Congratulations to the 10 teams who have been selected to receive FY25 funding through U-M BME’s Coulter Translational Research Partnership Program.
Established with a $20M endowment, the U-M BME Coulter Translational Research Partnership Program supports research directed at promising technologies within research laboratories that are progressing towards commercial development and clinical practice. Outcomes of previous Coulter funding and support include the formation of 22 start-up companies and over $544 million raised in angel or venture capital from 2006 through 2023.
“On behalf of the Coulter Program’s Oversight Committee, I am delighted to congratulate these teams of engineering and clinical investigators on receiving these awards in support of their translational research projects,” said Mary-Ann Mycek, William and Valerie Hall Department Chair, Biomedical Engineering and Professor, Biomedical Engineering. “The Oversight Committee selected an exciting portfolio of projects from across biomedical engineering research areas and we look forward to impactful project outcomes over the coming year.”
“The U-M BME Coulter Translational Research Program has been in existence since 2006 and employs a proven model of funding and support to foster translation of laboratory research towards commercial development with follow-on funding,” said Thomas Marten, Managing Director, Coulter Program, Biomedical Engineering. “The 10 projects selected for funding this year are well-positioned to continue the success of the program and include a wide range of novel technologies spanning from medical devices to diagnostics to regenerative medicine.”
For more information about the Coulter Translational Research Partnership Program, please contact Tom Marten at tmarten@umich.edu.
Here are the FY 2025 Coulter Translational Research Partnership Program Funded Teams:
- “Regenerative Reprogramming to Revert Trauma-Induced Fibrosis”
- PIs: Carlos Aguilar, PhD, Biomedical Engineering and Paul Cederna, MD, Plastic Surgery
- Traumatic musculoskeletal injuries result in the loss of a critical volume of skeletal muscle. This is referred to as volumetric muscle loss (VML) and is largely due to the muscle fibrosis or scarring that occurs after injuries. VML is responsible for more than 90% of all muscle conditions that lead to long-term disability and is the principal cause of nearly 10% of all medical retirements from the military. VML results in reduced quality of life through pronounced disabilities ranging from reduced muscle function and atrophy to aggressive development of osteoarthritis. The U-M team is developing a regenerative medicine based therapeutic for volumetric muscle loss that reduces fibrosis or scarring and restores normal muscle function. Coulter funding will be used to manufacture the treatment and conduct pre-clinical testing to evaluate the ability to reverse scarring and improve muscle function.
- “Subcellular carbon fiber electrodes for human brain recording
- PIs: Cynthia Chestek, PhD, Biomedical Engineering and Oren Sagher, MD, Neurosurgery
- In certain neurosurgical procedures, such as resections of brain tumors and selected areas of the brain causing epileptic seizures or in emerging applications to restore function, it is imperative to identify or map critical brain regions in detail. This enables the surgeon to resect the tumor or epileptogenic tissue while avoiding critical regions of the brain required for normal physiological functioning. The U-M team is developing subcellular-sized carbon fiber electrodes designed in an array that can safely record from the human brain to enable detailed functional mapping of brain areas prior to resection surgeries. Coulter funding will support studies using the carbon fiber array of multiple electrodes in an animal model and a single carbon fiber array during actual surgery in a human brain to record brain neurological activity.
- “Osteo-Sleeve”
- PIs: Alexis Donneys, MD, MS, Orthopaedic Surgery, Claudia Loebel, MD, PhD, Materials Science and Engineering, Kurt Hankenson, DVM, PhD, Orthopaedic Surgery, Jaimo Ahn, MD, PhD, Orthopedic Surgery
- Non-union long bone fractures and bone defects create surgical reconstruction challenges and moreover, even greater recovery challenges for the patient. These procedures are highly invasive, require lengthy healing times, and often require repeated operations. The goal of surgical reconstruction is to regenerate the bone necessary for structure and function. However, successful bone bridging is not guaranteed, and when bridging does not occur, the reconstructed bone does not faithfully recapitulate its original form and structure. The U-M team—consisting of engineers, scientists and clinician-scientists—is developing an orthopaedic device called “Osteo-Sleeve” that will provide for guided bone regeneration while preventing the encroachment of obstructive tissues into bone defect sites. The team will use Coulter funding to identify suitable candidate biomaterials for Osteo-Sleeve that meet product design requirements and are suitable for manufacturing as a medical device for implantable clinical use.
- “Rapid extracellular vesicle isolation and identification as a versatile disease biomarker”
- PIs: Nicholas A Kotov, PhD, Chemical Engineering, Scott VanEpps, MD, Emergency Medicine
- Sepsis is characterized by a dysregulated immune response to an infection and is a life-threatening condition with nearly 1 in 3 hospital admissions ending in death. Diagnostic criteria for sepsis have been developed by expert consensus, rather than being based on accurate detection of specific disease pathologies, which presents challenges in accurately diagnosing sepsis. None of these methods is specifically tailored to delineate distinct subtypes of the condition with predictions of disease progression or treatment responses. A sepsis screening tool with predictive biomarkers is essential for the rapid identification of high-risk patients and optimization of treatment. Extracellular vesicles have emerged as an important avenue of research in sepsis and contain biomarkers that may serve to facilitate diagnosis and personalized treatment for sepsis. With Coulter funding, the team will develop a functional device prototype capable of capturing and detecting alterations in EV biomolecules and validate the device’s diagnostic accuracy using clinical samples related to sepsis. This technology will also serve as a platform for use in other diseases and applications including cancer, autoimmune diseases, and pharmaceutical development and delivery.
- “Asleep intraoperative directional functional mapping for deep brain stimulation”
- PIs: Enrico Opri, PhD, Biomedical Engineering, Daniel Leventhal, MD, PhD, Neurology
- Neurological disorders such as Parkinson’s Disease (PD) impact one million people in the U.S. PD is a progressive neurodegenerative disease that significantly impairs motor control, leading to symptoms like tremors and involuntary muscle contractions, which severely impact patients’ quality of life. While medication can help patients in the early stages of this disease, effectiveness diminishes over time. For advanced patients, deep brain stimulation or DBS has become the preferred therapy for patients unresponsive to medication to alleviate symptoms of PD and related conditions such as dystonia. DBS involves placement of a lead (wire that runs from the surface of the brain to an area deep within the brain) into a targeted location in the brain and providing an electrical stimulation, which impacts aberrant brain neurological activity to quiet tremors and involuntary muscle contractions. The therapeutic success of DBS depends on precise lead placement in brain target areas. The U-M team is working on developing a novel DBS lead placement software platform that will interact with existing equipment utilized during DBS procedures and designed to offer a new real-time modality for guiding and validating the surgical implantation of DBS implants for PD and dystonia patients. The platform will enable precise electrode placement during asleep surgeries and provide novel directional mapping to confirm optimal lead placement. The proposed system is intended to integrate with current surgical practices and used during both awake and asleep cases using intraoperative imaging. With Coulter funding, the U-M team will implement a real-time intraoperative version of the proposed software system and conduct a validation study for intraoperative mapping during actual DBS patient procedures.
- “Dialy-Safe” needle – The smart dialysis needle that converts pain to promise by improving cannulation and reducing infiltration
- PIs: Albert Shih, PhD, Mechanical Engineering, Karthik Ramani, MD, Internal Medicine, Nephrology
- More than 800,000 patients in the U.S. with end-stage kidney disease undergo lifesaving blood cleaning therapy called dialysis, which is performed three times per week and involves placement of needles through a vascular access site such as an arteriovenous (AV) fistula. An arteriovenous (AV) fistula is a connection, made by a vascular surgeon, of an artery to a vein. This provides appropriate blood flow for dialysis, and the patency of this conduit becomes a lifeline for the patient. However, the technique of dialysis needle placement, or cannulation, can result in infiltrations or injuries where the needle punctures through the back wall of the fistula. This occurs more than 2 million times a year. The U-M team is developing a novel smart dialysis needle, “Dialy-Safe,” that seeks to address these issues by ensuring accurate needle placement, reducing the risk of infiltrations, and improving patient safety and comfort. Supported by Coulter funding, the team will refine prototypes, conduct benchtop testing, and explore cost-effective manufacturing strategies to make this innovative technology accessible and affordable for the hemodialysis market.
- “Endoscopic microdiscectomy device for safe and efficient removal of cartilaginous endplates in minimally invasive lumbar fusion surgeries”
- PIs: Albert Shih, PhD, Mechanical Engineering, Yamaan Saadeh, MD, Neurosurgery
- Degenerative disc disease, spondylolisthesis, lumbar spinal stenosis, herniated disc, spinal tumors, infections, and fractures are common causes of back pain and instability in the spine. To treat all these ailments, orthopedic or neurosurgeons often recommend that patients undergo lumbar spinal fusion surgery (LSFS), which consists of fusing one vertebra to another, thereby reducing pain and providing stability to the spine. Surgically, this requires the complete removal of the soft disc materials (mainly cartilage) during a procedure called discectomy without causing harm to the underlying bone. Current discectomy devices have limited capabilities for soft tissue removal and create challenges for surgeons performing this procedure. With Coulter funding, the team will conduct preliminary tests on an endoscopic microdiscectomy device prototype that provides surgeons visual inspection and efficient removal of cartilage, while protecting the vertebral bony surfaces and peripheral nerves and tissue.
- “In situ Continuous Observation of Metastasis with Engineered Tissues (iCOMET)”
- PIs: Lonnie Shea, PhD, Biomedical Engineering, Jacqueline Jeruss, MD, PhD, Surgery, Pathology, Biomedical Engineering
- Currently, cancer recurrence is monitored by patient self-reporting of symptoms and clinical detection of metastasis by CT, MRI, or PET imaging. However, these methods are unable to identify early-stage metastatic events. Newer liquid biopsy blood test approaches for recurrence detection have shown to be moderately effective, but provide no information to guide therapy selection. With Coulter funding, the iCOMET project team is developing a subcutaneously implanted device that non-invasively monitors for detection of key biomarkers to identify cancer recurrence, while also providing information to guide cancer therapy decision making. This product concept will also serve as a platform for use in other diseases and applications including diabetes and transplant rejection.
- “Multimodal, head worn interface for blind assistive technology”
- PIs: James Weiland, PhD, Biomedical Engineering, Sherry Day, OD, FAAO, Ophthalmology and Visual Sciences, Josh Ehrlich, MD, Ophthalmology and Visual Sciences
- Blind and visually impaired individuals (BVI) face significant hurdles while navigating through the world. Smartphone apps exist to help guide BVI individuals but are cumbersome to use and have demonstrated limited usability and effectiveness. The U-M team is developing a headworn user interface designed specifically to work with smartphone assistive technology apps. Coulter funding will be used to build prototypes and test prototypes of the system with BVI participants. The team has engaged with companies involved with BVI assistive technologies and apps who are interested in collaborating on this research.
- “Original Focused Flat Ultrasound Transducer (Focused FUTure) for Histotripsy Treatment of Shallow Tumors”
- PIs: Zhen Xu, PhD, Biomedical Engineering, Andrzej Dlugosz, MD, Cutaneous Oncology, Dermatology
- Histotripsy, a targeted ultrasound system for non-invasively, mechanically ablating tissue invented at U-M, has been extensively developed to treat deep target tissue, such as liver, kidney, and pancreas. In 2023, the EdisonTM platform from HistoSonics was approved by the FDA to non-invasively treat liver tumors utilizing histotripsy technology. While the current Edison TM device is designed for treating deeper tissue, histotripsy can be modified to target shallow tissue and provide a non-surgical approach for the treatment of skin cancers. With Coulter funding, the U-M team is developing a low-cost, compact, easy-to-use Focused Flat Ultrasound Transducer (Focused FUTure) for non-invasive histotripsy treatment of shallow tumors.
