July 22, 2016
The UM Coulter Translational Research Partnership Program “Coulter Program” is pleased to announce its funding selection for FY 2017.
The Coulter Program funds translational research projects between Engineering and Clinical faculty co-investigators. These projects aim to develop medical devices or other biomedical products with the goal of new company formation or a technology license to industry partners. Throughout the funding period and beyond, teams receive a high level of guidance and support for new product planning, market opportunity evaluation, patent filing, prototype development, regulatory strategy planning, and sourcing for follow-on funding or licensing.
For the FY 2017 funding cycle, four projects were selected for funding:
Cryo-Anesthesia for Intravitreal Injections
Current anesthetic procedures prior to intravitreal injections are uncomfortable and painful for patients, increase procedure time, and can increase the occurrence of ocular surface bleeding. Retinal Specialist Cagri Besirli, MD, PhD, and Mechanical Engineer Kevin Pipe, PhD, have developed a handheld device that delivers thermoelectric, contact cooling to the ocular surface as a rapid anesthetic for performing painless intravitreal injections in less time. This project also received Coulter funding last year for the FY16 cycle. During their first year of Coulter funding, the team developed their first prototype and conducted device safety testing to determine optimal parameters for safe use. The team received IRB approval for a first-in-human (FIH) study which they initiated at the Kellogg Eye Center. With this second year of Coulter funding, the team will refine their current prototype using FIH study outcomes, design for manufacturability changes, and professional market research feedback. Regulatory consultation leading to a Pre-Submission meeting with the FDA will pave the way to a second clinical study funded by Coulter to demonstrate improved patient-reported outcomes and reduced anesthesia times compared to standard-of-care anesthesia methods. This project will likely lead to an exciting start-up company to commercialize the device.
“Slit-Stent” Lacrimal Drainage Device for the Treatment of Epiphora Due to Insufficient Drainage
Oculoplastic surgeons treat epiphora, or excessive tearing, by surgically creating a new tear drainage system and placing a lacrimal stent to allow healing. Current stents take up space in the newly created tear drainage system, and patients do not experience relief from epiphora until the stent is removed 3-6 months later. Oculoplastic Surgeon Alon Kahana, MD, PhD, teamed up with Mechanical Engineers Albert Shih, PhD and Jeffrey Plott, to develop the “Slit-Stent”, a lacrimal stent constructed to facilitate drainage of tears through the stent after placement, which will provide patients immediate symptomatic relief. With Coulter funding, the team will pursue an Investigational Device Exemption (IDE) and conduct a clinical study to demonstrate that “Slit-Stent” provides improved symptomatic relief from epiphora while maintaining mechanical integrity and having no significant difference in infection risk compared to standard stents. Positive clinical study outcomes will provide a strong position for licensing of the technology to an existing ophthalmic medical device company.
Dynamic Arterial Morphology Analysis for Prediction of Intradialytic Hypotension
Intradialytic hypotension (IDH), a drop in blood pressure that cannot be compensated for by vasoconstriction, occurs in 20-30% of all hemodialysis sessions. This sometimes leads to session abandonment and fluid overload as patients are not able to be adequately dialyzed. Emergency Medicine Physician Kevin Ward, MD, Mechanical Engineer Kenn Oldham, PhD, and Computational Medicine and Bioinformatics Associate Professor Kayvan Najarian, PhD, have developed a small, wearable, noninvasive monitor that predicts the onset of IDH during hemodialysis and provides a warning to dialysis clinic staff, allowing them to implement countermeasures to prevent the hypotensive episode and continue the dialysis session. With Coulter funding, the team will build prototype devices to obtain clinical data on patients undergoing dialysis in the U-M Acute Dialysis Unit to refine and optimize the prediction algorithm. The goal of the study is to demonstrate the ability to predict IDH within 2 minutes of onset with 80% sensitivity and specificity. Positive results from this clinical study on the ability to predict IDH will greatly accelerate development and licensing to a commercial partner.
Miniaturized HemoRetractoMeter (mHRM) Blood Coagulation Diagnostic
Blood coagulation is a critical hemostatic process that must be properly regulated to maintain the delicate balance between bleeding and clotting. Coagulation diagnostics using whole blood thromboelastography measurements are rapidly gaining clinical acceptance, but commercially available systems are significantly limited by their size, cost, inter-assay variability, and significant user intervention. Emergency Medicine Physician Kevin Ward, MD and Mechanical Engineer Jianping Fu, PhD, have developed a small, inexpensive, easy-to-use and maintain, near point-of-care whole blood thromboelastography device (mHRM) that provides equivalent results to commercially available thromboelastography devices in less time. With Coulter funding, the team will improve the mHRM manufacturing method, conduct clinical testing to verify mHRM reliability on samples with known coagulation profiles, and demonstrate equivalency of the mHRM to commercially available thromboelastography devices. Positive results from this clinical study will strongly position this technology for commercial partnering with existing companies in the coagulation monitoring space.
See http://bme.umich.edu/research/coulter/ for more information about these newly funded projects. For more information about the Coulter Program, contact Thomas Marten, Coulter Program Director, at firstname.lastname@example.org. Look for the next Coulter Call For Proposals in late Fall 2016.