Singapore-Based Innovative Biomedical Start-Up Achieves'Strategic Triumph'to Conquer Chinese Med-Tech Market

  • NMPA grants Syntellix product approval for the world's most important future market with more than 1.4 billion people
  • Syntellix'product approval forChinais the largest and most important success in the company's history; product approval inChinawas the company's most important strategic and operational goal
  • Syntellix had previously already been granted the accelerated'innovative pathway'by the NMPA due to the exceptional benefits of its products
  • In total, product approvals for Syntellix products have accumulated to date in countries with more than 5.5 billion inhabitants; product approvals had already been achieved in 73 countries and regions on five continents before current success inChina
  • Development of the prioritized core markets ofChina,India, and ASEAN is being carried out via Syntellix Asia Pte Ltd inSingaporeas manufacturing facility& sales hub
  • Syntellix Asia Pte Ltd has been supported by the Singapore Economic Development Board (EDB); Syntellix AG targets IPO on the Singapore Exchange (SGX)
  • Syntellix and Syntellix Asia CEO Claassen:"After 7 years of focusing onChina, we have achieved what almost everyone considered impossible. As a startup with its operational heart inSingapore, we have written a pioneering story worldwide, whose global medical success can now no longer be stopped. I sincerely thank the Singapore Economic Development Board (EDB) for its far-sighted contribution to the operational and structural foundation of our rollout inAsiaby providing expertise and financial support for the establishment and expansion of our production facility inSingapore, which will now also become anAsia-wide and global sales hub as planned."

HANOVER, Germany, andBEIJINGandSINGAPORE,July 23, 2025/PRNewswire/ -- Syntellix AG, parent company ofSingapore-based, Syntellix Asia Pte Ltd, has received product approval forthe People's Republic of Chinafrom the Chinese NMPA (National Medical Products Administration) inBeijing, which is responsible for the government regulation, registration, and monitoring of medical devices for the Chinese market. This product approval for the world's most important future market, with more than 1.4 billion people, is by far the greatest and most important success in the company's history. Syntellix AG had declared the development of the vast Chinese market its top strategic priority following Professor DrUtz Claassen'sassumption of office as CEO of the company. After Syntellix had already previously been granted the accelerated'innovative pathway'by the NMPA due to the particular advantages of its products, the initial approval process has now been completed extremely successfully. It was the most complex, intensive, and sophisticated approval process Syntellix has ever undergone in terms of product safety and quality management systems.

Syntellix now has obtained product approvals in countries with more than 5.5 billion inhabitants, or more than two thirds of the world's population. Syntellix had previously received product approvals in 73 countries and regions on five continents, including all ofEurope,AustraliaandNew Zealand,South Africa,Singapore,Israel, andSaudi Arabia, as well as fast-growing, demographically dynamic countries such asIndonesia,Vietnam,the Philippines, andThailand, as well as the world's most populous country –India.ChinaandIndia, with a combined population of almost 3 billion, open up entirely new dimensions of potential for the company in many respects. Syntellix'highly innovative bioabsorbable metallic implants are produced by Syntellix Asia Pte Ltd which is based in JTC's Tuas Biomedical Park. The Economic Development Board (EDB) had provided initial grants to Syntellix to support the establishment of its manufacturing presence and global sales hub inSingapore.

With the product approval now achieved inChina, labelled by German news platform'Pressefeuer'a'strategic triumph'that could revolutionize the world of biomedical engineering and is a decisive step for theHanover-based company', Syntellix has achieved its most important strategic and operational goal. The strategic decision to develop the prioritized core markets ofChina,India, and ASEAN through Syntellix Asia Pte Ltd inSingapore, and to locate and expand the main production site in the ultra-modern and highly efficient island nation ofSingapore, has proven to be both expedient and entirely correct. Establishing anAsia-centric production chain was strategically and operationally the right decision, as the production and sales hub inSingaporecan supply and serve most of the world better and faster than fromGermanyorEurope. More than 3.5 billion people live inChina,India, and the ASEAN region alone, which is more than 40 times the population of the Federal Republic ofGermany, while at the same time experiencing significantly greater dynamics in terms of population growth, market growth, and economic power and perspectives.

For this purpose – establishing and expanding production inSingapore, tapping into the South Asian, Southeast Asian, and East Asian markets, and obtaining the necessary product approvals, particularly inChina, – Syntellix, CEO Professor, DrUtz Claassen, who is also Executive Chairman& CEO of Syntellix Asia Pte Ltd inSingapore, relocated his residence fromGermanytoSingaporemore than five years ago in consultation and coordination with the Supervisory Board of Syntellix AG.

Syntellix CEO ProfessorUtz Claassenthus commented very positively on the product approval now achieved inChina:"After more than 17 years of work and more than 7 years of focusing onChinaalone, we have achieved what almost everyone considered impossible. As a startup fromHanoverwith ist operational heart inSingapore, we have written a pioneering story worldwide, whose global medical success is now unstoppable. Those who win inChinaare strategically and operationally ideally positioned. The largest hospitals inChinaindividually have higher patient volumes and more operations for our highly innovative products than most countries in the European Union. Without neglecting our homeland, we are proud and grateful to now be able to use our products, which are so beneficial for patients, users, and the healthcare system, inChina, with its 5,000 years of cultural history, its magnificent medical tradition, and its unique future prospects. This is a game changer for our company, both qualitatively and quantitatively."

Claassen emphasizes both the abstract and concrete positive conditions for the successful development of Syntellix'activities inAsia, and also specifically inSingapore, and he is grateful for the very positive environment here:"I would like to expressly thank our outstanding Chinese partners for their tremendous support and cooperation, and the NMPA for an outstandingly differentiated and structured approval process. I would also like to sincerely thank the Singapore Economic Development Board (EDB) for its far-sighted contribution to the operational and structural foundation of our rollout inAsiaby providing expertise and financial support for the establishment and expansion of our production facility inSingapore, which will now also become anAsia-wide and global sales hub as planned. This will create many attractive jobs inSingaporeand set new international standards in biomedical engineering under market conditions that are not found inGermanyorEurope, and building on government funding from the Republic ofSingapore."

Syntellix AG, as a joint-stock company under German stockholding law already a public company, also targets an IPO on the Singapore Exchange (SGX), the preparations of which have already been ongoing for several years with the help of Singaporean banks and law firms, well supported by SGX management under the leadership of its CEO MrLoh Boon Chyeand coordinated by MsAlice Gwee.

About Syntellix:

Syntellix AG, a global pioneer in biomedical engineering, materials, and life sciences, is the only company in the world with approvals for bioabsorbable metallic implants in more than 70 countries on five continents, tens of thousands of successful surgeries, and the highest level of patient satisfaction. Syntellix is a global protagonist and market and technology leader in the field of bioabsorbable metallic orthopaedic implants. The company has received numerous prestigious awards and prizes, including the Innovation Award of the German Economy, the German Healthcare Industry Future Award, the German Medical Award, the STEP Award, the"Innovator of the Year"award, the German Innovation Award in Gold, and the Sustainability Award as"Product of the Year."More than 50 medical and scientific publications have meanwhile documented the safety, efficacy, and reliability of the MAGNEZIX® implants developed by Syntellix, which have been described as"advantageous"and even"clinically superior"to conventional titanium implants for numerous clinical applications.

Syntellix Asia Pte Ltd inSingaporeis a wholly-owned subsidiary of Syntellix AG. It is the operational heart of the group. The manufacturing facility for the highly innovative MAGNEZIX® implants is located inSingapore, in JTC's Biomedical Park in Tuas. Syntellix Asia Pte Ltd, which in turn has the subsidiaries Syntellix China Pte Ltd, Syntellix Philippines Incorporated inSan JuanCity, and Syntellix India Private Limited inNew Delhiand Jaipur, Rajasthan, serves not only the internationally leading medical hub ofSingaporeitself with its numerous world-class hospitals, but also major markets in countries throughout the ASEAN region, includingThailand,Malaysia,Vietnam, andIndonesia."

Contact:

T +49 511 270 413 50

F +49 511 270 413 79

info@syntellix.com

www.syntellix.com 

 

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