ReGelTec | Top Spine Solutions Company 2023

MedTech Outlook Magazine

ReGelTec
Percutaneous Treatment for Degenerative Disc Disease

Bill Niland, CEO, ReGelTecBill Niland, CEO
Discogenic pain is considered a normal part of aging. As the spinal disc wears down with age, disc fluid starts to dry out and no longer cushions the bones, leaving people to endure chronic pain. While conservative treatment and opioid injections offer temporary pain relief, there is no effective, long-term treatment for degenerative disc disease. With the ineffectiveness of regenerative stem cell therapy for discogenic pain in the elderly, an increasing number of people with chronic lower back pain are left with no option but to opt for complicated, high-risk spinal surgeries.

ReGelTec, a clinical-stage medical device company, breaks through the conventional way of treating degenerative disc disease with its novel proprietary product, HYDRAFIL.

“According to two years of patient data, we successfully treated moderate to severe conditions of degeneration of the disc using a simple injection that helps patients get back to their normal lifestyle,” says Bill Niland, CEO of ReGelTec.

ReGelTec is transforming degenerative disc disease treatment by introducing Hydrafil a next generation of injectable spinal implant treatment options for chronic back pain caused by DDD. A proficient team of medical advisors and executives has engineered a percutaneous treatment for degenerative disc disease that offer long-term relief from pain and disability with minimal recovery time.

HYDRAFIL is an investigational device gaining popularity for its injectable hydrogel technology. With the help of fluoroscopic imaging, it is injected using a 17-gauge needle into the nucleus of an intervertebral disc, augmenting the residual nucleus pulposus as the heated liquid solidifies between the vertebrae, forming a contiguous implant and restoring the biomechanical integrity of the disc. It helps relieve pain and improve spinal alignment.
Following three cohort studies with two years of patient data, ReGelTec is improving the lives of many patients by providing rapid relief from chronic pain. After successful preclinical work in animal models, ReGelTec felt confident and comfortable moving on to humans. For example, a 21-year-old patient from Colombia, South America, suffered excruciating pain due to severe disc degeneration. At the 2-year follow-up, ReGelTec noted a dramatic change in the pain scale. After treatment, she was able to move normally and pain-free.

In another instance, one of the third cohort’s Canadian patients was confined to a wheelchair, suffering from MS and degenerative disc disease. She traveled from Toronto to Calgary for treatment after learning about this procedure. ReGelTec’s HYDRAFIL considerably enhanced her life. She is still confined to a wheelchair because of MS, but the daily, extreme pain that she was experiencing has been dramatically reduced, from an eight to a two on the pain level scale.

  • According to two-year patients data, we successfully treated moderate to severe disc degeneration conditions using a simple injection that helps patients get back to their normal lifestyle


ReGelTec’s simple, underone-hour, HYDRFIL-injecting procedure helps interventional neurologists provide clinically impactful and cost-effective treatment to their patients. Treated patients observe substantial pain relief within 30 days of treatment, potentially lasting up to more than 10 years. Diversifying the clinical study by raising funds for its pivotal trials in the U.S., ReGelTec expects FDA regulatory approval for IDE in Q2 of 2023 and a CE mark for commercialization in European countries in Q1 of 2023.

ReGelTec is dedicated to treating degenerative disc disease patients and giving them pain-free lives in a non-invasive manner.

Top 10 Spine Solutions Companies - 2022

Company
ReGelTec

Management
Bill Niland, CEO

Description
ReGelTec is a clinical-stage medical device company transforming degenerative disc disease treatment by introducing the next generation of minimally invasive spinal implant treatment options for chronic back pain beyond traditional conservative care.

ReGelTec News

The FDA Approves IDE for ReGelTec’s Pivotal Study of HYDRAFIL® for Chronic Low Back Pain due to Degenerative Disc Disease

tures more than 28 PB of data to help accelerate scientific discovery and improve human health
BALTIMORE - ReGelTec, Inc., announced that the U.S. Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System. The HYDRAFIL System contains an injectable polymer that is implanted percutaneously via a needle to augment the native disc in a procedure performed under local anesthesia at an outpatient surgery center. The HYDRogel Augmentation For Intervertebral Lumbar Discs (HYDRAFIL-D) Study, is a multicenter, single-blinded, randomized, controlled trial to evaluate the safety and efficacy of the HYDRAFIL System for treatment of chronic low back pain due to degenerative disc disease. The HYDRAFIL-D Study will enroll approximately 225 patients in up to fifteen centers across North America and is expected to start in early 2024 after the company completes its next round of financing.
“I have been advising ReGelTec on their injectable hydrogel for chronic low back pain for more than four years and was able to treat a number of patients with the device during the initial studies performed outside the United States. The early results are excellenti and I can’t wait to begin the HYDRAFIL-D Study here in Oklahoma City,” said Dr. Douglas Beall, Chief of Interventional Spine Services, Comprehensive Specialty Care, Edmond, Oklahoma, who is an advisor to ReGelTec and one of two national principal investigators for the trial. Dr. Kasra Amirdelfan, Director of Clinical Research at Boomerang Healthcare, Inc. in Walnut Creek, CA and the other national principal investigator said, “the HYDRAFIL System is designed for a segment of the chronic low back pain population who are not very good candidates for conventional spine surgery. When conservative care fails, these patients have limited treatment options. HYDRAFIL appears to be a great option for these patients, and we are excited to demonstrate the value of the technology in this randomized, controlled trial.”
“Obtaining IDE Approval for the HYDRAFIL-D Study from the FDA is a major milestone for ReGelTec,” said Bill Niland, the company’s co-founder and CEO who has successfully founded and exited multiple healthcare companies including Harpoon Medical, Inc., Vapotherm (NYSE:VAPO), and National Sleep Technologies. The company has treated more than 70 patients with 1-year follow-up on the first sixty patients showing a 69% reduction in pain scores and an 81% improvement in Oswestry Disability Index, a measurement of how low back pain is impacting a person’s daily living.ii Mr. Niland said that “once we were able to share the 1-year follow-up data on our first sixty patients with the FDA, the team was able to work with the agency to obtain IDE approval, and now we are fundraising to secure the capital needed to fund the study and attain FDA approval.”