INDIANAPOLIS — Two Indiana University startup companies — one developing a new generation of cardio monitoring instruments, the other designing a single system to capture and process multiple bioelectric measures — recently received Phase I Small Business Technology Transfer awards totaling $423,215 from the National Institutes of Health.
Arrhythmotech LLC received $212,634 in support of work on its neuECG, a device that can record and process both sympathetic nerve activity and electrocardiogram signals without entering the body.
To date, no device allows simultaneous sympathetic nerve activity and electrocardiogram detection in this manner, said Joe Trebley, head of startup support and development for the Indiana University Research Technology Corp. and its Spin Up program. While several electrocardiogram technologies are non-invasive, sympathetic nerve activity detection requires direct nerve contact.
“This technology will significantly advance our understanding of the sympathetic control of heart rhythm in humans,” Arrhythmotech co-founder Peng-Sheng Chen said. “It may also help us develop better methods for sudden death risk stratification. I am very pleased that the NIH recognized the potential of this technology and funded the grant application.”
Chen serves as division chief of the Krannert Institute of Cardiology and is the Medtronic Zipes Chair in Cardiology at the Indiana University School of Medicine in Indianapolis. His business partner, Shien-Fong Lin, is a professor of medicine at the IU School of Medicine and director of the Institute for Biomedical Engineering at National Chiao Tung University in Taiwan.
The pair launched Arrhythmotech in 2012 and have collaborated in arrhythmia research for more than 15 years, Chen said.
The $210,581 received by Refer2Input will support work on its Universal Invertible Amplifier, or UIA System. It is designed to simultaneously track electrical measures that indicate brain, heart, optical and musculoskeletal activity. Current technologies only track individual signals from single physiological sources, Trebley said.
Refer2Input’s founder is Ken Yoshida, an assistant professor of biomedical engineering in the School of Engineering and Technology at Indiana University-Purdue University Indianapolis. William Combs, a clinical associate professor of biomedical engineering at the school, serves as a Refer2Input adviser. Combs is a veteran in medical device development and serves as principle investigator on the grant.
Better implant decisions
The need for devices such as Arrhythmotech’s neuECG is driven by the dilemmas that physicians face in treating patients at risk of sudden cardiac death.
Heart disease is the leading cause of death in the U.S., according to the Centers for Disease Control and Prevention. Sudden cardiac death accounts for nearly half of those fatalities. Of those cases, more than 80 percent are linked to structural heart disease, coronary artery disease and non-ischemic dilated cardiomyopathy, Trebley said.
To reduce mortality, implantable cardioverter-defibrillators are used. However, it costs about $50,000 to purchase and implant such devices, and the benefits are often questionable.
“Many patients indicated for ICDs do not show significant improvement, which suggests that many ICDs are implanted for no good medical reason,” Chen said. “Yet a majority of sudden cardiac deaths occur in patients not eligible for primary prevention ICDs. This suggests that many patients require ICDs but are not indicated as such. Our non-invasive device will help physicians better select patients who need an ICD.”
The prototype for neuECG produced strong preliminary results in canine tests. The NIH grant will help Arrhythmotech develop a beta version for tests on human volunteers and patients with cardiac symptoms.
From there, the company plans to apply for Phase II Small Business Technology Transfer funding to take its product to market. Arrhythmotech also has a licensing option for exclusive, global rights to the intellectual property developed at the IU School of Medicine, Trebley said.
Although current bioelectric monitoring systems work well, they are designed for a specific use. When multiple devices are needed, the costs involved multiply as well — something Refer2Input’s UIA System seeks to eliminate.
“There is a need to be able to capture and integrate signals originating across multiple tissue sources within a single, universal system to both effectively and economically provide dynamic bioelectric measures,” Trebley said.
Refer2Input currently is testing its prototype, using a single software suite to process and analyze real-time data. Once UIA is optimized, the company plans to target the biomedical, orthopedic, and neuroscience sectors, with secondary efforts focused on the rehabilitation and fitness industries, he said.
Both Arrhythmotech and Refer2Input also will receive matching funds of $50,000 each from Elevate Ventures, a nonprofit organization that provides state dollars to promising, early-stage entrepreneurs who have received funding through small business grants.
IURTC is a not-for-profit agency that helps IU faculty and researchers realize the commercial potential of their discoveries. It partners with leading technology, life science, and manufacturing companies to bring IU research to market. Since 1997, university clients of IURTC have accounted for more than 2,800 inventions, more than 1,900 U.S. patent applications and 77 start-up companies based on IU intellectual property.
Indiana University is designated as an Innovation and Economic Prosperity University by the Association of Public and Land-Grant Universities. This recognizes IU’s commitment across all of its campuses to being a leading institution in fostering regional economic development.