Bioheart, Inc. And Cytori Therapeutics: The Difference Is In The Business Plan

Bioheart, Inc. and Cytori Therapeutics are included in our small cap sector companies.  Both extract and create a broth of stem and other autologus, adipose derived, regenerative cells (here, as in the medical devices the companies are relying upon, there are proprietary differences) which can be reintroduced to the patient for therapeutic use.  While Cytori (perhaps because of its early partnership with Olympus) has pressed for regulatory approval and market introduction in Europe and Japan, Bioheart has been attempting to gain approvals in the U.S. and European markets.  Bioheart has a market value of 11 million; Cytori's market value is 111 million.

Cytori has developed and patented a device (the Celution™ System) which extracts adipose tissue (fat), separates out stem (and what Cytori refers to as 'other regenerative cells) cells, and prepares them for redelivery to the patient at point of care.  Bioheart has developed a culturing process for myoblasts described in their 10k as follows:

MyoCell is a clinical therapy intended to improve cardiac function and designed to be utilized months or even years after a patient has suffered severe heart damage due to a heart attack or other cause. We believe that MyoCell has the potential to become a leading treatment for severe, chronic damage to the heart due to its perceived ability to satisfy, at least in part, what we believe to be an unmet demand for more effective and/or more affordable therapies for chronic heart damage. MyoCell uses myoblasts, cells that are precursors to muscle cells, from the patient’s own body. The myoblasts are removed from a patient’s thigh muscle, isolated, grown through our proprietary cell culturing process, and injected directly in the scar tissue of a patient’s heart. 

Bioheart is also developing an immediate response product for myocardial infarction called Bioheart Acute Cell Therapy and intends to use a product made by Tissue Genesis (TGI 1200 is the product, Tissue Genesis is a private company) that does basically the same thing Cytori's Celution system does.  Bioheart's Acute Cell Therapy is a patient derived cell therapy for the treatment of acute Myocardial Infarction (MI), an area also being pursued by Cytori. Unlike MyoCell, which is intended to be used to treat severe heart damage months or even years after a heart attack, Bioheart's Acute Cell Therapy is being designed to be used for the treatment of muscle damage immediately following a heart attack.

Bioheart hopes to demonstrate that the injection of endothelial progenitor and stem cells derived from fat tissue by the TGI 1200 is a safe and effective means of limiting or reversing some of the effects of acute MI and preventing or slowing a patient’s progression from MI to heart failure. On December 12, 2006, Bioheart entered into an agreement with Tissue Genesis that provides Bioheart an exclusive worldwide right to individually use or to sell or lease to medical practitioners and related healthcare entities the following items for the treatment of acute MI and heart failure: The TGI 1200 and certain disposable products used in conjunction with the devices, or the TGI Licensed Processes; and the cells derived using the TGI Licensed Product Candidates and/or the TGI Licensed Processes, or the TGI Licensed Cells.

The following is the description of Cytori's Celution System as set forth in their 10k filed with the SEC in 2007:

"Cytori’s Celution™ System is a sophisticated medical device that allows physicians to offer regenerative therapies at the point of care using the patients' own cells.  It standardizes and automates a process that releases stem and regenerative cells residing naturally within a patient’s own adipose (fat) tissue. The adipose tissue is taken from the patient using a minor liposuction-like procedure, placed into the system and, with the touch of a button, the processing begins. About an hour later, following a tissue wash, cell separation and concentration by the Celution™ System, a prescribed dose of stem and regenerative cells may be delivered back to the patient.

Our Celution™ System will utilize a single-use therapeutic sets containing proprietary Cytori technology, to be used on a per-patient basis. Each therapeutic set is unique and specific for each therapeutic application. For example, the therapeutic set for cardiovascular disease is distinct from that used in reconstructive surgery."

The Tissue Genesis TGI 1200 is described in a recent press release as follows:

"The Tissue Genesis Cell Isolation System is a fully automated system that recovers
potentially regenerative cells from a patient’s own fat in about an hour, with minimal
operator intervention. No tissue pre-processing is required. The system accepts adipose
(fat) tissue from the same device used for liposuctioning the tissue from the patient. The
compact desktop unit readily fits into any clinical environment and uses preconfigured
disposables for quick and easy assembly
.
The company’s Tissue Genesis Cell Isolation System has successfully completed safety
certification testing necessary to complete its declaration of conformity, allowing the
company to apply the CE mark.

Tissue Genesis is currently fulfilling a number of orders from two of its
key Commercialization Consortium partners. Bioheart, Inc. – a biotechnology company
focused on autologous cell therapies for the treatment of chronic and acute heart damage
– recently ordered five systems for its European customers, which are expected to be
delivered by the end of the year.

'This CE marking of the Tissue Genesis Cell Isolation System marks an important
milestone for Bioheart as we transition into a commercial company,” said Howard J.
Leonhardt, Bioheart’s Chairman, CEO and CTO. “We are extremely excited to
commence shipping the systems to our customers.'"

It is easy enough to see that these two companies are using similar technology to achieve therapeutic applications in regenerative medicine.  Both are very early in their commercialization of the technology with Cytori ahead in time and implementation.  Should Cytori have a market value ten times as great as Bioheart?  We will find out over the next two to five years.