BALTIMORE--(BUSINESS WIRE)--ReGelTec, Inc. (ReGelTec) announced that it has entered into an agreement with BCWorld Healthcare Co., Ltd. (BCWH) that provides BCWP exclusive rights to distribute the HYDRAFIL™ System for the treatment of Chronic Low Back Pain (CLBP) due to Degenerative Disc Disease (DDD) in the South Korean market. The agreement includes an investment by BCWH in ReGelTec. BCWH will also fund a clinical study in South Korea to support regulatory approval from the Ministry of Food and Drug Safety (MFDS) with ReGelTec providing HYDRAFIL™ Systems for the study. The companies have already started planning regulatory strategies for approval and expect the trial to begin in 2024.
HYDRAFIL™ is a hydrogel that is heated and injected into a disc using a fine gauge needle during a minimally-invasive outpatient procedure. The injected hydrogel augments the degenerated nucleus and fills in cracks and tears to help restore natural biomechanical properties while preserving spinal motion and relieving pain. The device received breakthrough device designation in 2020 from the Center for Devices and Radiological Health of the Food and Drug Administration (FDA). More than sixty people have been treated with HYDRAFIL™ in clinical studies in Barranquilla and Cali, Colombia, and in Calgary, Canada with promising clinical results out to 2-years in the initial cohort patients.
“We are excited to secure the rights to distribute the HYDRAFIL™ System in South Korea,” said Steve Hong, CEO and President of BCWH. “This is meaningful as it is our first investment in a private company, and is our first step to expand into the medical device arena and diversify our product offerings beyond the current business model.” Once regulatory approval is obtained, the HYDRAFIL™ System will be added to pain management products that BCWH and its parent company BCWorld Pharm. Co., Ltd. offer to pain physicians. “The HYDRAFIL™ System will be a milestone to entry into innovative business aligning with our mission, ‘commit to a better future for patients.’” said Steve Hong.
“We are always looking for strategic partners that can help us expand the reach of the HYDRAFIL™ System,” said Bill Niland, ReGelTec’s co-founder and CEO. “Now that we have 2-year follow-up data on initial patients and 1-year follow-up on the first 60 patients treated with HYDRAFIL™, we know that the technology has the potential to transform the treatment of CLBP due to DDD. Our partnership with BCWH will also help the company generate additional clinical evidence to demonstrate the safety, efficacy, and economic impact of the HYDRAFIL™ System.”
Founded in 2017, BCWorld Healthcare Co., Ltd. (“BCWH”) is a subsidiary of BCWorld Pharm. Co., Ltd., a Korean pharmaceutical company with expertise in drug development, especially for long-acting injectables and orally disintegrating tablets. BCWH has built the first MFDS-approved, carbapenem-dedicated manufacturing facility in Korea and is leading the supply of antibiotics in the domestic market and pursuing to expand their territories to the global market. Beyond BCWorld Pharm., BCWH plans to accelerate its business diversification plan to discover innovative healthcare products, including pharmaceuticals, digital therapeutics, and customized health functional food.
ABOUT 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 with multiple successful startup exits. Once approved, the HYDRAFIL™ System will offer patients suffering from chronic back pain due to degenerative disc disease a minimally invasive treatment option beyond traditional conservative care. HYDRAFIL™ is an investigational device, limited by United States law to investigational use.