HORIEN Biotech Expands Globally with Thai FDA Approvals and a U.S. Patent for a Biodegradable Ureteral Stent

TAICHUNG, Taiwan – On September 8, 2026, HORIEN Biochemical Technology Co., Ltd. (TPEx: 7814) lifted the curtain on what it calls a "double milestone" in its push to become a truly global player in regenerative medicine. The company not only secured three Class 4 approvals from the Thai Food and Drug Administration, but also clinched a U.S. invention patent for its novel biodegradable ureteral stent.

Those three Thai‑FDA‑cleared products are all built on the same porcine‑derived collagen platform, produced through a blend of dehydrothermal treatment (DHT) and decellularisation. First up is the “Horien” Collagen Bone Graft Matrix – a porous scaffold designed for guided bone regeneration, where it acts like a friendly scaffold for the body’s own bone cells. Then there’s the “Horien” Collagen Matrix, essentially a plug‑and‑sheet that soaks up fluids, stabilises clots and provides a smooth covering for wounds in dental or surgical settings. Finally, the “Horien” Extracellular Membrane comes from porcine small‑intestinal submucosa and is aimed at guided tissue regeneration and alveolar ridge preservation.

Why does this matter? Thailand’s healthcare market is on a growth spurt. According to Grand View Research, the dental equipment sector alone was worth US$383 million in 2024 and is projected to surge past US$569 million by 2030. General surgery devices and regenerative‑medicine products are also expected to jump 7‑10 % annually. In short, the demand for high‑quality, regenerative solutions is rising fast, and HORIEN is positioning itself right at the heart of that wave.

At the same time, the company celebrated a very different kind of win on the other side of the world – a U.S. patent for its biodegradable ureteral stent. This little device is meant to dissolve on its own after the urinary tract has healed, sparing patients a second procedure to have it removed. Less pain, fewer infections and lower overall costs – the kind of benefits that doctors and patients alike love to hear about.

"Thailand is a pivotal corner‑stone for our Southeast Asian ambitions," said Hsin‑Yu Ho, General Manager of HORIEN. "Getting three Class 4 approvals validates the safety and efficacy of our collagen platform, and the U.S. patent shows that our R&D can push the envelope beyond oral and wound care into high‑value urology."

HORIEN isn’t just waiting for distributors to knock on its door; it’s actively courting partners who can bring the products to clinicians, train them, and help build a sustainable market. Ideal partners will have strong networks in dental, surgical or regenerative‑medicine channels, solid regulatory know‑how, and a genuine commitment to education.

What’s in it for a Thai distributor? Immediate access to an FDA‑approved product suite, manufacturing that meets ISO/GMP standards, comprehensive scientific and technical support, co‑marketing resources, and a long‑term partnership outlook. HORIEN’s own “Horien” Collagen Matrix already pulls in over US$1.2 million in annual revenue in Taiwan – a clear sign that the technology has both clinical traction and commercial viability.

All told, HORIEN’s twin achievements – Thai regulatory clearance and a U.S. patent – underline the company’s strategy of leveraging solid IP and local market entry to become a recognizable name in regenerative biomaterials worldwide.