NEXT BIOMEDICAL seeks FDA breakthrough device designation for Nexsphere-F

NEXT BIOMEDICAL, a Korean medical solutions company, said it has applied for the U.S. Food and Drug Administration’s Breakthrough Device Designation for its musculoskeletal embolization treatment, Nexsphere-F.

The U.S. FDA's Breakthrough Device Designation program accelerates the approval process for medical devices, demonstrating significant innovation and advantages over existing treatments. If granted, the designation will facilitate close collaboration with the FDA, ensuring priority review and expedited regulatory approval.

It also enhances the likelihood of Medicare reimbursement and offers increased flexibility in clinical trial design, significantly shortening the time required for market entry.

Nexsphere-F is a biodegradable embolization treatment for musculoskeletal pain. It utilizes fast-acting microspheres to embolize abnormal blood vessels responsible for arthritis pain.

These microspheres dissolve within two to six hours, leading to the necrosis of pain-inducing nerve cells and subsequent pain relief. The device has already secured Investigational Device Exemption (IDE) approval from the FDA, with plans to initiate a clinical trial involving about 120 patients at major U.S. university hospitals this year.

Unlike non-degradable embolization devices associated with post-procedural pain, skin discoloration, and necrosis, Nexsphere-F addresses the increasing clinical demand for degradable alternatives in the arthritis pain embolization market.

It is the only biodegradable musculoskeletal embolization product to receive CE-MDD certification in Europe. Recently launched in key European markets, the device is also under commercialization discussions with global medical device companies.

Clinical findings on Nexsphere-F were recently presented at the Global Embolization Symposium and Technologies for Musculoskeletal (GEST MSK) conference in Europe, attracting significant attention from medical professionals and experts worldwide.

"If our application for Breakthrough Device Designation is approved, we anticipate a more streamlined FDA approval process, which will positively impact our collaborations with global medical device companies and further solidify our business strategy,” a NEXT BIOMEDICAL official said.