HYDRAFIL system is the company’s percutaneous treatment intended for patients with low back pain caused due to degenerative disc disease
Clinical stage medical device company ReGelTec has received the US Food and Drug Administration (FDA) Breakthrough Device designation for its HYDRAFIL system.
The HYDRAFIL system is the company’s patented hydrogel that is heated before injection into the nucleus of a degenerated disc using a 17-gauge needle. It is intended to treat low back pain caused due to degenerative disc disease.
HYDRAFIL is designed to form a contiguous implant within the nucleus, after cooled to body temperature, to augment the disc, restore the biomechanical properties of that spinal segment, and mitigate the pain.
ReGelTec medical advisory board chairman Douglas Beall said: “I am very happy that the FDA has recognized the potential of HYDRAFIL to treat one of the most prevalent, debilitating, and costly conditions that I see in my practice in patients with chronic low back pain and degenerative disc disease.
“This designation will allow us to more rapidly move clinical work to the US and expand our clinical trials, building on the promising results of the Early Feasibility Study.”
ReGelTec conducted percutaneous procedures using HYDRAFIL system in Colombia
With the Breakthrough Device Designation, ReGelTec is provided with FDA priority review and interactive communication pertaining the device development and clinical trial protocols.
The company has completed the procedures using HYDRAFIL system, as part of its ongoing Early Feasibility Study in Barranquilla, Colombia, in 20 patients.
The percutaneous procedures have been conducted without any complications, with patients awake and under local anaesthesia in an outpatient clinic.
Patients were up and started walking within one to two hours of the injection, and most were sent home on standard over the counter pain medication.
All the study participants are currently in the follow up phase, with significant pain relief and reduction of disability at 30 and 90 day follow up visits, said the company.
Also, the company has closed a fully subscribed Series A financing at a total of $4m, to support its ongoing clinical and development work.
Once approved, the HYDRAFIL System is expected to serve as a non-surgical treatment option for patients with chronic back pain due to degenerative disc disease.
ReGelTec co-founder and CTO Anthony Lowman said: “It is exciting to see the potential of this technology recognized by the FDA, coupled with the clinical success of our Early Feasibility Study.
“Our years of development work point to this being an effective alternative for patients suffering from chronic low back pain.”