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The New Standard of Care for Drug Delivery Injection Technology Investor Presentation – February 2014 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, 2012. 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. 2 3 Investment Highlights For the first three quarters in 2013 the company is cash flow positive and profitable In November Milestone Medical raised $3M at a post money valuation of $33M and listed on the Warsaw Stock Exchange under the ticker MMD Two medical products are now commercialized and are waiting regulatory approval Conventional needle syringes present significant challenges for patients, doctors and the medical industry – including safety, cost, and malpractice insurance Over 24 patents surrounding injection/drug delivery system Patented and FDA approved painless injection/drug delivery system Opportunity to expand into new drug delivery applications Recent partnership with Tri-anim provides expansive distribution for the epidural instrument Disposables create high-margin recurring-revenue model Highly scalable business utilizing outsourced production model 4 Hypodermic Needle Syringes • An efficient means of drug delivery, but with weaknesses that have not been addressed since its invention almost 150 years ago • Drawbacks: – – – – – 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 including patient fatality 5 CompuFlo®/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 6 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 versus 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 7 Proprietary Advantages • There are approximately 40 million dental phobics—people afraid to visit a dentist, in the United States – Causing over 25% of appointments to be canceled Patient • Eliminates pain • Reduces needle anxiety • No collateral numbing Doctor • Site specific targeting • Precision fluid metering • Eliminates needle deflection • Safe, disposable handpiece 8 • Rapid onset anesthesia/ reduced waiting time • Better ergonomics • New injection techniques • No missed blocks 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 9 Aseptico Partnership • Formed strategic alliance with Aseptico – – • Aseptico will take over responsibility for marketing directly to individual dentists and small offices – – – – • Aseptico will serve as the exclusive distributor of STA Systems and related disposable items Aseptico has served the dental market for over 38 years and markets their products to over 150,000 dentists across the U.S. and Canada Expected to significantly reduce sales and marketing expenses Aseptico participates in over 70 dental shows annually Will attend pediatric dental shows in the U.S. and Canada Aseptico has committed to an active advertising initiative targeting major dental publications, as well as direct mailing campaigns Scalable Business Model – Aseptico will handle all sales & marketing to individual dentists and single office practices • Year 1: Milestone’s sales and marketing expenses will be reduced over $200K – Anticipated revenue growth should drive profitability and cash flow on the dental business alone 10 Intellectual Property Computer Controlled Drug Delivery Systems Dental Anesthetic and Delivery Injection Unit Design for a Dental Anesthetic Delivery System Holder Design for a Dental Anesthetic Delivery System Housing Design for a Dental Anesthetic Delivery System Handle Cartridge Holder for Injection Device Dental Anesthetic Delivery Injection Unit Microprocessor-controlled Fluid Dispensing Apparatus Pressure/Force Computer Controlled Drug Delivery System Dental Anesthetic and Delivery Injection Unit with Automated Rate Control Pressure/Force Computer Controlled Drug Delivery System with Exit Pressure Pressure/Force Computer Controlled Drug Delivery System with Automated Charging Drug Delivery System with Profiles Cartridge Holder for Anesthetic and Delivery Injection Device Design for Drive Unit for Anesthetic Design for Drive Unit for Anesthetic Drug Infusion Device with Tissue Identification Using Pressure Sensing Computer Controlled Drug Delivery Systems with Pressure Sensing Hand Piece for Fluid Administration Self-Administration Injection System Engineered Sharps Injury Protection Devices Handpiece for Injection Device with a Retractable and Rotating Needle Safety IV Catheter Device Safety IV Catheter Infusion Device Handpiece for Injection Device with a Retractable and Rotating Needle 11 PATENT DATE 6,022,337 D422,361 D423,665 D427,314 6,132,414 6,152,734 6,159,161 6,200,289 6,652,482 6,786,885 6,887,216 6,945,954 D558,340 D566,265 D579,540 7,449,008 7,618,409 7,625,354 7,740,612 2/8/2000 4/4/2000 4/25/2000 6/27/2000 10/17/2000 11/28/2000 12/12/2000 3/13/2001 11/25/2003 9/14/2004 5/3/2005 9/20/2005 12/25/2007 4/8/2008 10/28/2008 11/11/2008 11/17/2009 12/1/2009 6/22/2010 6,428,517 6,726,658 6,905,482 6,966,899 8/6/2002 4/27/2004 6/14/2005 11/22/2005 Breakthrough Medical Applications • Unique ability to identify the tissue in which the needle tip is imbedded – • • Management believes our products will improve safety, reduce costs including malpractice and broaden the market due to reduced risk factors Over 700 potential discrete injection applications according to an independent analysis – Clinical evidence demonstrating benefits in epidurals, intra-articular injections, colorectal surgery, podiatry, dermatology, nasal/sinus surgery, hair transplant and cosmetic surgery – Other applications include: neurosurgical injections/aspirations, ophthalmic surgery, cosmetic surgery, botox, dermatology, etc. New products subject to 510(k) submission, reducing cost and time to market 12 Market Overview: Epidural • Epidural market is estimated over $1 billion annually per year in the U.S. alone – 2.4 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 • 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 13 Epidural Instrument • • • In clinical studies, 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) • Milestone partnership with Tri-anim speeds distribution 14 Tri-anim Health Services Partnership • • 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 15 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 doctors often fail to locate intra-articular space or use inappropriate volumes 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 ) 16 Milestone Medical • In November Milestone Medical raised $3M, 50% of the funding was provided by the third largest open pension fund in Poland, at a post money valuation of $33M and listed on the Warsaw Stock Exchange under the ticker MMD • The two products developed are epidural and intra-articular drug delivery instruments utilizing DPS® technology • Milestone provides exclusive worldwide royalty-free license for use of its patents as they relate to these 2 instruments 17 9 mo. Highlights • Revenue for the nine months ended September 30, 2013 was $7.2 million versus $6.4 million for same period in 2012 – Total domestic sales increased 20% to $3.9 million – Achieved a 52.0% increase in domestic instrument sales – International sales increased to $3.3 million versus $3.1 million • Gross profit increased 17.5% to $5.0 million versus the same period in 2012 – Gross margin increased 260 basis points to 69.0% • Third consecutive quarter of profitability • At the end of the third quarter the company remains cash flow positive for the year 18 Income Statement Highlights Quarter Ended Nine Months Ended September 30, September 30, 2013 Revenue Gross Profit Gross Margin Operating Income (Loss) Net Income (Loss) 2012 $2,444,195 $2,129,241 2013 2012 $7,211,973 $6,377,574 1,766,403 1,503,531 4,978,029 4,234,913 72% 71% 69% 66% 436,272 51,647 755,145 (235,110) $218,523 $15,150 443,277 (504,571) 19 Balance Sheet Highlights 30-Sep-13 31-Dec-12 Cash and cash equivalents Total current assets Total assets $ 401,836 3,597,904 6,347,527 $ 165,249 2,498,822 5,661,103 Total current liabilities Total long-term liabilities Total liabilities 2,553,700 2,553,700 3,274,564 450,000 3,724,564 Total stockholders equity $3,793,827 $1,936,539 Clean capital structure with no warrants, convertible debt or preferred shares outstanding 20 Management Team Leonard Osser, CEO & Director. Mr. Osser served as the Company’s Chairman from 1991 until September of 2009, and since 2007, was Chief Executive Officer of the Company. 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. Mark Hochman, D.D.S., Director of Clinical Affairs. Dr. Hochman has served as Director of Clinical Affairs and Director of R&D 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 articles in this area, and shares in the responsibility for inventing much of the technology 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. 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. 21 Management Team (cont’d) Dale Johnson, Director of International Distribution. Mr. Johnson joined Milestone in 2010. His 25-year tenure in the pharmaceutical industry includes key marketing positions in the international arena, including Director of Marketing and then Vice President, International Business at Zila Pharmaceuticals, Inc., a leader in the prevention and treatment of oral diseases. Prior executive posts included Executive Vice President at MedLearning, a communications company serving the pharmaceutical and biotech industries and Group Vice President of Business Development at DOBI Medical Systems, a technology company engaged in the diagnosis of breast cancer. He also held key marketing positions at Apex Communications, Inc., a medical communications company and at Glaxo, Inc., where he spent eleven years and rose through the ranks to International Marketing Director for Dermatology Products. Joseph D’Agostino, CPA, COO & CFO. Mr. D’Agostino became CFO in October 2008. Prior to joining Milestone, Mr. D’Agostino served as Senior VP 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 EVP and CFO of Haynes Security, Inc., EVP of Finance and Administration for Casio, Inc., the U.S. subsidiary of Casio Computer Co., Ltd.; and Manager of Accounting and Auditing for Main Hurdman’s National Office in New York City (merged into KPMG). Renee Cultrara, Director of Education. Ms. Cultrara joined Milestone Scientific in 2008. She has been a practicing clinical hygienist for 23 years. Her responsibilities at Milestone include training and educating field reps, group accounts and our inside sales team. She is a Registered Dental Hygienist. Dr. Eugene Casagrande, Director of Int’l & Professional Relations. Dr. Casagrande joined the company in 1998 and is charged with pursuing a broad range of clinical and industry-related strategic business opportunities for the Company. He has also lectured both nationally and internationally at over 35 dental schools and in over 22 countries on Computer-Controlled Local Anesthesia Delivery. Dr. Casagrande is past president of the California State Board of Dentistry and the Los Angeles Dental Society and is a Fellow of the American and International Colleges of Dentists and has served on the faculty of the University of Southern California, School of Dentistry. 22 Investment Highlights For the first three quarters in 2013 the company is cash flow positive and profitable In November Milestone Medical raised $3M at a post money valuation of $33M and listed on the Warsaw Stock Exchange under the ticker MMD Two medical products are now commercialized and are waiting regulatory approval Conventional needle syringes present significant challenges for patients, doctors and the medical industry – including safety, cost, and malpractice insurance Over 24 patents surrounding injection/drug delivery system Patented and FDA approved painless injection/drug delivery system Opportunity to expand into new drug delivery applications Recent partnership with Tri-anim provides expansive distribution for the epidural instrument Disposables create high-margin recurring-revenue model Highly scalable business utilizing outsourced production model 23 Appendix: Key Statistics Ticker: MLSS Exchange: OTCQB Share price (as of 2/03/2014): $1.40 Common shares outstanding: 17.6 M Market capitalization: $24.7 M Total shareholder’s equity (9/30/2013): $3.8 M 9 mo. revenue $7.2 M 9 mo. net income $443,277 9 mo. EPS $0.03 Fiscal year-end: December 31 Security Ownership of Management: 23.2% 24 Appendix: Board of Directors Leonard Osser, CEO & Director. Mr. Osser served as the Company’s Chairman from 1991 until September of 2009, and since 2007, was Chief Executive Officer of the Company. 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. Leslie Bernhard, Chairman of the Board. Leslie Bernhard assumed the position of Chairman in October 2009 and previously served as an Independent Director since May 2003. She co-founded AdStar, Inc. and since 1986 has served as its President, Chief Executive Officer and Executive Director. AdStar is an application service provider for the newspaper classified advertising industry. She also serves on the Board of Directors of Universal Power Group (AMEX:UPG) of Dallas, Texas. Leonard M. Schiller, Director. Mr. Schiller has been a director of Milestone since April 1997. Mr. Schiller has been a partner in the Chicago law firm of Schiller, Klein & McElroy, P.C. since 1977. He has also been President of The Dearborn Group, a residential property management and real estate acquisition company since 1980. Mr. Schiller became a Director of the Gravitas Cayman Corporation in February 2010. Gravitas Cayman Corporation is an Investment Fund. Pablo Felipe Serna Cardenas, Director. Mr. Serna Cardenas has been a director of Milestone since June 2006. He is the founder of SPOT Investments, a European-based financial services firm. Previously, from 2001 to 2005, he was a director and Senior Manager at Dynamic Decisions Group Ltd, an equity research and valuation consulting firm. In that capacity, Mr. Serna Cardenas led the corporate finance team at Dynamic Decisions in investment banking and project valuation consulting. Prior to joining Dynamic Decisions, from 1999-2001, Mr. Serna Cardenas served as an associate with Real Options Group. Real Options Group is an international academic research center consulting to business entities. Before joining Real Options Group, Mr. Serna Cardenas was the general manager with Estudios, Consultorias y Asesorias Financieras, a Financial Consulting firm in Columbia. He has been a director of Pairstech Fund, a UK hedge Fund since 2008. 25 The New Standard of Care for Drug Delivery Injection Technology Thank you.