Curia Medical's Biodegradable Microspheres Receive FDA Breakthrough Device Designation, Pioneering a New Era in Knee Osteoarthritis Treatment and Expanding Embolotherapy Indications

Cardiolink Science, with independent intellectual property rights, has developed the full-stack "biodegradable microspheres" product, which has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).(Breakthrough Device Designation, BDD). This product, developed based on biodegradable materials, is used to treat pain associated with knee osteoarthritis (Knee Osteoarthritis, KOA). This designation marks that the innovative achievements of Cardiolink Science's full-stack development have been recognized by international authoritative institutions, and it is expected to bring a revolutionary treatment option to millions of patients with knee osteoarthritis.

Knee osteoarthritis is a common degenerative joint disease that leads to the gradual deterioration of joint function, significantly impacting patients' quality of life. Currently, in international clinical practice, precise embolization interventional surgery (GAE) has shown promising clinical outcomes: by accurately blocking blood vessels around the joint, it reduces inflammatory responses, effectively alleviates pain, and improves joint function. The adoption rate of GAE surgery is on the rise. Cardiolink Science's biodegradable microsphere product, with its unique design and materials, offers a controlled and targeted minimally invasive embolization treatment option for patients with knee osteoarthritis.

FDA's Breakthrough Device Designation aims to accelerate the development and evaluation of medical devices that offer more effective treatments for life-threatening or irreversibly debilitating diseases. Cardiolink Science’s "Biodegradable Microsphere Product" receiving this designation not only confirms its innovation and unique value in treating knee osteoarthritis but also indicates that the product will enjoy an expedited regulatory review process, benefiting patients more quickly.