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March 28, 2008

Aspect Medical Systems in the Spotlight- The Bis Monitor, Medical Need and The Capital Markets

Analysis of: Anesthesia Awareness and the Bispectral Index | content.nejm.org
This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Analysis By:
Jason Campagna, MD,PhD, Director of Clinical Quality and AnalyticsJason Campagna, MD,PhD
Director of Clinical Quality and Analytics, Cottage Health System
Implications: 1. The market for "depth of anesthesia" monitors has depended very much on marketing and public perception of the problem. This article shines a bright light on the more objective issues of utility and efficacy. 2. Aspect Medical has made a number of mis-steps over the years that have alienated them from anesthesiologists and have made them a target for any and all negative news surrounding this area. The NEJM article may have a catalyzing effect on this already negative trend. 3. There has always been doubt as to the prevalence of "awareness" and the fact that the issue has become a public concern (CNN, CMS) rendered much of these concerns silent. Yet, those concerns were and are real and the NEJM article reminds both anesthesiologists and the general readership that the problem as we understand it is more complex than made out in the media and that the technologies to address the problem are limited by our poor understanding of it.

Analysis: Much has been written, spoken of and debated about in both the lay/popular press and in the Anesthesia specialty literature of the problem of "awareness" during general anesthesia. While all agree that the phenomenon is real, there is far from universal consensus as to the extent of the problem, nor which patients are at risk. These facts however have not stopped the capital markets from proffering solutions in the form of "monitors" that can divine the extent to which a person is "asleep" or "unaware". The long-standing concern has always been that in the same way that an alarm in your car is not a "theft" alarm (the alarm, when triggered, may indicate a theft, but also heavy rain or a bump from another car), a monitor that gives some measure of brain activity is not an awareness monitor (a high number may mean awareness, or it may mean a number of other things not related to "theft" so to speak). Sadly, none of these subtleties have ever made into the public arena for discourse and in this context, it is very gratifying to see this behind-the-scenes-debate spill over into the pages of the widely read, and widely respected New England Journal of Medicine.

The day this article was released, the capital markets reacted swiftly, and ruthlessly to punish Aspect for its supposed frailties and its proffering of a product without merit. This rebuke was welcome, no doubt, by many Anesthesiologists who have long had grievances with Aspects "Tanya Harding" approach to marketing: if you will not buy our device then we will break your kneecaps (in their case, making a public fear the specter of being awake under anesthesia). Although Aspect can and has been chided for such practices it is important to note that a major consequence of them has been that Apsect has never been able to be included within the enormous cultural "tent" that comprises the modern medical practice of Anesthesia. Because culture and marketing and emotion were so prevalent in the debates about this device, the NEJM article is most welcome because it injects the more sober and boring element of data into the picture.

I would like to highlight three important reasons why the efforts of Aspect Medical Systems should be lauded and even when considered against the context of this NEJM article, should give the capital markets reason to take a breath and think cogently and dispassionately about this subject.

1. Aspect accepted risk. They chose a path, proffered their innovation to the rough and tumble world of the capital markets. For those of us armchair quarterbacks (this author included!), we should and need to be reminded that credit should be given where credit is due. This is a brutal and unforgiving game they entered.

2. Aspect brought welcome attention to an area of clinical practice that was clearly in a position to benefit from the efforts and knowledge base of the basic neuroscience arena. Today, many neuroscientists are heavily invested into applying their knowledge to the "problem" of a practical, portable, reliable monitor that can be used to gauge the depth to which they have been rendered unconscious. The fruits of such labor are already evident in the 2nd generation technologies of entropy monitoring (GE) and even 3rd generation technologies like Mid-Latency Auditory Evoked Responses (MLAER) monitors. It is an unassailable fact that once such creative minds focus on a problem, the genie is out of the proverbial bottle and good things will continue to pour forth from that spout.

3. Aspect surmounted a hurdle that in the early and mid 1990's seemed insurmountable. The quest for a technology that was accurate, inexpensive and not cumbersome which could aid anesthesiologists in their determination of what the optimal dosing of their medications could be remained seemingly out of reach. Bis 1.0, despite many limitations, met these seemingly impossible goals. Where MANY had tried and failed before, Aspect INNOVATED. Lest we forget the goal of the game here-- innovation is the currency of the realm.

The future of Aspect Medical and the BIS is far from clear. It may go the way of the Xerox STAR (mouse and MAC today) or it may become a true word in our lexicon like XEROX or GOOGLE. Two things remain true. First the spotlight is still shining on this area of medicine and that means the technology, and perhaps the name brand of Aspect remains a coveted thing. Firesales often bring in unlikely suitors and perhaps a Baxter or a J&J will swoop in and decide to decisively and cheaply enter this market. Second-- the market has not gone anywhere. There remains a need for a device that allows anesthesiologists to better be able to ascertain what the brain of their patients is doing in response to some of their drugs and interventions. Dr. Evers excellent article and the resulting broad discourse and dialogue should help to more rapidly bring Aspect to its endgame (good or bad). In that process however, I would encourage others not to obscure the value created and opportunity created by that 100 Million dollar loss of market capitalization on March 12, 2008.

Other Analyses of the Same Source Article:
Investors Have Overreacted: The Use of BIS Devices to Monitor the Depth of Anesthesia Will Not Be Affected by One Negative Article
April 14, 2008, Author: Alex Bekker, MD, PhD, Associate Professor, Anesthesiology & Neurosurgery, NYU Medical Center

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