Presentation on theme: "IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE."— Presentation transcript:
IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE
Page 2 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. 1/11/2014 2:54 PM
Page 3 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
Page 4 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 BArthritic pain: $59 B Cosmetic surgery: $9.4 B Cardiovascular: $142.5 B Stem cell therapy: $5.6 B Orthopedics: $22.5 B
Page 5 Case Studies Failed TRAM post breast reconstruction Post-breast CA, 2 failed flaps, radiation treatment inhibits healing Begin Ivivi PEMF Therapy Nine Weeks PEMF Thirteen Weeks PEMF 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.
Page 6 Indian Health Service Venous Stasis Ulcer Venous stasis ulcer unresponsive for 10 months 10 months Venous stasis ulcer healed (3 wounds total) at 12 weeks 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.
Page 7 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)
Page 8 Ivivi Wheel of Innovation
Page 9 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
Page 10 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)
Page 11 EXAMPLE SIGNAL CONFIGURATION Tendon Repair Model (Strauch, et al, JHS 2006) (MRT) (SofPulse)
Page 12 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
Page 14 STRATEGIC BUSINESS MODEL Beta market testing Initial Marketing & Sales Large Scale Distribution Basic Science Clinical Efficacy Validate Therapy Seed Target Markets Negotiate Partnerships Negotiate Partnerships
Page 15 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, 250% reduction in pain medication (Heden 2007) Post-facial surgery study underway Post-adomonoplasty study anticipated Capsular contracture study anticipated
Page 16 $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 WOUND CARE 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.
Page 17 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 WOUND CARE
Page 18 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)
Page 19 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 * American College of Rheumatology
Page 20 Angiogenesis – creation of new blood vessels Initial applications in Stem Cells, Tissue Regeneration, Neurology, and Cardiology ANGIOGENESIS Placebo-treated arterial loop Actively treated arterial loop Arterial loops in rats at 8 weeks show 500% increase 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.
Page 21 CARDIOVASCULAR ANGIOGENESIS Effects on injured heart in animal model Total global market opportunity: $142.5 Billion (AHA 2006) With Treatment Without Treatment (sham) New vessel growth Heart tissue near injury 100% increase in new blood vessels in treated animals 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.
Page 22 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
Page 23 OPERATING RESULTS For the 12 months ended March 31 For the 9 months ended December 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)
Page 24 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
Page 25 CAPITALIZATION 01/31/2008 Founders1,495,000 Conversion of Notes2,061,783 ADM Tronics shares3,250,000 IPO Underwriters purchase option Exercised Options Exercised Warrants Private Placement 2,500, ,000 52,125 82,235 1,000,000 Total shares outstanding10,691,143 Warrants outstanding2,643,191 Options outstanding2,714,975 Number of fully diluted shares16,049,309
Page 26 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