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IVIVI TECHNOLOGIES, INC.
3/25/2017 THE TECHNOLOGY OF LIFE IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI
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FORWARD-LOOKING STATEMENT
3/25/2017 FORWARD-LOOKING STATEMENT Statements 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
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OVERVIEW NASDAQ: IVVI Recent Price: $5.25*
3/25/2017 OVERVIEW NASDAQ: IVVI Recent 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
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3/25/2017 HIGHLIGHTS Proven, science-based “platform technology” – targeted electrotherapies for treatment of diseases Non-invasive, non-pharmacologic treatment with no known side effects FDA cleared to treat post-operative pain and edema in soft tissue Published studies provide clinical evidence of efficacy Growing number of partnerships and alliances Multi-disciplinary team of scientists, engineers, physicians and executives Large and diverse market opportunities Current Future Chronic wound care: $3.8 B Arthritic pain: $59 B Cosmetic surgery: $9.4 B Cardiovascular: $142.5 B Stem cell therapy: $5.6 B Orthopedics: $22.5 B
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Case Studies Post-breast CA, 2 failed flaps,
3/25/2017 Case Studies Post-breast CA, 2 failed flaps, radiation treatment inhibits healing Begin Ivivi PEMF Therapy Nine Weeks PEMF Failed TRAM post breast reconstruction Today 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 PEMF This 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.
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Indian Health Service Venous Stasis Ulcer
3/25/2017 Indian Health Service Venous Stasis Ulcer admitted 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 weeks Venous stasis ulcer unresponsive for 10 months This 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.
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TECHNOLOGY VALIDATION AND CLINICAL EVIDENCE
3/25/2017 TECHNOLOGY VALIDATION AND CLINICAL EVIDENCE Technology Validation: CMS (Medicare) issued National Coverage Determination for PEMF for healing chronic wounds AHCPR Federal Guidelines for Pressure Ulcers: “electrotherapies” only effective adjunctive treatment ASAPS endorses 40% acceleration in healing in human burn model Clinical 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)
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Ivivi Wheel of Innovation
3/25/2017 Ivivi Wheel of Innovation Today 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.
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HOW ELECTROCEUTICALS WORK
3/25/2017 HOW ELECTROCEUTICALS WORK Disease: Disruption of cellular electrochemistry Healing: Restoration of key electrochemical processes that initiate the anti-inflammatory and growth factor cascades First class of Electroceuticals Enhance healing Easy-to-use, FDA-cleared technology Non-invasive No known side effects No effects on healthy tissue Increase efficiency of natural anti-inflammatory response All biological activity can be thought of as complex, inter-related cascades
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EVOLUTION OF ELECTROCEUTICALS
3/25/2017 EVOLUTION OF ELECTROCEUTICALS Pulsed Diathermy High power PEMF to treat pain and edema (1930s) Bone Growth Stimulators PEMF to heal recalcitrant fractures (1974) Standard of care in orthopedics Targeted PEMFs Target specific electrochemical processes (Calcium/CalModulin Binding) Exploits science of electrochemistry for therapy (like MRI or CAT scan does for diagnosis)
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EXAMPLE SIGNAL CONFIGURATION
Tendon Repair Model (Strauch, et al, JHS 2006) (MRT) (SofPulse)
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INTELLECTUAL PROPERTY
3/25/2017 INTELLECTUAL PROPERTY Proprietary product development Broad basic targeted PEMF patents Picket-fence strategy – surround main patents with applications 16 issued and pending patents Independent audit supports broad patent protection Technology advancement: Mathematical Computer Modeling of Cellular Activity, Design, Testing, Manufacturing (like David’s). See the page from Steven Second slide on patent protection
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MARKET OPPORTUNITY CURRENT MARKETS FUTURE MARKETS
3/25/2017 MARKET OPPORTUNITY CURRENT MARKETS Chronic Wound Care: $3.8 Billion Cosmetic Surgery: $9.4 Billion FUTURE MARKETS Osteoarthritic Pain: $59 Billion Stem Cells and Tissue Regeneration: $5.6 Billion Orthopedic Applications: $22.5 Billion Angiogenesis and Vascularization: $142.5 Billion
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STRATEGIC BUSINESS MODEL
3/25/2017 STRATEGIC BUSINESS MODEL Validate Therapy Seed Target Markets Negotiate Partnerships Beta market testing Initial Marketing & Sales Large Scale Distribution Basic Science For Example: Wound Care Rent products into acute care, LTACHs, VA, Skilled Nursing and Home Health Care Independent distributors in select markets Cosmetic Surgery Sell disposable products to surgeons Pass-through or mark-up Clinical Efficacy
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COSMETIC SURGERY Partner: Allergan (AGN)
3/25/2017 COSMETIC SURGERY Partner: Allergan (AGN) Exclusive world-wide distribution (cosmetic, bariatric surgery only) 8-year term, minimum performance Upfront licensing fee, advantageous revenue split Initial 20,000 unit order received September 2007 Marketing underway, unit pricing ~$250 Market Opportunity > $500 million 650,000 Breast procedures 540,000 Facial Procedures 575,000 Liposuction/Abdominal 1,500,000 Non-surgical procedures (peels, micro-dermabrasion) Clinical Support 80% acceleration in post-surgery pain relief, % reduction in pain medication (Heden 2007) Post-facial surgery study underway Post-adomonoplasty study anticipated Capsular contracture study anticipated
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WOUND CARE $3.3 Billion Market Opportunity (2004/2005 data)
3/25/2017 WOUND CARE $3.3 Billion Market Opportunity (2004/2005 data) 5 million chronic wounds (US) Long-Term Acute Care (LTACH): 440 / $15.6 million Nursing Homes: 14,900 / $187 million Hospitals: 4,900 / $176 million Home Health Care: 7.6 million / $3 billion Medicare Issued National Coverage Determination Clinical Evidence, Cost Savings Driving Usage 72% decrease in wound size (Kloth, et al 1999) LTACH competitive analysis driving unit gains This 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.
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WOUND CARE Seeding Initiatives Ongoing Next Steps
3/25/2017 WOUND CARE Seeding Initiatives Ongoing Over 600,000 treatments n/k side effects Rental + disposable model 9 sales people in NY and TX areas Initial targets LTACHS, VA and Skilled Nursing Facilities Next Steps National Contracts with LTACHS Regency Hospital Company 1/08 Product evaluations by other chains ongoing Healing rates of 49-99% being achieved within weeks often after negative pressure therapy failed Announce wound partners DSI Renal 2/08 Additional discussions underway
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CHRONIC KIDNEY DISEASE (CKD)
License agreement with DSI Renal, Inc 120 Dialysis Centers, 400 affiliated MDs, 8000 patients High prevalence of diabetics, diabetic ulcers, and other vascular disorders Founders are successful serial entrepreneurs in CKD Phase I: DSI significant multi-center clinical trials Double-blind, randomized placebo-controlled 150 patients Primary end-points: time to complete healing degree of wound healing expressed as % total volume area healed at a specific time % of non-healing wounds Start by 6/30/08 Phase II: Sell technology into CKD market 20 million in US with CKD (Source: Kidney Foundation 2008)
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3/25/2017 CONSUMER PAIN RELIEF 21 million U.S. osteoarthritis patients* Non-invasive, non-pharmacologic alternative to NSAID (e.g. aspirin) No known side-effects 7-fold decrease in edema in acute injury (Pilla, et al 1999) Current status Prototypes developed On-label regulatory strategy 510-K filing planned Prescription strength Over-the-counter Studies for marketing claims planned Partner discussions ongoing $4 Billion in devices, Chronic pain afflicts 40 million Americans, Cost to economy over $100 Billion No known side-effects, No known long-tem effects, Safe and effective * American College of Rheumatology
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ANGIOGENESIS Angiogenesis – creation of new blood vessels
3/25/2017 ANGIOGENESIS Angiogenesis – creation of new blood vessels Initial applications in Stem Cells, Tissue Regeneration, Neurology, and Cardiology Arterial loops in rats at 8 weeks show 500% increase Placebo-treated arterial loop Actively treated arterial loop Roland, et al., 2000 and Weber, et al., 2004 Plastic and Reconstructive Surgery 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.
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CARDIOVASCULAR ANGIOGENESIS
3/25/2017 CARDIOVASCULAR ANGIOGENESIS Effects on injured heart in animal model Without Treatment (sham) With Treatment Heart tissue near injury Heart tissue near injury New vessel growth New vessel growth Cleveland Clinic Study to be completed by 1st Q 2007 100% increase in new blood vessels in treated animals Total 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.
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Cleveland Clinic Florida
3/25/2017 Cleveland Clinic Florida Initial human clinical trial Randomized, double blinded, placebo controlled End-stage ischemic heart disease 30 patients (15 active, 15 sham) Endpoints improvement in regional myocardial perfusion and function improvement in angina and EX tolerance Last patient completed trial January 2008 Preliminary results expected by June 30, 2008 $4 Billion in devices, Chronic pain afflicts 40 million Americans, Cost to economy over $100 Billion No known side-effects, No known long-tem effects, Safe and effective
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For the 12 months ended March 31 For the 9 months ended December 31
3/25/2017 OPERATING RESULTS For the 12 months ended March 31 For the 9 months ended December 31 2007 2006 Total revenues $1,182,340 $786,512 $1,080,347 $813,174 Research and dev. $1,610,232 $1,334,637 $1,515,396 $1,644,029 Sales and marketing $1,098,266 $1,152,947 $1,391,098 $913,086 General and admin. $2,217,743 $2,055,865 $3,423,992 $2,694,857 Total oper. expenses $7,269,363 $5,478,121 $6,586,684 $5,379,399 Operating 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.
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3/25/2017 BALANCE SHEETS December 31, 2007 (unaudited) March 31, 2007 (audited) Total current assets $9,301,864 $8,926,511 Total assets $10,524,264 $9,303,473 Working capital $8,194,640 $7,883,879 Total liabilities $1,534,307 $1,516,590 Stockholders’ equity $8,989,957 $7,786,883 Looking 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.
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CAPITALIZATION 01/31/2008 Founders 1,495,000 Conversion of Notes
3/25/2017 CAPITALIZATION 01/31/2008 Founders 1,495,000 Conversion of Notes 2,061,783 ADM Tronics’ shares 3,250,000 IPO Underwriters purchase option Exercised Options Exercised Warrants Private Placement 2,500,000 250,000 52,125 82,235 1,000,000 Total shares outstanding 10,691,143 Warrants outstanding 2,643,191 Options outstanding 2,714,975 Number of fully diluted shares 16,049,309
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3/25/2017 SELECT MILESTONES Oct. ‘06 Pricing of Initial Public Offering, Listing on AMEX Nov. ‘06 Allergan Worldwide Distribution Agreement Apr. ‘07 Health Canada Approval of Roma3 Electrotherapy Device for Treatment of Wounds Jun. ‘07 CE Approval of Certain Electrotherapy Devices Jun. ‘07 Completion of Patient Enrollment for Cardiac Clinical Trial at the Cleveland Clinic, Florida Sep. ‘07 Received Initial 20,000 Unit Order from Allergan; Launch Underway Oct. ‘07 Completed $5 million private placement Jan. ‘08 Listing on NASDAQ Capital Market Jan. ’08 Three Year Contract with Regency Hospital Company Feb. ‘08 Research and Licensing Agreement with DSI Renal Upcoming Milestones Potential partnerships for additional market verticals 510(k) application for OTC and prescription pain technology Cleveland Clinic cardiovascular study results And 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.
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3/25/2017 NASDAQ - IVVI
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