Tampa, FL 33609, US
Medical Devices & Equipment
www.afpii.com
A NEW NON-RADIATION BASED BREAST IMAGING PLATFORM FOR EARLY BREAST CANCER DETECTION, addressing the growing dissatisfaction with mammography’s diagnostic accuracy.
Advanced fPAT Imaging Inc. is commercializing the JBI-360, the first breast imaging device to incorporate Functional PhotoAcoustic Tomography (fPAT). Developed at the University of Florida, fPAT offers an imaging alternative that does not have the loss of diagnostic accuracy in dense breast tissue that mammography faces. Over 50% of the population have dense breast tissue and should not rely on mammography for breast cancer screening. The JBI-360 provides a comfortable imaging experience that does not require radiation, injections of contrast agents, or painful breast compression.
AfPII’s management team strongly feels that fPAT imaging will have the same impact that CT and MRI had on the diagnostic imaging community. The diagnostic imaging marketplace exceeds $32B in 2015 and will grow to over $49B by 2020. To enter this market, AfPII is soliciting a seed capital investment of $300,000 to $500,000. The Florida Institute for the Commercialization of Public Research will match this seed investment up to $300K. AfPII has developed an excellent set of documents that describe this new imaging technology and the potential for substantial returns that can be realized from a seed capital investment. For additional information, please contact Michael Addley, CEO, at mike@afpii.com or 954.338.4635.
The JBI-360 Breast Imaging System (pat. pend.) incorporates new Functional PhotoAcoustic Tomography technology whose diagnostic accuracy is not affected by breast tissue density. The technique uses pulses of laser light and sensitive ultrasound detectors to create high-resolution images of Optical Absorption, Oxygenated and Deoxygenated Hemoglobin, and Oxygen Saturation within the breast. For the first time, the Radiologist and Oncologist will have a noninvasive technique that provides both anatomical and physiological information (at the cellular level) about possible cancers within the breast without the use of ionizing radiation or contrast agents.
The JBI-360 is demonstrating superiority over both MRI and mammography in early clinical trials, especially when imaging dense breast tissue. Recent clinical studies show that the JBI-360 could provide a new, more accurate diagnostic tool for radiologists trying to see and diagnose cancer earlier, especially through dense breast tissue.
Michael is a successful national and international medical market executive with a career of senior management positions, including President, CEO, COO, VP of New Business Development, and VP of Sales and Marketing. He has an extensive and diverse range of medical device experience that includes Diagnostic Imaging, Computer Aided Diagnosis (breast cancer), Cardiology, Neurosurgery, Laser Vision Correction, Cosmetic Surgery, and surgical clinic private ownership. Michael is comfortable working in either a private or a public company atmosphere. Over his career, he has introduced several medical market ‘firsts’, including the first MRI system sales and the first cardiac laser angioplasty lab. Michael also has broad range of experience dealing with the US FDA PMA and 510(k) processes. He brings a strong entrepreneurial spirit to the position of President/CEO.
A Pruitt Family Professor of Biomedical Engineering at the University of Florida, Dr. Jiang is the principal inventor of the JBI-360 breast imaging system, which is a culmination of over 20 years of his work in medical optical imaging. A respected leader in the research and development of all things ‘optical imaging’, Dr. Jiang focuses his research on discovering and developing fundamentally new optical-based imaging technologies for in vivo visualization of tissue at both the macroscopic and microscopic scales. His often unique approach combines optics with sophisticated computational programs to create novel imaging tools that can be used to detect cancers, map brain activities, probe inflammations, or guide cancer therapies in both animals and humans. Dr. Jiang has a considerable portfolio of published peer-reviewed articles and US and foreign patents.
Brian brings to AFPII over 30 years of front-line manufacturing experience with the last 18 years dedicated to overseeing the manufacture of medical related Optical Imaging devices from bench prototype to fully commercialized products. Over his career, he has been responsible for a diverse and broad range of key production requirements related to bringing a medical device to market. Brian is fully knowledgeable with respect to meeting regulatory requirements: US FDA, CE, ISO 13485, ISO 9001, UL / CSA, and GMP, to name a few. Brian also has an extensive background in servicing diagnostic imaging devices and has managed production /assembly lines.
Dr. Ponder has over 20 years of research and development expertise in the field of medical imaging, including magnetic resonance imaging, diffuse optical tomography, reflectance spectrophotometry, and more recently photoacoustic tomography. He has played major roles in transforming prototype imaging systems into approved medical devices. Dr. Ponder has experience in virtually every aspect of the FDA pre-market approval process, and is versed in the requirements of the ISO 13485 standard for medical devices as well the European Union’s Medical Devices Directive. His experience in product development ranges from capturing the initial requirements of the end user to providing training on finished products.