RegenoCELL Therapeutics Inc. (OTCBB: RCLL), a provider of stem cell therapy for congestive heart failure and developer of therapeutics for peripheral artery disease , differs from Aastrom Biosciences Inc. (NASDAQ: ASTM) or Advanced Cell Technology (OTCBB: ACTC.OB) in that it is already actively marketing its therapy and simultaneously developing a U.S./E.U. solution.
Efficacious Treatment Already Generating Revenues
RegenoCELL is unique in that it’s already generating revenues from stem cell therapy that targets congestive heart failure. Many of these patients only have 3-6 months to live and have run out of options within the United States. Patients simply have a half liter of blood drawn which is sent to the company’s Israeli facility where stem cells and other more mature cells are extracted and replicated.
Since stem cell procedures for indications other than cancer require approval in the United States, patients are transported to countries where autologous (same patient) stem cell treatments are permitted to undergo an angioplasty-like procedure. The stem cells help create blood vessels in order to improve blood flow in the heart. While the procedure isn’t covered by insurance right now, the company has already realized over $600,000 in sales so far in 2011.
After undergoing the treatment, patients almost immediately report feeling better and realize the majority of the benefits after 3-6 months. With more than 500 patients treated, the company has seen a 90%+ survival rate after two years. This statistic is impressive given that many of these patients were so-called “no option” patients with 3 to 6 months to live.
Profits Used to Fund U.S. and E.U. Clinical Trials
RegenoCELL is working to scale its revenue generating business to help support its U.S. and E.U. clinical trials. With just 8 cell batches per month required to break even on its revenue generating business, the company has a very scalable model and is poised to get beyond break even at its cell processing operations in Israel next year. That cash coupled with raises over two years will fund these upcoming clinical trials.
The clinical trials will be focused on peripheral artery disease, but will use the same stem cell treatment as its congestive heart failure therapy. That is, stem cells are used to support angiogenesis and improve blood flow. Ultimately, an approval for this indication would enable it to receive insurance payouts and target much larger potential markets.
The data generated in its existing business may also help it expedite clinical trials. For instance, the safety profile of the therapy is well established with over 500 patients treated, meaning that it may be able to skip or fast track its way through Phase I safety trials. And the efficacy data could even help expedite its Phase II preliminary efficacy trials.
A Great Investment Opportunity
RegenoCELL is unlike many other stem cell companies in that it’s already generating revenues, but still has long-term plans to market in the U.S. and E.U. On top of this, the favorable results from 500 patients already treated should help give some clarity to its clinical pipeline. Combined, this makes it an attractive investment opportunity for those in biotech.
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