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IonMed Plasma Tissue Welding Investor Presentation Series B Financing

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

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

2 Technology Animation

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

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

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

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

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

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

9 Need- duration & friendliness
Sutures Staples Glue IonMed Closure duration User friendliness Good solution for need Does not answer need 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
Sutures Staples Glue IonMed Healing duration Infection tendency Good solution for need Does not answer need 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 Mean* % survival of bacteria vs. BioWelding time (sec) Mean value calculated on two strains of bacteria, low and high concentrations Power 1 Power 2 Power 3

12 Value Proposition Physicians: Improved clinical outcomes Hospitals:
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 Reduced pain

13 Go to market strategy Initial market Launch plan Market validation
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

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

15 Team 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

16 SAB 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 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

17 KOL Testimonials* “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 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" *January 2013 KOL seminar

18 IP Overview 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

19 Regulatory Pathway US EU 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) Initial consultation from Adres (Israel) and Hogan-Lovells (US)

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

21 Sales 4-10 reference sites
Work Plan 2013 2014 2015 2016 Europe Marketing & Sales Validation FDA Internal Organ Closure System Strategic Partner Transfer to Production CE approval Product launch EU Sales 4-10 reference sites Product manager and distributors Sales Pilot Trial Approval R&D work

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

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

24 Opportunity 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

25 Contact Ronen Lam Founder, VP Business Development HaCochav Building
HaCarmel Street Yokneam, Israel Office:

26 Backup Slides

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

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

29 Intradermal Sutures 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

30 Staples and Glue Staples Glue 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 Clinical drawbacks Undesired tissue sticking/surgeon’s fingers stick

31 First Clinical Trial 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 A B Biowelded incision Lap appendectomy, 14 days post op Sutured incision Lap appendectomy, 14 days post op

32 Third Clinical Trial (CE)
No. of Subjects # Screened 21 # Screen fails 1 # Enrolled 20 # Withdrew (for any reason) 2 # Lost to follow-up # 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

33 Third Clinical Trial (CE)
Incision length 180 mm, 1.5 year ongoing follow-up 21 days post op 45 days post op

34 Solutions & Technologies in Development
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

35 Ongoing Discussions: Potential Partners
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)

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

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

38 Animal trial - Video

39 Need- clinical outcome
Current complications


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