AMS BioteQ's Innovative Medical Device Officially Enters Japan, Obtains Taiwan's First Japanese Medical Device Permit

AMS BioteQ (Stock Code: 6864), a biotech company, announced on July 11 that its innovative medical device "SIPSIP Foam Wound Dressing" has successfully obtained the first-class medical device sales permit from Japan's PMDA, officially entering the Japanese market. The product has excellent anti-adhesion properties, high absorbency, and tissue regeneration capabilities, particularly suitable for the wound care needs of the elderly and diabetic populations. This is the first Taiwanese "cotton-based wound dressing" medical device to receive approval in Japan, which is not only significant in terms of product development and the company's mission, but also a milestone in AMS BioteQ's global market expansion for its self-developed brand.

Japan is the world's second-largest medical device market with very strict regulatory standards and certification processes. Before entering the Japanese market, all medical devices must first obtain approval from Japan's PMDA. The innovative SIPSIP hydrophilic dressing series is a highlight product of the company's innovative medical devices. It was first showcased at the Tokyo International Medical Exhibition in Japan last year and received high attention from all parties. In addition to already having certifications from the US FDA and Taiwan TFDA, the successful acquisition of the Japanese PMDA medical device permit is a great affirmation for AMS BioteQ, recognizing the company's innovative capabilities in the field of tissue regeneration technology and bringing a new choice to the Japanese medical device market. AMS BioteQ stated that it is currently in negotiations with Japanese distribution agents and is actively expanding into the Japanese Rakuten e-commerce market to jointly promote the sales and marketing of the SIPSIP Foam wound dressing.

Due to the increasing prevalence of diabetes and other chronic diseases, an aging population, and a rise in the number of surgeries, the global incidence of chronic wounds has been on the rise. According to Research Nester, the global chronic wound care market is expected to reach $20 billion by the end of 2033, with a compound annual growth rate (CAGR) of 10%, and the foam dressing market is expected to reach $2.52 billion. The Asia-Pacific region, with a faster aging process than other regions, is expected to account for about 24% of the global wound care market in the next decade. This has further increased public awareness of wound care and the demand for medical device equipment.

AMS BioteQ emphasizes that the SIPSIP Foam wound dressing is just the beginning of the product series. In the second half of the year, the company plans to launch more advanced innovative medical devices - SIPSIP Pro and SIPSIP Complex hydrophilic dressings. The key highlights of this innovative medical device series include wound regeneration technology patents, unique physical dressing structures, non-allergenic properties, and high absorbency. They have also been proven effective in promoting wound healing and functional tissue regeneration through animal experiments on mouse wound models, particularly for difficult and deep wounds, providing superior performance compared to similar products and giving them a strong market competitive advantage.

In addition to the Japanese market, AMS BioteQ is actively expanding its business presence in Southeast Asia, the Middle East and North Africa (MENA) region, and the ASEAN countries. The company has also been in contact with post-war reconstruction channels in Ukraine, hoping to leverage its own technology and medical device development experience to establish a robust medical care system to address the needs of the military and post-war markets, with the goal of helping more patients and collectively solving global wound care challenges, becoming a leading brand in innovative medical care.