What are the treatment options for stroke or traumatic spinal cord injury? Can treatments influence the deteriorating effects of diseases such as Alzheimer’s or even severe depression? Will advances in neurotechnology bring the medical device industry new revenue and profit potential while helping to improve patients’ quality of life?
As neuromodulation grows more sophisticated, devices such as Cyberkinetics’ Andara OFS System for treatment of acute spinal cord injury are poised to offer dramatic quality-of-life changes for patients…
With more than two billion people in the world afflicted with brain-related illnesses, the economic burden for these conditions is more than $2 trillion per year (more than $1 trillion of which is based
in the United States)…According to recent research from NeuroInsights’ The Neurotechnology Industry 2007 Report, neurodevice revenues in 2006 were $4.5 billion (and diagnostics were $15 billion). Venture capitalists invested $1.67 billion in the overall market in 2006, a 7.5% increase from the prior year. At least 500 companies worldwide currently are operating in the neurotechnology industry.
Indeed, neuroscience is such a hot market right now that even the Cleveland Clinic jumped on the bandwagon last year when its annual Medical Innovation Summit was devoted to neurological advances in
medicine…Furthermore, on Sept. 25, Nasdaq launched a new index of companies whose primary focus involves neurological and psychiatric medicine. As one of the first indexes focusing on a specific disease category, the Nasdaq NeuroInsights Neurotech Index (created in conjunction with NeuroInsights) includes 32 companies from the drug, device and diagnostic sectors, which have combined market value of $71 billion…
In the neurodevice sector, three major markets have emerged, according to Lynch. The largest is the $2.5 billion neurosurgical market, consisting of tools used for procedures such as tumor removals or neurovascular interventions (such as to treat stroke victims) using coils, balloons, stents and other products. Neuromodulation, which encompasses stimulation devices used to restore function, is a $1.38 billion market. The final category is neuroprosthetics, a $540 million market consisting of products such as cochlear implants for hearing-impaired individuals, implants for spinal injuries and retinal implants (still in development)…
…deep brain stimulation (DBS), already available from large device companies such as Medtronic and St. Jude Medical, will be the “hot market” in years to come. In fact, neurostimulation, which relies on devices that are similar in design to pacemakers and implantable cardiovascular defibrillators, will keep growing and gain wider use for a variety of applications. “We’re just at the edge of a massive explosion in the specificity of these devices. The technology is making it more possible for us to create devices that can target areas of the brain with ever more precise specificity…
Already FDA-approved for treatment of tremors caused by Parkinson’s disease, DBS is nearing approval for treatment of obsessive-compulsive disorder and is in clinical trials as a therapy for depression. Some studies have shown DBS also may help control symptoms of Alzheimer’s disease, paralytic muscle rigidity, epilepsy, Tourette syndrome, some addictions and various other conditions.
One patient population of great interest to medical device inventors today is stroke victims, and for good reason. The annual cost for treatment, post-stroke care, rehabilitation and lost income to victims is $30 billion, according to the American Heart Association. Many of the more than three million survivors are left with decreased functioning, and their needs have been largely unmet to date—but they have reason for hope of better quality of life, thanks to various emerging companies working on devices that, if proven safe and effective, will change a stroke survivor’s fate.
Take Northstar Neuroscience’s Renova device, for example. This implantable technology, which is still in the investigative stage, differs from what’s already on the market because it uses a less-invasive approach than DBS devices, stimulating the cerebral cortex (the outer layer) of the brain. In the company’s ADAM and BAKER clinical trials, preliminary results have shown an average of 20%-30% improvement in function…
While the Seattle, WA-based company is heavily focused on gaining approval for a stroke indication, Northstar also is investigating use for treatment-resistant depression by stimulating neural firing at the brain’s cortex level. Although approval would be several years down the line, Bowers said preliminary results from its Prospect feasibility trial are significant for this patient population…
Neurostimulation products aren’t just being developed for use in the brain itself. For instance, Cyberkinetics Neurotechnology Systems, Inc. in Foxborough, MA has developed its Andara OFS System to stimulate the growth of new nerve fibers by applying a low-voltage, direct electrical current to create an oscillating electrical field around the injured area of the spinal cord. The company has applied for a humanitarian device exemption from the FDA for the device as a treatment for acute spinal cord injury.
People with spinal cord injuries lose motor function, sensory function and autonomic function—which controls heart and respiration rates, as well as digestion and other important bodily functions…
Cyberonics, a Houston, TX-based pure-play neuromodulation company in operation for more than 20 years, is well known in the medical device industry for its Vagus Nerve Stimulation (VNS) Therapy. Indicated for treatment of both pharmacoresistant epilepsy and treatment-resistant depression (TRD), VNS Therapy consists of a pacemaker-like device implanted in the chest that delivers mild pulsed signals to the brain via the vagus nerve in the neck…
Cyberonics’ VNS Therapy, shown above, is a unique treatment because its pulsed signals are delivered to the brain via the vagus nerve…
While investigations are ongoing for devices that will help restore function in stroke survivors, other companies are rolling out products that will revolutionize the care given to patients who need urgent care when a stroke occurs. Each year, 550,000 people in the United States have strokes, and one third of them die, according to the American Heart Association. Several companies are working on technologies that have the potential to greatly reduce that incidence.
There are two types of stroke: ischemic (the most common) and hemorrhagic (the most deadly). One company, Micrus Endovascular in San Jose, CA, is devoted to making sure patients who have hemorrhagic strokes due to a burst aneurysm don’t have to endure the traditionally invasive surgical approach, such as a craniotomy. Just as we’ve seen in the cardiovascular realm, when dealing with an aneurysm today, the typical arsenal of products used during a hemorrhagic stroke procedure includes guidewires, microcatheters, coils, stents and balloons. Micrus Endovascular launched its ACT MicroCoil Delivery System in Europe in 2000 and in the United States in 2001 and has since rolled out a variety of the main products used in procedures that treat hemorrhagic stroke victims…
…about 40% of aneurysms currently are treated endovascularly, with the remainder being performed through surgery. However, the market is shifting at a rate of about 15%-20% from the use of clipping toward the use of coiling, which is less invasive than the former approach…
As of press time, the company was preparing to launch its Enzo device, the first “steerable” microcatheter…
Cyberkinetics also is developing a neural interface system that potentially could restore functionality for severely impaired individuals. The BrainGate Neural Interface System, currently in pilot clinical testing, enables a person with quadriplegia to use his/her own brain signals, or thoughts about moving, to control a computer cursor to perform a wide range of self-directed activities, including communication and speech software, telephones, a television or lights, and even a wheelchair. A small, baby aspirin-sized implantable sensor is placed on the area of the motor cortex that controls arm and hand movement to pick up and transmit brain signals to a computer that translates the signals that move the computer cursor on the screen, just as a hand would do with a mouse. The goal of this development program would be to allow these individuals to one day use their own arms and hands again…
But how will the market shape up from a business perspective? After all, if there’s one consistent trend in the medical device industry over the past year or two, it’s been one of consolidation, with mergers and acquisitions dominating the news…
With the recognition that innovation usually doesn’t occur in a silo, two organizations are making it easier than ever for device developers and clinical practitioners to collaborate and create optimal products for neurotechnology markets.
Founded in 1998, the Center for Integration of Medicine and Innovative Technology (CIMIT), through its NeuroTechnology Program, is one such entity helping to facilitate convergence of these groups. Led by Steven Schachter, MD, a nationally renowned epilepsy expert and professor of neurology at Harvard Medical School, the CIMIT NeuroTechnology Program forms bridges between world-class technology partners (eg, MIT, Draper Laboratory and Boston University) and clinicians at Harvard teaching hospitals and Boston Medical Center…
Similarly, the Neurotechnology Industry Organization (NIO), headquartered in San Francisco, CA, is a non-profit trade association that represents neurotech companies, neuroscience research centers and brain disease advocacy groups. NIO has a three-pronged strategy: promote, advocate and support the neurotech industry.
For example, NIO is spearheading the National Neurotechnology Initiative, a new federal R&D program aimed at accelerating translational neurotech innovation and improving the timeliness of the FDA review process for neuroscience drugs, devices and diagnostics. Other areas of interest include issues pertaining to tax code, intellectual property, neuroethics, public policy, reimbursement and patient advocacy. In addition, NIO focuses on neurotech companies’ funding needs from both private and public sectors. Benefits of NIO membership include representation in Washington, DC, startup marketing support; inclusion in the neurotech industry business directory; participation in an annual public policy tour in Washington, DC; being featured in the public relations campaigns; and discounts on reports and conferences.
For more information on these entities, visit CIMIT’s Web site at www.cimit.org and NIO’s Web site at www.neurotechindustry.org.