Skip to main content
Skip to content
Case File
efta-efta01117402DOJ Data Set 9Other

DS9 Document EFTA01117402

Date
Unknown
Source
DOJ Data Set 9
Reference
efta-efta01117402
Pages
44
Persons
0
Integrity
No Hash Available

Summary

Ask AI About This Document

0Share
PostReddit

Extracted Text (OCR)

EFTA Disclosure
Text extracted via OCR from the original document. May contain errors from the scanning process.
r s. I fmt . I'M S M. 0 IM OM I= JEW MrIll= MIL Mb MI I IMP NM IM Mr Wirdir +Pew !Igor ow- 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 'I l 1 1' I ll r 1M I li kr , r 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* O $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-": - TECHNOLOGIES, INC. 3 EFTA01117404 Neutral Advantage" technology RyMed's "10-Point Standard" =.7a . ra la ir V - . -.4.-q-1-z.r-s r. TECHNOLOGIES INC RyMed's patented InVision-Plus® Needleless I.V. Connector System is 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 catheter issues facing healthcare worldwide EFTA01117405 The Advantage is Clear Statement Negative Fluid Displacement Baxter ClearLink®(example) RyMed Technologies 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 IIL IC m• L _ 1 ES z. g ,:_rT-61/19/.496YEs, 5 EFTA01117406 Snapshot RyMed HISTORY: 1994 Company Founded 1997 InVision-Plus® Development Began 2004 Market Introduction 2006 Began hiring Direct Sales Force 2007 InVision-Plus® Red® Introduction 2008 InVision-Plus® Junior® Introduction 2009 InVision-Plus® Epi® Introduction 2010 Walgreens National Formulary (April) FDA Alert — Positive Pressure IV connectors FDA Clearance — In Vision-Plus® CS TM 2011 CS® beta site product trials began CVS Caremark (April) Amerinet - First GPO Contract HEADQUARTERS: OPERATIONS: MANUFACTURING: EMPLOYEE COUNT: Franklin, TN Austin, TX El Paso, TX/Juarez Mexico 23 Recent *News* July 2011 iData Research , Vancouver British Columbia Canada stated RyMed Technologies is one of the major forces in Needleless IV Connectors in the U.S. Market November US Army began purchasing December Company received supply contract from Mayo Clinic's January 2012 Two supportive peer-reviewed clinical poster presentations accepted by Oncology Nursing Society Europe Geneva — April January B-D Posi-Flo® and Baxter Flo-Link® Positive Pressure Needleless IV Connector discontinued. 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 2012 SALES PLAN U.S. Field Sales Plan OEM Sales InVision-Plus® CS® Sales International Sales TOTAL SALES PLAN $ 7.1 MM (To Distributors) $ 9.5 MM $ 0.8 MM $ 2.2 MM $ 0.6 MM $ 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 r7cifietocits, 7 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 = Mt. - ra I 1 •• a MEL me '0 on a a L TECHNOLOGIES, IN 9 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 1,844 1,750 1,625 1.732 1.521 1,500 1,420 1,321 1,250 1,227 1,000 750 500 250 0 2010 2011 2012 2013 2014 2015 2016 A M Ad Source: iData Research Inc., Vancouver, Canada U.S. Market for Vascular Access Devices and Accessories, February 2010 - TECHNOLOGIES, INC. 10 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 imr Imr SI. or- -• •1 a a a* a [repeated 3 times] 7. I: :lir= 11 [repeated 3 times] a a IL a -' TECNNGLOG/ES /M EFTA01117412 RyMed's Competitors Clinical Infectious Diseases 2009: 49-1821-7 "Health care-associated, central venous catheter-related bloodstream infections (HA-BSIs) are a major cause of morbidity and mortality" "Needleless connectors are an important component of the intravenous system" "Needleless connectors initially were introduced to reduce health care worker needle stick injuries, yet some of these needleless connectors may increase HA-BSI risk" "The Centers for Disease Control and Prevention (CDC) estimates that, in US intensive care unit (ICU) patients, > 80,000 HA-BSIs occur, costing up to $29 billion annually." Conclusions: "We found strong evidence that Mechanical Valve Needleless Connectors (MV-NCs) were associated with increased HA-BSI rates, despite similar BSI surveillance, definitions, and prevention strategies" MAJOR ARUM Health Care—Associated Bloodsucam Infections Associated with Negative- or Positive-Prev,on: or Displacement NtetiLmical \IdNe NeedleleNs Connectors .err. Atom Lorre Irreir.' Mr I.. rat. Posit %Or r Fur. ItOrrfl rieevIvei 4shre 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 11.• •VIIMONI reeporim ev rile Avekrav• nig may. craves Ilv /wave* PIO Ir IA I filer iverril. I ...hp oar 414 te/v ire Ina/ rn lb Orin/ ink, All I *ere • Mein/A, kW rowlerid PIA SY whore gal( %N.. iv Os owed vir hewn'. 41111MOIR Muir, err. el Wt. /It Pri err 'mono remora MIT virrrial Ism pm WC renal MY Pen. .1 in WV reed Peas Ile In kJ rev tun.. re Iltrzell smile Ave NAL. ve nerved ilIVNC• le d• Ittridar RA Pi rat news, revelleurar Wier ra I44-4 n Enda yore niesiel be Witlirolle IS este lei a pre amyl ...gm tat IV: 14berr . it in rverielen• orenr1 Ili -IN. Pe Ai Da A IAN SO ...trial Ito re it 4•V4. NW., ME 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 Wier a Oa Atriol Am. ern lass 4arlairrirnoril trelrown AN rase IA brew iv birder An-venewed caner .(a.i Illvifrons Alums PI. Hi lea =NI _.nary sJ •••IINPIO - name n tee l• rams siorg....••••• • *wool • - . - y a w , - O . , I T ` , - ^ - • Mit.. ruars.rmm.rrar..•••vie Ay 1•14•01M•Irre• 14.01014• Two I II n/earn iv Cl..A 4.44rOP rN flonien Ira) Oda/ft *at re Pi MYR. CM -P WI, Wert ')fl H' It94 rag yr to Cr !Ala stay I It Oars. YID. 1fro Cars Ma I4 reel folavall farix,•41114 W Ana Stellituareuer any. eiseellsoll sad Fermat Mt XA KY a 'IA ▪ revernee••••• arm' brawler Steed noire Arab nil en IV Arriviasweinikedifiadr• ure viriar Ilir VII at& elan Pint lie IN CrAmparraell idler Ad Holt Alio. mowers rrAmmeAlal ui• a..0 pea. lb 1•1•4 to la pretater el Pim Anton irridivel stot wile ...ha mei Ir 1 1 l l I `MI IMM‘ II , ra fri - - as.. TA - P lia ass a* S' .m INS IMP IV tat - €1 TECHNOLOGIES, NC 12 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 CM: IRtnewoolnal Prot.-al.. System Iesifon-Plas iziViii;;;iiiiii ,, Designed for all I.V. and Blood Administration/Blood Sampling Designed for Visual Identification of Non-Venous Catheters Designed for Neonatal & Pediatric Patients Designed for use with Pain Management Catheters RyMed/Bacterin International Chlorhexidine+Silver Ion A new transformational technoloav gill V it'll INC 15 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® •Silver only coated fluid pathway •96 hour effectiveness •Negative Fluid Displacement B. Braun UltraSite Ag® . Silver only impregnated fluid pathway components . 96 hour effectiveness . 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 •41•111111•1 /INN/NM TECHNOLOGIES, INC 16 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, '=` EL a TECHNOLOGIES, INC 17 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) Split-Septum: InVision-Plus®: Reduction %: ICU 15.3 12.3 20% t - • s . In-Patient 8.3 4.5 46% Sutter Hospital Roseville. CA 200 Bed Community Hospital Before InVision-Plus® Implementation 2005 - 767 11 CR-BSI I or caring for 1 CR-BSI - $25,000 - $56,000 ,A [ter InVision-Plus* 2006 —1,558 2007 — 2,278 2008 - 2,313 2009 > 2,400 2010 > 2,400 2011 > 2,400 0 CR-BSI [repeated 6 times] .7.. - - =- itai I— = •• NOM . , I ow ini F I . ut-Patient 4.7 0.8 84% RyMed InVision-Plus® Reduced MD Anderson Cancer Center catheter infections by 10-fold within Intensive Care Unit Texas Children's Hospital Neonatal Intensive Care Department The largest NICU department in the U.S. A total of 288 NICU beds Before InVision-Plus® is implemented Monthly CR-BSI Rate -28 After InVision-Plus® is implemented Monthly CR-BSI Rate - 1 (96% Reduction) TECNNLLOG/ES, INC 19 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 ••▪ ••• ••• ...ma dm •••••• I•011,4 wrorai" . j=r•••• ana••••••• tom me., iefieelled Theatrical Mode --.-t-757.:41*.ett=er purpose ucmoieer iVnifif CHM,. ••••I•I IND .0130N el Vas nuilaellet •••tv ••• 44•••••••••• ininn••• OH) ••••• Wel sx•••••• o nasals* •••••••• •••••••••••I ...Aim le an. lone S pin Septum (I f.71O.aln ern >SW* Pstg." 11OO6 ton 41,1. • fe ted. Wf.:64ton Iona) lee • WS or SA.Sf on.. awn to an ISO I eneW Itiatal el 4111.711.2,Intieler dav•I ••• •V•CliOn rain pH SOO) Carat*/ Ref ,01•0 Results Paired t • teat • toed to rumen. , difference* Alpha level Of aos. - . . - 1 - , - ^ - . x . 1 ^ - , lob* Mean infection Sate* by Sell log Dec 1000 Catheter On* Mai Took. Mean 'Median eata* py Co.necter Ty Pa pet 1000 Cativo* Dan Lid Ore/Pint Comparison Acadia Group vs. Connector On? ICOI Results St tistically significant difference In rata of lnbetl p = 0.0008 ••••• Kel• ••••••••• c4, /a 0•1•. •• I I. la on MP lliaoncorl I S- K4fn. Pi- no. to. fx1 Items 41J -NANO. . Walleer4, M1CU. *Ku. howtoom so. We. genial ymel••• and INO1011•1•0CDO • titre: t 1±.... ••=j er CAA MV. wcuau.c. ry alla•Ptla COMIUSIOIIS tale•••••••• *wee ••••••••• ••• p.1 PO •••••••• tilare.••••••••••••••• ...••••••• Mi.. Mato... Maar •••••• ••••• ••• * a. /So gh•••••• fel WI, * sl••••••• Zia Verb". ••••• ••••,•-• SO MS./ ••••CTA Con •••••••••••••• IAA IS limitation* • Oka Maata COY'S. • Cala. •••• Il•a• • Caala Ia. deaf flala ataai• lona. Ntl farlj I mptations • Imil•••••••••• ••••••• • •••••••na end nu..., n-t•-•‘•• wag. be indwootioa !hod m • ads,. /We Ot •••••144..vlOnan• enl••••••• Munn* •••••••• net le be tb.• VONA lineal on not , . F.-M.8 Disclosures EFTA01117421 New Product Development Projects The Spectrum of Protection® Line of Products InVision-Plus® HDTM with Chlorhexidine + Silver Ions for Hemodialysis Catheters Addressable U.S. Market Size — > 50 Million Units Annually "Sentry CS(R) Prniect" Anti-Bacterial Prntective End Caps for Needleless IV Connectors Addressable U.S. Market Size — > 3.0 Billion Units Annually "Germinator Project" Cleaning/Disinfection System Designed to be used on Needleless I.V. Connectors/Catheter Lumens Addressable U.S. Market Size — > 3.0 Billion Units Annually Anti-Bacterial Dead End Caps for IV Administration Line Designed to be used on I.V. Administration Lines Addressable U.S. Market Size — > 1.0 Billion Units Annually "Sentry CS Project" Anti-Bacterial Protective End Caps for Hemodialysis Catheters IV Start Packs for Peripheral IV Catheter Placement i . , ,.. mai = !a I a .• a• .- ..t =I I P. i ir •••4 IMO\ •US nl a 2 , i: I ' 1 UM U1 : U/ IMP w• •• •• an 101 0 •• a .a . •P• SUP ID •16 nA V TECHNOLOGIES, INC 21 EFTA01117422 Distribution Venues Amerinet One of six major healthcare "super group" GPO's Privately owned by Intermountain Healthcare and Administrative Resources, Inc. Headquartered in Saint Louis, formed in 1986 from smaller regional GPO's Membership spans the full spectrum of healthcare provider facilities Membershi Acute Care Hospitals Clinics 18 Long-Term Alternate Care Hospitals Physicians (Hospital Based) 2, Surgery Centers 2,38 Emergency Medical Services 441 Other 18.347 TOTALS: 51,372 Marquis Alternate Site Accounts PharMerica National Account Walgreens National Formulary CVS Caremark Trials Began S IS rIN S. •- , [repeated 3 times] a—aole SEM EL .r/Sout .1 is to _2 IS SO 1.1 -a s -- TECHNOLOGIES, INC, EFTA01117423 Manufacturing & Operations 9 SPEC), PG /)ROTEc...\ Jim Kaiser Chief Operations Officer Operations Office: Austin, TX 23 EFTA01117424 Corporate & Mfg./ Distribution Locations Z till Z - `•1 • -JO * tr. .4, 5, ON YAM •• I la VI * RyMed Headquarters *Franklin, TN - RyMed Distribution Locations: * Austin. TX - RyMed * El Paso, TX - Accellent Sterilization Locations: * El Paso, TX - STERN * Santa Teresa, NM - Stcrigenics * Manufacturing/Assembly Locations: * Anaheim. CA - HiTech Rubber * Upland, CA - Accellent * Juarez, Chihuahua - Accellent -• S tSnZe TECHNOLOGIES, INC EFTA01117425 Manufacturing and Operations RyMed Agreements: Accellent - Supply and Manufacturing of all products - Distribution of Finished Goods - Multi -Year Agreements - Cancellation with 180 days notice without cause Benefits: - 60 day payment terms - Reduced infrastructure • Materials Planning • Vendor Audits • Warehousing Space and Operations • Payables (virtually one vendor) - Inventory Reduction Cost Savings • Inventory Valuation 12-31-2010: $900,113 • Inventory Valuation 12-31-2011: $593,483 Bacterin International - Treatment of InVision-Plus® Septum component with Chlorhexidine + Silver Ions - Worldwide, Exclusive Rights for Needle-Free IV Connectors - Multi -Year with Automatic Renewal rt a -va-fl a ore is r SO 'MI 7. f •• e 'I' TECHNOLOGIES, INC 25 EFTA01117426 Current Manufacturing Capacity RyMed owns a total of 4 assembly machines • Each Semi-automated module consists of - Two assembly machines ► Cost: < $ 200,000 - One set of production molds ► Cost: < $ 700,000 • Current annual capacity: 30 million units - N.A.S.P. - $ 1.58 each (2011) - Total Sales from current capacity: $ 47.4 million • Current overall Gross Margin is 53% - Gross Margin can be improved through: ■ Larger cavitation molds ■ Semi or full automation - 2012 Target Gross Profit: 60% - 65% with semi-automation ■ > 70% with full automation NO PI /2 - , - _2 - - • • EL • u S ASIA TECHNOLOGIES, INC 26 EFTA01117427 Leadership Financials Growth Strategy -a / TECHNOLOGIES NC. SPEci„ 'P6 , • 9‹: de* A ROT ECC\ EFTA01117428 Management Tam Dana Wm. Ryan, President & CEO (Founded 1994) Over 39 years of high volume, disposable medical device experience in sales, management, product marketing, development. Holds over 35 patents to date worldwide. 3M — sales engineer. Arbrook/Surkigos (J&J) — Head of New Products Department. Deseret Company ( Warner-Lambert) — Director of Marketing. Ryan Medical — Founder/CEO — 14 patents in safety medical products in the field of blood collection and intravenous therapy. Small Business of the Year Award, Nashville, TN 1990, Company was sold in 1992. Symbiosis Corporation — Design, develop and manage. Symbiosis was sold to American Home Products in 1994. Major in mathematics (Arkansas State University). 1968-70 played professional baseball for the Chicago White Sox organization. James M. Kaiser, Chief Operations Officer and Financial Director (1997) Over 40 years of high volume, disposable medical device manufacturing. Cutter Laboratories — manufacturing, sterilization, and materials management. Deseret Company — Production Superintendent (1,200 employees). Healthcare Group — Vice President of Operations. Ryan Medical — EVP Manufacturing. Isomedix, inc. — General Manager and later Group VP at HDQ. MBA (Southland University). Tony Ryherd, Director of Engineering & Manufacturing (2007) Over 24 years of industrial manufacturing experience ranging from aerospace engineering to medical device development and expert in Operation Management Systems. Boeing Aerospace — Lead on China technology transfer. Accellent Endoscopy — head of engineering development. BS in Manufacturing Engineering (Bradley University). Brandon D. Ryan, National Sales Director (2006) Over 12 years leadership experience in medical sales. Began as ABC news anchor, then CBS nightly news anchor/reporter hosting political roundtable "Behind the Headlines". Bristol-Myers Squibb as Territory Manager. TAP Pharmaceuticals — Senior Specialty Sales Representative (top performer). BA in Broadcast Journalism (University of Mississippi). inh a I VS S I NS Cw.ei sie II Si JIM S s s , Ms= a. a sh. 7 TECHNOLOGIES, INC 28 EFTA01117429 Management Tea D. Scott Chase, Director of Marketing (2006) Over 12 years of composite O.R.based device sales experience,. Techmedica/Sulzer Medica, Inc. (Camarillo, CA), TMJ Implants, Inc. (Golden, CO), and W. Lorenz Surgical/Biomet, Inc. (Jacksonville, FL), focusing primarily on the sale of titanium and resorbable craniofacial reconstructive implants, biomaterials and instruments to the neuro, plastic and reconstructive, ENT, oral/maxillofacial surgical specialties. BA in Mathematics (Vanderbilt University). Anna McCutchen, Director of Quality Control & Regulatory Affairs (2005) 7 years experience in quality assurance management of government regulated products. Expertise in quality systems, procedures, documentation and regulations. Triad Foods Group — Quality Assurance Manager. Cargill — Quality Assurance Manager plus plant level auditing of 7 facilities. BA in Food Science and Technologies (Texas ). David Rogers, Director of Logistics & Operations Support (2006) Over 35 years leadership experience in strategic planning, human resources and budgetary controls. In 1967, began career as second military lieutenant rising to Chief of Staff of the Alaskan Air Command and three times as a Director of Personnel at a Major Air Command. . Responsible for 3500 person staff with $1.1 billion budget. Numerous military awards and distinctions. Masters Degrees - University of Arkansas 1974 (Management) and University of Oklahoma 1979 (Public Administration). Paul L. Blackburn, RN, MNA, Senior Director, Clinical Education (Starting date: February 139') Over 20 years managerial and clinical education teaching experience. CR-Bard, Bard-Access Systems, Salt Lake City, UT , Director of Clinical Education. Managed over 150 clinical nurses and team developed all the clinical education programs for Bard-Access PICC catheter product lines. New President-elect of the Association for Vascular Access (AVA). Jim Hinkel, Controller (Starting date: February 1st) Over 30 years of experience in operational accounting, financial analysis, audit responsibility, budgeting, and accounting control systems.. His experience spans both large and small companies, including a start up company. Jim has a BBA in Accounting and received his CPA from the State of Illinois (non active). vs in' a , OM I I" .in ai IL Si Emi Om am? .. / Ca dinmii IS II mos —a IMO ./ Illea 4 ••, • Ift--.4 n. .7= 7 7 - ' ' ' 7 t r I. n s'-. -; TECHNOLOGIES, INC 29 EFTA01117430 Revenue Growth Projection $25,000,000 $20,000,000 $15,000,000 $10,000,000 $5,000,000 $0 513.054, $7,087,928 ,mingimmummir 2004A 2005A 2006A 2007A 2008A 2009A 2010A 2011A 2012E 2013E 30 EFTA01117431 Summary Financial Statements Summary Income Statement 2011 Condensed Balance Sheet Dec. 31 2011 ASSETS Revenue $ 7,081,019 Cash $ 68,500 Cost of Goods Sold 3,337,755 Accounts Receivable 607,756 Gross Profit 3,721,767 Other Current Assets 831,998 Fixed Assets 814,882 SG&A 6,467,986 Other Assets 94.439 Operating Profit/(Loss) (2,746,219) TOTAL $2.417.577 Other (47,895) LIABILITIES Current $2,021,945 Long Term 4,302,360* Pre-Tax Profit/(Loss) (2,794,114) Total 6,324,305 Taxes - Net Profit/(Loss) $(2.794.114). EQUITY ($3,906,729) TOTAL $2.417,577 TECHNOLOGIES, INC EFTA01117432 2011 Milestones Lk r• rnmeilichmantc January • Began Beta Site Trials with InVision-Plus® CST'' with Chlorhexidine+Silver Ion Engineering February - March • 11th National Conference on Cancer Nursing Research — Cynthia Chernecky, PhD • InVision-Plus® reduced infections and occlusions - Silver treated connectors show ineffectiveness in presence of blood • Journal of Advanced Nursing — Comparative evaluation of five needleless I.V. connectors; Chernecky & Waller April - May • SHEA Conference 2011 — Dallas, TX — Chernecky, Jarvis. Macklin; • Silver treated needleless connectors show ineffectiveness in presence of blood (abstract poster) 8-states; 122,000 catheter-days; comparative study - InVision-Plus® - Up to 92% reduction in CR-BSIs May • Naval Hospital, Jacksonville, FL - InVision-Plus product trial • VA Medical Center, San Antonio, TX — Reported "zero" CRBSIs in product trials • Spaulding Hospital, Cambridge, MA (Partners) — InVision-Plus product trial* June APIC Conference, Baltimore, MD . Clinical Poster Presentation —122,000 Catheter Day Study . Clinical Poster Presentation — Texas Children's Hospital NICU, Houston, TX AVA Conference — Accepted Clinical Poster Presentation — Methodist Extended Care Hospital • CANS Conference, Washington, DC — Accepted Two Poster Presentations, Dr. Cynthia Chernecky PhD frg sr. _a a [repeated 4 times] al a —a• It ANL a NIL aa TECHNOLOGIES, INC. 32 EFTA01117433 2011 Ililestames Lir rn rri nl i rri tc July VA Hospital, Jackson, MS - Conversion to InVision-Plus - All Lines Mayo Clinic, Jacksonville, FL — Straight conversion to InVision-Plus VA Hospital, Atlanta, GA - Began InVision-Plus product trial Duke University, Oncology Dept., Durham, NC — Began CS product trial (Oncology) Sutter Medical Center, Roseville, CA reported zero CR-BSIs for 5 1/2 years with InVision-Plus August • VA Medical Center, San Antonio. TX — Reported "zero" CRBSIs in product trials September APIC Conference, Baltimore, MD . Clinical Poster Presentation — 122,000 Catheter Day Study . Clinical Poster Presentation — Texas Children's Hospital NICU, Houston, TX • Danbury Hospital, Danbury, MA conversion to InVision-Plus October • AVA Conference — Clinical Poster Presentation — Methodist Extended Care Hospital • CANS Conference, Washington, DC — Two Poster Presentations, Dr. Cynthia Chernecky PhD • Duke University, Oncology Dept., Durham, NC — Completed CS product trial — Zero CR-BSIs • Spaulding Hospital, Cambridge, MA (Partners) — InVision-Plus successful product trial completed November-December • Received supply agreement from Mayo Clinics • Received supply agreement from Partners Alliance in Boston, MA • U.S. Army purchasing InVision-Plus product line ros - - • ;%1 r ti t. n el TECHNOLOGIES, INC 33 EFTA01117434 Strate • is Goals I Quarter. 2012 aoals Complete $10.0mm Growth Capital Financing Engage new accounting firm and new audit firm Hire new Controller and Senior Director, Marketing & Clinical Education Expand direct sales force and clinical team Continue ISO Certification documentation to move international by early Q3 2012 Begin semi-automation modification assembly machine project on to improve margins Explore supply/distribution agreements and/or joint ventures Continue developing Amerinet relationships across the U.S Continue Balance Sheet improvement Begin new Product Development programs to expand product lines t, TECHNOLOGIES, INC. 34 EFTA01117435 Strate • is Goals mnnrn nnaIc ­ Expand board to five members Introduce product lines into targeted international markets Expand manufacturing capabilities and improve margins Execute worldwide sales, marketing & distribution agreements with major IV players ­ Continue to expand GPO contracts in U.S. Further New Product Development programs to expand product lines Additional participation at industry conventions and analyst presentations ­ Establish clinical advisory committee Successfully defend ourselves against ICU Medical litigation cases during 2012 = Tt rc_ m 7...• I - TECHNOLOGIES, INC. 35 EFTA01117436 Potential Risks Ability to secure growth capital financings as needed Ability to keep and attract new sales and support team talent Ability to secure additional GPO contracts Continue to penetrate Needleless IV Connector markets Continue to successfully defend against ICU Medical current litigation cases Entry of new competition and technologies tar - =t---TECHNOLOGIES, INC 36 EFTA01117437 Strategic Growth Capital Finance Plan Growth Capital Financing: $ 10.0 Million Use of Proceeds: Breakdown: Expansion of direct sales force and support personnel Cost of goods reduction program Expansion of manufacturing capacities Expand into targeted international markets, Increase industry and public market visibility Infrastructure InVision-Plus® CST" Expansion Payoff targeted notes Laboratory In-Vitro Testing Assembly Machine Modification Capital Equipment ISO Certification/Mark Patients/Patient Maintenance Product Development Litigation Reserve Working Capital Total Use of Funds $ 1.75 $ 0.50 $ 2.00 $ 0.10 $ 0.25 $ 0.50 $ 0.06 $ 0.05 $ 0.70 $ 0.80 $ 3.29 $10.00 Million fl . -a. a- a Ill MI fa a v an a.= Imi i I : sa TECNNOL00/ES, /NC 37 EFTA01117438 Summary • Strong opportunities for high revenue growth: — 2012 introduction of new transformation InVision-Plus® CS® technology — New product developments into additional catheter care & maintenance product lines — Increased standardization by acute care hospitals, long-term care facilities and home infusion companies, to include PICCs, CVCs, Stopcocks, and PIVs — Strategic joint venture relationships and sales, marketing & distribution partners — Geographic expansion into targeted international markets Business model is capable of generating high margins (> 65%) and recurring revenue High barriers to entry (intellectual property, regulatory, product safety & efficacy features, and product development expenses) with limited competition and first to market advantage Strong executive, clinical, sales, marketing and manufacturing management team Continued focus of the FDA on RyMed's competitors products as they relate to increase in CR-BSIs (catheter-related bloodstream infections) 38 '" TECHNOLOGIES, INC EFTA01117439 Thank You for IktirrlibmwdlOweitaxnEttizit 39 EFTA01117440 Reference Slides Only 1•=1,^ I I I /II a V PH TECHNOLOGIES, INC 40 EFTA01117441 FDA Alert & Notification Letter IVA U.S. Food and Drug Administration Mont I food i Ora. IMotleA Deocom"c An, Anat. Bagel I Inn& roam." I Genoa, I AaaartniatIns Asthma] taw. Ati..e, (AZ Ott. South 0 Medical Devices mwe Envl m.aae 6 cnn.' One MGCAtoc. tot, • • on. moocaOnta •_n, A.,4 avr4104."••• 61.40 Positive Displacement Needieless Connectors and Bloodstream Infections: Initial Communication 2). AuLlioao, Moth Cara OrOntrA0nAs AUAlica opwalally: InIOCIAn COntoll sawn.", eA Mee one soon' Sevetavre.moel AtoCa Studs?, Mien er Acreme m ooeitrearr ntec•Ans Anon; tyr nt•VOUCten SM Ole CA CAA0ve 61COaCement AtedttAnf CO•roCAre n o.oltheite 'Keen an Aril et redon Inn to Sedan, Mgr covolln) to soon hooe M oeo‘taom conn, AX Atwever. one n nooffoett nfimodOen to deferown the noonflude of the en Of ber(AbbAan rAKAcen rolA thew devAAA comp.,' woe other neadeago canoe/ tom et to Simon whetter an nil a on000led mt. sone ei al pf sone OfploCeoent Mellen Cenoectets 'PA o °HAT" a) mato soveltanCt to bent. AntOsotad the Mk Of Aloolteta nokotAno from we of restore Anplaement nee:Yarns connectors neVICAC A or.itheo ditplacilmint rindhillAi Connate( pat of median. gotten tad tor Ydravarealat %CASS. 'RASO &MACS May AGO AA (Atanal TO So now Xlivatal Yana? 'OMANI( WA' it 'ACC•fain.• and way to ',Oaten, pressure Si 'NAM,. as/ex.:mane Ai Una pc00ACt aircelpoons. Meconwnewilollions to lieolthowe Professionals: :0011. two toeFenAtAl AOCnbe) nand citaatenl m nine Pens Of tAntfitS atoned It Wen (hit,' fAvon. panals seepage odwecheter2004/29/51)9 Thor pirlerre Sr.. 'D. not use Knob,-penoe AmOteaos caveat*" eon Anemia waref before a then,* ArleAlrrOnt of oOn. benefit,. MO COJC400, MOVAMO Mile, sot. The [DOA rstr.Y evolusbm lupoort. on r•Clen.WeeNb0. Pallaladad Simonton°. Stwilleo ' DA a spoon, compooes out reaulactano AWN,' Oisplacomool medals. connectors to COlduCt pOdtroakOt lurvellioCA ttudiat. Site SWOON. All NO Clint/ MA nloc n0i 35.140at‘C mth Out. metes end datna Woo percale Met neat and tenets. t4AnufaCeSact tilt be taAtes:1 to codAct dna OA illoOd.troarn AIKL4Chl• IA 0-atiefta who AlCaesd tow dart° COripa“ to wenn APIA r•C arra] Out totes of eaeataate CCITACGAA. Mote 'JOWL Can CA toad n MA% weer to inAKIIOn Control OcOlearnalt weeny emblems he pal' r.S.Pl Annie., of ...nonevents can help r04 edirely sod bolter trderstind the Alio associate/ eea necked onreagn veil suspect ratans eaa. tee use of positive seplaterrot nowllegrei correcton. we "-cottage ,is,, to fie • volnteri report Meer teneaSteh. Me 'OA Sliety Worriagion ore Adverse Font Iiiipetoo agorae. endorse remoras tiniroyeol IrCellel that Coe mime' to MA'S devire ter rocky resole; neunnents rein Ones the 'Mono, vaccine ntaAohed by llwr lookers. Meth care ,,teas are woo On:Corapor to mole and raaitet throcaoa <cam panonr... Her towed a [omen deptaconeant missed correcta conetutoo to a boxickwawn nioCUCes. c—a IstIoniseksio II see ler. *nom aboce this COluntroCatiri. Pelee COotaft ONO CivesCo ir Sae/ isruloctorery interreions and canon' Airootwee (DACCA) ot A.a6.Gda 000-03•204I atkliticool neormaeloor . FOr. mese* M Pacoatat Swoolliwc• etudes • tatter re InIscOon Contra rroreitionals TM donireee nonocts Fent current a•mayaS et avilaOlo nAamatAaL n nannat .CO In COnnienttne W Worn Me otiW about ondAed essay maws <Iowa, aanos. Try nava frAoyatues And *ono.. Ana: einkartr v.pact of the stuatun JO • NY' Vd.t ant. A•As-Al -AO A ..pet Assts add Motion (Han.. Ont.) Aro-ASA:A "to. MINT Lail ffialisSIPOLLTI. StawCennorvainn, Nth: MAIM AtertolaA SoodiCAIDAICeS te,M0Atilte on Drone StIMb looloiiirmiti Ikeda Doacep July 2010 FDA notifies Infection Control Officer's and Manufacturers via the ALERT & NOTIFICATION LETTER on Positive Displacement I.V. Connectors RyMed is the ONLY manufacturer not sited in this FDA Alert 41 EFTA01117442 Negative Fluid Displacement * * BiofiIm Colonization * * RyMed's InVision-Plus® in-vitro test study results: 93.0% - 99.9 % reduction of biofilm colonization over other Competitive I.V. connectors tested 1.0£•.05 1.0E -O4 of MT 0 3 CU 1.0E-0-02 1.0E+00 Bacterin International, Inc.. Belgrade MT conducted the test study Al awls !Smart Site el La miB. Braun UN re- SHOD O F Aeon ger FLOUNK I 44D Pool Flow so I ant or CLS AFtl_ INK C:1.„I CL AVE C1000 - IC LI CLCZ2000 CO Al ails S man Site a NI iogy0o n Max Plum COMO 0-elly le CI ICU M io roCLA VS þy Mrl 10%11 on -el Us .t nal v - -5 " .M.a, in I" In I =An MI IN TECHNOLOGIES, NC. 42 EFTA01117443 Key Product Design Issues ** Septum Seal Integrity * * Large gaps, openings or certain septum surface designs compromise nursing swabbing and disinfection practice and contribute to downstream microbial ingress and biofilm colonization potential Before Swabbing After Aggressive Swabbing After Disconnect Product shown is currently one of the market leaders RvNled - InVision-Plus® with Neutral Advantage"' A fully compressed and tightly sealed septum surface design is important to fully support nursing swabbing and disinfection practice for effective downstream microbial ingress and biofilm colonization lEr a: After 5 Second Swab After Disconnect MI ar —.1o. '.al r - a sr .• an In . m•W 'V la es'''. am a. V' -, a [repeated 3 times] / -= Me I= a * a 8 UV 110 0 la/ la laa a a IS le an 43 MIL al..I .€ 1 TICWIO17611, INC EFTA01117444 Key Product Design Issues **Fluid Pathwa ** Most competitive I.V. connectors have large fluid dead space within the fluid pathway. Dead space entraps the patient's blood, contributing to biofilm colonization CareFusion B. Braun SmartSite® UltraSite® CareFusion® MaxClearTM MI I 1)1111:: ,141 Dead space (Pink) — Complicated, ineffective flushing RyMed - InVision-Plus® with Neutral Advantage"' Straight-through fluid pathway Zero dead space Zero fluid displacement Low priming volume (0.027mL) 99.94% effective blood clearing after 1 ml normal saline r - [repeated 3 times] S Ala -a a- Is ra At vi, 7 1 ra ff-t Sr: 1"-s• TECHNOLOGIES, INC. 44 EFTA01117445

Technical Artifacts (9)

View in Artifacts Browser

Email addresses, URLs, phone numbers, and other technical indicators extracted from this document.

Domainwww.rymedtech.com
IPv61111::
Phone278 2008
Phone313 2009
Phone400 2010
Phone400 2011
Phone558 2007
Wire RefReference
Wire Refrefluxing

Forum Discussions

This document was digitized, indexed, and cross-referenced with 1,400+ persons in the Epstein files. 100% free, ad-free, and independent.

Annotations powered by Hypothesis. Select any text on this page to annotate or highlight it.