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IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE
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IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

Mar 26, 2015

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Page 1: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

IVIVI TECHNOLOGIES, INC.

NASDAQ

Symbol: IVVI

THETECHNOLOGY

OF LIFE

Page 2: 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.

04/10/23 20:08

Page 3: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

Page 3

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

Page 4: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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 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

Page 5: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

Page 5

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.

Page 6: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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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.

Page 7: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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 TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

Page 8

Ivivi Wheel of Innovation

Page 9: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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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

Page 10: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

Page 11

EXAMPLE SIGNAL CONFIGURATION

Tendon Repair Model (Strauch, et al, JHS 2006)

(MRT) (SofPulse)

Page 12: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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 13: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

Page 13

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

Page 14: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

Page 14

STRATEGIC BUSINESS MODEL

Beta markettesting

InitialMarketing & Sales

Large Scale Distribution

Basic Science

Clinical Efficacy

Validate Therapy Seed Target Markets

Negotiate Partnerships

Negotiate Partnerships

Page 15: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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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.

Page 17: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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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

Page 18: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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 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.

Page 21: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

Page 21

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.

Page 22: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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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

Page 23: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

Page 23

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)

Page 24: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

Page 25

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

Page 26: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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

Page 27: IVIVI TECHNOLOGIES, INC. NASDAQ Symbol: IVVI THE TECHNOLOGY OF LIFE.

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NASDAQ - IVVI