colon patch

© Copyright Lean LaunchPad Singapore. All Rights Reserved.

A Surgical Sealant for Anastomosis LeakageAjith Isaac

David NgEe Bin LiewGary AngSamarth BhargavaShawn Xiang GaoRidzuan Farouk*

*Principle Investigator

BioRidge

© Copyright Lean LaunchPad Singapore. All Rights Reserved. 2

Value Proposition

A fast and effective way to prevent post-op anastomosis leak (AL)


-Reduce risk of anas-tomotic Leakage

-Improve healing rate

-Lower Risk of re-surgery

-Ease-of-use, versatile

Surgeons

Patients

Nurses

face-to-face meetings

academic conference stalls

road show demos

Publications and conference posters

Technical assistance

Generating Clinical data

-SOPs for synthesis of adhesives and additives (antibiotics, healing factors)-Animal experiments, clinical trials-Regulatory approvals-Clinical adoptability

-IP-materials science exp-Bioengineers

Universities

Hospital Colorectal Department

Suture/Staple manufacturers

Nurses

-Sale of product-technology license and product license-Government subsidy

Animal testing and clinical trialsCost for making the delivery medical deviceClinican trainingChemical Pre-cursorsLabor Cost

Initial Business Assumptions


Key IntervieweesClinicians• Ridzuan Farouk, Dept. of Colorectal Surgery, NUH• Alfredo Franco, General Surgery, NUH• Clement Chia, General Surgery, KTP Hospital• Wu Qiang, Shenyang Chest Hospital• Dr. Yang, China Medical University Hospital• Lawarence Ho Khek Yu, NUH• Sharon Koh ZL, NUHScientists• Chooi Kum Fai, Preclinical Research & Drug Dev.,TP• Zhang Pengchi, Biotechnology, TP• Patel Kadamb, Biosensors, TP• TAN ENG LEE, Biomedial Center, SP• Pastorin Giorgia, Dept. of Pharmacy, NUSHCPs• Ma Yuntao XNY Medical, Medical Disposables & equipments• Sales Rep, KXBD, Stapler Manufacturer• Joyce Wang, Alton, Medical Equipments• Jina Ha, BNR Endoscopic Surgical Instruments• Former New Zealand Health Ministry Official• Ding Ding, Changi General Hospital, Nurse

4 Colorectal Cancer Patients


Overview of Interviews

Customer segments

Very interested Nice to have Not

interestedSurgeons /

DoctorsTotal=15

5 (Colorectal)

10 (General) -

PatientsTotal=4

- 3 1

HCPsTotal=20

2 14 4

NUMBER OF INTERVIEWS: 39


-Reduce risk of anas-tomotic Leakage

-Improve healing rate

-Lower Risk of re-surgery

-Ease-of-use, versatile

Surgeons

Patients

Nurses

KOL/MSL/Distributors

Surgeons

Direct Sales

Publications and conference posters

Technical assistance

Generating Clinical data

-SOPs for synthesis of adhesives and additives (antibiotics, healing factors)-Animal experiments, clinical trials-Regulatory approvals-Clinical adoptability

-IP-materials science exp-Bioengineers

Universities/Polytechnics

Hospital Colorectal Department

Suture/Staple manufacturers

Nurses

-Sale of product-technology license and product license-Government subsidy

Animal testing and clinical trialsCost for making the delivery medical deviceClinican trainingChemical Pre-cursorsLabor Cost

After 10 weeks…


Key Learning Points

• Surgical adoptability is THE key factor• No MVP for our device, the product has to be

effective and safe from the beginning • R&D of Medtech product takes >3 years• We have a well-defined market segment


AHA! Moments

• >100 companies manufacture ‘copycat’ medical devices in the surgical stapler sector alone

• Globally, 2-3 groups are working on the same problem (AL)

• AL is indeed an unmet medical need• Stapler companies are stuck with legacy products =

limited innovation


Institutes / Academia

• Chemistry Innovation• Research and Development• Provide animal platform for preclinical testing• Train Students and Technicians A safe and

effective surgical product

Hospital • Full support from Dept. of Colorectal Surgery• Patient samples and grant application support

Key Partners

Build collaboration framework


Our endpoint users What they said..

SurgeonsVP: Effective, Safe, Fast, Adoptable

• AL happens erratically and no current solution• Has to be bio-degradable; abscess should no form

post-application

PatientsVP: Effective, reimbursable

• Stoma bag interferes with daily life and reduces Quality of Life

HCPsVP: Sustainable • Should consider sustainable development (other

revenue streams)

Customer Segments


Competitor Analysis

11

Spee

d an

d ea

se o

f use

Effectiveness* $= cost per unit

Circular Staplers

All Sutures

*Grey out, not available in the market

$$$

$


Competitor Analysis(+Colon Patch)

12

Spee

d an

d ea

se o

f use

Effectiveness* $= cost per unit

Circular Staplers

All Sutures

*Grey out, not available in the market

$$$

$

Colon Patch

Colon Patch

+

+


Market Opportunity

• Average cost per Colorectal Surgery: US$ 25,000• Number of Surgeries a year: 1.1 million• Colon Patch is to be used as a prophylactic in every

surgery


Next Steps

Human Trials

(Mar 2020)

Regulatory approvals

(Nov 2020)

Marketing (Dec

2020)

Proof of ValueFunding: PoV Grant, ONEstart OBR,

Tech Incubator Scheme

MarketEfficacy Pilot

Study(Nov 2019)

Proof of ConceptFunding: Practicum Grant,

PoC Grant; SMART

Improving Synthesis & Adhesion (Nov 2017)

Animal Efficacy Studies

(Jul 2018)

Delivery system

(Nov 2017)

Patents(Nov 2018)

• Raising SGD 500k to complete the Proof of Concept stage at 30k burn pm


Team

Shawn GaoPhD - NUS Medicine

Ajith AmrithrajPhD - NUS Medicine

Dr Ridzuan FaroukSenior Colorectal Surgeon

Ee Bin LiewIndustry Mentor

• Dr Gary Ang, Epidemologist, NHG• David Ng, Biomed Engineer• Dr John Kuang, Materials Scientist, IMRE,

A*Star• Dr Hongye, Materials Scientist, IMRE,

A*Star• Andriana Justine, Industrial Design, NUS• Samarth Bhargava, PhD Chemistry, NUS

Potential Collaborators:• Dr Giorgia Pastorin, Pharmacy, NUS• Animal Facility, Temasek Polytechnic• Biomedical Research Centre, Singapore

Polytechnic

colon patch

Health & Medicine