Yasmin Wadia, M.D.

Founder and CEO

Enabling Hemostasis and Sutureless Surgery

Point . Aim . Fuse

PresenterPresentation NotesLaser tissue welding; An evolution to sutureless surgery. Good Morning, I am Yasmin Wadia founder and CEO of Laser Tissue Welding---------------------------------------------------------------------------------------------------------------------------------------------

Company Overview•

Incorporated:

2004 Delaware C-Corp

•

Pre-revenue•

Business Model:

Vertically Integrated

•

Razor, Razor-Blade: Direct sales strategy

LTW is a Platform Surgical DeviceMarket size for one application

Liver surgery is $650 M

PresenterPresentation NotesSlide 2: Laser Tissue Welding was incorporated in Delaware in 2004 as a C-Corp with the intent to innovate, design, develop, manufacture and market its products. -Sales are anticipated through distributors.-We have two proprietary platforms-Laser tissue welding: which joins and stops bleeding from surfaces of the liver spleen and kidney in surgical applications involving trauma, tumors and transplantation. This is a 650 Million dollar market -The second platform is a customized transparent bio-absorbable burns and wound dressing. A 1 billion dollar market. Today we will be focusing on the laser tissue welding platform

Product Strategy and Offering

The Laser Tissue Welding System:

A surgical device to join and seal tissues to stop bleeding and fluid leaks

without compression, sutures,

blood products or thermal ablation.

Point . Aim . Fuse

Combination Product (Device)

Laser Tissue Welding System

•

Albumin-Indocyanine Solder: Albu-Green™ (Consumable)

•

Denatured Albumin Scaffold: D-Albumin™ (Consumable)

•

810nm Semiconductor Diode Laser (Hardware)

PresenterPresentation NotesSlide 3: The Laser tissue welding system is a combination device, consisting of Albumin-Indocyanine solder, Denatured albumin scaffold sheet and a 810 nm semiconductor diode laser.

Technology Basics: Fusion

Liquid Albumin with Indocyanine green dye Solder

Liquid Albumin with Indocyanine green dye Solder

Solid scaffold which is welded to tissues

Solid Transparent Albumin Scaffold

Liquid Albumin with Indocyanine green dye Solder

Tissue

PresenterPresentation NotesSlide 4: The first part of the technology involves joining two pieces of tissue with the albumin-ICG solder. The solder coagulates when activated by the laser, thus welding the tissue. Since this weld is weak, we have strengthened it by welding a scaffold as second layer.

POINT . AIM . FUSE

HISTOLOGY Raw Surface Repair

Acute Study-

3 hrs

Chronic StudyTwo Weeks

Chronic StudyFour Weeks

*All 11 chronic animals healed without complicating infection, hemorrhage or bile leakage

*Yasmin Wadia, M.D., Hua

Xie, M.D. Michio

Kajitani, M.D.

Sutureless Liver Repair and Hemorrhage Control Using Laser-Mediated Fusion of Human Albumin as a Solder. J Trauma. 2001;51:51-59

(http://www.lasertissuewelding.com/media/docs/Laser_welding_of_the_liver.pdf)

PresenterPresentation NotesSlide 10: Histological evidence of thermal damage is 500 microns or less, complete healing is present at 2 weeks and there is no evidence of inflammation, infection, secondary hemorrhage or bile leakage up to 4 weeks.--------------------------------------------------------------------------------------------------------------------------------------------

Value Proposition: New Paradigm An enhanced surgical capability

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Saves lives: Quickly repairs and controls of hemorrhage in patients who cannot clot

•

Blood conservation: Reduced transfusion requirements•

Salvages organs and tissues: Repairs without burning

•

Enabling curative surgical resection: Does not ablate tumors.

Provides

tissue diagnosis of tumor free margins.

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Shorting operating time: Quick and accurate•

Faster Healing and Shorter hospital stay: Due to decreased tissue trauma

•

Sterilizes contaminated wounds of drug-resistant super bugs

Methicillin-Resistant Staphylococcus aureus

(MRSA)•

Increases donor pool for liver transplantation: Simplifying split liver transplants

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Fibro-optic capable:

Laparoscopic & robotic

Market Segments for Liver Surgery

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Market size: 624,464 patients

–

Split Liver Transplantation

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Primary & Metastatic Tumors

–

Trauma

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5% Market penetration in 1st

yr by 2011

31,223 patients

•

30% year over year growth

PresenterPresentation NotesSlide 12: The three market segments, that relate to liver surgery: split liver transplantation of living related and cadaver livers, liver tumors (primary 15% and metastastic 85%) and civilian trauma. These account for an estimated 160,000 patients a year in the US---------------------------------------------------------------------------------------------------------------------------------------------

Surgical resection, radiofrequency ablation, PEI, chemotherapy, cryosurgery, chemoembolization, and hepatic arterial infusion chemotherapy.

Primary Liver Cancer*530,000 new cases worldwide. Primary liver cancer is one of the most common malignancies in the world, with approximately 1,000,000 cases reported every year. This ranges from 15,000 cases in the United States to more than a 250,000 in China. *22,000 new cases every year in USA*17500 deaths each year Surgical removal of liver cancer is still considered to be best to achieve cure but nearly 85% of patients with liver cancer are unable to undergo surgery due to the presence of complicating factors such as cirrhosis.

Metastatic Liver Cancer: 25% surgical candidates- 23,000The liver provides a fertile soil in which metastases can establish, not only because of its rich, dual blood supply but also because of humoral factors that promote cell growth. Most liver metastases are multiple, involving both lobes in 77% patients, and only 10% are solitary.

New cases of colorectal cancer850,000 world wide129,400 in USA 70 % of all colon cancers will develop metastasis to the liver during the course of the disease

Others malignancies: Kidney, sarcoma, melanoma, thyroid, neuroendocrine tumors

Technology Readiness Level: TRL 8

IP protectionPreclinical Animal safety Clean-room facility In-house manufacturingSubmission of 510k

GMP

•Safety & Efficacy Clinical Trial•Pilot Scale up•Marketing

Raw Materials & Supplies

R&DManufacturing& Assembly

Inventory & Quality Control

Sales & Marketing

Distribution & Service

Direct sales

Strategic alliances

Infrastructure, IT, Human Resources, Procurement

2006 -2008

TRL-8

2009 -2011

Actual system completed and 'flight qualified' through test and demonstration

Hard Assets: Prototype Manufacturing Facility

PresenterPresentation NotesSlide 7: This is the prototype manufacturing facility: The modular clean-room suite consists of 3 rooms: an ISO 6 (Class 1000) changing room, followed by an ISO 5 (class 100) and an ISO 4 (class 10) class clean-rooms with magnetic lockout doors with air pressure differential between the rooms to prevent cross contamination. It has a load bearing double wall system with baked enamel over aluminum as the outside skin and stainless steel as the skin on the inner cleanroom walls. ---------------------------------------------------------------------------------------------------------------------------------------------

Competing TechnologiesLIVER

ApplicationsHaemostatic

patches & glues

Radiofrequency Ablation (RITA)

TissueLink & Argon Beam

LTWLTW

Transplant •

Resection • •

Tumor Percutaneous

•

Trauma • • •

Future Applications

Haemostatic Radiofrequency Ablation

TissueLink & Argon Beam

LTWLTW

Kidney/ Spleen ••

Neurosurgery • ••

Plastic Surgery ••

Vascular Surgery

••

PresenterPresentation NotesSlide 16: Comparing the current areas of competition, LTW is enabling in areas of transplantation, tumors, and trauma. Radiofrequency ablation has the advantage in the percutaneous tumor removals.Laser tissue welding will move ahead to evolve to other applications such as trauma of the spleen and kidney, plastic and vascular surgery and burns.---------------------------------------------------------------------------------------------------------------------------------------------

LTW Team

Yasmin Wadia, M.D.

Chairman & CEO

Founder Inventor

Harsh Singh President & CFO

Serial entrepreneur

R Patrick Wood, M.D. Chief Surgeon, Liver Institute St. Luke's Episcopal Hospital

Milton V Marshall, PhD.

Director of QA and QC

PresenterPresentation NotesSlide 17: At present we are a 2 person company:I am the chairman, CEO and the cleaning lady. I am a physician trained as a general and cardiothoracic vascular surgeon and the inventor of this application and the enabling biomaterials.Mr. Harsh Singh is the President and CFO. He is a serial entrepreneur managing 7 companies in India, in diverse areas of mining, transportation, construction, real estate and publishing.--------------------------------------------------------------------------------------------------------------------------------------------

http://k.b5z.net/i/u/6019232/i/CV-__Harsh_Singh.pdf

COLLABORATORS

Advisory BoardO. H. Frazier, MD, FACS, FACC

Chief Cardiopulm. Transplant Service,

St. Luke’s Episcopal Hospital

Ben D. Tobor

PartnerGreenberg Traurig

LLP

R Patrick Wood, M.D.

Surgeon, Liver Institute

St. Luke's Episcopal Hospital

Paul Mark Allison, M.D., MBA Department of Clinical Pathology

St. Luke’s Episcopal Hospital

Milton V Marshall, PhD, DABT

Director of Quality Assurance & compliance, Dept of Radiology

University of Texas

Deborah Mansfield, MS, MBA

Director, Life Sciences Program

Houston Technology Center

PresenterPresentation NotesSlide 18: We have a sophisticated advisory board of opinion leaders and top-notch experienced consultants in key areas. We are collaboration with the global leader in ophthalmic & dermatology lasers Iridex corporation, and with St. Lukes Episcopal hospital which is undoubtedly recognized for excellence at a national level.--------------------------------------------------------------------------------------------------------------------------------------------

Return on InvestmentRazor, Razor-Blade Model Hardware at-cost:

810nm LaserLaser wand (optical bundle)Stainless Steel LTW hand-piece

Disposables charged:Albu-Green™

Solder

D-Albumin ScaffoldProfit margin: 200% Break Even point is in the 1st year

PresenterPresentation NotesSlide 20: Our revenue and pricing model is the razor-razor blade model. We plan to give the laser free of cost to the hospitals using our consumables.We expect a 10 % market penetration by 2011 with a 30% year over year growth. Considering the developmental costs, cost of lasers and operational cost, the total cost per patient is $440.Unit price of the 5 ml solder and the denatured albumin sheet should be $500 each. Our expectation is that each patient will require 15-20ml of solder and 3-4 sheets of D-Albumin. The price per patient should be $3000-4000. A profit margin of 600-900%. This is comparable to radiofrequency ablation disposables sold by RITA Medical systems Although they do not absorb the cost of their hardware and sell it at $23000 a piece.--------------------------------------------------------------------------------------------------------------------------------------------

Financing so far

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2006-2008: Re-Seed, Pre-revenue

•

Prototype Manufacturing/ sterility/shelf life validation:

Founders: $1,084,000

Federal: SBIR I: $ 161,789

State: Texas ETF: $ 160,000

Total: $1,405,789

PresenterPresentation NotesSlide 22: Financial Needs: We have fulfilled our financial need for the prototype manufacturing-validation phase. Our requirement for the pre-clinical safety testing and the pilot clinical study is 1.5 M. We anticipate using the SBIR peer reviewed grant mechanism and TETF chapter E equity warrants.Our requirements for the pivotal study and scaled up manufacturing is 8 M of which 4 M dollars are slotted to be raised through a series A round of financing in 2008.--------------------------------------------------------------------------------------------------------------------------------------------

Investment

Seeking $ 5M for Series A preferred

•

Pilot scale-up

•

Clinical Trials

•

Aggressive Marketing

Exit Strategy: Acquisition

Key Contact

Yasmin Wadia, M.D.

Laser Tissue Welding, Inc

Phone: (713) 857-7294 Fax: (281) 852-0677

yasminwadia@lasertissuewelding.com www.lasertissuewelding.com

PresenterPresentation NotesThe best way to contact me is through the website at www.lasertissuewelding.com. --------------------------------------------------------------------------------------------------------------------------------------------

Enabling Hemostasis and Sutureless SurgeryCompany OverviewProduct Strategy and OfferingCombination Product (Device)Technology Basics: Fusion Slide Number 6Slide Number 7Value Proposition: New Paradigm�An enhanced surgical capabilityMarket Segments for Liver SurgeryTechnology Readiness Level: TRL 8Hard Assets: Prototype Manufacturing FacilityCompeting TechnologiesLTW TeamCOLLABORATORSAdvisory BoardReturn on InvestmentFinancing so farInvestment Key Contact