By restoring vertebral disc height with an injectable, durable hydrogel, ReGelTec aims to give interventional spine and pain clinicians an effective option for one of the most common causes of low back pain. .
As many as 80% of people in the US experience low back pain at some point in life, making it one of the most common symptoms prompting a doctor visit. For those with degenerative disc disease (DDD), which typically appears around age 40 and is influenced by genetics and lifestyle factors such as repetitive motion, that pain is chronic and a detriment to quality of life.
When the spine is subjected to frequent pressure in a localized area, the spaces between the vertebrae that make up the spinal cord can diminish and eventually disappear, pushing the soft nucleus of the disc against the annulus that surrounds it. In some cases, if the structural integrity of the annulus is sufficiently compromised, the disc may herniate as the nucleus ruptures the annulus and exudes spinal fluid inside the body.
Those who struggle with DDD can receive physical therapy and epidural injections to manage their pain but when conservative care falls short of addressing the problem, spinal fusion surgery is the leading long-term option. Baltimore, MD-based medical device start-up ReGelTec Inc. was founded with hopes of changing the status quo for DDD patients by offering a minimally invasive, hydrogel-based solution. President and CEO Bill Niland believes many will find it preferable to spinal fusion or disc replacement, both open surgeries that require significant recovery time and often reduce mobility in the vicinity of the discs fused or replaced.
Niland is a veteran of the medical device industry with more than 30 years of experience across myriad therapeutic areas and 22 registered patents to his name. Most recently, prior to founding ReGelTec, Niland ran and sold mitral valve repair company Harpoon Medical, which was acquired by heart valve leader Edwards Lifesciences Corp. just four years after the start-up’s founding.
ReGelTec’s product, the Hydrafil system, utilizes a patented hydrogel made of a blend of polymers and a minimally invasive delivery system with an ergonomic hand screw injection device to fill the disc and restore disc volume to relieve the effects of DDD. The system is not intended for use with herniated disc patients, as it requires a competent annulus to withstand the addition of the hydrogel without the risk of rupture.
The gel is heated prior to implantation to reduce its viscosity, allowing it to pass through the 17-gauge needle, then sets as it cools to body temperature. This deliberate formulation and delivery system ensures that the gel will not leak from the point of injection. Niland reports the percutaneous procedure takes around 30 minutes for a single level injection, and patients can walk out of the hospital in as little as two hours.
On the eight-point Pfirrmann scale by which disc degeneration is graded, ReGelTec is focused on the four to eight range, targeting patients with moderate to severe low back pain. In the foreseeable future, Niland says the company is working on a version designed for the cervical spine, the smaller discs near the neck, to complement the current system designed for the lumbar area.
Niland says the advantage that Hydrafil offers over current DDD treatments is multifaceted. Unlike epidural injections, the long-term gel implant should not diminish in effectiveness over time. One prior clinical trial participant for Hydrafil inventor and ReGelTec CTO Dr. Tony Lowman’s previous venture, Gelifex lived with a previous version of the hydrogel fully intact for more than a decade. (ReGelTech acquired all of the Gelifex patents).
The composition of the gel mimics the properties of the natural nucleus material in the disc, absorbing and releasing water in a similar fashion. By comparison, spinal fusion is only successful in reducing back pain about 50% of the time it’s performed, and even then only decreases the level of pain by roughly 50%, while also resulting in a reduction of mobility.
Full disc replacement is also a solution for DDD, although the procedure has been sparsely adopted due to difficulty in identifying good surgical candidates as well as the cost of the procedure itself. Some promise has been shown with stem cell applications, which are most effective in younger patients with Pfirrmann scores of four or below. Though specific pricing for Hydrafil has yet to be determined, Niland is certain that it will cost substantially less than surgical alternatives.
Three surgeons so far, two primary investigators and ReGelTec medical advisor Douglas P. Beall, MD (whose Edmond, OK practice focuses on interventional pain and orthopedic imaging) have had the opportunity to use the device as part of the company’s clinical trial in Colombia. At this point, all 20 initial patients have been enrolled, with half treated for single-level degeneration and half treated for multilevel degeneration, though a maximum of two levels of gel have been placed in any one patient. ReGelTec is currently requesting INVIMA, the Colombian health administration, to increase the trial population to 50, and in parallel is meeting with the FDA. Niland hopes to begin a US pilot study with 5-10 sites by mid-year. The company also received Breakthrough Device designation from the FDA in early December, which should speed time to market as well as smooth the pathway to reimbursement.
Niland says the advantage that Hydrafil offers over current DDD treatments is multifaceted. Unlike epidural injections, the long-term gel implant should not diminish in effectiveness over time.
The executive leadership of ReGelTec is a combination of the team from Harpoon, a team of hydrogel experts, plus a few other medical industry veterans. When Harpoon was sold to Edwards, team members spent time consulting individually then reunited the following year with the goal of commercializing Dr. Lowman’s invention. With chronic low back pain already a multibillion-dollar market and growing, the iron was hot to strike at the opportunity to disrupt interventional care. The start-up has secured $6 million in total funding, led by the Maryland Venture Fund, the Rowan Innovation Venture Fund, the Abel Foundation, and several angels, and a Series B is underway, with a goal of raising $10 million to further the clinical studies, primarily the US pilot trial.