FDA Approves New Drug/Device Trial

Jun 13, 2017

Sioux Falls researchers are employing light to open blood vessels. The US Food and Drug Administration is green-lighting a trial that could help patients who suffer from peripheral vascular disease. Doctors say more than 8 million people live with the condition.

Research leaders say the FDA okays a study that uses NVS to treat PVD. Acronyms aside, leaders have the go-ahead for a clinical trial. It may determine whether a new combination of a medical device and a drug can help people with leg problems related to their blood vessels.

"It’s very similar to what happens in heart disease when you get a narrowing of the coronary arteries," Dr. Myles Greenberg, CEO of Alucent Medical, says.

"They become blocked by plaque," Greenberg says. "And patients who have lower extremity peripheral vascular disease will experience symptoms like pain, numbness, and can even experience the loss of their limbs as a result of severe peripheral vascular disease."

Dr. Myles Greenberg is President/CEO of Alucent.
Credit Kealey Bultena / SDPB

Greenberg says the current standard of care is balloon angioplasty. Doctors feed a balloon into an artery. Then they inflate it. The balloon expands, pushing plaque clogging the vessel out of the way. Greenberg says that opens the artery and allows better circulation.
"The trouble with this therapy is that it tends not to last. The walls of the vessel will close in again. The athroscloratic plaque will occur again, and there’s often a need for frequent retreatment of these patients," Greenberg says.

Jim Corbett is chairman of the board for Alucent.

"So you can imagine: you have trouble walking. You get angioplasty, and you get a stent, and 50 percent of the time, they have to go in and do something with it," Corbett says. "And that is a challenge, and part of the challenge is not just the re-occurence of the disease but it is the leave-behind of the hardware, the implant, that stent that exists in the artery."

Corbett says he has 30 years invested in medical device development. Corbett says technology such as stents that dissolve take several years to absorb into the body. He says metal stents that work for hearts are less effective in limbs.

"You would think the heart would be harder than the leg, until I describe it this way: your heart is a vessel that sits there, and the vessels don’t move around. If you have it in your leg, you move it hundreds of times a day and flex it, and you go upstairs and you go around a corner and you sit down and you stand up," Corbett says. "And every time you do that, you stress it."

Jim Corbett is Chairman of the Board for Alucent.
Credit Kealey Bultena / SDPB

Corbett says Natural Vascular Scaffolding (NVS) could eliminate complications that come with stents. 

"The first time I heard about this, I was like, ‘Come on. That’s not gonna happen.’ And I will tell you, with the work that’s been done here at Alumend and the experiments and the proof that Ron and his team have developed, I became a believer," Corbett says.

Corbett refers to Ron Utecht. He’s the lead scientist who holds about 20 patents for a treatment that uses light to repair tissue. Natural Vascular Scaffolding helps the body craft its own stent. Doctors insert an angioplasty balloon and inflate it to hold the vessel open. They also also administer a drug. Then they apply light.

Greenberg says that catalyst activates the pharmaceutical and prompts the body to build support for the artery. 

"It cross-links a protein called collagen, which is the natural scaffolding in the vessel, and it cross-links it in the new configuration, meaning open versus closed," Greenberg says.

Greenberg says the treatment could "leapfrog" current methods.
NVS is FDA-approved for Phase 1 clinical trials. Those are slated for Ohio, Pennsylvania, and Tennessee. Leaders say the trial isn’t happening in Sioux Falls to maintain efficacy and objectivity.

Avera Health owns the subsidiary called Alumend, which is a research and development enterprise.
Alumend licenses Alucent, the company testing and marketing the treatment now FDA-approved for trial.

South Dakota scientists are researching other uses for NVS from cancer treatment to orthopedics and even cosmetics.

Credit Kealey Bultena / SDPB