Baltimore medical device startup ReGelTec is conducting a trial on patients and reporting new $3.75 million in funding as it develops a treatment for chronic low back pain.
It’s a couple notes of 2020 progress from the Camden Yards-based startup, which is helmed by longtime medtech executive Bill Niland and execs who led Baltimore startup Harpoon Medical to $100 million-plus acquisition by Edwards Lifesciences. (Along with having experience in building medical device companies, Niland also has experience with back pain, having had three degenerated discs and multiple procedures over the years.) The technology was invented by Dr. Anthony Lowman, and Niland determined it was at a point where it was ready for the clinic.
As with any medical technology, however, getting to that point will require showing proof of its safety and effectiveness. ReGelTec is currently conducting an early feasibility study in Barranquilla, Colombia. This involves treating patients with degenerative disc disease with the company’s hydrogel. Called HYDRAFIL, the gel is injected into the nucleus of a disc, then cools to form an implant. This is designed to ease pain, and restore parts of the disc that were lost.
So far, 11 patients underwent the procedure. With ReGelTec overseeing remotely via Zoom, they were awake and under local anesthesia, and were up and walking within an hour or two, per info from the company. Its statement said patients reported “significant pain reduction and improvements in functional status at 30-days.” Dr. Douglass Beall, chairman of the company’s advisory board, called the results “very promising.”
ReGelTec will continue this study with nine more patients, and expects to finish enrollment by the end of October.
The company raised new funding in order to continue this trial and work toward clinical trials in the U.S. The $3.75 million Series A included participation from Baltimore’s Abell Foundation, which earned a 10-time return on Harpoon, and angel investors, Niland said.
“The COVID-19 pandemic has added complexity and additional challenges to conducting the early clinical work, which makes our clinical results even more exciting,” Niland said.-30-
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