NEEDLE-FREE INJECTION SAFE. EASY. NO NEEDLE.



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Transcription:

Stratis NEEDLE-FREE INJECTION SAFE. EASY. NO NEEDLE.

COMPANY OVERVIEW Based in Golden, Colorado, PharmaJet s mission is worldwide acceptance of PharmaJet Needle- Free devices as a standard of care in the vaccine delivery market. The innovative PharmaJet Stratis Needle-Free Injector has U.S. FDA 510(k) marketing clearance, CE Mark and WHO PQS certification among other countries specific regulatory approvals to deliver medications and vaccines intramuscularly or subcutaneously. In August 2014, the PharmaJet Stratis Needle-Free Injector was approved for delivery of an influenza vaccine to deliver needle-free flu shots. The PharmaJet Needle-Free Injector is easy-touse, eliminates needlestick injuries, needle reuse, and cross contamination, and helps reduce sharps waste disposal. For more information, visit www.pharmajet.com.

PRODUCT OVERVIEW The PharmaJet Needle-Free Injector administers vaccines either intramuscularly (directly into the muscle) or subcutaneously (just below the skin) by means of a narrow, precise fluid stream that penetrates the skin in about one-tenth of a second and gets the vaccine where it needs to be. SPECIFICATIONS Vaccine Injectable IM/SC 0.5 ml Adults 18-64 years of age STRATIS DESIGN Convenient one-hand Syringe attachment and ejection Smooth, easy trigger force and ergonomic design Minimal training required Tested to 20,000 cycles SYSTEM COMPONENTS: Reusable Hardware Disposables Injector 0.5 ml IM, SC Reset Station Syringe 0.5 ml Needle-free 13mm Vial / Filling Adapter EASY FOUR STEP PROCESS: 1 2 3 4 Prepare the Injector Fill the Syringe Load Injector Give Injection Refer to Instructions for Use and the individual device and vaccine labeling to ensure safe injections and to review risks.

THE NEEDLE-FREE OPPORTUNITY WHY IS NEEDLE-FREE IMPORTANT? The Occupational Safety & Health Administration (OSHA) estimates that there are as many as 800,000 needlestick injuries, from all sources, to healthcare workers every year in the U.S. alone. 1 Needlestick injuries can expose healthcare workers to up to 20 different blood borne pathogens including HIV and hepatitis B and/or C. 2 Each needlestick injury costs approximately $3,000 for lab fees, labor and post-exposure follow-ups. 3 PharmaJet s Needle-Free Injector provides a safe option for patients and healthcare providers. Because there is no needle, needlestick injuries are eliminated, and sharps management and disposal costs are reduced. ELIMINATE NEEDLES = CREATE A SAFER WORKPLACE References 1 Safer Needle Devices: Protecting Health Care Workers. OSHA.gov. OSHA, n.d. Web. <https://www.osha.gov/dte/library/bloodborne/saferneedledevices/index.html>. 2 Cost of Needle Stick Injuries. Leeject.com. LeEject Syringe & Needle, n.d. Web. <http://www.leeject.com/download/leeject_appendix3.pdf>. 3 Needlestick Injuries Are Preventable Events. Needlestick Injuries Are Preventable Events. Healthcare Risk Management Reivew, 09 May 2013. Web.

NEEDLE-FREE FLU SHOTS THE MARKET OPPORTUNITY FOR NEEDLE-FREE FLU SHOTS PharmaJet Needle-Free Flu Shots are an alternative for everyone 18-64 years of age. According to the Centers for Disease Control, flu immunization rates have stood at about 40% over the past 5 years and over HALF of those that get flu shots would prefer no needle. Of the 60% that forego a seasonal flu shot, nearly a quarter do so because they have an aversion to needles. Combining these statistics results in 35% of the U.S. adult market, or 71 million people that could be interested in a needle-free option. The PharmaJet Needle-Free Injector is the only jet injector to be indicated on a flu vaccine label PHARMAJET BENEFITS l. SAFE for Patients and Healthcare Providers Eliminates needlestick injuries Reduces sharps management and disposal costs 2. FAST and EASY Delivers the vaccine into the muscle in about 1/10 of a second Majority of users self-trained within 20 minutes 3. PATIENTS and HEALTHCARE PROVIDERS CHOOSE IT Post marketing surveys support patient and healthcare provider preference and satisfaction with needle-free flu shots PATIENTS CHOOSE IT HEALTHCARE PROVIDERS WANT IT 93% 93% 87% 87% of patients surveyed would choose a needle-free flu shot again. 1 of healthcare providers surveyed want needlefree flu shots at their facility. 2 References 1 PharmaJet, Inc. (2014) 61-10201 Post Market Surveillance Patients Combined internal company report, February 2015 2 PharmaJet, Inc. (2015) 61-10194 Post Market Surveillance HealthCare Providers internal company report, February 2015

EXECUTIVE BIOS Ron Lowy, Chairman and Chief Executive Officer Mr. Lowy has a Bachelor of Science degree in Mechanical Engineering from the University of New Hampshire and a Master of Business Administration from the University of Wisconsin. Ron joined PharmaJet as Co-Chairman of the Board of Directors in October 2011 and was appointed Chief Executive Officer in early 2013. He is also the Chairman of the RAL Group, LLC, a venture and technology management group. He has more than 30 years of experience managing and growing technology based global businesses. Mr. Lowy serves on the Boards and as an advisor to several medical device, education and information technology companies. Ron also serves on the Board of Directors of BookTrust, a non-profit focused on inspiring kid s passion for reading. He served as the interim CEO of Helicos in 2009/10. Previous to that Mr. Lowy served as the President and CEO of Fisher Biosciences, a division of Fisher Scientific. Before joining Fisher Biosciences, Mr. Lowy was President of Global Connectivity Solutions for ADC Telecommunications. He also served as President and Chief Operating Officer at the KRONE Group. Mr. Lowy spent the first 15 years of his career in operations, technology and general management positions at GE Medical Systems. Jeffrey A. Jordan, Chief Financial Officer Mr. Jordan has a Bachelor of Science degree in Mechanical Engineering from the United States Military Academy at West Point and a MBA from the University of Maryland. Jeff has more than 20 years of experience in corporate finance. In his previous role, he directed the global finance functions for the Laboratory Products Group of Thermo Fisher Scientific, supporting $1.9B in annual revenue and 10,000 employees. Jeff has worked in several industries including life science tools, telecommunications and industrial chemicals. He has extensive experience in strategic planning, forecasting, significant capital investments, acquisitions and integration activities. John Grosh, Chief Operating Officer Mr. Grosh earned his Bachelor of Science degree in Mechanical Engineering from Ohio State University, a Master s degree in Mechanical Engineering from the University of Florida and a MBA from the University of California. John has more than 30 years of global experience in technical, operational, and executive leadership roles at Terumo Blood Collection Technologies, Thermo Fisher Scientific, and the Krone Group. He has expertise in complex technology and scale up, from product development to manufacturing for new businesses, as well as operational execution for large multi-continent businesses.

EXECUTIVE BIOS Heather Callender-Potters, Vice Chairman and Chief Business Development Officer Ms. Callender-Potters has a Bachelor of Arts degree in International Management from Claremont McKenna College and an MBA from Wharton, the University of Pennsylvania. One of the co-founders of the company, Heather has 24 years of Private Equity fund management and international investment (BCEE; Enterprise Investors) across multiple international jurisdictions, and has managed individual investments and financial investor consortiums, ranging from $1 million to an excess of $100 million. She has also held board positions with several companies across a variety of industries ranging from auto-parts, to systems integration, publishing, lightmanufacturing and healthcare. Chris Cappello, Chief Technology Officer Mr. Cappello has a Bachelor of Science degree in Mechanical Engineering from Colorado State University and his PMP certification. He has over 10 years of Project/Program Management experience and experiential Medical Device development. Chris has managed multiple cross functional teams and departments in the successful design, development, clearance and launch of both reusable & high volume disposable medical devices. He has driven the development of disruptive medical device technologies at companies such as AlloSource and Applied Medical. Michael Seely, Vice President Sales Michael has a Bachelor of Arts degree in Neuroscience from Amherst College. He has led high-performance sales and marketing organizations in the medical device arena in the US, Asia, Europe and Latin America. Mr. Seely has held executive leadership roles at Pfizer Pharmaceuticals, Johnson & Johnson, Gambro, CaridianBCT, and most recently, MBio Diagnostics. He is experienced with both direct and distributor channels commercializing existing medical devices as well as launching new and disruptive technologies. Michael speaks Spanish and Portuguese, and has been an ex-patriot in Singapore, Mexico, Brazil and Europe.