A smart enteral feeding system with integrated reflux monitoring and prevention. The system comprises of both proprietary hardware and software. A feeding tube (LifeSafe Tube™) with embedded sensors collects data continuously. Proprietary algorithms analyze the collected data, weighing multiple risk factors such as patient position and physiological functions (ie: sneezing, coughing) to predict when reflux will occur. This information is used to automatically calibrate a feeding pump and optimize feeding rate in order to prevent reflux.

1. 1
TM

2. 2
PROJECT
EsoGlove
JUMPstart-ECD Program
Stage1 Presentation (73 interviews in LLP, Total 110+ interviews)
• A collaborative NUS/NTU Joint University Medtech Commercialization Program
PI: Dr Raye Yeow, NUS, Biomedical Engineering
Team: Jane Wang, Hong Kai Yap, Tiana
Commercial Champion: Vijay Kumar
A soft robotic glove designed to help patients regain lost hand functions

3. 3THE NEED
Regaining Functionality of Impaired Hand

4. 4THE NEED
Regaining Functionality of Impaired Hand
Supervision of rehabilitation
with occupational therapists
- Labour Intensive
(Courtesy of https://www.youtube.com/watch?v=gP_e6uR9LoY&t=50s
https://www.youtube.com/watch?v=1bRkddWvyUM
In Hospital& Clinic
Over 60% of stroke
patients are still
struggling to achieve
full hand recovery

5. 5THE NEED
Regaining Functionality of Impaired Hand
Difficulty of Performing
functional tasks
- Demoralising
At Home
(Courtesy of https://www.youtube.com/watch?v=gP_e6uR9LoY&t=50s
https://www.youtube.com/watch?v=1bRkddWvyUM
Supervision of rehabilitation
with occupational therapists
- Labour Intensive
In Hospital& Clinic
Over 60% of stroke
patients are still
struggling to achieve
full hand recovery

6. 6Every year, 17 million people
worldwide suffer a stroke.

7. 7
THE CHALLENGES
Hospital
Limited manpower & productivity
Existing Solutions
Adopting robotic solutions to
improve productivity
Occupational Therapists
Increasing clinical load
Patients
Cannot perform functional tasks
Not motivated during therapy
Challenges
Group session
Rely on family
members/caretakers
Limitations
• Limited to clinical use only
(Bulky, Size Constraints)
• Intimidating to wear
(Rigid components)
• Long setup time
(>10min, 30% of visit)
• Less Affordable
• Do not support functional
tasks

8. 8
THE APPROACH
A product that is
• Easily Wearable
• Affordable
• Portable (<1kg)
• Translatable from in-clinic use to home
EsoGlove
And Most of all it
• Supports functional task in
rehabilitation
• Serves as assistive device

9. 9
THE APPROACH
Features
• Soft Actuation Technology
• Wearable & Lightweight
• Portable Control System
• Programmable Actions
EsoGlove

10. 10
EsoGlove
Features
• Soft Actuation Technology
• Wearable & Lightweight
• Portable Control System
• Programmable Actions
Intended Use
Functional tasks during
ADLs and rehabilitation
Continuous passive
hand mobilization
THE APPROACH

11. 11
ADVANTAGES OVER CURRENT SOLUTIONS
Hospital & Occupational Therapists
• Automated solution with higher repetition & intensity
(240-720reps/session) vs OT-assisted therapy (<200reps/session)
• Increased portability
(<1.5kg)
• Lower space constraint
(<1m3)
• Easily wearable, reduces setup time
(<3min)
Patients
• Assist with functional tasks
during therapy session/at home
(grasping bottle, holding pen)
 Increase Patients Motivation
• Allow at-home therapy
(240-720reps/hr)

12. 12
COST – BENEFIT ANALYSIS
Benefits
> 20% improvement in productivity
(treat at least 20% more patients)
>$48,000/yr
Generate revenue through rental
S$900 per patient
Hospitals Patients
>3x improvement in patient
functional outcome with robotic
solution after 6 months
>6x more at home therapy time
(Higher Intensity, Faster
Recovery
Costs
Initial Setup Cost (~$5000/set)
Maintenance Cost (~$500/yr)
Training Cost (~$100/hr)
Component Replacement Cost
(~$100/glove)

13. 13
VALIDATED CLINICAL NEED
We do not have any
equipment that helps
patients exercise their
limbs and then allows at
home usage. I cannot
wait to see this device
available in hospital
My left hand would
benefit from your
device. It helps me with
my grip function. I have
a keen interest to see
this succeed
I have to help my
husband exercising his
hand at home. This
device is extremely
useful to us!
Dr Lim Jeong Hoon,
Neurologist, NUH
Anthony
Quadriplegic
Patient
Mrs Yap
Family member of stroke
survivor
• 100+ Interviews with Clinicians, Occupational Therapists, Caregivers and Patients
• >20 enquiries (purchase interest from hospitals, distributor interest, participate in trial,
online enquiries from patients,)
With the robotic
automation, we see 20%
more improvements in
the upper limb functions
of patients. We can also
serve 20% more patients
Mr Chan
Dpty Director, Rehab Division
St Lukes Hospital

14. 14
BENEFIT JUSTIFICATION
Benefits
> 20% improvement in productivity
(treat at least 20% more patients)
>3x improvement in patient
outcome with robotic solution
>6x at home therapy time
Productivity
1 OT  8 patients/day  30-45min/patient/session
Hand Passive Mobilization: 8min/patient (Assumption)
1 OT  8 patients * 8min saved = 64min/day ~> 1.5-2 more patients
~seeing 20% more patients
At least 20% more patients
One day original 10 patients treat 2 patients more
1 patient cost per session 100  200/day 1000/week  4000/mth  48K/yr
Patient Outcome (Clinical Evidences)
With robot-assisted fingers training, the patients achieved 3x improvement in finger individualization
index (fine movement control) after 20 sessions. (Efficacy of robot-assisted fingers training in chronic stroke survivors:
a pilot randomized-controlled trial, 2015)
Feasible in recovering fine manual dexterity and strength and reducing arm disability in sub-acute
hemiplegic patients. Achieved at least 4x improvements in all clinical measurements. (Feasibility and
efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: A randomized pilot controlled study)
Assume patient originally 6 months, now take 2 month to recover.
4 months  48 session  $4800/patients
At Home Therapy Time
Patients don’t do exercise at home. Assuming at most 10min per day
Hand Passive Mobilization: 1hr per day  >6x at home therapy time

15. 15
COMPETITION
EsoGlove
Hand of Hope
Saebo Glove
Light Weight, Portability, Wearability
Supported Movements,
Functional Tasks
Gloreha
RAPAEL
Unique Soft Robotic Technology
Light Weight (<1kg)
Do not require precise alignment
• Fast setup time (<3min)
Support functional tasks
• Rehabilitation therapy
• Activities of daily living
Mass Producible – Low Cost
800g, 10min 100g, 3min
>5
2
1
0

16. 16
COMPETITION

17. 17
COMPETITION
Light Weight, Easily Wearable
(<120g, Setup Time < 3min)
Support Functional Tasks
Portable (<1.5kg, <1m3)
Mass Producible &Low Cost

18. 18
COMPETITION
Lateral Tripod GraspSpherical Grasp Key PinchPower Grip Cylindrical Grip
Critical Movements for Functional Tasks
(Image Courtesy: Rejoyce)

19. 19
THE MARKET
TAM
S$4.5
Billion
SAM
S$450
Million
Target
Market
S$17.5
Million
Target Market – SG and China
S$5,000 x 150 target customers x 10 per customer +
S$100 x 100,000 patients = S$17,500,000
Rehabilitation and Wearable Robots Market:
• US$257.9 million in 2015  US$3.2 billion by 2021
(CAGR: 52.15%)
• Huge opportunity for launching a homecare equipment
• Countries like China with a large number of aging population is
expected to drive the market.
21% of global population will be 65 year old and
above by 2050
~Three-quarters of all strokes occur in people over
the age of 65.

20. 20
Key
Partners
• Manufacturers &
Components
Suppliers
• Health insurance
companies
• Hospitals
• Telemedicine
platform
Key
Activities
• QMS, Regulatory
Approval and
Certification (ISO,
CE, HSA, FDA,
CFDA)
• User Trials
• Technology
development
Value
Propositions
• Assist with functional
tasks during ADLs &
Rehab
• Improved productivity
(treat 20% more patient)
• Product wearability &
portability
(<5min setup time,
<1.5kg)
• Low-cost (~$5K-10K)
Customer
Relationships
• Conferences and
seminars (MFA,ACRM)
• Publications in clinical
journals (APMR,JNER)
• Recommendation from
health professionals;
Customer
Segments
• Hospitals with rehab
department
• Patients undergo
neurological/
orthopaedic rehab
Key
Resources
• Intellectual property
(Technology
Platform)
• Manpower (R&D,
Sales Headcount)
Channels
• Direct sales;
• National and international
distributors;
• Retail stores and
ecommerce platform
Cost Structure
• Certifications and Regulatory Approvals
• Intellectual Property – application, licensing, renewal
• R&D, Clinical Trials
• Recurring Cost (Manpower, Logistics, Sales, Manufacturing)
Revenue Streams
Recurring Revenue
• Maintenance & Services (~$1000/yr)
• Replacement of Parts (~$100/glove)
One-Time Revenue
• Per Unit Sales
(~$5000)

21. 21
REVENUE MODEL
B2B (Corporate Clients)
Hospitals
Rehabilitation Centers
Direct/Distributor Sales
• Recurring Revenue
• Actuator/Glove Replacement
• System Maintenance
Patients
Device RentalRental and
cleaning fee Device and
accessary sales

22. 22
DEVELOPMENT STATUS
• Prototype Technology Readiness Level:
6
• Device Manufacturing:
IPTEC
• Intellectual Property:
3 Patent-Pending
• Patient Testing:
7 Patients

23. 23
PATIENT TRIALS
Significant Improvement
in Functional Tasks
Feedback:
Patients like it!

24. 24
REGULATORY PATHWAY
QMS Implementation
CE
HSA
Regulatory
Documentation
FDA CFDA

25. 25
REGULATORY PATHWAY
EsoGlove
Europe: Class IIa, Rule 9
Medical Device Directive 93/42/EEC (MDD), EN-ISO std.
Singapore: Class B, Rule 9 (i)
GN-13-R1.1 Guidance on the Risk Classification of General
Medical Devices

26. 26
REGULATORY PATHWAY
Europe: Class IIa, Rule 9
Medical Device Directive 93/42/EEC (MDD)
• Compile a medical device CE Marking Technical File
with evidence of compliance to the medical devices
Directive
• Receive a medical device CE Mark certificate from a
Notified Body
• Appoint a European Authorized Representative if no
physical location in Europe.
• Register medical devices with the EU Competent
Authorities, where applicable.
Technical File
show evidence of compliance of the applicable MDD,
consider applying ISO 14971 for risk management, and
any other applicable standards
• Bench Testing Requirements and Standards
• Clinical Evaluation Reports

27. 27
REGULATORY PATHWAY
Singapore: Class B, Rule 9 (i)
GN-13-R1.1 Guidance on the Risk Classification of General Medical Devices

28. 28
REGULATORY PATHWAY
Class II, 890.1375, EMG-triggered powered exercise equipment
(Diagnostic electromyograph), OAL
Class I, 890.5380, Powered Exerciser (Powered Exercise Equipment),
product code BXB
Class I, 890.3475, Support, Arm (Limb Orthosis), product code IOY
Class I, 890.3475, Orthosis Limb Brace (Limb Orthosis), product code
IQI
Class I, 890.5410, Powered finger exerciser
Class I, 890.5380, Powered Exerciser (Powered Exercise Equipment),
product code BXB
Class I, 890.3475, Orthosis Limb Brace (Limb Orthosis), product code
IQI
Predicate: Myomo (FDA Class II)
Predicate: SaeboGlove (FDA Class I)
EsoGlove
US: FDA (PART 890 - PHYSICAL MEDICINE DEVICES)
510k Exempt, Registration & Listing, 21 CFR Part 801 (Labelling) and 820 (QMS)

29. 29
REGULATORY PATHWAY
US: FDA (510k, Premarket Notification)
The basic regulatory requirements that manufacturers of medical devices distributed in the U.S most comply with are:
• Establishment registration
• Medical Device Listing
• Premarket Notification 510(k),
• Investigational Device Exemption (IDE) for clinical studies
• Labelling requirements, and
• Medical Device Reporting (MDR)
Manufactures from domestic and foreign and importers of medical devices must register their establishments with the FDA and
pay an establishment registration fee. All establishment regulations must be submitted electronically unless a waiver has been
granted by FDA. All registration information must be verified annually. In addition to registration, foreign manufacturers must also
designate a U.S agent.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed has safety and efficacy, that is
substantially equivalent, to a legally marketed device that is not subject to PMA. Submitters must compare their device to one or
more similar legally marketed devices and make and support their substantial equivalency claims. A legally marketed device is a
device that was legally marketed prior to May 28.1976, for which a PMA is not required, or a device which has been reclassified
from Class III or Class I, or a device which has been found substantially equivalent through the 510(k) process. The legally
marketed devices to which equivalence is drawn is known as the “predicate device” or “Predicate”.

30. 30
REGULATORY PATHWAY
China: CFDA
As part of its regulatory clearance process, the China Food and Drug Administration (CFDA) requires
certain types of medical devices undergo clinical trials in China prior to granting certification. While the
CFDA (CFDA Order 153) classifies devices into three risk-based categories similar to the FDA in the US,
individual devices may be classified differently in China. Similarly, China's definition of predicate device is
stricter than that used by the FDA in the 510(k) clearance pathway. The CFDA classifies Medical Devices
into three categories according to their respective risk potential:
Class I Medical Devices are those for which safety and effectiveness can be ensured through routine
administration.
Class II Medical Devices are those for which further control is required to ensure their safety and
effectiveness.
Class III Medical Devices are those which are implanted into the human body, or used for life support or
sustenance, or pose potential risks to the human body, and thus must be strictly controlled with respect to
safety and effectiveness.
Manufacturers of Class II and III medical devices are required to demonstrate that the device has been
approved by the country of origin with documents like a CE certificate, 510(k) letter and PMA approval and
compliance with ISO 13485, and may be required to submit clinical data in support of their application. In
addition to these requirements, all medical device manufacturers must also include product information in
Chinese on all packaging and labelling, as detailed in CFDA Order No. 64.
Finally, manufacturers exporting medical devices to China must appoint several China-based agents to act
on their behalf. These include a registration agent to coordinate the CFDA registration process, a legal
agent to handle any adverse events reported with a registered device, including a product recall, and an
after sales agent to provide technical service and maintenance support.

31. 31
REGULATORY PATHWAY
China: CFDA
接 触 人 体 器 械
有源医
疗器械
使用状态
使用形式
轻微损伤 中度损伤 严重损伤
1
能量治
疗器械
Ⅱ Ⅱ Ⅲ
2
诊断监
护器械
Ⅱ Ⅱ Ⅲ
3
液体输
送器械
Ⅱ Ⅱ Ⅲ
4
电离辐
射器械
Ⅱ Ⅱ Ⅲ
5
植入器
械
Ⅲ Ⅲ Ⅲ
6
其他有
源器械
Ⅱ Ⅱ Ⅲ
Powered device with contact with
human body. Light damage to
human when out of control

32. 32
KNOWLEDGE GAPS
QMS Implementation
Regulatory
Documentation
Reimbursement
Strategy
Associated Risks
• Backlog, causing delayed of
successful QMS implementation
• Additional costs incurred in
product design with unclear
design inputs, standards
compliance
• Delayed in regulatory approval
• Delayed in reimbursement
• Commercial Failure

33. 33
TRACTION & MILESTONES
Jan 2016 – EsoGlove was featured in more than 22 local and 25 international media reports
More than 20 enquiries from the public (purchase interest, participate in trial, online enquiries)
Jun 2016 – Pilot Patient Feasibility Trial in NUH
Sep 2016 – Obtained Exclusive License with NUS
Oct 2016 – IPTEC Manufacturing of alpha prototype commenced
Dec 2016 – Patent National Phase Entry
Mar 2017 – Received Alpha Prototype of Control Box

34. 34
HELP & RESOURCES
• Funding: Entrepreneur Project Fund (S$20,000)
 Equipment (3D printer) & consumables for rapid prototyping/refinement of actuators/components (Design for
manufacturing) (S$5,000)
 To engage contract manufacturer for beta prototype manufacturing after refinement (TRL:7) (S$10,000)
 Product demo video for fund raising (S$5,000)
Start EsoGlove Lite Prototype
Design and Manufacturing
' 17 Jan
2017
Feb Mar Apr May Jun Jul ' 17
Glove and control box
prototype – 2 sets
Prototype design
and manufacturing
Discuss Clinical Trial
Partnership
QMS Preparation
EPF: $20,000 funding
Jumpstart
Stage 1
QMI: $20,000
Start Next Clinical Trial
Establish QMS
• Equipment & material –
3D printer - $5,000
• Prototype refinement
(TRL:7) and production -
$10,000
• Product Video - $5,000

35. 35
HELP & RESOURCES
Item Budget
QMS Implementation 20,000
Regulatory Approval (CE, HSA) 30,000
Prototyping Services 50,000
Manufacturing 35,000
Material and consumables 15,000
IP Licensing & Filling 50,000
• Funding
 Equipment (3D printer) & consumables for rapid prototyping/refinement of actuators/components (Design
for manufacturing) (S$5000)
 To engage contract manufacturer for beta prototype manufacturing after refinement (S$10000)
 Product demo video for fund raising (S$5000)
 To cover the IP licensing and national phase filling cost – 50K (not covered by Jumpstart)
• Consultancy services
 To guide us on QMS documentation and implementation in order to be ISO 13485 certified
 To guide us on the regulatory process to obtain CE, HSA approvals
EPF
~20K

36. 36
MARKET AND TECHNOLOGY ROAD MAP
Platform Technology
Products
Value-added Features
Target Groups
Geographical Markets
Additional IPs
Hand Wrist Arm Ankle Knee
Gamification Platform TelerehabSensor-Enabled
Soft Robotics
Stroke
Spinal Cord
Injury
Brachial
Plexus
Injury
Muscular
Dystrophy
Orthopaedic
Singapore China EU US ROW
BCI

37. 37
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