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The new standard of care indrug delivery injection technology.
Investor Presentation – October 2016Leonard Osser, CEO of Milestone ScientificGian Domenico Trombetta, CEO of Wand Dental, Inc.
Safe Harbor
This presentation contains forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and risk factors detailed from time to time in Milestone's periodic filings with the Securities and Exchange Commission, including without limitation, Milestone's Annual Report for the year ended December 31, 2013. The forward-looking statements in this press release are based upon management's reasonable belief as of the date hereof. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
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Presentation Outline
• Business Overview
• Strategy
• Products & Market Opportunity
• Financial Overview
• Summary
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Key Statistics
Ticker: MLSS
Exchange: NYSE
Share price (as of 10/07/2016): $1.93
Common shares outstanding: 27.3 M
Preferred shares (stated value $ 1,000 per share) 7,000
Market capitalization*: $52.7 M
Cash and Treasury Bills (As of 6/30/16) : $3.2 M
Working Capital: $7.7 M
Total shareholder’s equity (6/30/2016): $8.4 M
2015 Revenue $9.5 M
2015 Net Income (loss) $(5.5) M
2015 EPS $(0.26)
Fiscal year-end: December 31
Security Ownership of Management*: 39.1%
*Does not include conversion of preferred shares
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Company Overview
R&D company with growing portfolio of computer-controlled drug delivery injection instruments; strategy to incubate, commercialize and monetize applications through an equipment/disposable model
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Innovative Platform
Broad IP
Regulatory Approval
Efficient Strategy
Solid Financials
• Alternative to the syringe; provides safe, controlled and painless injections and reduces costs
• Reduced malpractice risk & ability to electronically record data mandated under ACA
• Over 20 patents surrounding injection/drug delivery system • Many high impact applications identified for development
• FDA & CE approval on dental injection/drug delivery instruments • CE approval on first two medical instruments; FDA approval pending
• Commercialize products through JV, licensing, and distribution partnerships• Recurring revenue model with growing margins
• $9.5 million in revenue in 2015 generated by core dental division• Clean balance sheet with $3.2M cash, $8.6M shareholder’s equity and no debt
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Drug Delivery Evolution
• The hypodermic syringe has been the primary injection means for almost 160 years
• Syringe presents several weaknesses not yet addressed– Pain and the fear of pain – Tissue damage caused by uncontrolled flow rates– Transient or permanent paralysis– Post-operative complications– Risk of medical emergencies including patient fatality– Inability to know precisely where the drug is placed
• Milestone’s instrument overcomes the traditional syringe’s drawbacks through innovative features:
– Measures tissue density to identify the precise needle location – Regulates and controls flow rate of fluid with consistency and accuracy– Disposable handpiece provides precise tactile control – Controls pain that patients typically associate with injections
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Market Overview
• Unique ability to identify tissue type and control flow rate – Allows for wide array of medical instruments across disciplines
• >700 potential applications identified by independent analysis
• JVs and Licensing in place for epidural, intra-articular, botox and ophthalmic instruments
• Completed development on first 2 medical instruments– Received CE Mark approval on epidural and intra-articular
instruments– Pending FDA approval on epidural and intra-articular
instruments
• Other applications under review in attractive markets with favorable competitive landscape (e.g. opthalmic & cosmetic)
• Plan to develop and commercialize through partnerships with key players
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Dental
Epidural
Intra-Articular
Ophthalmic
Botulinumtoxin
Veterinary
Podiatry
Dermatology
Nasal/Sinus
Neurosurgical
Cosmetic
Colorectal
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Dental Instrument
• Dentists administer injections accurately & painlessly – Capable of performing all injections done with conventional syringe – Allows for anesthetizing a single tooth as primary injection
• Proven effectiveness– Over 65 MM injections delivered to date– Favorably evaluated in more than 50 peer reviewed and
independent clinical research reports
• Better experience for patients– Painless and reduction of injection anxiety– No collateral anesthesia in the cheek, lips or tongue– Reduction in chair time
• Improved effectiveness for doctors– Fewer complications– Reduced quantity of anesthetic– Increase in number of procedures
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Wand STA
Dental Distribution – International
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Established markets Developing markets Other target markets
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Dentists(/000)
Pop (MM)
1 US & CANADA 157 349
2 COLOMBIA 34 48
3 UK & IRELAND 34 69
4 GERMANY 71 95
5 SWITZERLAND 4 8
6 POLAND 22 39
7 SCANDINAVIA 17 21
8 UKRAINE 19 46
9 CZECH REPUBLIC 7 11
10 MIDDLE EAST 5 37
11 SOUTH AFRICA 6 53
12 AUSTRALIA 9 23
Total 385 799
Sources: Health Statistics 2014, OECDManual of Dental Practice 2009, Council of European DentistsThe Oral Health Atlas 2009, World Dental Federation
* > 40 minor distributors worldwide with sporadic sales in over 60 countries
Dentists (/000)
Pop (MM)
1 ARGENTINA 29 41
2 CROATIA 5 4
3 ITALY 48 61
4 SPAIN 22 47
5 PORTUGAL 9 10
6 TURKEY 18 74
7 BALTICS 7 7
8 BELARUS 5 9
9 RUSSIA 85 145
10 CHINA 137 1.351
Total 365 1.749
Dentists(/000)
Pop (MM)
1 FRANCE 41 66
2 BENELUX 17 28
3 EAST EU/BALKANS 42 68
4 BRAZIL 223 199
5 MEXICO 138 121
6 VENEZUELA 14 30
7 OTHER LATAM 42 113
8 JAPAN 100 128
9 INDIA 34 1.237
10 INDONESIA 9 247
Total 660 2.237
Epidural Instrument
• Epidural market over $1B per year in the US alone– 2.4MM epidurals for childbirth (out of 4.2MM total child births) – Additional 1.8MM potential epidurals for child birth– More than 8.9MM other epidurals
• Conventional syringes present high risk for patients– Doctors identify epidural space relying on subjective perception– Average cost for epidural malpractice settlement: $362,000
• Milestone’s instrument is able to reliably identify epidural space eliminating the risk of human error– Patented DPS® technology provides real-time analysis of pressure
characteristics of different tissues when performing epidural Location of the needle easily determined in real time
– Injection record database; soon mandatory under U.S. ACA
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Potential complications with
conventional standard of care
• Wet Tap (1 in 30)
• Neurological injury for <1
year (1 in 6,700)
• Neurological injury for >1
year (1 in 240,000)
• Paraplegia (1 in 250,000) 100% success in clinical studies using medical residents
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Epidural Instrument – Clinical Trial
• COMPASS Study (CompuFlo® Assessment Study)– Randomized, controlled, parallel group, multicenter, pivotal study to assess the safety
and effectiveness of the epidural space verification with the CompuFlo® Epidural Computer Controlled System
– The clinical trial for the epidural instrument reached an enrollment of 400 patients and consisted of two separate arms:
• (i) pain management
• (ii) labor and delivery
– Both arms were compared against the current medical standards of care.
– The goal of the pivotal IDE clinical trial was to demonstrate the accuracy of the CompuFlo technology in identifying and confirming the epidural space location
– Designed to support not only submission to the FDA, but also facilitate U.S. reimbursement submissions as well as worldwide marketing
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Filed 510(k) application with the U.S. Food & Drug Administration (FDA) in July 2016 for marketing clearance of the epidural instrument and disposables in the United States.
Recent Publications
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Recent Publications
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Recent Publications
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Intra-Articular Instrument (Osteoarthritis)
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• Intra-articular market projected $7B by 2015 in US alone– Osteoarthritis affects 33M patients in US– 21M people receive intra-articular injections regularly, 3-4 times
per year
• Low effectiveness of conventional injections:
– Failure to locate intra-articular space– Inappropriate use of volume of hyaluronic acid– Only 77.3% success using traditional techniques in knee injections
• Ultrasound techniques - capital intensive & requires changes– Estimated cost of equipment: $20/40k– Relevant training need– Significantly changes the way of administering injections
• Dynamic Pressure Sensing (DPS®) has been successful inidentifying intra-articular space for administration ofmedications to treat a variety of joint pathologies in anindependent study*
*In-vivo animal study; White paper on file, 2008
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Botulinumtoxin (BOTOX) Instrument
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• Botox®/Dysport® injections represent a growing multi-billiondollar worldwide market
• The procedure can be painful and result in complications dueto improper drug delivery
• Developing a painless and effective means of drug delivery
– Based on Milestone’s computer-controlled injection and drugdelivery technology
• “Milestone Advanced Cosmetic Systems, Inc.” - 50% owned byMLSS (70% defacto ownership) and 50% owned by MilestoneChina (40% owned by MLSS)
– Milestone China has contributed $900,000 for development
– MLSS contributed a limited license for this procedure
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MILESTONE MEDICAL: EPIDURAL BUSINESS
MILESTONE CHINA PARTNERSHIP
1. Agreements signed for distribution of epidural and intra-articularinstruments in China pending CFDA approval
2. Annual minimum purchases in place for each instrument
• Epidural minimums
‐ Year one: 250
‐ Year two: 550
‐ Year three: 750
• Intra-Articular minimums-
‐ Year one: 300
‐ Year two: 600
‐ Year three: 800
3. Regional coverage to include China and other parts of Asia
4. Milestone China is a joint venture between Milestone Scientific and ateam headed by a senior healthcare executive from China
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Ophthalmic Instrument
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• Intravitreal (IVT) injections are one of the most commonly
performed procedures across all specialties
– According to the AMA, IVT injections are the fastest growing
procedure in ophthalmology
– The number of IVT injections has increased from more than 3,000
per year in 1999 to more than 2MM injections in 2012
• A variety of complications can potentially be reduced or
avoided using our technology, including:
– Bleeding; retinal tear / detachment; cataract; increased intraocular
pressure; as well as other risk factors
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Veterinary Instruments
• Signed Letter of Intent in April 2015 with MILA International – MILA International is a U.S.-based global marketer and distributor of veterinary
products
• Collaboration to develop and market anesthetic drug delivery instrument for equine maxillary nerve block procedures in horses
– Initial research and clinical validation conducted by Cornell University College of Veterinary Medicine
• Signed Distribution Agreement in August 2016 with MILA International to market and distribute an anesthetic Instrument for nerve blocks in horses
• Milestone Scientific’s first foray into the veterinary realm– FDA approval not required
• Global animal health industry is a $24 billion market
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Regulatory Process / Approval
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• CompuFlo® technology previously FDA approved
• Received CE approval on epidural & intra-articular instruments in September 2014
• FDA US 510(k)s Submitted for both epidural and intra-articular instruments– Clinical trial for epidural commenced March 2015– No clinical trial required for intra-articular
• New products subject to 510(k) FDA process– Easier and faster approval process– Reducing cost and time to market
• All new future applications should benefit from the accelerated approval process
*In-vivo animal study; White paper on file, 2008
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2015 Full Year Results
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Twelve Months Ended
Dec. 31,
2015 2014
Revenue $9,491,569 $10,333,090
Gross Profit 6,443,309 6,702,325
Gross Margin 68% 65%
Operating Inc. (3,056,748) (790,176)
Net Income $(5,539,903) ($1,702,024)
Income Statement Balance Sheet
Clean capital structure with no warrants and no debt
Finan
cial Overview
31-Dec-15 31-Dec-14
Cash and cash equivalents 4,194,384$ $10,367,993
Total current assets 11,824,151 15,582,333
Other assets 985,176 1,829,095
Total assets 12,809,327 17,477,428
Total current liabilities 3,643,835 2,435,076
Total long-term liabilities - -
Total liabilities 3,643,835 2,435,076
Working Capital 8,180,316 13,147,257
Total stockholders' equity $10,308,575 $14,647,824
First Six Months 2016
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Six Months Ended
June 30,
2016 2015
Revenue $5,836,196 $4,536,963
Gross Profit $3,678,206 $3,033,086
Gross Margin 63% 67%
Operating Inc. (3,066,683) (1,484,830)
Net Income (3,354,962) (2,546,310)
Income Statement Balance Sheet
30/Jun/16 31/Dec/15
Cash and cash equivalents 3,183,727$ $4,194,384
Total current assets 11,693,684 11,824,151
Other assets 908,537 985,176
Total assets 12,602,221 12,809,327
Total current liabilities $3,990,639 $3,643,835
Total long-term liabilities - -
Total liabilities 3,990,639 3,643,835
Working Capital 7,703,045 8,180,316
Total stockholders' equity $8,429,951 $10,308,575
Future Growth & Profitability
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Distribution partnerships and/or licensing of instruments and disposables
Expansion into higher price/margin medical instruments and disposables
Disposables provide a high margin recurring revenue stream
Structural margin improvement with growth of installed base of instruments
Highly scalable business model due to outsourced production model
Finan
cial Overview
In Summary…
R&D platform is complete and secure by virtue of over 20 patents
Proven technology across multiple areas and instruments
Plan to commercialize and monetize new instruments across numerous medical disciplines is underway
– The launch of each new instrument significantly expands the addressable markets
– Proven strategy partnering with industry leaders and distributors is evidenced by dental business
Financially stable: positioned to incubate multiple opportunities
– Disposables provide high-margin recurring revenue stream
– Highly scalable business model
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Dental Instrument
Epidural Instrument
Intra-Articular Instrument
Sum
mary
The new standard of care indrug delivery injection technology.
Thank you.25
Executive TeamLeonard Osser, Chief Executive Officer and DirectorIn March of 2009, Leonard assumed the position of Milestone's Chief Executive Officer and he has served as the Company's Chairman from 1991 until September of 2009. Between 1991 and 2007, he was Chief Executive Officer of the Company. From 1980 until the consummation of Milestone's public offering in November 1995, Leonard was primarily engaged as the principal owner and Chief Executive Officer of U.S. Asian Consulting Group, Inc., a New Jersey-based provider of consulting services specializing in distressed or turnaround situations in both the public and private markets.
Joseph D'Agostino, Chief Financial OfficerJoseph joined Milestone in 2008 and brings wealth of finance and accounting experience earned over 25 years in both publiclyand privately held companies. He has specific proven expertise in treasury and cash management, strategic planning, information technology, internal controls, Sarbanes-Oxley compliance, operations and financial and tax accounting. Joseph served as Senior Vice President and Treasurer of Summit Global Logistics, a publicly traded, full service international freight forwarder and customs broker with operations in the United States and China. Previous executive posts also included Executive Vice President and CFO of Haynes Security, Inc., a leading electronic and manned security solutions company; Executive Vice President of Finance and Administration for Casio, Inc., the U.S. subsidiary of Casio Computer Co., Ltd., a leading manufacturer of consumer electronics;and Manager of Accounting and Auditing for KPMG's national office in New York City. Joseph is a Certified Public Accountant andholds memberships in the American Institute of CPA's and the New Jersey Society of CPA's.
Gian Domenico Trombetta, Chief Executive Officer – Wand Dental, IncGian Domenico was appointed as Chief Executive Officer of the dental division (now Wand Dental Inc) in May 2014. Mr. Trombettaalso serves as a member of Milestone Scientific’s Board of Directors. He is the President and CEO of Innovest S.p.A., a Milan based equity and special situation investment company with a specific focus on investment niches. In the past, he has served as CEO and board member for numerous private companies. Mr. Trombetta’s appointment followed a $10 Million private placement into Milestone Scientific led by Innovest S.p.A in May 2014.
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Executive Team (Con’t)
James McAvinn, Senior Vice President of Sales & MarketingMr. McAvinn brings over 40 years of experience in the healthcare industry including senior management, consulting, product management and marketing positions. Most recently, he served as a principal of MRA Consulting, where he served as a strategicadvisor to leading pharmaceutical, medical device and OEM suppliers. From 2013 to 2016, he served as Managing Director of Product Management for 3si | Surgical Safety Solutions, where he drove product strategy and execution in global surgical and interventional markets. He has also held senior executive roles at Macquet Cardiovascular, The Nova Group, MD Analytics Group, Boston Scientific Corp., Meadox Medicals, and Baxter Healthcare Corp. He holds four U.S patents for medical and surgical devices.
Mark Hochman, D.D.S., Director of Clinical AffairsDr. Hochman has served as Director of Clinical Affairs and Director of Research and Development since 1999. He has a Doctorate of Dental Surgery with advanced training in the specialties of Periodontics and Orthodontics from New York University of Dentistry and has been practicing dentistry since 1984. He holds a faculty appointment as a clinical associate professor at NYU School ofDental Surgery. Recognized as a world authority on Advanced Drug Delivery Systems, Dr. Hochman has published numerous articles in this area, and shares in the responsibility for inventing much of the technology currently available from Milestone.
Stephen Solomon, Director, Engineering and Regulatory AffairsStephen joined Milestone in 2007 as a Director of Engineering and Regulatory Affairs. He has over 30 years of experience in thecomputer, electronics and medical device industries. Prior to joining Milestone, Stephen ran the engineering services department at RFL Electronics from 1998 to 2007. He also worked in various Director and Senior Mechanical Engineering positions for MedjetInc., Datascope Corporation, Unisys Corporation and PerkinElmer, Inc. His career began in 1970 with Rockwell International, where he was responsible for designing environmental protection equipment as a Mechanical Design Engineer. Stephen is a member of the Institute of Electrical and Electronics Engineers - the world's leading professional association for the advancement of technology.
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Scientific Advisory BoardOlivier Choquet, M.D. Department of Clinical Anesthesiology and Critical Care Medicine, Lapeyronie Hospital, Montpellier, France. Widely published in the area of guided anesthesia and in multiple specialty areas of pain management. Dr. Choquet is the President of the committee against pain at Montpellier University Hospital and the Medical Director of the emergency surgicalteam at Lapeyronie hospital. He received his M.D. and Certification in Anesthesiology from Université Lille II and Is a Knight of the order of academic palms.
Paul Davis, M.D. Director of Ordway Research Institute from 2002 to 2011. Currently a Professor of Pharmacy at Albany College of Pharmacy and Health Sciences and a Professor in the Department of Medicine at Albany Medical College. He holds four U.S. patents, one Australian patent and is the inventor on 30 additional pending U.S. and International patents. Dr. Davis is the author or co-author of more than 200 scholarly medical articles. He has contributed chapters to more than 30 medical text books. Dr. Davis holds a medical degree from Harvard Medical School and a B.A. magnum cum laude from Westminster College.
Ralf Erich Gebhard, M.D. Professor in the Departments of Anesthesiology and Orthopedics/Rehabilitation in the University of Miami Miller School of Medicine. He has authored chapters in medical books as well as two dozen published refereed articles on various topics in Anesthesia including Epidural Space. He is co-author of more than 40 articles relating to epidurals and on epidural related injuries. Has been the principal investigator or co-investigator in funded research projects on epidurals, nerve blocks and their consequences or related areas. He also holds editorial responsibilities in various publications in Anesthesiology and Pain Management. Dr. Gebhard holds a medical degree from the Rheinisch-Westfalische-Technische Hochsschule Medical School in Aachen, Germany,
Lorrence Howell Green PhD. Founder and President of Westbury Diagnostics Inc., a conductor of clinical trials since 1993. Previously, he was a Director of New Product Development at Analytab Products, a division of Wyeth Pharmaceuticals where his responsibilities included determining causes of all product problems and implementing manufacturing corrections. He holds a Ph.D. in cell and molecular biology from Indiana University, an M.A. Degree in Zoology from Indiana University and a B.A. inbiology from Brooklyn College.
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Currently, 22 MM PNBs are preformed in the US, EU5, Japan and Brazil, with market growth projected to be 3% annually
Surgical Use
Used for both intra-operative anesthesia
and to manage post-operative pain
Most commonly used in procedures
involving the shoulder, arm, knee, and
ankle/foot
~3 Million PNBs completed in the US1,
with another 7M in the EU, Japan and
Brazil2
Non-Surgical Use
Used to control pain (neuralgia,
complex regional pain syndrome,
Morton’s neuroma) or following an injury
Used as diagnostic procedure to
pinpoint the location/source of a
patient’s pain
~4 MM PNBs were preformed in the
US1, with another 7MM in the EU,
Japan and Brazil2
Peripheral Nerve Block Market Overview
Sources: 1) Medicare data, cms.gov, see appendix for details 2) world Bank Database, see appendix for calculations 3) Adverse Outcomes Associated with
Nerve-Stimulator and Ultrasound-Guided Peripheral Nerve Blocks
10.2 10.6 11.0 11.5 12.0 12.4 12.9 13.4 14.0 14.5 15.1
11.4 11.6 11.7 11.9 12.1 12.2 12.4 12.6 12.8 13.0 13.2
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Non-Surgical
Surgical
Projected Market Growth – US, EU5, Japan and Brazil
Growth driven by trend towards more outpatient surgery and regional
anesthesia and slight expansion of market
PN
Bs
(Mill
ion
s)
3% compound annual growth
rate
Current Techniques
Electric Nerve Stimulation
Current Use – Used by health care professionals (HCP) without access or not trained in use of Ultrasound, used alone in ~10-20% of cases in the US3
Shortcomings – Can get false readings and inject into nerve
Fluoroscopy
Current Use – Used in pain management / clinic setting by doctors with device (used more commonly for facet joint blocks)
Shortcomings – Adds additional procedure time and exposes patient to radiation. High capital and operating costs
Ultrasound
Current Use - Current standardof care (SOC); Lowest rate of complications among current techniques used ~70-80% in the US3
Shortcomings - Hard to see in patients with high Body Mass Index (BMI)
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The peripheral nerve block opportunity appears promising, with projected annual global revenue of ~$190 MM
The global PNB market is estimated to be ~41 MM procedures conducted annually, with a 3% annual growth rate
Ultrasound guidance is the current standard of care in many countries. However, unmet needs exist in terms of incidence of complications, long onset of pain control in some cases, and patient satisfaction all relating to higher costs
CompuFlo’s unique pressure sensing technology, automatic documentation of procedure details, and ability to improve procedural workflow can address the market’s unmet needs, and is therefore expected to be able to justify a premium price
The peak adoption of CompuFlo by an independent analysis for PNBs done in a surgical setting is expected to be 25% in the US and 20% in the EU
Overall, the global peak revenue of CompuFlo is forecasted at $190 MM
– ~85% of the revenue coming from surgical applications
– ~32% is coming from the US and ~30% from the EU5
– Revenue from instrument placements in the US is projected to be ~$6 MM, which represents <2% of total anesthesiology capital cost in the US1.
– Incremental procedure cost of $30-$50 represents <0.5% of average total reimbursement for major shoulder or knee surgical procedures2
Note: 1) Capital costs related to anesthesia were $330MM in 2013; data from CMS and accessed via TheMax. 2) Major lower and upper body joint
procedures in patients without major comorbidities had an average total reimbursed cost of $15M in 2013; data pulled from CMS
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TRIMED - Distribution Partnership
• In March 2015, subsidiary Milestone Medical entered into a three year exclusive distribution agreement with Poland-based TRIMED for Milestone’s epidural instrument
• TRIMED is one of the largest distributors of diagnostic equipment in Poland
• Guaranteed annual minimum purchases
• The addressable market in Poland alone includes over 8MM people suffering from chronic pain
• Legislation pending to allow reimbursement of epidural anesthesia in natural childbirth
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MILESTONE MEDICAL: EPIDURAL BUSINESS
MOSS PARTNERSHIP FOR EPIDURAL INSTRUMENT IN ITALY
1. Exclusive distribution agreement with Italy-based Moss forMilestone’s epidural instrument
2. Moss is one of the leading distributors of diagnostic and specialtysurgery equipment in Italy
3. Guaranteed annual minimum purchases
4. High growing addressable market in Italy
• Over 1MM Epidural anesthesia delivered for surgeries peryear
• 60.000+ Epidural anesthesia delivered for childbirth per year
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