MEDIA RELEASE - For immediate release
Contact: George Barr 704. 241.5029
VasoWave™ Technology Poised to Transform Organ Transplant Process
Company aims for 2012 approval of new technology
NOVEMBER 17, 2010 – North Carolina-based Smart Perfusion is finalizing its revolutionary organ transplant technology, VasoWave™, a system that completely transforms the transplant process both for organ recipients and the doctors who perform the surgeries.
Founded in 2007 by CEO George Barr and Chief Technical Officer Donald Faulkner, Smart Perfusion has embraced the value of organ preservation using machine perfusion, an idea that has been talked about in the medical community for more than 40 years, and now made it a reality. VasoWave’s technology will assess, condition, restore and preserve organs – beginning with kidney and liver - during the time they are out of the body and prior to the transplant procedure. What happens during this critical out-of-body timeframe impacts the success of the transplant both at the time of the surgery and in the patient’s body.
“This is transformative technology and we’re going into a space where there is nothing comparable for liver transplant,” said Dr. David Gerber, Smart Perfusion’s chief medical officer and the division chief of Abdominal Transplant Surgery at the University of North Carolina at Chapel Hill. “It surges past the technology now available for kidneys. VasoWave is an unprecedented innovation.”
Dr. Gerber said that organ transplantation is still being done using the same technology and procedures that were used in 1970. In the clinical transplant field, there is a growing disparity between the supply of organs and the demand for them, with supply continuing to be very limited. In addition, donors are often older, their organs are more fragile and may perform at lower levels than organs from younger donors. Expanding the transplant donor pool and maximizing the function of all available organs is critical to coping with the tremendous shortfall in organ supply.
“We have shown that the unique waveform and conditions of VasoWave’s organ preservation do just that – they preserve organs instead of slowing their deterioration,” said Dr. John Robertson, the company’s chief science officer and expert in translational medical problem solving. “We can demonstrate very effective fluid circulation down to the level of tiny capillaries, the place where cells interface with the circulation. We have demonstrated that a unique pulse waveform helps create better transplants – ones more likely to work and to continue to work.”
The VasoWave system puts organs destined for transplant in an environment very close to their natural physiological state, in conditions similar to the body, according to Faulkner, who is heading up the equipment development process that will move the VasoWave technology out of the lab and into actual practice. He calls this point in the creation of the VasoWave System “an exciting juncture where we are translating an idea through the basic physiologic and engineering science into a robust medical application.”
The VasoWave system is capable of preserving organs of any size, from tiny pediatric kidneys to full-size livers that can be up to 20 times larger than a kidney. VasoWave organ preservation can be precisely matched to the individual needs of each organ to ensure the very best outcome.
Drs. Gerber and Robertson have led the biomedical development process of VasoWave during the last three years, progressing from laboratory animals to pigs with kidney testing and then to larger animals and humans with liver testing. Dr. Gerber said another positive aspect is that better science and knowledge have been developed during this research effort that show the VasoWave system provides significantly improved organ preservation functions compared with what has been available for the past four decades.
A key VasoWave milestone is that six pig livers and two human livers have been successfully put on the VasoWave system in pre-clinical trials at the research and development laboratories at Virginia Tech and at UNC-Chapel Hill. Pigs are an excellent pre-clinical translational model for this work since they have a similar organ size, composition/structure and physiology to people. Because porcine livers most closely match those of a human, these continued and successful porcine tests of VasoWave pave the way for final medical validation and FDA approval.
Smart Perfusion’s CEO Barr said the technology company is moving ahead with raising $1.5 million needed for the next step of introducing to the medical community. The technology’s impact is something of which he is very certain and why the team was put in place in 2007.
“The impact is massive, it’s a new Gold Standard for the transplant world,” Barr said. “VasoWave is revolutionary because it will deliver on the long-held promise of increasing the organ supply. All who need one can get one.”
Making the technology available as soon as possible will bring immediate results, according to Dr. Robertson.
“Transplantation itself was a revolution. We are now ready to take it from something helping 10-15% of the people who desperately need it to 100% of those who do,” said Dr. Robertson. “We may not hit 100% immediately, but if we don’t perfect and deploy VasoWave, 85% of those patients desperately needing organs are not going to get them.”
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Smart Perfusion www.smartperfusion.com 704 241 5029 gbarr@smartperfusion.com