Whiteboard2Boardroom presents innovations from regional universities, hospitals, and research organizations to encourage commercialization.

1. Non-Invasive Bowel
Monitoring Systems
January 27, 2021

2. Non-Invasive Bowel Monitoring System
John Rosen, MD
jmrosen@cmh.edu
WHITEBOARD 2BOARDROOM, 1/27/2021

3. What is the problem?
 Clinical decisions rely on subjective or invasive
measurement of bowel activity
 Inefficient decisions
 Potential for complications
 No method provides objective, continuous (long-
term) monitoring of colon activity for patients in or
out of the hospital

4. How does product solve the problem?
 Utilizes skin electrodes to measure electrical
bioimpedance (EBI) and EMG signals
continuous and objective measure of bowel activity
 Incorporates into existing patient monitoring
systems or as a stand-alone system
 May be configured as a wearable device for ambulatory
(including at-home) monitoring
 May be configured to alert patients or caregivers
 Can be used while non-sedentary

5. What is the market use?
 Monitoring of colon activity in acute or chronic
medical conditions and bowel dysfunctions
 Inpatient monitoring (standard of care)
 Post surgical (ileus)
 Acute and chronic conditions
 Patients with limited communication
 Outpatient monitoring
 Biofeedback behavior modification for toilet training
 Phamacodynamic studies
 Animal health – post surgical care

6. What competition exists?
 There are no non-invasive colon activity monitoring
devices in use
 There are no outpatient methods to monitor colon
activity
 Identified 2 companies developing non-invasive
devices – research stage
 Abstats - measures acoustic signal
 G-Tech Medical - measures colonic electrical signals

7. What is the status of the intellectual property?
 PCT Patent application filed August 2018
 US, Canada, EU, Japan and Australia National Stage
applications filed February 2020

8. What is the stage of development?
 Pre-clinical studies have been conducted and
additional studies are currently underway which
show proof of concept and include measurements:
 At rest in semi-recumbent position
 During hip flexion
 When applying external stomach pressure
 Bearing down
 After ingestion of a stimulant laxative
medication

9. What is needed for further development?
 Optimization of electrode placement and
determination of best data analysis methods
 Complete current study of comparing manometry –
indwelling catheter measuring colon pressure
 Assess correlation between EBI/EMG data and manometry
 Secure commercial partner

10. Appendix
Annual Projections with Unit Replacement
BAMS Market Analysis
Total Devices 7134 Total Device Uses Annually 465563
Price of Device $800 Price of Disposables 18.00
$
2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032
New Devices 1000 2500 3500 214 220 227 234 241 248 256 263
Replacement devices 0 0 0 250 500 1000 1000 1000 1000 1000 1000
Total Devices 1000 2500 3500 464 720 1227 1234 1241 1248 1256 1263
Total Device Revenue $800,000 $2,000,000 $2,800,000 $371,216 $576,352 $981,643 $987,092 $992,705 $998,486 $1,004,441 $1,010,574
Disposable Leads 465563 465563 465563 479529 493915 508733 523995 539715 555906 572583 589761
Total Disposables Revenue $8,380,125 $8,380,125 $8,380,125 $8,631,529 $8,890,475 $9,157,189 $9,431,905 $9,714,862 $10,006,308 $10,306,497 $10,615,692
Total Revenue $9,180,125 $10,380,125 $11,180,125 $9,002,745 $9,466,827 $10,138,832 $10,418,997 $10,707,567 $11,004,794 $11,310,938 $11,626,266
BAMS Market Opportunity
Total Devices 35670 Total Device Uses Annually 3593795
Price of Device $800 Price of Disposables 18.00
$
2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032
New Devices 5000 12500 17500 525 541 557 574 591 609 627 646
Replacement devices 0 0 0 1250 2500 5000 5000 5000 5000 5000 5000
Total Devices 5000 12500 17500 1775 3041 5557 5574 5591 5609 5627 5646
Total Device Revenue $4,000,000 $10,000,000 $14,000,000 $1,420,000 $2,432,600 $4,445,578 $4,458,945 $4,472,714 $4,486,895 $4,501,502 $4,516,547
Disposable Leads 3593795 3593795 3593795 3701609 3812657 3927037 4044848 4166193 4291179 4419915 4552512
Total Disposables Revenue $64,688,310 $64,688,310 $64,688,310 $66,628,959 $68,627,828 $70,686,663 $72,807,263 $74,991,481 $77,241,225 $79,558,462 $81,945,216
Total Revenue $68,688,310 $74,688,310 $78,688,310 $68,048,959 $71,060,428 $75,132,241 $77,266,208 $79,464,194 $81,728,120 $84,059,964 $86,461,763

11. Appendix
Market Growth
• global postoperative care management market is
expected to reach $105.8 billion in 2025, from
$67.4 billion in 2017, growing at a CAGR of 5.8%
from 2018-2025
• global vital signs monitoring devices market was
$4.1 billion in 2016 and is expected to grow at a
CAGR of 6.5% through 2025

12. COLON ACTIVITY
Appendix

13. Ileus after surgery
case example
Postoperative Ileus (US)
Estimated annual cost $1.7 billion
Early identification important
Avoid interventions that worsen
Implement treatment strategies
Abdominal surgery (highest risk group)
870K patients at risk
25% have postoperative ileus
Orthopedic surgery (2nd highest risk group)
Case Example:
105K spinal fusion at risk
3-6% have postoperative ileus
2.5 days longer in the hospital, $7K excess costs
Appendix