Ray Vito, a professor at the Georgia Institute of Technology (Georgia Tech), has been named as the recipient of the Wallace H. Coulter Award for Innovation and Entrepreneurship. Selected from more than 50 research abstracts worldwide, Vito’s work is being recognized for its excellent science, innovation, and potential broad patient impact.

Vito has developed a clinical device that, when implanted mechanically, stimulates growth of new arteries in patients preparing for coronary artery bypass surgery (CABG). The new arteries, when harvested and used as grafts, have the potential to greatly improve the long-term outcomes of bypass patients.

The Coulter Award and a stipend of $100,000 which accompanies it will be presented to Vito on the evening of Friday, Nov. 1, during the Georgia Tech College of Engineering Awards Ceremony in Atlanta.

The award recognizes visionary research in health care technology to help patients – a continuation of Wallace Coulter’s own contributions to the field. Coulter was a member of Georgia Tech’s Class of 1934. His legacy in the field of clinical laboratory medicine is evident every day in thousands of hospitals and clinics around the world. His Coulter Counter is used to perform the most requested and informative diagnostic test in medicine – the complete blood count, or “CBC.” Wallace Coulter, who died in 1998, sought no public acclaim. Instead, he derived satisfaction from the knowledge that his work had improved the quality of life for millions of people.

Distraction Angiogenesis: A Breakthrough in Biomechanics

Designed to stimulate growth in the gastroepiploic artery – a small, disease-free artery about 3-7 mm diameters in size and located below the stomach – the device has shown to be effective in lengthening arterial tissue in pigs by as much as 30 cm – enough for a patient to undergo at least two CABG procedures.

The patented process, developed at Georgia Tech, has been coined “distraction angiogenesis” by Vito, a professor whose primary appointment is in the Woodruff School of Mechanical Engineering. He is also on the program faculty of the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.

Vito is president and CEO of Medanoia Medical Inc., a company he formed in February 2001, along with Jack Griffis, COO, to develop, manufacture and market the device. The process is similar to distraction osteogenesis – a process that has been used clinically since the 1950’s to lengthen bones, especially in the legs and face.

“The long-term outcome of coronary bypass surgery is critically dependent on the graft that is used,” Vito said. “The consensus among surgeons and cardiologists is that arterial grafts are preferable to venous grafts (veins) because they stay open much longer. However, the human body has a very limited supply of arterial tissue that can be harvested without consequence to the patient. Distraction angiogenesis increases the supply of arterial tissue suitable for use as grafts.”

Coronary artery bypass surgery is among the most common operations performed in the world and accounts for more resources expended in cardiovascular medicine than any other single procedure, according to the American Heart Association.

The device, when fully developed, is intended for endoscopic implantation about 30 days prior to a patient’s bypass surgery. After it is implanted, the device is autonomous and continuously distends the gastroepiploic artery, gradually increasing its length. Distraction angiogenesis uses mechanical forces to stimulate the body’s own adaptive processes to produce additional artery.

The engineered artery and device are harvested endoscopically at the time of CABG surgery. The residual artery may be surgically repaired by an end-to-end anastamosis (joining) so that normal blood flow is restored.

Vito and his colleague Griffis plan to continue animal testing and improving the device during the next year, followed by clinical trials. The team hopes to receive FDA approval and bring the product to market within five years or less.

Vito estimates that about 35 percent of the 400,000 bypass patients each year in the U.S. alone do not have the necessary blood vessels for grafting during bypass surgery or other medical procedures. He says surgeons could turn to preserved human (autogenous) veins, but very rarely do so because veins preserved by cryo-preservation or other processes are not durable. Despite considerable industry and university-led efforts, there are no man-made, vascular grafts currently approved for use in CABG.

“The evidence supporting the superiority of arteries as conduits for CABG procedures is overwhelming,” Vito said. “Distraction angiogenesis is a relatively simple way of increasing the supply of autologous arterial tissue without compromising the perfusion of healthy tissue. An all arterial revascularization is cost effective and could dramatically reduce the need for further treatment.”

A Distinguished Career

Vito arrived at Georgia Tech in the fall of 1974 as an assistant professor. He received his Ph.D. from Cornell University in 1971, after earning a bachelor’s and a master’s degree from the State University of New York at Buffalo in 1964 and 1965, respectively. Before joining the Georgia Tech faculty, Vito was a postdoctoral fellow at McMaster University in Canada.

He began his research career studying nonlinear vibrations. After receiving his Ph.D., he changed his focus to biomechanics, particularly soft tissue mechanics. Today Vito’s work is funded by the National Science Foundation, through its support of the Georgia Tech-Emory Center for the Engineering of Living Tissues, and the National Institutes of Health. His focus is on the mechanics of blood vessels, particularly as they relate to vascular grafts for cardiac bypass surgery, and “plaque rupture,” the event that precedes most heart attacks and strokes.

In 1997, Vito was named a fellow of the American Society of Mechanical Engineers. In 2000, he received two distinguished awards reflecting his outstanding abilities as a professor and administrator, one from Georgia Tech’s students and one from its faculty. In the same year, Vito received the Outstanding Service Award and ANAK’s Outstanding Professor Award.

List of Semifinalists

There were five semifinalists, each receiving a stipend of $10,000:

Susan P. James, Ph.D. and Joan M. Burleigh, Ph.D.
Colorado State University
SyncPhase Labs, LLC, has patent-pending technology for the diagnosis and accommodation of central auditory processing disorders involving Binaural Asynchronies. Typically, individuals with central auditory processing disorders have completely normal peripheral hearing but have great difficulty understanding speech stimuli when background noise is present. Many also have challenges in speech, visual and motor function that can be helped with SyncPhase Labs’ technology.

Paul Sanberg, Ph.D. and Don Cameron, Ph.D.
Saneron CCEL Therapeutics, Inc.
Saneron CCEL Therapeutics, Inc., is an entrepreneurial, biotechnology R&D start-up company focused on neurological cell therapy for the early intervention and treatment of several devastating or deadly diseases, which currently lack adequate treatment options. Saneron CCEL is committed to providing readily available, non-controversial, ethically acceptable stem cells for cellular therapies and has exclusively licensed patented technology relating to our platform technology of umbilical cord blood and Sertoli cells.

Melissa Knothe Tate, Ph.D. and Ulf Knothe, M.D.
Departments of Biomedical Engineering and Orthopaedics
The Lerner Research Institute, Cleveland Clinic Foundation
Melissa Knothe Tate, a mechanical engineer and bone biologist, and Ulf Knothe, an orthopaedic surgeon, have joined forces to develop novel, bioactive materials for the orthobiologics market. The material has unique biophysical and functional characteristics for skeletal tissue engineering and regeneration. It is designed to increase success rates and longevity of joint replacements.

Geoffrey Thrope and Warren Grill, Ph.D.
NDI Medical, LLC
Case Western Reserve University
Geoffrey Thrope is president of NDI Medical, LLC, and Warren Grill is a professor at Case Western Reserve University. NDI Medical, LLC, is an early stage neurological medical device start-up company engaged in the development of an electrical stimulation platform technology that will be used as a foundation for treating bladder, bowel and sexual conditions. The company is in the process of transferring technology from Case Western Reserve University to commercialize a product that will address urinary incontinence.

Edmund K. Waller, M.D., Ph.D.
Emory University School of Medicine, Bone Marrow and Stem Cell Transplant Center, Department of Hematology/Oncology, Winship Cancer Institute
Ned Waller has developed a novel method of treating cancer patients: removing the cells that suppress natural anti-cancer immune responses. These cells have been associated with an increased rate of relapse in patients undergoing donor bone marrow transplants as treatment for leukemia or lymphoma. Waller’s research has shown that the removal of this subset of dendritic cells can increase the ability of transplanted donor cells to eradicate the residual cancer cells that persist in patients after treatment with chemotherapy.

Last Year of the Award

The Wallace H. Coulter Award for Innovation and Entrepreneurship was the first program initiated by the Wallace H. Coulter Foundation in 1998, which at that time was in its formation. The award was developed in order to stimulate innovation and support visionary researchers, so that they would have a chance to succeed in launching health care technology.

Five worthy inventors around the country have been recognized over the years (list can be found at www.coulter.gatech.edu). The award gave these individuals funds to move their technology closer toward broad patient access through commercialization.

The Award also cemented Georgia Tech’s relationship with the Coulter Foundation that resulted in a $25 million grant to name the joint biomedical engineering department between Georgia Tech and Emory in Wallace Coulter’s honor. Eight millions dollars of the grant supports a cutting edge program to fund translational biomedical engineering research with the goal of accelerating research from the lab to the bedside. Although still in its infancy this program already has funded 7 collaborative projects resulting in patents issued, companies launched and follow-on capital being raised.

This will be the final year of The Wallace H. Coulter Award for Innovation and Entrepreneurship in this format. Its objective to encourage translational research in biomedical engineering will be supported more comprehensively in the Foundation’s future programs.