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Transfusion & Transplantation Technologies LLC (3Ti) |
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March 18, 2013 Issue |
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The Most Powerful Name In Corporate News and Information |
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Transfusion & Transplantation Technologies LLC (3Ti) is the First Company to Automate the Flow Cytometry Technology used in their Aegis Blood Analyzer for the Pre-Transfusion Diagnostics Market offering Accurate Detection of a Multitude of Antigens in a Single Cell All at the Same Time |
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Transfusion &
Transplantation Technologies (3Ti) is a pre-revenue stage in-vitro
diagnostics company developing novel automated technology for the diagnostic
testing of blood associated with blood transfusions. The Company intends to
compete in the ~$1.4 billion pre-transfusion/immunohematology diagnostics
market worldwide. 3Ti's initial product, the Aegis Blood Analyzer and
associated consumables ("the Aegis System"), is being designed to perform
highly accurate, rapid and cost-effective blood grouping (ABO and Rh), red
blood cell antibody screening/identification, donor/recipient cross-matching
tests and tests for infectious diseases—all with true walk-away automation
and all on a single analyzer. 3Ti believes the Aegis System will be
attractive to hospital transfusion services, clinical reference labs and
blood collections centers contemplating automation for the first time, which
represent a majority of the blood bank testing sites today. 3Ti also
believes the Aegis System will be attractive to currently automated blood
bank sites contemplating replacing and/or upgrading their current systems
with a new or next generation instrumentation like 3Ti’s Aegis System. 3Ti
remains committed to its Mission of
"becoming the standard of care in automated
transfusion blood diagnostics testing worldwide."
President
& CEO |
Medical Device
Transfusion & Transplantation Technologies LLC (3Ti)
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Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – March 18, 2013
CEOCFO: Mr. Walts, what is the concept at Transfusion and Transplantation Technologies, also known as 3Ti? Mr. Walts: We are a devices diagnostic company developing a next generation, automated blood analyzer for the pre-transfusion diagnostics market. Our Aegis analyzer is being developed for the pre-transfusion testing of donated blood as well as blood of a recipient prior to a transfusion. A series of mandated tests are required to make sure that blood involved in blood transfusions is safe and effective. Our automated analyzer will test for blood typing, for certain antibodies, for a cross match test mixing donor and recipient blood and for infectious diseases. Our analyzer incorporates a long proven analytical technology called flow cytometry. We have put that technology in an automated platform and will be the first to successfully bring that technology to blood banking. Its advantages are that it is very, very accurate and sensitive; that it can detect a multitude of antigens located on a single cell—all at the same time, that it can do both cellular and molecular based tests, and that it can automate all of the less routine as well as routine tests—again all on the same instrument. No other technologies on the market or in development have the potential to make similar claims.
CEOCFO: What have you figured out that others have not, to allow you to bring this instrumentation to this situation? Mr. Walts: My Company was founded by two world renowned blood bank doctor physicians at Emory University. Both had long utilized current manual and automated technologies in running the blood bank at Emory. Both were very aware of certain deficiencies in blood bank automation today. They concluded “why can’t blood bank labs be like traditional clinical chemistry labs today, where virtually all tests done in those labs are performed on single automated platform?” That is not the case in blood banking today. Today you do have very good systems, but these systems remain based on over twenty year old off-patent technologies with inherent limitations. Our MD founders felt there was a really big need to get blood bank labs into what they called the twenty first century, where via true and full automation a lab could reduce even further or eliminate the possibility human testing error. And at the same time fully automate virtually all lab tests and all on a single analyzer. They were the ones to explore and select flow cytometry as offering huge potential to help bring blood bank labs into the 21st century. They started the company in the early 2000’s initially as a research venture. I then joined them in the mid 2000’s to help advance the technology and bring it to market. We intend to reach these goals over the next year or so.
CEOCFO: What is the market opportunity? Whom will you be replacing and how do you get them to allow you to do so? Mr. Walts: We will first focus on the large already automated sites in their fourth or fifth year of automation with their current analyzer. It is at this time that these sites have decided to replace their current systems for obsolescence or for wear out reasons. We know which sites are automated sites today and we also know which sites are in their fourth or fifth year with their current automated system. Those sites, by definition will be preparing and budgeting for a new system. Therefore, we will concentrate first on those sites and saying, “Why replace your current system with a newer version of the same automated technology when that core technology remains over 20 years old and still with inherent limitations? Why not put in a next generation automated system capable of automating virtually all your tests “faster, better and cheaper and all on the same instrument?” Because of the high sensitivity and accuracy of our technology we will only require, in certain instances, only one two hundredth the volume reagent to prepare sample for processing versus the current technologies. The reason this is important to you is that we will be able to pass along significant savings in your consumables (reagent) costs, helping you better control your overall lab costs. We think that in some instances you will experience as much as a twenty or thirty percent savings on these consumables, which is significant.
CEOCFO: Where are you in the process? Mr. Walts: We are almost completely finished with our instrument, we are about seventy percent finished on the instrument’s software development and we are about fifty percent finished on reformulating our reagents for use in our system. We anticipate having our FDA clinical trials performed sometime later this year. If things go as expected, we will submit for FDA approval late this or early next year. Then, in about a year from submission we would expect FDA approval—which translates into approval by early 2015.
CEOCFO: What has been the hardest part of the technology to put together? Mr. Walts: Interestingly, the technology development is a very low risk part of our venture. The clinical trials, which typically are very risky and costly when involving therapeutics, are not expected to be a significant risk or cost to us being a diagnostics/device. That is because we are taking already tested blood samples and retesting them and showing equivalency or better—that is it. Said another way, there will be no actual blood transfusion decisions made involving real patients in our clinical studies as that step is not needed to demonstrate efficacy and safety. Also, the regulatory path is pretty straightforward. The instrument application to the FDA will be a straightforward 510(k), because there are already existing predicate devices on the market. And the reagents application will require a BLA, a Biological License Application. Therefore, we think the traditional development and clinical/regulatory risks common to therapeutic or other biotech ventures will be comparatively low and relatively inexpensive for our venture. Probably the single biggest risk remains the securing of adequate outside capital to complete our development and initiate commercialization in support of our current plans—a typical risk of all medical startups. We will likely commercialize through strategic partners to help minimize our commercialization risks as well.
CEOCFO: In terms of funding, different parts of health and devices seem to be in favor at different times. Is your area something that investors tend to look at today? Mr. Walts: The whole institutional investor community is going through a shakeout period as their funding and returns models are pretty broken given our overall economy since say 2008. Early stage or late stage pre-revenue technology companies have always had a difficult time attracting capital but today it is particularly acute. My Company is currently seeking a two and a half million funding round, which will be our first institutional equity financing when it closes. We think this will be particularly attractive to certain investors participating in this round at this time. To our credit we have already raised over $6 million largely by way of NIH STTR grants. We have been awarded seven such grants since founding, which is quite impressive and a vote of confidence that our technology seven different times was judged fund worthy by seven different panels made up of industry experts.
CEOCFO: Is there much, or is there any competing research, that is of note? Mr. Walts: No. A couple other companies are developing their own automated analyzers, but their technologies also have inherent limitations in our opinion. The challenge is not in automating any particular assay--anyone can do that. The challenge is in finding an analyzer technology that that can automate a broad range of assays—all on the same instrument and less expensively than today’s analyzers. No one has been able to do that as of yet. 3Ti believes it will be the first to do this. We know of no other technology with the advantages we have under development today.
CEOCFO: You personally have a long history in the field. What have you learned in past experience that is most applicable at Transfusion & Transplantation Technologies? Mr. Walts: The biggest two priorities for a CEO for these type ventures is bringing on an excellent team and securing financing. Last year we were able to attract a seasoned industry veteran who actually came from a competing company, with twenty-four years heading up their R&D effort as VP of R&D. Prior to joining them he also was the co-inventor of one of the two leading immunoassay technologies on the market today. He also launched the very first automated analyzer in this market in 1998 as well as three subsequent systems while at his last company. Therefore, one key is having an excellent, experienced team with domain experience, and he certainly has that. The other one is fund raising. Fund raising remains no easy feat. But this is my tenth start up during my twenty five years in medical devices and diagnostics. I have taken two startups public and had three of my startups subsequently acquired by industry leaders or a strategic investor. As a result I have developed a large Rolodex of outside institutional investors to tap into over the years. They also know me and my track record which also helps. Our situation at 3Ti is not whether, but when and who will be doing our next financing. Getting an excellent team, having innovative next generation technology with strong IP, and funding are three important ingredients to success. We currently have two of those and are looking to add the third ingredient over the next several months.
CEOCFO: Why does 3Ti, Transfusion Transplantation Technologies, stand out for investors and people in the business community?
Mr. Walts:
To summarize, we have an
enabling, truly novel next generation automated technology in our Aegis
System that will help bring blood bank diagnostics testing into the twenty
first century. Our system is faster and better in terms of more accuracy and
sensitivity than today’s analyzers on the market or in development today.
Our Aegis System will also be able to provide significant cost savings to
blood bank labs continually trying to control their overall costs in the
form of lower cost consumables. The Aegis System is also a “one
system tests all”
platform. This will help address a major problem in blood banking today,
that being a serious and growing shortage of qualified lab technicians to
run the lab. The more a lab can automate its total assay workload, the less
dependent it will be on lab technicians to manually test the “unautomated
assays” still being tested manually even in currently automated labs. Why
not put in an automated system that will allow your lab the ability to fully
automate all your tests so that at a minimum you can redeploy your current
staff for more productivity gains? In short, we intend to revolutionize
blood bank diagnostics and help bring these labs in to the 21st
century in automated diagnostics testing. |
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“We are a devices diagnostic company developing a next generation, automated blood analyzer for the pre-transfusion diagnostics market. Our Aegis analyzer is being developed for the pre-transfusion testing of donated blood as well as blood of a recipient prior to a transfusion. A series of mandated tests are required to make sure that blood involved in blood transfusions is safe and effective. Our automated analyzer will test for blood typing, for certain antibodies, for a cross match test mixing donor and recipient blood and for infectious diseases. Our analyzer incorporates a long proven analytical technology called flow cytometry. We have put that technology in an automated platform and will be the first to successfully bring that technology to blood banking. Its advantages are that it is very, very accurate and sensitive; that it can detect a multitude of antigens located on a single cell—all at the same time, that it can do both cellular and molecular based tests, and that it can automate all of the less routine as well as routine tests—again all on the same instrument. No other technologies on the market or in development have the potential to make similar claims.” - Terence A. Walts |
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Pre-Transfusion Diagnostics, Transfusion & Transplantation Technologies LLC, CEO Interviews 2013, 3Ti, Aegis Blood Analyzer for hospital transfusion services, clinical reference labs, blood collections centers, blood bank testing sites. Medical Device Companies, Recent CEO Interviews, Medical Device Stock, Automated Flow Cytometry Technology, Healthcare Stocks, accurate detection of a multitude of antigens in a single cell at the same time, automated technology for the diagnostic testing of blood associated with blood transfusions, pre-transfusion, immunohematology diagnostics, Aegis Blood Analyzer and associated consumables, the Aegis System designed to perform highly accurate, rapid and cost-effective blood grouping (ABO and Rh), red blood cell antibody screening/identification, donor/recipient cross-matching tests and tests for infectious diseases—all with true walk-away automation and all on a single analyzer, Transfusion & Transplantation Technologies LLC Press Releases, News, Companies looking for venture capital, Angel Investors, private companies looking for investors, healthcare companies seeking investors, medical device companies needing investment capital |
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