EFTA01117402.pdf

fmt . I'M S M. 0 IM OM I= JEW MrIll= MIL Mb MI • I IMP NM IM Mr Wirdir r +Pew !Igor ow- s. I RyMed's patented disruptive technology provides the only clinically- proven solution in combating both Catheter-related Bloodstream Infections (CR-BSIs) and Intraluminal Thrombotic Catheter Occlusions (Blood Clots), two of the most severe patient issues plaguing Healthcare today. Investor Presentation February 2012 1 Middlebury Group EFTA01117402  Safe Harbor Statement All statements other than statements of historical facts included herein regarding the Company's financial position, business strategy, growth strategy and other plans and objectives for future operations, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "plan" and similar expressions that may tend to suggest a future event or outcome are not guarantees of performance and are inherently subject to numerous risks and uncertainties, many of which cannot be predicted or anticipated. Future events and actual results, financial or otherwise, could differ materially from those contained herein. Potential investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve significant risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements as a result of various factors. Potential investors are urged to carefully consider all risk-factors highlighted in the private placement memorandum. All forward-looking statements are expressly qualified in their entirety by the foregoing cautionary statement. This is not a solicitation to sell nor offer to buy. RyMed Technologies, Inc. 137 Third Avenue North Franklin, TN 37064 www.rymedtech.com Ilr 1 I I 1' ll li 'I r l 1M • r kr , • • • a a 4••=1IS TECHNOLOGIES, INC. EFTA01117403  Creation of a Problem Prior to RyMed's InVision-Plus® technology introduction in May 2004, Needleless I.V. Connector Systems were designed to protect healthcare professionals from accidental needle stick injuries, AIDS and hepatitis transmission. Unbeknown to the design engineers, they solved one problem by protecting the healthcare worker from accidental needle stick injuries, BUT created a new patient safety problem. Vascular Access Healthcare Crisis • 250,000 — 500,000 catheter-related bloodstream infections yearly in US * • 12-25% mortality rate associated with an intravascular-related BSI* • ICU Length of Stay can increase by as much as 20 days; hospitals by 22 days* ❖ $2.3 - S28 Billion/year spent to treat CR-BSIs* 'Maki. D. G.. Kluge, D M . & Crnich. C J (2006). May Clinic Proceedings. 81(9). 1159-1171. Needleless I.V. Connector Product Design Flaws All competitive (Negative & Positive) needleless I.V. connector designs exhibit one or more fluid pathway concerns: Negative Fluid Displacement Lack of Septum Seal Integrity Fluid Pathway Dead Space Ineffective Septum Surface Design Tortuous Fluid Pathways • =3 IC frE - , Zw-": 3 - TECHNOLOGIES, INC. EFTA01117404  Neutral Advantage" technology RyMed's "10-Point Standard" =.7a . ra la ir V .. -- _,,, _a -.4.-=71-1-z.r-s RyMed's patented InVision-Plus® Needleless I.V. Connector System is r. - -, .-,--_-- - believed to be the first and only product of its kind that was created from the • "ground up" in order to protect patients from the two critical vascular access TECHNOLOGIES INC catheter issues facing healthcare worldwide EFTA01117405  The Advantage is Clear Statement Negative Fluid Displacement RyMed Technologies Baxter ClearLink®(example) The ONLY Zero Fluid Displacement System Negative fluid displacement, or blood refluxing into the catheter lumen, develops blood fibrin, a food source for micro-organisms that develops into biofilm colonization, a source of catheter bloodstream infections. 2 m•L IIL IC _ 1 ES z. g 5 ,:_rT-61/19/.496YEs, EFTA01117406  Snapshot RyMed Recent *News* HISTORY: 1994 Company Founded 1997 InVision-Plus® Development Began July 2011 iData Research , Vancouver British Columbia Canada stated RyMed 2004 Market Introduction Technologies is one of the major 2006 Began hiring Direct Sales Force forces in Needleless IV Connectors in 2007 InVision-Plus® Red® Introduction the U.S. Market 2008 InVision-Plus® Junior® Introduction November US Army began purchasing 2009 InVision-Plus® Epi® Introduction 2010 Walgreens National Formulary (April) December Company received supply FDA Alert — Positive Pressure IV connectors contract from Mayo Clinic's FDA Clearance — InVision-Plus® CS TM January 2012 Two supportive peer-reviewed 2011 CS® beta site product trials began clinical poster presentations accepted CVS Caremark (April) by Oncology Nursing Society Europe Amerinet - First GPO Contract Geneva — April January B-D Posi-Flo® and Baxter Flo-Link® HEADQUARTERS: Franklin, TN Positive Pressure Needleless IV OPERATIONS: Austin, TX Connector discontinued. MANUFACTURING: El Paso, TX/Juarez Mexico EMPLOYEE COUNT: 23 Revenue $5,095 56,239 $7,088 $13,084 $22,800 Net Income ($6,070) (53,263) ($2,794) $890 98,851 le= • • r....77.7;t/ am a la I las •• 6 TECHNOLOGIES, INC EFTA01117407  RyMed Snapshot 2012 Sales Projection 2011 Actual $ 7.1 MM (To Distributors) 2012 SALES PLAN U.S. Field Sales Plan $ 9.5 MM OEM Sales $ 0.8 MM InVision-Plus® CS® Sales $ 2.2 MM International Sales $ 0.6 MM TOTAL SALES PLAN $ 13.1 MM + 84.2% 2012Sales Force Expansion: Add an additional 13 field sales representatives (April-June 2012) Add two new clinical RNs (April-June 2012) New Controller (Feb 2012) New Senior Director, Marketing & Clinical Education (Feb 2012) New Director, National Accounts position (Jan 2012) tie.d .1111 7 r7cifietocits, EFTA01117408  RyMed Snapshot 2012 U.S. Market Landscape Clinical Proof of InVision-Plus® Safety & Efficacy - Exceeding Expectations New InVision-Plus® CS® with Chlorhexidine + Silver Ion Technology A NEW TRANSFORMATIONAL NEEDLELESS IV CONNECTOR SYSTEM > Received FDA 510(k) Approval > Kills the eight (8) common microorganisms associated with CR-BSIs > Full seven (7) day usage potential > A 7.0 log reduction of MRSA > All beta-sites reported "zero" CR-BSIs during their trial period in 2011 Medicare Non-Reimbursement for CR-BSIs VA Hospitals Alert Warning of Positive Pressure Needless IV Connectors FDA Alert & Notification of Positive Pressure Needleless IV Connectors Dr. Jarvis M.D. — Clinical Journal Articles on potential risks for CR-BSIs Dr. Jarvis M.D. — Clinical Journal Article on competitive "Silver-only" Needleless IV Connectors - Blood Inactivates (Reported to be published in 2012) Baxter Healthcare V-Link® > Care Fusion Max-GuardTm (Positive Pressure) > B. Braun UltraSite Ag TM (Positive Pressure) .1•1. 8 TECHNOLOGIES, IN EFTA01117409  RyMed Snapshot 2012 U.S. Market & Sales Landscape iData Research Study - U.S. Vascular Access Market Needleless IV Connectors will be the driving force within healthcare facilities RyMed Technologies - One of the major forces in Needleless IV Connectors Continued standardization trend PICCs, CVCs and PIVs — (1) Needleless IV Connector • Shorter sales cycle time from introduction ft- New emphasis from "C-Suite" administrators New attitude on CR-BSIs - "Soft Savings- . "Hard Savings" Eliminate CR-BSIs - Reduce Costs and Risks First major GPO — Amerinet (September 2011) • 2.700+ member hospitals. IDNs Paul Blackburn — New Senior Director, Marketing & Clinical Education • Starting Date: February 13. 2012 • Coming from Bard-Access Systems • New President-elect — Association for Vascular Access (AVA - Sept 2012) Jim Hinkel — New Controller Starting Date: February 1. 2012 ICU Medical Litigation • Most Clave and MicroClave U.S. patents expired December 18. 2011: Improved clarity with new trial - May 7. 2012: One patent, one independent claim: literal infringement only RyMed's new "work around" component design re I 1 = -Mt. •• a • ra ••• MEL • • me '0 • on a a 9 L TECHNOLOGIES, IN EFTA01117410 Needleless I.V.. Comactees ",US USW Siam 2011: 1.32 Billion Units x $2.65 = $3.5 Billion 2016: 1.84 Billion Units x $3.50 = $6.5 Billion CAGR 111 - 16') - +7.1% Total U.S. UNIT Market Projections - Needleless I.V. Connectors F r- 2,250 2,000 1,750 1.732 1,844 1,625 1.521 1,500 1,420 1,321 1,227 1,250 1,000 750 500 250 0 2010 2011 2012 2013 2014 2015 2016 A Source: iData Research Inc., Vancouver, Canada U.S. Market MAd for Vascular Access Devices and Accessories, February 2010 10 - TECHNOLOGIES, INC. EFTA01117411  Design Evolution Needleless IV Connector Devices • Recessed needles (late 1980s) - No negative fluid displacement • Split Septum or Blunt Cannula devices with Negative Fluid Displacement (early 1990s) - Negative fluid displacement upon disconnection — Dr. William Jarvis MD article "Increased CR-BSIs associated with the use of Negative and Positive Displacement Needleless IV Connectors" • Luer-Activated devices with Negative Displacement (mid 1990s) Negative fluid displacement upon disconnection Dr. William Jarvis MD article "Increased CR-BSIs associated with the use of Negative and Positive Displacement Needleless IV Connectors" • Luer-Activated devices with Positive Fluid Displacement (late 1990s) Negative fluid displacement upon connection VA Administration Warning Letter — December 2007 FDA Alert & Notification Letter — July 2010 Dr. William Jarvis MD article "Increased CR-BSIs associated with the use of Negative and Positive Displacement Needleless IV Connectors" • RyMed's InVision-Plus® (Introduction May 2004) - Neutral Fluid Displacement (Patent Issued) - Zero Fluid Displacement (Patent Issued — January 2012) - Double Microbial Barrier Design (Patented technology) Sla lar SIM a alt Si V" IN mpg SI. or- -• • imr Imr • 7. I: :lir= 1 a a a* a a a • • a • a 11 IL a -' TECNNGLOG/ES /M EFTA01117412  RyMed's Competitors Clinical Infectious Diseases 2009: 49-1821-7 MAJOR ARUM "Health care-associated, central venous catheter-related bloodstream infections (HA-BSIs) are a major cause of Health Care—Associated Bloodsucam Infections Associated with Negative- or Positive-Prev,on: morbidity and mortality" or Displacement NtetiLmical \IdNe NeedleleNs Connectors "Needleless connectors are an important component of .err. Atom Lorre Irreir.' Mr I.. rat. Posit %Or r Fur. ItOrrfl the intravenous system" rieevIvei 4 shre Seel eve ' 1"... Aire reeiv Aveleiv Ikelek• • Iv •I AAA'. arr.. enk See wire wan .r. nun& Am atriedrie4 re PISA Ivies ran motet meets./ semi re en dam VA NA Aunt MOM NI kites& VA aLmial Ph M era.. wrier, enn•••••44 ran I k 14i I rl...11141Mtliatiarnal "Needleless connectors initially were introduced to reduce 11.• •VIIMONI reeporim ev rile PIO IrIA I filer iverril. Avekrav• nig may. craves I ...hp oar 414 te/v ire Ina/ rn lb Orin/ ink, All I *ere Ilv /wave* • Mein/A, kW rowlerid PIA SY whore gal( %N.. iv Os owed vir hewn'. 41111MOIR health care worker needle stick injuries, yet some of Muir, err. el Wt. Pen. .1 in WV reed /It Pri err Peas Ile In kJ rev tun.. re 'mono remora MIT virrrial Ism Iltrzell smile Ave NAL. ve nerved pm WC renal MY ilIVNC• le d• these needleless connectors may increase HA-BSI risk" Ittridar RA Pi rat news, revelleurar Wier ra I44-4 n Enda yore niesiel be Witlirolle IS este lei pre amyl ...gm tat IV: 14berr NW., ME. it in rverielen• orenr1 Ili -IN. Pe Ai Da A IAN SO ...trial Ito a re it 4•V4. regArier• mho.. tin Ails te ea n Aga r4. MA OA' dn• rAtin tit I le re. erradvere beervI4 • IA, le Ti Pell !erne ramp. ra arias PA An IIV al 14N reale Csil•••••• ivror vsisred Ark rirrevrvi Hi III 'dm. &Ave ends' ON verriewee. Mena.. rid rewire. •nrwirer Karl psenol seen by PIA IV Al../ direr or awry{ rya.. OM wit a an.. ivisivre, Iva "The Centers for Disease Control and Prevention (CDC) Wier a Oa Atriol Am. ern lass 4arlairrirnoril trelrown AN rase 14.01014• Two I II n/earn iv Cl..A 4.44rOP rN flonien Ira) Oda/ft *at re Pi estimates that, in US intensive care unit (ICU) patients, IA brew iv birder An-venewed caner .(a.i Illvifrons Alums PI. Hi lea MYR. CM -P WI, Wert ')fl • rag yr to Cr !Ala stay H' It94 I It =NI _.nary sJ •••IINPIO Oars. YID. 1fro Cars Ma I4 reel folavall > 80,000 HA-BSIs occur, costing up to $29 billion farix,•41114 W Ana Stellituareuer any. eiseellsoll sad Fermat Mt XA KY a 'IA annually." ▪ revernee••••• arm' noire brawler Steed • - name n tee l•rams siorg....••••• • *wool • Arab nil en IV Arriviasweinikedifiadr• ure viriar Ilir VII at& elan • -.- yaw,- O., IT `, -^ -• Pint lie IN CrAmparraell idler Ad Holt Alio. •••••••••••••• •••••• mowers rrAmmeAlal • Mit.. ruars.rmm.rrar..•••vie Ay a..0 1•14•01M•Irre• ui• pea. lb 1•1•4 to la pretater Conclusions: "We found strong evidence that Mechanical el Pim Anton irridivel stot wile ...ha mei Valve Needleless Connectors (MV-NCs) were associated with increased HA-BSI rates, despite similar BSI surveillance, definitions, and prevention strategies" Ir 1 1 ra fri - - l l IMM‘ II , I `MI • • -as.. - TA ass a* - P lia .m INS IMP • • S' IV tat - 12 €1 TECHNOLOGIES, NC EFTA01117413  Federal Medicare Mandates October 2008 Medicare stopped paying hospitals for treating the following conditions: Catheter-associated urinary tract infections Pressure ulcers • Vascular catheter-associated infections (CR-BSIs) • Mediastinitis after coronary artery bypass • Fractures, dislocations, or other injuries • Objects left in during surgery • Air embolisms • Blood incompatibilities July 2010 FDA notifies Infection Control Officer's and Manufacturers via the ALERT & NOTIFICATION LETTER on Positive Displacement I.V. Connectors RifMed is believed to be the ONLY MANUFACTURER selling in the U.S. not cited in this FDA Alert 13 EFTA01117414 Product Technology EFTA01117415  Segmentation Strategy The S • ectrum of Protection® Line of Products Designed for all I.V. and Blood Administration/Blood Sampling Designed for Visual Identification of Non-Venous Catheters CM: Designed for Neonatal & Pediatric Patients IRtnewoolnal Prot.-al.. System Designed for use with Pain Management Catheters Iesifon-Plas RyMed/Bacterin International Chlorhexidine+Silver Ion A new transformational technoloav iziViii;;;iiiiii ,, gill V it'll 15 INC EFTA01117416  A new transformational technology RyMed Technologies new anti-bacterial InVision-Plus® CS® with Chlorhexidine + Silver Ions within its patented "Double Microbial Barrier" design does not come in contact with the patients blood. It is the first and only Needleless I.V. Connector System in the world that has received FDA or other regulatory body approval clearance with Cag and up to 7 days of usage. Kills the 8 common microorganisms associated with CR-BSIs Up to a 7.0 Log (99.99999%) Reduction MRSA — 7 days RyMed's Competition: In a recent in-vitro study by Nelson Laboratories, Salt Lake City, UT on the "silver only" anti-bacterial I.V. connectors, it was discovered that competitive products shield the silver from the micro-organisms with a coating of blood fibrin. Each of the competitive connectors actually grew micro-organisms as reported in the study. Baxter Healthcare V-Link® B. Braun UltraSite Ag® •Silver only coated fluid pathway . Silver only impregnated fluid pathway components •96 hour effectiveness . 96 hour effectiveness •Negative Fluid Displacement . Positive Pressure Displacement (FDA Alert) CareFusion MaxGuard® . Silver only impregnated fluid pathway components . 24 hour effectiveness . Positive Pressure Displacement (FDA Alert) r N ii i r i ii, r '0 • r— . a • • • 1m.. Al 16 •41•111111•1 /INN/NM TECHNOLOGIES, INC EFTA01117417  Beta Site Trills I nVision-Plus® CS® with Chlorhexidine + Silver Ions 2011 4 Beta Site Product Trials Phoenix Children's (PICU), Phoenix, AZ . 90 day trial — All patients, all lines . Product trial completed — Reported "Zero" CR-BSIs Los Angeles Medical Center (NICU) — Kaiser Permanente . 90 day trial - Neonatal patients . Product trial completed — Reported "Zero" CR-BSIs Methodist Long-Term Care Hospital, Memphis, TN . 90 day trial — All patients, all lines . Product trial completed — Reported "Zero" CR-BSIs Duke University Medical Center, Durham, NC . 120 day trial — All patients, all lines — Oncology Department . Product trial completed — Reported "Zero" CR-BSIs ACTION PLAN: HIGH VOLUME SCALE-UP PROCESS IS BEING FINALIZED rp. ,-Ft Arc, • • •,--• '=` 17 EL a TECHNOLOGIES, INC EFTA01117418  Intellectual Property • Nine (9) U.S. Patents Issued Five U.S. Patents Issued on InVision-Plus technology) InVision-Plus current IP runs from 2023 through 2032 - Double Microbial Barrier - 3 Piece Valve System - Neutral Fluid Displacement - Zero Fluid Displacement • Foreign Patents Issued - All major markets - Additional pending • Numerous Trademarks Registered & Pending EFTA01117419  Positive Patient Results rialinderson_C.ancet.Cente (Monthly Average Occlusion Incidence) t • -s . F I . ICU In-Patient ut-Patient Split-Septum: 15.3 8.3 4.7 RyMed InVision-Plus® Reduced MD Anderson Cancer Center InVision-Plus®: 12.3 4.5 0.8 catheter infections by 10-fold within Intensive Care Unit Reduction %: 20% ■ 46% 84% Sutter Hospital Roseville. CA 200 Bed Community Hospital Before InVision-Plus® Implementation Texas Children's Hospital 2005 - 767 11 CR-BSI Neonatal Intensive Care Department The largest NICU department in the U.S. I or caring for 1 CR-BSI - $25,000 - $56,000 A total of 288 NICU beds ,A [ter InVision-Plus* Before InVision-Plus® is implemented 2006 —1,558 0 CR-BSI Monthly CR-BSI Rate -28 2007 — 2,278 0 CR-BSI After InVision-Plus® is implemented 2008 - 2,313 0 CR-BSI Monthly CR-BSI Rate - 1 (96% Reduction) 2009 > 2,400 0 CR-BSI 2010 > 2,400 0 CR-BSI 2011 > 2,400 0 CR-BSI -. . . -... .7.. ='"'" I— = •• NOM , .• ... - -=- ,• i- itai - - - -- ''' ''' I ow ini 19 TECNNLLOG/ES, INC EFTA01117420  122,000 Catheter Days of Aggregated Data Participants in the study reported 178 infections were prevented and approximately $6.2 million in savings to the hospitals 2011 Association for Professional in Infection Control & Epidemiology Conference (APIC) Clinical Comparisons of Split Septum Positive and Negative Mechanical Valve Intravenous Connectors to an Intraluminal Protection Connector on Infection Rates Denim Macklin, BSN, RN-C, Consultant, Marietta, GA Cynthia Chamecky PhD, RN, AOCN, FAAN, Georgia Health Sciences University, Augusta, Georgia William R. Jervis MD, Jason & Jarvis Associates, LLC, Hilton Head island, SC Jennifer Waller, PhD, Georgia Health Sciences University, Augusta, Georgia APIC 2011 Baltimore, MD iefieelled Results lliaoncorl MP Paired t • teat • toed to rumen. , difference* • I S- K4fn. Pi- no. to. fx1 Alpha level Of aos. . Items 41J -NANO. Walleer4, M1CU. *Ku. howtoom so. ••▪••• ••• ...ma dm •••••• I•011,4 wrorai" . genial ymel••• and INO1011•1•0CDO We. • titre: t ±1 .... ••=j e r CAA MV. wcuau.c. -• .. • -1 -,-^- l•••••••• ••••••=0 ••• .x. j=r•••• ana••••••• tom me., 1•^-, ry •••••••••••••••••••••••••••••••••••ar• •••••••• alla•Ptla lob* Mean infection Sate* by Sell log Took. Mean 'Median eata* py Co.necter Dec 1000 Catheter On* Ty Pa pet 1000 Cativo* Dan Theatrical Mode COMIUSIOIIS Mai Lid tale•••••••• *wee ••••••••• ••• p.1 PO •••••••• tilare.••••••••••••••• ...••••••• Mi.. Mato... d••••••••••••••••••••• Maar •••••• ••••• ••• * a. /So gh•••••• fel WI, * ••• ••••y sl••••••• ••••••••••••••••••••••••••••••••• Zia Verb". ••••• ••••,•-• SO --t-757.: . 41*.ett=er MS./ f•••••• ••••CTA Con •••••••••••••• IAA IS Ore/Pint Comparison Acadia Group vs. Connector On? ICOI limitation* on purpose • Oka Maata COY'S. *Ma ••••••••••• ucmoieer iVnifif • Cala. •••••••••1 •••• Il•a• CHM,. ••••I•I IND .0130N el Vas nuilaellet •••• •••tv ••• 44•••••••••• ••••••••••• ininn••• • Caala Ia. deaf flala ataai• OH) ••••• ••• ••• 01•••••••••• lona. Wel sx•••••• o nasals* •••••••• •••••••••••I ...Aim le an.