First Patients Enrolled in STEM Trial of Balt’s Squid Liquid Embolic Agent

December 1, 2020—Balt announced that the first patients have been enrolled in STEM, the Squid trial for the embolization of the middle meningeal artery (MMA), which is evaluating the company’s Squid liquid embolic agent to treat chronic subdural hematoma (cSDH). Balt seeks to use the trial data to gain FDA approval of the Squid liquid embolic system for this indication.

According to the company, the pivotal STEM study is a prospective, international, multicenter, randomized controlled trial comparing MMA embolization with Squid to standard therapy for patients undergoing surgery and patients undergoing medical management. Patients will be randomized 1:1 to assess the safety and effectiveness of the Squid treatment.

The STEM trial’s coprincipal investigators are David Fiorella, MD, and Adam Arthur, MD. Dr. Fiorella is from Stony Brook University Medical Center in Stony Brook, New York. Dr. Arthur is from Semmes-Murphey Neurologic and Spine Institute and the University of Tennessee Health Sciences Center in Memphis, Tennessee.

“We are excited to have started enrollment in the pivotal STEM trial,” commented Dr. Fiorella in the company’s announcement. “We have seen some tremendous preliminary results with this procedure in clinical practice. STEM provides the opportunity to confirm these observations with level 1 evidence from a randomized controlled clinical trial. We are optimistic that middle meningeal artery embolization with Squid will advance the standard of care for cSDH and improve the quality of life for patients with this common and disabling disease.”

Dr. Arthur added, “Having the first patients enrolled in the STEM trial is an important milestone. The results of STEM are critical as they are going to substantially add to our knowledge base on chronic subdural hematomas. Not only will this trial tell us whether treatment of cSDH with the Squid liquid embolic system is safe and effective, it will also provide tremendous insight into the disease’s natural history and the safety and efficacy of the currently available treatment strategies, which are not yet well characterized.”