EpiSonica’s flagship product, the ArcBlate MRgHIFU—an image-guided focused ultrasound surgical system—has received market clearance from the Thai Food and Drug Administration, following its approval by Indonesia’s Ministry of Health in late August last year. The device is approved for the treatment of adenomyosis and uterine fibroids.

Chairperson Mei-Hsueh Lin stated that the company is positioning Taiwan as a demonstration hub while prioritizing expansion into Southeast Asian markets. Plans are also in place to gradually enter other Asian territories, including Mainland China and Japan. EpiSonica is currently in talks with potential distributors in Indonesia and is actively participating in medical trade exhibitions in both Thailand and Indonesia to seek further business opportunities. The company is also optimistic about securing regulatory approvals in the EU and Singapore this year. Lin emphasized the company’s continued commitment to innovation and quality, aiming to provide safe and effective medical solutions that improve patients’ quality of life.

Indonesia and Thailand are the two largest economies in Southeast Asia. Indonesia, with a population of approximately 280 million, ranks as the fourth most populous country globally, while Thailand has a population of around 65.95 million. As both countries push to enhance the quality of their healthcare systems amid economic growth, demand for advanced medical technologies has surged. With regulatory approvals now in hand, EpiSonica is aggressively entering these key healthcare markets.

The ArcBlate system utilizes MR-guided high-intensity focused ultrasound (MRgHIFU) technology—a non-invasive, incision-free, radiation-free thermal ablation treatment that offers precise targeting. For women of reproductive age, particularly those suffering from adenomyosis-related infertility, the ArcBlate system provides MRI-guided precision treatment that minimizes damage to the endometrium. This can reduce the time required to prepare for pregnancy and offers a promising new option in infertility care.

Resource: 振磬科技獲印、泰醫材上市許可 積極布局東南亞市場