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you have a fracture,” Neer says. So some patients forget to take their drugs, or just assume they don’t need to take them because they feel okay, he says. “It’s kind of like termites—you don’t realize anything’s wrong until something collapses.”
Patients in the trial received teriparatide through the MicroCHIPS device for one month. During the study, changes in blood calcium and other biological markers of bone strengthening proved similar to those that were shown in previous studies of women taking daily injections. Farra says MicroCHIPS will spend the next two years or so making a chip that can hold 365 doses of the osteoporosis drug and getting it ready for longer-term trials, which he hopes to initiate in 2014.
Designing the osteoporosis drug/device combo was far from easy. Neer, who has advised MicroCHIPS for the past 10 years, says it was a challenge for the company to devise a formulation of the drug that would remain stable for up to a year, and that would diffuse properly from the tiny reservoirs on the chip. Furthermore, the device had to be waterproof so it wouldn’t be destroyed by the natural liquids in the body. “They had to figure out how to make it water-tight, but without welding it at a high temperature, ” he recalls, because that would have endangered the stability of the drug.
Still, MicroCHIPS’s biggest challenges may lie ahead. The FDA has not yet advised the company on the scope of future trials, but Neer predicts the agency will require at least one study that goes on for two years. And there’s a small chance the FDA will also ask the company to do a “fracture-prevention” trial to show the device is at least as good as currently marketed products at fending off dangerous fractures. Such a study, Neer says, “would require testing it in several thousand patients over several years.”
Should the company survive a rigorous trial process, it will likely face some marketing challenges as it tries to persuade physicians to replace easy-to-prescribe drugs with something that has to be implanted. “The company will need to show the treatment is as effective or more effective than pills or injections,” Neer says. “If they can show it improves bone density better than any injection, that will impress doctors.”
MicroCHIPS has a syndicate of investors that includes InterWest Partners, Polaris Venture Partners, Novartis Venture Fund, Flybridge Capital Partners, Medtronic, Saints Capital, Intersouth Partners, Care Capital, and CSK Venture Capital. Farra says all the investors have “expressed continued support” but that the company is currently looking for further funding and possible partnerships.
As for the challenge of convincing the FDA—and ultimately doctors and patients—that an implanted device is the way to go in osteoporosis, Farra isn’t worried. “Only 25 percent of people who start Forteo complete all 24 months of treatment,” he says. “This implant is sensible—it will allow physicians to give their patients the full benefit of treatment.”