History

Privately-held LoneStar Heart, Inc. was founded in June 2010 to develop a cluster of novel technologies and research projects aimed at transforming the treatment of Advanced Heart Failure, one of the most challenging, widespread, and expensive medical conditions affecting societies with ageing populations. Its scientific founders included James T. Willerson, MD, president and medical director of the Texas Heart Institute, and Eric N. Olson, Ph.D., Chairman of the Department of Molecular Biology at the University of Texas Southwestern Medical Center who is one of the world’s leading experts in developmental biology of the heart.

Upon completion of its first round of financing, LoneStar Heart acquired CardioPolymers, Inc., the company originally involved in the development of Algisyl®. The first Algisyl® patient was treated successfully in Munich, Germany in 2009. Having demonstrated safety and long term efficacy of Algisyl in a controlled randomized clinical trial, the product in its surgical (epicardial) version received European approval to market and a US Investigational Device Exemption and approval for a Post Market Approval (PMA) study. In parallel, the Company continued development of a percutaneous approach to deliver Algisyl® in a minimally invasive (endocardial) procedure with MyoTEC™, a catheter system that will be available to interventional cardiologists. Initial clinical studies are being carried out in 2017.

Besides the Algisyl® program, LoneStar Heart gained worldwide exclusive rights to various additional patented technologies aimed at regenerating heart muscle. They include a family of small molecules in addition to stem cell – and gene therapy biologics. The small molecule program also led to the identification of a drug candidate for the treatment of diabetes.

Headquartered in Irvine, California, LoneStar Heart has gone through 3 series of equity financing. It operates on a cash-efficient business model whereby a small core of highly experienced senior managers direct activities primarily through established collaborations with academic and private contract partners ranging from research labs to licensed manufacturers and clinical networks.