Medical device for cervical cancer

1. An integrated solution to identify & treat cervical pre-
cancers in a single-visit in low resource outpatient settings
Submitted by Vaishnavi G V S & team
In 18 months - A comprehensive low-cost human testable
device to ‘screen & treat’ cervical precancers in a single
OPD visit.
> 1 Lakh women affected
> 60,000 lives lost p.a
70% screened +ve patients
lost to follow up
Colposcope, Ablation
devices – current Dx & Rx
• @ THC
• Costly, infra intensive,
not OPD friendly
Neighbourhood
gynec doesn’t have
Dx & Rx devices
- Our target
customer
- 20,000 gynec,
CHC/DH
become target
customers
- 1.2cr CIN lost
now treated
- 1300cr market

2. The proposed solution
Technical Details (1/2)
One stop solution for Cervical Precancers
Diagnosis:
15x magnification
White/Green light
Handheld
Treatment:
Plug & play ablation probe
Fits into current management protocol
Current management cycle
Management cycle with our device

3. Technical Details (2/2)
(Or Supporting Evidence/background data)
Single visit See & Treat
Current status of work: POC
Photo of functioning prototype
Evidence for each of these modalities as best:
Diagnosis - magnified visualization -
colposcopy standard but device not suitable
for low resource settings
Treatment - Thermal ablation & cryo standard
line of treatment for low grade CIN , thermal
ablation superior due to multiple reasons but
devices not optimized

4. Team
Dr. Gaurav G
Clinical
Lead
Rakesh Patel
Instrumentation
Lead
Vaishnavi G V S
Business
Lead
Sugat Ingle
Design
Lead
Dr. Neerja
Bhatla
Prof OBG
AIIMS
Dr. Roopa
Hariprasad
Scientist D
NICPR ICMR
Dr. PVM
Rao
HOD Design
IIT-D
Dr. Jay
Dhariwal
Asst. Prof
IIT-D
Dr. Avijit
Bansal
Mentor
SiB
Dr. Sandeep
Singh
Mentor
SiB
Clinical Advisors Design Advisors Business Advisors

5. Novelty
○ Only device that embodies WHO’s see & treat
○ Temperature time controllability- multiple treatment applications
○ only visual guided thermal ablation device
○ Portable suitable for out-patient settings
○ Line of sight display
○ Real time data transfer - specialist consultation
Feasibility
○ State of the art technology – visualization & thermal ablation
○ Proof of equivalence to predicates
IP Strategy
○ Provisional Patent filed
○ Improvement in disease management through integrated solution
○ Full patent and PCT by December 2020
○ FTO study conducted and product can be commercialized without
infringing on competing device patents

6. Asia-Pacific Cervical Cancer Diagnostics and Therapeutics market
USD 811.81 Million in 2019 , CAGR of 6.2% till 2024
Market

7. Competitive Landscape
Benefits Video
Colposcope
Periwinkle
SmartScope
CERVA WiSAP C3 Cryogun Benefits
Single Hand
Operation
✘ ✔ ✔ ✔ ✔ ✘ Quick Procedure
Low Infra Req ✘ ✘ ✔ ✔ ✔ ✘ Low Infra Req
Portability ✘ ✔ ✔ ✔ ✔ ✘ Portability
Line of Sight
Display
✘ ✘ ✔ ✔ ✘ ✘ Visual Guided
Ablation
Cost ₹ 1.5 L ₹ 2 L ₹ 2.5 L ₹ 5 L ₹ 2 L Cost
Diagnostic Options Today Treatment Options Today
In 5 years

8. Define Differentiation of Proposed Solution
○ One-stop diagnosis & treatment solution for out-patient settings
○ Time and temperature controllable ablation probe
○ Low cost, portable, low infrastructure requirement
○ Only visual guided ablation device in the market
Mention what is the Value Proposition
○ In the govt sector- decentralization of cervical precancer management
■ Population screening, deployable at DH/CHC/PHC close to patient
■ Reduces loss to follow up
○ For the patient this results in much shorter management cycle & saving of
wages, prevents disease progression, DALYs saved
○ From the gyne perspective: patients not lost, added revenue stream, skill gain
■ Enables telemedicine and expert consultation
○ Import substitution for Indian medical device industry
○ Deployment in PHCs enables skill gain for healthcare workers & ANMs

9. When do you plan to set up your startup? End of 2020
Have you discussed about your solution with Target Customers? How many
>100,>50,>25,>10,>5, None? What is the feedback?
50 gynaecologists surveyed
○ 88% do not have dx tx devices - pvt clinics
○ 85% feel good investment at 2.5L price point
○ 91% from all feel suitable device for OPD/field use
Have you discussed your solution with business mentor? What is the
feedback?
○ Strong positive feedback and believe our solution will be a scalable
business as it is addressing a pressing need with a large untapped
yet attainable market

10. Projected Time to Hit the Market
3-5 year Road Map
○ Product development first 1-1.5 years
○ Clinical study, predicate equivalence, regulatory 1st to 2nd year
○ Pilot sales from year 3 - 1st year 20 units, 2nd year - 100 units, 3rd year
- 500 units; subsequently expand to other LMICs
○ From 3rd year, R&D for product line expansion
Business Plan
○ Aim to startup by end of 2020 beginning with CERVA as our first low-
cost capital equipment product
○ Target Customer : Gynecologists with their own clinics/nursing homes,
govt health centres like DHs/CHCs/PHCs;
○ Revenue Model : Product sale with B2C and B2G model
Device will be priced at 2.5 Lakh Rupees
BOM estimated at Rs 25,000

11. Funds Received So far
(BIRAC & Non BIRAC)