Here are a few thoughts from the DD I have completed over the past couple of days. Please do not make any decisions on this information alone. There is much to learn about ASTM and what they are doing. My thoughts come from reading through information provided by the company (Annual Report, 10Q, etc.), conversation with CFO of the Company, and other relevant information that has been provided here and on other net forums. I will try not to reiterate any obvious facts already presented.
As we know from the latest press release ASTM just received the CE mark in Europe which allows them to begin marketing their system in the European market. France, Germany, Italy, Belgium were names that were mentioned as possibilities. According to the Company they are currently handling European marketing "in-house" and are in the process of identifying marketing and distribution relationships. From my understanding the major difference between approval in the U.S. and Europe is that in Europe ASTM platform is considered medical equipment whereas here it is considered a "medical device." I am not quite sure what the distinction is here. The goal for the U.S. is to obtain Premarket Approval(PMA) necessary to market ASTM system. To this end there are multi-site clinical trials being conducted in the U.S. In collaboration with Loyola Univ. Medical Center and Hackensack Univ. Medical Center, ASTM is conducting two trials. One in which the "ASTM cells grown from small aspirate bone marrow collections are the sole source of ablative chemotherapy" and one in which ASTM method is used to complement more traditional methods. Also umbilical cord transplant trials are going on at Duke University for pediatric patients and at Loyola and Hackensack Universities for adult patients. Here is where I have seen the first "human" impact of this system. In the annual report is a picture of a little girl named Fabiana Leibl, a cord blood transplant patient. With here is Joanne Kurtzberg, M.D. director of Duke University Medical Center. She states "For Fabiana, the critical challenge was obtaining enough cells for transplant. By using the AastromReplicell System, we succeeded!...and now she has a second chance at life." This is pretty powerful stuff.
From what I have gathered there appears to be four distinct advantages that ASTM has over traditional cell therapy.
1) "Small volume cell collection for ASTM system requires less than 2 hours and only a few needle sticks, whereas PBSC collection can require over 20 hours and 100 or more needle pricks.
2) "Research studies have demonstrated ASTM's systems purges tumors as part of its process whereby traditional methods require additional processing steps that add technical risk and cost.
3) "Tradiional procedures allow only one transplant procedure , ASTM allows multiple transplant procedures from a single collection.
4) "Traditional methods restrict transplant to small patients, ASTM allows transplants to adults due to larger cell doses.
There are approximately 50,000 stem cell transplants done worldwire each year. The cost of these procedures range from $10,000 to $20,000 making this a 1/2 to 1 billion dollar market.
The company currently has about $12m dollars in liquid assets. (Cash and cash equivilants) From their cash flow statement it appears they are using about $3m a quarter. One concern I have heard is that the Federal ban on cell research might affect ASTM's ability to receive additional funding. This is not the case. The type of research ASTM is doing is not embryonic research like Geron is doing and according to the Company they will not be affected at all by any of these Federal bans should they continue. I don't think raising funds is that great a concern at this point. The Company has several funding options including grant revenue, research funding, restricted preferred stock sells, joint venture possibilities, etc. IMO they may also be seriously looked at as a buyout. Their patents alone make them an attractive company.
There are many articles written by and about ASTM and its processes. Some of the most interesting include an article seen in The New York Times dated July 7, 1997 written by Teresa Riordan entitled "A doctor finds a way to induce rare bone marrow cells to reproduce themselves in the laboratory." This may be where the rumor of a New York Times article was started. Also BioWorld Today on July 24, 1997, "Aastrom Biosciences Granted Four Patents for Method to Culture Cells Ex Vivo."
Others with articles include "Experimental Hematology", "Biotechnology and Bioengineering", "Journal of Hematology","Cytotechnology", and many more.
It appears to me that the Company's main focus right now is on making the medical community aware of its results and receiving clearence from the FDA to begin U.S. marketing. I don't think there prime concern is impressing the Street or being on 60 minutes. I think this is where individul investors can really make a difference by getting the word out to the media, analysts, brokers, etc. I know there are tons I am omitting , but I only have so much time for DD. If anyone has specific questions pleas PM me and I will try to contact the company for follow up questions.
Good luck,
LFISKY
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