TRUE MINIMALLY INVASIVE SPINAL FUSION

TRUE MINIMALLY INVASIVE SPINAL FUSIONOFER LEVYCEO

Nov. 2020

www.ZygoFix.com © All rights reserved to ZygoFix

http://www.zygofix.com/

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3Zygofix True minimally invasive spinal fusion|

ZygoFix zLOCK’s unique design enables outpatient spinal fusion with a simple and safe approach

Investor (and private investors)

3 granted patents

Successful Clinical Outcomes at 24 month F/U

ZYGOFIX, IN BRIEF

Winner of the 2017 Spine Technology Award -2019 MC Israel Gold Winner


Chronic Back Pain May Require Surgical Intervention


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)

Cervical Fusion

http://www.weillcornellbrainandspine.org/

http://www.k2m.com/


Opportunitythe market seeks a simpler, safer

and less invasive solution to enable out-patient procedures


If you were a candidate for spinal fusion,which would you prefer placed in your back?


ZygoFix’s zLOCK: The first 3D printed spinal implant that fits itself to the individual patient’s anatomy

Small, spinal implant inserted IN the jointzLOCK miniature 3D printed implant provides a simpler, safer and less invasive spinal fusion option


How We Do it: Our Unique DesignSmall 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


zxOR time = 100 $ /min** Hospitalization night cost = $3900*** selling price of $2,400 [pedicle screw ASP $3,500]

Minimally Invasive Simpler to Place Suitable to all types of anatomies Cost-effective

Feature 1 vs. 3 incisions No screw placement Adjusts to all anatomies Completely 3D printed

Patient Less scars, less intimidating,Suitable for outpatient

Shorter procedure, 70% radiation,

faster rehabilitation

More patients will benefit the procedure

Surgeon Less hospitalization days**,Short recovery,

Low risk of complications

More procedures in less time Requires less planningCompetitive

pricing***Medical Center / Payer Shorter OR time*

Potential savings of $7,000 per case (considering a reduction of 20min OR time and 1 night hospitalization)!

Value Proposition

zx


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

12-months post op. x-ray

Successful 24 Month Follow-up

Principal investigator (1 day after FIM surgery)


zLOCK is suitable for a number of fusion applications

Lumbar

SI (sacrum ilium)

Cervical

• Lumbar Fusion –510k [Q4/22]

• SI Fusion – 510k [Q4/23]

• Cervical Fusion – 510k [Q4/24]

• Facet Fusion – [Q1/21]

• SI Fusion – [Q4/23]

• Cervical Fusion – [Q4/24]

zLOCK Applications


Sources: ONN Spine Report October 2017; Spinemarket data; Meddevicetracker spinal fusion report (02.2018)

TAM US ($)System priceTAM US (Procedures)

504M$2,400210,000Lumbar

435M$3,000145,000Cervical

68M$4,00017,000SI

$1BTotal:

Assumptions: System cost excludes tool set I Global market is estimated as 2x the US: $2B

$2B Global Market Opportunity

Lumbar market breakdown

• 450,000 lumbar fusions in 2017 (US only). 3.5% CAGR -> 500,000 procedure in 2020.

• 40% pedicle screws only -> 60% are suitable for zLOCK = 120,000 cases.

• 45% screws with IBF -> 40% are suitable for zLOCK = 90,000 cases.

• TAM (US): 210,000 cases

• Additional potential markets – replacing facet injections; IPDs


90+ inquiries, from 22 countries, of surgeons and distributors interested in

use/distribution

2019 MassChallengeIsrael Gold Winner

2017 Spine Technology Award winner

Continuous patient interest about

inclusion in the study!

Gaining Market TractionWide interest in zLOCK from interventional spine professionals:


IP - Portfolio of 3 PatentsUnique design provides strong claims and IP!

02

Implant design protecting patent

WO2019111175

Granted in USIn national phase

Basic implant design patent

Granted in EU,China, JapanPending in US, Brazil

WO2017046667

01

Implant Delivery System

Granted in USIn national phase

WO2019111176

03

https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2017046667






Jon Luedke

Ofer Levy CEO

Uri Arnin Co-founder. CTO

Prof. Yizhar FlomanCo-founder. Medical Director

Barak Singer

Man

agem

ent

Adam Lewis MD Babak Barcohana MDIra Fedder MD

15+ years experience in medical device industry; Former vice president of Qsiteconsulting 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 ShamirR&D Manager

Dr. Hanna LevyClinical 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, AssutaHospital, Tel Aviv; former President of the Israeli Orthopedic Association

ZygoFix Team

Ofir Hazut

Boar

d

Advi

sory

Bo

ard

THANK [email protected]

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TRUE MINIMALLY INVASIVE SPINAL FUSION