November 13, 2009
We've all heard about "the power of the press." At Neuro Kinetics, we've been reminded in recent days just how powerful media reports can be, especially in this age of online information.
I write today to our customers, prospects, investors, friends and other stakeholders to correct misinformation about our company that originally appeared in a newspaper article and then relayed by a competitor.
The saga began late last month when we put out a news release about our collaboration with the U.S. military to find new means of detecting brain injuries in wounded soldiers. That news release apparently prompted a reporter at the Pittsburgh Tribune Review, in our hometown, to take a look at us. The reporter searched online for background on Neuro Kinetics and called me for an interview. Last Friday, November 6th, the newspaper published an article that contained incorrect information about our interaction with the U.S. Food & Drug Administration (FDA).
After this article appeared, we contacted the newspaper to communicate our concern about its reporting.
To its credit, the newspaper subsequently published a correction, which you can read: http://www.pittsburghlive.com/x/pittsburghtrib/business/s_653063.html.
(A note: the newspaper also revised its original article slightly; the first version, as published last week, is no longer available on its Web site.)
We also posted on our Web site and distributed via a commercial news service a statement from me.
We had hoped that with the newspaper's correction and my statement, this situation was behind us.
However, we just learned of an e-mail sent earlier this week by the CEO of one of our competitors. We do not know exactly who received the e-mail but if you received a copy of it, either directly or indirectly, I am now compelled to correct misstatements made in it.
The competitor's e-mail reiterates the Tribune Review's incorrect reporting that Neuro Kinetics "was forced to recall" devices. That is not true. We said before that our "recall" was actually a voluntary software update to remove a small slice of the software's normative data we had made available to our users. We cannot control the terminology the FDA uses but one can question the use of the word "recall" in this circumstance. And we were not "forced" to do anything.
I am concerned that some readers of our competitors' e-mail, as well as of the original newspaper article, could infer that we asked our equipment users to return their devices to us. Our action concerning our software did not involve any physical equipment.
Indeed, no Neuro Kinetics physical device has ever been recalled anywhere in the world at any time in our twenty-five year history.
Also, in the newspaper's correction, the word "ongoing" is used. This episode is "ongoing" only in the sense that some of our users have not completed their software update. There are no compliance issues with the FDA that remain "ongoing."
The competitor's e-mail states that its writer could not find evidence that we had "complied with the FDA" because he could not find our most recent 510(k) document online. (A '510(k)' is a regulatory compliance document filed with the FDA.)
In fact, we have a 510(k) for our I-Portal products and it is accessible on the FDA's Web site: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29647
In the spirit that robust competition benefits all, we have respected our competitor as a worthy player in the medical device industry. It is disheartening now to see that company diminished by undignified comments from its CEO. Just as the newspaper in Pittsburgh did the right thing and published its correction, we ask that the competitor's CEO correct the wrong information in his e-mail.
We are proud of the advances and innovation Neuro Kinetics has brought to the marketplace and invite you to browse our Web site (www.neuro-kinetics.com) for details about our exciting work.
Let me conclude with a pledge to you. We take our responsibilities as scientists and as a medical device manufacturer very seriously. We will continue to do everything we can to maintain the high levels of safety, efficiency, effectiveness and innovation that are our hallmarks. And we will continue to comply with all regulatory mandates from the FDA and other regulatory agencies around the world.
I deeply regret the necessity of sending out this e-mail.
Thank you for your continued support of Neuro Kinetics. Now let's get back to work.
Neuro Kinetics, Inc.
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