Demand is on upswing for Indiana firm's implantable devices
Those who have lost a limb may one day be fitted with a prosthetic replacement that is wired not only to respond to their commands but also to provide them with sensory feedback.
An Indiana company, Ardiem Medical, is pointing toward that day with some of the sophisticated biomedical devices it produces or has on the drawing board. Those include a prototype prosthetic arm and various electrodes designed to interface with the body's nerves.
Ardiem is positioned to ride a rising wave of interest in the field of neuromodulation -- in the company's case, electrical signals acting on nerves "to effect a therapeutic end to a disease or a condition," according to Jim Cupp, president of the small firm.
Cupp said Ardiem has found its niche producing implantable electrodes that are tailored to each customer's specifications. "We work with numerous customers in the research field and even in the commercial arena," he said. As such, Ardiem is part of a worldwide neuromodulation device industry that had an estimated value of $3 billion in 2008, according to a market research study from Neurotech Reports, an industry publication.
Among Ardiem's products that have seen a growth in demand is a neural cuff electrode. Wrapped around a nerve bundle, it allows for an electrical impulse to be delivered or received through targeted nerves.
Ardiem has developed the electrode based on technology it licensed from Case Western Reserve University in Ohio, one of the company's long-standing partners in research and development.
Cupp explained the self-sizing, spiral-shaped device is "almost like a low-force silicone spring" that can fit itself to a variety of nerve bundles.
Linked with a control unit, the body's muscles and/or a prosthetic device, the electrodes can be used for a variety of needs -- blocking pain, restoring function for an amputee and even allowing a paralyzed person to once more stand.
Case Western is serving as a subcontractor to Ardiem in development of an advanced myoelectric prosthetic arm. The Louis Stokes VA Medical Center and the U.S. Army also have been involved in launching the project.
Cupp explained the arm will represent a step forward from other versions of electrically operated limbs because the Ardiem design has controls implanted under the amputee's skin. He noted other arms have made use of control elements placed on the surface that can easily get bumped out of position or lose contact due to perspiration.
If the technology proves feasible for widespread use, it could provide an improved quality of life for those who don't make full use of existing prosthetic limbs due to problems with reliability and awkwardness.
Cupp noted, "We had a local amputee come in who has a $100,000 arm, but he only uses it a couple of times a year."
Christi Park is Ardiem's program manager and the principal investigator for the prosthetic arm project.
"I'm most excited about where we can go with this," Park said of the project. "There's a lot of potential."
Cupp said Case Western is screening patients for a possible human trial later this year. The first step, slated in May, will be testing the implants in animals to demonstrate their safety as a requirement for eventual approval by the U.S. Food and Drug Administration.
The most important goal is to give an amputee control over the prosthetic arm, with electrodes connected to the nerves that normally would guide muscles. Cupp indicated the company also eventually wants to pair the devices with different nerves that can accept sensory input from the arm. "We know it can be done," he said.
An added challenge is tailoring the implanted devices to the individual patient, Cupp said, noting that each person's nerves are wired a little differently. "You have a bundle of nerves that you put an electrode on, and you try to differentiate between the different nerves," he explained.
There's more of a need than ever for improved prostheses due to the nature of injuries and modern medical care for troops in Iraq and Afghanistan. "People are surviving, but their limbs and heads are exposed," Cupp said.
Cupp gained added inspiration for working on the project when he met some of the injured soldiers who might someday use the artificial limbs his company is working to perfect.
""Whatever we can do to help them stand or walk or hold their kids again is the important thing," he said. "They want to be back to normal and get back to life. That's encouraging."
The Ardiem staff likewise came away energized after meeting a Florida woman who is successfully using a stimulator the company produced through another partnership with Case Western.
The woman, who is paralyzed, demonstrated the device while speaking at an industry convention. Activating a controller unit, she was able within five seconds to rise from her chair to stand at the podium.
"It's amazing to watch people who thought they would be stuck in a wheelchair the rest of their lives, and now they are able to stand up," Park said.
For a paraplegic, "Being able to stand and talk to people on a face-to-face standpoint is a really big deal," Cupp added.
He said the woman has advanced from a basic stimulator model, featuring eight electrodes, to an updated version with at least 16 electrodes. The device operates through two-way communication between the implanted electrodes and the controller unit. In such a device, Cupp explained, "Some of the electrodes record the neural signals. There are others to stimulate the muscles or nerves."
In the beginning
Ardiem began operations in 2002, founded by Cupp and several others who had worked for a previous local medical device company, Biocontrol Technology. Cupp's experience in the field goes back to 1974, beginning with a predecessor company, Coratomic, that made pacemakers.
"A couple of research grants started us off," Cupp said of Ardiem. The company was able to build on relationships the founding members had developed with university research programs while at Biocontrol Technology.
Staying local, since they lived in the area, the founding partners set up shop in an 18,000-square-foot portion of a former shopping plaza at Wayne Avenue and Hospital Road that was anchored by a now-vacant BiLo supermarket.
Cupp also is involved with a sister venture, Synergy Contracting, that makes specialized industrial cables and coaxial wire cables. He said that company has a different ownership mix to take advantage of programs available to firms owned by women.
Starting with "a couple of computers and some desks," he said, Ardiem now has manufacturing equipment that includes ruby lasers for welding hermetic enclosures. sealed metal casings that keep an implantable device's electronics from contact with any body fluids.
At the heart of Ardiem's manufacturing process is a "Class 10,000" clean room necessary for assembly of medical devices. Cupp explained HEPA (high-efficiency particulate air) filters and exchanges of air are used to control the level of airborne particles inside the room. Ardiem's clean room, which covers a few thousand square feet, is certified to have no more than 10,000 particles -- each no larger than 3 microns --...per cubic meter of air. One micron equals 39 millionths of an inch, with a grain of salt measuring about 60 microns. Cupp noted the room was laid out with a modular design so that it can be added to as warranted by increases in the company's production level.
Given the nature of its work, Ardiem's 10-member staff includes plenty of engineering talent. Cupp and Park are among three staffers who split up the project management chores, leading teams that are assigned to development of different devices. As projects unfold, Cupp noted, "We notify each other and keep everybody in the loop," so that no potential insight or idea is overlooked.
Others work in fabrication, including technicians who concentrate on precision work in the clean room.
But, in a small company, Cupp pointed out, "You have to be extremely multi-talented. Everybody does everything." He's been known to take a turn in the clean room, when needed, to meet a production deadline.
For the company's research-driven projects, the payoff in the form of a finished device is often a long-term prospect.
"It's a very long process to go from a prototype to a regulated device," Cupp pointed out. "There are scientific and safety protocols you have to follow. To get to the final stage of clinical trials, 10 years is nothing."
But Ardiem also turns out devices for other companies and has seen a recent increased demand for items such as its electrodes.
"We're providing a service," Cupp noted. "We have products we can adapt to different applications for our customers. If it's something we can do, we'll take it on. We don't turn a lot of things away."
Building and growing
Ardiem's customer base and inquiries about its products have increased over the past year. Its clients include firms from other nations, such as India and Germany.
As a result, after years of maintaining a steady employment level, Park noted the company is looking to hire two or three additional technicians by the end of this year.
To fill those positions, Ardiem management isn't interested in applicants who know a lot about medicine or engineering. Rather, they value workers with good hand skills, accuracy and attention to detail -- for instance, anglers who may tie flies as a hobby.
"This is a no-error type of proposition," Cupp said of the precision required for the company's small, sophisticated medical devices. "Most everything we do is manufactured under a microscope."
Park noted those who have a talent for needle crafts also would be well suited for technician posts.
"There are people who won't put those things on their resume," she said, "but that's exactly what we're looking for."
Ardiem has made some other medical-related products, including surgical instruments, but Park said business has really started to pick up since the company concentrated more of its efforts on the neuromodulation field and electrodes.
Park recalled when a research partner at Case Western told the Ardiem staff, "Do you realize there's nobody else out there that's doing this?" "That's when we had a big ah-hah moment," she said. "That's when we started focusing more on neuromodulation."
Park noted the company now is looking to take care of such marketing chores as updating its website to more strongly reflect the specialized direction in which its work and technology are headed.
Conferences on neuromodulation have provided Ardiem good opportunities for networking with potential clients, Cupp said. "We make contact with people, and they remember us when they get a future grant."
Word of mouth has also been an effective means of gaining work, he said, noting, "The research community is relatively small."
In addition to Case Western, Ardiem has partnered on research projects with UCLA and the University of London.
The company also made electrodes for use at Penn State.
Working with the University of Pittsburgh and the Navy, Ardiem researched and produced several versions of cooling devices. That project explored the possibility of inducing full-body hypothermia to limit tissue degeneration while transporting wounded service members with blood loss from the field to a hospital. But that effort is on hold, Cupp said, as research is now focused on cooling specific areas rather than the whole body.
Nearly a year ago, Ardiem launched its first collaboration with neighboring Indiana University of Pennsylvania. Faculty from IUP's physics and biology departments helped Ardiem develop a Phase 1 application for a Small Business Innovation Research Grant offered through the National Institutes of Health. The program offers grants not to exceed $150,000 in total costs over six months.
If it's ultimately awarded, Ardiem plans to use the grant to pursue improvements to its electrodes. "The grant will enable our project engineers to partner with IUP to help us research and test the product design," Cupp said at the time of the application.
So far, that grant application has not borne fruit. "That's not atypical," Cupp noted of such funding processes. He said the company intends to revise and resubmit the application." But, with a resubmission, "The clock starts over again. It can be a couple of years before you get a grant awarded."
Ardiem still plans to work with IUP but may look to recruit an additional partner for the project, Cupp indicated. "We've started to forge relationships with IUP, and we want to forge even better relationships with them."
At the time of the application, Tracey Missien, IUP's interim director of economic development, said the university was looking forward to the project as "a new milestone that we believe will continue to advance our reputation as a research university." Missien was unavailable for further comment this week.
While Ardiem's research-driven projects so far have not felt the pinch of the recent national recession, Cupp acknowledged some of the company's clients in other medical-related sectors have. That includes a medical instrument company that was affected by a drop in elective surgeries. "Plastic surgery was hit by the recession," Cupp said.
If gasoline prices continue on an upward trend, it will eventually affect costs for some of the materials and transportation services the company uses. But, "It's not hurting us too bad at this point," Cupp said.
It may be too soon to predict potential ripple effects from the natural and nuclear disasters that struck Japan earlier this month and were expected to disrupt some of its key exports. Cupp noted Ardiem obtains most of the technology components for its products from domestic sources.
Such global economic factors haven't changed Cupp's goals for the company: "For the short term, we want to build our customer base. In the long term, we want to be known as the leader in neuromodulation and be supportive of research programs."