices and Radiological Health


● Devices are categorized into classes:
  Class 1 = simple, noninvasive, do not induce treatment effect
  Class 2 = not implantable, but more invasive than class 1
  Class 3 = implantable devices, increased risk to patients
―This device would most likely be class 1.‖

● What would be required for FDA approval of proposed application/technology?
―In vitro studies showing how the device works, information on which to base
labeling and indications for use.‖
―Must demonstrate the device can indeed measure differences in acute pain.‖

● What regulation is needed to initiate clinical studies?
―Since likely Class 1, would not require IDE (investigational device exemption).
Would need hospital’s IRB approval.‖
However, prior to beginning the study, recommend pre-approval meeting with FDA to
learn FDA thoughts, suggestions regarding the clinical trial.‖


    Pain Monitor - A Direct Way to Measure Acute Pain
    Rahul Dhanda
    Director of Marketing, T2 Biosystems, Inc.
 ―Monitoring pain directly is its own company.‖

 ―Sounds solid – what is the comparator? We know there is nothing.‖

Potential uses:

 ―Everything’s subjective, pain management centers where subjectivity
forces decisions regarding narcotics, the clinical trials world, people want
indications for pain.‖

 ―CROs would have a leg up.‖

 A recent study by a large biotech company examined pain with stents -
was difficult to conduct, as there was no quantifiable outcome measure for
pain.

   Pain Monitor - A Direct Way to Measure Acute Pain
Marko Poolamets
Head of Quality Management
Oriola (a Finnish distributor of healthcare products)


   ―Hospitals in Estonia are skeptical about new
    devices, but would buy Pain Monitor after it is
    widely in use in Finland, Sweden and
    Germany.‖
   ―I also see potential market in outpatient
    surgery, cosmetic surgery and dental surgery,
    as anesthesia there is less deep and precise
    monitoring is more critical than in the case of
    long operations.‖
   ―I would predict the sales of ca 100 units in
    Estonia, assuming that the price is reasonable.‖

Pain Monitor - A Direct Way to Measure Acute Pain
Additional Interviews and Resources

   Marisa Fox, RN
    Department of Public Health

   Denise A. LaGasse
    Licensing Manager
    Partners Healthcare Systems

   Gary Leeman, MBA, CPA, PC

   Direct access to anesthesiologists

   Direct access to FDA
Pain Monitor - A Direct Way to Measure Acute Pain

								
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