Varian Announces First Participant Treated in GENESIS II Clinical Trial of Genicular Artery Embolization for Knee Osteoarthritis

Rhea-AI Summary

On Nov. 17, 2022, Varian announced the initiation of the GENESIS II trial, the largest randomized clinical study of genicular artery embolization (GAE) aimed at treating mild to moderate knee osteoarthritis. Conducted at the Royal Berkshire NHS Foundation Trust in Reading, UK, the trial will evaluate the efficacy of Embozene microspheres in pain relief. With FDA Breakthrough Device Designation secured in October 2021, Embozene is marketed in 60 countries for embolization procedures. The trial includes a sham control group to ensure robust results and validate earlier findings from a smaller study.

Positive

• Launch of GENESIS II trial, the largest randomized study for GAE in knee osteoarthritis.
• FDA Breakthrough Device Designation obtained for Embozene microspheres.
• Potential to enhance understanding of GAE and improve patient outcomes.

Negative

• None.

PALO ALTO, Calif., Nov. 17, 2022 /PRNewswire/ -- Varian, a Siemens Healthineers company, announced today that the first trial participant has been treated as part of GENESIS II (Genicular artEry embolisatioN in patiEnts with oSteoarthrItiS of the knee), a study of Embozene^® microspheres for genicular artery embolization (GAE) as treatment of mild to moderate knee osteoarthritis. GENESIS II is the largest randomized clinical trial of GAE to assess pain relief from this debilitating condition.

GENESIS II is being conducted at the University Department of Radiology, Royal Berkshire NHS Foundation Trust, in Reading, UK. The trial targets mild to moderate osteoarthritis (OA) of the knee joint, a common condition and a leading cause of chronic disability. GAE is a minimally invasive procedure in which a small catheter is advanced into the genicular arteries, the small blood vessels that supply the knee joint and contribute to the inflammatory process. The Embozene microspheres are delivered through the catheter to reduce the blood supply to the areas of greatest inflammation in the knee with the goal of reducing pain.

In the GENESIS II clinical trial, patients with knee osteoarthritis will either receive treatment with the Embozene microspheres or a sham control; they have the option to receive Embozene treatment later in the clinical trial. This clinical trial design allows more accurate assessment of pain relief from the new treatment.

In October 2021, the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for Embozene microspheres for GAE for OA. The medical device is marketed in 60 countries for embolization, a procedure that blocks or reduces blood supply to a target area in the body. Currently, Embozene is used to treat hypervascular tumors, arteriovenous malformations, uterine fibroids, and benign prostatic hyperplasia. Embolics are not yet authorized for marketing anywhere for genicular artery embolization.

Professor Mark Little, Consultant Diagnostic & Interventional Radiologist, Radiology Research Lead, at the University Department of Radiology at the Royal Berkshire NHS Foundation Trust, is the Principal Investigator of the GENESIS II study. "In GENESIS, our previous 38-patient prospective study, GAE in patients with mild to moderate knee OA was found to be safe and effective at early follow-up," said Professor Little. "We're excited to build upon this foundation with GENESIS II, which has the potential to improve our understanding of the clinical applications for the procedure. Including a sham-treated group provides the opportunity to validate the findings of GENESIS as well as gain insight into longer term follow-up and patient quality of life."

"Varian is committed to supporting research that has the potential to improve outcomes and enhance the quality of life for patients around the world, and we view the GENESIS II study as an important opportunity to do this," said David Hahn, MD, Chief Medical Officer, Interventional Solutions, at Varian. "Interventional radiology is defined by minimally invasive techniques, and we believe the treatment of chronic pain is a natural fit for this specialty, particularly given the World Health Organization's guidance on this subject. We look forward to better understanding the possible role of GAE in addressing a pressing challenge for care providers and patients."

About Genicular Artery Embolization (GAE)

GAE is a minimally invasive procedure in which a small catheter is advanced into the genicular arteries, the small blood vessels that supply the knee joint and contribute to the inflammatory process. Embolic microspheres are delivered through the catheter to reduce the blood supply to the areas of greatest inflammation.

About Knee Osteoarthritis (OA)

Osteoarthritis of the knee joint is a highly common, debilitating condition, and a leading cause of chronic disability.ⁱ Approximately 13% of women and 10% of men aged 60 years and older have symptomatic knee OA.ⁱⁱ In addition to treatment, affected individuals and their families often must adapt their lives and homes to the disease.ⁱⁱⁱ The pain and other symptoms of OA may have a profound effect on quality of life, impacting both physical function and psychological wellbeing.

About Varian Interventional Solutions

Varian, a Siemens Healthineers company, is investing in the future of interventional radiology through our Interventional Solutions group. By partnering with interventional radiologists and researchers in the field, we are delivering a portfolio of intelligent solutions to benefit patients around the globe. We are committed to enhancing the patient experience at every stage of care by developing and delivering innovative solutions in ablation, embolization and beyond.

About Varian

At Varian, a Siemens Healthineers company, we envision a world without fear of cancer. For more than 70 years, we have developed, built and delivered innovative cancer care technologies and solutions for our clinical partners around the globe to help them treat millions of patients each year. With an Intelligent Cancer Care approach, we are harnessing advanced technologies like artificial intelligence, machine learning and data analytics to enhance cancer treatment and expand access to care. Our 11,000 employees across 70 locations keep the patient and our clinical partners at the center of our thinking as we power new victories in cancer care. Because, for cancer patients everywhere, their fight is our fight. For more information, visit http://www.varian.com and follow @VarianMedSys on Twitter.

Press Contact
Katie Villany
Varian Corporate Communications
Katie.villany@varian.com

ⁱ J. Bijlsma, F. Berenbaum and F. Lafeber. "Osteoarthritis: an update with relevance for clinical practice."
Lancet. Jun 2011:377(9783):2115–2126.
ⁱⁱ B. Heidari. "Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I." Caspian J Intern Med. ,2011(2):205-12.
ⁱⁱⁱ R. Altman, "Early management of osteoarthritis.," Am J Manag Care, March 2010(16):41-47.

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SOURCE Varian

FAQ

What is the GENESIS II trial by Varian about?

The GENESIS II trial is a large clinical study assessing the effectiveness of genicular artery embolization (GAE) using Embozene microspheres for treating mild to moderate knee osteoarthritis.

When was the first participant treated in the GENESIS II trial?

The first participant was treated on Nov. 17, 2022.

What is the significance of the FDA Breakthrough Device Designation for Embozene?

The FDA Breakthrough Device Designation highlights the potential of Embozene microspheres to address unmet medical needs and expedite their availability for patients.

Where is the GENESIS II trial being conducted?

The GENESIS II trial is being conducted at the Royal Berkshire NHS Foundation Trust in Reading, UK.

What impact could the GENESIS II trial have on Varian's stock symbol VAR?

Positive outcomes from the GENESIS II trial could enhance investor confidence in Varian, potentially influencing stock performance favorably.