Major players in the medical device industry are circling their wagons for another go-around in the battle to win hearts and, now, minds, bones and wrinkles.
A shock to the system
St. Jude said it completed implanting the devices into 136 patients for a clinical study of neurostimulation and Parkinson’s disease.
The pivotal clinical study aims to determine whether the company’s Libra and LibraXP DBS systems can help control motor problems related to Parkinson’s, a neurological disorder affecting more than 6 million people worldwide.
According to the trial’s company-sponsored website, the devices send electronic signals directly into the brain via embedded leads connected to a programmable neurostimulator implanted in the patients’ chests.
Boston Scientific is also deep into the neurostimulation and neuromodulation business, developing products for the treatment of hemorrhagic stroke, intracranial athero disease, and acute ischemic stroke. Medtronic is studying the effects of deep-brain stimulation on obsessive-compulsive disorder.
Besides its Parkinson’s study, St. Jude Medical has clinical trials examining the effect of DBS on depression and essential tremor.
Putty in the hands
Word out of Dallas is that Bone Solutions Inc. landed 501(K) clearance from the Food & Drug Administration for its first product, an injectable, moldable magnesium-based bone void filler.
It’s indicated for use on bony voids or defects of the long bone and the pelvis, just like Hopkinton-based Stryker Biotech’s OP-1 bone morphogenetic protein, which has been on the market for years.
What a difference a day makes
Shares of Palomar soared after the announcement to a 52-week high. Trading opened at $12.17 Friday before reaching a high of $18.17, compared with a prior high of $15.93 last August 15.
The OTC device is a shot across local rival Candela Corp.‘s bow. The Wayland cosmetic laser device maker has yet to release a product that can be sold directly to consumers, aiming instead at sales to physicians and other practitioners.
Of course, Palomar’s stock is well off its peak of two years ago, when it regularly traded at $30-plus per share.
But then again, what isn’t off from two years ago?