Broken bones often have to be temporarily fixed in place with screws, nails or plates to enable them to heal and grow back together again. In the past, these implants, made of stainless steel or titanium, usually had to be removed again in a second operation because this foreign material would otherwise have remained in the body where it could lead to problems (infections, bone shrinkage). Medical research has therefore been searching for many years for material capable of being naturally absorbed. Thanks to close co-operation and its major commitment to basic research, Syntellix succeeded in achieving the pioneering breakthrough with a major innovation. Previously only dreamed of by patients and doctors, this innovation has now turned these dreams into reality, and has already been used thousands of times: a biotransformable and metallic (stable) material for implants.
Syntellix AG was established in 2008 by innovation-friendly and forward-looking investors in Niedersachsen (Lower-Saxony) in Germany, under the overall management of Prof. Dr. Utz Claassen. Established in Hannover, the start-up succeeded in making the breakthrough after a great deal of highly committed work: by setting up an interdisciplinary network of outstanding scientists at various research locations, Syntellix succeeded in developing MAGNEZIX® within five years and launching it on the market - a truly revolutionary material which, despite its metallic properties and high stability, can be completely absorbed within the body - and even replaced at the same time by the body's own bone tissue.
After countless biomechanical studies, in-vitro and in-vivo tests, MAGNEZIX® was the first bioabsorbable metallic implant world-wide to receive approval in 2013 (CE label). In March 2013, Syntellix AG won the prestigious and internationally renowned German Industry Innovation Prize - first innovation prize in the world® for its unique innovation MAGNEZIX®. Only two years later, the company also won the Top Innovator of German Medium-sized Enterprises award in 2015. It won the prize again as the Top Innovator in 2016, in the same year that Syntellix also won the Future Prize of the Health Industry Club. These prizes confirm Syntellix AG's technological leadership. Another milestone in 2016 was the state authorisation of MAGNEZIX® by the prestigious Health Science Authority (HSA) in Singapore. Syntellix is now the world's number 1 in the bioabsorbable metal implant sector, and currently active in 35 countries. Patients have already been successfully operated on thousands of times with Syntellix products.
History of Syntellix AG
On the basis of numerous highly promising results and findings from research carried out on magnesium-based degradable implants, Syntellix was founded in 2008 as a spin-off from the special research unit "Hannoversche Sonderforschungsbereich 599 (SFB 599, project division R)". The company was established with the intention of using all of this theoretical knowledge to finally develop and launch a bioabsorbable magnesium implant for medical applications.
2008 - 2010
MATERIAL RESEARCH AND DEVELOPMENT MAGNEZIX®
Together with new network partners which came on board (Institute for Functional Materials at the Technical University Clausthal), research was carried out in the following years on suitable materials. With the help of sophisticated mechanical, degradation and animal testing, MAGNEZIX® was finally developed, tested and optimised. MAGNEZIX® is a magnesium alloy based on the WE 43 alloy system which forms the adequate basis for bioabsorbable medical implants. The production design was finalised in co-operation with the Leibniz University Hannover.
2010 - 2012
SUCCESSFUL CONCLUSION OF CLINICAL STUDIES (PROOF OF CONCEPT)
The excellent results from numerous pre-clinical studies and tests carried out during 2010 to 2012, finally led to authorisation by the ethics commission for a clinical (approval) study on human patients with MAGNEZIX® compression screws. The clinical study was successfully carried out at the Hannover Medical School (MHH).
During the course of the clinical study, the biocompatibility of MAGNEZIX® pursuant to the ISO 10993 standard was confirmed and verified by numerous tests analysing aspects such as cytotoxicity, genotoxicity, oncogenicity, systemic toxicity, and many sensitivity tests (December 2012).
AWARD "GERMAN INDUSTRY INNOVATION PRIZE - FIRST INNOVATION PRIZE IN THE WORLD"
With its pioneering innovation MAGNEZIX® CS 3.2, Syntellix AG won the prestigious international German Industry Innovation Prize - first innovation prize in the world® in March 2013. This innovation is unmatched world-wide and generates a unique stand-alone position for Syntellix AG, and technological leadership in the metallic bioabsorbable implant sector.
CE-APPROVAL MAGNEZIX® CS 3.2 FOR 30 COUNTRIES
MAGNEZIX® CS 3.2 was awarded CE-approval as a medical product by TÜV Rheinland - which meant that after five years of research and development work, the world's first magnesium-based and bio-transformable implant for use in humans was now finally available.
This certification was shortly followed by the first operations during standard clinical practise.
MARKET LAUNCH IN GERMANY
Within a very short period of time after its market launch in Germany, more than 200 operations had already been carried out with Syntellix implants at 65 different clinics.
EUROPEAN DISTRIBUTION OF MAGNEZIX® STARTS
The first supplies to Italy, Austria, Slovenia, as well as to Turkey, Switzerland and the Netherlands then followed.
EXPANSION OF THE MAGNEZIX® CS PORTFOLIO
To satisfy a broader spectrum of indications, Syntellix began an R&D campaign at the beginning of August 2014 to develop MAGNEZIX® CS screws with additional thread diameters of 2.0, 2.7 and 4.8 mm.
GLOBAL DISTRIBUTION OF MAGNEZIX® STARTS
International sales of MAGNEZIX® CS 3.2 began at the beginning of the year focussing on dynamic growth markets. Market launches in Europe in Bulgaria, Poland, Norway, Finland and Ireland then followed.
Less than 1.5 years after being launched on the market, more than 1,500 implants had already been successfully realised.
FIRST OPERATION IN SINGAPORE, THE GATEWAY TO THE ASIAN MARKET
Leading technology from Hannover is now also revolutionising the Asian market: first operation with MAGNEZIX®, a metal-absorbable implant, in the high-tech metropolis of Singapore. Leading doctors at the prestigious Tan Tok Seng Hospital convinced about the advantages of the revolutionary technology.
GLOBAL DISTRIBUTION OF MAGNEZIX® SPEEDS UP
MAGNEZIX® has received the basic registration in Iran in record time, and is now also available in the United Kingdom, Chile and the United Arab Emirates.
One year after receiving approval, MAGNEZIX® CS 3.2 implants have already been sold 2,000 times.
SYNTELLIX WINS "TOP-INNOVATOR 2015" AWARD
Syntellix is one of the most innovative companies amongst German medium-sized enterprises.
Success thanks to forward-looking corporate strategy: Syntellix AG wins an award as one of the most innovative medium-sized enterprises in Germany at the German Medium-sized Enterprises Summit in Essen on 26 June. - "Top 100" - mentor Ranga Yogeshwar awards the company from Hannover the - "Top 100" - label which has been awarded for more than 20 years. Before receiving the award, Syntellix was vetted during a two-stage scientific analysis process. In only its first year of participation, the company already leapt into the number 2 position in the group for companies with up to 50 employees.
INTERIM ASSESSMENT AFTER TWO YEARS
This month boasted market launches in South Africa, Spain, Hong Kong and Macao. This means that only two years since it was launched, Syntellix products have now become available in 16 countries.
4000 implants have been sold so far internationally.
MAGNEZIX® CS APPROVED IN A RANGE OF NEW SIZES
CE approval was issued for the additional diameters as part of the CS portfolio expansion in summer 2015. MAGNEZIX® CS screws are now available in four diameters and a total of 61 sizes. In addition, Syntellix is continuing its research on additional areas of application and use, and submitted a completely new product category to TÜV Rheinland for approval testing in the form of the MAGNEZIX® Pin, a bone pin available in four dimensions and 69 sizes.
STATE APPROVAL FOR MAGNEZIX® IN SINGAPORE
Following the use of MAGNEZIX® implants in the Tan Tock Seng Hospital in Singapore since the end of March on the basis of a special authorisation, MAGNEZIX® has now received official approval from the prestigious state Health Science Authority (HSA).
A new milestone: the 10,000th MAGNEZIX® implant sold.
FIRST MAGNEZIX® SUPPLY CONTRACT
On the basis of an AOK co-operation agreement with the health centre at the ukb (accident & emergency hospital Berlin), patients covered by AOK medical insurance can now immediately benefit from MAGNEZIX® implants - all costs are completely borne by the health insurance company.
PREMIERE: MAGNEZIX® IN ORAL SURGERY
The first jaw operation with MAGNEZIX® took place in May in the Clinic and Polyclinic for Oral and maxillofacial Surgery at the University Clinic in Dresden (www.uniklinikum-dresden.de).
The successful outcome of this first operation of its kind in the world confirms the versatility and reliability of implants made from MAGNEZIX®, and opens up a completely new spectrum of applications in oral and maxillofacial surgery.
SYNTELLIX AG WINS THE TOP-INNOVATOR AWARD AGAIN
Syntellix AG is again amongst the TOP 100 this year after being assessed as part of a challenging scientific selection process looking at its innovation management and innovation success.
NEW MAGNEZIX® PIN GAINS CE APPROVAL
From innovation to innovation: MAGNEZIX®, a globally unique material for simultaneously stable and degradable metal implants, is now also available as a CE-approved pin!
MAGNEZIX® - CLINICAL FINDINGS AFTER 3 YEARS
The clinical findings of the three-year study with implants made of MAGNEZIX® demonstrate the special efficiency of this revolutionary technology. Patients involved were treated for a symptomatic Hallux valgus.
The findings revealed that the standard treatment with titanium implants and the use of MAGNEZIX® screws produced the same good results in both groups - but that the MAGNEZIX® implants have impressive advantages: the use of magnetic resonance tomography (MRT) in particular revealed that no metallic residues of the MAGNEZIX® screws were detectable after three years at the implant position. The MRT results also impressively demonstrated the bone remodelling with cortical tissue in parts.
SYNTELLIX WINS GERMAN HEALTHCARE FUTURE PRIZE
Syntellix AG (together with HappyMed from Vienna) was awarded with the German Healthcare Future Prize by the Health Industry Club (cdgw) for its innovative medical products in Berlin on 10.11.2016.
MAGNEZIX® continues to make its mark: with 25,000 MAGNEZIX® implants, more implants were placed on the market within just 12 months than in the previous 2.5 years. No suprise, with the advantages offered by magnesium implants compared to titanium and polymers.
With Syntellix Asia in Singapore, Syntellix AG founds its first international subsidiary with a focus on the booming Asian healthcare sector. At the same time, the entry of Wintop Capital as the first international investor marks an important business milestone.
AWARD: INDUSTRIAL PRICE 2017
Innovative medical device: MAGNEZIX® implants from Syntellix are among the leading solutions from over 1,000 applicants!
INNOVATOR OF THE YEAR 2017
Syntellix is awarded a prestigious award as a highly professional, agile start-up company, which has succeeded in developing a world-wide novelty for surgery with enormous market potential, particularly through an impressive network and part management.
Jury: "The company's development could serve as template for a guide 'How to start a med tech start-up'."