Health Market Science

MicroCHIPS recently announced the results of its first successful human clinical trial with an implantable, wirelessly controlled programmable microchip-based drug delivery device.

According to the trial's lead author, Robert Farra, the medical device was designed to take the place of injections for patients requiring regular medication. The device aims to improve the management of chronic diseases, such as osteoporosis, whose sufferers tend to report problems of adherence to recommended drug therapy.

“We look forward to making further progress to advance our first device toward regulatory approvals, as well as developing a range of products for use in important disease areas such as osteoporosis, cardiovascular disease, multiple sclerosis, cancer, and chronic pain," Farra said.

In the trial, women with osteoporosis were given doses of the drug teriparatide through microchip delivery rather than a daily injection. The drug released from the medical device reported similar measures of safety and therapeutic levels in the blood as what is found in the recommended injections of the drug.

The study involved seven postmenopausal patients between 65 and 70 years of age receiving the microchip-based implant. The goal of the trial was to assess the pharmocokinetics of the drug being released with the device. Safety measures conducted by the researchers included evaluating the biological response to the implant and monitoring any levels of toxicity in the blood. The trial also aimed to assess the bioactivity of the drug and evaluate the reliability of dispensing the treatment via microchip.

Patients reported no adverse immune reaction to the device, and the programmable implant was able to deliver the drug successfully at scheduled intervals throughout the day. To assess the efficacy and improvement in bone fracture risk while using the medical device, the researchers measured biological markers of bone formation and bone resorption. The study showed the changes in serum calcium, P1NP and CTX as a result of the drug were the same as those reported with the injection.

“This trial demonstrates how drug can be delivered through an implantable device that can be monitored and controlled remotely, providing new opportunities to improve treatment for patients and to realize the potential of telemedicine,” said study co-author Robert Langer, Institute Professor at the David H. Koch Institute for Integrative Cancer Research at MIT. “The convergence of drug delivery and electronic technologies gives physicians a real-time connection to their patient’s health, and patients are freed from the daily reminder, or burden, of disease by eliminating the need for regular injections.”

Mark Salzman, a biomedical engineer at Yale University, told the Wall Street Journal that the results of the clinical trial opens up doors for other drugs and devices that could help improve adherence levels in a variety of patient populations. The goal of these devices will be to delivery the prescribed treatment over a long period of time, granting control to the patient or healthcare provider.