TRUE MINIMALLY INVASIVE SPINAL FUSION SYSTEM - OFER LEVY, CEO July 2019
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
TRUE MINIMALLY
INVASIVE SPINAL
FUSION SYSTEM
OFER LEVY, CEO
July 2019
© All rights reserved to ZygoFix www.ZygoFix.com
Legal disclaimer
IMPORTANT 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 this
presentation 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.
2
ZYGOFIX, IN BRIEF
ZygoFix’s zLOCK is the first and only screw-less implant for
spinal joint fusion
Successful Winner of the 3 patents Investor
Clinical 2017 Spine (1 issued in
Study w. 12 Technology EU)
month FU Award
3
Lower Back Disorders Cause Severe Pain
Spondylolisthesis
Degenerative Disc Disease
Spinal Stenosis
SI Dysfunction
4
Spinal Fusion May Be Required
Lumbar Fusion SI (Sacrum Ilium) Fusion
Images (from left to right): (1) weillcornellbrainandspine.org; (2) http://www.k2m.com; (3) SI Bone
5
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
6
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
7
Rigid and Flexible Combined
The only implant capable of following the joint’s anatomy
zLOCK in clinical use
8
Technology and Material
• Medical grade Titanium [Ti]
• Fully 3D printed (low COGS)
• Porous Design
• First flexible spinal implant
9
zLOCK Surgical Procedure
Procedure animation
Percutaneous
approach
Easy and quick
www.zygofix.com
positioning in the
https://www.youtube.com/watch?v=vHw3cOKn_HM
facet space
Suitable for
outpatient
procedure for
certain indications!
10zLOCK System Advantages
Less
invasive
procedure Fits any
joint
anatomy
Reduced
procedure
Easy complexity
& quick
positioning
11Successful 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
12US Market Opportunity
TAM US TAM US ($)
(Procedures)
Facet Fusion 200,000 600M
SI Fusion 17,000 68M
Total: $668M
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
(sources) ONN Spine Report October 2017; Spinemarket data
13Market Traction
Interest 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
14Regulatory Strategy
FDA: CE:
1. SI Fusion – 510k [Q4/20] Facet Fusion – class IIb
2. Facet Fusion – 510k (w. clinical data) [Q4/21]
(w. clinical data)*
* Based on MRCA regulatory consultancy
15IP - Portfolio of 3 Patents
Basic implant PCT PCT
01 02 03
design patent application application
Approved in EU for main surgical
for alternative
Submitted implant designs technique tool
nationally to US, (filed Nov. 2017) (filed Nov. 2017)
China, Japan,
Brazil
WO2017046667 WO2019111175
16Timeline & Task Costs
FIM Clinical FIM 1 Year
Company
Study (Lumbar FU (Lumbar
inception
Fusion) Fusion)
2017 2018 2019 2020 2021 2022
Q3/19 Q4/20 Q4/21 FDA Clearance
Israel study FDA Clearance CE Certification (Facet fusion)
Site initiation (SI fusion) (Facet fusion)
(Facet fusion)
17Management ZygoFix’s Team
Ofer Levy, Uri Arnin, Prof. Yizhar Floman
CEO Co-founder, CTO Co-founder, Medical Director
Todd Dollinger, Barak
Board
Chairman Singer Prof. Yizhar
Uri Arnin
Floman
Adam Ira Babak Jon
Advisory
Board
Lewis, MD Fedder, MD Barcohana, Luedke
(USA) (USA) MD (USA) (USA)
18THANK YOU! ofer@zygofix.com www.ZygoFix.com
You can also read
