IonMed
Plasma Tissue Welding
Investor Presentation
Series B Financing
February 2013
Technology Animation
2
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
Disinfection capabilities
3
SystemTM Components
BioWeld Device
Box (controller, gas tank, RF generator)
Handpiece and cable
Disposables
Chitoplast plaster (bioadhesive chitosan strip)
Tip
4
Market need
Significant Aesthetic results
improvement
Reduced procedure time
Improve Clinical outcome
Sources
Procedure time: http://www.ncbi.nlm.nih.gov/pubmed/19700995
Faster healing time: http://www.mpe-garching.mpg.de/theory/plasma-med/images/PlasmaJDDG.PDF
Surgical site infection: http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf
5
Need- Aesthetic results
Comparison C-section short term
Staples 5 days post op
Intradermal sutures 5 days post op
Biowelding 7 days post op
6
Need- Aesthetic results
Animal study (pigs) demonstrating Biowelding advantages
Closed with metal staples
Biowelded incision
7 days post op
7
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
8
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
9
Need- clinical outcome
Sutures
Staples
Glue
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
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IonMed
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
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Value Proposition
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
12
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
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Pricing Model
Product
OR Disposable
Generator
Pricing
Comments
End-user
$50
Includes plaster and tips
Cost
$4
End-user
$4,000
Cost
$1,500
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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
15
SAB
Prof. Yossef Ezra, MD, Specialist in
OB/GYN, Dir., High-Risk Pregnancy and
Obstetrics, Hadassah-Hebrew University
Medical Center, Israel
Prof. Anna Maria Marconi,
MD, Assoc. Professor and Head,
OB/GYN Unit, University of
Milan, Italy
Dr. Josef Haik, Specialist in Plastic
Surgery, Dir., Intensive Care Burn Unit,
Dept. of Plastic Surgery, Sheba Medical
Center, Israel
Prof. Corinne Hubinont , MD,
Department of Obstetrics, SaintLuc University Hospital, Brussels,
Belgium
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. Eberhard Merz, MD,
Dir., Dept. OB/GYN, Krankenhaus
Nordwest, Frankfurt/Main,
Germany
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
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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
“The device is rapid and easy to use with
a great potential for a widest application,
not only in obstetrics.”
Prof. Anna Maria Marconi, MD, Chairman, Dept. OB/GYN
San Paolo Hospital Med. School | Univ. of Milano, Italy
"The BioWeld procedure is a stunning technique that
has a high potential of revolutionizing skin closure
in obstetrics and other surgical fields"
Prof. Eberhard Merz, MD , Director of the Department of Obstetrics and Gynecology
Krankenhaus Nordwest, Frankfurt/Main, Germany
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*January 2013 KOL seminar
IP Overview
IonMed Patent
Portfolio
IM04:
IM01:
IM02:
IM03:
Microplasma head for
medical applications
Plasma head for tissue
welding
Tissue welding using
plasma
Improved plasma
heads and additional
devices for tissue
welding
Pending application in
US
Pending application in
US, IL, EP, JP, CN, AU,
CA
PCT application
Provisional application;
new provisional in
preparation.
National phase 11/13
PCT to file 10/13
Comprehensive work on IP strategy performed by Finnegan, Washington DC
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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)
Initial consultation from Adres (Israel) and Hogan-Lovells (US)
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Reimbursement
Covered within a surgery “basket”
(paid for the entire procedure)
20
Work Plan
2013
Europe
Marketing &
Sales
Validation
2014
2015
2016
CE approval
Product launch EU
Sales 4-10 reference sites
Product manager
and distributors
Sales
Pilot
FDA
Trial
Approval
R&D work
Internal Organ
Closure System
Strategic
Partner
Transfer to
Production
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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
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Q4
FDA approval
US sales
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
Apr 2012
Successful preclinical study
Sep 2012
Successful 2nd human study
Nov 2012
Completed successful CE trial
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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
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Contact
Ronen Lam
Founder, VP Business Development
HaCochav Building
HaCarmel Street
Yokneam, Israel
Office: +972 52-6178460
ronen@ion-med.com
www.ion-med.com
Backup
Slides
$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.
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Leading Players: US Market Share (%)
US Suture Market (%)
US Staple Market (%)
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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
29
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
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
31
Third Clinical Trial (CE)
# Screened
# Screen fails
# Enrolled
# Withdrew (for any reason)
# Lost to follow-up
# Completed 21 days
# Completed 45 days (not final)
No. of Subjects
21
1
20
2
2
16
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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Solutions & Technologies in Development
Company
Product
Description
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
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Commercialized
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)
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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
Benchmarks for Company Valuation
M&A in the field
Omrix , acquired by Johnson & Johnson in November 2008
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$432M
Animal trial - Video
38
Need- clinical outcome
Current complications
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