Harvest Technologies is a private company now competing head to head with our Publicly Traded Sector Company, Thermogenesis (KOOL). We say 'now' because, while Harvest has been in the bone marrow stem cell point of care harvesting and processing business for some time, Thermogenesis now has an entry in this market as well.
What these three companies have in common is this: Each subscribes to the notion that point of care processing and delivery of autologous stem cells and related growth factors will be superior to existing approaches and to alternative stem cell treatment solutions for certain therapeutic applications. Each company is supporting one or more clinical tests that use the particular company's stem cell processing device, an approach that feeds the implication that a therapeutic result is tied directly to the use of the device.
Harvest Technologies, a privately held company, has upped the ante by being the first of the three to gain FDA approval for a clinical test here in the United States. The Food and Drug Administration has granted Investigational Device Exemption (IDE) approval to commence Harvest's BMAC Enhanced coronary artery bypass grafting (CABG) Trial. This is a two phase 42-patient 'feasibility' clinical trial using the company's BMAC System to concentrate autologous bone marrow cells to treat patients with congestive heart failure undergoing treatment with coronary artery bypass grafting surgery.
Both Cytori Therapeutics (CYTX) and Thermogenesis (KOOL) are supporting European trials that use their processing devices. Cytori is sponsoring two European clinical trials that evaluate the use of adipose-derived stem and regenerative cells (ADRCs) to treat acute myocardial infarction (heart attack) and chronic myocardial ischemia (a severe form of coronary artery disease).
Thermogenesis has provided its MarrowXpress bone marrow stem cell processing device to the Univesity of Naples where a study on the effect of bone marrow derived mononuclear cells on patients with critical limb ischemia (CLI) is taking place.
We've posted on several occasions about the similarities and differences between our two Stem Cell Sector companies, Thermogenesis (KOOL) and Cytori Therapeutics (CYTX). Type 'Cytori and Thermogenesis' in the custom Google search engine in the right column and you'll find them all.
Both Cytori and Thermogenesis make devices that extract and process stem cells. Both companies make equipment to cryopreserve stem cells. Cytori's Celution system for adipose stem cells works at point of care. Thermogenesis began in cryopreservation business for cord blood stem cells. Equipment made specifically for and sold into that market has made them a $20 million per years sales company, although the company is still not profitable. Thermogenesis has entered the point of care competition with its Res-Q device. It's MarrowXpress is a rapid bone marrow stem cell processing device for use in the laboratory.
See the Harvest Technologies announcement via Reuters.
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