Hydrafil helps treat chronic low back pain due to degenerative disc disease. Credit: TB studio / Shutterstock.com.

ReGelTec has reached an exclusive agreement with BCWorld Healthcare (BCWH) for the distribution of the former’s Hydrafil system in South Korea.

Hydrafil is intended to treat chronic low back pain (CLBP) resulting from degenerative disc disease (DDD).

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BCWH has committed to investing in ReGelTec as part of the agreement. It will further provide funding for a clinical trial in South Korea to assist in securing regulatory approval from the Ministry of Food and Drug Safety.

ReGelTec will supply the Hydrafil systems required for the study, which is expected to commence next year.

BCWH CEO and president Steve Hong said: “We are excited to secure the rights to distribute the Hydrafil system in South Korea.

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“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.”

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Hydrafil is a hydrogel implant placed within a pre-filled syringe that is inserted into the delivery system. The hydrogel is heated within the delivery system and injected through a 17-gauge needle into an intervertebral disc during a minimally invasive outpatient procedure.

The injected hydrogel fills cracks and tears, adhering to the disc’s centre and outer layer.

It aids in the augmentation of the disc and restoration of its natural biomechanical properties. The process also preserves spinal motion and alleviates pain.

In 2020, the US Food and Drug Administration’s Center for Devices and Radiological Health awarded the breakthrough device status for the device.

ReGelTec co-founder and CEO Bill Niland said: “Now that we have two-year follow-up data on initial patients and one-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.”