Eight in 10 people experience lower-back pain during their lifetimes. It’s one of the leading reasons people visit a doctor. It’s also the most common cause of job-related disability and a leading contributor to missed work days and lost productivity. And most people never find relief.
“About a third of Americans see a clinician for back pain every year. ... Between $50 billion and $100 billion a year is spent on treatment,” said Tom Hedman, an associate professor in the department of biomedical engineering at the University of Kentucky.
In addition to his duties at the university, Hedman founded his start-up company Intralink Spine, which is located at UK’s Coldstream Research Campus. The company has recently made progress toward European approval of its chief product, a non-surgical injectable agent called Rejuve, and it hopes to bring the backpain treatment option to market across the Atlantic in 2016.
One of the more serious lower-back problems is degenerative disc disease, caused by a deteriorating disc in the spine. It infl icts excruciating pain for the sufferer and may include radiating weakness or numbness. Réjuve is designed to treat people with serious lowerback problems such as degenerative disc disease by immediately reinforcing and steadying the spinal discs, strengthening tissue, resisting tears and stabilizing joints in the problem area. Réjuve is being developed as a possible stand-alone treatment, administered in an outpatient setting, or as an adjunct to surgery, said Hedman, who has spent much of his career focused on softtissue biomechanics.
“There are surgeries conducted where they cut away part of the disc to relieve pressure on a nerve,” Hedman explained. “Our Réjuve treatment on the remaining portion of the disc restabilizes it after it has been surgically destabilized.”
Patients well-suited for the treatment would include those with both early-stage and late-stage lower back pain. A potential treatment plan might call for two injections of Réjuve per affected disc. The type of clinicians giving injections would be interventionists and pain management specialists, as well as spine and orthopedic surgeons. Treatments could be delivered in a clinic or in a fluoroscopy suite, where a fluoroscope would obtain real-time views of the needle being inserted into the internal structures of the patient’s damaged back, Hedman said.
After years of development, Réjuve is still not quite ready for prime time.
“We’re still in the development stage,” said Hedman. “We have an ongoing, long-term large-animal study that’s been going on for five months now. We’ll also be doing clinical trials in the fi rst quarter of 2015.”
In 2010, Hedman moved his company to Lexington to take advantage of state matching grants as part of Kentucky Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. The company also won several federal grants from the National Institutes of Health, one of the world’s premier medical research centers. UK offers strong support as well, Hedman said. Intralink Spine has three employees and works with some additional contractors in the Cincinnati area. More high-tech manufacturing jobs could be added, Hedman said, if the company takes off.
Hedman has worked to push Intralink Spine and Réjuve from concept to commercialization. But progress slowed, he said, in part because the leadership team was focused on other initiatives. Hedman and former Interlink Spine CEO Eric Hauck spent several years developing and launching an equine-related business called Equinext, located next door to Intralink Spine at the Coldstream complex. Equinext is working to develop, manufacture, and sell an injectable reagent for the treatment of equine ligament, tendon, tissue and joint injuries in various breeds of working and competitive horses.
“Only about a year and a half ago, I started working on Intralink Spine again,” said Hedman. Hauck is now CEO of Equinext.
Réjuve may be available in Europe before it appears in the United States because of the more rigorous U.S. regulatory process. In a company news release, Intralink Spine’s current CEO, Lyle Hawkins, seemed pleased with news from Europe in recent months about Réjuve’s preliminary approval.
Intralink Spine expects to receive the full European-equivalent of FDA approval for Réjuve as a micro-invasive medical device in 15 months.
“We’ll be able to sell the product [at that point],” Hedman said, adding that such a development would bring associated manufacturing, marketing and distribution requirements with it.
In the meantime, CEO Hawkins said he and his associates aren’t “sitting and celebrating.”
“We’re continuing to move full speed ahead towards CE [European] certifi cation,” he said. “Our early interest from European distributors continues to grow. We’re excited about the pre-assessment and what the future holds for employees and investors.”