Zylox Unicorn™ Vascular Closure Device Gains Regulatory Approval in Indonesia
Zylox Unicorn™ Vascular Closure Device Gains Approval in Indonesia
Zylox-Tonbridge Medical Technology Co., Ltd. has officially announced that its innovative ZYLOX Unicorn™ Vascular Closure Device (VCD) has received regulatory approval in Indonesia. This achievement represents the ZYLOX Unicorn's first entry into an international market and marks a pivotal advancement in the company's expansion within Southeast Asia.
As China's first domestically-developed vascular closure device, the ZYLOX Unicorn™ offers an impressive closure range from 5F to 22F. This capability makes it suitable for large-bore access sites (≥8F), allowing it to meet diverse clinical needs that were previously unmet in vascular interventions. The device is strategically designed to align with global standards, ensuring it can provide high-quality care while maintaining affordability. In premarket clinical trials, it showcased robust safety and efficacy performance, further strengthening its readiness for market entry.
The advantages of the ZYLOX Unicorn™ VCD are numerous; it facilitates effective vascular closure, which in turn significantly reduces the time patients need to remain immobilized post-procedure. This capability is crucial as it addresses some of the common complications associated with puncture sites, thus enhancing patient outcomes.
This regulatory approval comes at an opportune time for Indonesia, the world's fourth most populous nation, creating vast opportunities for individuals needing advanced vascular intervention solutions. For healthcare professionals and patients alike, the introduction of Zylox-Tonbridge's device means improved access to comprehensive vascular treatment options that are both effective and economical.
Previously, in June 2024, the ZYLOX Unicorn™ had already received marketing authorization in China, and now with the approval in Indonesia, the company is set to extend its influence further throughout Southeast Asia. Zylox-Tonbridge has experienced rapid growth in its international business ventures, with revenues soaring to approximately USD 3.1 million in 2024, reflecting a remarkable compound annual growth rate (CAGR) of 87% over the past four years.
The reach of Zylox-Tonbridge has expanded to multiple regions globally, including Europe, the Americas, the Middle East, and Africa, effectively covering countries like France, Germany, Italy, Spain, Turkey, Saudi Arabia, Argentina, Brazil, and South Africa. Throughout 2025, the company has actively participated in major international congresses, such as LINC, PAIRS, CICE, and ESOC, significantly boosting its global brand visibility.
Looking forward, Zylox-Tonbridge remains committed to its mission of "Innovation for Quality Life." The company places a steadfast focus on expanding access to its high-quality and affordable treatment solutions across the globe. This strategy will be further supported by enhancing localized processes and seeking out strategic market entry points to maximize its reach and impact.
In summary, Zylox-Tonbridge's regulatory approval of the ZYLOX Unicorn™ Vascular Closure Device in Indonesia is a significant milestone not just for the company but also for the region's healthcare landscape. It underscores the promise of improved healthcare access and the potential for innovative medical solutions to create positive patient outcomes in the field of vascular interventions.