SBIR-STTR Award

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to provide a tool for real-time direct visual guidance of surgery with sub-millimeter accuracy in a clinical relevant setting. It is a critical challenge to locate an implanted device, interventional device, needle biopsy device, or lesion that is planned to be removed during a surgical procedure. The proposed study provides a way to overcome the abovementioned challenge by taking advantage of an internal sound source which can be directly visualize via a hybrid augmented reality technology. As an example of breast cancer surgery, a direct tumor visualization tool will greatly reduce the surgical time and improve the surgical outcome. This innovation will bring considerable market opportunity. According to the market report, the U.S. breast lesion localization market will reach $878 million by 2020 from USD 445.9 Million in 2015, with a compound annual growth rate of 14.5%. With the value we potentially provide, our total addressable market is estimated to ~$200 million in 2020, which is a considerable and healthy market. Other market including visualization of an interventional device or implanted device will further increase the value of the proposed innovation. This proposed project is to develop an intraoperative tool to visually locate the breast tumor with high accuracy. In 2015, there were 231,840 new cases of invasive breast cancer, and an estimated 60,290 additional cases of noninvasive breast cancer. It is challenging for the surgeon to accurately localize the tumor during lumpectomy, especially when the tumor is non-palpable. However, the current technologies cannot provide quantitative location of the implanted device and real-time visual feedback of that location. Therefore, it creates problems on a large re-excision rate, and a prolonged surgical time. The project proposes to address these unmet needs by developing an acoustic guide-wire with an augmented reality system that can provide real-time visual feedback on the location of the tumor with sub-millimeter variance. These functions are enabled by two of our innovations: 1) Visualization of the location of an acoustic source in turbid media for tumor localization using acoustic radar and augmented reality concept; 2) An ultra-low cost, miniaturized, omni-directional acoustic source. Owing to these advantages, this technology has the potential to optimize surgical planning, minimize surgical delays and reduce the re-excision rate.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to serve the breast cancer community. In 2015 there were 231,840 new cases of invasive breast cancer. The surgical procedure cost ~$6000 with an average $60 per minute cost and 25% re-operation rate. Owing to its competitive advantages, the AcouStar can effectively reduce the surgical delay and potentially minimize the re-excision rate. Therefore, AcouStar can effectively reduce the surgical cost for the hospital, the reimbursement cost for the insurance company, and physical pain and emotional distress for the patients. The company's innovation addresses a considerable market opportunity. According to a market report, the U.S. breast lesion localization market will reach $878 million by 2020 from USD 445.9 Million in 2015, with a compound annual growth rate of 14.5%. With the value the company may potentially provide, the total addressable market is estimated to be ~$200 million in 2020. This innovation will not only be applicable for breast cancer surgery navigation, it may also be used as an internal tracking device for multiple other applications, such as implantable device tracking, endoscope tracking, navigation for partial kidney removal etc. This Small Business Innovation Research Phase II project aims to solve the problems of surgical navigation in lumpectomy. Breast conserving therapy, or lumpectomy, with radiation therapy has become a preferable choice over mastectomy for its better cosmetic outcome and patient health care. However, it is challenging for the surgeon to accurately localize the tumor during lumpectomy, especially when the tumor is non-palpable. Current technologies cannot provide quantitative location of the implanted device and real-time visual feedback of that location. Vibronix, Inc proposes to address these unmet needs by developing an acoustic guide-wire with an augmented reality system that can provide real-time visual feedback on the location of the tumor with sub-millimeter variance. These functions are enabled by two of our innovations: 1) Visualization of the location of an acoustic source in turbid media for tumor localization using acoustic radar and augmented reality concept; 2) An ultra-low cost, miniaturized, omni-directional acoustic source. Owing to these advantages, this device, named the AcouStar system, has the potential to optimize surgical planning, minimize surgical delays, and reduce the re-excision rate. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.