14 de octubre de 2020, 05:55 AM hora de verano del Este
BALTIMORE–(BUSINESS WIRE)–ReGelTec, Inc., a medical device company developing a percutaneous treatment for chronic low back pain, announced today that eleven patients with degenerative disc disease have been enrolled in the Company’s Early Feasibility Study in Barranquilla, Colombia. The procedures were proctored remotely via Zoom and all eleven patients were successfully treated with HYDRAFIL™, a patented hydrogel that is melted prior to injection into the nucleus of a degenerated disc via a 17-gauge needle. When HYDRAFIL™ cools to body temperature it forms a contiguous implant within the nucleus of the degenerated disc to augment the residual nucleus pulposus, restore normal biomechanical properties of the disc and alleviate pain. The procedures were completed while patients were awake and under local anesthesia in an outpatient clinic. Patients were up and walking within one to two hours of the injection. Most patients were sent home on standard over the counter pain medication and procedural related pain generally resolved within 24-72 hours. Patient follow-up is ongoing with initial patients reporting significant pain reduction and improvements in functional status at 30-days.
ReGelTec también ha anunciado que la empresa ha obtenido más de 3,75 millones de dólares en financiación de serie A durante la pandemia de COVID-19. Los fondos se utilizarán para apoyar la inscripción continua en el Estudio de Viabilidad Temprana en Colombia y las actividades de desarrollo en curso necesarias para comenzar los estudios clínicos en los Estados Unidos.
“Back pain is the single most common cause of disability worldwide and degenerative disc disease is the leading cause of chronic low back pain,” said Douglas Beall, MD the chairman of the company’s medical advisory board. “There has been a significant unmet clinical need to repair degenerated lumbar discs for decades. Based on the initial clinical results, HYDRAFIL™ appears to be uniquely positioned to treat degenerative disc disease by functionally replacing a substantial amount of disc material lost to disc degeneration. The early results are very promising, and I am very excited to continue working on the HYDRAFIL™ clinical program.”
Bill Niland, emprendedor en serie y director general de la empresa, ha declarado: "Tengo tres discos degenerados y me he sometido a múltiples intervenciones en los últimos 30 años, por lo que, tras vender Harpoon Medical a Edwards Lifesciences, la oportunidad de desarrollar una tecnología para una afección que me afectaba personalmente me resultó muy atractiva. Tenía un equipo de ejecutivos de dispositivos médicos con talento que estaban entusiasmados con su próximo proyecto y el Dr. Lowman, el inventor principal, tenía una tecnología que estaba lista para la clínica. La pandemia de COVID-19 ha añadido complejidad y retos adicionales a la realización de los primeros trabajos clínicos, lo que hace que nuestros resultados clínicos sean aún más emocionantes."
ACERCA DE REGELTEC, INC:
ReGelTec, Inc. is a clinical stage medical device company commercializing HYDRAFIL™, a percutaneous treatment for low back pain due to degenerative disc disease. The company was formed when a team of chemical engineers with extensive experience in polymer science partnered with a cross-functional team of medical device professionals who had recently sold their former company Harpoon Medical, Inc. to Edwards Lifesciences. Once approved, the HYDRAFIL™ System will offer patients suffering from chronic back pain due to degenerative disc disease a non-surgical treatment option when traditional conservative care fails.
Bill Niland, Director General
Teléfono: (443) 956-4465
bniland@regeltec.com