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TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM OFER LEVY, CEO July 2019 www.ZygoFix.com © All rights reserved to ZygoFix

TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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Page 1: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM

OFER LEVY, CEOJuly 2019

www.ZygoFix.com© All rights reserved to ZygoFix

Page 2: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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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.

Page 3: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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ZYGOFIX, IN BRIEFZygoFix’s zLOCK is the first and only screw-less implant for spinal joint fusion

Winner of the 2017 Spine Technology

Award

Successful Clinical

Study w. 12 month FU

3 patents(1 issued in

EU)

Investor

Page 4: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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Lower Back Disorders Cause Severe Pain

Spondylolisthesis

Degenerative Disc Disease

Spinal Stenosis

SI Dysfunction

Page 5: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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Spinal Fusion May Be Required

Images (from left to right): (1) weillcornellbrainandspine.org; (2) http://www.k2m.com; (3) SI Bone

Lumbar Fusion SI (Sacrum Ilium) Fusion

Page 6: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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Current Industry Standard - Pedicle Screws

Invasive procedure(2-3 incisions per side)

Risk of screw misplacement

Complex and time consuming

Mission: simplify spinal fusion with screw-less technology for great outcomes in outpatient surgery

Page 7: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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Introducing ZygoFix’s zLOCK: 3D Printed Miniature Implant

Small, screwless spinal implant inserted IN the joint

zLOCK utilizes our anatomy and eliminates the need to use

screws and rods!Facet joint

Page 8: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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Rigid and Flexible CombinedThe only implant capable of following the joint’s anatomy

zLOCK in clinical use

Page 9: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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Technology and Material

• Medical grade Titanium [Ti]• Fully 3D printed (low COGS)• Porous Design • First flexible spinal implant

Page 10: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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zLOCK Surgical Procedure

Percutaneous approach

Easy and quick positioning in the facet space

Suitable for outpatient procedure for certain indications!

Procedure animation

www.zygofix.com

https://www.youtube.com/watch?v=vHw3cOKn_HM

Page 11: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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zLOCK System Advantages

Less invasive

procedure Fits any joint

anatomy

Reduced procedure complexityEasy

& quick positioning

Page 12: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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Successful 12 Months 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

Page 13: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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US Market Opportunity

(sources) ONN Spine Report October 2017; Spinemarket data

TAM US ($)TAM US (Procedures)

600M200,000Facet Fusion

68M17,000SI Fusion

$668MTotal:

Considering

• $2,000 per SI implant, 2 implants per procedure

• $1,500 per Facet implant, 2 implants per procedure

• World market is estimated as X2 of US

Page 14: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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Market TractionInterest in zLOCK from a wide range of interventional spine professionals:• 50+ inquiries from surgeons and distributors interested in

use/ distribution in 16 different countries, 20+ from US • Awarded 2017 Spine Technology Award• Received seal of Excellence from prestigious European

H2020 Program

Page 15: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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Regulatory Strategy

* Based on MRCA regulatory consultancy

FDA:

1. SI Fusion – 510k [Q4/20]

2. Facet Fusion – 510k

(w. clinical data)*

CE:

Facet Fusion – class IIb

(w. clinical data) [Q4/21]

Page 16: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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IP - Portfolio of 3 Patents

Basic implant design patent

Approved in EU

Submittednationally to US, China, Japan, Brazil

01 02 03PCT application

for alternative implant designs (filed Nov. 2017)

PCT application

for main surgical technique tool (filed Nov. 2017)

WO2017046667 WO2019111175

Page 17: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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Timeline & Task Costs

Company inception

Q3/19Israel studySite initiation (Facet fusion)

Q4/20FDA Clearance(SI fusion)

Q4/21CE Certification(Facet fusion)

FDA Clearance(Facet fusion)

2017 2019 20212018 2020 2022

FIM ClinicalStudy (Lumbar Fusion)

FIM 1 YearFU (Lumbar Fusion)

Page 18: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

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ZygoFix’s Team

Jon

Luedke

(USA)

Ofer Levy, CEO

Uri Arnin,

Co-founder, CTO

Prof. Yizhar Floman

Co-founder, Medical Director

Todd Dollinger, Chairman

Barak Singer

Man

agem

ent

Boa

rdA

dvi

sory

Boa

rd

Adam

Lewis, MD

(USA)

Babak

Barcohana, MD (USA)

Ira

Fedder, MD

(USA)

Prof. Yizhar

FlomanUri Arnin

Page 19: TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM · US Market Opportunity (sources) ONN Spine Report October 2017; Spinemarket data . TAM US ... $2,000 per SI implant, 2 implants per

THANK [email protected]