A New Milestone for SciVision
As the aesthetic medical industry enters the MDR era, only a limited number of manufacturers worldwide have successfully achieved certification under the European Union Medical Device Regulation (MDR).
We are proud to announce that SciVision Biotech has officially obtained CE certification under the MDR framework for our Class III non-lidocaine dermal filler products. This achievement reflects our long-term commitment to product quality, patient safety, regulatory excellence, and international standards.
The MDR certification marks another important milestone in SciVision’s global development and further strengthens our dedication to providing safe, innovative, and high-quality medical aesthetic solutions to healthcare professionals and patients worldwide.
SciVision Biotech Inc. has been granted a Taiwan invention patent (Patent No. I920698), titled “Method for Manufacturing Crosslinked Hyaluronic Acid Gel Containing Triamcinolone and Crosslinked Hyaluronic Acid Gel Thereof.” This patented technology is designed for the production of triamcinolone-containing crosslinked hyaluronic acid (HA) gels intended for the treatment of osteoarthritis patients.
Triamcinolone is a type of corticosteroid commonly used in intra-articular injections to relieve inflammation and pain associated with osteoarthritis. Corticosteroids may be naturally produced by the adrenal cortex or synthetically manufactured for medical applications. When combined with crosslinked hyaluronic acid for joint injection, the therapeutic effect can be further enhanced. Corticosteroids are known to provide rapid pain relief during the first few days following injection.
Leveraging SciVision’s proprietary CHAP crosslinking platform technology together with its newly developed uniform particle dispersion technology, triamcinolone can be evenly distributed throughout the crosslinked HA gel matrix. The resulting formulation enables sustained drug release, thereby prolonging the anti-inflammatory and analgesic effects of the corticosteroid.
This invention patent represents a key technological advancement in drug-device combination products based on crosslinked hyaluronic acid matrices. The newly granted patent marks a significant breakthrough for SciVision in the development and manufacturing of HA-based drug-containing products. The patent scope covers both manufacturing methods and composition claims, providing strong protection against competitive development of similar products and further strengthening SciVision’s leadership position in the hyaluronic acid market.
Recently, we have received reports from a partner regarding the purchase of our joint synovial fluid supplement product, HYAJOINT Plus, from a company in Turkey. We would like to clarify that SciVision currently does not have any authorized distributors in Turkey. Additionally, SciVision is the sole manufacturer of this product.
Our company has secured a patent from the Taiwan Intellectual Property Office (TIPO) for the 'METHOD OF MANUFACTURING AUTO-CROSSLINKED HYALURONIC ACID GEL AND PRODUCTS THEREOF'.
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