North Bay businesses are on the cutting edge of new medical technology.
Creative thinkers with new ideas are always in our midst, and 21st century innovators with the advantage of modern technology continue to make medical advances, some of them in the North Bay. Among them, Neurovations, Osseon Therapeutics and Sanovas are doing significant work that promises to deliver benefits to patients, doctors and even the bottom line.
Sanovas: Downsizing the technology
Tucked away in an unassuming building on the Richardson Bay shoreline in Sausalito, Larry Gerrans and Erhan Gunday of Sanovas are doing groundbreaking work developing minimally invasive surgical devices to diagnose and treat lung disease.
“In 2002, we asked ourselves, ‘How come nobody’s doing anything with the lungs?’” says CEO and founder Gerrans. They discovered physicians lacked the capability to go into the lungs effectively, because the space available for getting an image and delivering drugs is limited and accessing the lungs carries significant risk. “The lungs, unlike the heart, can’t be turned off,” says Gerrans. “When working in the lungs, you have to continue to enable the patient to breathe.”
Gerrans and Gunday, an engineer and Sanovas’ chief technology officer, took on the challenge of miniaturizing technology for use in the lungs with input from some of the top pulmonologists in the world. Both were well equipped for the task because they had experience working in the development of minimally invasive surgery and imaging earlier in their careers. But technical expertise alone wasn’t enough to ensure success—an understanding of anatomy also was essential. “If you don’t understand [lung] anatomy, you’re going to cause damage,” says Gerrans.
“Companies have failed despite their best intentions because they didn’t understand the anatomy,” he adds, explaining that previous devices risked doing harm to a patient because they weren’t sufficiently miniaturized for the small spaces doctors have to access.
They began to develop steerable catheters. The result of their work is a series of tiny bronchoscopes—the size is comparable to the tip of a ballpoint pen—that can perform a range of tasks such as facilitating biopsies, removing obstructions and delivering medication. “Basically, we tried to create a tool belt, rather than a tool, for the doctors,” says Gerrans. To explain their approach, he uses what he calls the “millimeter man” analogy: “I imagine myself about 1 millimeter tall and go inside people and things,” he says. “It’s guided our focus, and it’s also guided our innovation.”
Sanovas’ products also include imaging devices that let doctors see the interior of the lung. Gerrans describes the procedure as similar to working in a dark cave with a light—the light is behind, and a big shadow is in front. “The instrument gives you an image of what it’s like in that dark hole,” he says.
A patent is pending for another new device, PhysioSense, which gathers analytics and gives feedback (such as dimensions and the modulus of elasticity of the vessel walls) to physicians. Density measurements are real-time analytics on an ongoing basis.
Research, development, clinical investigation and validation of products take about five years, and FDA approval takes three to four months. Sanovas hopes to have PhysioSense in the marketplace at the end of next year.
A high price to pay
According to Gerrans, 47 million Americans currently have pulmonary disease—that’s one in seven people—and one in every three people is at risk. “What was out there in the 1970s and 1980s, the damage [to one’s health] is done,” says Gerrans. He adds that doctors who treat the lungs deal with more failure than success because two-thirds of a person’s lung capacity can often be compromised before symptoms emerge. In many cases, the onset of disease is swift once diagnosed. Because of this, “[Pulmonary specialists] are the most humble physicians I’ve come across,” he says.
Noting that 85 percent of lung cancer sufferers die within five years, he says, “Lung cancer is the deadliest of all cancers. It’s the only cancer in 30 years that hasn’t demonstrated an improvement in survival rates.
“The cost burden of pulmonary disease on the U.S. GDP amounts to about $154 billion annually, which we all pay for because Medicaid is picking up the cost,” he adds. “Congress recognizes that pulmonary disease is becoming epidemic,” he says, and he believes that the government should step in and join the fight. “Procrastinating isn’t solving the problem.”
Looking forward
Although Sanovas is currently staked in miniaturizing technology for diagnosing and treating the lungs, Gerrans believes Sanovas will have opportunities to modify what it’s doing to improve technologies for use in other areas, and it’s created a platform that can apply to other surgeries, such as those in the heart and stomach. He also foresees the day when pulmonary screening will allow early detection and be as common as mammograms and colorectal and prostate screening.
Gerrans describes Sanovas as an “engineering-centric” company and says he and Gunday are very disciplined and intense. He calls engineers in the area of medical research “modern-day guardian angels” and says, “Their contribution to mankind is indelible.”
“We’re at the tip of the spear,” says Gerrans “For us, it’s been very gratifying, very validating. Every day is a good deed.”
Osseon Therapeutics: A flexible option
Innovative devices for repairing compression fractures of the spine—in which a vertebra collapses, often as a result of osteoperosis—are at the heart of Osseon Therapeutics, which is located in a quiet business complex in Santa Rosa.
Among Osseon’s products is the Osseoflex SN, a steerable needle that a doctor can insert into the vertebral body at the site of a fracture to fill the space with special bone cement. “Other medical device companies use a bipedicular approach with two straight needles. Our unipedicular technology adds steerability to the mix, with one versus two access points, which is safer and results in less operative pain to the patient,” says CEO John Stalcup, Ph.D.
A procedure to repair compression fractures has been in use for several years, and it represents a sea change in thinking from years past, when the prevailing protocol dictated not treating such fractures at all. These days, the favored treatment is inserting cement through a loadable needle—using a fluoroscope to see an image of the site—to stabilize the fracture as soon as possible. “Simplified, the treatment involves a sterile, steerable needle that delivers bone cement to fracture lines in the vertebra,” says Stalcup.
Michael Bivens, director of business development, says Osseon asked physicians how they might improve this procedure and discovered that a steerable needle/delivery device would indeed be an improvement. “Our technology is totally different to everyone else’s,” says Bivens, “because we listened to physicians.” He explains that with the Osseoflex, doctors can deliver the desired amount of bone cement directly to the pathology. “It’s an even flow of cement, and we can deliver it where we want every time,” he says.
Stalcup adds that the Osseoflex is less invasive because it requires only one puncture, whereas other devices require two. “Once versus twice is safer,” he says. “Anytime you’re accessing the spine, it’s best to do it less often.”
And the treatment is effective. Stalcup observes that people who have compression fractures are in tremendous pain—on a visual analog scale (VAS) to measure pain, most of them present between an eight and a 10 (on a scale of 0 to 10), which is excruciating. “When they leave the hospital after this procedure, they’re anywhere from zero to two,” he says, which is, on average, a 67 percent reduction in pain—a remarkable outcome.
“It’s really miraculous,” he says. “When they walk out the door, they’re still crying—but it’s because they’re happy. To see that kind of change in the quality of somebody’s life is rewarding.”
Osseon went to the marketplace in 2009 and, so far, 3,000 patients have received the treatment—2,500 in the United States and 500 abroad. “Everyone sees improvement. It’s consistent,” says Bivens.
Meeting new challenges
Stalcup says the procedure takes about half the time of other methods. That translates into less operating room time, less physician time, less risk to patients and, ultimately, less cost, because doctors are using one needle instead of two. It means economic benefits for hospitals and also Medicare, because patients needing these procedures tend to be older. “In the bigger picture of health care cost management, our technology is designed to meet that challenge,” says Stalcup.
Osseon’s newest device is a steerable balloon, which doctors can inflate to create a cavity in the fractured vertebra to ready it for the cement. Once the balloon goes in, “it’s steered directly to the pathology,” explains Stalcup. “The balloon is the raison d’être of our platform now,” he adds. “This is fighting its way through the last stages of the FDA.”
“This is a tipping point for our company and for treatment of compression fractures. We think it’s going to change the way this procedure is performed,” says Bivens, who expects the balloon to reach the U.S. marketplace by July or August. The initial launch in Germany is targeted for February or March 2012 after receiving CE Marking, which shows it has the approval of the agency that monitors device and drug approvals in Europe (the equivalent of the FDA).
“We feel this technology is the next generation for treatment of compression fractures,” says Stalcup, who sees the possibility of applying the technology to other parts of the body, perhaps the hip, and believes that, in the future, a bone density test will determine how fragile a bone is. “An augmented version of Osseoflex SN will be able to treat hip fractures; using a DEXA scan, we can determine how susceptible you are to hip fractures,” he says. He also foresees a device that not only repairs fractures, but prophylactically prevents them by putting cement in to strengthen the bone.
Treatment of hip fractures is “on our drawing board, but we’re not actually going down that path just yet,” he says “Right now, we’re focused on what we call our suite of osseoplasty products for spine treatments. It’s very satisfying to see someone adopt our technology and comment how it’s the next generation.”
Neurovations: Relieving pain
At Neurovations, the focus is treatments for pain and neurologic conditions. With Dr. Eric Grigsby, founder and president, at the helm, the Napa facility conducts both big and small clinical trials for companies ranging from startups to large medical device and pharmaceutical companies like Medtronic and Pfizer. Grigsby explains that when a company is seeking FDA approval, it must compile data and produce results. Neurovations manages the clinical research component to obtain the results.
Grigsby earned his medical degree at Boston University and studied at the Mayo Clinic (he’s now president of the Mayo Clinic Alumni Association). He started the Pain Institute at UC Davis and moved to Napa in 1989 to practice medicine. In 1991, he started the Napa Pain Institute (NPI) and says, “It’s grown reasonably well since then. We have the busiest pain management practice in the Bay Area.”
NPI expanded into research, and the next step was founding Neurovations in 2006. Grigsby says it was a natural progression for Neurovations to do clinical research and, currently, the company is managing six clinical trials.
“Our business is more than half organized around medical devices,” says Grigsby, adding, “They represent a high degree of sophistication.” He then describes a device that places a small wire on the spinal cord or brain to cause a short circuit, thereby relieving pain.
He notes the importance of such electrical stimulation devices as well as pumps (implanted devices that use an infusion of liquid medicine) into the spine. Neurovations has been central in the development of those two therapies and, says Grigsby, “In the field of pain and neurological disease, they’re tremendously important.”
Grigsby first came across the pump when he was studying at the Mayo Clinic, and he became one of the first to implant the device. He says pumps have been through a lot of iterations and developments since then, and he envisions new uses in the future, predicting that, some day, they’ll deliver medication for the treatment of conditions such as Alzheimer’s, Parkinson’s and epilepsy. “The importance of treatment for neurological disease and pain is huge,” he says. ”We’re at an early stage of the development. In the next 20 years, we’ll see a lot of improvement in that area.”
A costly process
Development is expensive, however. Grigsby says that, to get a new drug or device to the marketplace, and to go through the process of FDA approval for a single therapy can cost more than $100 million. The randomized trials required by the FDA are essential, but they’re also a big part of the expense. As a result, Grigsby says some companies are taking their business to other countries, such as India, Brazil, Russia and China, to avoid the regulatory burden of the FDA and the expense of conducting trials in the United States. This trend makes U.S. citizens the last to get valuable new therapies, in some cases.
He’s looking for ways to keep the costs down, but the FDA has specific requirements, so the number of things he can do is limited. He’s also looking at operational efficiencies and faster enrollment of subjects for trials, which is a possibility because Neurovations has access to a large, well-educated population in the Bay Area.
The number of participants in a trial depends on the drug being tested or the device being evaluated. Devices require 200 or 300 people, while 2,000 to 3,000 might take part in a pharmaceutical trial. Neurovations finds participants through meetings, radio spots, newspapers and other media, as well as from the Napa Pain Institute. “We have a lot of patients in our practice who’d benefit,” says Grigsby.
An international impact
Neurovations also offers educational opportunities. The company has an education and high-tech surgical training center, where it trains doctors and holds seminars. “We also have an affiliation with the Mayo Clinic in Minnesota,” says Grigsby, explaining that fellows in pain do a one-month rotation in Napa.
It also hosts international clinical conferences. The Future of Interthecal Drug Delivery is scheduled for May 2012, and Grigsby says it’s the first and only conference in the world focused on the direct delivery of drugs to the brain and spinal cord.
The 19th Napa Pain Conference, which often presents new clinical data for the first time, will take place in September 2012. “We have everybody who’s anybody in the field of pain management as faculty and attendees,” Grigsby says, adding that, with respect to the Targeted Drug Delivery Conference, the speakers are mostly scientists who give 30- or 40-minute presentations in their areas of interest. He describes the conferences as “a who’s who of international scientists involved in the field.”
The accomplishments are paramount, but for Grigsby, the location is also important. “What I’m the most proud of is that we live in the small town of Napa but have ourselves in the middle of the international conversation about pain management and neurologic disease,” he says.
Modern pioneers
Part of a long tradition in an ever-changing world, the innovators at Neurovations, Sanovas and Osseon Therapeutics demonstrate a pioneering spirit that goes beyond borders as they look past what already exists to pursue new ideas, share them and make life better. In Gerrans’ words, “Their contribution is going to leave a footprint on the legacy of mankind.”
