Driven by a growing clinical understanding of how the human brain functions and enhancements in the size and reliability of medical technologies, the field of neurology is receiving unprecedented levels of attention from physicians and industry alike.
According to The Neurotechnology Industry 2006 Report by NeuroInsights (San Francisco), neurological diseases and psychiatric illnesses represent the largest and fastest-growing unmet medical market, with conditions affecting 1.5 billion people worldwide. The report breaks the $110 billion neurotechnology industry into three sectors: neuropharmaceuticals, neurodevices, and neurodiagnostics. While the neurodevices sector's estimated annual revenue of $3.4 billion represents the smallest of the three slices, its 21% annual growth rate far exceeds those of neuropharmaceuticals and neurodiagnostics, at 7% and 11% respectively.
Medtronic's Richard E. Kuntz, MD, on the breakthroughs making neurology one of medtech's most promising sectors.
Such growth projections have not been ignored by medical device manufacturers. In addition to numerous start-ups and early-stage companies targeting the neurology sector, some of medtech's biggest players have recently sought entrance to the growing field. And many of these forays are already starting to pay off. In June 2004, Boston Scientific Corp. (Natick, MA) acquired implantable neurostimulation device manufacturer Advanced Bionics Corp. (Sylmar, CA) for $740 million. In Boston Scientific's most recent quarterly earnings release, the company reported that revenues for its neuromodulation division had grown 78% over the year-ago period.
Likewise, in late 2005, St. Jude Medical Inc. (St. Paul, MN) acquired Advanced Neuromodulation Systems Inc. (ANS; Plano, TX) for about $1.3 billion. In its most recent quarterly earnings release, St. Jude Medical's sales of neuromodulation products totaled $44 million, up 13% from Advanced Neuromodulation Systems' stand-alone sales in the year-ago period.
In November, the Cleveland Clinic Medical Innovation Summit will focus on new technologies, economics, and trends in the field of neurosciences. Featured speakers are expected to include Richard E. Kuntz, MD, senior vice president of Medtronic Inc. (Minneapolis) and president of the company's neurological division. With a background in interventional cardiology and cardiovascular disease clinical research, Kuntz has been guiding and growing Medtronic's industry-leading, billion-dollar neurology division for the past year.
In excerpted interview with MX editor-in-chief Steve Halasey, Kuntz discusses the clinical and technological innovations at the heart of neurology's rise in prominence, as well as the opportunities and obstacles facing the sector's device manufacturers.
MX: The clinical need for therapies to treat neurological disorders has been apparent for many years. What factors have led to the rise of this new field now?
Richard E. Kuntz, MD: The rise has been occurring for some time, but the treatments are just now starting to gain momentum. The history of device interaction with the central nervous system started 30 to 40 years ago. The reason such devices are taking off now is because the technology has gotten small enough and reliable enough for practical use. Many neuromodulation technologies derive from pacemaker and implantable cardioverter defibrillator (ICD) platforms, taking niche applications that have been around for 20 or 30 years and making them more mainstream.
In addition to technology enhancements, over the past 20 years there has been a persistent evolution of our general understanding of neuroscience. This understanding has been enhanced by better imaging technologies and anatomical studies.
That is how medical technology evolves: technology gets smaller, technology gets better. In my previous life as an interventional cardiologist, I witnessed those cycles on a yearly basis. Medtronic is the biggest medical technology company in the world. It has an intense group of engineers and manufacturers that constantly make the company's devices better, smaller, and more reliable. These enhancements are coupled with an increased understanding of the most complicated part of the body, the central nervous system, as well as growing populations of people who will suffer from neurological diseases. Therefore, growth in the neurological sector is inevitable.
How influential are the advances in clinical understanding in this area relative to the technological advances? Are they even-handed contributions moving forward at similar paces or is one leading the other?
The general philosophy of therapy and medicine has always been a dance between the improved understanding of the natural history of diseases, spanning from basic science to large-scale anatomical and pathological studies, to the clinical outcomes of studies that evaluate parallel technologies. One side aims to make new clinical discoveries, the other aims to develop solutions that might find a good fit with a new discovery.
There is a classic ebb and flow between the development of improvements in electronics and technology and improvements in the understanding of diseases. There are plenty of examples throughout medicine in which technology and disease understanding develop in tandem. For example, in neuroscience, our understanding of different connected networks within the brainparticularly the deep braincontinues to evolve. We have a greater understanding of how certain centers within these networks contribute to the overall function of the body, as well as how they malfunction in a disease state. As a result, we have a theoretical understanding of how stimulation of certain areas in the brain already discovered by neuroanatomists might alter the aberrant pathways in these networks.
These theories parallel the availability of small implantable devices that now can better target certain areas of the brain due to enhanced navigation techniques. So again, the dance between clinical understanding and technological advances goes back and forth. In order to stay on top of cutting-edge developments in the field of neuroscience and therefore improve the company's chances of making new discoveries in this area, Medtronic employs a significant number of neuroscientists.
In order to make use of new clinical discoveries, how important are continued technological advances?
They are critical. There are several elements that need to be in place in order to capitalize on clinical discoveries in the neurological field. One is having a strong track record in the continual development and improvement of technologies. If one thing is certain, it is that technology is going to continue to advance. Technological developments and improvements are inevitable; they are going to happen whether Medtronic is a player in the field or not. But we intend to position ourselves solidly in the mainstream to be part of that process. A second required element is a better scientific understanding of the way the body works. And a third element is an understanding of clinical research. Companies and scientists working in the field must understand how to interpret phenomena that have already been documented and how to design prospective studies to prove hypotheses. Medtronic wants to harness all three of these elements in order to make advances in treating disease.
How is clinical testing of proposed neuromodulation technologies carried out? Does it differ from clinical research in other medical fields such as cardiology, a field in which you are a known expert?
Ideas for new applications of new and existing technologies generally come from either physicians in the field or from technologists in industry. Physicians at universities or in practice often develop ideas for building a better mousetrap. They provide raw ideas that our company can develop, or they come up with new applications of our existing devices. We work on those ideas, filter them to determine which ones are good, and then move those along to the next stage.
Another way that ideas are brought forward is through a company's internal expertise in technology development. Often, Medtronic's technologists come up with solid ideas about how new technologies and concepts can be applied to medicine. We take these ideas back to doctors and get their input to gauge whether they are practical.
In short, ideas for new neuromodulation technologies are generated by both internal personnel as well as external university and nonuniversity physiciansand sometimes even patients. Such a cooperative effort is generally only seen in industries such as ours in which technologists, engineers, and scientists can all come together in a concentrated effort to formulate solutions.
Following the identification of a promising technological solution, our process requires a good deal of preclinical testing and bench work, followed by animal testing to show safety and efficacy. When we finally move to human trials, we do so with only the best physicians in highly controlled studies in order to provide the safest possible environments for patients who agree to participate in the studies. We closely follow regulatory requirements to ensure that every test we perform adheres to the most ethical and efficient pathway possible.
When conducting clinical trials, are you testing only the device or are you also testing the background research and the procedures that led you to identify the device as a potential therapy?
Every device-related therapy is a combination of the basic disease state of the patient, the operative procedure, and the device itself. It is difficult to distinguish the contributions of one from the other. When we begin testing a neuromodulation device for an application such as depression, we focus our observations on the change in the patient. We know the patient has a certain set of disease conditions, we know the patient received an operation, and we know that the patient received a device. However, especially early on in the evaluation process, it is generally not known how each of these three components contributes to the overall state of the patient. But if the overall effect is positive, we start to gain a more detailed understanding about how the device contributes. This enhanced understanding comes through controlled, randomized studies.
Medtronic's neuromodulation program includes a drug-delivery component whose core technology is an implantable pump. How do the device and drug components of Medtronic's businesses relate to one another? What is Medtronic's relationship to the drugs used in this type of therapy?
Drug delivery is a complex area. It offers targeted, more-regulated delivery of therapy, beyond simply distributing a drug through the gut. Drug delivery will likely play a significant role in Medtronic's future.
In regard to the actual development of drugs, so far as Medtronic's neurological division is concerned, we are mainly focused on the development of the machines that deliver the drugs, not the drugs themselves. Drug development is too big of a task for our division to bite off right now. There is an adequate number of biological and pharmaceutical companies already capable of developing drugs. Our division focuses on understanding how our devices can interface with such drugs and how we can develop novel ways of delivering those drugs. We think limiting the scope of our goals in such a way is appropriate.
So Medtronic is a licensee of the drugs it uses, not a developer?
Licensing is one of a variety of different models that the company uses to interact with companies that develop drugs.
Small Companies, Big Companies
Cardiology powerhouses Medtronic, St. Jude Medical, and Boston Scientific are each very interested in the field of neuromodulation. Is there a reason that cardiology companies would be first to leap onto the opportunities in this field?
We view ourselves as a medical device company. It just so happens that one of the most predominant medical device categories is implantable cardiology devices: pacemakers, defibrillation devices, and coronary stents. Medtronic pioneered the neurodevice arena. In light of its success, it is not surprising that other major competitors also want to enter the market.
Earlier, you mentioned the pacemaker platform being used in neurostimulation applications. Do companies with expertise in cardiology have a leg up on the technology involved in the neurological sector?
Medtronic's history in pacing does provide the company with a strong platform for developing new devices.
Most of Medtronic's efforts in the neuromodulation field have been homegrown, but other major players in the field have been active on the acquisition side. When Medtronic surveys the field of neuromodulation, does it see mostly competitors or also potential acquisition targets?
Philosophically, we see acquisitions as a way to augment our footprint in markets in which we can add value and in which we have core competencies. We don't make acquisitions simply to increase the scale of the business.
Are you active in funding small companies through venture capital?
Yes. Medtronic has minority investments in many companies. They're all listed in our 10-K. For a company the size of Medtronic, it is responsible to maintain such a position with small-cap companies.
It is often said that small companies are the engines of medtech innovation. But in this field, large companies are already moving in to take up the opportunities. In such an environment, can small companies compete and develop new technologies?
I cannot provide a blanket yes or no answer to that question. There is a lot of room in the neuroscience area for the development of clever solutions. The neuro sector is a sophisticated sector with sophisticated diseases. There are a lot of diseases out there, and they affect a lot of people.
Neuromodulation has the potential to offer a lot of solutions that have yet to be discovered, and there are opportunities for companies both big and small to develop such solutions. The barrier faced by small companies is that they may lack the horsepower needed to develop the solutions. And if they are able to overcome that hurdle, they may lack distribution capabilities once they enter the market. Companies that have greater resources and better distribution channels have a leg up.
That is often the case for small medtech companies when they reach the stage at which they are beginning to market their products. But in regard to the earlier stages of development, do you sense that there is significant innovation taking place in small companies? Do they have access to the clinical information that is being used to generate new ideas in the neuromodulation sector?
As a large company, Medtronic has several ongoing internal projects in this area at any given time. On the other hand, most small companies focus on one project. So there are projects out there beyond what the big companies are doing that have a lot of potential. But small companies rarely work on more than one project. Medtronic's projects have the same level of niche focus, discovery, and interest as the smaller companies' projects. Medtronic just has more of them.
The Clinical Opportunities
Many diseases have been identified as important targets for neuromodulation therapies, including Alzheimer's disease, depression, epilepsy, pain management, Parkinson's disease, urinary incontinence, and schizophrenia. What can you tell us about our current understanding of each area and how the medtech opportunities are gradually being revealed?
One of Medtronic's core competencies is in understanding technology opportunitieswhere they are and where they aren't. The company also has the capabilities needed to interpret intellectual properties being developed both internally and externally and determine what the likelihood is that they will have applications for patients in the coming years. Medtronic has developed a critical mass of this type of internal expertise.
In terms of the current understanding of neuromodulation applications in the brain, we have a relatively good grasp on how to treat common diseases that fall under the classification of movement disorders. There is a consensus on the anatomical structures and their functions within the deep brain that are involved in the movement network. We've demonstrated reproducibility in how these structures respond to stimulation, and as a result, we think that neuromodulation has profound, consistent impact on diseases such as Parkinson's. Patients in advanced stages of the disease who have had complications with other forms of therapy have responded positively to neuromodulation treatment. We think neuromodulation has also shown clear-cut and straightforward results in treating essential tremor and dystonia.
Another area where neuromodulation is showing promise is in the treatment of epilepsy. There's less evidence here than there is for movement disorders, but we think this is an opportunity on the cusp. Beyond that, we think there are other areas in which there is enough preliminary evidence to raise our eyebrows to the point where we want to invest in further research. Such areas include headaches, pain, and depression. The preliminary data look strong, but the research in these areas is far from producing solid evidence.
In the therapy areas that I've mentioned, the hypotheses are consistent enough with other applications for deep brain stimulation that they warrant Medtronic's involvement in studying the applications at a more serious level.
As you've mentioned, there are a host of other applications that scientists have raised as possible areas in which neuromodulation may be effective, such as Alzheimer's disease and schizophrenia. Medtronic recognizes that such applications could be promising, but we do not think there is enough good, solid clinical evidence to make any positive statements. But the diseases are so broad and affect so many people that the company obviously has a huge interest in trying to understand whether there is an application for deep brain stimulation. But at this point, the question is only theoretical in those areas.
There is also tremendous promise in certain areas of the brain for local delivery of drugs and gene therapy. Some diseases for which these therapies show promise include Huntington's disease and Parkinson's disease. But again, we are in the very preliminary stages of looking at therapies in these areas. These are applications for which we have available technologies with theoretical promise but no solid clinical evidence yet. But the opportunities are still on Medtronic's radar screen.
Are all of the applications you've mentioned related to deep brain stimulation?
All of these are treatments within the cranium. Medtronic has a broad interest in all applications of neurodevices within the cranium. Some applications and technologies are wholly owned and organically developed by companies such as Medtronic. Others present potential partnership opportunities, and our company is actively evaluating how we can work with outside entities to develop projects that are still in preliminary stages. And, of course, we continue to keep an eye on and communicate with companies operating in other areas in neuromodulation that are separate from Medtronic's core focus.
Aside from putting a therapy in place and seeing how it affects patients, what kind of diagnostics can be used to evaluate deep brain stimulation? Are there imaging technologies that can determine the effects of therapy on particular parts of the brain?
Medtronic uses sophisticated imaging techniques and three-dimensional navigation software that the company developed internally to navigate devices to the proper parts of the brain.
Is there a way to noninvasively monitor the ongoing effectiveness of neuromodulation?
There are two parts to this monitoring. First, we monitor the implant procedure to ensure the leads are inserted in the right place within the brain. That is done by monitoring the electrophysiological signal in the brain while the procedure is being performed and also by mapping the location of the leads using three-dimensional software on images acquired by computed tomography and magnetic resonance imaging. That is the navigational part.
As far as noninvasive monitoring following the procedure, we may use imaging techniques on some patients to confirm the location of the leads, but that is usually the exception to the rule. Usually the level of accuracy in lead placement is very high.
So the key in determining whether neuromodulation therapy is successful is the alleviation of symptoms rather than what is visible on a scan.
Before receiving deep brain stimulation, patients undergo various screening processes to make sure they are appropriate candidates. During the implantation procedure, precise imaging techniques are used to navigate the devices to their precise locations. This process is also confirmed through electrophysiological testing, which tells us whether the leads are in the right spot in the brain. In light of the prescreening and placement confirmation procedures, the success rate associated with neuromodulation is extremely high. Symptoms are relieved, and many times this relief can be confirmed during the operation itself.
Have you been surprised by the directions of new research, or by the results of particular studies?
I am not so much surprised as I am amazed and hopeful. The preliminary results of treatment for depression and obsessive-compulsive disorder with neuromodulation are exciting due to the promise that's been shown.
On a more fundamental level, it's fascinating that we can use devices to treat psychiatric diseases. The gap between psychiatry and neurophysiology and anatomya gap that has been evident for several hundred yearsis starting to close. The goal of treating psychiatric illnesses by making alterations to the anatomy of the brain or its chemical function has been a pipe dream for a couple hundred years. But over the past couple of years, most people have started recognizing that our psychesincluding psychiatric illnesses and psychological thinkingare derived from the actual substance within our craniums.
Over the last 30 or 40 years, neurosurgeons have made some progress in restoring normal functions of the brain through the discreet destruction of certain brain elements. But such progress isn't fully satisfying because it requires destruction of brain tissue. So it is exciting that we are discovering that stimulation of certain pathological parts of the brainor other parts that defeat the pathological problemscan lead to useful therapies. The discovery is at its earliest stages of understanding for obsessive-compulsive disorders and depression. And that is fascinating.
Is device therapy establishing itself as playing a stronger role in treating neuropsychiatric diseases than might have previously been expected?
It is too early to say. We hope that devices will play a big role in helping patients that suffer from such diseases. Major psychiatric illnesses are some of the most devastating illnesses in regard to how they affect people's lives. They contribute to the greatest levels of disability, they contribute to the lowest levels of quality of life, and they produce some of the most significant pain and suffering in society today. So we are extremely hopeful that Medtronic will be able to contribute to solutions for such diseases. The preliminary data suggest there is reason for such hope, but we do not have enough data yet.
One thing is for certain: No matter what Medtronic develops in the way of neurological devices, none will be a sole therapy for the treatment of psychiatric illnesses. Every development will help enhance other therapies, including psychotherapy and drugs. There might be a substantial reduction in the need for these two therapies, but I doubt we will see a total solution within a device.
One driver in many medical device sectors is the aging population within the industrialized world. Given that some of these diseases are related to aging, how would you gauge the pace of the clinical and technological developments in neuromodulation? Are we going to achieve the necessary developments and solutions before the baby boom generation needs them?
That is a hard question to answer because it requires multiple assumptions. We know that improvements in healthcare are leading to an increase in the mean age of patients. A higher proportion of patients are living beyond 70, 80, even 90 years old. We know that these people will have a higher incidence of dementia and a higher incidence of other neurodegenerative diseasesthat's certain.
Currently, we know that we can offer solutions for the treatment of Parkinson's disease, which is a neurodegenerative disease. We currently have a pretty good treatment option for advanced Parkinson's disease--one that reduces symptoms substantially. That technology is relatively well developed and should offer a treatment option for aging baby boomers.
In the case of Alzheimer's and other diseases, we are doing as much as we can to understand the symptoms and gauge whether there is an appropriate technology solution. We currently do not have an option for Alzheimer's disease, and I have no idea as to whether we will have one by the time this disease is at its peak within the baby boomer generation. We hope solutions can be developed, particularly as the incidence of Alzheimer's is expected to increase, but we do not know for sure whether this will happen.
Solutions for degenerative diseases such as Huntington's and others are in a development phase somewhere in between the significant progress we've made with Parkinson's and the very preliminary progress being made on Alzheimer's. Solutions for Huntington's disease have yet to reach the level of those for Parkinson's disease.
In addition, depression is somewhat related to age. There is a higher incidence of depression among older people. We have some preliminary evidence for a treatment that looks promising. But again, there is no certainty. We have to conduct more studies. But if further studies pan out the way we hope they will, a solution will be available for at least for some of the people who suffer from the most severe forms of depression.
How would you rank the funding available to researchers in the field relative to the opportunities? Is there enough to maintain the optimal pace?
If we had unlimited funding, we could put 100 people on each project and move the device development as quickly as possible. But that is impossibleno company can afford that. So like other companies, Medtronic constantly struggles with investing as much money as possible in developing a new technology but at the same time staying solvent. Judging by Medtronic's financial performance, I think the company achieves a very healthy balance. The company spends about 10% of its revenue on research and development, which is very high for a device company. The company is dedicated to putting a lot of its revenue back into research and development for therapies.
What is the current reimbursement policy for these technologies and what will it look like down the road?
It is impossible to forecast reimbursement policy. All we can do is look at guidance from the Centers for Medicare and Medicaid Services (CMS). So far, CMS has been very fair in its reimbursement for Medtronic's treatments. Under the current reimbursement policieswhich are only applicable for the next couple of years due to the regular changes made to these policieswe think we will be able to continue to manufacture these devices and still do some research.
Do you work with any specialty societies to move products to standard of care and to develop a rationale for reimbursement?
We work with societies closely to make sure we understand what physicians need. Their input also provides us with an understanding of which patients we can help and in which areas we should place our emphasis. That describes our main interactions with societies.
Cost-effectiveness and pricing models are developed mainly by Medtronic's marketing and pricing groups. Recently device companies, including Medtronic, have started placing an emphasis on gathering data related to cost during clinical trials. That new emphasis is being driven by societal demands. Medtronic wants to continue to demonstrate that its devices are worthy of their price. Medtronic's studies all have cost-effectiveness components because it is important to show people that these devices are a bargain and make sense financially. That is why we employ state-of-the-art cost studies.
How a company sets prices and how it works with CMS is not completely dependent on demonstrating cost-effectiveness. As in many other areas, a balance is struck among a variety of healthy tensions. Payers want to pay less, and companies want to make enough money to conduct research and stay on top of technology developments.
In what areas do you think the earliest breakthroughs are likely to develop? How long will it take to make them happen?
Deep brain stimulation is a breakthrough area, and it may also be a disruptive area. We currently have treatment options for three movement disorders, and these options represent a gateway to potential new therapies in the future. I am very bullish that improvements in our technology, better navigation techniques, and a wider understanding about how the brain works will lead to a wider application of deep brain stimulation. This platform will help patients who suffer from a variety of diseases.
Another breakthrough area is in drug delivery. The use of drug delivery outside the gut and in targeted organs to deliver more-regulated drugs, proteins, and hormones is an important breakthrough therapy area in which I think we will see great advances relatively soon.
In addition, neuromodulation applications within the spine, focused on the intrathecal space and the epidural space, will continue to evolve. In the future, we will start to use better, more-target-specific therapies for patients who suffer from cerebral palsy, pain, and possibly even stroke. These therapies will become more refined over time. These are the areas Medtronic will continue to explore.
What I've described above is an overview of the opportunities in neuromodulation. Beyond that, I think Medtronic's neurological division is based on an emerging therapy platform. The platform is relatively new, and future developments will include exciting therapies. However, this platform is not stable. It is not like the category of coronary stents. The industry knows how coronary stents work, and the current advances in these devices are focused on better delivery and lower rates of restenosisgoals that are already being achieved. Although incremental advances are worthy and necessary endeavors, developments in such therapies are not going to be as remarkable as those in neuromodulation.
You mentioned the spine area. What is the relationship between the fields of neuromodulation and orthopedics? Is your division working closely with any companies in that area?
Medtronic doesn't have a business unit that deals exclusively with what is classically called orthopedics, meaning artificial joints, limb salvage, and other bony treatments. Our neuromodulation group does not really have any relationships with other orthopedic companies of that sort.
However, we are developing a strong relationship with Medtronic's spine division, formerly Sofamor Danek, the largest spine company in the world. It was acquired by Medtronic about six years ago, and has been fully merged with Medtronic's broader corporate culture. As the company has become more integrated, more relationships have been forged between our business units to identify common ground. We think there is a lot of potential synergism between our division and the spine division, which provides treatments for bony spine disease.
We have very similar distribution channels with respect to our customers. In some instances, both entities offer treatments for similar conditions, such as lower back painour division uses neuromodulation, the spine division uses surgery. So there is a lot of overlap, and there is a great opportunity to capitalize on these synergies.
When two separate internal units work together in the way you describe, how do they relate to one another?
There are no solid rules, and every company works differently. Medtronic has a lot of cross-communication among its business units. Its culture encourages interaction among business units. For efficiency, the divisions operate as separate business units, but the value of Medtronic as a whole is represented by the collection of these business units and their interactions.
The interactions among the neurological division and others have grown stronger. It is not unusual for me to talk to several people from other business units every week. For example, the neurology division has a lot of crossover with Medtronic's diabetes unit. That unit has dominated the market for insulin pumps. Hands down, that unit has the most experience with insulin pumps of any company in the world. It's a tremendous opportunity for our division to be able to work with that unit's technology in developing our own pump technology.
Where do you think the field of neuromodulation will be a decade from now?
Neuromodulation is an umbrella term used to refer to both electrical stimulation and the delivery of drugs to the central nervous system. Without a doubt, this field will be stronger in a decade; that is a given. Neuromodulation is here to stay.
Medtronic's competitors in this sector will continue to grow as well. The field will expand, providing more solutions for more patients. There is no question that will happen.
In terms of areas of expansion, we hope to expand our treatment of diseases for which we already offer solutions. We want to help more patients with Parkinson's disease. We want to help more patients with essential tremor and dystonia. There's no question that we want to further develop these areas. We are not satisfied with the current levels of patients being treated in these areas. We want to gain a better understanding of the diseases and be able to help more patients who suffer from those diseases.
As far as new applications we are looking at, we are hopeful that this might have an impact on patients who suffer from psychiatric diseases such as obsessive-compulsive disorder, and we hope to develop a proven therapy for patients who suffer from treatment-resistant depression. A lot of our division's resources go to in research and development. There are at least 20 to 40 new areas in which we are actively exploring potential neuromodulation applications. We've discussed some of them, but the areas we're exploring right now are too numerous to list. Some of the areas are showing promiseand we'll continue to expand our research effortsbut due to my background in clinical research, I tend to be a skeptic until I see all of the data associated with a new treatment.
Do you think neuromodulation will be a larger part of Medtronic's overall business a decade from now?
I think it will be. We plan to grow our division aggressively over the next five to 10 years. Neuromodulation is going to be an application that will help a lot of patients. It's impossible to gauge what proportion neuromodulation will represent in the context of Medtronic's overall corporate structurewhether it will represent a larger or smaller proportion than it does now. Medtronic has other business units that also have huge growth potential. But I know our division is going to grow.