Over the last few years, Cytori Therapeutics (NASDAQ:CYTX) has had a very poor record of delivering on its own words, specifically as they relate to the timing of partnerships, the need for additional capital and an expected EU approval for the treatment of No Option CMI (chronic myocardial ischemia) patients. With the exception of a huge but unexpected victory related to its $106,000,000 contract with the Biomedical Advanced Research and Developmental Authority last year (discussed in depth here), this inability to deliver has spooked investors, damaged credibility and hammered its share price.
So how might management react in the face of shareholder outrage over repeated delays in meeting its goals, failures that where probably as unexpected to Cytori as they were to its shareholder base? Well, we may have just seen a hint of this in today's very short and understated press release:
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics has received a CE Mark in Europe for Intravase®, a reagent intended to be used with Cytori's Celution® System for preparing safe and optimized adipose-derived stem and regenerative cells (ADRCs) for intravascular delivery into the same patient.
"This approval expands our market access for our cell therapy platform to include intravascular applications," said Marc Hedrick, President of Cytori Therapeutics. "As a result, this is expected to contribute to revenue growth in 2013 and beyond. We will target select centers to build patient data, which we believe can be used to further expand these claims and increase the adoption of our technology. Furthermore, CE Mark approval of Intravase will allow independent European investigators to conduct their own vascular studies."
Intravase is a sterile, GMP-grade secondary reagent used with the Celution System to prepare the Celution cell output for safe intravascular delivery. Intravase is currently being used in both our U.S. ATHENA trial in patients with refractory heart failure due to chronic myocardial ischemia and the European ADVANCE trial for acute heart attack patients.
Instead of continuing the pattern of over-promising and under-delivering, based on this short and curt press release in what should be a very significant step in Cytori's ultimate goal of creating a regenerative platform of therapeutic treatments that harnesses the body's own regenerative cells, the new thinking at Cytori may just be, "let's keep our collective mouth shut and just let execution speak for itself ... no more promises!".
Despite its plain vanilla tone, this news release is very significant, not just to Cytori but for the advancement of regenerative medicine in general. Cytori becomes the first cell based company that can market and sell its ADRC platform in Europe for the delivery of regenerative cells into the same patient for the treatment any vascular related disease. This broad approval covers many indications, including myocardial ischemia (for which it is still awaiting specific EU approval), acute myocardial infacrtion (heart attack), stroke, peripheral vascular disease among other vascular related diseases. This approval represents a back door approach to getting its technology into the European market and will result in several patient registries that will monitor results that have been shown to be very effective in previous clinical trials. In the upcoming months and years, with successful treatment results, Cytori can submit registry data to authorities for reimbursement based on what should be a very cost effective treatment compared to the status quo. Reimbursement will allow Cytori to expand its market share exponentially in many muti-billion dollar markets. Just as important, this approval creates a badly needed and immediate revenue opportunity for Cytori and gives them one more feather in their cap with regard to negotiations related to partnership opportunities.
Patients have been clamoring for stem cell treatments where conventional treatments have failed them. The proliferation of stem cell clinics throughout the world, few of which are legitimate, is evidence of regenerative treatment technologies moving faster than the ability of global regulatory authorities keep up and to the desperation of those who can no longer afford to wait for treatment. Some have seen this as a legitimate opportunity. Last August I wrote about a first class treatment center, called the Okyanos Heart Institute, that was being set up in the Bahamas to treat no option heart disease patents based solely on Cytori's PRECISE clinical results. I viewed Okyanos as further independent evidence of the promise of Cytori's platform.
The problem with Cytori has never been with the science but on its ability to execute versus the expectations it has created among investors. Hopefully 2013 will see this pattern reversed.
Additional disclosure: These are the personal views of Wall Street Titan and should not be relied upon for investment decisions. All investors should always do their own due diligence.