2 June 2023 - - US-based ReGelTec, Inc has entered into an agreement with BCWorld Healthcare Co., Ltd. that provides BCWP exclusive rights to distribute the HYDRAFIL System for the treatment of Chronic Low Back Pain due to Degenerative Disc Disease in the South Korean market, the company said.

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 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.

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.

Founded in 2017, BCWorld Healthcare Co., Ltd. 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.

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.