ReGelTec’s HYDRAFIL System Gains European CE Mark Approval for Chronic Low Back Pain

Shots:ReGelTec has received European MDR CE Mark approval for its Class III HYDRAFIL System, a disc augmentation therapy designed to reduce pain, improve daily function & eliminate the need for invasive surgeriesApproval was based on a study of 75 pts showing over 80% improvement in Oswestry Disability Index (ODI) scores & >70% pain…

ByRidhi RastogiMay 22, 2025

NEWS

Mainstay Medical Reports Data from RESTORE Trial of ReActiv8 Implantable Device to Treat Chronic Low Back Pain

Shots:The RESTORE trial assessed the ReActiv8 Restorative Neurostimulation therapy (n=99) vs SoC (n=104) for 1yr. to treat intractable chronic low back pain in patients (N=203) The data showed a mean improvement in ODI score (1EP; -19.7 ± 1.4 vs -2.9 ± 1.4), back pain measured by 11-pts. NRS (2EPs; -3.6 ± 0.2 vs…

BySenior EditorJanuary 16, 2025

VIEWPOINTS

Funds Raised: Jason Hannon from Mainstay Medical in a Stimulating Conversation with PharmaShots

Shots: Mainstay Medical recently raised $125M in the company’s largest funding round. The financing is intended to accelerate the commercial growth of the company’s ReActiv8, a restorative Neurostimulation therapy in the US, Europe, and Australia Today, at PharmaShots, we had Jason Hannon, CEO of Mainstay Medical, who talked in great length about the ReActiv8 Restorative Neuromodulation System developed for…

BySaurabh ChaubeyMay 27, 2024

ReGelTec’s HYDRAFIL System Gains European CE Mark Approval for Chronic Low Back Pain

Mainstay Medical Reports Data from RESTORE Trial of ReActiv8 Implantable Device to Treat Chronic Low Back Pain

Funds Raised: Jason Hannon from Mainstay Medical in a Stimulating Conversation with PharmaShots

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