By Tom Ballard, Director of Innovation and Entrepreneurial Initiatives, Pershing Yoakley & Associates, P.C.
We periodically follow-up with entrepreneurs whom we have previously profiled on teknovation.biz, particularly if they have indicated to us some upcoming milestones.
One of those is Ben Curry who launched a testing division of Ension, Inc., last August. The new operation of the Pennsylvania-based medical device company is located in the Fairview Technology Center off Solway Road in West Knox County.
During our interview last fall that produced this story, Curry told us about some upcoming opportunities. We caught-up with him recently to get an update on Ension’s progress.
“We have been designing an advanced compact device (the Ension Triad System or ETS) to help test how small medical devices (stents, catheters or any blood-contacting device) and biomaterials interact with blood,” he said. “Blood is a tricky biological fluid, because it’s always moving and if you disrupt that movement with an artificial surface, the body wants to respond to it by clotting or initiating an inflammatory response.”
As a result, Curry explained that medical product developers have to be very selective when they decide what materials to employ to make their blood-contacting medical devices and how best to apply a surface modification to make the underlying biomaterial more blood-compatible.
“The advantage of Ension’s new testing approach is our proprietary surface modification that we apply to all components of the system to mimic the endothelial surface layer that lines all of the blood vessels in the body,” Curry said. “So, when we put blood into our system, it behaves much like it would in the body by not clotting and not causing an inflammatory response.”
The Ension methodology provides a distinct advantage for medical product developers and other parties interested in assessing performance.
“Once you place a sample of a biomaterial into our testing chamber, any changes that happen with the blood (clotting rates or inflammation) are solely due to the biomaterial, which can be tweaked and slightly altered to interact more favorably with the circulating blood,” Curry explained.
The ETS significantly enhances pre-clinical testing of medical product biomaterials prior to costly animal studies during several stages of medical product development and evaluation.
“We are currently working with the U.S. Food and Drug Administration (FDA) to develop the ETS through the Medical Device Development Tool (MDDT) Program,” Curry said. A proposal that he prepared and submitted in October has made it to the pre-qualification stage where the FDA will provide a substantial review of Ension’s proposed characterization and validation studies.
If the studies are successful and the FDA is pleased with the outcomes, Curry expects Ension will be asked to submit a formal FDA qualification package to have the ETS be an FDA-accredited medical device development tool.
“This essentially means they would recognize our system and comprehensive testing criteria, and could require all blood contacting devices to pass our testing criteria before being approved by the FDA,” Curry said. “We hope this leads to a better understanding of how blood interacts with artificial surfaces and, ultimately, the development of medical products that are safer and minimize complications to provide better clinical outcomes in the patients.”