Upload
others
View
2
Download
0
Embed Size (px)
Citation preview
TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM
OFER LEVY, CEOJuly 2019
www.ZygoFix.com© All rights reserved to ZygoFix
2
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.
3
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
4
Lower Back Disorders Cause Severe Pain
Spondylolisthesis
Degenerative Disc Disease
Spinal Stenosis
SI Dysfunction
5
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
6
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
7
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
8
Rigid and Flexible CombinedThe only implant capable of following the joint’s anatomy
zLOCK in clinical use
9
Technology and Material
• Medical grade Titanium [Ti]• Fully 3D printed (low COGS)• Porous Design • First flexible spinal implant
10
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
11
zLOCK System Advantages
Less invasive
procedure Fits any joint
anatomy
Reduced procedure complexityEasy
& quick positioning
12
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
13
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
14
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
15
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]
16
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
17
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)
18
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
THANK [email protected]