Safety Analysis Results of Innovative Hubly Surgical Cranial Access Drill with Smart Auto-Stop for ICU

LISLE, Ill., Aug. 18, 2023 /PRNewswire/ -- Hubly Surgical announced today the results from the first peer-reviewed study comparing the safety and efficacy of their recently FDA-cleared portable cranial access drill with Smart Auto-Stop to a well-established, non-portable neurosurgical perforator. The paper is published in Operative Neurosurgery and was authored by neurosurgeons at the University of Miami. In the study, the Hubly Drill Smart Auto-Stop engaged properly in 100% of the 174 craniotomies. 

Additionally, all perforations were complete and performed within 30 seconds or less—an improvement over the established perforator, which did not complete 5.5% of perforations. The authors concluded that Hubly Drill is both effective and safe for helping prevent accidental plunge, which can lead to serious neurological complications and even death.

Historical records indicate that burr hole craniotomies date back millennia. The utility of this relatively simple yet potentially dangerous procedure remains, particularly in instances where there is a need to rapidly decompress elevated intracranial pressure caused by conditions like traumatic brain injury, ruptured aneurysm, and intracranial hemorrhage. 

Surprisingly, portable manual hand crank drills lacking an auto-stop mechanism are still used to perform these procedures in the ICU (at the bedside). These primitive tools require careful handling to avoid inadvertently plunging into the dura or brain, a complication that occurs up to 2% of the time, even with experienced users (Reinges 1998). According to Caird 2003., 66% of surgeons have experienced plunging, which carries a 12% increased risk of death or permanent neurological morbidity.

"It has been our vision from the very beginning to modernize the Neuro ICU. We aim to eliminate catastrophic plunge by equipping ICU cranial drills with advanced features for safety and efficiency normally only seen in operating room drills," said Founder/CEO Casey Qadir (née Grage). "The results from this peer-reviewed study stating Hubly Drill performs equally to, and in some ways better than, a well-established cranial perforator used only in the operating room goes a long way toward making that vision a reality."

Hubly Drill's advanced safety features highlighted by the authors include a Smart Auto-Stop, proprietary tapered drill bit that provides secondary mechanical plunge prevention, and a first-of-kind LED Force Indicator that changes color with force, enhancing user control. 

Casey Qadir added, "There are certain errors in healthcare called 'never events.' These are defined as medical errors that are clearly identifiable and preventable. Accidental plunge with antiquated technology falls into this category. We believe our advanced technology will not only help eliminate these errors, but restore confidence in bedside cranial access, leading to reduced costs and improved outcomes."

About Hubly Surgical
Founded in 2019, Hubly Surgical is a medical device company with a mission to improve patient outcomes and quality of care for surgical procedures, inclusively, across standard and underserved settings, starting with bedside cranial surgery. The Company has developed and launched Hubly Drill with a vision to become the standard of care for bedside cranial access, making its lethal complications a "never event." The Company is located in Lisle, IL.

Casey Qadir (m. Grage)
[email protected] 
1-(844)-HUBLY-42

SOURCE Hubly Surgical

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