The mission of the Biomedical Advanced Research and Development Authority (BARDA) is "to develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases." One can only imagine how the recent nonstop barrage of saber-rattling by North Korea to unleash its self proclaimed nuclear arsenal on its neighbors and the United States has raised the concerns of Carol Linden, its Director, even if the intelligence is mixed with regard Kim Jong-un's ability to do so.
Six months ago, BARDA took an important step forward to fulfill its responsibility to mitigate the effects of a nuclear event when it signed a $106,000,000 agreement with Cytori Therapeutics (NASDAQ:CYTX) that finances a cutting edge stem cell technology to treat survivors who may have been exposed to thermal burns in conjunction with radiation poisoning. The market has not given Cytori much credit for this watershed agreement considering that BARDA will finance the entire development of the next generation, table top version of Cytori's technology that is the core of a platform to treat multiple diseases. All that Cytori needs to do is demonstrate that it can treat large animals with concurrent radiation and thermal burn wounds to get to the next phase of the contract. Importantly, it has already done both in humans, although not concurrently. BARDA envisions purchasing thousands of these tabletop units for widespread distribution into hospitals throughout the nation, along with the specific consumables that are used for this procedure. For those who are unfamiliar with Cytori's technology, it utilizes the most abundant source of stem cells in the human body, fat, and quickly extracts a mixture of adipose derived regenerative cells that have been shown to have remarkable powers to treat multiple afflictions.
In a Seeking Alpha article dated October 8th, I went in to great detail about the specifics and financial ramifications of the BARDA contract. Those who want a better understanding of the contract would be well advised to read that article and follow the links as part of their due diligence. As previously mentioned, the first phase of the BARDA contract ($4.7 million), currently in the implementation stage, envisioned a 2 year time frame to show efficacy in a pre-clinical study on large animals. However, in a recent presentation, Cytori CFO Mark Saad stated, "…our objective is to get this done by the end of the year." Investors may not appreciate that BARDA has the ability begin procuring Cytori technology upon completion of this first stage of the contract, for hospitals and medical clinics throughout the nation, as part of its national defense plan. The procurement of the device by BARDA is NOT part of this $106,000,000 contract. It should be pretty obvious what success here would mean to Cytori's share price.
Importantly for Cytori, BARDA does not require FDA approval to implement this procurement plan even though it is financing Cytori's path to FDA clearance for the new desktop device and for the specific indication of treating of thermal radiation burns. It is interesting to note that the FDA is a sister organization of BARDA. Other obvious markets for this treatment are Japan and South Korea. Don't you think that both of these countries, especially Japan with its nuclear history, are looking at protecting their citizens from the North Korean threat?
I've only touched on a small portion of Cytori's potential in this article and so far my bullish stance over the last few years has been premature due to failures by the company to execute to the market's expectations and, for that matter, to management's own expectations. However, the bottom line is that Cytori possesses an IP protected technology that will likely have a profound effect on medical care as we know it and the BARDA contract is a key catalyst in reaching its goals. BARDA surely evaluated several proposals from competing regenerative medicine companies and chose the Cytori approach. That says something about Cytori's technology. It's just a matter of time before investors begin recognizing this.
Additional disclosure: These are the personal views of Wall Street Titan and should not be relied upon for your investment decisions. All investors should always do their own due diligence!