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Copyright Medergo Private Limited © All rights reserved
Smart Feed TM: Safer Nasogastric (NG) Enteral Feeding Solution
Team
 Warren Lee (Co-founder, Biz Dev)
 Saurabh Bhandari (Co-founder, Tech Dev & Operations)
Commercial Champions
 Lim Teck Sin, Kooprime
 Georgette Kuek, Kooprime
Advisors
 Dr. Foong Shaohui, Asst Professor SUTD
 Dr. Asim Shabbir, Senior Consultant & Clinical Director, NUHS
Copyright Medergo Private Limited © All rights reserved
Test Aspirate
Confirm Placement
Doctor prescribes
enteral feeding
Nurse inserts
NG tube
Patient receives
nutrition
Up to 8 Hours
The Problem
Monthly
1
Blind insertion
Draw aspirate
Poor Patient Outcome
Copyright Medergo Private Limited © All rights reserved
Current Methods - ineffective and costly…
X- Rays: Still DangerousPH Test: Do not work
What about nursing homes where x-rays are not even an option?
Source: NUH 2009-2012 Source: NHS 2008
Inconclusive
20%
No aspirate
80%
US
$100
MM
Deaths
19%
Severe
harm
23%
Modera
te Harm
23%
No
Harm
35%
Source: NHS 2008
 Radiation exposure
46%
42%
12%
Feed into
lungs
Delay in
Feeding
Others
210 Chest X-Ray based feeding episodes
US
$1.5B
192 doubtful placements based on PH test
2
Copyright Medergo Private Limited © All rights reserved
Our solution Get it Right – The first time
Smart Feed TM
Smart Sense TM
(Reusable)
Smart Tube TM
(Disposable)
 Embedded Magnetic Marker
 Radio Opaque
 Standards Compliant
• ISO 80369-1
• EnFIT StandardEM Marker
1
Placement Confirmed!!
3
 Easy to use
 Accurate
 Affordable
 Portable
Copyright Medergo Private Limited © All rights reserved
Cost-Benefit for Patient
Existing
pH Strip: $0.10
Tube: $30
X-ray: $30
Average cost per procedure = $60.10
Average time per procedure = 45 minutes
Average error per procedure = 13-50%
Versus
Smart Feed TM
Smart Sense TM : $350
Smart Tube TM : $30
(feedings per Smart Sense TM = 1200)
Average cost per procedure = $30.10
Average time per procedure = <9 minutes
Average error per procedure = <1%
Benefits to stakeholders
To Hospitals
 Better patient outcomes
 Increase in productivity
 Reduced training cost
 Potential elimination of X-rays
To Users (Nurses/Caregivers)
 Assurance of safe procedure
 Real-time recognition of error
 Avoidance of adverse events
 Reduced hassle
To Patients
 Increased Safety
 Faster time to therapy
 Reduced wait time and distress
 Reduced overall cost of healthcare
50% cost savings per treatment
($30 compared to existing $60)
80% time saving per treatment
(reduction from 45 minutes to 9 minutes)
4
Source: Corpak FDA filings, Benya, Langer, & Mobarhan, 1990; Metheny, Spies, & Eisenberg, 1986; Neumann, Meyer, Dutton, & Smith, 1995), Metheny and colleagues (1986)
Copyright Medergo Private Limited © All rights reserved
Our Market
Source: Rn Market research, Transparency research, interviews
SG Market
Global
Market Size
US $1.8B
US $5.6
MM
APAC+EU
$1.1B
CAGR 7%
per annum
Target segments
Hospitals
Nursing homes
Home care
5
Copyright Medergo Private Limited © All rights reserved
Company Technology Product & Cost Key
Markets
Electromagnetic
Smart Tube TM = $30
Smart Sense TM = $350
APAC, EU,
US
Radiofrequency
smARTrack
(Estimated same as
Corpak)
Israel, US
Radiofrequency
Tube = $175
Cortrak 2 = $30,000 UK, China
Disposable
Endoscope
IRIS tube = $200
IRIS sense = $45,000 US
Competitive landscape
6
Copyright Medergo Private Limited © All rights reserved
Value propositions
High
(Minimal training)
Lowest
(Specialized Training)
Ease Of Use Affordability Positioning Accuracy
High
(Lowest price)
Low
(Highest price)
High
(Go/ no-go)
Lower
(Tissue imaging)
7
Copyright Medergo Private Limited © All rights reserved
BMC
Hospitals
Distributors
Direct sales
Recurring sales
Smart Tube TM = $30
Fixed Costs
Regulatory = $300,000
Certifications = $100,000
R&D Costs
Patents
Regulatory
Approvals
Nursing training
institutes
Medical device
companies with
enteral feeding
portfolio
Suppliers
User training
IP protection
Standard
setting
Easy to use
Accurate
Affordable
Portable
Key opinion leader
engagement
Coverage in
medical reviews
Variable Costs
Smart Tube TM = $30
Smart Sense TM = $30
One Off sales
Smart Sense TM = $350
Nursing
homes
Home
care
$1.8 Billion
Validated
with
Doctors
(16)
Nurses
(19)
Other
(22)
8
Copyright Medergo Private Limited © All rights reserved
Regulatory pathway
Smart Sense TM : Class I self certified
Smart Tube TM : Class IIb
Identified Notified Body: TUV SUD
CE Mark HSA
CE FDA
Approval Date Application Date Approval Date
Cortrak (K113351) Sep 2012 Dec 15 2011 Jan 10 2012
Covidien IRIS (K123555) Sep 2013 Apr 3 2014 Apr 9 2014
Art Healthcare NA Apr 20 2015 June 8 2015
Expected time to
approval < 30 days
Device Classification: Tubes, gastrointestinal
(and accessories)
Regulation Number: 21 CFR §876.5980
Regulation Name: Gastrointestinal tube and
accessories
Regulatory Class: II
Product Code: KNT
FDA : 510(k) or Premarket Notification
Prerequisites:
ISO 10993 (Biocompatibility)
• Cytotoxicity using ISO elution method
• Systemic injection test
• Implantation and subacute toxicity study
IEC 60601:2005/2006/2007 (EM compatibility)
Software verification and validation (Moderate)
3
1 2
Started discussions with HSA in March 2017
9
Copyright Medergo Private Limited © All rights reserved
Key resources
Cadaver TestBench Test
Patents
US: US20160287134A1
SG: 11201604079
10
Copyright Medergo Private Limited © All rights reserved
Commercialization plan
Clinical Trials
Feasibility study
Clinical trial
Q3 2017 Q1 2018 Q3 2018Today
$40,000
 Biocompatibility
 Electromagnetic compatibility
Usage of funds SGD
Consumables and
equipment
$30,000
Consultancy $10,000
$300,000 $500,000
Beta
Prototype &
Bench Test
Cadaver
Trials
11
Copyright Medergo Private Limited © All rights reserved
Financials
Q2 2017 Q3 Q4 Q1 2018 Q2 Q3 Q4
IP Consultancy $5,000 $30,000
DFM Consultancy (QMI) $5,000
QMS ISO 13485 (QMI) $6,000
Regulatory consultancy –
CE/ HSA
$2,000 $20,000
Regulatory consultancy –
FDA (510K/PMN)
$2,000 $20,000
Manpower cost Engineering x 1 ($60,000)
Clinical x 1 ($45,000)
Engineering x 2 ($120,000)
Clinical x 1 ($45,000)
Manufacturing cost $10,000 $20,000 $50,000
Bench test
 ISO 10993
(Biocompatibility)
 IEC
60601:2005/2006/200
7 (Electromagnetic
compatibility)
$10,000
Animal/Cadaver trials
 Ex-Vivo
 In-Vivo
$30,000
Clinical trial
 Feasibility study
(n=10)
$100,000
Clinical trial
 Stage 2 (n=20)
$200,000
Go to market 1 - SG $10,000 $20,000
Funding NUS/NTU Jumpstart ($30,000) TECS POC ($250,000) TECS POV ($500,000)
Founders full time 1st Revenue
12
Copyright Medergo Private Limited © All rights reserved
Thank you
Contact Us:
Warren (Co-founder, Biz Dev)
+65 8363 9525
warrenstanlee@u.nus.edu

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Medergo

  • 1. Copyright Medergo Private Limited © All rights reserved Smart Feed TM: Safer Nasogastric (NG) Enteral Feeding Solution Team  Warren Lee (Co-founder, Biz Dev)  Saurabh Bhandari (Co-founder, Tech Dev & Operations) Commercial Champions  Lim Teck Sin, Kooprime  Georgette Kuek, Kooprime Advisors  Dr. Foong Shaohui, Asst Professor SUTD  Dr. Asim Shabbir, Senior Consultant & Clinical Director, NUHS
  • 2. Copyright Medergo Private Limited © All rights reserved Test Aspirate Confirm Placement Doctor prescribes enteral feeding Nurse inserts NG tube Patient receives nutrition Up to 8 Hours The Problem Monthly 1 Blind insertion Draw aspirate Poor Patient Outcome
  • 3. Copyright Medergo Private Limited © All rights reserved Current Methods - ineffective and costly… X- Rays: Still DangerousPH Test: Do not work What about nursing homes where x-rays are not even an option? Source: NUH 2009-2012 Source: NHS 2008 Inconclusive 20% No aspirate 80% US $100 MM Deaths 19% Severe harm 23% Modera te Harm 23% No Harm 35% Source: NHS 2008  Radiation exposure 46% 42% 12% Feed into lungs Delay in Feeding Others 210 Chest X-Ray based feeding episodes US $1.5B 192 doubtful placements based on PH test 2
  • 4. Copyright Medergo Private Limited © All rights reserved Our solution Get it Right – The first time Smart Feed TM Smart Sense TM (Reusable) Smart Tube TM (Disposable)  Embedded Magnetic Marker  Radio Opaque  Standards Compliant • ISO 80369-1 • EnFIT StandardEM Marker 1 Placement Confirmed!! 3  Easy to use  Accurate  Affordable  Portable
  • 5. Copyright Medergo Private Limited © All rights reserved Cost-Benefit for Patient Existing pH Strip: $0.10 Tube: $30 X-ray: $30 Average cost per procedure = $60.10 Average time per procedure = 45 minutes Average error per procedure = 13-50% Versus Smart Feed TM Smart Sense TM : $350 Smart Tube TM : $30 (feedings per Smart Sense TM = 1200) Average cost per procedure = $30.10 Average time per procedure = <9 minutes Average error per procedure = <1% Benefits to stakeholders To Hospitals  Better patient outcomes  Increase in productivity  Reduced training cost  Potential elimination of X-rays To Users (Nurses/Caregivers)  Assurance of safe procedure  Real-time recognition of error  Avoidance of adverse events  Reduced hassle To Patients  Increased Safety  Faster time to therapy  Reduced wait time and distress  Reduced overall cost of healthcare 50% cost savings per treatment ($30 compared to existing $60) 80% time saving per treatment (reduction from 45 minutes to 9 minutes) 4 Source: Corpak FDA filings, Benya, Langer, & Mobarhan, 1990; Metheny, Spies, & Eisenberg, 1986; Neumann, Meyer, Dutton, & Smith, 1995), Metheny and colleagues (1986)
  • 6. Copyright Medergo Private Limited © All rights reserved Our Market Source: Rn Market research, Transparency research, interviews SG Market Global Market Size US $1.8B US $5.6 MM APAC+EU $1.1B CAGR 7% per annum Target segments Hospitals Nursing homes Home care 5
  • 7. Copyright Medergo Private Limited © All rights reserved Company Technology Product & Cost Key Markets Electromagnetic Smart Tube TM = $30 Smart Sense TM = $350 APAC, EU, US Radiofrequency smARTrack (Estimated same as Corpak) Israel, US Radiofrequency Tube = $175 Cortrak 2 = $30,000 UK, China Disposable Endoscope IRIS tube = $200 IRIS sense = $45,000 US Competitive landscape 6
  • 8. Copyright Medergo Private Limited © All rights reserved Value propositions High (Minimal training) Lowest (Specialized Training) Ease Of Use Affordability Positioning Accuracy High (Lowest price) Low (Highest price) High (Go/ no-go) Lower (Tissue imaging) 7
  • 9. Copyright Medergo Private Limited © All rights reserved BMC Hospitals Distributors Direct sales Recurring sales Smart Tube TM = $30 Fixed Costs Regulatory = $300,000 Certifications = $100,000 R&D Costs Patents Regulatory Approvals Nursing training institutes Medical device companies with enteral feeding portfolio Suppliers User training IP protection Standard setting Easy to use Accurate Affordable Portable Key opinion leader engagement Coverage in medical reviews Variable Costs Smart Tube TM = $30 Smart Sense TM = $30 One Off sales Smart Sense TM = $350 Nursing homes Home care $1.8 Billion Validated with Doctors (16) Nurses (19) Other (22) 8
  • 10. Copyright Medergo Private Limited © All rights reserved Regulatory pathway Smart Sense TM : Class I self certified Smart Tube TM : Class IIb Identified Notified Body: TUV SUD CE Mark HSA CE FDA Approval Date Application Date Approval Date Cortrak (K113351) Sep 2012 Dec 15 2011 Jan 10 2012 Covidien IRIS (K123555) Sep 2013 Apr 3 2014 Apr 9 2014 Art Healthcare NA Apr 20 2015 June 8 2015 Expected time to approval < 30 days Device Classification: Tubes, gastrointestinal (and accessories) Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT FDA : 510(k) or Premarket Notification Prerequisites: ISO 10993 (Biocompatibility) • Cytotoxicity using ISO elution method • Systemic injection test • Implantation and subacute toxicity study IEC 60601:2005/2006/2007 (EM compatibility) Software verification and validation (Moderate) 3 1 2 Started discussions with HSA in March 2017 9
  • 11. Copyright Medergo Private Limited © All rights reserved Key resources Cadaver TestBench Test Patents US: US20160287134A1 SG: 11201604079 10
  • 12. Copyright Medergo Private Limited © All rights reserved Commercialization plan Clinical Trials Feasibility study Clinical trial Q3 2017 Q1 2018 Q3 2018Today $40,000  Biocompatibility  Electromagnetic compatibility Usage of funds SGD Consumables and equipment $30,000 Consultancy $10,000 $300,000 $500,000 Beta Prototype & Bench Test Cadaver Trials 11
  • 13. Copyright Medergo Private Limited © All rights reserved Financials Q2 2017 Q3 Q4 Q1 2018 Q2 Q3 Q4 IP Consultancy $5,000 $30,000 DFM Consultancy (QMI) $5,000 QMS ISO 13485 (QMI) $6,000 Regulatory consultancy – CE/ HSA $2,000 $20,000 Regulatory consultancy – FDA (510K/PMN) $2,000 $20,000 Manpower cost Engineering x 1 ($60,000) Clinical x 1 ($45,000) Engineering x 2 ($120,000) Clinical x 1 ($45,000) Manufacturing cost $10,000 $20,000 $50,000 Bench test  ISO 10993 (Biocompatibility)  IEC 60601:2005/2006/200 7 (Electromagnetic compatibility) $10,000 Animal/Cadaver trials  Ex-Vivo  In-Vivo $30,000 Clinical trial  Feasibility study (n=10) $100,000 Clinical trial  Stage 2 (n=20) $200,000 Go to market 1 - SG $10,000 $20,000 Funding NUS/NTU Jumpstart ($30,000) TECS POC ($250,000) TECS POV ($500,000) Founders full time 1st Revenue 12
  • 14. Copyright Medergo Private Limited © All rights reserved Thank you Contact Us: Warren (Co-founder, Biz Dev) +65 8363 9525 warrenstanlee@u.nus.edu