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HYDRAFIL System

Chronic low back pain due to degenerative disc disease (DDD)

Pivotal Trial (IDE)Active

Key Facts

Indication
Chronic low back pain due to degenerative disc disease (DDD)
Phase
Pivotal Trial (IDE)
Status
Active
Company

About ReGelTec

ReGelTec is pioneering a next-generation, minimally invasive solution for the massive problem of degenerative disc disease (DDD). Its lead product, the HYDRAFIL System, is a proprietary hydrogel that is injected as a liquid through a needle and solidifies in the disc nucleus to mimic natural biomechanics. The company has achieved significant milestones, including CE Mark approval in Europe and the initiation of a pivotal FDA IDE study in the US, supported by strong 1- and 2-year clinical data showing significant reductions in pain and disability. With an experienced leadership team and a technology that addresses a key unmet need between conservative care and major surgery, ReGelTec is positioned as a compelling player in the spinal intervention market.

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Therapeutic Areas