CrannMed has obtained a Breakthrough Device Designation by the U.S Food and Drug Administration for its EmboSure Microspheres used to treat patients suffering from pain associated with Knee Osteoarthritis (KOA).

Knee Osteoarthritis is a degenerative disease and debilitating condition due to the progressive deterioration of joint function, resulting in diminished quality of life for the patient. CrannMed’s SakuraBead Microspheres are resorbable embolic particles designed to provide controlled, targeted, minimally invasive embolization of the genicular artery to treat patients suffering from pain due to KOA.

The FDA’s Breakthrough Device Designation provides patients and healthcare providers timely access to medical devices by speeding up their development, assessment, and review. For CrannMed this designation confirms the innovative and unique nature of the SakuraBead Microspheres and the positive impact the therapy is expected to have on patients suffering from KOA. This novel device, that has the opportunity to positively impact millions of people suffering with KOA, now has a high potential pathway for accelerated regulatory approval.