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ANFIM. Association of Needle Free Injection Manufacturers. ANFIM MISSION. The Mission of ANFIM is to promote and protect public health through the advancement of needle-free injection technology. ANFIM GOALS. Our Mission is achieved by the accomplishment of the following Goals:
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ANFIM Association of Needle Free Injection Manufacturers
ANFIM MISSION The Mission of ANFIM is to promote and protect public health through the advancement of needle-free injection technology. SIGN Conference
ANFIM GOALS • Our Mission is achieved by the accomplishment of the following Goals: • Advocacy: Providing exposure, education, and information to the healthcare, pharmaceutical, and health insurance industries and to consumers. • Image: Creating a positive, professional image for the needle-free industry. • Information: Providing members with access to information regarding industry issues. SIGN Conference
ANFIM MEMBERS • Class 1: Manufacturer • Antares Pharma (Mediject) - Bioject, Inc. • Equidyne Systems, Inc. - Keystone Industries • Class 2: Developer • DCI, Inc. - Felton International • Team Consulting Ltd. - PowderJect Vaccines • Class 3: Related Industry Members • Eli Lilly & Company - Novo Nordisk A/S • Class 4: Representatives from • Centers for Disease Control (CDC) • Program for Appropriate Technology in Health (PATH) • US Food and Drug Administration (FDA) SIGN Conference
Needle Free Technology • What problems does it solve • Avoids needle stick hazard • No sharps disposal problems • Eliminates the concern for the re-use of needles • Injection pain is reduced in most cases • Speeds the injection cycle • Improved bio-availability of vaccines • Reduces the system cost of injection SIGN Conference
Needle Free History • In use since 1947 • Military • International Public Health Campaigns • Widely used for mass immunizations and disease eradication. • Smallpox (1975) • Polio (when injected) • Measles (Brazil; 1990 to 1996) SIGN Conference
Needle Free Requirements for the Developing World • Safety • Pathogen Transfer Issues • Disposal of Bio-Hazardous Material • Speed • High Thru-put • Ease of Use • Minimize training • Reduce repetitive motion injuries for health care workers • Simplify maintenance and spares logistics • Energy • Should be capable of being self powered • Cost • Must be comparable or less than traditional needle and syringe on a per injection basis SIGN Conference
Review of the Industry • The following slides will provide a company by company review of the state of the art. SIGN Conference
TEAM CONSULTINGwww.team-consulting.com • TEAM is one of the leading product development consultancies in the U.K., primarily serving the medical device and healthcare markets. • Developing CHEMOMOTOR • Motor Technology for Needle-free and Needled Auto-injectors • Low cost energy source • Tailored power profiles • Several thousand injections from a single filled device • Silent operation SIGN Conference
PowderJectDNA Vaccines Advantages: • Direct Intracellular Delivery • 1,000-fold less DNA than Needle & Syringe delivery • Lower Cost • Safer • Elicits both Antibody and Cellular Responses • Potential for both Px and Rx products SIGN Conference
PowderJectHepatitis B DNA Vaccination • PowderJect has achieved both antibody and cellular responses • PowderJect uses up to 2,500x lower dose PowderJect is the world leader in DNA vaccination SIGN Conference
Biojectwww.bioject.com • Biojector 2000 • Designed for the professional healthcare market • Immunization programs • Hospitals • Clinics • Self Injectors • Spring powered • CO2 powered with electronics SIGN Conference
Why Consider the Bioject Needle Free System ? • Proven Technology -- safer, faster, less invasive • Cost savings -- reduces expense of sharps waste disposal • Workforce Protection -- prevents dangerous and expensive needle stick injuries; meets new OSHA safety requirements • Clinical efficacy -- improves vaccine efficacy, faster onset of desired immune response • Operational Flexibility -- safely and quickly gives immunizations, even in non- clinical locations • Patient Compliance -- patients prefer needlefree over the needle and syringe SIGN Conference
from DCI, Inc. LectraJet HS (high speed) Jet Injection Kit (pat. pend.) For Mass Immunization Campaigns Funding provided byCenters for Disease Control and Prevention (SBIR Contract # 200-2000-10049) Linda D’Antonio, DCI, Inc. LindaD1@twcny.rr.com SIGN Conference
LectraJet HS Key Requirements • Eliminate the risk of cross-infection • High Speed – up to 600 shots per hour SIGN Conference
LectraJet HS • Single-use-auto-disable Ampules • DCI Ampule Management System • Rapid retrieval and ejection of Ampules • No contact with Ampule before or after shot • On-site Ampule filling system • Electrical or Manual Power • Complete injection Kit SIGN Conference
Issues for Campaigns • Safety • Eliminate risk of pathogen transfer • Re-use of needles • Nozzle contamination • Eliminate sharps disposal • Speed • Up to 600 injections per hour • Cost • Comparable or less than the cost of needle and syringe systems SIGN Conference
Thank You ANFIM
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Oklahoma Preference Survey Graph 2: Clients receiving multiple injection only. Were you satisfied with your needle-free injection method? No = 3% Don't Know Yes = 87% = 10% Results from those clients receiving multiple injections with the Biojector were tabulated, showing an 87% satisfaction rating for the needle-free system. SIGN Conference