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Injections Reinvented
Warsaw Investor Presentation – 2013
Safe Harbor
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Certain of the statements and the projections set forth in this presentation constitute
“forward-looking statements.” Forward-looking statements include, without limitation, any
statement that may predict, forecast, indicate, or imply future results, performance or
achievements, and may contain the words “estimate,” “project,” “intend,” “forecast,”
“anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “will likely,” “should,” “could,”
“would,” “may” or words or expressions of similar meaning. All such forward-looking
statements involve risks and uncertainties, including but not limited to the factors set forth in
the Risk Factors section of this presentation and to the particular risks inherent in any
development stage company that has developed new products for which it has not yet
demonstrated market acceptance or generated any historical sales.
Prospective investors are cautioned that there also can be no assurance that the forwardlooking statements included in this presentation will prove to be accurate. In light of the
significant uncertainties inherent in the forward-looking statements included herein, the
inclusion of such information should not be regarded as a representation or warranty by us
or any other person that our objectives and plans will be achieved in any specified
timeframe, if at all. Except to the extent required by applicable laws or rules, we do not
undertake any obligation to update any forward-looking statements or to announce revisions
to any of the forward-looking statements.
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Company Highlights
 Over 24 patents surrounding injection/drug delivery system
 Partnership with Tri-anim greatly expands distribution potential
 FDA & CE certification filed for epidural and osteoarthritis instruments
 Scientific precision, cost-effectiveness and safety for medical professionals
 Virtually painless injections for patients
 Disposable handpieces create high-margin recurring-revenue model
 Highly scalable business utilizing outsourced production model
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Hypodermic Needle Syringe
• An efficient means of drug delivery, but with drawbacks that have not
been addressed since its invention almost 150 years ago
• Issues:
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Pain and the fear of pain
Tissue damage caused by uncontrolled flow rates of medication into tissue
Transient or permanent paralysis
Post-operative complications
Risk of medical emergencies, even including patient fatality
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DPS® Technology
• Regulates and controls flow rate of fluid
• Dynamic Pressure Sensing® capability provides visual and audible in-tissue
pressure feedback
– Ability to identify tissue types and inject drugs at precisely the
location needed, eliminating guesswork
– Minimizes tissue damage and eliminates the pain of the
injection because the flow rate and pressure
of the injection are controlled
• Disposable injection handpiece allows
precise tactile control during the injection
• Demonstrated success in dentistry,
dermatology, rhinoplasty, podiatry and other uses
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Tri-anim Health Services Partnership
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Three-year agreement announced in July 2013; begins after FDA marketing
clearance
Tri-anim to be distributor of Milestone’s epidural injection technology for
childbirth and other pain management needs in the pain management/hospital
sector
– Nation’s largest provider of specialty sales and distribution solutions for healthcare, and
largest distributor to birthing pain management centers
– Tri-anim is a division of Sarnova, which offers healthcare products to thousands of
customers across the U.S.
– Partnership gives Milestone’s products national reach
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Market Overview: Epidural
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Epidural market is estimated over $1 billion annually in the U.S. alone
– 2.5 million women receive epidurals while in labor each year in the U.S.
– More than 8.9 million epidurals administered for other purposes each year
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Doctors using conventional syringes identify the epidural space by relying on
subjective perception
– 1 in 30 women suffer complications with conventional standard of care – ranging from
severe pain to wet tap to paraplegia and even death
– Average cost per epidural malpractice settlement: $362,000
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Epidural Instrument
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Milestone’s epidural instrument is able to reliably identify pressure characteristics
of the different tissues, including the decrease in pressure in the epidural space
Within seconds, the location of the needle can easily be determined, with higher
pressures indicating the needle is in the ligamentum flavum
Practitioners using Milestone’s instrument correctly identified the epidural space
with a success rate of 100% (Gelber, Gebhard, et al. Regional Anesthesia and Pain
Medicine, 33:4; 2008)
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Milestone partnership with Tri-anim speeds distribution
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Osteoarthritis
• Intra-articular market expected to reach $7 billion by 2015
– Osteoarthritis affects 33 million patients in U.S. alone
– 21 million in U.S. receive intra-articular injections
• Conventional injections less efficacious, as doctor often fails to locate
intra-articular space or uses inappropriate volume of hyaluronic acid
• DPS® has been successful in identifying the intra-articular space for the
administration of medications to treat a variety of joint pathologies in an
independent study (In-vivo animal study; White paper on file, 2008 )
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Beijing 3H Joint Venture
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Formed medical joint venture with Beijing
3H (Heart-Help-Health) Scientific
Technology in July 2011
Two products under development:
epidural and intra-articular drug delivery
instruments utilizing DPS® technology
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50/50 arrangement between Beijing 3H
and Milestone
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Milestone provides exclusive worldwide
royalty-free license for use of its patents
as they relate to these two instruments
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Shareholders, including the general
manager of Beijing 3H, contributed $1.5
million to the medical joint venture
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Beijing 3H
Exclusive
worldwide
patents
Epidural
50%
50%
$1.5 million
Intra-articular
Successful Track Record: STA System
• Single Tooth Anesthesia (STA) System allows dentists to administer
injections accurately and painlessly into the periodontal ligament space,
effectively anesthetizing a single tooth
• Anesthetizes the tooth within one or two minutes vs. 8-18 minutes for a
block injection
– No pain or collateral anesthesia in the cheek, lips or tongue
• Capable of performing all injections done with a conventional syringe
• Over 50 million injections successfully
delivered to date
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Industry Recognition
• Favorably evaluated in more than 50 peer reviewed and
independent clinical research reports
“Many doctors have found that as a result of the unique characteristics of
Computer-Controlled Local Anesthesia Delivery (C-CLAD™), most
traditional dental injection techniques can be performed with greater
predictability and with less discomfort.” - Dr. Stanley F. Malamed, Professor of
Anesthesia and Medicine at the University of Southern California School of Dentistry
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Appendix: Global Distribution Channels
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Aseptico
Henry Schein
Patterson Dental Supply
Benco Dental
Milestone Deutschland
FM Produkty
Executive Dental
Medenta
Nabd Al Hayat
Karr Dental
Dental Practice Systems
China National Medicines Corporation
Istrodent Pty Ltd AB
Unident AB
USA & Canada
USA
USA
USA
Germany
Poland
Puerto Rico/US Virgin Islands
Russia
Saudi Arabia
Switzerland
United Kingdom
China
South Africa
Scandinavia
Over 47 distributors worldwide in over 60 countries
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Appendix: Management Team
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Leonard Osser, Chief Executive Officer. Mr. Osser has been Chief Executive Officer of Milestone Medical since its founding in March 2011.
He has also served as Milestone Scientific’s Chief Executive Officer since September 2009. Prior to that, he served as Milestone Scientific’s
Chairman from 1991 until September of 2009, and during that time, from 1991 until 2007, was also its Chief Executive Officer. In
September 2009, he resigned as Chairman of Milestone Scientific and assumed the position of Chief Executive Officer. From 1980 until the
consummation of Milestone’s public offering in November 1995, Mr. Osser 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.
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Joseph D’Agostino, Chief Financial Officer. Mr. D’Agostino has been Milestone Medical’s Chief Financial Officer since its founding in March
2011. He has also served as Milestone Scientific’s Chief Financial Officer since January 2008, and was given the additional position of Chief
Operating Officer of Milestone Scientific in September 2011. Mr. D’Agostino brings to Milestone Medical a wealth of finance and accounting
experience earned over 25 years serving both publicly and privately held companies. He has proven expertise in treasury and cash
management, strategic planning, information technology, internal controls, Sarbanes-Oxley compliance, operations, and financial and tax
accounting. Immediately prior to joining Milestone, Mr. D’Agostino 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 U.S. and China. Previous executive
posts held by Mr. D’Agostino include Executive Vice President and CFO of Haynes Security, Inc., a leading electronic and manned security
solutions company serving government agencies and commercial enterprises; 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 with subsidiaries around the
world; and Manager of Accounting and Auditing for Main Hurdman’s National Office in New York City (merged into KPMG). Mr. D’Agostino is a
Certified Public Accountant and holds memberships in the American Institute of CPAs, the New Jersey Society of CPAs, the Financial Executive
Institute, the Consumer Electronics Industry Association and the Homeland Security Industry Association. He is a graduate of William
Paterson University where he earned a Bachelor of Arts degree in science.
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Joe Bjorklund, Director of Sales and Business Development. Prior to joining Milestone, Mr. Bjorklund was Vice President of Business
Development, Vice President Sales-North America and Business Manager, Emerging Markets of Ultrsonix, Inc., a manufacturer of diagnostic
ultrasound systems from 2006 to 2011. Before that he was National Sales Director-Hospital Business for RF Technologies and a regional sales
manager for SonoSite Inc. from 2001 to 2003. Earlier in his career he was a Research and Laboratory Coordinator – ARIC (Arthrosclerosis Risk
in Communities) at the University of Minnesota Division of Epidemiology from 1995 to 1999. He holds a Bachelor of Arts degree from St.
John’s University, Minnesota.
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Management Team, Continued
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Mark Hochman, D.D.S., Clinical Director and Director of Research and Development. Dr. Hochman has served as Clinical Director and
Director of Research and Development of Milestone Medical since March 2011 and of Milestone Scientific 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 of Dental Surgery. Recognized
as a world authority on advanced drug delivery instruments, Dr. Hochman has published numerous studies and articles and has lectured
throughout the world on this topic. He shares in the responsibility for inventing much of the technology currently available from Milestone
Scientific.
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Stephen Solomon, Director of Engineering and Regulatory Affairs. Mr. Solomon has served as Milestone’s Director of Engineering and
Regulatory Affairs since March 2011 and of Milestone Scientific since 2007. Previously he was Manager of Engineering Services of RFL
Electronics from 1998 to 2007, Director of Technology Transfer at Medjet from 1996 to 1998 and Manager of Engineering Services from 1991
to 1996. Previously he held managerial and staff engineering positions at Unisys Burroughs Corporation and Perkin-Elmer Interdata. He
holds a Master of Science degree in mechanical engineering from Loyola University, a Master of Business Administration from Rutgers and a
Bachelor of Science in engineering and applied sciences from the University of California.
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Edward Zelnick, M.D., Director of Clinical Research. Dr. Zelnick, prior to joining Milestone, was the co-founder and Chief Executive Officer of
Horizon Institute for Clinical Research, which provided central trial organization and recruitment for clinical research organizations and
pharmaceutical companies from 2000 to 2011. Before that, he was engaged in the practice of medicine as a physician and surgeon
specializing in obstetrics and gynecology from 1972 to 2000, and had multi-year terms as chief of the department of ob-gyn at Hollywood
Medical Center, Memorial Regional Hospital and Memorial Hospital West. His research experience includes a study of “Human Participant
Protection Education for Research Teams” for the National Institutes of Health and participation in numerous clinical research studies in
diverse fields including cardiology, dermatology, endocrinology, gastroenterology, gynecology, hematology, infectious diseases, neurology,
oncology, ophthalmology, orthopedics, pain management, pulmonology, radiology, renal disease, rheumatology, urology and vascular
disease. He holds a medical degree from New York Medical College and Bachelor of Arts degree from the University of Pittsburgh.
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Feng Yulin, M.D., Director. Dr. Feng has been the General Manager of Beijing 3H and Beijing Hengtaixinkang Medical Group Co, Ltd. since
2004. Before that he was General Manager of Beijing Kangdahuli Medical Group Co. Ltd. since 2000. Earlier in his career he was regional
manager for various medical businesses in China following a position as sales manager for a Johnson & Johnson Chinese affiliate. Following
graduation from medical school in 1988 he was engaged in the general practice of medicine at Beijing Youan Hospital. Dr. Feng holds a
medical degree from Chongqing Medical University.
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Appendix: Scientific Advisory Board
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Mark Hochman, D.D.S. Dr. Hochman has served as clinical director and director of research and development of Milestone Medical
since March 2011, and of Milestone Scientific since 1999. He has a doctorate of dental surgery with advanced training in periodontics
and orthodontics from New York University College of Dentistry and has been practicing dentistry since 1984. He holds a faculty
appointment as a clinical associate professor of dental surgery at NYU. Recognized as a world authority on advanced drug delivery
instruments, Dr. Hochman has published numerous studies and articles and has lectured around the world. He shares in the
responsibility for inventing much of the technology currently available from Milestone Scientific.
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Edward Zelnick. M.D. Dr. Zelnick, prior to joining Milestone, was the co-founder and Chief Executive Officer of Horizon Institute for
Clinical Research, which provided central trial organization and recruitment for clinical research organizations and pharmaceutical
companies from 2000 to 2011. Before that, he was a physician and surgeon specializing in obstetrics and gynecology from 1972 to
2000, and was chief of the department of ob-gyn at Hollywood Medical Center, Memorial Regional Hospital and Memorial Hospital
West. His research experience includes a study of “Human Participant Protection Education for Research Teams” for the National
Institutes of Health and participation in clinical studies in cardiology, dermatology, endocrinology, gastroenterology, gynecology,
hematology, infectious diseases, neurology, oncology, ophthalmology, orthopedics, pain management, pulmonology, radiology, renal
disease, rheumatology, urology and vascular disease. He holds a medical degree from New York Medical College and a Bachelor of
Arts degree from the University of Pittsburgh.
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Todd R. Schinnick, M.D. Dr. Schinnick is a board certified medical practitioner in internal medicine with a clinical practice in New York.
He graduated with a medical degree from St. George’s University in 1990.
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Scientific Advisory Board, Continued
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Paul Davis, M.D. Dr. Davis was the director of Ordway Research Institute from 2002 to 2011. He is 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 textbooks.
Dr. Davis holds a medical degree from Harvard Medical School and a Bachelor of Arts magna cum laude from Westminster College.
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Lorrence Howell Green, Ph.D. Dr. Howell founded and has been president of Westbury Diagnostics, Inc., a conductor of clinical trials,
since 1993. Previously he was 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, a master’s degree in zoology from Indiana University and a Bachelor of
Arts degree in biology from Brooklyn College.
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Ralf Erich Gebhard, M.D. Dr. Gebhard is a professor at the University of Miami’s Miller School of Medicine, where he serves as the
director of regional anesthesia and acute perioperative pain management. He also practices at the Bascom Palmer Eye Institute at
Miami. Certified by the American Board of Anesthesiology, he has practiced at hospitals in Texas and Florida, as well as in Germany. In
addition to speaking at national and international meetings and conferences around the world, Dr. Gebhard has taught as a visiting
professor at numerous universities, and contributed to textbooks and scholarly publications. Dr. Gebhard earned a medical degree
from Rheinische Westfaelische Technische Hochschule in Aachen, Germany, and completed his residency at Kliniken der Stadt Koln in
Cologne.
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Injections Reinvented
Thank you.