Drug-coated stents, which are used to open clogged arteries, can be life savers-if they're implanted correctly.
The $6 billion global stent market has come under scrutiny lately from doctors and researchers concerned that poor technique by cardiologists may contribute to rare but dangerous blood clots that can form after a stent is inserted.
Stents that aren't placed properly over the affected area may enable clots to form. But a device developed by an IUPUI researcher could prevent mishaps by helping guide deployment and improving placement and fitting.
Ghassan S. Kassab, 40, a professor in the Biomedical Engineering Department, is creator of the LumenRECON technology that has caught the attention of the local life sciences and biotech community. His device is nearing the human-testing stage. Indiana life sciences business development initiative BioCrossroads has invested $250,000 from its Indiana Seed Fund I in FlowCo, the company formed in June to take the catheter-type device to market.
Tim Parshall, who was director of corporate marketing and planning at Guidant Corp. before Boston Scientific Corp. acquired the is consult- ing with Kassab and overseeing operations. Before Guidant, Parshall spent 13 years at Eli Lilly and Co. in sales and marketing, most notably as director of global strategy for Zyprexa.
The potential of Kassab's technology and the confidence BioCrossroads President and CEO David Johnson has in him swayed decision-makers to grant the cash infusion.
FlowCo is just the third company to receive funding from BioCrossroads' seed fund and follows CS-Keys Inc., a developer of diagnostic tools to detect breast cancer, and SonarMed Inc., which is creating a new type of breathing tube.
"Is this person really going to be able to go the distance?" Johnson asked. "That's the judgment we're asked to make, and this guy really rang the bell for us. He's a star."
Kassab does have the pedigree to make many venture capitalists drool. FlowCo is the first spinout from 3DT Holdings LLC, a loose acronym for "devices and drugs for diagnostics and therapies." The company has office space on Zionsville Road and holds 50 of his patents, which focus mainly on the areas of organ failure and restoring blood flow to the heart, as well as aneurisms and bariatrics.
Kassab grew up in San Diego and earned undergraduate, graduate and doctorate degrees in various engineering fields from the University of California, San Diego. Upon concluding his studies, he trained under Y.C. Fung, widely known as the father of biomechanics, and ultimately inherited his program at U of C, San Diego.
The university's sister campus in Irvine recruited Kassab in 2001 to help launch its biomedical engineering school, where he stayed until last year. Armed with an endowment, IUPUI attracted Kassab to become the Thomas J. Linnemeier Guidant Chair of the Biomedical Engineering Department and develop a cardiovascular engineering program. He brought 14 people with him, along with his technology.
"I felt this would be a great home," Kassab said. "I realized I was sitting on a lot of [intellectual property] that had been worked out, but I needed the people who I could trust to take it to the patient."
Kassab credits Dr. Gus Watanabe-chairman of BioCrossroads, retired president of Lilly Research Labs and a director of a half-dozen life sciences firms around the nation-for convincing him to make the move.
Kassab's device uses electricity to measure the dimensions of a blood vessel by mounting small electrical wires on a standard catheter. Electrical currents are sent to the electrodes, which give the cardiologist a digital output in real time of the blood vessel's diameter to provide a better fit for the stent. The device also sizes the stent itself.
Johnson & Johnson and Boston Scientific Corp., the purchaser of locally based Guidant, make the two drug-coated stents currently on the U.S. market. A recent study sponsored by Johnson found that two-thirds of the stents were implanted incorrectly.
In most instances, physicians gauge the measurement by looking at an X-ray to best guess the size of a stent. Blood running between the artery wall and the stent can, in rare cases, cause turbulence that leads to thrombosis, or clot formation.
It is estimated, however, that clotting occurs in less than 0.5 percent of the roughly 1 million stent procedures done in the United States each year.
New imaging technology called intravascular ultrasound, or IVUS, can help guide or verify proper development. It is a two-step procedure in which the imaging technology is not imbedded in the same catheter, unlike Kassab's device.
The difference could give Lumen-RECON an advantage, said Dr. Michael Venturini, chief medical officer of Community Health Network's Indiana Heart Hospital.
"If, for instance, a single piece of equipment could be used to deliver and deploy the stent, and give more precise information about the appropriateness of expansion and sizing," Venturini said, "I could see how that would have great potential and value."
The device has proven successful in animal testing using pigs, Kassab said. The next step is human clinical trials that could begin next summer. Several local companies are assisting in the process.
Catheter Research Inc. is designing the catheter and Priio the digital readout technology. Indianapolis-based law firm Ice Miller LLP is licensing the intellectual property and The Anson Group LLC is handling regulatory consulting.
Besides the investment from BioCrossroads, Kassab is seeking additional funding from the Indiana 21st Century Research and Technology Fund-the state's showcase program for investments in budding high-tech firms.