CTE

[Michael]

Hi Poorman

It seems like you will soon have to change your screen name - that is if you are still holding CTE 

Even though the fundamentals of CTE existing business are attractive the real play here is the approval of CABG.

Today we got the first of a number of press releases which I expect the company will issue over the coming months and the news is very good:

CardioTech Begins Process to Obtain an IDE in the U.S. for CardioPass Coronary Graft
Wednesday January 25, 10:00 am ET 
Company Also Provides Update on CE Mark Progress in Europe
Conference Call to be Held Wednesday, January 25 at 4:10 EST

WILMINGTON, MA, Jan. 25 /PRNewswire-FirstCall/ -- CardioTech International, Inc. (Amex: CTE - News), a manufacturer of advanced surgical devices treating cardiovascular disease, today announced that it has begun taking steps to apply to the FDA for an Investigational Device Exemption ("IDE") for CardioPass by initiating discussions with potential Principal Investigators. CardioPass is CardioTech's patented artificial coronary artery bypass graft, designed to extend the life of end-stage, no-option coronary disease patients.

IDE

CardioTech has made the strategic decision to apply for an IDE, while simultaneously pursuing the CE Mark. The Company has initiated discussions with thought-leaders in the cardiac surgical field for them to become Principal Investigators in a clinical trial. The trial will target "no- option" patients with insufficient autologous blood vessels who face imminent death from end-stage coronary artery disease. CardioTech's clinical end points are patient survivability, quality of life, freedom from angina, and graft patency.

CardioPass is a Class III (highest risk) device that requires a Pre Manufacturing Approval (PMA) from the FDA. Under the PMA process, it must first obtain an IDE before it can begin clinical trials on humans in the United States to determine the safety and efficacy of the graft.

Michael Szycher, Ph.D., Chairman and CEO, CardioTech, commented: "The start of an IDE, which begins by identifying Principal Investigators, represents a major milestone for any company developing a synthetic coronary bypass graft, which has proven to be a challenging path for over 40 years. We estimate that there are more than 100,000 'no-option' patients annually in the United States that can benefit from this technology."

CE Mark

In January 2006, CardioTech was advised by the Notified Body that it is currently in the final stages of an independent clinical review of the CardioPass dossier for "no-option" patients. A Notified Body is a European equivalent to the FDA that has the authority to grant a company the CE Mark (marketing approval) for a medical device.

S. Eric Ryan, MD, clinical consultant to CardioTech, stated: "The attainment of a positive recommendation by the 'independent clinical review' would represent a meaningful step towards the receipt of a CE Mark for CardioPass."

Broader Indications for CardioPass

CardioTech has contacted Austrian and Italian surgeons to serve as Principal Investigators in a European clinical trial which will address broader indications beyond the "no-option" patient category. For instance, CardioPass could be used in those patients requiring only one bypass.

Especially the expansion of the trials to include not only "no-options" patients is great news.

And it seems the market like the news!

Mike

[Michael]

CTE came with a pretty disappointing Q3 a couple of weeks ago. We can discuss whether it actually was so disaapointing as the headlines indicates. It seems like some of the increased cost were related to future revenue. But that is really to miss the point.

I hope nobody have bought CTE because of their existing revenue generating business. That is only icing on the cake.

The approval for CardioPass is really the driver for this stock. This is addressing a +1 billion USD market and CTE's market cap is 57 million USD.

As said before all Brazillian patience are still going strong with CardioPass and as the years pass it seems more and more ridicolous that people are dying everyday because they don't have suitable venes for transplatation while the whole medical community knows that there are a "cure".

CTE expects to receive approval in Europe this year. I believe that it will happen in the first half of the year but that is really not important. What is important is that when it happens CTE's share price will increase (I was thinking about writing "go through the roof" but that is really not my style so  )

I am buying CTE at these levels.

Mike

[bjc]

It's awesome to have such an excellent fundamental analyst on the board.

Thanks for all the great analysis Michael.  It's much appreciated.

[usedcasting]

Some news and stock price up 7.5%

CardioTech Plans Abbreviated Trial for CardioPass Based on Notified Body Response
Wednesday March 8, 10:30 am ET
Expanded Indications, Addressing Larger Worldwide Market, to Include Patients with Suboptimal Vessels
Conference call to be held March 8 at 4:10 Eastern Time

WILMINGTON, Mass., March 8 /PRNewswire-FirstCall/ -- CardioTech International, Inc. (Amex: CTE - News) today announced that it has received an official response to its submission for CE-Mark approval for its CardioPass Artificial Coronary Artery Graft for the indication for use with "no-option" patients. After a thorough review of the medical necessity of such a graft and CardioTech's technical dossier, CardioTech's notified body has requested CardioTech to acquire additional limited clinical data, with a more defined and broader indication, in an abbreviated trial. A CE-Mark approval allows for the marketing and sale of a product throughout Europe and many other international countries which recognize this standard, excluding the United States and Japan.

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Based on this response, CardioTech is now in the process of planning a limited European clinical trial. The Company plans to expand the initial indication for use of the CardioPass graft from "no option" patients to patients who present with suboptimal (diseased or inferior) vessels discovered while undergoing surgery. CardioTech believes that up to 15% of the 600,000 patients annually undergoing bypass surgery worldwide have suboptimal vessels.

The expanded indications would allow surgeons to determine during the bypass operation if the patient has the required native vessels of sufficient quality to complete the revascularization. Currently, when a surgeon is unable to identify such native vessels during the restricted time that the patient can reasonably be kept on bypass, the surgeon is often forced to complete the operation utilizing suboptimal vessels. The clinical availability of the CardioPass graft would offer the surgeon the ability to intraoperatively choose to utilize the CardioPass to complete the needed revascularization.

Michael Szycher, Ph.D., Chairman and CEO, CardioTech, stated, "We regard this response by the notified body as an important, positive milestone to obtaining marketing approval in Europe for the CardioPass graft. We believe that CardioTech is the only company that is actively seeking regulatory approval for a synthetic coronary artificial bypass graft to address the growing, unmet need for today's bypass patients who have advanced coronary disease."

Data collected during this European trial may also be used to support the application to obtain an Investigational Device Exemption (IDE) in the United States is granted by the FDA to allow clinical trials in the United States. CardioTech will be working with the broad depth of clinical, surgical, and regulatory experts available to the company to construct and perform this trial in accordance with Good Clinical Practice (GCP) standards.

Ye ha !!!!

Thanks Michael

[Michael]

Hi Usedcast,

You are most welcome 

Quite funny to see the reaction to the press release today.

The stock started trading down. I guess because everybody had hoped for an approval. Instead CTE have to make additional trials.

But here is the real news. CTE had asked for approval for only "no-option" patients and the notifying body turns around and say we would like to expand that to Patients suboptimal vessels.

Now this is great news. Not only do they between the lines say that they like CardioPass they also say that they would like to expand the indication for which CardioPass can be used for. This means a dramatic increase in the market potential for CardioPass.

Great news and it seems like when the market had time to digest the press release they turned around and allowed the stock to run

Mike

[la-onda]

nice move but I can´t find any news...

[fous]

Lol what a deja-vu,

i just saw this ticker on an old notepad that i wrote on i had lying around like yesterday or something and was meaning to check it out and see what was going on with the chart. And now i know 

Thanks for the update oliver(applauds)

chart looks hot lately, might be something to look into

-fous

[la-onda]

reason for todays price action ?

CardioTech Signs Exclusive Supply and Royalty Agreement, Marking Entry Into Orthopedic Market for its Polymer Technology
Tuesday October 24, 10:30 am ET

WILMINGTON, Mass., Oct. 24 /PRNewswire-FirstCall/ -- CardioTech International, Inc. (Amex: CTE - News), a developer and manufacturer of advanced materials and medical devices for the treatment of cardiovascular and other diseases, today reported that it has signed a supply and royalty agreement with a leading developer and manufacturer of orthopedic devices. Under the terms of the in-perpetuity agreement, the Company provides exclusive use and supply of its proprietary ChronoFlex® polymer material that is specifically formulated for the development of orthopedic implant devices.
Commenting on the new partnership, Michael Adams, CEO and President, CardioTech said: "We are excited about this partnership. This agreement fits into our strategic goal to incorporate our proprietary polymer technology into a wide range of breakthrough medical applications."
"This agreement represents the first application of CardioTech's proprietary polymer technology for orthopedic devices. Our novel polymers have an array of mechanical properties that can be customized for a wide spectrum of applications in many medical fields," said Dr. Andrew M. Reed, CardioTech's Vice President of Science and Technology.