“What if we could glue broken bones instead of using casts, rods, pins, and screws? What if we could glue soft-tissues, muscles, tendons, or cartilage instead of using sutures? What if we could reinforce weakened osteoporotic bones before they failed? If we had the right materials, we could,” said Darren Nolen, Founder & CEO of Nolen Ortho located in Middleton, NH.
With an extensive background in pharmaceuticals, medical devices, and human tissue product development, Nolen realized the problem was not just the materials, it was the entire way in which we were using the materials.
“Human tissue is intricately structured and repair materials should be similarly structured,” he explained, “Even advanced repair materials end up as simple, homogeneous blobs of cured polymer once they are implanted. Our tissues don’t like simple and they don’t like homogeneous. They don’t much like the repair materials we currently have.”
“The problem is the activation,” Nolen commented, “How do you turn this liquid polymer into a solid repair material inside the body?” Currently, the reaction is immediate, curing in seconds or minutes at most, when materials are prepared in an operating room.
The Nolen Ortho innovation is in controlling that activation. The company micro-encapsulates their chemical curing agents inside a temperature sensitive shell, then mixes into the polymer, giving as much time as needed to fine tune the formulation and the microstructure of the material to the tissue it is repairing.
“It is like the old M&M’s candy commercial, ‘Melts in your mouth, not in your hand,’” he explained.
The controlled activation is applicable to a wide range of polymers, and it has a wide range of indications Nolen noted, “We started with the idea of an improved bone graft, which is a $1.8 billion market and very much in need of better materials. Then we realized that the same technology, paired with one of the bio-inspired high-strength polysaccharide adhesives that are causing great excitement in research circles could give us an actual glue.”
“Polysaccharides are these amazing long-chain sugar molecules. That may not sound strong, but these are the molecules that hold up trees (Lignin), make our clothes (Cellulose) and form the shells of crustaceans (Chitin). They are low cost, green, biocompatible, resorbable, and can be incredibly strong.”
One indication that particularly excites Nolen is osteoporosis treatment. “There are 300,000 hip fractures every year in the U.S. with a typical rehabilitation of 6-9 months. Few ever regain the quality of life they had and the pain and long recovery lead to isolation from friends, family, and co-workers. After recovery, the fear of fracture leads them to abandon activities. Half, or 150,000 patients every year, never return home.”
“We are working to develop an injectable material that would be implanted inside a patient’s weakened femurs. It would solidify and bond, then trigger the body’s natural regeneration to build new bone as the material slowly resorbs. It would be an outpatient surgery, an hour, to an hour and a half per leg with patients going home that day. We identify those at risk using a simple x-ray screening. We prevent those fractures from ever happening.”
“The average cost for a hip fracture is $60,000, and with 300,000 of them a year in the U.S. alone, this is a pretty big untapped market and an opportunity to give people back their lives.”
Nolen Ortho’s newest potential indication is in the field of 3-D printing of engineered tissues and organs. The company just filed IP for using their encapsulated curing agent polymers to create a new type of bio-ink. This could be the key technology that finally allows the industry to print cellular structures at the sub-100 micron scale with more robust polymer scaffolding.
“I learned about ARMI through an online search about Regenerative Medicine and then met a member of the staff at a local NH start-up competition,” explained Darren Nolen, “We are very early in our development, all conceptual stage, and we recognize that a community of similarly enthusiastic people is going to be needed to move into commercialization. We also think we have some pretty interesting ideas, and a lot of industry experience in product development, manufacturing, and Quality Systems that we will be extremely happy to share with other ARMI Members.”