Digital Light Innovations...Life Sciences Economic Impact on Austin • Dean of Dell Medical School...

Digital Light Hyperspectral Imaging for the Medical Arena

Brian Crowell

May 6, 2014

A Texas Technology Story 9 Years in the Making

Digital Light Hyperspectral Imaging for the Medical Arena

Chronicling the journey of commercializing innovative imaging technology for

A Texas Technology Story 9 Years in the Making

surgical & medical applications

A Joint Texas Entrepreneurial Venture

TX Industry Military

Federal & TX Government

Austin

San Antonio

Plano

Dallas Arlington

Houston

Fort Worth

& Academic Institutions TX Medical Centers

The DLHsi Commercialization Stages

I. The Science & Technology

II. Early Research & Support

III. Clinical Exercises

IV. Entrepreneurship / Eng / Dev

V. Commercialization

Stage I. The Science & Technology

I. The Science & Technology

II. Early Research & Support

III. Clinical Exercises

IV. Entrepreneurship / Eng / Dev

V. Commercialization

Stage I. The Science & Technology

Video: Intro to Hyperspectral Imaging

Dr. Karel Zuzak, P.h.D. – DLHsi Inventor

• Developed Hyperspectral Imaging, Hsi, at the University of Texas Arlington

• Translated Hsi to the surgical and clinical bedside at UT Southwestern Medical Center

• Founded The Laboratory of Biomedical Imaging (LBI) at UTA

Arlington

• By measuring the spectrum of reflected light, the biochemical composition of the tissue can be evaluated

• DLP ® technology has the unique ability to conform light to any desired spectral illumination scheme - Active Illumination

• Real-time mapping & visualization of tissue oxygen levels of a patient 10

20

30

40

50

60 Relative HbO2

DLHsi for Medical & Surgical Utilities

Arlington

DLHsi for Medical & Surgical Utilities

• As expected the tissue oxygenation falls below normal with a tourniquet restricting blood flow to a finger and above normal after removing the tourniquet

Tourniquet In-Place:

58 % HbO2

Tourniquet Removed:

83 % HbO2

Arlington

10

20

30

40

50

60

70

80

90

Percentage HbO

2

82%HbO2

DLHsi Prototype Setup

Texas Instruments DLP® Chip

Arlington

Stage II: Early Research & Support

I. The Science & Technology

II. Early Research & Support

III. Clinical Exercises

IV. Entrepreneurship / Eng / Dev

V. Commercialization

University of Texas at Arlington

Engineering Laboratory Building

Arlington

UTA Chemistry & Science Building

The Laboratory of Biomedical Imaging (LBI)

The Laboratory of Biomedical Imaging

Mission

Bringing Better Health To Everyone by Developing Hyperspectral Imaging for Surgical and Clinical Utilities

Arlington

Texas Congressman Joe Barton

Representative Joe Barton

R-Texas, 6th District

Fort Worth

Texas Congressman Joe Barton

Demonstrating DLHsi to Congressman Joe Barton

• Provided funding to support the translation of medical imaging technology from the research laboratories at UT Arlington to the clinics and surgeries at UT Southwestern Medical Center

• Resulted in building the Advanced Medical Imaging Laboratory on the UT Southwestern campus

• Created a complete team of specialists from the research & developers, to the clinicians that will use the technology

Congressman Joe Barton giving Funding Check

Fort Worth

Texas Instruments

Plano

Texas Instruments, Plano, TX

Platform Technology Patent

• Research resulted in a Platform Technology Patent application being issued in 2012

• UT system as the IP Assignee

Arlington

Stage III. Clinical Exercises

I. The Science & Technology

II. Early Research & Support

III. Clinical Exercises

IV. Entrepreneurship / Eng / Dev

V. Commercialization

UT Southwestern Medical Center

• The premier location for the Biomedical Industry to interact with clinical, surgical, academic, sciences, engineering, and technology.

UT Southwestern Medical Center, Dallas, TX

UT Southwestern Medical Center, Dallas, TX

Dallas

Clinical Collaborators – Endocrinology

Dr. Edward Livingston, M.D.

• Chairman of GI Endocrine Surgery • Southwestern Medical Center • Clinical & Surgical collaborator • Early Clinical Advocate • Helped acquire TI funding • Used own endowment to fund preliminary data collection

Dallas

Clinical Collaborators – Plastic Surgery

Dr. Michel Saint-Cyr, M.D.

Skin Flaps

Dr. Lawrence Lavery, D.P.M.

Lower Limb Amputation

Dr. Javier La Fontaine, D.P.M.

Lower Limb Wounds/Wound Debridement

Dallas

Clinical Collaborators - Endoscopy

Dr. Jeffrey Cadeddu, M.D.

• Director of the UT Southwestern Clinical Center for Minimally Invasive Treatment of Urologic Cancer

• Endoscopy

Dallas

Dallas Veterans Affairs Medical Center

Dallas

Dallas VA Medical Center, Dallas, TX

United States Army – Fort Sam Houston

Brooke Army Medical Center (BAMC) - San Antonio, TX Fort Sam Houston - San Antonio, TX

San Antonio

Clinical Collaborators – Combat Medicine / Burns

Leopoldo C. Cancio, M.D., FACS

• Colonel, MC, US Army

• Brooke Army Medical Center

• Critical Care Fellow

• Combat Medicine & Burns

San Antonio

Stage IV: Entrepreneurship / Engineering / Standards

I. The Science & Technology

II. Early Research & Support

III. Clinical Exercises

IV. Entrepreneurship / Eng / Dev

V. Commercialization

Digital Light Innovations (DLi)

DLP ® Design House

Austin

Digital Light Innovations (DLi)

DLP ® Design House

Austin

Video: Intro to DLP ® Technology

Digital Light Innovations (DLi)

• Authorized Design House for DLP® embedded products

• DLi TI DLP® Symposium

• Recognized Zuzak & HSi at research state

• Hired Dr. Zuzak from UTA

• Began licensing negotiations for UTA IP

• Zuzak & DLi engineers quickly added synergistic IP applications

• Implemented ISO 13485 & FDA 21 CFR 820 Design Controls

Austin

Digital Light Innovations (DLi)

• Licensing Contracted with large medical device channel owner for development, sales & support of DLHsi device

• Other, clinically proven, fields of use

• Opportunity to broaden technology within medical market, additional biomarkers

• Ability to add complementary technology (non-contact, 3D measurement, vein location) to DLHsi device

• Researching extending technology into adjacent markets, i.e. food safety (preliminary)

Austin

TIETRONIX Software

• Software development partner

• ISO 13485 and 21 CFR 820 Compliant

• Strategic initiative to penetrate Austin medical development market

• Deliver complex, mission-critical systems to NASA’s space flight operations

• Augmented Reality

Houston

ISO Certification

• ISO 13485 Compliant Processes

• Represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices

• EMERGO GROUP consulted on our implementation

• Building Design History File

•Third-Party Audit in Q4 2014

Austin

FDA Certification

• Food & Drug Administration

• Compliance for Medical Devices

• 21 CFR 820 Certification

• Code of Federal Regulations Title 21

Austin

Stage V. Commercialization

I. The Science & Technology

II. Early Research & Support

III. Clinical Exercises

IV. Entrepreneurship / Eng / Dev

V. Commercialization

The Client – Texas Medical Device Company

• Headquartered in Texas

• Worldwide footprint

• Clinic & hospital environments

• Multi-billion dollar revenue

• Focusing on improving standard of care while reducing direct & indirect costs of healthcare within field of use

Economic Spend

I. The Science & Technology $1M UTA < 2005

II. Early Research & Support $1M Gov/TI 2006/2010

III. Clinical Exercises $0.5M UTSWMC 2009/2010

IV. Entrepreneurship/Eng/Dev > $0.5M DLi 2011

V. Pre-sales Commercialization > $6M Client 2014

Life Sciences Economic Impact on Austin

• Dean of Dell Medical School at University of Texas Austin

• Dr. Clay Johnston

• Digital Healthcare Initiative

• Austin-Round Rock-San Marcos Metropolitan Area (MSA)

* The Life Sciences sector in Austin MSA represents:

• > $1 billion in value added to the regional economy

• 206 companies

• Approximately 6,052 jobs

• Five industries contributed > $100 million

Dr. Clay Johnston, M.D., Ph.D. Dean of Dell Medical School, UT Austin

Digital Light Hyperspectral Imaging for the Medical Arena

Thank You

A Texas Technology Story 9 Years in the Making