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Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding.

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Presentation on theme: "Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding."— Presentation transcript:

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

2 Technology Animation 2

3 Cold plasma Ionized gas, close to room temperature Disinfection capabilities Promotes natural healing process Solder Made of chitosan -chitin Clotting properties Disinfection capabilities Technology highlights The Biowelding technology 3

4 BioWeld Device Box (controller, gas tank, RF generator) Handpiece and cable Disposables Chitoplast plaster (bioadhesive chitosan strip) Tip System TM Components 4

5 Sources Procedure time: Faster healing time: Surgical site infection: Market need Significant Aesthetic results improvement Reduced procedure time Improve Clinical outcome 5

6 Need- Aesthetic results 6 Intradermal sutures 5 days post opStaples 5 days post op Biowelding 7 days post op Comparison C-section short term

7 Closed with metal staples Biowelded incision Animal study (pigs) demonstrating Biowelding advantages Need- Aesthetic results 7 7 days post op

8 C-section, 19 days post opC-section, 45 days post op Need- Aesthetic results Second clinical trial- 6 patients C-Section incisions, up to 180 mm Ongoing 1.5 year follow-up All incisions well closed 8

9 Need- duration & friendliness Good solution for need Does not answer need SuturesStaplesGlueIonMed Closure duration User friendliness 9  C-section closure ~ 10 minutes (~30% of C-section procedure length)  For optimal results- intradermal sutures should be done by plastic surgeon

10 Need- clinical outcome Good solution for need Does not answer need SuturesStaplesGlueIonMed Healing duration Infection tendency 10  Plasma promotes the natural healing  Plasma disinfect  No foreign body holding the incision closed

11 Need- clinical outcome Plasma on petri dish shows efficient inhibition of bacterial growth 11 Power 1 Mean* % survival of bacteria vs. BioWelding time (sec) Mean value calculated on two strains of bacteria, low and high concentrations Power 2Power 3

12 Physicians: Improved clinical outcomes Reduces infection Improved incision healing Less scarring Procedure length and ease of use Hospitals: Reduced costs Reduced hospital-acquired infections Reduced procedure time Relatively short learning curve Patients: Improved satisfaction Less scarring Reduced pain Value Proposition 12

13 Go to market strategy Initial market C-sections - EU: 2.5 million Launch plan Post marketing trial ~300 patients 6 leading centers and KOL’s in EU and IL All Procedures monitored by IonMed Market validation Expend to up to 10 centers and in each center: Become the leading method for closure- 80% of the C-section Strategic partner/distribution agreement Expand sales by strategic partnering or by distribution agreement Secondary market Plastics 13

14 Product PricingComments OR Disposable End-user$50Includes plaster and tips Cost$4 Generator End-user$4,000 Cost$1,500 Pricing Model 14

15 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 15

16 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/GYN and Centre for Perinatal and Reproductive Medicine, Santa Maria della Misericordia University Hospital San Sisto – Perugia, Italy 16

17 “I enjoyed the time spent in the seminar discussing about 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* 17 *January 2013 KOL seminar Prof. Anna Maria Marconi, MD, Chairman, Dept. OB/GYN San Paolo Hospital Med. School | Univ. of Milano, Italy “The device is rapid and easy to use with a great potential for a widest application, not only in obstetrics.” Prof. Eberhard Merz, MD, Director of the Department of Obstetrics and Gynecology Krankenhaus Nordwest, Frankfurt/Main, Germany "The BioWeld procedure is a stunning technique that has a high potential of revolutionizing skin closure in obstetrics and other surgical fields"

18 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 application National 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 18

19 Regulatory Pathway US Completed pre-IDE with the FDA 510K or de novo pathway EU Technical files and CE trial report submitted to notified B Estimate: CE mark by mid-June (latest) 19 Initial consultation from Adres (Israel) and Hogan-Lovells (US)

20 Reimbursement Covered within a surgery “basket” (paid for the entire procedure) 20

21 Work Plan 21 2013201420152016 Europe Marketing & Sales Validation FDA Internal Organ Closure System Strategic Partner Transfer to Production CE approval Sales 4-10 reference sites Product manager and distributors Sales Pilot Trial Approval R&D work Product launch EU

22 Funding Strategy Seeks to raise $4.5 million EU initial sales FDA clearance US initial sales R&D product development and new products Q1/2013 Q2 CE mark Q3 EU Product launch Q1/2014 Commence FDA trials; EU sales Q4 FDA approval US sales 22

23 Nov 2009Founded, Misgav Venture Accelerator (Trendlines, OCS) Q1-3/2010Successful animal studies Oct 2010Advanced prototype ready Dec 2010Successful first in human Aug 2011Completed “A” round (Crossroads Venture Capital) Apr 2012Completed engineering prototype Apr 2012Successful preclinical study Sep 2012Successful 2nd human study Nov 2012Completed successful CE trial IonMed achievements 23

24 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 24

25 Contact Ronen Lam Founder, VP Business Development HaCochav Building HaCarmel Street Yokneam, Israel Office: +972 52-6178460

26 Backup Slides

27 EuropeUnited States $4.5 Billion Skin Closure Market Source: “Surgical Incision Closures,” A Global Strategic Business Report, October 2011, Global Industry Analysts, Inc. 27 USA- 1.5M procedures/year EU- 2.5M procedures/year C-section Market:

28 US Staple Market (%) US Suture Market (%) Leading Players: US Market Share (%) 28

29 40% of the global market Average price: $10 Disadvantages Lengthy procedure: ~ 10 minutes (~30% of C-section procedure length) Failed suture: morbidity and mortality occurrence of needle stabbing Need 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 29

30 Staples and Glue Staples 35% of global market Price: $5-$10 Disadvantages Inferior clinical outcome Inferior cosmetic outcome Pain and patient satisfaction Needs to be removed at a later date Glue 9% of global market Disadvantages Clinical drawbacks Inferior cosmetic outcome Undesired tissue sticking/surgeon’s fingers stick 30

31 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 31

32 Third Clinical Trial (CE) No. of Subjects # Screened21 # Screen fails1 # Enrolled20 # Withdrew (for any reason)2 # Lost to follow-up2 # Completed 21 days16 # 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 32

33 Third Clinical Trial (CE) Incision length 180 mm, 1.5 year ongoing follow-up 21 days post op45 days post op 33

34 CompanyProductDescriptionCommercialized 3MClozexPlaster-based closure Univ. of New South Wales (UNSW) SurgiLux Chitosan-based film + surgical laser Zipline MedicalZiplineTape-based closure Wound Care Technologies DermaCloseWire-based closure Incisive SurgicalINSORBAbsorbable skin staples AdvanTech SurgicalEkkyLite Laser Post closure treatment healing; laser-based IVT Medical Ltd.TopclosureTape-based closure Solutions & Technologies in Development 34

35 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 35

36 Cold Plasma Plasma is a gas in which a certain portion of the particles are ionized Fourth state of matter Under the influence of electricity, it may form structures such as beams 36

37 Benchmarks for Company Valuation Omrix, acquired by Johnson & Johnson in November 2008$432M 37 M&A in the field

38 Animal trial - Video 38

39 Need- clinical outcome 39 Current complications

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