● Market entry at a major national specialist congress in Tianjin/China with several tens of thousands of participants

● NMPA granted Syntellix product approval for the world's most iportant future market with more than 1.4 billion people in early summer

● Product approval in china was the company's most important strategic and operational objective; the actual market entry now unlocks the long-sought potential

● Syntellix CEO Claassen: "After 17 years of work and 7 years of focus on China, we have achieved what almost everyone thought impossible and some tried to prevent: as a startup from Hannover, we opened the door to the Middle Kingdom and were warmly welcomed there. Achieving this is a milestone for us."

Hannover/Tianjin/Singapore. A few months after Syntellix AG received product approval for the People’s Republic of China from the Chinese NMPA (National Medical Products Administration) in Beijing — the state authority responsible for regulating, registering, and monitoring medical devices in China — the company has now successfully completed its market entry into China. The market launch took place during the 24th Academic Conference of the Chinese Medical Association and the 17th COA Congress of the Chinese Orthopaedic Association (COA) in November 2025 in Tianjin, China, organized by the local Tianjin Medical Association, with several tens of thousands of participants from all orthopaedic specialties. The event’s thematic focus was “Integration of basic research and clinical practice, multidisciplinary collaboration to build a first-class academic platform.”

Situated directly alongside established global players, Syntellix presented itself with a modern exhibition booth designed specifically for this event. The response to Syntellix’s globally unique implants — offering tremendous advantages for both patients and users — was outstanding as expected. The first significant shipment to China has already been delivered, and several additional shipments are scheduled for imminent delivery to Syntellix’s highly committed Chinese distribution and cooperation partner, who has set up entirely new facilities in China specifically for its activities involving Syntellix products. With product approval already obtained in early summer, Syntellix achieved its most important strategic objective — and with the now successfully completed market launch, the company can unlock the potential of the world’s most important market with its 1.4 billion people.

About Syntellix:
Syntellix AG, a global pioneer in biomedical engineering, material and life sciences, is the only company in the world with approvals for bioabsorbable metallic implants in more than 70 countries across 5 continents, with tens of thousands of successfully performed surgeries and the highest levels of patient satisfaction. The company is a global protagonist and the market and technology leader in the field of bioabsorbable metallic orthopaedic implants. It has been honored with numerous significant awards, including the Innovation Award of the German Economy, the Future Award of the German Healthcare Industry, the German Medical Award, the STEP Award, recognition as “Innovator of the Year,” and the German Innovation Award in Gold, as well as international recognition as “Product of the Year” at the Sustainability Award.

To date, more than 50 medical and scientific publications have demonstrated the safety, efficacy, and reliability of Syntellix’s MAGNEZIX® implants, which have been described as “advantageous” and even “clinically superior” to conventional titanium implants for numerous clinical applications.

● NMPA grants Syntellix Product Approval for the world's most important future market with more than 1.4 billion people

● 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 were achieved 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

● Product approval in China was the company's most important strategic and operational goal

● Development of the prioritized core markets of China, India, and ASEAN is being carried out via Syntellix Asia Pte Ltd in Singapore as a manufacturing facility and sales hub

● Syntellix CEO Claassen: "After 17 years of work and 7 years of focusing on China, we have achieved what almost everyone considered impossible and some even wanted to prevent. As a startup from Hanover, we have written a pioneering story worldwide, whose global medical success can now no longer be stopped. Those who win in China are ideally positioned strategically and operationally“

Hanover/Beijing/Singapore, July 18, 2025. Syntellix AG has received product approval for the People's Republic of China from the Chinese NMPA (National Medical Products Administration) in Beijing, 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 Dr. Utz Claassen's assumption 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 positively and 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 of Europe, Australia and New Zealand, South Africa, Singapore, Israel, and Saudi Arabia, as well as fast-growing, demographically dynamic countries such as Indonesia, Vietnam, the Philippines, and Thailand, as well as the world's most populous country – India. China and India, with a combined population of almost 3 billion, open up entirely new dimensions of potential for the company in many respects.

With the product approval now achieved in China, Syntellix has achieved its most important strategic and operational goal. The strategic decision to develop the prioritized core markets of China, India, and ASEAN through Syntellix Asia Pte Ltd in Singapore, and to locate and expand the main production site in the ultra-modern and highly efficient island nation of Singapore, has proven to be both expedient and entirely correct. Establishing an Asia-centric production chain was strategically and operationally the right decision, as the production and sales hub in Singapore can supply and serve most of the world better and faster than from Germany or Europe. More than 3.5 billion people live in China, India, and the ASEAN region alone, which is more than 40 times the population of the Federal Republic of Germany, while at the same time experiencing significantly greater dynamics in terms of population growth, market growth, and economic power.

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

Syntellix CEO Professor Utz Claassen thus commented very positively on the product approval now achieved in China: "After more than 17 years of work and more than seven years of focusing on China alone, we have achieved what almost everyone considered impossible and some wanted to prevent. As a startup from Hanover, we have written a pioneering story worldwide, whose global medical success is now unstoppable. Those who win in China are strategically and operationally ideally positioned. The largest hospitals in China individually 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, in China, 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's activities in Asia and is grateful for the very positive environment there: "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 thank the Economic Development Board (EDB) of the Republic of Singapore for its far-sighted contribution to the operational and structural foundation of our rollout in Asia by providing expertise and financial support for the establishment and expansion of our production facility in Singapore, which will now also become a sales hub as planned. This will enable German technology to set new international standards in biomedical engineering under market conditions that are not found in Germany or Europe, and building on government funding from the Republic of Singapore."

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 orthopedic 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 in Singapore is 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 in Singapore. Syntellix Asia Pte Ltd, which in turn has the subsidiaries Syntellix China Pte Ltd, Syntellix Philippines Incorporated in San Juan City, and Syntellix India Private Limited in New Delhi and Jaipur, Rajasthan, serves not only the internationally leading medical hub of Singapore itself, but also major markets in populous countries throughout the ASEAN region, including Thailand, Malaysia, Vietnam, and Indonesia."