Clinical Results

Results from our Pilot Clinical Trial

The Pilot Study of Genicular Artery Embolization (GAE) using SakuraBead was completed with 15 patients suffering with significant knee pain as a result of knee osteoarthritis.

GAE Procedure and the SURE Trial

Hear Dr. Ari Isaacson, the SURE trial Principal Investigator explain the GAE procedure and what participation in the trial will be like for patients.

Pilot Clinical Study
This video also outlines the first study using SakuraBead in the treatment of knee osteoarthritis that involved 15 patients and was completed in early 2024.

International Publication

We were proud to share the results from the pilot study of SakuraBead, at the prestigious CIRSE Conference in September 2024. CIRSE is a physician conference attended by over 6,000 practicing physicians who deal with embolization and pain on a daily basis.

This presentation highlights the exciting potential of SakuraBead in treating knee osteoarthritis.

US Clinical Trial

The SURE Study is a registered Clinical Trial to determine whether Genicular Artery Embolization (GAE) is superior to standard of care steroid injection in reducing knee pain as a result of osteoarthritis.

Recruitment for the trial is currently underway with initial clinical results expected in the second half of 2025.

Of the 89 patients, 60 people will have the GAE procedure and 29 will receive a steroid injection. The selection of patients to get GAE or steroid injections is randomized in a 2:1 ratio. After the procedure there will be a number of follow ups to check how you are doing and to track your progress and pain relief. Those who initially receive treatment with a steroid injection will have the opportunity to “cross over” and also receive treatment with GAE if you do not receive a sufficient benefit from the steroid injection.

The trial has been designed in collaboration with leading US and international physicians and in consultation with long term osteoarthritis patients.

The trial has also been designed with oversight from US and international regulators. The US principal investigator for the trial is Dr Ari Isaacson who has significant experience in leading clinical trials over the last 10 years.

The trial overview committee consists of a group of nationally recognized physicians.

These physicians will help ensure the highest standards of patient safety and clinical research are achieved.

See our Advisory Board

Frequently Asked Questions

How long does the procedure take?

You will spend about 4 or 5 hours in the doctor’s surgery. The actual procedure is much shorter and in most cases is complete in 1 –2 hrs .

Will it hurt?

The GAE procedure should not be particularly painful. You will feel a pinch of pain when the physician uses a needle to get access to your blood vessels. Some patients feel pain similar to their osteoarthritis knee pain at the time of injection. None of these pains last more than a few seconds. After the procedure you may continue to have some pain from the access site for a day or two. This pain should be well managed with regular over the counter pain medication.

If the treatment doesn’t work for me, can I still get a knee replacement?

Yes – Having either a GAE or Steroid injection will not impact your suitability for knee replacement surgery.

Is the treatment effective?

The procedure has been shown to be effective for the majority of patients in previously trial however SakuraBead remains an investigational device.

Who will do the GAE procedure?

The GAE procedure will only be performed by board certified interventional radiologist. The physicians chosen for this trial are all experts in the procedure and have typically done the procedure more than 50 50 times.

What are the risks?

There most common side effects of this procedure are skin discolorations at the site of the embolization. This areas of discolouration are expected to be short term and should resolve within a few hours without additional treatment.