Blood pumps: technologies and markets in transformation.

The heart failure industry or sector of blood pump technologies comprised of scientists, medicine, and business has inadequate attention from the financial community due to the perception of unmet market potential and regulatory hurdles. There are more than 20 mechanical circulatory support technologies currently in some stage of development. The application is defined initially for emerging technologies as bridge-to-transplant whereas more mature devices have focused on bridge-to-recovery and alternative-to-transplant. Regulatory hurdles and financing resources have dictated this initial application strategy. Whether a technology has valves, bearings, is magnetically suspended, acts as a pressure cuff, and so on, the future will belong in large part to those technologies that are less expensive, have improved ergonomics, are simpler in surgical application, and can demonstrate efficacy levels that are an improvement over today's approved devices. Today's devices have provided a valuable platform for the emerging technologies. However, there has been little market expansion over these past years, relative to the potential market. The cardiologist is the patient's gatekeeper, and drugs appear to be the therapy of choice as options are considered. Technologies without a business model will have a difficult time attracting much needed funding, the result being protracted development times or project termination. MicroMed has modified its ventricular assist device (VAD) focus, with a broader look at treating the heart failure patient. MicroMed recently entered into an agreement with Chrysalis Biotechnology, Inc., Galveston, TX, covering a synthetic peptide technology (Chrysalin) that when injected into tissue has demonstrated an angiogenic effect without the concerns inherent in recombinant angiogenic/growth factors. We believe a combination therapy of the DeBakey VAD-synthetic peptide could provide sufficient revascularization for bridge-to-recovery or as an alternative-to-transplant in certain patients.