Impressio, MedShape partner on joint replacement device

AURORA, Colo.—Impressio Inc. said it has perfected the use of liquid crystal elastomers outside the body with a novel approach to energy-absorbent helmet liners, research that has landed the company on a short list to receive a $1 million prize from the NFL.

Now, the small startup outside Denver will look to move its patented dissipative polymers inside the body, collaborating with Atlanta-based MedShape, Inc., to create a joint replacement device for an arthritic condition that occurs in the big toe.

Impressio and MedShape—which share similar leadership pedigrees—recently received a prestigious $250,000 grant from the National Science Foundation for the research, which both companies hope will lead to a certified and commoditized device several years from now.

"We believe our innovative material can improve human life from head to toe," said Amir Torbati, chief scientific officer and co-founder of Impressio. "After receiving this NSF SBIR Phase I award, we will be focusing on the MTP joint as our first entry point into the body. Once we successfully prove that our technology works in joint replacements, we will start focusing on knee and spine implants."

The mission is complex, as the companies attempt to develop a new surgical treatment for hallux rigidus, a disorder of the metatarsalphalangeal joint located at the base of the big toe. As experts in the foot and ankle surgical device realm, MedShape will help develop the device that contains the LCE produced by Impressio. According to MedShape, the potential device would mimic the function of native cartilage in the MTP joint while reducing wear.

"MedShape has extensive experience in developing and commercializing foot and ankle orthopedic devices manufactured out of unique biomaterials," said David Safranski, director of basic research at MedShape. "With that, MedShape will help with designing a finished device from the liquid crystal elastomer and performing the necessary biomechanical testing to validate the device performance."

And getting the product to market is the ultimate goal for the two companies, as well as the intent of the grant from the NSF, according to Torbati. Impressio is the official grantee and will spend about 60 percent of the $250,000, while MedShape is the sub-awardee and will have access to between 30 and 40 percent of the money.

"NSF is proud to support the technology of the future by thinking beyond incremental developments, and funding the most creative, impactful ideas across all markets and areas of science and engineering," said Andrea Belz, director of the Division of Industrial Innovation and Partnerships at NSF. "With the support of our research funds, any deep technology startup or small business can guide basic science into meaningful solutions that address tremendous needs."

According to Belz, after a small business earns a Phase I grant, it can apply for a second grant worth up to $1 million. Businesses then are eligible to receive an additional $500,000 in matching funds with qualifying third-party investment or sales.

"Being vetted by the NSF is a great confirmation of our technology, but our team has been even more impressed with the NSF resources such as the I-Corps program that gave us an opportunity to gain valuable understanding of the medical device space," said Christopher Yakacki, CEO and co-founder of Impressio.

All in the synthesis

The technology going into the LCE might be ground-breaking for concussion protection and orthopedic devices, however the raw material is not.

Liquid crystal elastomers—which have liquid crystals embedded in the backbone of the polymer—have been around for 50 years, Torbati said, and are a known quantity for vibration isolation, as well as heat and energy dissipation.

"We didn't invent liquid crystal elastomers," Torbati said. "What we worked on was the synthesis, how to make these in a scalable manner. It was a long process from the starting material."

Many times the elastomer is air- or moisture-sensitive, and this often prevents scaled-up materials, Torbati said.

"It's not the material itself; it's the know-how," he said. "We can make materials slightly harder or slightly softer. We can make it into films, for pillars in a cylindrical shape. Nylon was expensive 20 to 30 years ago, and still is relatively speaking, but it has been commoditized. We are hoping our LCE can be scalable."

This "tunability" with its patented LCE allows Impressio to optimize the material for the application. For instance, in its protective helmet applications (for everything from bike helmets to ice hockey helmets to football helmets to its largest market, military helmets), a 3D-printed, thermoplastic lattice structure is employed that serves as a placeholder for the LCE.

The elastomer is then placed within the lattice structure in a cylindrical shape and the entire structure serves as a helmet liner. A cylindrical shape to the LCE also is planned for the joint replacement device in the foot, Torbati said.

In helmets, not only does the lattice structure help to dissipate heat on a hot day on the gridiron in Arizona, the LCE itself can conform to body temperature—making it the perfect material for a cold day in Buffalo, or for biomedical applications.

Fast forward to 2017, when Impressio decided to transition this platform technology developed around helmets and other "outside the body" applications to biomedical functions.

"We wanted to mimic a joint with energy-absorbent material," Torbati said. "We first looked to the spine and the knee, but the problem is it is hard to get into those areas. This NSF grant could be our entry into the medical market."

And MedShape made the perfect partner for the research, as Impressio CEO Yakacki used to work there. The orthopedic device company that began in 2005 said it hopes to expand its product portfolio with the potential device, while also bringing new materials into clinical use that offer better performance, Safranski said.

"MedShape has the medical device and regulatory knowledge to guide this product from the development phase through to commercial launch," he said. "The proposed MTP replacement could serve as a stepping stone for future expansion of the liquid crystal elastomers into other joint replacement applications."

The timeline for development of the joint replacement device in the big toe could be anywhere from two to five years, Torbati said. Phase I will last one year, during which time the companies will attempt to secure design and formulate the crucial shear properties of the LCE. Clinical studies in animals will be done in Phase II and then the device will be issued to the FDA for approval in human beings.

"Their team is focused on designing our product and in helping to take it through its clinical studies," Torbati said. "Then they will help it through FDA, and after that, hopefully put it on the market."

And Torbati said the companies "are not designing a device blindly," as a customer discovery process is part of the NSF's grant requirements.

"The NSF makes you understand your possible customers," Torbati said. "We have talked to about 10 surgeons, getting traction from them for solutions that do and do not work, and why. They are very interested to hear more. That customer feedback and relationship has been very useful to us."

'Pressing, pulling, punching' for predictions

Protective helmets have evolved from leather caps to their current form due to the materials innovation boom in plastics during the middle of the last century, according to Impressio.

However, no new energy-absorbing materials have been introduced into helmets over the previous 50 years. As a result, helmet manufacturers are actively seeking novel solutions to helmet designs to improve player safety.

"Without using novel materials or advanced manufacturing techniques, improvements to helmet safety will remain incremental," the company states on its website.

As Impressio looks to make its foray into biomedical, it caught the eye of the NFL earlier this summer as the league awarded Impressio $492,000 of a $1.37 million overall grant to research helmet protection as it pertains to concussions.

Three other consortiums—a group led by football equipment manufacturer Xenith; Kollide; and a group led by the University of Virginia—also received grant money.

If Impressio's helmet prototype is accepted by the league, Impressio could earn another $1 million in prize money. The helmet challenge culminates in July 2021.

"By bringing together experts from multiple disciplines, the NFL Helmet Challenge aims to encourage revolutionary advances in helmet design," said Jeff Miller, NFL executive vice president of communications, public affairs and policy, who oversees the NFL's health and safety work. "The awardees demonstrated the potential to do just that. We're very excited to support their efforts and test their prototypes next year. This is one more sign of the recent transformation in the protective equipment space—more in the last couple of years than over the previous decade—and we are committed to keeping this momentum going."