IVIVI TECHNOLOGIES, INC.
NASDAQ
Symbol: IVVI
THETECHNOLOGY
OF LIFE
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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.
04/10/23 20:08
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OVERVIEW
NASDAQ: IVVI Recent Price: $5.25* 52 Week Range: $3.00 - $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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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 FutureChronic 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
Failed TRAM Failed TRAM post breast post breast reconstructionreconstruction
Post-breast CA, Post-breast CA, 2 failed flaps,2 failed flaps,radiation radiation treatment treatment inhibits healinginhibits healing
Begin Ivivi PEMF TherapyBegin Ivivi PEMF Therapy Nine Weeks PEMFNine Weeks PEMF
Thirteen Weeks PEMFThirteen 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
Venous stasis ulcer Venous stasis ulcer unresponsive forunresponsive for
10 months10 months
Venous stasis ulcer Venous stasis ulcer healed (3 wounds total)healed (3 wounds total)
at 12 weeksat 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.
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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
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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
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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
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
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MARKET OPPORTUNITY
CURRENT MARKETS
FUTURE MARKETS
Stem Cells and Tissue Regeneration: $5.6 Billion
Cosmetic Surgery: $9.4 Billion
Chronic Wound Care: $3.8 Billion
Orthopedic Applications: $22.5 Billion
Angiogenesis and Vascularization: $142.5 Billion
Osteoarthritic Pain: $59 Billion
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STRATEGIC BUSINESS MODEL
Beta markettesting
InitialMarketing & Sales
Large Scale Distribution
Basic Science
Clinical Efficacy
Validate Therapy Seed Target Markets
Negotiate Partnerships
Negotiate Partnerships
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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
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$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.
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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
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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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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
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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 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.
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CARDIOVASCULAR ANGIOGENESIS
Effects on injured heart in animal model
Total global market opportunity: $142.5 Billion (AHA 2006)
With TreatmentWithout Treatment (sham)
New vessel growth
New vessel growth
Heart tissue near injury 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.
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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
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OPERATING RESULTS
For the 12 months ended March 31
For the 9 months ended December 31
2007 2006 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)
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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
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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
2,500,000250,000
52,12582,235
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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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
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NASDAQ - IVVI