Presentation on theme: "IVIVI TECHNOLOGIES, INC."— Presentation transcript:
1IVIVI TECHNOLOGIES, INC. 3/25/2017THETECHNOLOGYOF LIFEIVIVI TECHNOLOGIES, INC.NASDAQSymbol: IVVI
2FORWARD-LOOKING STATEMENT 3/25/2017FORWARD-LOOKING STATEMENTStatements may be made in the course of this presentation with respect to the Company's or management's intentions, hopes, beliefs, expectations or predictions of the future. These are forward-looking statements that involve risks and uncertainties. It is important to note that the Company's actual results could differ materially from those projected in any forward-looking statements. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained in the Company's filings with the Securities and Exchange Commission (“SEC”), including its Form 10-KSB for the fiscal year ended March 31, 2007 and other reports filed by the Company from time to time with the SEC.3/25/ :33 AM
3OVERVIEW NASDAQ: IVVI Recent Price: $5.25* 3/25/2017OVERVIEWNASDAQ: IVVIRecent Price: $5.25*52 Week Range: $ $6.64*Market Capitalization: $55.6 million*Total shares outstanding: 10.7 million (12/31/07)* as of 02/22/08
43/25/2017HIGHLIGHTSProven, science-based “platform technology” – targeted electrotherapies for treatment of diseasesNon-invasive, non-pharmacologic treatment with no known side effectsFDA cleared to treat post-operative pain and edema in soft tissuePublished studies provide clinical evidence of efficacyGrowing number of partnerships and alliancesMulti-disciplinary team of scientists, engineers, physicians and executivesLarge and diverse market opportunitiesCurrent FutureChronic wound care: $3.8 B Arthritic pain: $59 B Cosmetic surgery: $9.4 B Cardiovascular: $142.5 BStem cell therapy: $5.6 BOrthopedics: $22.5 B
5Case Studies Post-breast CA, 2 failed flaps, 3/25/2017Case StudiesPost-breast CA, 2 failed flaps,radiation treatment inhibits healingBegin Ivivi PEMF Therapy Nine Weeks PEMFFailed TRAM post breast reconstructionToday we are already generating revenue in 2 markets - the Cosmetic and Bariatric Surgery Market, as well as the Chronic wound care market. In addition to these 2 markets we have a number of patents pending for 9 other specific vertical medical market opportunities including opthalmic, neurological, cardiac, orthopedics and others.Thirteen Weeks PEMFThis slide contains before and after photographs showing the results of a single therapeutic use in humans. These photographs are presented for illustration purposes only and do not guarantee similar results in all cases.
6Indian Health Service Venous Stasis Ulcer 3/25/2017Indian Health Service Venous Stasis Ulceradmitted with severe lower body lymphedema with open venous wounds bilaterally acquired 8/06. Tx started in wound care on 11/06. pmx of etoh with liver disease, decreased h&h, low albumin, asthma, and htn use of bilateral lymphedema pumps for two months until patient developed pul edema and was dc'd from pump s/p hospitalization.wounds non healing in spite of conservative therapy until ivivi started on 6/15/07.since 6/15 wt from 231 down to 213, wounds healed by 9/7/07, no htn, pt received arginade for albumin fluid shift and has not had reoccurance of wounds.Venous stasis ulcer healed (3 wounds total)at 12 weeksVenous stasis ulcer unresponsive for10 monthsThis slide contains before and after photographs showing the results of a single therapeutic use in humans. These photographs are presented for illustration purposes only and do not guarantee similar results in all cases.
7TECHNOLOGY VALIDATION AND CLINICAL EVIDENCE 3/25/2017TECHNOLOGY VALIDATION AND CLINICAL EVIDENCETechnology Validation:CMS (Medicare) issued National Coverage Determination for PEMF for healing chronic woundsAHCPR Federal Guidelines for Pressure Ulcers: “electrotherapies” only effective adjunctive treatmentASAPS endorses 40% acceleration in healing in human burn modelClinical Evidence:72% reduction of sacral ulcers in paraplegics (Kloth, et al 1999)700% reduction in swelling, acute ankle sprain (Pilla, et al 1996, 1999)69% acceleration in tendon healing (Strauch, Pilla et al; The Journal of Hand Surgery, September 2006)500% increase in new blood vessels (Roland, et al, 2000 and Weber, et al, 2004 Plastic and Reconstructive Surgery)59% increase in surgical wound healing (Strauch, Pilla et al; Plastic and Reconstructive Surgery, August 2007)40% acceleration in post-surgery recovery (ASAPS, 2001)80% acceleration in post-surgery pain relief (Heden, 2007)60% more significant soft-tissue repair than for bone growth (Akai M, Hayashi K meta-analysis, Bioelectromagnetics, 2002)
8Ivivi Wheel of Innovation 3/25/2017Ivivi Wheel of InnovationToday we are already generating revenue in 2 markets - the Cosmetic and Bariatric Surgery Market, as well as the Chronic wound care market. In addition to these 2 markets we have a number of patents pending for 9 other specific vertical medical market opportunities including opthalmic, neurological, cardiac, orthopedics and others.
9HOW ELECTROCEUTICALS WORK 3/25/2017HOW ELECTROCEUTICALS WORKDisease: Disruption of cellular electrochemistryHealing: Restoration of key electrochemical processes that initiate the anti-inflammatory and growth factor cascadesFirst class of ElectroceuticalsEnhance healingEasy-to-use, FDA-cleared technologyNon-invasiveNo known side effectsNo effects on healthy tissueIncrease efficiency of natural anti-inflammatory responseAll biological activity can be thought of as complex, inter-related cascades
10EVOLUTION OF ELECTROCEUTICALS 3/25/2017EVOLUTION OF ELECTROCEUTICALSPulsed DiathermyHigh power PEMF to treat pain and edema (1930s)Bone Growth StimulatorsPEMF to heal recalcitrant fractures (1974)Standard of care in orthopedicsTargeted PEMFsTarget specific electrochemical processes (Calcium/CalModulin Binding)Exploits science of electrochemistry for therapy (like MRI or CAT scan does for diagnosis)
11EXAMPLE SIGNAL CONFIGURATION Tendon Repair Model (Strauch, et al, JHS 2006)(MRT) (SofPulse)
12INTELLECTUAL PROPERTY 3/25/2017INTELLECTUAL PROPERTYProprietary product developmentBroad basic targeted PEMF patentsPicket-fence strategy – surround main patents with applications16 issued and pending patentsIndependent audit supports broad patent protectionTechnology advancement: Mathematical Computer Modeling of Cellular Activity, Design, Testing, Manufacturing (like David’s). See the page from StevenSecond slide on patent protection
14STRATEGIC BUSINESS MODEL 3/25/2017STRATEGIC BUSINESS MODELValidateTherapySeed Target MarketsNegotiatePartnershipsBeta markettestingInitialMarketing & SalesLarge Scale DistributionBasic ScienceFor Example:Wound CareRent products into acute care, LTACHs, VA, Skilled Nursing and Home Health CareIndependent distributors in select marketsCosmetic SurgerySell disposable products to surgeonsPass-through or mark-upClinicalEfficacy
15COSMETIC SURGERY Partner: Allergan (AGN) 3/25/2017COSMETIC SURGERYPartner: Allergan (AGN)Exclusive world-wide distribution (cosmetic, bariatric surgery only)8-year term, minimum performanceUpfront licensing fee, advantageous revenue splitInitial 20,000 unit order received September 2007Marketing underway, unit pricing ~$250Market Opportunity > $500 million650,000 Breast procedures540,000 Facial Procedures575,000 Liposuction/Abdominal1,500,000 Non-surgical procedures (peels, micro-dermabrasion)Clinical Support80% acceleration in post-surgery pain relief, % reduction in pain medication (Heden 2007)Post-facial surgery study underwayPost-adomonoplasty study anticipatedCapsular contracture study anticipated
16WOUND CARE $3.3 Billion Market Opportunity (2004/2005 data) 3/25/2017WOUND CARE$3.3 Billion Market Opportunity (2004/2005 data)5 million chronic wounds (US)Long-Term Acute Care (LTACH): 440 / $15.6 millionNursing Homes: 14,900 / $187 millionHospitals: 4,900 / $176 millionHome Health Care: 7.6 million / $3 billionMedicare Issued National Coverage DeterminationClinical Evidence, Cost Savings Driving Usage72% decrease in wound size (Kloth, et al 1999)LTACH competitive analysis driving unit gainsThis slide contains before and after photographs showing the results of a single therapeutic use in humans. These photographs are presented for illustration purposes only and do not guarantee similar results in all cases.
17WOUND CARE Seeding Initiatives Ongoing Next Steps 3/25/2017WOUND CARESeeding Initiatives OngoingOver 600,000 treatments n/k side effectsRental + disposable model9 sales people in NY and TX areasInitial targets LTACHS, VA and Skilled Nursing FacilitiesNext StepsNational Contracts with LTACHSRegency Hospital Company 1/08Product evaluations by other chains ongoingHealing rates of 49-99% being achieved within weeks often after negative pressure therapy failedAnnounce wound partnersDSI Renal 2/08Additional discussions underway
18CHRONIC KIDNEY DISEASE (CKD) License agreement with DSI Renal, Inc120 Dialysis Centers, 400 affiliated MDs, 8000 patientsHigh prevalence of diabetics, diabetic ulcers, and other vascular disordersFounders are successful serial entrepreneurs in CKDPhase I: DSI significant multi-center clinical trialsDouble-blind, randomized placebo-controlled150 patientsPrimary end-points:time to complete healingdegree of wound healing expressed as % total volume area healed at a specific time% of non-healing woundsStart by 6/30/08Phase II: Sell technology into CKD market20 million in US with CKD (Source: Kidney Foundation 2008)
193/25/2017CONSUMER PAIN RELIEF21 million U.S. osteoarthritis patients*Non-invasive, non-pharmacologic alternative to NSAID (e.g. aspirin)No known side-effects7-fold decrease in edema in acute injury (Pilla, et al 1999)Current statusPrototypes developedOn-label regulatory strategy510-K filing plannedPrescription strengthOver-the-counterStudies for marketing claims plannedPartner discussions ongoing$4 Billion in devices, Chronic pain afflicts 40 million Americans, Cost to economy over $100 BillionNo known side-effects, No known long-tem effects, Safe and effective* American College of Rheumatology
20ANGIOGENESIS Angiogenesis – creation of new blood vessels 3/25/2017ANGIOGENESISAngiogenesis – creation of new blood vesselsInitial applications in Stem Cells, Tissue Regeneration, Neurology, and CardiologyArterial loops in rats at 8 weeks show 500% increasePlacebo-treated arterial loopActively treated arterial loopRoland, et al., 2000 and Weber, et al., 2004 Plastic and Reconstructive SurgeryThis slide contains before and after photographs showing research results in animal models. These photographs are presented for illustrating research activities only and do not guarantee similar results in humans.
21CARDIOVASCULAR ANGIOGENESIS 3/25/2017CARDIOVASCULAR ANGIOGENESISEffects on injured heart in animal modelWithout Treatment (sham)With TreatmentHeart tissue near injuryHeart tissue near injuryNew vessel growthNew vessel growthCleveland Clinic Study to be completed by 1st Q 2007100% increase in new blood vessels in treated animalsTotal global market opportunity: $142.5 Billion (AHA 2006)This slide contains before and after photographs showing research results in animal models. These photographs are presented for illustrating research activities only and do not guarantee similar results in humans.
22Cleveland Clinic Florida 3/25/2017Cleveland Clinic FloridaInitial human clinical trialRandomized, double blinded, placebo controlledEnd-stage ischemic heart disease30 patients (15 active, 15 sham)Endpointsimprovement in regional myocardial perfusion and functionimprovement in angina and EX toleranceLast patient completed trial January 2008Preliminary results expected by June 30, 2008$4 Billion in devices, Chronic pain afflicts 40 million Americans, Cost to economy over $100 BillionNo known side-effects, No known long-tem effects, Safe and effective
23For the 12 months ended March 31 For the 9 months ended December 31 3/25/2017OPERATING RESULTSFor the 12 months ended March 31For the 9 months ended December 3120072006Total revenues$1,182,340$786,512$1,080,347$813,174Research and dev.$1,610,232$1,334,637$1,515,396$1,644,029Sales and marketing$1,098,266$1,152,947$1,391,098$913,086General and admin.$2,217,743$2,055,865$3,423,992$2,694,857Total oper. expenses$7,269,363$5,478,121$6,586,684$5,379,399Operating loss$(6,087,023)$(4,691,609)$(5,506,337)$(4,566,225)Just briefly on our operating results. Revenues in Fiscal 2007 which ended March 31 was approximately $1.2 million compared to $786,000 in fiscal and we had an operating loss of approximately $6.1 million. For the first two months of fiscal 2008, revenues were $687 thousand compared to $586 thousand. Year to date, for the first six months of fiscal 2008 we had an operating loss of $3.2 million.
243/25/2017BALANCE SHEETSDecember 31, 2007(unaudited)March 31, 2007(audited)Total current assets$9,301,864$8,926,511Total assets$10,524,264$9,303,473Working capital$8,194,640$7,883,879Total liabilities$1,534,307$1,516,590Stockholders’ equity$8,989,957$7,786,883Looking at our balance sheet, at September 30, 2007 we had current assets of $5.9 million and in October we raised an additional $4.8 million dollars in cash. With a current burn rate of $xxx,xxx per month we have sufficient capital for at least the next 12 months. Total shares outstanding after the offering are approximately 10.6 million. We do have outstanding warrants, which if exercised would bring in an additional $xx million and brings fully diluted shares outstanding to just over 16 million.
25CAPITALIZATION 01/31/2008 Founders 1,495,000 Conversion of Notes 3/25/2017CAPITALIZATION01/31/2008Founders1,495,000Conversion of Notes2,061,783ADM Tronics’ shares3,250,000IPOUnderwriters purchase optionExercised OptionsExercised WarrantsPrivate Placement2,500,000250,00052,12582,2351,000,000Total shares outstanding10,691,143Warrants outstanding2,643,191Options outstanding2,714,975Number of fully diluted shares16,049,309
263/25/2017SELECT MILESTONESOct. ‘06 Pricing of Initial Public Offering, Listing on AMEXNov. ‘06 Allergan Worldwide Distribution AgreementApr. ‘07 Health Canada Approval of Roma3 Electrotherapy Device for Treatment of WoundsJun. ‘07 CE Approval of Certain Electrotherapy DevicesJun. ‘07 Completion of Patient Enrollment for Cardiac Clinical Trial at the Cleveland Clinic, FloridaSep. ‘07 Received Initial 20,000 Unit Order from Allergan; Launch UnderwayOct. ‘07 Completed $5 million private placementJan. ‘08 Listing on NASDAQ Capital MarketJan. ’08 Three Year Contract with Regency Hospital CompanyFeb. ‘08 Research and Licensing Agreement with DSI RenalUpcoming MilestonesPotential partnerships for additional market verticals510(k) application for OTC and prescription pain technologyCleveland Clinic cardiovascular study resultsAnd now to conclude, I want to share with you some of the upcoming milestones to watch for as we move Ivivi to the next level.We have made significant progress since our IPO in October of We announced our agreement with Allergan in November of 2006 and in September of 2007 received our first order signaling the start of the US launch. We received marketing approvals in Canada and the European Union for the wound care indication in April and June of 2007 respectively. We completed enrollment of our Cleveland Clinic Cardiac trial in June. In October of 2007, we completed a $5 million private placement at slightly above market price with no warrants - significantly strengthening our balance sheet. We also had several clinical trials published during the year as well.Looking ahead, we hope to sign contracts with hospital chains to expand use of our technology in the treatment of chronic wounds and be able to announce a partner for the wound care space. We are also preparing to file a 510-K for a consumer pain device. And finally, we look forward to receiving the results of the Cleveland Clinic cardiac study which, if positive as we hope, will mean an even larger study and possible discussions with potential partners in this market as well.We hope you found this presentation interesting and that you now know why we are excited about our company and our future. Thank you for your time in allowing us to tell you about Ivivi Technologies.