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Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

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Page 1: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Investor PresentationSeries B FinancingFebruary 2013

IonMedPlasma Tissue Welding

Page 2: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Technology Animation

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Page 3: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Cold plasmaIonized gas, close to room temperatureDisinfection capabilities Promotes natural healing process

SolderMade of chitosan -chitinClotting propertiesDisinfection capabilities

Technology highlights

The Biowelding technology

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Page 4: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

BioWeld DeviceBox (controller, gas tank, RF generator)Handpiece and cable

DisposablesChitoplast plaster (bioadhesive chitosan strip)Tip

SystemTM Components

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Page 5: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

SourcesProcedure time: http://www.ncbi.nlm.nih.gov/pubmed/19700995Faster healing time: http://www.mpe-garching.mpg.de/theory/plasma-med/images/PlasmaJDDG.PDFSurgical site infection: http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

Market need

Significant Aesthetic results improvement

Reduced procedure time

Improve Clinical outcome

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Page 6: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Need- Aesthetic results

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Intradermal sutures 5 days post opStaples 5 days post op

Biowelding 7 days post op

Comparison C-section short term

Page 7: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Closed with metal staples

Biowelded incision

Animal study (pigs) demonstrating Biowelding advantages

Need- Aesthetic results

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7 days post op

Page 8: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

C-section, 19 days post op C-section, 45 days post op

Need- Aesthetic results

Second clinical trial- 6 patientsC-Section incisions, up to 180 mm

Ongoing 1.5 year follow-up

All incisions well closed

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Page 9: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Need- duration & friendliness

Good solution for need Does not answer need

Sutures Staples Glue IonMed

Closure duration

User friendliness

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C-section closure ~ 10 minutes (~30% of C-section procedure length) For optimal results- intradermal sutures should be done by plastic surgeon

Page 10: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Need- clinical outcome

Good solution for need Does not answer need

Sutures Staples Glue IonMed

Healing duration

Infection tendency

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Plasma promotes the natural healing Plasma disinfect No foreign body holding the incision closed

Page 11: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Need- clinical outcome

Plasma on petri dish shows efficient inhibition of bacterial growth

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Power 1

Mean* % survival of bacteria vs. BioWelding time (sec)

Mean value calculated on two strains of bacteria, low and high concentrations

Power 2 Power 3

Page 12: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Physicians:Improved clinical outcomes

Reduces infectionImproved incision healingLess scarringProcedure length and ease of use

Hospitals: Reduced costs

Reduced hospital-acquired infectionsReduced procedure timeRelatively short learning curve

Patients: Improved satisfaction

Less scarringReduced pain

Value Proposition

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Page 13: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Go to market strategy

Initial marketC-sections - EU: 2.5 million

Launch planPost marketing trial ~300 patients6 leading centers and KOL’s in EU and IL All Procedures monitored by IonMed

Market validationExpend to up to 10 centers and in each center:Become the leading method for closure- 80% of the C-section

Strategic partner/distribution agreementExpand sales by strategic partnering or by distribution agreement

Secondary marketPlastics

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Page 14: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Product Pricing Comments

OR Disposable End-user $50 Includes plaster and tips

Cost $4

Generator End-user $4,000

Cost $1,500

Pricing Model

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Page 15: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Amnon Lam, Founder and CEO

Ronen Lam, Founder and VP Business

Roni Bibi, COO, Vice President of Operations

Michael Maller, R&D Chief Engineer

Dr. Yaara Yarmut, DVM, Regulatory and QA Manager

Team

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Page 16: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

SAB

Prof. Anna Maria Marconi, MD, Assoc. Professor and Head, OB/GYN Unit, University of Milan, Italy

Prof. Corinne Hubinont , MD, Department of Obstetrics, Saint-Luc University Hospital, Brussels, Belgium

Prof. Eberhard Merz, MD, Dir., Dept. OB/GYN, Krankenhaus Nordwest, Frankfurt/Main, Germany

Prof. Yossef Ezra, MD, Specialist in OB/GYN, Dir., High-Risk Pregnancy and Obstetrics, Hadassah-Hebrew University Medical Center, Israel

Dr. Josef Haik, Specialist in Plastic Surgery, Dir., Intensive Care Burn Unit, Dept. of Plastic Surgery, Sheba Medical Center, Israel

Prof. Ariel Mani, MD, Dept. of OB/GYN, Dir., Labor and Delivery and ER Divisions, Lis Maternity Hospital, Tel Aviv Sourasky Medical Center, Israel

Prof. Gian Carlo Di Renzo, MD Professor and Chairman Dept. OB/GYNand Centre for Perinatal and Reproductive Medicine, Santa Maria della Misericordia University Hospital San Sisto – Perugia, Italy

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Page 17: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

“I enjoyed the time spent in the seminar discussingabout the BioWeld1 device. I foresee a bright future. I look forward to the continuing cooperation.”

Prof. Gian Carlo Di Renzo, Secretary General of FIGO (World Federation of OB/GYN)Prof. and Chairman, Dept. of OB/GYN | Santa Maria della Misericordia Univ. Hosp. | Perugia, Italy

KOL Testimonials*

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*January 2013 KOL seminar

Prof. Anna Maria Marconi, MD, Chairman, Dept. OB/GYNSan Paolo Hospital Med. School | Univ. of Milano, Italy

“The device is rapid and easy to use witha great potential for a widest application,not only in obstetrics.”

Prof. Eberhard Merz, MD , Director of the Department of Obstetrics and GynecologyKrankenhaus Nordwest, Frankfurt/Main, Germany

"The BioWeld procedure is a stunning technique thathas a high potential of revolutionizing skin closurein obstetrics and other surgical fields"

Page 18: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

IonMed Patent Portfolio

IM01:Microplasma head for medical applications

Pending application in US

IM02:Plasma head for tissue

welding

Pending application in US, IL, EP, JP, CN, AU,

CA

IM03: Tissue welding using

plasma

PCT applicationNational phase 11/13

IM04:Improved plasma

heads and additional devices for tissue

welding

Provisional application; new provisional in preparation.

PCT to file 10/13

Comprehensive work on IP strategy performed by Finnegan, Washington DC

IP Overview

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Page 19: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Regulatory Pathway

USCompleted pre-IDE with the FDA

510K or de novo pathway

EUTechnical files and CE trial report submitted to notified B

Estimate: CE mark by mid-June (latest)

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Initial consultation from Adres (Israel) and Hogan-Lovells (US)

Page 20: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Reimbursement

Covered within a surgery “basket”(paid for the entire procedure)

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Page 21: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Work Plan

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2013 2014 2015 2016

Europe

Marketing & SalesValidation

FDA

Internal Organ Closure SystemStrategic PartnerTransfer to Production

CE approval

Sales 4-10 reference sites

Product manager and distributors

SalesPilot

TrialApproval

R&D work

Product launch EU

Page 22: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Funding Strategy

Seeks to raise $4.5 millionEU initial salesFDA clearanceUS initial salesR&D product development and new products

Q1/2013Q2CE

mark

Q3EU

Product launch

Q1/2014Commence FDA trials;

EU sales

Q4FDA approval

US sales

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Page 23: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Nov 2009 Founded, Misgav Venture Accelerator (Trendlines, OCS)Q1-3/2010 Successful animal studiesOct 2010 Advanced prototype readyDec 2010 Successful first in humanAug 2011 Completed “A” round (Crossroads Venture Capital)Apr 2012 Completed engineering prototypeApr 2012 Successful preclinical studySep 2012 Successful 2nd human studyNov 2012 Completed successful CE trial

IonMed achievements

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Page 24: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Novel technology to transform the incision closure market

Large, $4.5 billion market- Europe and US alone

Significant clinical advantages

Successful Clinical studies

Financially compelling business model

Strong patent position

Clear regulatory path

Reimbursement in place

Opportunity

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Page 25: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Contact

Ronen LamFounder, VP Business DevelopmentHaCochav BuildingHaCarmel StreetYokneam, Israel

Office: +972 [email protected]

Page 26: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Backup Slides

Page 27: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

EuropeUnited States

$4.5 Billion Skin Closure Market

Source: “Surgical Incision Closures,” A Global Strategic Business Report, October 2011, Global Industry Analysts , Inc.

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USA- 1.5M procedures/yearEU- 2.5M procedures/year

C-section Market:

Page 28: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

US Staple Market (%)

US Suture Market (%)

Leading Players: US Market Share (%)

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Page 29: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

40% of the global market

Average price: $10

DisadvantagesLengthy procedure: ~ 10 minutes (~30% of C-section procedure length)Failed suture: morbidity and mortality occurrence of needle stabbingNeed to apply constant tension on suture wire (to prevent foreign tissue between sutures)Risk of passing a suture through neighboring tissue , a fatal complication

Intradermal Sutures

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Page 30: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Staples and Glue

Staples35% of global marketPrice: $5-$10Disadvantages

Inferior clinical outcomeInferior cosmetic outcomePain and patient satisfactionNeeds to be removed at a later date

Glue 9% of global marketDisadvantages

Clinical drawbacksInferior cosmetic outcomeUndesired tissue sticking/surgeon’s fingers stick

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Page 31: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

5 patients, laparoscopic procedures (1 sterilization, 1 diagnostic,3 appendectomies)Each patient: One BioWeld incision (20 mm), one sutured incision (10 mm control)

Follow-up: Short term, up to 14 days

First Clinical Trial

Biowelded incision Lap appendectomy, 14 days post op

Sutured incision Lap appendectomy, 14 days post op

A B

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Page 32: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Third Clinical Trial (CE)

No. of Subjects # Screened 21 # Screen fails 1 # Enrolled 20 # Withdrew (for any reason) 2 # Lost to follow-up 2 # Completed 21 days 16 # Completed 45 days (not final) 12

No device-related SAEs reported No burns caused by the device No dehiscence reported No superficial infection of the incision reported Subjects reported very low level of pain during post-procedure follow-up

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Page 33: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Third Clinical Trial (CE)

Incision length 180 mm, 1.5 year ongoing follow-up

21 days post op 45 days post op

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Page 34: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Company Product Description Commercialized

3M Clozex Plaster-based closure

Univ. of New South Wales (UNSW) SurgiLux Chitosan-based film +

surgical laser

Zipline Medical Zipline Tape-based closure

Wound Care Technologies DermaClose Wire-based closure

Incisive Surgical INSORB Absorbable skin staples

AdvanTech Surgical EkkyLite Laser Post closure treatment healing; laser-based

IVT Medical Ltd. Topclosure Tape-based closure

Solutions & Technologies in Development

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Page 35: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

3M Healthcare

Ethicon Endo Surg (US)

Stryker Orthopedics (US)

Baxter International (US)

Pressure Products: Phillip Frost Company

Bovie Medical Corp (US)

Aesculap AG (Germany)

Covidien (US)

Becton, Dickinson (US)

Medline (US)

Ongoing Discussions: Potential Partners

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Page 36: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Cold Plasma

Plasma is a gas in which a certain portion of the particles are ionizedFourth state of matterUnder the influence of electricity, it may form structures such as beams

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Page 37: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Benchmarks for Company Valuation

Omrix , acquired by Johnson & Johnson in November 2008 $432M

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M&A in the field

Page 38: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Animal trial - Video

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Page 39: Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding

Need- clinical outcome

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Current complications