December 1, 2020
Balt STEM Trial: The company recently announced that the first patients have been enrolled in the clinical trial; The SquidTM Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic subdural hematoma [NCT04410146]. This marks the first patients enrolled in a prospective, randomized, international trial of a liquid embolic agent for the treatment of chronic subdural hematoma (cSDH), a common disease affecting primarily older adults.
“We are excited to have started enrollment in the pivotal STEM trial,” stated Dr. David Fiorella, (Stony Brook University Medical Center) Co-Primary Investigator of the STEM trial. “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. Adam Arthur (Semmes-Murphey Neurologic and Spine Institute and University of Tennessee Health Sciences Center), Co-Primary Investigator, 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.”
The STEM study is the first-of-its-kind, pivotal, multi-center, randomized controlled trial comparing embolization of the middle meningeal artery with Squid to standard therapy for patients undergoing surgery and patients undergoing medical management. Balt seeks to use these data to gain US FDA approval of the Squid Liquid Embolic System for this indication.
STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH).
“We are proud to have the first patients enrolled and to be conducting the first PMA trial for this critically important and novel indication,” commented Balt CEO Pascal Girin. “The STEM study represents the first of several PMA trials planned in the next 12 to 18 months, delivering on the promise to bring Balt’s portfolio of innovative and novel products into the US market.”