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TRUE MINIMALLY INVASIVE SPINAL FUSION
OFER LEVY, CEO
April 2020
www.ZygoFix.com© All rights reserved to ZygoFix
Legal disclaimerIMPORTANT NOTICE
This presentation has been prepared by ZygoFix Ltd. (the “Company”) solely for informational purposes. The information contained herein has been prepared to assist prospective investors in making their own evaluation of the Company and does not purport to be complete or to contain all of the information a prospective or existing investor may desire. In all cases, interested parties should conduct their own investigation and analysis of the Company and the data set forth in this information. The Company has prepared thispresentation based on information available to it, including information derived from public sources that have not been independently verified. The Company makes no representation or warranty as to the accuracy or completeness of this information and shall not have any liability for any representations (expressed or implied) regarding information contained in, or for any errors omissions in, this presentation. This presentation includes certain statements and estimates provided by the Company with respect to the projected future performance of the Company. Such statements, estimates and projections reflect various assumptions by management concerning possible anticipated results, which assumptions may or may not be correct. No representations are made as to the accuracy of such statements, estimates or projections. This presentation may contain statements that are not historical facts, referred to as “forward looking statements.” The Company’s actual future results may differ materially from those suggested by such statements. No assurance can be given that future events will occur or that projections will be achieved. Past performance is not a reliable indication of future performance. This presentation is not, and nothing in it should be construed as, an offer, invitation or recommendation in respect of the Company’s securities, or an offer to sell, or a solicitation of an offer to buy, the Company’s securities in any jurisdiction. Neither this presentation nor anything in it shall form the basis of any contract or commitment. Prospective investors should not construe the contents of this presentation as business, legal, tax, investment or other advice. Each prospective investor should make his, her or its own inquiries and consult his, her or its own advisors as to the appropriateness and desirability of an investment in the Company and as to business, legal, tax and related matters concerning an investment in the Company.
An investment in the Company shall be allowed only to such number and category of investors in accordance with applicable laws and regulations and pursuant to a predetermined process. Accordingly, detailed information in connection with the investment shall be revealed and delivered only to a limited number of qualifying investors as provided by law.
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ZYGOFIX, IN BRIEF
ZygoFix’s zLOCK is the first and only screwless implant for spinal joint fusion
Winner of the 2017 Spine Technology
Award
Successful clinical study, 12-month
follow-up
$2.2B market opportunity
Investor (and private investors)
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Suffer From Back Pain?Your’re Not Alone
▪ The leading cause of disability worldwide, affecting 540 million at any one time
▪ 80% suffer back pain at some point
▪ A $50b direct annual expense ($100b indirect) in the US alone!
Source: American Chiropractic Association
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Images (left to right): (1) SI Bone (2) www.weillcornellbrainandspine.org; (3) http://www.k2m.com;
Lumbar FusionSI (Sacrum Ilium) Fusion
Patients fear and refrain from the current surgical offering (mostly screw-based implants)
Chronic Back Pain May Require Surgical Intervention
Cervical Fusion
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Opportunity: the market seeks a simpler, safer and improved clinical fusion solution
If you were a candidate for spinal fusion, which would you prefer placed in your back?
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ZygoFix’s zLOCK: The First Flexible Spinal Implant
zLOCK miniature 3D printed implant
Provides a simpler, safer and more minimally invasive spinal fusion option
Small, screwless spinal implant inserted IN the joint
8
How We Do it: Our Unique Design
Small package – a lot of know-how
▪ Our flexible proprietary design enables:
• to bend rigid titanium
• to suit all spinal joint variations
▪ Porous design enhances bone fusion
▪ Custom tools enable simple minimally invasive procedure
Fits all shapes and
anatomies
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zLOCK System Advantages
Less invasive
procedure Fits any joint
anatomy
Outpatient in suitable indicationsFast
& easy positioning
The simplest fusion procedure in the market
See procedure animation:
https://www.youtube.com/watch?v=vHw3cOKn_HM
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Successful 12 Month Follow-up
Entered clinical phase in April 2018
“patient doing extremely well and reports no pain! I can hardly believe it... I could discharge the patient even today! Practically no blood loss.”
Principal investigator (1 day after FIM surgery)
12-months post op. x-ray
(Lumbar facet fusion)
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zLOCK First FDA Clearance – Q4/2020
zLOCK is suitable for a number of joint fusion applications
Lumbar facet joint
SI (sacrum ilium) joint
Cervical facet joint
Application Timeline
CommercialFDA clearance
Q1/22Q4/20SI
Q4/23Q3/23Lumbar
Q2/25Q4/24Cervical
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Gaining Market Traction
Wide interest in zLOCK from interventional spine professionals:
• 80+ inquiries from surgeons and distributors interested in use/distribution from 22 countries
• 2019 MassChallenge Israel Gold Winner
• 2017 Spine Technology Award winner
• Continuous patient interest about inclusion in the study!
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Regulatory Strategy
FDA:
1. SI Fusion – 510k [Q4/20]
2. Lumbar Fusion – 510k [Q3/23] (w. clinical data)
3. Cervical Fusion – 510k [Q4/24]
CE:
Facet Fusion – class IIb
(w. clinical data) [Q4/21]
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IP - Portfolio of 3 Patents
Basic implant design patent
▪ Granted in EU, China, Japan
▪ Pending in US, Brazil
01 02 03Implant design protecting patent
PCT application
for surgical tool (filed Nov. 2017)
WO2017046667 WO2019111175
▪ Granted in US
▪ Pending in EU, China, Japan, Brazil
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$2.2B Global Market Opportunity
Sources: ONN Spine Report October 2017; Spinemarket data; Meddevicetracker spinal fusion report (02.2018)
TAM US ($)TAM Global (Procedures)
TAM US (Procedures)
1,200M400,000200,000Facet Fusion
136M34,00017,000SI Fusion
870M290,000145,000Cervical Fusion
$2.2BTotal:
Assumptions:
• $2,000 per SI implant, 2 implants per procedure
• $1,500 per Facet implant, 2 implants per procedure
• $1,500 per Cervical implant, 2 implants per procedure
• Global market is estimated as 2x the US
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Timeline
Company inception
Q2/20Israel studySite initiation (Lumbar Facet fusion)
Q4/20FDA Clearance(SI fusion)
Q4/21CE Certification(Lumbar Facet fusion)
FDA Clearance(Lumbar Facet fusion)
2017 2019 20212018 2020 2022
FIM ClinicalStudy (Lumbar Facet Fusion)
FIM 1-YearFU (LumbarFacet Fusion)
Commercialization
FIM 2-Year FU (LumbarFacet Fusion)
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Jon
Luedke
Ofer Levy
CEO
Uri Arnin
Co-founder. CTO
Prof. Yizhar Floman
Co-founder. Medical
Director
Ofir Hazut Barak
Singer
Man
ag
em
en
tB
oa
rd
Ad
vis
ory
Bo
ard
Adam
Lewis MDBabak
Barcohana MD
Ira
Fedder MD
15+ years
experience in
medical device
industry; Former
vice president of
Qsite consulting firm
Serial entrepreneur;
20+ years experience
in medical device
industry; 29 issued
patents and 39+
pending (all in spine);
founder/CTO ApiFix
(MIS scoliosis
correction system)
15+ years of
experience in R&D
and medical device
industry in particular
with extensive
knowledge in all
stages of
development
Oded Shamir
R&D Manager
Dr. Hanna Levy
Clinical Manager
Expert in clinical trials and
biostatistics for medical
device and
pharmaceuticals. Managed
multiple clinical studies
including large international
multi-center studies in US,
EU and Israel in different
scientific fields
Chairman and
Director of the Israel
Spine Center, Assuta
Hospital, Tel Aviv;
former President of
the Israeli Orthopedic
Association
ZygoFix Team
