Nov 142012
 

The Israel Brain Technologies (IBT) has announced the launch of one-million US$ B.R.A.I.N. Prize (Breakthrough Research And Innovation in Neurotechnology) to support the development of a disruptive and medically significant neural technology toward its commercialization. An international judging committee, composed of distinguished leaders in neurotechnology and business including two Nobel Prize Laureates, will select an individual or a group from across the globe to support continued development and commercialization of the technology in collaboration with Israeli researchers and entrepreneurs. The applicants must have already produced a working prototype and be able to demonstrate a clear path to commercialization.

“The B.R.A.I.N. Prize will bring together the best minds across geographic boundaries to create the next generation of brain-related innovation, from Brain Machine Interface to Brain Inspired Computing to urgently-needed solutions for brain disease,” says Dr. Rafi Gidron, Founder and Chairman of IBT. “It’s a global brain-gain. Our aim is to open minds…quite literally.”

“We invite innovators around the world to enter the B.R.A.I.N. Prize competition, so we can tackle some of the most exciting challenges facing our planet,” said IBT Executive Director Miri Polachek. “Our aim is to bring Israeli technology to the world, and the world to Israeli technology. We want to turn the ‘Start-up Nation’ into the ‘Brain Nation.’”

In the words of Israeli President Shimon Peres, a leading proponent of brain research and technology. “There is no doubt that brain research in the next decade will revolutionize our lives and impact such major domains as medicine, education, computing, and the human mind, to name but some. Moreover, it will not only relieve the suffering of patients of such debilitating diseases as Parkinson’s and Alzheimer’s, but it will also engender large economic rewards as well.”

Prize winners could, for example, help treat neurological disorders like Alzheimer’s, Parkinson’s, depression, PTSD or even sports-related brain trauma. Or they could create the next cutting-edge brain-inspired technology that will alter our day-to-day lives.

Interested contestants can visit www.IsraelBrain.org to receive more information and to apply online. The submission deadline is March 15, 2013, and the Prize will be awarded at IBT’s International Brain Technology Conference in October 2013.

Sep 292012
 

Earlier this year, the National University of Singapore (NUS), Singapore’s Agency for Science, Technology and Research (A*STAR) and the Ministry of Defense joined their efforts in establishing the SINAPSE: Singapore Institute for Neurotechnology.  With the initial funding of 20M SGD (~16M USD) and allocated space of 1000 square meters in the NUS Center for Life Science, the newly-formed institute already has 5 primary and 5 affiliated faculty members as well as 10 postdoctoral fellows and research assistants.  The Institute’s director is Prof. Nitish V. Thakor, who is also the BME professor at Johns Hopkins University, Editor-in-Chief of IEEE Trans Neural Rehab Eng, and founder of 3 startups.  The SINAPSE institute has specific interest in the development of peripheral and central neuroprosthetics, neuromorphic systems and neurochips, and other research areas in clinical and cognitive neuroengineering. The director’s over-arching vision is to create the environment for interaction among basic scientists, computational scientists, experimentalists and clinicians, engineers, innovators and entrepreneurs. Prof. Thakor is presently in a recruitment mode, aiming during the next 1-2 years to hire 4 additional faculty members and 10 postdocs, essentially doubling the institute’s manpower. He is looking for researchers that pursue clinically-applied brain research, technology development, and commercial translation of devices. For detailed job offerings, please visit the NTZ Jobs page and the official SINAPSE site. If you plan to attend our ICNPD-2012 meeting in Freiburg, Germany this November, you can stop by SINAPSE’s booth and discuss the job requirements and benefits with Prof. Thakor.

May 302012
 

The FCC recently allocated a dedicated RF spectrum for Medical Body Area Network (MBAN) technologies. The MBAN spectrum can be used for low-power and short-range medical applications as well as other, perhaps unprecedented, uses in consumer electronics, personal entertainment, gaming, sport training, and social network applications. The transmitting/emitting devices can be implanted or placed on the surface or around the body of humans (or animals). The MBAN adheres to IEEE 802.15.6-2012 standard and supports the data rates up to 10 Mbps. The allocated frequency bands include 402–405, 420 –450, 863 –870, 902 –928, 950 –956, 2360 –2400, and 2400 –2483.5MHz. Creation of the MBAN spectrum has been driven by the “last meter” challenge of untethering the patient from the bedside monitoring and treatment equipment. In addition to the bedside applications of MBAN spectrum, the neural interface devices are also likely to benefit from the new bandwidth. MBAN can spur the development of novel data-intensive neural interfaces, ranging from EEG and ECoG to cochlear and retinal implants. The newly-allocated bandwidth can be readily utilized for sending the wide-band neural signals from hundreds of recording electrodes or for sending the control signals to hundreds of stimulation electrodes. Use of the bandwidth reduces the need for incorporating the multiplexing and signal-processing circuits inside the implantable device and, instead, sending the raw data to an external controller, such as a body-worn smartphone-like device. My personal hope is that simplification and standardization of the implantable electronics will lead to the considerable price reduction and eventual emergence of consumer-oriented implantable neural interfaces for non-medical use.

May 242012
 

One and a half years ago, NeuroTechZone reported on initial success of subretinal implants from the Retina Implant AG in three retinitis pigmentosa (RP) patients from Germany. The international multi-center phase of the clinical trial with the wireless implant Alpha-IMS was initiated in late 2011, involving two additional sites in Germany, two sites in London, UK and one site in Hong Kong, China. Altogether, 26 patients have received subretinal implants in the trial. The first two UK patients with RP were implanted in April 2011 and the UK doctors are recruiting additional 10 patients. The first Chinese patient was implanted on February 2012, with two more to follow. Additional sites in Hungary, Italy and the United States will soon join the trial. The data from recently implanted patients indicate a restoration of useful vision in daily life. Many of them experience visual perception in both dim and bright environments. Some patients have reported the ability to see objects 30 feet away and to read numbers on a pair of dice. Unexpectedly, one of the British patients reported having dreams in color for the first time in 25 years since becoming blind.

Mar 182012
 

A few months ago, our blog post discussed a possibility of direct-to-consumer neurotech devices reaching the market in a near future. Among available brain stimulation techniques, transcranial direct-current stimulation (tDCS) is a fairly simple non-invasive method for cortical stimulation. A recent study, conducted by researchers at the University of New Mexico, seems to support the cognitive-enhancing effect of the technique. Learning and performance in a shooting video game was increased two-fold following 30-min tDCS as compared to control, even after one-hour delay. Other studies found beneficial tDCS effects on working and visual memory. Capitalizing on the enthusiasm generated by these studies, the website GoFlow is planning to offer a DIY kit for tDCS with a price tag of $99! Understandably, the kit is very bare-bone, and includes only a battery, a few scalp electrodes, resistor, and a potentiometer.  I would venture to guess that the kit would attract avid brain-hacking enthusiasts and perhaps some students desperately trying to memorize the material before the exam. For the rest of us, let’s wait for a more mature product to hit the shelves.

Mar 092012
 

In order to use a medical device in the US, a device manufacturer has to get an approval from FDA. Invasive devices, such as neural implants, are classified as Class III and can be approved in one of two ways: 1) a comprehensive “de novo” Premarket Approval (PMA) or 2) a streamlined 510(k) clearance, also called a Premarket Notification (PMN), when the device is “substantially equivalent” to an existing approved device. The complete device development and approval process takes 4-10 years and costs $5-300 million depending on the complexity of the device and FDA approval process. Approximately 40 PMAs and 3,000 510(k) clearances are approved each year by the FDA.

Cortical and spinal neural implants are among the most invasive and, therefore, always require a PMA approval. In comparison, the “Cranial Electrotherapy Stimulator” (CES) devices, are implanted under the scalp and pose fewer surgical risks. Until recently, they required only a 510(k) clearance, and such relaxed approval process resulted in their multiple applications for neurological and psychiatric disorders, such as anxiety, depression, insomnia, chronic pain, and migraine.

In August 2011, FDA proposed a new rule to require PMAs for CES devices, and the device makers responded by proposing instead that the devices be given less stringent Class II status, which often does not require PMA approval. In February 2012, the Neurological Devices Panel of the Medical Devices Advisory Committee at the FDA advised against such downgrade, so the CES devices would still require a lengthy and expensive PMA process. According to recent estimates, an average PMA approval process would take ~27 weeks and would cost the CES device makers an additional $1 million, as compared to 510(k).

Feb 172012
 

In recent years, the medical manufacturing company Greatbatch Inc. has made several steps indicating its ambition to become a major player in the neuroprosthetic device arena, currently dominated by Medtronic, St. Jude, and Boston Scientific. Until recently, Greatbatch’s two subsidiaries, Greatbatch Medical and Electrochem Solutions, were mostly known for producing the pacemakers, vascular catheters, orthopedic implants, leads, and batteries. The company does not market any neurostimulation devices, although several other manufacturers use Greatbatch’s batteries and leads in their neuromodulation implants (e.g. obstructive sleep apnea device by Inspire Medical). In fact, 95% of all pulse generators worldwide contain at least one Greatbatch’s component. In 2008, Greatbatch created the QiG Group, its third subsidiary, with a goal of making targeted investments in innovative cardiovascular catheters and neuromodulation devices. Last year, QiG has started the Algostim brand of spinal cord stimulation devices to treat chronic pain, The QiG has also invested, along with Boston Scientific, into Intelect Medical, an early-stage company developing deep brain stimulation devices for traumatic brain injury, and stroke. And most recently, on February 17, 2012, Greatbatch’s QiG Group announced its acquisition of NeuroNexus for $12 million. Dr. Daryl Kipke, NeuroNexus President and CEO, indicated that its technologies would be used to develop novel “neuromodulation clinical therapies”. It remains to be seen whether the Greatbatch’s definition of “neuromodulation” will be modified, as the key NeuroNexus technologies, the high-density silicon-based electrodes and their interconnects, are more suited toward neuroprosthetic rather than neuromodulation therapies. But, in any case, this news brings us one step closer to a long-awaited clinical trial of probes developed using the semiconductor microfabrication technologies.

Oct 232011
 

As documented in other posts on this blog, mutliple neural prosthetic devices are currently being developed by startup companies throughout the US, Europe, and Asia. Practically all of these startups are pursuing the well-established R&D strategy of building a device to treat a specific neurological disorder and going through a lengthy process toward eventual FDA approval and reimbursement by private and government-run health insurance companies. In following with this R&D strategy, the resulting device is usually fully implanted and contains only the circuitry needed for its primary function to treat a specific disorder. The device is designed for autonomous operation without user accessibility, and any device’s software tuning/upgrade requires a physician and specialized clinical equipment. These features are aimed at limiting the manufacturer’s and surgeon’s liabilities.
Here, I would like to propose a possibility of developing the consumer-oriented neural interfaces. Such a strategy is inspired by recent developments in the consumer electronics industry and, particularly, by a wide adoption of body-worn health monitoring gadgets (such as a sleep sensor Lark, EEG monitoring device Mynd, and muscle stimulator Compex). The proposed new strategy requires a fundamental shift in the user attitudes toward body-worn neural interfaces. Instead of treating the neural interface as a “band-aid” for restoring the lost or damaged neurological function, the users would treat the neural interface as a sensory or motor extension of their existing own nervous system. The following table illustrates the key attributes that differentiate a conventional neurological treatment device from a consumer-oriented device:

Attribute Conventional device Consumer-oriented device
Usage Repair of lost/damaged neural functions Enhanced use and preventing the decay of existing neural functions due to Alzheimer’s
Customer Hospital, doctor End user
Reimbursement Health insurance company End user
Implanted components Electrodes, active electronics Electrodes only (minimally-invasive placement)
Body-worn interface (BWI) Telemetry for battery re-charging and data input/output User-controlled multi-purpose graphical computer interface
Placement of BWI Inconspicuous or hidden from view Prominent
Operation of BWI Primarily by a physician By the end user
Communication with other devices None (standalone use) Standard wireless protocols (Bluetooth, WiFi, 3G)

 

As can be seen in the table above, the fundamental changes in the R&D strategy relate to every aspect from the device marketing to its configuration, operation, and user control. The reduced complexity and size of the implanted device are crucial for allowing a minimally invasive implantation that can be performed by a neurologist (rather than a neurosurgeon) in an outpatient clinic. Fabrication of a simple implantable device combined with a simple surgery can dramatically reduce the overall user cost (perhaps to a sub-$10,000 level) and therefore make the devices applicable for non-medical applications, such as memory improvement, cognitive training, and around-the-clock personal assistance.

Continuing the parallel with the consumer electronics, let’s think for a moment about our computer use just 10 years ago. The computers back then could serve specific functions, such as data entry, word processing, accounting, etc. Our everyday lives, however, have been rather “un-tethered”, as we lived our lives oblivious to a possibility of having constant access to our email inbox or a Facebook status. There is no denying, that we are evolving into a new social species, the “homo twitterus”, with the reported ~60% of smartphone users waking up voluntarily during the night to check their messages. Let’s compare that with our evolving attitude toward the neural interfaces.  In the classic SciFi movies Star Trek: First Contact (1996) and The Matrix (1999), a images of the brain and spinal interfaces were positively repulsive. A decade later, in the movie Tron: Legacy (2010), the Identity Discs worn by the Grid inhabitants, prominently featured on their back, appear rather attractive and stylish. The public interest in the consumer-oriented neural interfaces may start initially among the techno-gadget aficionados and gradually spread to general population. Similar evolution has occured with the computer use and has now reached the stage where pure functionality and low cost of the device are no longer as important as its esthetic, social-status, and “coolness” appeal (think of Apple’s Macbook Air, iPad, and iPhone). While many Android phones are arguably more feature-rich and less expensive than iPhone 4S, Apple Inc. is enjoying robust growth by strengthening its deep personal relationship with customers and by changing their lifestyle in a profound way. The proposed consumer uses of neural interfaces can bring such device-user relationship to a whole new level, with the person’s everyday life being dependent on bidirectional exchange with their body-worn personal assistant. A rich virtual environment provided by the neural interface can be used, for example, by retired baby-boomers for muscle exercise and rehabilitation; memory improvement and cognitive fitness; and learning of visual and motor skills (e.g. golf, tennis, driving). Many other applications, perhaps even more pervasive and lifestyle-changing (such as novel sensory/motor modalities), could emerge as the neural interface technology takes hold in the society.

Oct 202011
 

As the number of people with Alzheimer’s disease (AD) is rising with aging population, there is an increasing urgency in developing an effective approach to slow its progression. Despite the efforts by pharmaceutical companies, currently approved drugs provide only modest effects and are often difficult to target to the brain without avoiding the systemic side effects. A possibility of using electrical stimulation for combating the disease has not been considered until a serendipitous discovery reported in 2008 by Dr. Andres Lozano, a neurosurgeon at the University of Toronto. He applied the DBS stimulation at the satiety-controlling region of the brain, the fornix, in a patient with morbid obesity with a hope of reducing the sensation of hunger. Surprisingly, the psychological tests have shown a significant improvement in patient’s memory. The follow-up study in AD patients, published in 2010, showed that the fornix stimulation can slow the memory decay. The authors of the study speculate that possible mechanism of action involves plasticity in the limbic circuitry counteracting the AD-related neurodegeneration. As a result of these findings, a startup company called Functional Neuromodulation Inc. was formed in 2010 to commercialize the DBS use in the fornix for AD patients. It recently obtained funding from Genesys Capital and Medtronic to conduct the second clinical trial in the AD patients. It is worth mentioning that other companies, such as Medtronic and St. Jude Medical, have considerable intellectual property on electrical stimulation of other limbic areas, such as the anterior thalamic nucleus, internal capsule, and subgenual cingulate cortex, which may also play an important role the memory formation process. We will anxiously await further developments in the use of DBS to counteract the progression of AD.

Sep 292011
 

Kip Ludwig, who was recently appointed as program director in repair and plasticity at the NIH National Institute for Neurological Disorders and Stroke, will deliver the keynote address at the 11th annual Neurotech Leaders Forum, which will take place in San Francisco on October 17-18, 2011. Ludwig will offer attendees his views on his new role with the NIH and how it impacts the neurotechnology industry.

Ludwig received his Ph.D. in Bioengineering at the University of Michigan, followed by post-doctoral work at the same institution. More recently, Ludwig worked in industry at CVRx as a research scientist, where he and his team conceived, developed and demonstrated the chronic efficacy of a next-generation neural stimulation electrode for reducing blood pressure in both pre-clinical and clinical trials.

The 2011 event will also feature an in-depth session on reimbursement issues affecting neurotechnology manufacturers in light of new health care reform legislation.

Venture capital professionals Heath Lukatch of Novo Ventures, Paul Grand of RCT BioVentures, Mikhail Shapiro, formerly of Third Rock Ventures, and Jonas Hansson of HealthCap in Sweden will participate. Other speakers include Don Deyo, vice president of R&D at Medtronic Neuromodulation, medical device reimbursement expert Tom Hughes, and Victor Pikov of Huntington Medical Research Institutes.

The 2011 event will feature a first-ever Consumer Neurotech Conference on October 18, the second day of the event. The full-day meeting will include sessions on neuromarketing, gaming, training, and cognitive enhancement applications of neurotechnology. Companies represented on the agenda include EmSense Corp., NeuroSky, Inc., and Technology Partners. Victor Pikov will also speak on neural interface lifestyle issues.

For more information on the 2011 Neurotech Leaders Forum, including sponsorship opportunities, call 415 546 1259.

Aug 272011
 

One does not need the future-telling skills of Ray Kurzweil to predict the rise and eventual dominance of China in manufacturing of neurotech devices. Outsourcing of medical device manufacturing to China has been on the rise in the last few years as evidenced, for example, by a reduced US export-import surplus for medical devices from $6 billion in 2005 to $3 billion in 2010 (according to US officials), of which $1.2 billion is the trade surplus with China. The market for medical devices in China is at $14 billion and is projected to double by 2014. The rise in China’s medical device market is fueled by an ongoing government-funded healthcare reform ($123 billion over the next four years), which aims, among other things, to make medical devices affordable by subsidizing their domestic manufacturing. The importance of such governmental  subsidies can be illustrated by the stunning revelation that in 2008 the number of cardioverter-defibrillator implants in China was fewer than 700 compared with 100,000+ implants annually in the United States.

Unlike the biomedical device industry as a whole, the implantable neural device industry has so far been resilient to migration to the land of rising dragon from its birthplaces in the US, Europe, and Australia. There are multiple reasons for that, which perhaps could be better explained by an economist. In my view, there had been two key obstacles: 1) assuring the regulatory conformance of the China-assembled medical device in the western countries; and 2) poor protection of intellectual property rights in China, making western device makers uneasy about sharing their fabrication secrets with Chinese subsidiaries. Both of these obstacles seem to be melting away. The regulatory conformance is rapidly improving as more reciprocal agreements are being ironed out between the US FDA and its Chinese counterpart, while inadequate IP rights protection no longer stops the leading electronics companies, such as Apple and Sony, from manufacturing their cutting-edge devices (e.g. iPhone, iPad, and PlayStation) in the Foxconn’s Chinese factories.  

With gradual dissolution of the economic barriers, we are now faced with a barrier of a different kind: an acceptance of the level-playing field in the emerging global medical device market. When Terry Gou, the CEO of Foxconn (the largest exporter and largest private employer in China), first approached Steve Jobs, the Apple’s CEO, he had to force Mr. Jobs to give him his business card. Now, a decade later, the relationship between the two companies has evolved from a contract manufacturing to a strong and dedicated partnership, with Foxconn being a main producer of iPhone and iPads. One can hope that a similar transformation is taking place in the mindsets of leading implantable neural device makers. China has recently begun fabrication of its own cochlear implants and DBS devices. The production rate of these domestically-made devices is not high enough to compete with large multinational companies, which still control 90+ percent of the Chinese market.

In anticipation of a looming challenge, the multinationals are expanding their operations in China. For example, Medtronic reported the opening a patient care center in Beijing in 2010 and its new regional headquarters in Shanghai earlier this year, with plans to double its workforce in China to 2,000 employees by 2015 (while reducing the same amount of workforce in other countries). Similarly, Boston Scientific announced a five-year, $150 million investment in China, including the construction of new manufacturing and research facilities and addition of 1,000 workers to the current 200. Following in the footsteps of its competitors, St. Jude Medical announced the opening of an R&D center in Beijing along with a manufacturing facility and training center in Malaysia. It makes sense for the neurotech device industry to embrace the Chinese emerging economy to utilize its consumers, labor, and innovation. According to this report from the Economist, Chinese R&D centers have already developed some innovative medical devices with a price tag one tenth of comparable products in the West. There’s no doubt that we’ll be seeing even more innovation from and investment in China’s neurotech industry. And with more than 1 billion of human capital at hand, it is easy to imagine the potential.

Jul 292011
 

The 2011 meeting of the International Neuromodulation Society, which took place in London, England in May 2011, featured a large number of oral and poster presentations offering updated technical and clinical information on neuromodulation topics. There was also a full day of sessions devoted to commercialization, investment, and industry issues affecting neuromodulation startup firms.

But as is the case with many meetings that draw attendance from different fields of endeavor, there was as much to learn from the informal scuttlebutt going on between sessions as there was from the posters and oral presentations themselves. We offer here some of our observations based on random comments from attendees.

After the Sunday session on future innovations in neuromodulation, some attendees were perplexed by Greatbatch Inc.’s efforts to launch a new spinal cord stimulation device company, called Algostim LLC. Given that Greatbatch supplies components such as batteries and leads to many manufacturers of implanted neurostimulation systems, it raised the question as to why Greatbatch would want to compete with its customers. Greatbatch CEO Tom Hook made the case that by incubating new device startups that will eventually be spun off, Greatbatch will cultivate a greater customer base in the future. It will be interesting to see how that situation plays out.

That controversy might have presented an opportunity for component supplier Cirtec Medical to drum up business, had they have more of a presence at the event. But that company has been hit by the departure of some key staff members, including its former president Barry Smith.

There was also some discussion on the competitive positioning of new entrants in the spinal cord stimulation business such as Nevro, Spinal Modulation, and Neuros Medical. Several attendees thought that Neuros has a sound technology base, though probably the smallest market opportunity of the three. There was speculation that Nevro and Spinal Modulation might be ripe targets for acquisition by existing players in the SCS market. It will be interesting to see if either firm makes it to the market approval stage, let alone profitability, before being snapped up by one of the big three.

Speaking of spinal cord stimulation, perhaps the most profound observation we heard at the conference was by Robert Levy of Northwestern University, who noted that the SCS systems that existed five to 10 years ago, which serve as the basis for many long-term pain studies, represent the worst case scenario. Today’s SCS systems, with their greater specificity, targeting capabilities, and control over stimulation parameters, offer a far better outcome for patients and vendors alike.

James Cavuoto
Editor and Publisher
Neurotech Reports
www.neurotechreports.com

Jul 182011
 

The University of Michigan is developing a minimally-invasive low-power brain implant, termed “BioBolt”, that transmits neural signals to a computer control station, and may someday be used to reactivate paralyzed limbs.

 

While the BioBolt carries enormous potential, the issues of intellectual property and market partnership raise a number of neuroethical questions. In our current era of fast-emerging innovative neurotechnology, we must critically confront the practical questions of how such technologies will be provided to those who need them. In our modern society, commutative justice theories establish the disproportionate provision of goods based upon relative (and unequal) need. Their fundamental assumption is that all patients who need such interventions would be provided access and means to acquire them. Implicit to this assumption are notions of neoclassical economics based upon Adam Smith’s construct of rational actors and unlimited resources (Smith, 1776). However, even a cursory analysis of the contemporary atmosphere of healthcare provision reveals such Smithian assumptions to be vastly unrealistic. In fact, resources are limited, and their provision is based upon a multidimensional calculus that determines the relative distribution of medical goods and services. Put simply, not everybody gets what they need, and this is particularly the case for high-tech medical interventions that are often only partially covered, and in some cases, not covered at all by the majority of health insurance plans. Moreover, some 57 million Americans are currently without health insurance (Wolf, 2010).

 

Now more than ever, we face the pragmatic charge of access: who will receive state-of-the-art neurotechnological interventions, such as the BioBolt? Will these approaches become part of a new ‘boutique neurology,’ or will there be active assertion and effort(s) to increase the utility and use of these interventions, so as to make them more affordable and more widely accessible within the general population of those patients who might require them? Will some newly developed medical criteria accommodate these decisions and actions, or, as is more likely, will the tipping points be governed by healthcare insurance provisions? How can and/or should healthcare reform(s) be adjusted and adjudicated in order to accommodate rapidly advancing science and the potential benefit(s) it might confer? While certain provisions of the new federal healthcare plan might support such directions, real availability and access will only be sustainable through a real shift toward a more demand-side health economics, which would constitute something of a sea change in our overall economic infrastructure. But rarely does such change occur all at once. Instead, it may be more viable to dedicate efforts to developing realistic designs for more equitable allocation of neurotechnologies. Such efforts, if appropriately subsidized and sustained, could be important droplets towards the sea change that may be necessary.

 

For further reference, see:

Giordano, J. (2010). Neuroethical Issues in Neurogenetic and Neuro-Implantation Technology: The Need for Pragmatism and Preparedness in Practice and Policy. Studies in Ethics, Law, and Technology. Vol. 4 (3): Article 4.

Giordano, J., Benedikter, R., and Boswell, M. V. (2010). Pain Medicine, Biotechnology and Market Effects: Tools, Tekne and Moral Responsibility. Ethics in Biology, Engineering, and Medicine. Vol. 1 (2): 135-42.

 

Jun 082011
 

It wasn’t that long ago that magnetic stimulation was looked at as somewhat suspect by many in the neurotechnology industry. But now the number of new entrants in the magnetic neuromodulation space is growing steadily, supplementing existing players using magnetic devices in stimulation, neurodiagnostics, and research.

Some of the credit for this upsurge in interest in magnetic stimulation can be attributed to Neuronetics, Inc., the Malvern, PA manufacturer of transcranial magnetic stimulation systems. The company’s NeuroStar system received FDA approval for major depressive disorder in 2008, and in 2011 Neuronetics announced that Category I CPT codes were available for the procedure, making reimbursement much easier.

At least one new entrant hopes to follow in Neuronetics’ footsteps. NeoStim Inc., a startup in San Mateo, CA, cites the existence of an FDA-cleared TMS therapy and the CPT codes as reasons why NeoStim is a sound investment. NeoStim’s device features an array of coils that the company says offers greater target selectivity than the NeuroStar system because of the multiple overlapping fields. The company plans to pursue other indications besides depression, including pain and addiction. Another startup, Israeli-based Neuronix Ltd., is developing a TMS system for treatment of mild to moderate Alzheimer’s disease.

eNeuras Therapeutics (formerly Neuralieve) in Sunnyvale, CA is developing a single-pulse TMS device for home use for treatment of migraine. Its SpringTMS Total Migraine System is placed at the back of the head for less than a minute, generating a focused, single magnetic pulse that induces a mild electric current in the back of the brain.

Magnetic stimulation devices are also gaining popularity in neurosensing and presurgical planning applications. Nexstim Ltd., the Finland-based manufacturer, markets its MRI-guided TMS system NBS to neurosurgeons as an alternative to direct cortical stimulation. The company is investigating other neurodiagnostic and therapeutic applications of its system, including stroke recovery and pain.

One of the oldest TMS product lines in existence is the MagVenture’s MagPro system, first introduced in 1992 (previously marketed under Dantec, Medtronic, and Natus Medical brand names).  UK-based MagStim Ltd. has also been marketing its line of TMS stimulators for many years. In 2010, the company teamed with the Dutch ANT B.V. (Advanced Neuro Technology) to market a magnetic neuronavigation system called Visor, which features integration with MRI, fMRI, and EEG.

We suspect that there will be even more magnetic ventures forthcoming in the years ahead as the road to FDA approval for more invasive forms of neuromodulation continues to be difficult.

Originally published in Neurotech Business Reports, May 2011, p2

Jun 052011
 

About one third of epilepsy sufferers are refractory to drug treatment.  When drugs are ineffective, these people find their hope in brain-applied electrical stimulation. Several commercial neuroprosthetic devices have been successful in providing at least partial relief. They include a vagal nerve stimulator (VNS) from Cyberonics Inc., and a deep brain stimulator from Medtronic Inc., and cortical stimulation device from NeuroPace Inc. These devices are surgically implanted and cut the number of seizures in half or more in about 40% of drug-resistant patients. Currently, there is no neurological test to predict who will benefit from electrical stimulation. To solve this problem, Dr. Christopher DeGiorgio, a neurologist at UCLA, decided to use an external stimulator to estimate whether the epilepsy sufferers would benefit stimulation therapy before an invasive surgery is performed to implant a permanent device. His stimulator activates a superficially-located trigeminal nerve, a large cranial nerve that projects to key parts of the brain that modulate seizure and mood. The stimulation is applied at the forehead, while the electrode leads are connected to a small wearable pulse generator. According to the initial clinical test, the stimulator has similar efficacy to the implantable VNS. A positive side-effect of trigeminal nerve stimulation is an improvement in mood, which is important as many epilepsy patients suffer from depression. A startup company NeuroSigma Inc. has licensed the approach to stimulate the trigeminal nerve for epilepsy, depression, and PTSD, and is developing an implantable version for those who find relief with the externally-applied device.