Taiwan's HORIEN Accelerates Global Footprint: Achieves Three Thai FDA Class 4 Approvals and Secures U.S. Patent for Biodegradable Ureteral Stent

Market-entry initiative targets qualified Thai distributors across dental, surgical, wound-care, and regenerative medicine channels, while solidifying global IP leadership in advanced urological biomaterials.

TAICHUNG, Sept. 8, 2026 /PRNewswire/ -- HORIEN Biochemical Technology Co., Ltd. (TPEx: 7814) today announced a major double milestone in its global expansion strategy: the formal entry into the Thai market following Thai Food and Drug Administration (Thai FDA) Class 4 approvals for three advanced regenerative medical devices, alongside securing a prestigious U.S. invention patent for its innovative biodegradable ureteral stent.

With its regulatory foundation fully established in Thailand, HORIEN is actively inviting qualified exclusive and strategic distribution partners to drive responsible market launch, clinician education, and long-term healthcare infrastructure development across the country. Concurrently, the newly granted U.S. patent underscores HORIEN's world-class R&D capabilities in cross-linked biomaterials, further bolstering the company's reputation as an emerging global leader in regenerative medicine.

Thai FDA Class 4 Approved Portfolio

The three newly approved devices form the core of HORIEN's porcine-derived collagen biomaterial portfolio, manufactured using state-of-the-art Dehydrothermal Treatment (DHT) and decellularization processes. These products establish a versatile framework for clinical deployment across dental, surgical, wound care, and regenerative applications:

1. "Horien" Collagen Bone Graft Matrix

A porous, implantable scaffold tailored for Guided Bone Regeneration (GBR) procedures, engineered to provide optimal architecture for natural bone-remodeling and cellular integration.

       2. "Horien" Collagen Matrix

A highly biocompatible collagen plug and sheet designed for rapid fluid absorption, local clot stabilization, and superior wound coverage across surgical and dental interventions.

       3. "Horien" Extracellular Membrane

A resorbable extracellular matrix derived from porcine Small Intestinal Submucosa (SIS), specialized for Guided Tissue Regeneration (GTR) and alveolar ridge preservation procedures.

Milestone R&D Achievement: U.S. Biodegradable Ureteral Stent Patent

Parallel to its commercial progress in Southeast Asia, HORIEN has been granted a key U.S. invention patent for its novel Biodegradable Ureteral Stent. Designed to address significant clinical pain points in urological procedures, this cutting-edge stent safely degrades within the body post-healing, eliminating the need for a secondary removal procedure and substantially lowering infection risks and patient discomfort. This landmark patent significantly expands HORIEN's technological moat as it expands its biomaterial expertise from oral and wound care into high-value urological applications globally.

Capitalizing on Thailand's Expanding Healthcare Ecosystem

Thailand's healthcare sector presents substantial commercial opportunity across all three focal areas of HORIEN's biomaterial platform. According to Grand View Research, Thailand's dental equipment and consumables market generated US$383.2 million in 2024 and is projected to reach US$569.5 million by 2030 (CAGR 6.9%). The general surgery devices market reached US$164.3 million in 2024 and is forecast to hit US$257.6 million by 2030 (CAGR 7.9%). Meanwhile, Thailand's regenerative medicine market stood at US$63.0 million in 2024 and is expected to grow to US$113.9 million by 2030 (CAGR 10.1%). Together, these robust growth trends signal an accelerating demand for premium regenerative solutions.

"Thailand represents a pivotal cornerstone in HORIEN's Southeast Asian expansion," said Hsin-Yu Ho, General Manager of HORIEN Biochemical Technology Co., Ltd. "Securing three Class 4 Thai FDA approvals validates the clinical safety and efficacy of our platform. Paired with our recent U.S. patent breakthrough for biodegradable ureteral stents, we are proving that Taiwanese medical technology stands at the forefront of international innovation.

Our top priority in Thailand is to establish sustainable partnerships with distributors who possess deep clinical reach and a strong commitment to professional medical education. In Taiwan, our 'Horien' Collagen Matrix alone generates over US$1.2 million in annual revenue, demonstrating strong clinical validation and commercial maturity that we look forward to sharing with our Thai partners."

Exclusive Distribution Partnership Opportunities in Thailand

HORIEN is actively hosting discussions with potential partners in Thailand for exclusive or strategic regional distribution rights. Preference will be given to distributors with established networks in dental, surgical, and regenerative medicine channels, robust regulatory compliance capabilities, and dedicated resources for clinician training and local market engagement.

Key benefits for prospective Thai partners include:

• Immediate market access with a Thai FDA-approved Class 4 product portfolio.
• Scalable, high-standard ISO/GMP-certified manufacturing capabilities.
• Comprehensive product training, scientific support, and technical education for local teams.
• Co-marketing resources and strategic business development assistance.
• Long-term collaboration with a publicly listed, innovation-driven biomaterials developer.

Qualified medical device distributors in Thailand are encouraged to contact HORIEN Biochemical Technology Co., Ltd. for partnership inquiries, product specifications, and commercial terms.

About HORIEN Biochemical Technology Co., Ltd.

HORIEN Biochemical Technology Co., Ltd. (TPEx: 7814) is a leading Taiwan-based biomedical company specializing in the research, development, and commercialization of advanced regenerative biomaterials for dental, oral surgery, wound care, tissue regeneration, and urological applications. Driven by proprietary processing technologies and international quality management standards, HORIEN maintains a dominant position in Taiwan's dental biomaterials market while rapidly expanding its global presence through FDA regulatory approvals, strategic patents, and premier international distribution partnerships.

SOURCE HORIEN BIOCHEMICAL TECHNOLOGY CO., LTD.