Finding Cancers When They're Small
SonoCiné, Inc is a privately held medical technology company that has developed an innovative, patented, imaging process, SonoCiné. Early study data suggest that SonoCiné may considerably enhance the physician's ability to diagnose disease and study tissues whose images have been generated by state-of-the-art medical scanners. The physician is thus able to provide patients with more definitive and reliable diagnoses from their imaging examinations. Breast, vascular and orthopedic ultrasound, echocardiography, MRI and CT are among some of the possible applications of SonoCiné.
SonoCiné holds 6 issued U.S. patents, 14 issued International patents and 8 patents pending which cover various aspects of the SonoCiné system. The patents are broad and blocking, giving SonoCiné a dominant technological advantage in this field.
SonoCiné Market Clearances and Indications For Use:
Europe: (MDD Approval & CE Mark)
♦ SonoCiné Adjunctive Whole Breast Ultrasound Screening (AWBUS), is indicated for
women with BIRADS 3 & 4 density and benign findings on screening
mammography.
♦ When integrated into a breast screening program, Sonociné AWBUS will
significantly increase thenumber of cancers found, compared with screening
mammography alone.
Canada: (Health Canada Class 2 Device License)
♦ The SonoCiné Automated Whole Breast Acquisition Screening System is an
accessory to approved ultrasound imaging systems for use as an adjunct
to mammography.
USA: (FDA 510(k) market clearance)
♦ The SonoCiné system received FDA 510(k) clearance in the U.S. in 2008; The
SonoCiné Adjunctive Breast Ultrasound System is indicated for use
as an adjunct to mammography for B-mode ultrasonic imaging of the
patient's breast when used with an automatic scanning linear array
transducer. This device is not intended to be used as a replacement for
screening mammography. In 2010 the first clinical study was published
in the peer reviewed medical journal, European Radiology. The
clinical study investigators reported that by adding an Automated Whole-Breast
Ultrasound as an adjunct to screening mammography, 100% more cancers were
detected in women dense-breast tissue than by mammography alone.
SonoCiné was founded by a breast radiologist with more than 30 years experience and the Company's principal is that commercial success will be based on the foundation of clinical benefit. The company has conducted two major trials, (1) a blinded, prospective, multicenter trial of more than 6,400 exams and (2) a blinded reader trial of paired data sets (12 readers reading the same data). These trials indicate that SonoCiné, as an adjunct to screening mammography, in dense-breasted women, is able to find more cancers than mammography alone and that those cancers found by SonoCiné, and not found by mammography, tend to be smaller than cancers found by mammography.
Executive Management
Karsten Damgaard-Iversen, BS, MBA – Chief Executive Officer
Roger Royce, BA – President & Chief Operating Officer
Safiye Cangal, BBA – Chief Financial Officer
Board of Directors
Kevin M. Kelly, MD – Chairman
Karsten Damgaard-Iversen, BS, MBA
Morgan W. Nields, BS, MBA
Steve H. Parker, MD
Roger Royce, BA
Medical Advisory Board
A. Thomas Stavros, MD, Chairman
Kevin M. Kelly, MD, Chief Medical Officer
Executive Management
Karsten Damgaard-Iversen, BS, MBA – Chief Executive Officer & Director
Karsten Damgaard-Iversen was elected a Director of the Company on January 11, 2011 and assumed the position of Chief Executive Officer on April 1, 2011. He has been serving as a management consultant to the Company since August 2010. Mr. Damgaard-Iversen is an internationally accomplished business professional with over 30 years of global experience in the healthcare imaging industry. He is a proven leader with a successful track record in operational and strategic management positions within small, medium and large medical imaging and healthcare technology companies. Mr. Damgaard-Iversen combines strong business acumen with in-depth technical and medical knowledge and has served in both executive and non-executive positions such as Chairman of Mirada Medical, Managing Director and Chief Group Executive of Toshiba Medical Systems Europe BV, Managing Director of Toshiba Medical Systems (UK) Ltd., Vice President of International Operations of Fisher Imaging Corporation and Director of Sales & Marketing of Storz Medical AG. Mr. Damgaard-Iversen has also been a direct contributor to the invention and development of specific laser and x-ray based medical products. He holds an MBA from Emory University and a BSc in electronic engineering from Copenhagen University College.
Roger Royce, BA – President, Chief Operating Officer & Director
Roger Royce has extensive domestic and international experience in corporate management and the development of new business ventures. He has established and built a number of successful companies with an emphasis on marketing and manufacturing. Since 2000 he has served in various executive positions with the Company, most recently as President, Chief Operating Officer, Secretary and a Director of SonoCiné. He founded and was President of Roger Royce, Inc. from 1997-2005, was Director of Business Development at Gordon & Ferguson, Inc. from 1994-1997, and founded and was President of Rohde-Royce, Inc. from 1988-1994. In 1977 Mr. Royce moved with his family to Hong Kong where he started SATCO, Ltd. and was Managing Director of the Asian-based trading company with worldwide clients and offices throughout Asia, India, Korea and the Philippines until 1988. He also founded and was President of Concept IV, Inc. (1974 - 1977); Senior Vice President of Sharpe Mfg. Company, Inc. (1969 – 1974); and Director of the Retail Division of Groves-Kelco, Inc. (1965 – 1969). Mr. Royce studied at Trinity College, Hartford, CT, the University of Minnesota and California State University at Northridge, graduating with degrees in Business and History.
Safiye Cangal, BBA – Chief Financial Officer
Safiye Cangal will join the Company as Chief Financial Officer on February 15, 2011. Ms. Cangal has over 20 years of experience in finance and accounting. She served the American Air Force Base (NATO) as Controller of government contracts in Ankara, Turkey. For the past fifteen years she worked as Vice President of Finance and Administration at Vital Systems Corporation Nevada's leading electronic contract design and manufacturing company producing electronics for Industrial and Medical applications. She holds an Associates Degree of Biology from Middle East Technical University in Ankara, Turkey, a BA in Economics from Anatolian University in Ankara, Turkey and a BA in Finance from University of Nevada Reno. She is currently working on her MBA at University of Nevada Reno.
Board of Directors
Kevin M. Kelly, MD – Chief Medical Officer, Board Chairman
Dr. Kelly founded the Company in 2000 and has served in various executive positions with the Company, most recently as Chief Medical Officer and a Director. He has been in private practice as a diagnostic radiologist for 34 years. He became Director of Breast Imaging for The Hall Center, Venice, CA, in January 2010. He was previously the Director of Breast Imaging for Huntington Memorial Hospital and of the Hill Breast Center, both in Pasadena, CA, for over ten years. Dr. Kelly earned his Bachelor of Science degree in biology at Georgetown University. He completed his Medical Degree at St. Louis University, following that with an internship and two years residency in diagnostic radiology at the St. Louis University Service of St. Louis City Hospital. Dr. Kelly was a Lt. Commander in the U.S. Public Health Service. He was the Leo G. Rigler Center research fellow at UCLA from 1973 to 1974 and completed his final year of residency at the Wadsworth Veterans Administration Hospital in Los Angeles. Dr. Kelly has written articles and lectured internationally on the use of ultrasound in the diagnosis of breast cancer. Since 1993, he has been conducting clinical research on the discovery and characterization of breast cancer by ultrasound. In 1997, he joined with Roger Royce to begin making the benefits of his research available to the general public. After conducting the first clinical trial of the SonoCiné process for breast cancer screening in 1999-2000, he patented his invention in early 2001.
Karsten Damgaard-Iversen, BS, MBA
Biography stated above in Executive Management
Morgan W. Nields, BS, MBA – Director
Morgan W. Nields was elected a Director of the Company in January 2010. He serves as the President and Chief Executive Officer of INTIO, Inc. (formerly known as Abla-Tx Inc.), and was one of its founders in 2005. Mr. Nields has spent 30 years in the medical imaging industry primarily as the CEO of Fischer Imaging. Fischer Imaging developed and marketed x-ray imaging systems including trauma systems, cardiac cath labs, dedicated x-ray systems for use in surgery, and a line of mammography systems. Following its incorporation in 1973 Mr. Nields took Fischer Imaging public in 1991 and served as its CEO until 2000 and Chairman through 2003. Mr. Nields twice served as the Chairman of the Board of the NEMA (National Electrical Manufacturers Association: www.nema.org ) Diagnostic Imaging Systems and Therapy Systems Division, a $5B division of the $100B trade association. He also served for 10 years as a Member of NEMA's Board of Governors. Mr. Nields is a Director and Treasurer of AdMeTech, a non-profit organization that identifies, funds, and manages research and development projects conducted at leading academic institutions to expedite advancement of imaging technologies that can improve the diagnosis and treatment of prostate cancer. Currently a member of several private company boards, Mr. Nields was a Board Member of Columbia Hospital Corporation, Diasonics Inc., Smith Laboratories, and Fischer Imaging Corporation. Mr. Nields holds a B.A. from Williams College and an M.B.A. from the Amos Tuck School of Business Administration at Dartmouth College.
Steve H. Parker, MD – Director
Dr. Parker was elected a Director of SonoCiné in January 2010. An interventional radiologist, Dr. Parker, the 2009 Pathfinder Lecturer in Radiology, is well known in the field of breast diagnosis. Dr. Parker has been a pioneer in the development and study of minimally invasive breast biopsy. His innovations have included stereotactic-guided core biopsy, ultrasound-guided core biopsy, stereotactic-guided vacuum assisted biopsy (VAB), ultrasound-guided VAB, ultrasound-guided sentinel node core biopsy/VAB and ultrasound-guided percutaneous excision of masses. While serving at Fitzsimons Army Medical Center, Dr. Parker developed the first use of image-guided percutaneous breast biopsy with a large-core needle. He was the principal author of a multi-institutional study showing that stereotactic and ultrasound large-core breast biopsy is as accurate as surgical biopsy. Dr. Parker further refined this technique by helping to develop additional minimally invasive tools including VAB devices. Dr. Parker was the course director of the “Breast Imaging and Intervention in the 21st Century” international breast conference for ten years and has lectured worldwide for the past two decades. Dr. Parker served in the U.S. Army Medical Corps from 1979 to 1989 and was a practicing radiologist at Radiology Imaging Associates, Englewood, Colorado, from 1989 to 2007. He was a co founder of medical device companies Biopsys (1993-1997), Opus (1999–2004) and SenoRx, Inc. (1997– present).
Roger Royce, BA
Biography stated above in Executive Management
Medical Advisory Board
A. Thomas Stavros, MD – Medical Advisory Board Chairman
Dr. Stavros is a practicing radiologist with more than 30 years of breast imaging experience. As author of the book “Breast Ultrasound,” the definitive work on this subject in the United States, he is considered one of the premier experts in the field and lectures worldwide at numerous clinical conferences each year. Dr. Stavros was a founding medical advisory board member for several breast radiology companies including Biopsys (the company that introduced the Mammotome Breast Biopsy system) and SenoRx (another breast biopsy company). Dr. Stavros currently practices breast imaging at the Sutter Memorial Hospital Breast Center in Santa Rosa, CA.
Kevin M. Kelly, MD, Chief Medical Officer
Biography stated above in Board of Directors
