Advanced Tactile Imaging, Inc. (Company) is an innovative medical device developer and manufacturer. It is founded and operated by a team of professionals with expertise in the diverse areas of biomechanics, medicine, biomedical engineering and medical device manufacturing. The Company is positioned with strong IP, commitment of the founders and federally funded biomedical research and development. Its founders built a foundation for the development and medical applications of the tactile and ultrasound imaging technologies.
The Company complies with the following regulations and standards:
- CFR Title 21, Part 820 - Quality System Regulation
- ISO 13485 - Quality Management System
- Federal Food, Drug, and Cosmetic Act (USA)
- Medical Device Directive 93/42/EEC (Europe)
- Regulatory Compliance Framework (Australia)
- Administration of Medical Devices (China)
Vladimir Egorov, PhD, Chairman, Chief Executive Officer, is a scientist and entrepreneur. He has received the MS in biophysics from the Moscow Institute of Physics and Technology and a PhD in biology working at the Institute of Basic Biological Problems, Pushchino, Russia. He participated in multiple NIH funded research projects with medical devices from feasibility up to commercialization. He, as a Principal Investigator, leads research and development of new medical devices related to women healthcare. His expertise covers technological design and implementations (hardware, software, algorithms, statistical data analysis), clinical studies (feasibility, development, validation), and regulatory compliance/approvals (FDA, CE, TGA, CFDA). Vladimir co-authored 58 peer-reviewed research publications and 27 issued patents.
Noune Sarvazyan, PhD, MBA, President, Chief Strategy Officer, combines research and business expertise with a MS in biophysics, a PhD in medical sciences and an MBA with distinction from the University of Michigan. In over 20 years of her serial entrepreneur and executive management experience she has been working on development, clinical validation and commercial introduction of medical instrumentation including those for tactile imaging in breast, prostate and vaginal floor applications. A recipient of the National Research Honor Award, she has extensive scientific and practical experience in clinical trials, FDA and CPT regulations.
Armen Sarvazyan, PhD, DSc, Chief Scientific Officer, an Adjunct Professor at the Surgery Department of Robert Wood Johnson Medical School, and Honorary Foreign Professor of Physics Faculty of Moscow State University. Armen Sarvazyan has extensive expertise in biophysics, acoustics, biomechanics, biomedical engineering, and in the design, construction and clinical testing of medical instrumentation. He holds over 100 US and international patents on ultrasonic and biomechanical methods and devices, has edited 6 books and published over 200 research papers. Inventor of Mechanical and Shear Wave Elasticity Imaging. Recipient of the Helmholtz-Rayleigh Interdisciplinary Silver Medal of the Acoustical Society of America for contributions to ultrasound imaging and its applications.
Heather van Raalte, MD, Chief Medical Officer, Chairman of Department of Ob/Gyn, University Medical Center at Princeton, NJ, and Chief Medical Officer at Princeton Urogynecology. Heather received his BS and MD from Vanderbilt University, and completed fellowship in urogynecology at The Institute for Female Pelvic Medicine and Reconstructive Surgery. Dr. van Raalte leads clinical research of complex pelvic floor disorders such as pelvic organ prolapse, stress urinary incontinence and overactive bladder. She significantly contributed to development of the Vaginal Tactile Imager for assessment of tissue elasticity, pelvic support and function. Dr. van Raalte has been recognized on a national and international level for her research efforts and has authored numerous articles within the field of urogynecology.