Team 10 - Team IGI TechLessons Learned

Total In person Video Chat Phone

102 53 6 43

Interview count (~11 a week)

Product: Laparoscopic image fusion box that works with a surgeon’s existing lap camera and ultrasound.

Total Available Market - Every operating room in the U.S.

Served Available Market - Every OR equipped for minimally invasive surgery (MIS)

Target - Thoracic Surgeons in the U.S.

$250M

$1B

$2B

IGI Technologies TeamPrincipal Investigator Raj Shekhar, PhD

Industry ExpertMark Chandler, MBA

EntrepreneurWilliam Plishker, PhD

● Principal investigator within the Sheikh Zayed Institute for Pediatric Surgical Innovation

● Focuses on clinically driven innovation

● 15 years of experience as a serial innovator of medical and surgical imaging technologies

● Two of his prior inventions have led to commercial products.

● CEO of IGI Technologies

● Builder and leader of startups, converting academic research into real-world products.

● 3 Different Silicon Valley startups as an engineer and marketer

● Mayfield Fellow

● Early stage medical device investor

● Expert in commercializing intellectual property (IP)

● Founder of Upstream Partners

● CEO of TAO Lifesciences

1st Business Canvas - what we thought

First Business Canvas - what we thought

So here’s what we did:

Experiment: Talk to a wide variety of lap surgeons outside of home institution

Insight: Very first interview, many lap surgeons do not have ultrasound, and do not want it.

We talked to surgeons - and learned we didn’t know them as well as we thought

Products/ servicesOverlay ultrasound on lap field of view

Guidance of ablative tools

Gain creators

Get to target more reliably than standalone ultrasound

Get to target faster than standalone ultrasound

Find targets

Pain relieversSingle display

Lower technical difficulty

Reduce risk of complication

Customer Job(s)Lap surgery -- ablation/resection

Pre-procedure -- diagnose

Post procedure patient monitoringOften no task for ultrasound

Gains

Belief in better patient care

More confidence in complete treatment

More lap target identification, less open surgeon

Faster procedures

PainsMental correlation across two screensUnfamiliarity with ultrasoundSteep learning curve

Complication risk

Surgeon Value Propositions Surgeon Pains/Gains

We refined surgeons into customer segments… and value propositions

Field High volume

procedure

core need currently uses lap

ultrasound

Does NOT use robot

Urology partial neph See target and vessels (fast, sans radiologist, mobile)⇒ do more laps (vs. open)

✔

Gynecology hysterec-tomies

See the ureter ⇒ fewer complications

no, but can read it

✔

Oncology liver resections/ ablations

See the target with ablation needle critical sections⇒ fewer readmissions

✔ ✔

Thoracic ? lesion location in collapsed lung⇒ less invasive (more laps, no hand port)

no ✔

Business Canvas Iteration - CS Refinement

So here’s what we did next:

Experiment: Talk to urologic surgeons (and oncologic, gynecologic, thoracic)

Insight: Good feedback on MVP from urologists, but thoracic presented as an even more compelling opportunity.

We kept talking to surgeons - and found patterns in thoracic surgery

Pains - Disorienting- Hour-long search“Would do anything to localize tumors minimally invasively”

We kept talking to surgeons - and found patterns in thoracic surgery

Pains - Disorienting- Hour-long search“Would do anything to localize tumors minimally invasively”

50-100 cases a year at academic hospitals⇒ $250M market opportunity

Customer segments - what we learned (# of people overall supporting)

High volume procedure

core need uses lap ultrasound

Does NOT use robot

Urology partial neph See target and vessels ⇒ do more laps (vs. open) ✔

Gyn hysterectomiesendometriosis?

endomet surgery is sensitive to depth⇒ provide real-time depth (1mm accuracy) to prevent uterus punctures (2)

no, and most (3) can’t

justify port

small but growing

Oncology focus on ablations

Losing cases to interv rads (9)⇒ tool nav in lap ablation is hard, we would track everything in one place

✔ ✔

Thoracic VATS for primary lung lesions

lesion location in collapsed lung⇒ less invasive (more laps, no hand port), easier workflow (no fiducials), organ sparing, find smaller nodules,⇒ no reliance on interv rad (12)

no, but willing to learn (10) limited

Business Canvas - Thoracic Pivot

KR

KA

KP

There were many other learnings...Luminary Surgeon

(KOL)

Ultrasound Company

Lap camera company

Software Devels OR AccessAPIs

Training Curriculum Enhancement

Lap Ultrasound Visualization Studies

Integration Refinement

CR - GET

Youtube

Publications

Conference Presentations

CS

Society Courses

Centers of Excellence

Surgeon

OR Mngr

Value asmt

commApp form & pres support

Proforma Financials

Admin council

Tech assmnt

committee

Youtube

Publications

Conference Presentations

Society Courses

Centers of Excellence

App form & pres support

Proforma Financials

InterestConsideration

Purchase

Awareness

Booth

Installation at luminary

sites/KOLs

Support

KeepTrack other tools

Use other camera/

ultrasound

UnbundleUpsell

Advanced Viz:Vessel seg

Advanced Viz:3D recon

Cross Sell

Other surgeons (thoracic, urologic,

oncology, gyn)

Referrals

Academic hospitals

Main-stream

hospitals

US comps

Co-sales

IGI Tech

surgns

Tracking company

OR Mngers

VAC

equipment supply contract

hospital

profit, etc.

disposab lmarkers

profit, etc.

disposable markers

… and we are in a better position than ever for commercializationPivot: Away from urology to thoracic

Customer Segments: Primary - Thoracic Secondary - Urology, Gynecology, Oncology

U.S. Market Opportunity: $250 Million

102 Interviews:55 Surgeons 6 Radiologists10 Surgical support10 Hospital administrators 5 Ultrasound company officials 3 Robot company officials 2 Tracking company officials 4 Regulatory, reimbursement, IP specialists 7 Misc

info@igitechnologies.comwww.igitechnologies.com

Product: Thoracic surgeons find small-cell carcinoma lung nodules twice as fast without preoperative preparation.

1st Business Canvas - what we thought

Business Canvas Iteration - CS Refinement

Business Canvas - Thoracic Pivot

With respect to submitting an SBIR/STTR Phase II application, we are making thefollowing decision (PICK ONE)

● Go with a nominal pivot: The feasibility data generated in the Phase I grant provide the appropriate technical foundation for a Phase II application, AND we are largely targeting the customer segments that we had originally anticipated*

● Go with a significant pivot: The feasibility data generated in the Phase I grant provide the appropriate technical foundation for a Phase II application, BUT we are targeting very different customer segments than we had originally anticipated

● No Go: We do not have a product/market fit that supports the continuation of this project in its current form, and/or we have made substantial pivots to the business model that require us to obtain additional technical feasibility data that should more appropriately be pursued under a new Phase I grant (or other R&D grant)

● No Go: We plan to continue pursuing this project, but we intend to finance this project through other non-federal sources (e.g., venture, strategic partner, etc)

*we view our thoracic segment as a refinement of our existing plan, and pivot within the course

Start

Current

IRL = 6 (soft)(we have mostly validated 4-6)