As we discussed in our first article on elite regenerative medicine companies, there are several methodologies to delineating the cream of the crop. In this exercise, we will take a look at the impact that regenerative medicine technologies can have on ischemic conditions where tissue in the heart, brain, organs or limbs are damaged as a result of restricted blood flow and identify some of the most innovative companies that have a strong upside based on the products and technologies they are developing, stage of development, and current valuations.
Ischemic conditions are expansive, covering common conditions such as stroke, heart disease and peripheral vascular disease (which in severe cases can result in critical limb ischemia, requiring amputation of digits or limbs). The economic impact of these types of conditions is also substantial. Research by the American Heart Association indicates that cardiovascular disease (most of which is ischemic in nature) comprises more than $300 billion in healthcare related expenses annually, accounting for more than 17% of total healthcare related expenses in the U.S. Furthermore, these conditions impose a huge quality of life burden for patients and their families, and therefore are areas of great unmet medical need.
From a company and investor perspective, they represent multi-billion-dollar opportunities. Cumulatively, hundreds of millions of people are affected globally, but traditional medicines and clinical treatments provide little benefit. Regenerative medicine technologies represent new options that could yield a new age of therapies and viable solutions for patients that presently have very few, if any, options.
In our initial article, Cytomedix, Inc. (OTCQX:CMXI) was omitted from the top five because of the broad scope of credentials defining companies with obvious headroom for growth. Within the parameters of ischemia-related treatments, however, the Gaithersburg, Maryland-based developer of biologically active regenerative therapies deserves a strong mention.
Cytomedix is developing platelet technologies for orthopedics and wound care and a pipeline of autologous (patient-derived) stem cell therapies for tissue repair. The company is already generating revenue through its AutoloGel System, a platelet rich plasma (PRP) producing device for exuding wounds, and its Angel Whole Blood Separation System, a blood processing device for separating whole blood into red cells, platelet poor plasma (PPP) and PRP for use in surgical and orthopedic settings. For the third quarter of 2012, total revenues increased 15% to $1.76 million from $1.53 million in the year prior quarter.
Honing in on the ischemic conditions, through the acquisition of Aldagen in February at a bargain price of $16 million in stock (plus additional shares upon milestones being met), Cytomedix gained control of Aldagens proprietary ALDH bright cell (ALDHbr) technology and finally made the transition from just a wound care company to cement its position as a leading developer of a promising new therapy to treat patients that have recently suffered a stroke.
The ALDHbr technology is used to isolate biologically active stem cells which have previously shown the potential to promote cell and tissue regeneration in preclinical studies. The cells are isolated from the patients own bone marrow, shipped to the company for subsequent expansion, and are then reinfused into the patient roughly 3 weeks later. A 100-patient Phase 2 trial for the treatment of ischemic stroke using ALDHbr Bright Cells derived from a patients own bone marrow is underway that will involve patients from 12 to 15 sites in the United States. Safety data from the first 10 patients in the Phase II RECOVER-Stroke study of ALD-401 were recently presented at the World Stroke Congress in Brazil showing a solid safety profile.
The clinical trials aim to build upon promising laboratory research. Mice treated with ALD-401 two weeks after an induced stroke demonstrated nearly four-fold improvement in motor function compared to controls. Further, stark improvements were seen in ALD-401 slowing decreases in brain volume and the reversal of decline in stroke-induced cell viability. Additional studies with ALD-401 in animal models showed perfusion (blood flow) levels returning to normal after four weeks in stroke-induced subjects receiving the ALDHbr cell treatment while untreated controls remained impaired.
This study is only one of several clinical trials being conducted to test Cytomedixs ALDHbr technology. ALD-201 has completed a Phase I clinical trial testing its safety as a therapeutic candidate for ischemic heart failure. The 20-patient trial showed ALD-201 to be well-tolerated and produced a statistically significant reduction in ischemia as well as improvement in MaxVO2, a measure of the bodys ability to take up oxygen during exercise, in patients receiving the ALDHbr therapy as compared to a placebo group.
In a 21-patient Phase 1/2 clinical trial on ALD-301 testing critical limb ischemia with no revascularization options, the treatment was again well-tolerated with data indicating improved blood flow. Patients with this condition face a 35% risk of limb amputation, but 10 of the 11 patients (91%) treated with ALD-301 required no such procedure.
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Top Three Regenerative Medicine Companies Targeting Ischemic Conditions