Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding.
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Transcript of Investor Presentation Series B Financing February 2013 IonMed Plasma Tissue Welding.
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Investor PresentationSeries B FinancingFebruary 2013
IonMedPlasma Tissue Welding
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Technology Animation
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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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BioWeld DeviceBox (controller, gas tank, RF generator)Handpiece and cable
DisposablesChitoplast plaster (bioadhesive chitosan strip)Tip
SystemTM Components
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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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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
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Closed with metal staples
Biowelded incision
Animal study (pigs) demonstrating Biowelding advantages
Need- Aesthetic results
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7 days post op
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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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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
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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
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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
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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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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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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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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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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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“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"
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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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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)
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Reimbursement
Covered within a surgery “basket”(paid for the entire procedure)
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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
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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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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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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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Contact
Ronen LamFounder, VP Business DevelopmentHaCochav BuildingHaCarmel StreetYokneam, Israel
Office: +972 [email protected]
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Backup Slides
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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:
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US Staple Market (%)
US Suture Market (%)
Leading Players: US Market Share (%)
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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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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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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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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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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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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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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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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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Benchmarks for Company Valuation
Omrix , acquired by Johnson & Johnson in November 2008 $432M
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M&A in the field
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Animal trial - Video
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Need- clinical outcome
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Current complications