QED Funding

QED: Awardees - Science Center

Introduction

Elements of the Program

How to Apply

Awardees

Market Representation

 

Spring 2009 Application Cycle

Spring 2009 projects will be completed from October/November 2009 – October/November 2010.

Nanostructured bactericidal sol‐gel thin films on percutaneous orthopaedic external fixator pins
Principal Investigator: Paul Ducheyne, Ph.D. (University of Pennsylvania)

About 2,000,000 fracture fixation devices, including internal and external fixation devices, are implanted annually in the United States. They incur a postoperative infection rate of 5% overall and there is no good treatment available when infection occurs. In the specific cases when external fixation is used to stabilize the bone fragments, the treatment itself  can promote infection; in fact, the incidence of deep infection using this procedure is much higher than the average, namely 16.2% overall, with 4.2% developing chronic osteomyelitis. A totally unacceptable rate of infection, up to 32.2%, has been reported for the external fixation of fractures of the femur. Clearly, fixation of compound fractures, for which external fixation is preferred, is a clinical challenge and better treatments are urgently needed to prevent bacterial ingress at the percutaneous passage of the pins.

Herein we pursue a fundamental solution for the dire clinical issue of infection with external fixation. The approach is based on reliably and continuously delivering bactericidals to the tissue sites using the novel, breakthrough technology of micron‐thin sol‐gel films on fracture fixation pins. The program is based on an excellent foundation in basic science, a strong patent position, and a team of investigators with a track record of collaboration and a documented ability to advance concepts to the clinic. Sol gel films were used before in animal studies for another, distinct, application with different therapeutics and effective controlled release from the films was achieved in vivo.

The market is significant (in the USA more than $ 100 M), and the opportunity is substantial, as there is no standard of care. Health care savings in excess of $ 1 billion could be achieved. The objective of this QED program is the elimination of a key investment risk factor, namely “does it work in vivo?”, as a result of which next levels of capital become available.

The program covers essential steps to advance to the clinic. We propose to demonstrate (i) that bactericidal sol‐gel films releasing therapeutic effective quantities can be deposited and (ii) that these antibacterial sol‐gel films can prevent external fixator pin infection in vivo using an established animal model. With proof‐of‐concept data becoming available midstream into the program, the product development program would be advanced to the next level in collaboration with a major corporate partner from the health care industry.

Near Infrared Wound Monitor
Principal Investigator: Elisabeth Papazoglou, Ph.D. (Drexel University)

Wound Clinics who see patients with challenging wounds need faster evaluation of the healing process to save costs, improve patient outcomes and to be able to transfer some of the wound care to less specialized environments. Yearly incidence of skin ulcers (pressure, venous and diabetic) in the U.S. is estimated to be 6 million patients, and the annual costs for management of these wounds are greater than $20 billion. The current paradigm is measurement of wound size, by tracing or by digital imaging. This superficial evaluation delays proper treatment and results in continuation of non‐efficacious products/methods which ultimately lead to amputations. The proposed device uses NIR technology to
measure the level of oxygenated and deoxygenated hemoglobin at the wound site and compares it to a control/nonwound site. The time course of the oxygenated hemoglobin was found to be a strong indicator of wound healing (data obtained in animals and humans during the last 18 months). Two provisional patent applications relate to the methods of evaluating the condition of the wound and will be combined and filed as one utility application. The third provisional patent application, related to the device, will be converted to a PCT application. We estimate that shortening by 50% the observation time based on wound size, the cost of care for chronic wounds would be reduced by 30‐60%. Third‐party payers are reimbursing chronic wound care. The work will focus on performing additional clinical tests to expand the number of patients from the existing 15 patients to the statistically significant 50 patients or more. During the study weekly NIR measurements and wound size measurements of chronic wound patients will be compared until healing occurs (or for a maximum of 30 weeks). The NIR healing index will be compared to wound contraction as a predictor of wound healing. The commercial “proof‐of‐concept” in this project, needed to attract investors and companies, is having a statistically significant clinical data set proving that the technology works. The Wallace H. Coulter Foundation has invested $200,000 in the research effort during 2006 and 2007 through a competitive proposal process and the business plan of this project just won the 2008‐2009 Wharton Business Plan Competition. Therefore the funding by QED will significantly move this project along the commercialization pathway producing very tangible and pivotal clinical data to support additional follow on funding.

Portable, Low-Cost, Radiation-Free Breast Cancer Detection for Dense Breasts
Principal Investigator: Wan Shih, Ph.D. (Drexel University)

The piezoelectric finger (PEF) device is intended for use in breast cancer screening and diagnosis in populations where mammography is not widely available or as an adjunct to mammography for women with dense breast tissue where the procedure has decreased utility. Breast cancer affects 1 in 8 women in the U.S. and is a growing health care concern in developing countries such as in India as women become more westernized in diet and child bearing practices. Mammography is the established standard for breast cancer screening in the U.S. and Europe although there are limitations to its utility: 1) it does not perform well in areas of the breast comprised of dense breast tissue; 2) it is an Xray procedure and is not recommended for younger women who may be at risk for breast cancer; 3) its proper use requires a specially trained radiology technician and a radiologist is needed for interpretation. In developing countries, the cost of the mammography unit and cost per test limits its adoption. Its use is further limited by the higher incidence of dense breasts in Asian women.

We will develop a non‐invasive, radiation‐free device for breast cancer detection based on measurements of tissue elasticity. Breast tumor tissue is stiffer than the surrounding normal breast tissue and this difference in elasticity can be measured by the PEF device along two axes – top down compression and lateral shear. While each of these measurements alone can yield useful information on breast tissue elasticity, integrating these two readings provides an especially sensitive reading of abnormal breast mass. The sensors can also identify masses that are typically too small for detection by other screening devices.

Using funding provided by Drexel’s Wallace H. Coulter Foundation Translational Research Partnership Award, the elasticity and shear sensors have been designed and the operation of the device has been demonstrated on excised breast tissue samples. QED project funding will be used to build a working prototype and to obtain proof‐of‐concept clinical data. The working prototype will form the basis for production of a low‐cost unit that can be introduced into developing countries; Clinical data from early use of the PEF device will provide the body of evidence to support a U.S. entry. Further design development to increase the number of sensors in the arrays and a robotic arm for automated reading will position this device for use in the U.S. as an adjunct to mammography.

For more information, contact us: qed@sciencecenter.org