Bioheart

Bioheart, Inc., which operated under the name U.S. Stem Cell, Inc. from 2015, positioned itself in the regenerative medicine sector, focusing on autologous cell therapies for degenerative conditions. The company was founded as Bioheart in early 1999 by Howard Leonhardt, an inventor and serial entrepreneur with numerous patents in cardiovascular disease treatments. Leonhardt's background in developing medical devices, including the TALENT stent graft, informed the company's initial focus on applying adult muscle stem cells to treat heart failure.

The company's business model encompassed several divisions, including physician training, veterinary applications through its Vetbiologics division, stem cell banking, and the management of stem cell clinics. Revenue was generated through these services and the sale of cell collection and treatment kits. A key product was AdipoCell™, a kit used to isolate a patient's own stem cells from adipose (fat) tissue. This procedure involves a minimally invasive liposuction to harvest about 60 ml of fat, which is then processed to isolate the stromal vascular fraction (SVF). The resulting concentration of stem cells was then administered back to the patient to potentially reduce inflammation and repair damaged tissue for a variety of conditions, including orthopedic, autoimmune, and neurological diseases.

In August 2015, Bioheart announced its plan to change its name to U.S. Stem Cell, Inc., a move that was finalized in November 2015. This rebranding was intended to align the corporate identity with its product offerings, as its customers already knew them by the U.S. Stem Cell brand. However, the company faced significant legal challenges. In May 2018, the U.S. Department of Justice, on behalf of the Food and Drug Administration (FDA), initiated legal action against U.S. Stem Cell and its Chief Scientific Officer, Kristin Comella. The FDA contended that the company's SVF products were unapproved drugs and that the company made unsubstantiated claims about their efficacy for treating serious diseases. In June 2019, a federal court granted an injunction, ordering the company to stop manufacturing and distributing its SVF products until they complied with FDA regulations. The court ruled that the products were both adulterated and misbranded. Kristin Comella resigned from her positions in September 2019. The company also had a history of financial disputes, including a 2015 lawsuit over millions in unpaid debt, which was eventually settled.

Keywords: Bioheart, U.S. Stem Cell Inc., Howard Leonhardt, regenerative medicine, autologous cell therapy, AdipoCell, stem cell therapy, adipose-derived stem cells, stromal vascular fraction, cardiovascular disease treatment, physician training, veterinary regenerative medicine, Vetbiologics, MyoCell, FDA injunction, Kristin Comella, cell-based therapeutics, stem cell banking, autologous muscle cells