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Corporate Overview January 2014 OTC/QB: LCDX

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Page 1: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

Corporate OverviewJanuary 2014

OTC/QB: LCDX

Page 2: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Forward-Looking Statements

This corporate overview contains statements about Caliber Imaging & Diagnostics’ or Caliber I.D.’s futureexpectations, plans and prospects that constitute forward-looking statements within the meaning ofSection 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of1934, as amended, including statements concerning the Company’s strategic goals and objectives relatingto, among other things: geographic and market expansion; new product opportunities; sales andmarketing initiatives; and research and development and financial projections. Actual results may differmaterially from those indicated by these forward-looking statements as a result of various importantfactors, including risks relating to: the Company’s ability to successfully obtain and maintain regulatoryapprovals; develop and market existing and new products; maintain key intellectual property rights;manage competitive pressures; successfully execute on its plans and strategies for growth; and overcomeadverse economic and market conditions, as well as those factors described in “Risk Factors” andelsewhere in the Company's Annual Report on Form 10-K for the year ended December 31, 2012 and anysubsequent Quarterly Reports on Form 10-Q filed to date. The forward-looking statements included inthis corporate overview represent the Company's views as of the date hereof. The Company anticipatesthat subsequent events and developments will cause its views to change. While the Company may elect toupdate these forward-looking statements in the future, the Company specifically disclaims any obligationto do so. These forward-looking statements should not be relied upon as representing the Company’sviews as of any date subsequent to the date hereof.

Page 3: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Developing and commercializing disruptive, non-invasive, point-of-care cellular imaging technologies

VivaScope® holds potential to improve patient outcomes while reducing costs to the healthcare system

VivaScope® provides physicians with a powerful tool to assist in the diagnosis of various conditions including skin cancers

VivaScope® has FDA 510(k) clearance and is supported by more than 350 independently sponsored studies and publications

Company Snapshot

Page 4: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Investment Thesis

Poised for Market Expansion Installed base of 450 systems globally and growing Regulatory approvals in the U.S. and all major markets Widespread, independent and growing support via clinical studies and publications IP protection from 78 issued or pending patents worldwide Applications in dermatology and in surgery

Compelling Economics and Benefits Significantly improves outcomes and reduces costs Allows fast detection of cancerous lesions that appear benign Dramatically reduces the need for expensive, painful and time-consuming biopsies Potential cost savings of more than $1 billion annually in the U.S., not including any

productivity improvements

Initial Success in Europe VivaScope® a standard-of-care in Germany

Reimbursement in place in Germany

Page 5: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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A Compelling Need For Non-Invasive Diagnosis

Page 6: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Initial Opportunity: Skin Cancer Screening

Prevalent, Treatable Cancers 1-in-5 (20%) Americans will develop skin cancer Melanoma accounts for 75% of all skin cancer

deaths, but is 95% curable if diagnosed early Non-melanoma skin cancer accounts for 3.5M

cancer diagnoses annually, 2.5x the number of all other cancers combined

Non-melanoma skin cancer diagnoses have increased 300% since 1994

Significant Expense Burden ~14M skin biopsies are performed annually 70% of biopsies by primary-care physicians are

benign Since 2008 treatment of non-melanoma skin

cancers has increased 137% The estimated direct cost of treating melanoma and

non-melanoma skin cancers in the U.S. exceeds $11B annually

Average number of deaths per year from melanoma

Page 7: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Your Eyes Can Deceive You…

Standard-of-Care is Visual Inspection Low accuracy Frequent misdiagnosis

A B C D E Guidelines A: Asymmetry B: Border C: Color D: Diameter E: Elevation Suspicious lesions are biopsied

Which of these 2 abnormalities is malignant

and which is benign?

Page 8: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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…and Can Lead to Inaccurate Results

A conventional diagnostic approach would have biopsied the benign mole and ignored the malignant melanoma

Malignant Melanoma Benign Mole

Page 9: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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A New Standard with High Sensitivity and Specificity

Study Type Number of Lesions Sensitivity Specificity

BCC 1 152 100% 71%

Melanoma 2 102 97% 72%

Melanoma 3 351 91% 69%

Melanoma and Benign Nevi 4

32698% w/ dermoscopy

91% standalone68%

Melanoma and BCC 5 710BCC: 100%

Melanoma: 88%BCC: 89%

Melanoma: 71%

“Gold Standard” Histopathology for

Melanoma 61249

Agreement among dermatopathologists:80% for invasive melanoma70% for in situ melanoma

Using the “Gold Standard” histopathology, pathologists disagree on the diagnosis of melanoma 20-30% of the time

Page 10: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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VivaScope®

Cellular Imaging Technology

Page 11: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Our Proprietary Technology

Confocal Cellular Imaging Creates layer-by-layer scans of living tissue, with a

>0.2mm imaging depth Provides a microscopic view of living cells in the skin,

with a 3-5 micron cellular resolution, comparable to histology

Point-of-Care Diagnosis Images entire lesions instead of portions of lesions Allows physicians to quickly diagnose melanoma and

other skin cancers, rashes and many common skin conditions

Reduces unnecessary biopsies of non-cancerous lesions

Cost-Efficient, Patient-Friendly Fast, painless procedure, allowing for accurate diagnosis

in minutes rather than days No side-effects from imaging procedure Eliminates the need for a follow-up visit

Pinhole and Detector

Laser

Scanning Opticsand Beam Splitter

Microscope Objective Lens

Horizontal Confocal Image

Page 12: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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The VivaScope® Platform: Products

VivaScope® 3000 FDA 510(k) cleared

In Vivo Cellular Imager

VivaScope® 1500 and VivaScope ®

1500 Multi LaserFDA 510(k) cleared

In Vivo Cellular Imager

VivaNet ® /VivaLANFDA Class 1 Device

TelepathologyVideoDermoscopy

In Vivo Cellular Imager

VivaCam ®

FDA 510(k) clearedVivaScope® 2500

FDA 510(k) cleared

Page 13: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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VivaScope® Confocal Imagers

Images can be interpreted by the physician at the point of patient care, and/or

Images can be securely transferred to a private-network pathologist for remote diagnosis

Basal Cell Carcinoma

Melanoma

Benign Mole

Squamous Cell Carcinoma

Page 14: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Robust Intellectual Property-78 Patents Issued or Pending

Patent TypeU.S.

Issued / PendingEurope

Issued / PendingPacific Rim

Issued / Pending

Latest Expiration Based on Issued

Patents

Imaging system technology 26/3 1/5 3/3 Jul-22

In vivo and ex vivo disease screening, diagnosis, treatment

and therapy monitoring25/4 3/8 5/2 Nov-20

Tissue stabilization 18/5 2/6 3/2 Nov-20

Image capture and mosaicing 6/1 0/5 1/3 Nov-20

Image transfer, storage, viewing and retrieval

2/1 0/2 4/2 Feb-17

Patented core technology with ancillary blocking patents that makes the technology clinically viable and effectively protects our intellectual property for years to come

Page 15: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Prestigious Customer Base

Cosmetic– Proctor & Gamble– Johnson & Johnson– Shiseido– L'Oréal – Avon– Amway

Academia– Rice– Texas A&M– Yale– Mass General

Current customers include some of the most highly regarded Fortune 500 companies, academic institutions and private practices

Over 300 units shipped into commercial research and academia markets and 125 units placed into dermatologist offices worldwide

Clinical– Memorial Sloan-Kettering Cancer

Center– University of Miami Dermatology– University of Connecticut– Rutgers University– Mayo Clinic

Page 16: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Commercial Strategy

Page 17: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Global Distribution and Regulatory Approvals

Distributor Territory *

Mavig GmbHEurope/Middle East

Emdutos Brazil

Integral Japan

Equipmed Australia

ConBio China

Shin Chen Instrument

Taiwan

True Systems South Korea

Filtech Enterprise Thailand

DirectNorth America

• Each territory has received regulatory approvals and recorded VivaScope® sales• Standard of care in Germany

Canada

Brazil

Australia

JapanChina

EuropeUnited States

Page 18: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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VivaScope® Revenue Stream

Imaging Process Can be done by

technician – frees up MD time

70% of biopsies test NEGATIVE!

Initial Examination

Diagnosis and Reporting

VivaNet Transfer and Storage Diagnosis to Patient and

Treatment PlanningSurgery can be

scheduled right away

$100 to ReferringPhysician

$100 to Imaging Center$50 to Caliber• System Sales• Recurring

revenue

$40 to Caliber• Per patient revenue

$60 to Pathologist

Page 19: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Sales & Marketing Priorities

Research Market sales

Increase penetration in existing R&D and international markets

Skin Cancer Screening• HMOs • ACOs • IHNs

Therapeutic

Monitoring• SRT• Brachytherapy• PDT

IntraoperativePathology• Head and neck• Oral• Cervical• Breast

Increase organization to address managed care and concierge medicine

Systems integration with companies manufacturing skin disease therapeutics

Develop devices and techniques for real-time pathology in the operating room

Q3/2013-Q4/2013-onward

2014 - onward

2016

Active projects with major corporations ongoing in each category

Product Optimization

2011-12

Page 20: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Beyond Diagnosis: Skin Cancer Treatment and Skin R&DTherapeutic Monitoring Examine tissue surrounding an excision to determine clear margins Examine tissue undergoing noninvasive therapy to determine therapeutic outcomes Reduce the number of noninvasive treatments required Currently in discussions with 2 significant OEMs

Skincare Product Research & Development Repeatedly and nondestructively examine tissue over time Determine safety and efficacy of commercially available skincare products Ability to perform a noninvasive cellular biopsy instead of relying on visual or indirect

measurement systems Contraction of product development cycles Attractive price point compared to other confocal devices Significant opportunity in U.S.; >300 devices shipped to-date, mostly OUS Hired first 2 salespeople to support this market in November 2013

Page 21: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Beyond Dermatology

Opportunities in neuropathy, cervical, breast, colon and prostate cancers

Large opportunity for excised tissues in the OR

IndicationTechnical Feasibility

Pilot Accuracy

Oral ✓ ✓

Head & Neck ✓ ✓

Neuropathy ✓ ✓

Breast ✓ ✓

Cervical ✓

National Cancer Institute ongoing study

European VivaNet study

Page 22: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Experienced Leadership Team

More than 15 years of experience as a CFO, and 15 years at publicly traded companies

Leadership positions at American Aerogel Co, HighRes Biosolutions, Inc., BioSense Corporation, Praxis International, Centennial Technologies and Conseco, Inc.

More than 20 years of experience advising, analyzing and managing in technology-driven companies

Leadership positions at American Aerogel, Conseco, Inc., Centennial Technologies and PSC, Inc.

More than 35 years of experience in sales, sales management and marketing

Leadership positions at Hewlett-Packard, PSC, Inc., Centennial Technologies and Conseco Insurance

More than 24 years of optical and medical device design, including medical image transfer and storage systems management

Leadership positions at Molded Interconnect Device (MID), Burron Medical and Fisher-Price

L. Michael HonePresident & CEO

Richard J. PulsiferChief Financial Officer

William J. FoxChief Technology Officer, VP Engineering

Richard StathesVP, Sales and Marketing

Page 23: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Key Financial Data

Equity Metrics (12/31/13)

Market cap: $4.6 million

Shares out: 8.4 million (1)

Balance Sheet (9/30/13)

Cash: $2.4 million

Debt: $11.8 million (2)

1 Excludes 7.7M options and warrants2 Principal of $6M plus interest will convert into common stock at offering close. Remaining debt matures in 2020

Revenue

9 mos. ended 9/30/13: $2.3 million

9 mos. ended 9/30/12: $1.3 million

Page 24: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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2012

Multiple Upcoming Catalysts

2013 2014 2015 2016

Redesigned entire product line Upgraded performance Improved reliability Improved manufacturability

Launched customer training program Rebranded company

Planned product improvements Stitching – improves image quality Strip mapping – 4x increase in speed MEMS technology – reduces size False coloring – matches histology

Continue process of obtaining reimbursement codes

Identified immediate revenue opportunities R&D companies and institutions Managed care organizations Concierge medicine

Launched video dermoscopy product Secured regulatory approval in Australia

(one of the largest markets) and Brazil Established development strategy for

thyroid/parathyroid surgery in the OR

Complete reimbursement code process

Launch real-time pathology line for use in the OR

Introduce fluorescent biomarkers designed to highlight cancerous cells

Continue execution/rollout of revenue plan

Launch new compact confocal imaging device leveraging novel technology currently in development at U of R

Seek partnership with a pharmaceutical company for neuropathy applications

Continue product life cycle development

Page 25: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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Investment Thesis

Poised for Market Expansion Installed base of 450 globally and growing Regulatory approvals in the U.S. and all major markets Widespread, independent and growing support via clinical studies and publications IP protection from 78 issued or pending patents worldwide Applications in dermatology and in surgery

Compelling Economics and Benefits Significantly improves outcomes and reduces costs Allows fast detection of cancerous lesions that appear benign Dramatically reduces the need for expensive, painful and time-consuming biopsies Potential cost savings of more than $1 billion annually in the U.S., not including any

productivity improvements

Initial Success in Europe VivaScope® now standard-of-care in Germany

Page 26: Caliber ID (LCDX) Corporate Presentation€¦ · Emdutos Brazil Integral Japan Equipmed Australia ConBio China Shin Chen Instrument Taiwan True Systems South Korea Filtech Enterprise

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References

1. Nori S, Rius-Díaz F, Cuevas J, Goldgeier M, Jaen P, Torres A, González S. Sensitivity and specificity of reflectance-mode confocal microscopy for in vivo diagnosis of basal cell carcinoma: a multicenter study. J Am Acad Dermatol. 2004 Dec;51(6):923-30.

2. Pellacani G, Cesinaro AM, Seidenari S.Reflectance-mode confocal microscopy of pigmented skin lesions--improvement in melanoma diagnostic specificity. J Am Acad Dermatol. 2005 Dec;53(6):979-85. Epub 2005 Oct 19.

3. Pellacani G, Guitera P, Longo C, Avramidis M, Seidenari S, Menzies S. The impact of in vivo reflectance confocal microscopy for the diagnostic accuracy of melanoma and equivocal melanocytic lesions. J Invest Dermatol. 2007 Dec;127(12):2759-65. Epub 2007 Jul 26.

4. Guitera P, Pellacani G, Longo C, Seidenari S, Avramidis M, Menzies SW, In vivo reflectance confocal microscopy enhances secondary evaluation of melanocytic lesions. J Invest Dermatol. 2009 Jan;129(1):131-8. doi: 10.1038/jid.2008.193. Epub 2008 Jul 17.

5. Guitera P, Menzies SW, Longo C, Cesinaro AM, Scolyer RA, Pellacani G. In vivo confocal microscopy for diagnosis of melanoma and basal cell carcinoma using a two-step method: analysis of 710 consecutive clinically equivocal cases. J Invest Dermatol. 2012 Oct;132(10):2386-94.

6. Braun RP, Gutkowicz-Krusin D, Rabinovitz H, Cognetta A, Hofmann-Wellenhof R, Ahlgrimm-Siess V, Polsky D, Oliviero M, KolmI, Googe P, King R, Prieto VG,French L, Marghoob A, Mihm M. Agreement of dermatopathologists in the evaluation of clinically difficult melanocytic lesions: how golden is the 'gold standard'? Dermatology. 2012;224(1):51-8. doi: 10.1159/000336886. Epub 2012 Mar 20.