Coulter Foundation Translational Research Partnership Program at Pitt invests in four medical technologies

PITTSBURGH  (August 5, 2013) … Fighting infection post-surgery with an antibiotic gel; developing a meniscus implant for temporomandibular joint (TMJ) patients; treating an overactive bladder through foot stimulation, and attacking skin cancer with a microneedle bandage were the latest innovative medical technologies selected for funding through the  Wallace H Coulter Translational Research Partners II (TPII) Program (Coulter Program)  this July at the University of Pittsburgh.

The Coulter Program, a campus-wide effort led by Pitt's Swanson School of Engineering, identifies, selects, funds and mentors translational research by clinician-bioengineer teams that address unmet clinical needs through innovative technologies. The University was awarded a $3.54 million grant from the Wallace H. Coulter Foundation in fall 2011 (one of only six awards nationwide), supplemented by $1.665 million in matching funds from the University's School of Medicine, Swanson School of Engineering, and Office of Technology Management.

This is the Coulter Program's second year of funding at Pitt; the program launched last year with four inaugural medical technology awards. Twenty-five proposals were submitted for consideration during this round of funding. 

"We are excited because these four technologies have already generated promising early animal test results; are being patent-protected; have significant clinical and commercial potential; and would benefit from a business focus and a financial "push" toward commercialization," explained  Pratap Khanwilkar, PhD, MBA , Professor of Bioengineering at the Swanson School and Coulter Program Director. "The Coulter Program at Pitt is pleased to provide funding to these research groups in order to transfer these potentially ground-breaking technologies from the work bench to the bedside."

Teams competing for Coulter Program funding are required to participate with Pitt MBA and law school students in a four-month "From Bench Top to Bedside" course. This course is designed to teach researchers how to develop key deliverables such as a business model, business plan, product development plan and investment pitch necessary to assess the clinical and commercial potential of each technology. The projects are then evaluated and selected by the Coulter Program's oversight committee and mentored by advisors, comprised of clinicians experienced in translation, business leaders accomplished in medical device commercialization including regulatory affairs and reimbursement, large medical device company representatives, and local and national angel investors and venture capitalists.

2013 FUNDED PROJECTS

TheraGel: Prevent Infection of Implanted Devices
Bioengineering Co-PI:Yadong Wang, PhD , Professor, Department of Bioengineering, University of Pittsburgh
Clinical Practitioner Co-PI:  David Schwartzman, MD, Professor of Medicine, University of Pittsburgh

Summary:  Despite best practices, infection of permanently implanted devices remains a serious problem post-surgery. Although uncommon, the ramifications of such infections are severe. Current products for infection prevention are cumbersome to use - which often complicates implantation - and have short release windows. New technologies to eliminate these problems would be of great human and economic value. TheraGel delivers high-dose antibiotics for a sustained period locally to a region encompassing a freshly implanted device. The in-situ gel solidifies upon tissue contact, conforms around the anatomical shape of the implanted device, and fills any voids, thus ensuring sterility and eliminating infection. Over the past year with the seed funding from Coulter TPII, the research team has demonstrated efficacy of the material in an animal model which mimics the human condition. Full TPII funding will be used to optimize TheraGel for this purpose and position it for commercialization.


MatriDisc: An Inductive, Scaffold Based Device for Reconstruction of the TMJ Meniscus
Bioengineering Co-PI: Bryan N. Brown, PhD , Assistant Professor, Department of Bioengineering, University of Pittsburgh
Bioengineering Co-PI: Alejandro J. Almarza, PhD , Assistant Professor, Departments of Oral Biology and Bioengineering, University of Pittsburgh
Clinical Practitioner Co-PI:William L. Chung, MD, DDS , Associate Professor, Departments of Oral and Maxillofacial Surgery, University of Pittsburgh

Summary:  Temporomandibular joint (TMJ) disorders affect more than 10 million Americans per year. For many patients, the only available treatment is removal of the joint meniscus, and there are no clinically effective options for replacement of the meniscus following removal. Matridisc is an "off-the-shelf" novel device for reconstruction of the TMJ meniscus. Particulate extracellular matrix (ECM) encased within sheets of ECM provides a resorbable interpositional "pillow" and an anchoring site to mimic the shape and size of the TMJ meniscus. With the seed funding from Coulter TPII, MatriDisc has become a fully developed and translation ready device in the past year. Currently, this project is preparing for a first-in-human clinical trial that will de-risk the opportunity to attract additional follow-on funding and commercialization partners 


FootStim™
Bioengineering Co-PI: Changfeng Tai, PhD , Assistant Professor, Departments of Urology and Bioengineering, University of Pittsburgh
Clinical Practitioner Co-PI:Mang Chen, MD , Assistant Professor, Department of Urology, University of Pittsburgh 

Summary:  Overactive bladder (OAB) is a common problem affecting about 1 of every 6 adults in the United States. Drug therapies are the first line treatment for OAB. However, more than 70 percent of patients stop taking drugs due to low efficacy and side effects. Current alternative treatments include sacral and tibial neuromodulation, and bladder botox injections. These are invasive, expensive, inconvenient, and carry significant risks. FootStimTM is a novel, non-invasive foot neuromodulation therapy for OAB that can decrease bladder activity through treatment performed at home safely, comfortably, and conveniently, with no adverse side effects. FootStim uses a small wearable stimulator to activate the nerves on the foot via skin surface electrodes that then alter nerve signals to the bladder. Studies in animals and humans have already shown that foot stimulation successfully inhibits bladder activity and increases urine storage volumes. 


Skinject PatchIT™
Bioengineering Co-PI: Louis Falo Jr, MD, PhD , Chairman, Department of Dermatology, Professor, Departments of Dermatology and Bioengineering, University of Pittsburgh
Clinical Practitioner Co-PI:  Larisa Geskin, MD, Associate Professor, Department of Dermatology, Director, Cutaneous Oncology Unit, University of Pittsburgh

Summary:  Skin cancer is the most commonly occurring cancer in the United States. Fifty percent of the population after age 65 is expected to develop skin cancer, the majority diagnosed with Basal Cell Carcinoma (BCC). BCC occurs typically on the face, head or neck and is a highly disfiguring disease. Current therapies involve invasive surgical procedures that are time-consuming, associated with patient recovery/morbidity and are expensive. Skinject PatchITTM is a novel, single use, topical drug delivery patch that, like a common adhesive bandage, is applied to the affected skin of those diagnosed with skin cancer. Skinject PatchIT is based on a proprietary patent-pending Micro-Needle Array drug delivery platform that uniquely delivers a potent generic chemotherapeutic agent and modifier to kill existing skin cancer and induce an immune response to prevent the cancer's re-occurrence. This project is ready to start human clinical trials at Pitt in two orphan indications, has confirmed high physician and patient acceptance from initial customer feedback and has already received significant interest from several investors.


About the Department of Bioengineering at the Swanson School of Engineering
Bioengineering is the application of engineering principles to analyze, design, and manufacture tools, structures, and processes to solve problems in the life sciences. Successful patient-focused and commercialization-oriented collaborations between engineers and physicians who traditionally employ differing methodologies are critical to the burgeoning field and to regional economic development. Pitt's Department of Bioengineering, established in 1998 as part of the Swanson School of Engineering, is ranked as one of the nation's top bioengineering programs and has received millions of dollars to fund research for such advances as the development of a tiny cardiac-assist device for infants; a blood-treatment tool that can free patients from ventilator dependence; and materials that help generate bone. 

About the Swanson School of Engineering
The University of Pittsburgh's Swanson School of Engineering is one of the oldest engineering programs in the United States and is consistently ranked among the top 50 engineering programs nationally. The Swanson School has excelled in basic and applied research during the past decade and is on the forefront of 21st century technology including energy systems, sustainability, bioengineering, micro- and nanosystems, computational modeling, and advanced materials development. Approximately 120 faculty members serve more than 2,600 undergraduate and graduate students and Ph.D. candidates in six departments, including Bioengineering, Chemical and Petroleum Engineering, Civil and Environmental Engineering, Electrical Engineering, Industrial Engineering, Mechanical Engineering, and Materials Science. In 2010 the Swanson School was ranked second in North America by the American Society for Engineering Education (ASEE) for the percentage of doctoral degrees awarded to women. 

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