Cleveland-area patient monitoring company Great Lakes NeuroTechnologies is using the momentum it’s built in the clinical trials market to drive penetration of its device/software technology for assessing Parkinson’s disease symptoms in to other markets this year.
The company’s U.S. Food and Drug Administration-cleared Kinesia technology platform is designed to give clinicians a quantitative way to assess the severity of motor-related symptoms associated with Parkinson’s. To use it, patients wear a motion sensor device on their fingers and perform a series of motor tests prompted by accompanying Web-based software. The sensor captures linear acceleration and angular velocity data and transmits it via Bluetooth to the software, which generates reports to help patients and clinicians track symptoms over time.
Company President Joe Giuffrida said the system is used primarily in three ways: by clinicians to monitor patients’ disease progression and how treatments affect their symptoms; by researchers to evaluate the effectiveness of drugs in clinical trials; and by neurologists to fine-tune the programming of deep brain stimulation devices after they’ve been implanted.
“We are getting a lot of traction in the clinical trials market right now,” Giuffrida said. That’s because Parkinson’s is an active space for drug development, with more than 150 individual programs, most of which are in the preclinical stage, according to research firm Datamonitor. The company hopes to expand international sales of the system this year as it received regulatory approval to market Kinesia in Australia earlier this month.
Plans for this year also include pushing further into the deep brain stimulation, or DBS, market. DBS involves the surgical implantation of a neurostimulator that delivers electrical stimulation to parts of the brain associated with motor function. It’s used in patients with neurological disorders that can’t be adequately controlled with medication, and it’s been an attractive area for product development by big medical device players like St. Jude Medical, Medtronic and Boston Scientific.
Great Lakes NeuroTech’s platform would help clinicians optimize the therapy by assessing how motor symptoms respond to certain levels of electrical stimulation. The company is set to begin testing the feasibility of using intelligent algorithms to guide DBS setting in a study at the University of Alabama funded by a $284,000 phase 1 Small Business Innovative Research grant.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Kinesia was cleared for marketing in the U.S. in 2007 as part of Cleveland Medical Devices. Great Lakes NeuroTechnologies was spun off from the company in 2011 to focus on movement disorders.
Giuffrida said we can expect to see new products launched this year.
[Photo from Great Lakes Neurotechnologies]
