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INSIDE SYNTELLIX THE COMPANY BEHIND GAME CHANGING INNOVATIONS Intelligent innovations for a better life. www.syntellix.com
INSIDE SYNTELLIX THE COMPANY BEHIND GAME CHANGING INNOVATIONS
Intelligent innovations for a better life.www.syntellix.com
THE IMPLANTS “CAN REDUCE RECOVERY DOWNTIME AND SAVE SURGERY BILLS.”
CHANNEL 5 SINGAPORE (2016)
“THIS IS A COMPANY, WHICH MOVES AHEAD WITH AN IMPRESSIVE STRATEGIC FORESIGHT AS WELL AS AN IMPRESSIVE STRATEGIC CONSEQUENCE.” EDELGARD BULMAHN, VP OF THE GERMAN PARLIAMENT (2017)
“SMALL SCREW – GREAT SUCCESS.”NEUE PRESSE HANOVER (2015)
“THIS IS A POTENTIALLY DISRUPTIVE INNOVATION ON A GLOBAL SCALE.” PROF. DR. NIKOLAUS FRANKE, BUSINESS UNIVERSITY VIENNA (2017)
“I GENUINELY BELIEVE THAT MAGNESIUM WILL BE THE GOLD STANDARD.”
PROF. GOWREESON THEVENDRAN, RAFFLES HOSPITAL SINGAPORE (2019)
Technological innovation driver
After fractures, bones often have to be fixed temporarily with screws, pins or plates in order to
heal and regain strength and stability. So far, these implants made of steel or titanium often had
to be removed in a second surgery, because permanent implants can cause stress shielding,
provoke inflammatory, pain or or foreign body reactions. In order to minimize these problems,
absorbable, yet stable implants have become subject of extensive research.
While there were many approaches to design a material that provides both adequate mechanical
and degradation properties combined with excellent biocompatibility, Syntellix succeeded in
developing a revolutionary technology: MAGNEZIX® orthopedic implants hit the market as the
first transfor mable metallic devices approved for use in humans worldwide.
Disruptive market leader
Today, Syntellix is an international medical technology company based in Hanover enjoying dynamic
growth around the globe. The company is specialized in research, development and marketing of a
range of innovative implants based on the new disruptive magnesium alloy MAGNEZIX®.
The devices, made from the MAGNEZIX® material, are nothing less than revolutionary – despite
having all the properties and stability of a metallic implant, they are fully absorbed by the body
and replaced by endogenous bone tissue.
The products have been already successfully launched in 38 countries worldwide under the
MAGNEZIX® brand. The feedback from surgeons, patients and media has been absolutely positive.
For the near future, Syntellix is in the process of increasing its product portfolio and expanding
geographically into new countries across the five continents.
Summary
INNOVATION DRIVER AND WORLD MARKET LEADER FOR TRANSFORMABLE, METALLIC IMPLANTS!
Headquarter Hanover, Germany
Subsidiaries Singapore, Brazil, Philippines, USA, China, India
Employees1 65 - 70
Registration highlights1 ∙ CE approval ∙ HSA Singapore ∙ MDA Malaysia ∙ MOH HTIA Israel ∙ SFDA Saudi Arabia
∙ TGA Australia∙ COFEPRIS Mexico ∙ NADFC Indonesia∙ DMEHW Vietnam ∙ DIGEMED Peru
Entered countries1 38 countries
Granted approvals1 55 countries
Devices marketed2 > 63,000
Successful surgeries2 > 23,500
MAGNEZIX® product range
∙ Compression Screws (CS, CSc)∙ Pins∙ Cortical Bone Screws (CBS)∙ StarFuse® ∙ Continuous portfolio extension
Advantages at a glance ∙ Patient benefit: Life quality enhancing - Shorter convalescence time
- No need for a second surgery for removal- Low risk of bone atrophy (no stress shielding)- Lower risk of refracture- Reduction of infection risk
∙ Societal benefit: Money saving- Reduced health spendings with improved benefit
∙ Economic benefit: Time saving- Less work time lost
1 Status: October 2019 2 Source: Official PMS (Post Market Survaillance) Syntellix AG, October 2019
Company founded
2012
2011
2010
2008
Material develop-ment with Institut für
Funktionswerk stoffe and Clausthal University of
Technology Product development
inhouse
Clinical study with surgeries performed at
Hanover Medical School
12/2012: Completion of tests on bio-compatibility of magnesium alloy according to EN ISO 10993
JAN. 2015
MAR. 2015
JUNE 2015
AUG. 2015
SEPT. 2015
Start market entry ROW
Production development in cooperation with Leibniz University of Hanover
Material, product and production development
First surgery in Asia performed at Tan Tock Seng Hospital, Singapore
Top-Innovator2015
(Pre-)clinical studies and further tests
Syntellix belongs to the most innovative companies in Germany
MAGNEZIX® implants receive the official approval from the renowned Health Science Authority (HSA) for Singapore
Top Innovator Award
HSA approval
2008
First deliveries into the Nether-lands, Italy, Austria, Switzerland, Bulgaria, Turkey, Slovenia
MAR. 2013
MAY 2013
JUNE 2013
JAN. 2014
2014
2015
2013
2008
SEPT. 2013
Innovation Award of the German Economy
First use of MAGNEZIX® CS 3.2 in clinical context outside the clinical study
Market entry EU
MAGNEZIX® CS 3.2: CE approval for 32 European countries
More than 200 operations at 65 hospitals with Syntellix implants in a very short time period after market entry
Market entry in Germany
CE approval for the new dimensions of MAGNEZIX® CS
Portfolio extension
Research and development of new screw sizes with thread diameters 2.0, 2.7 and 4.8 mm
AUG. 2014
Basis for the following CE approval
EN ISO 13485 Company Certification
MAGNEZIX® implants receive the official approval from the renowned Health Science Authority (HSA) for Singapore
MAGNEZIX® implants have become part of a special cooperation contract between ukb hospital (Unfallkranken haus Berlin) and health insurance company AOK
Excellent results demonstrate outstanding efficiency of MAGNEZIX® implants in Halluxvalgus surgery
HSA approval
2016
2017
2018
Second TopInnovator AwardFirst MAGNEZIX®
supply agreement Follow-up study after 3 years
New product MAGNEZIX® Pin receives CE approval
FEB. 2016
FEB. 2018
NOV. 2016
FEB. 2017
APR. 2017
MAY 2017
JUNE 2017
DEC. 2017
JUNE 2016
MAY 2016
JULY 2016
AUG.2016
First jaw surgery
University Clinic Dresden first to successfully test MAGNEZIX® for maxillo-facial surgery
German Future Prize Healthcare
Syntellix receives the Future Prize by cdgw (club of health economy) for its innovative medical products
EDB–Support (Singapore):
Commitment from one of the economically most stringent and most successful governments in the world
Entry of the first institutional investor in Asia Wintop Capital Healthcare Fund
Syntellix is the winner of the nationwide award “Innovator of the year 2017”
MAGNEZIX® CBS: CE approval for 32 European countries
Office opening Syntellix Asia Pte. Ltd.
Winner of “Tech Category” within the Step Award 2017
Submission of the FDA approval file
New renowned investors
Jürgen Fitschen (former CEO of Deutsche Bank)
Rolf Elgeti (Hevella Capital)
Clinical superiority of MAGNEZIX® Comparative study 100 MAGNEZIX® vs. 100 titanium implants
Syntellix wins the Germany Medical Award
Finalist German “Industry Award 2017”
MAGNEZIX® was voted into the Top 3 med-tech product solutions
Preisträger 2016Deutscher Zukun�spreis Gesundheitswirtscha�
Entry of a further institutional investor in Asia United Overseas Bank
Prof. Dr. Utz Claassen
New CEO and Chairman of the Executive Board
10-year Anniversary of Syntellix
10
JAN. 2018
MAR. 2018
2019 MAGNEZIX® CSc 4.8
obtains CE approval
FEB. 2019
JAN. 2019
MAR. 2019
APR. 2019
AUG. 2019
SEP. 2019
MAY 2019
German Innovation Award 2019 Gold Winner
Excellence in Business to Business – Medical Technologies
Syntellix Asia: New production facility
Tuas Biomedical Park, Singapore
Set up of Syntellix India Private Limited
“Magnesium – the New Gold Standard for orthopaedic and trauma surgery”
Prof. Gowreeson Thevendran, 67th Continuing Orthopaedic Education (COE) Congress, Solo City (Surakarta)
Far-reaching cooperation agreement with Chunli
China's leading orthopaedic implant supplier
Granted approvals for MAGNEZIX® CS
in over 50 countries
Successful re-certification
as per May 7, 2018
for another 5 years
First scientific publication in Asia confirms efficacy of MAGNEZIX® implants with Asian patients
Successful productregistration of MAGNEZIX® CS and Pin in Hong Kong
Growing relevance in Pediatrics
Supporting lectures and articles together with two renowned pediatric surgeons
Successful participation in funding program Horizon 2020
The Eurpean Framework Programme for Research and Innovation
Set up of Syntellix Philippines Inc. and Syntellix America Inc.
CFDA fast track approval process
MAGNEZIX® CS receives special approval procedure for innovative medical devices in China
Successful approval in Indonesia for MAGNEZIX®
Funding from 1st
Singapore-Germany Academic-Industry (2+2) International Collaboration
German AcceleratorLife Sciences
Selection to funding program
Sustainability Award Program
Winner of Product of the Year
Set up of Syntellix do Brasil Eireli
Mexico approval
Extensive approval of MAGNEZIX® implants for Mexico, North America's second most important market
Entry of new shareholders
Steven F. Mayer (Top US-investor)
Vesta GmbH
Wilfried Hüser (Entrepreneur)
MAY 2018
APR. 2018
DEC. 2018
OCT. 2018
JULY 2018
SEP. 2018
Complete acquisition of MSE
Materials Science and Engeneering Werkstoff- zentrum Clausthal GmbH
New product MAGNEZIX® StarFuse® receives CE approval
Set up of Syntellix China Pte. Ltd.
GROWING IN NUMBERS AND ACHIEVEMENTS: SYNTELLIX DEVELOPMENT TIMELINE
2008-2019.
0.06 % – this very low rate of announced events shows that MAGNEZIX® implants are safe and that there is no inade-quate risk for the clinical use of the implant in patients.
RELIABILITYIn relation to more than 63,000 marketed units
worldwide (1.614 received feedbacks), there
were just 38 genuine clinical undesirable effects
announced to us, of which only 4 had to be
reported to the health authorities (BfArM/BASG).
Further analysis and examinations proved that
not a single reported case could be attributed
to the implant itself.
Sour
ce: O
ffici
al P
MS
(Pos
t M
arke
t Su
rvai
llanc
e) S
ynte
lllix
AG
, Oct
ober
20
19
0 CASES ATTRIBUTED TO THE PRODUCT!
*All mentioned events seem to have been caused by the applicants' learning curve for the proper use and normal clinical course of the implant. Not a single case could be attributed to the product itself or its material.
4 REPORTED
CASES
38 UNDESIRED
EFFECTS
WHAT DRIVES THE COMPANY’S SUCCESS: KEY FACTORS AND FIGURES!
1.614 FEEDBACKS ON
IMPLANTS
KNOW HOWSyntellix is the world leader in the field of transformable
metallic implants. This internal know-how is completed by
an outstanding competence network.
PATENTSSyntellix holds an impressive range of patents
which are important assets of an innovative and
technologically driven company.
PEOPLEHighly motivated experts who have the courage to
change the world – welcome to the Syntellix team.
INNOVATIONSInnovative research leads to innovative products:
this is Syntellix's daily business.
QUALITYIn thousands of surgeries, not a single unwanted
result was attributed to the MAGNEZIX® product.*
MORE THAN
63,000 IMPLANTS
SYNTELLIX’S MISSION “INTELLIGENT INNOVATIONSFOR A BETTER LIFE” IS BASED ON UNIQUENESS AND A GLOBAL STAND-ALONE POSITION!
World-wide pioneer and technology-leader with the highest clinical evidence.
Holder of product approvals and patents in over 50 countries around the world.
Tens of thousands of marketed implants.
A multitude of convinced leading orthopaedists, sports physicians and paediatric surgeons around the globe.
Honored with numerous prestigious awards.
To date Syntellix occupies
100 % OF THE MARKET for internationally approved metallic transformable implants.
UNIQUE ... Alloy and generation process.
Product advantages: MAGNEZIX® is an innovation of global scale.
Product positioning: Syntellix is the only company worldwide which has obtained a CE approval and is No.1 in the world for transformable metallic implants.
Competence network.
Top-Innovator2015 & 2016
Preisträger 2016Deutscher Zukun�spreis Gesundheitswirtscha�Branchensieger
Tech 2017
THE NO. 1 in the world for transformable metallic implants
Syntellix Asia Pte Ltd2 Science Park Drive#02-10 AscentSingapore 118222
T +65 6265 1970F +65 6265 3346
M 7
901.
001.
003
10/1
9
Syntellix AGAegidientorplatz 2a30159 HannoverGermany
T +49 511 270 413 50F +49 511 270 413 79
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