CLXN - Has aquired worldwide exclusive Rights to the ThyroTest Pharma.This is a United on the
International Pharma Market, and i will bring CLX Medical a Great Great Performances, Big Profit will
come $$$$$$ The Share Price of CLXN will we extremely explode.A Big Run will come.
I have more
Informtions.his is my Advantage - I will not said it.I will definetly buy more and more of CLXN Stocks,
which makes e Rich and othe Investors make rich $$$$$$$$$$$$$$$$$$$$$$$$
CLXN - The $.10
will come.Thats Defenitly correct.Yea. will by more and will catch tommorrow more stocks and by mo9re and
more.
I have more Infom´formations too.
In the folling here a actuelle News from
17.09.2008, 23.09.2008, 25.08.2009 and the Interview betwen Q & A and Vera Leonard, CEO of CLXN Medical
with futere Targets.The Huge Great Next News will come as soon:
The News from
17.09.2008:
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CLX Medical, Inc. - CLXN
--------------------------------------------------------------------------------
CLX
Medical, Inc. Files Form 8-K on Definitive Agreement for the Acquisition of the ThyroTest(R) Rapid
Screening Device
2008-09-17 10:02 ET - News Release
MURRIETA, CA -- (MARKET WIRE)
-- 09/17/08
CLX Medical, Inc. (OTCBB: CLXN), which is focused on the marketing and
distribution of unique medical diagnostic testing products, has filed a Current Report on Form 8-K
regarding its planned purchase of ThyroTest®, a rapid thyroid stimulating hormone (TSH) screening device
used for the detection of hypothyroidism in adults, a common thyroid disease.
The Form 8-K can
be accessed through a link to SEC filings in the "Corporate" section of the CLX Medical website, CLX
MEDICAL INC..
The Form 8-K reports that on September 9, 2008, CLX Medical entered into a
product purchase agreement with ThyroTec, LLC, the developer of the ThyroTest® device, pursuant to which
CLX Medical will acquire from ThryoTec the exclusive, worldwide rights to ThyroTest®, together with
related packaging and marketing materials. The purchase price for the acquisition consists of a cash
payment of $750,000 upon closing and the issuance of Series C convertible preferred stock of CLX Medical
convertible into fifteen percent (15%) of the total, fully-diluted common stock of the company.
Upon closing, Jim Small, ThyroTec's chief executive officer, or his designate will be appointed as a
member of CLX Medical's board of directors. Mr. Small has 30 years of thyroid related pharmaceutical
experience and is the co-founder of ThyroTec.
The News from 23.09.2008:
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Re: CLX Medical, Inc. Files Form 8-K on Definitive Agreement
for the Acquisition of the ThyroTest(R
--------------------------------------------------------------------------------
Press
Release Source: CLX Medical, Inc.
CLX Medical, Inc. Announces Long Term Employment Agreement
with CEO Vera Leonard
Issued Tuesday September 23, 9:36 am ET
MURRIETA, CA--(MARKET
WIRE)--Sep. 23, 2008 -- CLX Medical, Inc. (OTC BB:
CLXN), which is focused on the marketing and
distribution of unique medical diagnostic
testing products, today announced a three year employment
agreement with Chief
Executive Officer Vera Leonard.
Ms. Leonard’s compensation package
includes a combination of a base salary, a schedule
of salary increases based on a variety of
factors including the company’s revenue and
profit performance, the granting of restricted common
stock, medical coverage, and
expense reimbursements. Ms. Leonard’s full employment agreement will
be filed as an
exhibit to the company’s annual report for the fiscal year ending September 30,
2008.
The employment contract was executed as CLX prepares to close the acquisition of
ThyroTest®, a rapid thyroid stimulating hormone (TSH) screening device used for the
detection of
hypothyroidism in adults, a common thyroid disease.
On September 9, 2008, CLX Medical entered into a
product purchase agreement with
ThyroTec, LLC, the developer of the ThyroTest® device, pursuant to
which CLX
Medical will acquire from ThryoTec the exclusive, worldwide rights to ThyroTest®. In
addition to working to close the transaction, Ms. Leonard and CLX Medical management
is focused on
the execution of a post-acquisition marketing and distribution plan for
ThyroTest®.
“I am
pleased to have reached agreement on a long term employment agreement with the
CLX Medical board and
look forward to the successful implementation of our strategy to
build value for CLX Medical
shareholders,” stated Ms. Leonard. “The pending
acquisition of ThyroTest® is expected to be a
major milestone in our efforts to establish
value in the company based on revenues from worldwide
sales of this device and
additional products that may be distributed in the future.”
Robert
McCoy, chairman of CLX Investment Company, commented, “The Board
believes that Ms. Leonard is the
right person to implement the marketing and distribution
strategy for ThyroTest®, and the execution
of this employment agreement, which ties
increases in her compensation to the revenue and profit
performance of CLX Medical, is
the right step for the company at this time. We look forward to
seeing the further
development of CLX Medical under her leadership.”
ThyroTest® is FDA
cleared and has also achieved CLIA waived status, so the test can be
administered in the more than
100,000 CLIA waived doctor’s offices in the U.S., as well
as in any non-waived laboratory. The
simple rapid diagnostic test is a qualitative
measurement that allows physicians to screen adult
patients for hypothyroidism in
approximately ten minutes with a whole blood sample.
To sign up
to receive information by email directly from CLX Medical, Inc. when new
press releases, investor
newsletters, SEC filings, or other information is disclosed, please
visit CLX MEDICAL INC..
About CLX Medical, Inc.
CLX Medical, Inc. (CLX MEDICAL INC.) holds a 51% equity interest in Zonda,
Inc.
(Zonda Incorporated - Official Web Site), which has developed several rapid point of care tests
for
medical and non-medical markets, including a rapid test for chlamydia. CLX has also
entered
into a definitive agreement to acquire ThyroTest®, a rapid thyroid stimulating
hormone (TSH)
screening device used for the detection of hypothyroidism in adults, a
common thyroid disease. CLX
Medical is focused on the successful worldwide
distribution of these and any additional products it
may acquire or license.
All statements included in this release, including statements regarding
potential future plans and objectives
of CLX Medical, Inc. are forward-looking statements. Such
statements are necessarily subject to risks and
uncertainties, some of which are significant in
scope and nature beyond CLX Medical’s control. There can
be no assurance that such statements will
prove accurate. Actual results and future events could differ
materially from those anticipated in
such statements depending on many factors. Historical results are not
necessarily indicative of
future performance.
Contact:
Gemini Financial Communications, Inc.
A. Beyer
951-677-8073
investors@clxmedical.com
The News from 25.09.2008:
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SOURCE: CLX Medical, Inc.
Sep 25, 2008 10:42 ET
CLX Medical, Inc. CEO Discusses Opportunity Presented by the Planned Acquisition of ThyroTest®
Highlighted Links
Zonda, Inc. Website
CLX Medical, Inc. Website
MURRIETA, CA--(Marketwire - September 25, 2008) - CLX Medical, Inc. (OTCBB: CLXN) CEO Vera Leonard
today commented on the opportunities presented by the acquisition of ThyroTest®, a rapid thyroid
stimulating hormone (TSH) screening device used for the detection of hypothyroidism in adults, a common
thyroid disease.
CLX Medical, which is focused on the marketing and distribution of unique
medical diagnostic testing products, has entered into a definitive agreement to acquire ThyroTest® and
is seeking to close the acquisition as soon as possible.
ThyroTest® is FDA cleared and has
also achieved CLIA waived status, so the test can be administered in the more than 100,000 CLIA waived
doctors' offices in the U.S., as well as in any non-waived laboratory.
Regarding the
acquisition of ThyroTest®, Ms. Leonard stated, "The ThyroTest® product offers a unique opportunity. Its
success will be realized through establishing the concept of in-office testing for hypothyroidism.
Getting practicing physicians to incorporate a new test into their office routine requires intense,
focused effort. Often, large companies, particularly those that operate in multiple markets, manage
multiple sales forces and must move quickly to make strategic acquisitions, find that the
return-on-investment from building a new opportunity from the ground up is not as attractive as that
offered by an accretive acquisition. A single product, even one with the potential of ThyroTest®, can
get lost in this environment.
"Having impact on the way a doctor manages a disease state
requires exquisite focus. We believe that as a small company CLX Medical can, and will, give ThyroTest®
the focused support it needs in order to capture this largely unrecognized and untapped market
opportunity.
"We will not be distracted in our pursuit of establishing ThyroTest® as the
dominant player in what we expect to be a $1 billion-plus worldwide screening market. We believe that
once the product is established and the diagnostic world recognizes the opportunity, we will see other
companies launch similar products. That is where being first-to-market comes in as a key strategy. Once
other players enter the market, the market grows and the product at the top of it grows exponentially
larger and faster than the newcomers. In other words, the pie gets bigger and the first-to-market company
continues to enjoy a bigger piece of the bigger pie.
"I hope this brief discussion regarding
the potential of ThyroTest® will help CLX Medical shareholders understand why we are so optimistic about
the product's potential and why we are so focused on closing this acquisition so our marketing and
distribution strategy can be implemented."
ThyroTest® is a qualitative rapid diagnostic test
that allows physicians to screen adult patients for hypothyroidism in approximately ten minutes with a
whole blood sample.
Hypothyroidism develops when the thyroid gland does not produce enough
thyroid hormone to properly regulate the body's metabolism. A lack of thyroid hormone affects many body
systems. The incidence of hypothyroidism tends to increase with age, with older people, especially women,
at highest risk. Common symptoms include weight gain, fatigue, mood swings, weakness, dry and coarse skin
and hair, hair loss, depression, decreased libido, trouble swallowing, increased cholesterol, heavy or
irregular periods or trouble getting pregnant.
Approximately 120 million thyroid-related lab
tests are performed in the United States each year. At an estimated average cost of $40 per test, the
U.S. market is currently valued at nearly $5 billion. Approximately 45 million of those tests are
conducted in order to diagnose thyroid dysfunction. CLX believes that ThyroTest® is an appropriate,
cost-effective first-step for those 45 million diagnostic TSH tests. This current U.S. market opportunity
is amplified by the CLIA waived status, which makes the opportunity to meet American Thyroid Association
recommendations for screening every individual at age 35 and every five years thereafter a reality.
To sign up to receive information by email directly from CLX Medical, Inc. when new press
releases, investor newsletters, SEC filings, or other information is disclosed, please visit CLX MEDICAL
INC..
About CLX Medical, Inc.
CLX Medical, Inc. (CLX MEDICAL INC.) holds a 51%
equity interest in Zonda, Inc. (Zonda Incorporated - Official Web Site), which has developed several
rapid point of care tests for medical and non-medical markets, including a rapid test for chlamydia. CLX
has also entered into a definitive agreement to acquire ThyroTest®, a rapid thyroid stimulating hormone
(TSH) screening device used for the detection of hypothyroidism in adults, a common thyroid disease. CLX
Medical is focused on the successful worldwide distribution of these and any additional products it may
acquire or license.
All statements included in this release, including statements regarding
potential future plans and objectives of CLX Medical, Inc. are forward-looking statements. Such
statements are necessarily subject to risks and uncertainties, some of which are significant in scope and
nature beyond CLX Medical's control. There can be no assurance that such statements will prove accurate.
Actual results and future events could differ materially from those anticipated in such statements
depending on many factors. Historical results are not necessarily indicative of future performance.
Contact:
Gemini Financial Communications, Inc.
A. Beyer
951-677-8073
Email
Contact Click here to see all recent news from this company
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The Interview with Q & A and Vera Leonard, CEO of CLX Medical:
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Interview
Q&A with
Ms. Vera Leonard,
Chief Executive Officer of CLX Medical, Inc.
Conducted: August
13, 2008
The following Q&A with Ms. Vera Leonard, CEO of CLX Medical, Inc., pertains to
the
planned acquisition of ThyroTest®, a rapid thyroid stimulating hormone (TSH)
screening device used
for the detection of hypothyroidism in adults, a common thyroid
disease. FDA clearance and CLIA
waived status have already been achieved for the
ThyroTest® product.
Q. CLX Medical just
announced its planned acquisition of ThyroTest. Why
did you target this device to be the next
product that CLX would bring under
management?
A. One of the things we look for in targeting an
acquisition is a product that addresses
a large market opportunity. The next item on the check list
is whether or not that market is currently being served.
When we uncover an opportunity that meets
both of those criteria we move to the next step; how close is the product
to being marketable, that
is, what regulatory hurdles does it still have in front of it? The ThyroTest product is a rare
fi nd
in that it addresses a huge, underserved market and already has all the regulatory hurdles behind it by
having the
FDA clearance and CLIA waived status. In our opinion the product is available because it
was never given a focused
sales and marketing effort. The existing market, the potential for growth
and the level of performance ThyroTest
offers make a compelling case for this acquisition.
Q.
How common are hypothyroidism and the symptoms that might indicate the condition?
A. That’s a good
question, and I think what you are really asking is: what is the market potential for a test that can
help diagnose hypothyroidism? I’ll answer it two ways. First, hypothyroidism is much more common that
most
people realize. Because the risk increases with age, the symptoms are often dismissed as just
“getting older.” There
are currently about 13 million individuals in the US that are currently
diagnosed as hypothyroid. Estimates are that
there are at least another 13 million that are
undiagnosed. Those are important statistics but they do not describe the
market for ThyroTest.
In large part, the market for ThyroTest is defi ned by its symptoms. Those symptoms include, gaining
weight
inappropriately, inability to lose weight with diet & exercise, feeling cold when others feel
hot, feeling fatigued or
lethargic, irregular menstrual cycles, infertility, depression, mood
swings, and increaed forgetfullness.
Because the number of symptoms is so vast and thyroid disorders
can negatively impact so many human body organs,
ThyroTest can make a real difference in several
therapeutic areas creating a signifi cant sales opportunity. Just looking
at the symptoms I have
mentioned; (and by the way, these are not all of the symptoms), you see that the product
has
usefulness to Obstetricians & Gynecologists, Infertility Specialists, Psychiatrists, Internists,
Endocrinologists,
Cardiologists, as well as Family Practitioners. This is the opportunity presented
by helping a doctor identify the
cause of a patient’s existing symptoms.
Hypothyroidism is
generally associated with aging; therefore the number of individuals suffering from hypothyroidism
is expected to grow with the aging of the population. Experts estimate the US market growth to be in
the range of
5-10% per year for the foreseeable future.
In addition, the American Thyroid
Association recommends that every person be screened for hypothyroidism at age
35 and every fi ve
years thereafter. That’s a huge market by anybody’s count.
1
Q. What is the strategy for
U.S. and worldwide distribution for ThyroTest?
A. In the U.S., working with our key consulting
group, American Health Partners, we will launch the product
through select national and regional
medical-surgical distributors. That product launch will be accompanied by ads
in appropriate medical
and industry journals, trade show attendance and targeted advertising campaigns.
Immediately upon
close of the acquisition we will apply for a CE certifi cate that will allow us to market the
product through our existing group of European distributors as we work with our Master Distributor to
identify and
engage additional distributors. Of course, already having FDA clearance and CLIA waiver
will make acquiring CE
certifi cation much easier and, we hope, much faster.
We will add other
countries to our distribution strategy once we have a solid base of business operating in the U.S.
and Europe.
Q. What advantages are there to having the CLIA Waived status for the ThyroTest
product?
A. Having CLIA waiver is huge! In order for doctors to screen individuals for
hypothyroidism, or to conduct an inoffi
ce work-up of patients presenting with symptoms he or she
must have a product that meets four criteria. It must
be reliable, it must be cost effective, it
must be able to give a rapid result, and it must be available. Irrespective of
any of its other
qualities, unless the device has CLIA waived status it is not available for use in most doctors’ offi
ces.
In that case, the doctor’s only option is to send the specimen out to a non-waived lab for
testing. This is an expensive
option for the patient so most doctors only use it when overt symptoms
are present.
If the only option available to the doctor is a lab test, the cost of testing prohibits
being able to screen for hypothyroidism.
Additionally, when a doctor sends a test out to the lab,
the doctor is not paid for the test, the lab is. So having a CLIA
waived test generates revenue for
the practice where sending it out does not, as well as keeping the cost of testing
low enough that
doctors can conduct screening in the offi ce.
Based on our most recent information there are 107,000
doctor offi ces with CLIA waived licenses.
Q. CLX Medical recently announced that it had targeted
LETI Laboratories to serve as European master
distributor for its subsidiary products. Will this
company distribute ThyroTest in Europe?
A. Yes. We expect to work with LETI for ex-US distribution
of all our products. There are several benefi ts to this
plan. It streamlines our inventory
management logistics tremendously. It simplifi es our worldwide receivables
process and will allow
us to more easily forecast demand for our contract manufacturers as we gain more insight
into
ordering patterns throughout Europe. Importantly we are building a relationship with a strong,
knowledgeable
partner who can help us develop and manage our ex-U.S. business. The individuals we
work with within LETI are
experts in diagnostic products from a scientifi c as well as a marketing
perspective. They understand the European and
worldwide markets and are excited about the unique
products we are bringing them. Still, successful relationships
come down to the people involved. Are
our values compatible, are we equally committed to mutual benefi t? We
believe we have found that
right kind of relationship with LETI.
Q&A with Ms. Vera Leonard,
Chief Executive Offi cer of
CLX Medical, Inc.
(continued)
2
LETI Laboratories is a well established company and highly
regarded in the diagnostics industry. In addition to
their operations in Europe; they have
operations in Latin America, South Africa and other areas that will likely be of
interest to us as
we expand our marketing efforts.
Q. What does the competitive landscape look like for ThyroTest?
A. While there are other rapid products that test for thyroid function, we believe that ThyroTest
offers signifi cant
opportunity to establish a dominant position in this market. Beyond product
performance, which, of course is very
important, competitive advantage can also be established
through a strong marketing and distribution strategy. Inoffi
ce screening for hypothyroidism is a
young market, fairly early in its development. We certainly expect to see
others enter the market as
its value becomes more widely recognized.
Our strategy is to establish ThyroTest as the
market
leader and maintain its position as the product of choice in a rapidly growing worldwide market.
Q.
How do you expect to fi nance the acquisition of ThyroTest and marketing for the product
postacquisition?
A. We have negotiated a good purchase price and process with ThyroTec, the company
that owns ThyroTest. We
are currently preparing a convertible preferred private placement offer
through which qualifi ed investors can benefi t
especially well from this acquisition. The private
placement memorandum will be available for distribution in the
next few days. Through this vehicle
we expect to raise enough fi nancing to complete the acquisition and fund at least
12 months of
operating costs going forward.
Q. It has been a year since you joined Zonda and 8 months since
joining CLX. How would you characterize
this fi rst year?
A. The fi rst words that come to mind
are challenge, potential and patience. The patience part has been one of the
biggest challenges. As
you may remember, shortly after I joined Zonda in August 2007, we were notifi ed that some
of our
European distributors were using product labeling that had not been added to the technical fi le required
for
sales in the European Union. So my fi rst offi cial act was to halt sales and take action to
avoid a mandatory product
recall. The process required pulling in all the labeling and artwork in
use throughout the European market, acquiring
professional translations of all the product
information, getting it through the approval process, and one-by-one,
allowing distributors to
resume sales of HandiLab products. Of course this took a few months to accomplish but
it gave me an
opportunity to meet with each of our distributors and quickly understand where opportunities for
improving our European distribution strategy lay.
It also helped me formulate a plan to become
owners of our own European Union certifi cation rather than relying
on our contract manufacturer for
that regulatory clearance. This is where “patience” comes in. We realized that
while the
products have a pretty good track record, and demand was increasing, we needed to go back and get some
foundational issues in place. Specifi cally, we needed to establish a quality system that meets ISO
standards. This
would be required in order to achieve FDA clearance for any of our products as well
as to become the certifi ed CE
holder for European sales. We researched regulatory consultant
services and contracted with Safi s Solutions in
Indianapolis, IN to help us with all our regulatory
processes including the establishment of a quality system.
Q&A with Ms. Vera Leonard,
Chief
Executive Offi cer of CLX Medical, Inc.
(continued)
3
I am pleased to say that we have
completed all the Standard Operating Procedures (SOPs), and internal systems
required. What remains
is to conduct a mock audit, address any defi ciencies the mock audit uncovers, and then
schedule an
offi cial audit by an accredited Notifi ed Body that will grant the CE certifi cates. This has been,
and
still is, a huge project but one we believe is critical for regulatory clearances as well as
market position as a quality
company.
Our next big decision came when we had an opportunity to
improve the readability of the HandiLab products
through an adjustment to the volume of reagents
used in the device. We were getting feedback that sometimes the
volume of reagent in the reading
chamber would wash out the end-result color making the result diffi cult to interpret.
We worked
with various adjustments to the reagent volume and were able to identify one that gave consistent
results
without interfering with the clarity of the end-result. We immediately ordered three lots of
the devices and started
looking for a virology lab to confi rm the performance at the new level and
perfect the protocol we would use for FDA
clinicals that we want to start as soon as possible.
Well, you know the issue we encountered in that process. What you may not know is that the concept of
the
HandiLab Chlamydia technology is unique in that it does not test for the presence of the
chlamydia organism; it tests
for the presence of an enzyme that the human body produces only in the
presence of the chlamydia organism. This
makes the lab approach to validation very different from
any standard validation procedure. Rather than ordering
several strains of chlamydia and testing
them on the device, the lab must order the organisms, grow them on human
tissue cells and then test
for the presence of the target enzyme. A validation process like this depends on quite a few
variables. You must use the right strain of organisms, they must be viable enough to grow dependably on
human
tissue cells and they must grow to an adequate concentration in order to produce enough target
enzyme to be detected
by the device. The more variables a process has, the less likely it will
succeed the fi rst time. We are working closely
with the lab through management of each of the
variables so that we can confi rm the performance of the new-fi ll
device and perfect the protocol
we will use in the FDA clinicals.
So, as a quick review, in this fi rst year we have:
•
Cleaned up all product labeling and translations worldwide to comply with European Union requirements
• Begun the process to acquire a CE certifi cation under our name so we can better manage our ex-US
distribution
and regulatory compliance
• Established a quality system required for all
regulatory clearances
• Completed a product improvement that will enhance ease-of-use and address
identifi ed customer needs
• Identifi ed and hired a fi rst-quality regulatory consultant fi rm to
guide us through all these crucial processes
• Initiated validation studies to confi rm the
performance of the new device design and prepare for FDA clinicals
• Identifi ed and negotiated an
agreement and detailed process with a Clinical Research Organization to conduct
and manage the FDA
clinicals on the HandiLab Chlamydia product
• Issued a Request for Proposal to selected European
distributors to establish a Master Distributor for our ex-US
business
• Selected and
negotiated the terms of a Master Distributor agreement with LETI Laboratories in Barcelona
Spain
• Identifi ed the ThyroTest device as a potential product for acquisition
• Negotiated an
acquisition plan
• Conducted due diligence on ThyroTest including an in-depth evaluation in the
clinical laboratory – results are
looking great! We will provide the data soon.
Q&A with Ms.
Vera Leonard,
Chief Executive Offi cer of CLX Medical, Inc.
(continued)
4
The next
steps to complete over the coming weeks include:
• Releasing the preferred placement memorandum
• Raising the fi nancing for the acquisition and operating expenses
• Finalizing the chlamydia
validation studies
• Releasing the results of the ThyroTest evaluation
• Completing the
ThyroTest acquisition and preparing for the product launch
• Finalizing the Master Distribution
Agreement and prepare for re-launch of products to European distributors
• Successful completion
of the quality system audits
Some of the projects we expect to accomplish after the fi rst of the
year include:
• Apply for CE certifi cation for both Chlamydia and ThyroTest products
•
Begin FDA clinical trials for HandiLab Chlamydia
• And last – but defi nitely not least –
generate revenue!!
Our stockholders have been incredibly patient and supportive of us. We intend to
repay that trust with strong
products, good business practices and an excellent return on
investment. As all of this is achieved, we are committed
to keeping shareholders informed on our
progress.
###
Q&A with Ms. Vera Leonard,
Chief Executive Offi cer of CLX Medical, Inc.
(continued)
5
CLXN - Stronng Buy - Very Bulish $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
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CLXN - CLX Medical, Inc. Files Form 8-K on Definitive Agreement for the Acquisition of the ThyroTest(R) Rapid Screening Device 
