Galaxy Therapeutics Completes Enrollment of Primary Cohort in Pivotal SEAL IT IDE Trial
"We are proud to have reached this important milestone," said Dr. David Altschul, Principal Investigator of SEAL IT and Chief of Neurointerventional Surgery at Montefiore Medical Center. "This trial represents the first prospective multicenter U.S. study evaluating the SEAL device for wide-neck bifurcation aneurysms — one of the most challenging anatomical presentations in our field."
Dr. Brian Jankowitz, also Principal Investigator and Chief of Neurosurgery and Co-Chair of Stroke and Neurovascular Program at the Hackensack Meridian Neuroscience Institute at JFK University Medical Center in Edison, New Jersey, added: "The SEAL device has consistently demonstrated ease of use and promising early outcomes in the investigation, in both ruptured and unruptured aneurysms. Completing enrollment in the primary cohort is an important achievement as we continue generating high-quality clinical evidence to support its use."
The SEAL IT trial continues to enroll patients in two additional cohorts evaluating use of the device with sidewall and ruptured aneurysms, with 52 patients planned for enrollment in each subgroup. In total, the SEAL device has been used in more than 300 patients worldwide across Galaxy-sponsored clinical studies.
Developed by physicians for physicians, the SEAL implant is a proprietary, self-expanding intrasaccular device designed to promote durable aneurysm occlusion without the need for adjunctive devices. It has shown encouraging safety and efficacy in earlier clinical studies including Pre-SEAL IT, which enrolled 33 patients at multiple international sites.
About Galaxy Therapeutics
Galaxy Therapeutics is a private, U.S.-based clinical-stage medical device company founded by four practicing neurointerventional physicians. The company has developed a novel implant technology for the treatment of brain aneurysms and holds multiple patents across the U.S., EU, China, and other key markets. Headquartered in Milpitas, California, Galaxy Therapeutics is advancing multiple clinical programs globally and is committed to delivering effective, evidence-based solutions to physicians and patients.
For more information, visit www.galaxytherapeutics.com, follow the company on Linkedin or please contact: Sergi López García, sergi@gtseal.com, contact@gtseal.com, +34690926013
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The city embraced them as champions, and the fans were as passionate as any I've ever observed.'The team's affable Hall of Fame coach Chancellor was a big reason. He celebrated the fans by handing out candy prior to each home game. Chancellor recently recalled an encounter he had with a season ticket holder looking for some sugar. 'Some lady (came) up to me and said, 'Hey, I'm in row 16, seat 3, would you please throw me a piece of candy?'' Chancellor said. 'In '97, '98 – those years, we had the best fanbase that's ever been in the WNBA.' Comets fans were all in. 'We would do an interview after each game, and fans wouldn't leave,' said Jim Kozimor, the play-by-play broadcaster in 1997 and '98. 'They wouldn't head to the exits (because) the show wasn't over. The players would acknowledge them, (and) they felt like they were a big part of the success. There was a real love affair." Hagedorn, who replaced Kozimor when he joined the Sacramento Kings, also witnessed the postgame hysteria. 'I couldn't leave my spot on press row; I was literally stuck. The fans were swarming! I just sat there watching, smiling and shaking my head. They were the toast of the town,' said Hagedorn, whose signature live call described any Comets player who was in the zone as: 'burning with the white-hot intensity of a thousand suns.' Chris Wragge, who alongside Mike Breen and Ann Meyers, was part of NBC's national broadcast team, was also impressed with the fan support. 'What Caitlin Clark is to the WNBA now, that is what the Comets were to the league,' said Wragge, who also served as sports anchor at KPRC in Houston. 'There was no better draw; there was never an empty seat in the house.' The fans were devoted during the good times and bad, including Game 2 of the 1999 WNBA Finals. The New York Liberty's Teresa Weatherspoon hit the game-winner with a three-quarter court buzzer beater to stun the Comets, 68-67. 'I've been doing this for 30 years and that was the loudest arena I have ever heard,' said Tom Savage, who ran Comets PR for two seasons. With confetti prematurely falling at the Compaq Center to celebrate a third title, the once-boisterous crowd grew silent. 'The quietness was deafening,' Savage said. '(It was) almost like your ears were ringing and then there was nothing.' Cooper said: 'That contrast was striking.' But while the fans displayed their affection with a quiet hush and a few tears, nothing compared to the way the community rallied around Kim Perrot, the scrappy point guard who made the team after impressing during an open tryout. Perrot was diagnosed with lung cancer in early 1999. The cancer spread to her brain and Perrot died six months later, on Aug. 19, 1999, at age 32. Among the initiatives Comets fans undertook on behalf of their beloved player was raising money for 'Kim's Place,' a lounge for teens and young adults battling cancer. Located at MD Anderson Cancer Center, the lounge has a jukebox, pool table, video games, and rooms for counseling and classes.'They let us know that they weren't just there as fans; they were there as a part of the Houston Comets organization – struggling with the same thing we were struggling with as far as losing Kim Perrot,' Cooper, a close friend of Perrot's, said. 'The city of Houston rallied around us.' The highs of lows that the franchise experienced, especially during the championship seasons, galvanized the community and their hometown heroes. 'The bond between the Comets and their fans was one rarely found in sports,' said Bob Schranz, the Comets media relations manager from 2001-2005. 'The season ticket holders were more like a family than a fanbase. You had players and a host of fans literally on a first-name basis.' With all its rich history and a once-fanatical following, could the WNBA resurrect the Comets? The Houston Rockets could be a part of the Comets return. 'We remain committed to exploring every avenue to bring a WNBA franchise back to the City of Houston,' Gretchen Sheirr, the Rockets president of business operations, said in a statement to USA TODAY Sports. The Rockets, led by their owner – restaurant and casino mogul Tilman Fertitta, are on board, and as for Houstonians – Chancellor summed it up by saying, 'This fanbase is ready to explode again.' Cooper, for one, saw that support first hand, listening to the crowd's roar from the locker room in 1999, running out of the tunnel to those cheers and delivering four titles. She has no doubt those same fans, paired with a new generation, would welcome a WNBA team. 'The city of Houston misses the Comets and misses having a WNBA franchise to support, and I think this is a great time for it,' Cooper said. 'I'm excited for the opportunity and the possibility, and I know that there are tons of fans here ready to support it.'
