The pursuit of “personalized medicine,” one of the newest ongoing waves in diagnostics, usually is associated with the advanced-generation diagnostic products and the newest molecular diagnostic systems, not usually with devices.
Now, a financing deal between Boston Scientific (Natick, Massachusetts) and consciousness monitoring firm Aspect Medical Systems (Newton, Massachusetts), unveiled yesterday, could put the development of new devices in the forefront of psychotropic drug prescribing, in a very much more personalized manner – and one very much needed, according to Aspect.
Boston Scientific has agreed to pay Aspect $25 million for R&D support over the next five years to develop an adaptation of Aspect’s Bispectral Index (BIS) system for the monitoring of drug use in psychiatric applications and Alzheimer’s disease, as well as in other neurological illnesses.
“This is an exciting opportunity to impact a lot of patients and build a brand new business to go beyond consciousness monitoring,” Nassib Chamoun, president and CEO of Aspect Medical Systems, told Medical Device Daily.
Aspect’s BIS system is used to help avoid “surgical consciousness,” those incidents in which surgical patients are not rendered unconscious by anesthesia – and also enabling the avoidance of delivering too much anesthesia – with the company’s cash flow derived largely from disposables for the system.
With the new funding from Boston Sci, Chamoun said Aspect will realign some of its R&D activities to focus on developing its system as an aid to assessing drugs for treating depression and the management of Alzheimer’s, plus other neurological applications.
He noted the huge subjective area currently employed in prescribing drugs in these sectors, and that success in Aspect’s new effort will bring “a more quantitative” strategy and a “trackable dimension” to these areas.
He called psychiatry “one of the last areas of medicine” lacking clear-cut methods for measuring the impact of drug treatments, and that Aspect’s expanding emphasis in this area could result in “opening up a brand new space in personalizing the progression of disease that effect the brain.”
Aspect said that the new alliance is being underlined this week through the presentation of four studies exploring the application of its BIS technology to neuroscience at this week’s meeting of the American Psychiatric Association (APA; Arlington, Virginia) in Atlanta.
Andrew Leuchter, MD, professor of psychiatry at the Semel Institute for Neuroscience and Human Behavior at the University of California at Los Angeles (UCLA) and chair of Aspect’s neuroscience advisory board, said: “A technology that could help clinicians identify neurological disease states, as well as the first, best medication or device-based therapies for treating psychiatric illnesses, could profoundly impact clinical practice. The challenge is finding the best treatment to help each individual recover quickly.”
He estimated that in depression, fewer than 50% of patients get well after their first course of antidepressant therapy, “and many patients become discouraged and give up when repeated attempts at treatment prove ineffective or cause severe side effects.”
He continued: “If Aspect’s technology could help determine at an early time if an antidepressant therapy is likely to speed recovery, it could help make depression easier to manage, improve treatment adherence and dramatically improve the quality of life for millions of patients.” And he said that for those not responding to medication, the technology being developed by Aspect “could potentially guide device-based neurostimulation therapy by helping clinicians determine if this approach would be effective prior to device implantation, and by helping clinicians determine the appropriate amount of stimulation to use.”
Chamoun told MDD that Aspect’s R&D reach into psychiatric and Alzheimer’s disease already has been a three-year effort, and then “kicked into high gear about two years ago.” The company, he said, already has produced around 20 abstracts from preliminary and proof-of-concept work in this area.
Near-term goals for the company in this effort, he said, are to move forward with pivotal trials by the end of 2006 or early 2007, and in “a three- to five-year time frame” have “some versions” of the new monitoring system approved with “some level of labeling.”
The new support from Boston Scientific, a much more broad-based and better-known company, he said, is a significant driver for the effort while also pushing forward an established relationship.
Boston Sci currently owns somewhat more than 27% of Aspect equity, and Aspect has amended its shareholder rights plan to provide for Boston Sci to commence a tender offer for just under 29.5% of Aspect’s stock without triggering the exercise of rights under the plan.
During a conference call yesterday, Larry Best, senior vice president and CFO of Boston Sci, said of the deal and its benefits: “We do like the neuroscience area.” And he noted that Aspect’s efforts represent movement into a sector offering “a sizable market for not only drugs but also devices in the area of depression.”
He said that Aspect is selling its sensors into a market with 85% gross margins, and – repeating an earlier estimate by Chamoun – that the neuroscience applications being proposed represent a fivefold-to-tenfold increase in sales. “As an investor, we certainly like that in terms of profit” as well as improved patient care.
The new deal between the companies calls for them to share equally in the profits from any products developed to treat and manage depression.
In the Alzheimer’s area, up to 20% of the funding provided by Boston Sci may be used to support Aspect’s R&D in that area, and Aspect will retain all commercial rights for products developed in this area.
Chamoun noted that the deal does not cut off any of its collaboration with other third parties in what the company termed “development of customized neurological assessment solutions.”
Aspect reports that its BIS product for consciousness monitoring has been used to assess more than 11.3 million patients and that the technology is the subject of about 1,800 published articles and abstracts.