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1
TM
2
PROJECT
EsoGlove
JUMPstart-ECD Program
Stage1 Presentation (73 interviews in LLP, Total 110+ interviews)
• A collaborati...
3THE NEED
Regaining Functionality of Impaired Hand
Difficulty of Performing
functional tasks
- Demoralising
At Home
(Court...
4Every year, 17 million people
worldwide suffer a stroke.
5
THE CHALLENGES
Hospital
Limited manpower & productivity
Existing Solutions
Adopting robotic solutions to
improve product...
6
THE APPROACH
A product that is
• Easily Wearable
• Affordable
• Portable (<1kg)
• Translatable from in-clinic use to hom...
7
EsoGlove
Features
• Soft Actuation Technology
• Wearable & Lightweight
• Portable Control System
• Programmable Actions
...
8
ADVANTAGES OVER CURRENT SOLUTIONS
Hospital & Occupational Therapists
• Automated solution with higher repetition & inten...
9
COST – BENEFIT ANALYSIS
Benefits
> 20% improvement in productivity
(treat at least 20% more patients)
>$48,000/yr
Genera...
10
VALIDATED CLINICAL NEED
We do not have any
equipment that helps
patients exercise their
limbs and then allows at
home u...
11
COMPETITION
EsoGlove
Hand of Hope
Saebo Glove
Light Weight, Portability, Wearability
Supported Movements,
Functional Ta...
12
COMPETITION
Lateral Tripod GraspSpherical Grasp Key PinchPower Grip Cylindrical Grip
Critical Movements for Functional ...
13
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 ...
14
Key
Partners
• Manufacturers &
Components
Suppliers
• Health insurance
companies
• Hospitals
• Telemedicine
platform
Ke...
15
DEVELOPMENT STATUS
• Prototype Technology Readiness Level:
6
• Device Manufacturing:
IPTEC
• Intellectual Property:
3 P...
16
PATIENT TRIALS
Significant Improvement
in Functional Tasks
Feedback:
Patients like it!
17
REGULATORY PATHWAY
QMS Implementation
CE
HSA
Regulatory
Documentation
FDA CFDA
18
REGULATORY PATHWAY
EsoGlove
Europe: Class IIa, Rule 9
Medical Device Directive 93/42/EEC (MDD), EN-ISO std.
Singapore: ...
19
REGULATORY PATHWAY
Class II, 890.1375, EMG-triggered powered exercise equipment
(Diagnostic electromyograph), OAL
Class...
20
KNOWLEDGE GAPS
QMS Implementation
Regulatory
Documentation
Reimbursement
Strategy
Associated Risks
• Backlog, causing d...
21
TRACTION & MILESTONES
Jan 2016 – EsoGlove was featured in more than 22 local and 25 international media reports
More th...
22
HELP & RESOURCES
• Funding: Entrepreneur Project Fund (S$20,000)
 Equipment (3D printer) & consumables for rapid proto...
23
rocesotech.com
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Roceso Technologies

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Our technology is a novel soft robotic glove that can be controlled through on-box buttons, a mobile app, residual muscle activity or a sensor glove to trigger robot-assisted hand movement to the affected hand, so as to facilitate performance of rehabilitative and activities of daily living.

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Roceso Technologies

  1. 1. 1 TM
  2. 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. 3. 3THE 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
  4. 4. 4Every year, 17 million people worldwide suffer a stroke.
  5. 5. 5 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
  6. 6. 6 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 tasks in rehabilitation • Serves as assistive device
  7. 7. 7 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
  8. 8. 8 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)
  9. 9. 9 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)
  10. 10. 10 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
  11. 11. 11 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
  12. 12. 12 COMPETITION Lateral Tripod GraspSpherical Grasp Key PinchPower Grip Cylindrical Grip Critical Movements for Functional Tasks (Image Courtesy: Rejoyce)
  13. 13. 13 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.
  14. 14. 14 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)
  15. 15. 15 DEVELOPMENT STATUS • Prototype Technology Readiness Level: 6 • Device Manufacturing: IPTEC • Intellectual Property: 3 Patent-Pending • Patient Testing: 7 Patients
  16. 16. 16 PATIENT TRIALS Significant Improvement in Functional Tasks Feedback: Patients like it!
  17. 17. 17 REGULATORY PATHWAY QMS Implementation CE HSA Regulatory Documentation FDA CFDA
  18. 18. 18 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
  19. 19. 19 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)
  20. 20. 20 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
  21. 21. 21 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
  22. 22. 22 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
  23. 23. 23 rocesotech.com

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