Biotechnology to the Rescue – By Arlene Weintraub Sept. 2, 2014 | 7:00 a.m. EDT


Wake Forest University’s regenerative medicine lab uses 3-D printing to produce a prototype of a kidney.

The life sciences industry is in the middle of a historic boom, churning out new medical weapons at an unprecedented pace. In 2012, the Food and Drug Administration approved 39 “new molecular entities,” completely novel drugs to treat everything from cancer to tuberculosis to HIV. It topped that off by adding 27 more last year, and there are now more than 4,000 investigational medicines in the pipeline.

Medical device-makers are also in high gear; the 33 products approved in 2013 include replacement hips, new cardiac stents and prosthetic spinal discs. Here’s a sampling of the most innovative developments transforming medical practice and offering patients new hope:

Brain boosters

When the complex communication circuits go awry, the result is a range of neurological disorders, including epilepsy, Parkinson’s disease and paralysis. Now researchers are figuring out how to manipulate neurological signals using tiny implants that, in essence, reset the brain. By targeting very precisely the region where seizures and tremors originate, for example, these minicomputers – sometimes in conjunction with drugs, sometimes on their own – can eliminate debilitating symptoms at their source.

Among the people already benefiting is Janie Norman, 43, of Marietta, Georgia, who was diagnosed with epilepsy at age 11. Norman was able to attend college, get married, and start a family, but she had such frequent seizures that she couldn’t get a driver’s license, go to the movies or grocery store on her own, or play a sport – all were too risky.

Then neurosurgeons at Emory University Hospital in Atlanta placed a tiny implant in her brain that detects the abnormal brain signals that usually precede seizures and responds by delivering short electrical pulses to stop the seizures before they start. Norman has been seizure-free ever since. “It’s a miracle,” she says. “I got my driver’s license. I can take my children to the park. It has really changed my life.”

The NeuroPace RNS System, as the device is called, was approved last year and has been adopted by more than 20 clinics specializing in epilepsy. It also features tiny programmable processors that store and transmit information about what exactly is happening in patients’ brains. By waving a wand over her head, Norman can download the information and transmit it to her doctor. The physicians can then use the information to adjust the device remotely.

An explosion of research that aims to “map” the brain’s function has doctors who treat neurologic disorders predicting a bright future. “The hope is that if we can restore some normal activity, then the natural ability of the brain to use those circuits will keep diseases from getting worse,” says Michael Kilgard, a professor at the University of Texas—Dallas whose research aims to normalize brain activity by sending electrical signals to it via electrodes attached to the vagus nerve in the neck.

Other scientists are developing implants that may someday restore movement in paralyzed patients by repairing damaged connections that instruct the muscles. The brain is great at “reorganizing itself,” Kilgard says. “We’re just guiding it in the right direction.”

Bionic body parts

Whether a patient is an amputee who needs a prosthetic limb or an aging person in need of a new knee or hip joint, the fundamental wish is the same: that the new part will work just as well as the old one did. The device industry is answering the call with myriad new technologies.

In May, the FDA approved the first prosthetic arm that will use special sensors and electrodes to pick up signals transmitted from nearby muscles and translate them to control multiple joints. That will allow users to perform complex tasks, such as grasping small items.

The DEKA Arm System, which goes by the Star Wars-inspired nickname “Luke,” also has sensors in its fingers that can detect how tightly the hand is grasping an object. It communicates that information to the patient through a device touching the skin that vibrates lightly in response to a delicate grip and more intensely as the grasp grows tighter. So a person can shake hands and sense how tight his or her grip is, says Justin Sanchez, program manager in the biological technologies office of the Defense Advanced Research Projects Agency, which funded the arm system’s development.

Retired Chicago police detective John Duffy, who was injured in a cycling accident, wears a prosthetic that flexes in response to signals from his environment.

Retired Chicago police detective John Duffy, who was injured in a cycling accident, wears a prosthetic that flexes in response to signals from his environment.

Prosthetic legs are becoming more lifelike, too. Retired Chicago police detective John Duffy, who lost his leg below the knee in a cycling accident, wears one of the new models that rely on hydraulic cylinders to flex the joints based on signals from a system of sensors and a microprocessor in the leg. As he walks, the sensors continually monitor environmental feedback and send signals to the microprocessor, which controls how much resistance the cylinders apply. The resistance varies according to how fast Duffy walks or whether he is on a flat surface, going up or down stairs, or heading uphill or downhill.

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