Press Releases
Preliminary Data Show Seno Medical Instruments’ Imagio™ Could Potentially Allow Doctors to Rule Out the Need for a Breast Biopsy
December 16, 2013SAN ANTONIO, TEXAS – December 17, 2013 – Seno Medical Instruments, Inc., the company pioneering opto-acoustic imaging as a tool to improve the process of diagnosing breast cancer, today announced new statistical analysis of outcomes from a Feasibility Study of its investigational Imagio™ breast imaging device.
The analysis of data from the Feasibility Study, presented at the San Antonio Breast Cancer Symposium (SABCS) 2013 (Abstract P4-01-14) on December 13, 2013, suggests that information from Imagio may have the potential to achieve clinically-meaningful sensitivity and specificity for breast cancer beyond those achievable with traditional, standalone diagnostic ultrasound. If confirmed in a larger Pivotal Study – currently underway in the U.S. – Imagio may be a useful tool to help physicians rule out the need for a biopsy in patients with benign breast masses.
“These preliminary findings are encouraging and may support the biopsy-sparing potential of Imagio,” said lead biostatistician Philip Lavin, PhD, FASA, FRAPS, who is a consultant to Seno Medical Instruments. “Surgical and core needle biopsies are considered the gold standard for breast cancer diagnosis, yet are the most expensive part of the diagnostic process. While existing breast imaging technologies are successful at positively identifying cancerous masses, it is very difficult to rule out cancer during the imaging phase and a large majority of biopsies come back negative for cancer.”
This new statistical analysis of various features of benign and malignant lesions captured in the Imagio opto-acoustic images during the Feasibility Study also suggests that Imagio may have the potential to provide additional information that could help clinicians grade the aggressiveness of cancerous breast tumors during the imaging phase of a woman’s diagnosis, if verified in the ongoing Pivotal Study.
Imagio combines an imaging technology based on light-in and sound-out called “opto-acoustics” with traditional ultrasound. The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Unlike other imaging modalities, Imagio doesn’t expose patients to potentially harmful ionizing radiation (x-rays) or injectable contrast agents.
For this study, proposed classification guidelines were developed to help identify features that differentiate images of benign and cancerous lesions, as well as the aggressiveness of the tumor. To develop the proposed classification guidelines, images of each tumor were assessed using three internal and two external features, which were scored on an ordinal scale from zero to five. The results were then summed to get a total internal score, total external score, and a total score. These results were then analyzed with five statistical classification methods.
“We are encouraged to see a high correlation between pathology results and classified features of masses captured in Imagio opto-acoustic images as part of this Feasibility Study,” said Thomas Stavros, MD, FACR, FSRU, FRANZCR, Medical Director, Seno Medical Instruments. “Our ongoing Pivotal Study will hopefully provide evidence to confirm our hypothesis and this early data.”
Each year in the U.S. 1.7 million women undergo core needle or surgical breast biopsies after a suspicious mass is found through breast imaging or self-exams. However, up to four out of five of these biopsies reveal benign pathology .
About San Antonio Breast Cancer Symposium (SABCS)
For thirty-six years, the Symposium’s mission has been to provide state-of-the-art information on breast cancer research. From a one-day regional conference, the Symposium has grown to a five-day program attended by a broad international audience of academic and private researchers and physicians from over 90 countries. The Symposium aims to achieve a balance of clinical, translational, and basic research, providing a forum for interaction, communication, and education for a broad spectrum of researchers, health professionals, and those with a special interest in breast cancer.
New Data Show Seno Medical Instruments’ Imagio™ May Help Reduce Negative Biopsies for Breast Cancer
December 03, 2013CHICAGO, ILLINOIS – December 4, 2013 – Seno Medical Instruments, Inc., the company pioneering opto-acoustic imaging as a tool to improve the process of diagnosing breast cancer, today announced preliminary information from a feasibility study of its Imagio™ breast imaging device. Results from the feasibility study suggest that information from Imagio, beyond that available from traditional breast ultrasound, may be helpful in assisting physicians in their decisions whether to recommend biopsies for women with suspicious breast masses. The data were presented at the annual meeting of the Radiological Society of America (RSNA), which concludes here this Friday.
Imagio combines an imaging technology based on light-in and sound-out called “opto-acoustics” with traditional ultrasound. The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Unlike other imaging modalities, Imagio doesn’t expose patients to potentially harmful ionizing radiation (x-rays) or injectable contrast agents.
“Given these early results, I believe that opto-acoustics could potentially spare some BI-RADS 4a cases and some BI-RADS 4b cases from needing to undergo biopsies,” said study investigator Kenneth Kist, M.D., Associate Professor of Radiology at UT Health Science Center in San Antonio, Texas. “This could represent a significant advance in the diagnostic path for breast cancer and I look forward to seeing the results of the ongoing U.S. Pivotal Study.”
The BI-RADS classification is used by radiologists to predict the probability of malignancy of a breast mass based on imaging results. A BI-RADS 3 mass only carries up to a 2% chance of being cancerous. Patients with masses in the BI-RADS 3 category can safely wait to see if the mass changes or grows. A BI-RADS 4a mass is considered to have more than a 2% but less than or equal to 10% chance of being cancerous, and a BI-RADS 4b mass is considered to carry from greater than 10% to less than or equal to 50% risk of malignancy. Patients whose masses are deemed BI-RADS 4a or higher will almost always undergo a core needle or surgical biopsy.
For this study (Abstract LL-BRS-WE5B), five blinded readers independently assessed Imagio images from 73 patients with 74 breast masses. All of the masses were biopsied to provide a gold-standard comparator. Readers were blinded to the subjects’ medical history, biopsy report, histology report, clinical records and follow-up. All 34 detected cancer masses remained at their original BI-RADS classification.
In the 40 remaining benign masses, downgrades to BI-RADS 3 were achieved in 12 of 22 original BI-RADS 4a diagnoses as a result of opto-acoustics. Three of 13 BI-RADS 4b masses were downgraded to BI-RADS 3.
Each year in the U.S. 1.7 million women undergo core needle or surgical breast biopsies after a suspicious mass is found through breast imaging or self-exams. However, up to four out of five of these biopsies reveal benign pathology.
A separate electronic exhibit (Abstract LL-BRE2487) providing an overview of opto-acoustic technology was also displayed throughout the meeting.
“These early results underscore the potential of opto-acoustic imaging technology which we believe represents a significant step forward in cancer diagnosis,” said Thomas Stavros, MD, FACR, FSRU, FRANZCR, Medical Director, Seno Medical Instruments. “This feasibility study shows that Imagio has potential to lead to better outcomes for women and fewer biopsies. We are working diligently with 16 leading breast imaging centers across the U.S. to complete our Imagio Pivotal Study that will form the basis of our Premarket Approval Application with the U.S. Food and Drug Administration.”
About the Radiological Society of North America(RSNA)
The Radiological Society of North America (RSNA®) is an international society of radiologists, medical physicists and other medical professionals with more than 51,000 members from 136 countries across the globe. RSNA hosts the world’s premier radiology forum, drawing approximately 55,000 attendees annually to McCormick Place in Chicago, and publishes two top peer-reviewed journals: Radiology, the highest-impact scientific journal in the field, and RadioGraphics, the only journal dedicated to continuing education in radiology. www.rsna.org
Seno Medical Instruments, Inc. Launches Pivotal Study of New Functional Imaging Platform in Breast Cancer Diagnosis
November 24, 2013SAN ANTONIO, TEXAS – November 25, 2013 – Seno Medical Instruments, Inc., the company pioneering opto-acoustic imaging as a tool to improve the diagnosis of cancer, announced today that the first 100 patients have been enrolled into its Pivotal Study of Imagio™, a new opto-acoustic imaging system that may help women with benign breast masses avoid negative, invasive biopsies.
Each year in the U.S. 1.7 million women undergo core needle or surgical breast biopsies after a suspicious mass is found through screening mammograms or self-exams and a series of diagnostic imaging tests are performed. However, four out of five of these biopsies reveal benign pathology.
Imagio™ combines traditional ultrasound with an imaging technology based on light in and sound out called “opto-acoustics.” The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Unlike other imaging modalities, Imagio™ doesn’t expose patients to potentially harmful ionizing radiation (x-rays) or injectable contrast agents.
“Although breast cancer is one of the most prevalent causes of death in women, the tools used to diagnose this disease have certain limitations that can make the process intrusive, costly and potentially harmful to patients,” said Thomas Stavros, M.D., Medical Director, Seno Medical Instruments. “Breast biopsies, the current standard of care for diagnosing or ruling out cancer, are the most expensive part of the breast cancer diagnostic process. By providing a real-time blood map co-registered with ultrasound images, we believe that opto-acoustics can provide radiologists more information than ever before to help them confidently rule out cancer so that fewer women with benign lesions will have to undergo biopsies and the worry that can come from the process.”
Because cancerous tumors grow relatively quickly, they require significant amounts of blood and oxygen, so a network of blood vessels grows around cancerous masses. Imagio™ provides images of these networks and a map of oxygen-rich or oxygen-deprived blood. Radiologists believe that Imagio™ images depicting significant vascular structures and low oxygen levels are likely to indicate cancer.
The Imagio™ Pivotal Study will include 16 leading hospitals and imaging centers throughout the United States.
“Scanning the first 100 patients and starting the active enrollment phase is an important milestone for us in our mission to deliver a new standard in breast cancer diagnosis,” said Janet Campbell, CEO of Seno Medical Instruments. “We believe Imagio™ can offer a better diagnostic alternative for women who have suspicious breast masses, and can help physicians more confidently rule out cancer with a less invasive test. Based on conversations with some of the top minds in radiology, we are encouraged that this new modality could have a significant impact breast cancer diagnosis.”
The American Cancer Society estimates that there were more than 2.9 million women with a history of invasive breast cancer living in the U.S. in 2012, with 226,870 of them diagnosed during the year.
Seno Medical Instruments, Inc. CEO Janet Campbell Wins Gold Stevie® Award in 2013 Stevie Awards for Women in Business
November 20, 2013SAN ANTONIO, TEXAS – November 21, 2013 – Seno Medical Instruments, Inc., the company pioneering opto-acoustic imaging as a tool to improve the diagnosis of cancer, today announced that CEO Janet Campbell has been named the winner of a Gold Stevie® Award for Female Entrepreneur of the Year in the 10th annual Stevie Awards for Women in Business 2013. Ms. Campbell received the honor in the consumer products category representing companies with 11 to 2,500 employees.
The Stevie Awards for Women in Business are the world’s top honors for female entrepreneurs, executives, employees and the organizations they run. All individuals and organizations worldwide are eligible to submit nominations – public and private, for-profit and non-profit, large and small. The 2013 awards received entries from 18 nations and territories. More than 1,200 nominations from organizations of all sizes and in virtually every industry were submitted this year.
“When my mother died of lung cancer, I dedicated myself to finding a way to make a significant impact on the fight against cancer by saving lives. It was with this goal in mind that I founded Seno Medical Instruments, to advance and develop a new imaging modality – called Imagio – based on opto-acoustic technology that could potentially improve how cancer is diagnosed,” said Janet. “I am honored to accept this award, and would like to sincerely thank the Stevie Awards judges for recognizing the work our company has accomplished so far.”
Imagio is an investigational opto-acoustic imaging system that may help women with benign breast masses avoid negative, invasive biopsies. It combines traditional ultrasound with an imaging technology based on light in and sound out called “opto-acoustics.” The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Unlike other imaging modalities, Imagio doesn’t expose patients to potentially harmful ionizing radiation (x-rays) or injectable contrast agents.
Because cancerous tumors grow relatively quickly, they require significant amounts of blood and oxygen, so a network of blood vessels grows around cancerous masses. Radiologists believe that Imagio images depicting significant vascular structures and low oxygen levels are likely to indicate cancer.
Seno is currently enrolling patients into the Imagio Pivotal Study, which will include 16 leading hospitals and imaging centers throughout the United States.
Seno Medical Instruments, Inc. Names Dr. Thomas Stavros Medical Director
November 18, 2013SAN ANTONIO, TEXAS – November 19, 2013 – Seno Medical Instruments, Inc., the company pioneering opto-acoustic imaging as a tool to improve the diagnosis of cancer, today announced that Thomas Stavros, MD, FACR, FSRU, FRANZCR, one of the world’s leading experts in breast radiology, has been named the company’s Medical Director.
“I am excited to join the Seno management team and help the company in its quest to develop and commercialize opto-acoustic imaging, which I believe could become a new standard in cancer diagnosis,” said Dr. Stavros. “I’ve spent my career working to develop safe and effective breast imaging solutions, and I believe opto-acoustic technology has the potential to significantly improve the breast cancer diagnostic and treatment path. The sad reality is that 80% of biopsies ultimately return negative results due to limitations of current imaging modalities. The Imagio system produces some of the most exciting images depicting angiogenesis and oxygen levels within and around suspicious masses that I’ve seen in my career and could enable us to more precisely diagnose or rule out breast cancer.”
The ImagioTM breast imaging system uses a combination of traditional breast ultrasound co-registered with opto-acoustic technology, and provides physicians real time anatomical images of the breast with a functional “blood map” of a potentially suspicious mass.
Dr. Stavros is a practicing women’s imaging radiologist with more than 30 years of breast imaging experience, and is currently a women’s imaging radiologist at Sutter Medical Group, Sacramento, California. Dr. Stavros has been involved in mammography since 1976 and has been actively involved in the development of high-frequency hand-held breast ultrasound since 1981. He is a reviewer for several medical journals and has written or co-authored numerous articles. Dr. Stavros has also written the textbook Breast Ultrasound, the definitive work on this subject in the United States.
Dr. Stavros lectures about ultrasound, particularly about breast ultrasound, at numerous clinical conferences worldwide and has presented more than 1,800 invited lectures and abstracts.
He is a fellow of the American College of Radiology, a fellow of the Society of Radiologists in Ultrasound, and an honorary fellow of the Royal Australian and New Zealand College of Radiology, where he was the Traveling Baker Professor in 1999. He received his medical degree from the University of Colorado School of Medicine in Denver and bachelor’s degree from St. Olaf College in Minnesota.
He has served as a clinical advisor for several ultrasound, breast imaging, and minimally invasive biopsy device companies including General Electric, Phillips and Ethicon Endo-Surgery.
“Dr. Stavros’ unprecedented experience in breast imaging using ultrasound makes him an ideal Medical Director for our company. We are proud to have him join our team,” said Janet Campbell, CEO, Seno Medical Instruments. “Tom is one of the leading minds in the field driving our clinical development path us and helping us in our goal to improve the diagnosis of breast cancer for women around the globe. He brings invaluable clinical experience that will help facilitate development of Imagio and help us bring this important technology to commercialization.”
Given the positive outcomes from the Feasibility Study, Seno’s management believes that Imagio has the potential to be an important factor in the diagnostic standard of care. The objective is to provide a better tool for the user and a more accurate, efficient, safer and cost effective diagnostic care path.
Seno Medical Instruments, Inc. Receives Prestigious Frost and Sullivan Emerging Company of the Year Award
March 10, 2009SAN ANTONIO, TEXAS – March 11, 2009 – Seno Medical Instruments, Inc. a San Antonio-based company engaged in the development of a next-generation, opto-acoustic cancer platform technology, today announced it has received the 2009 North American Medical Imaging Emerging Company of the Year Award from Frost & Sullivan.
The Award recognizes Seno Medical Instruments pioneering and industry-changing pre-clinical opto-acoustic imaging technology, its first product that was commercialized. Seno’s management team will be receiving this award March 18th in San Francisco.
In making the selection of Seno Medical Instruments as the recipient of the Emerging Company of the Year Award, representatives from Frost & Sullivan wrote in its Award review, “ Seno Medical Instruments, Inc. has favorably positioned itself to be an emerging technology provider whose products will help shape the future role of functional imaging and cancer diagnostics. The company continues to strive towards developing a flexible clinical platform technology that has the potential to significantly improve the continuum of care within a broad set of clinical segments including cardiovascular and oncology. Based on these factors, Seno Medical is proudly presented with the 2009 Frost & Sullivan Emerging Company of the Year Award in the North American Medical Imaging Industry.”
A coveted prize in industry circles and considered a major achievement, the Frost & Sullivan Award is based on a number of factors, including product development, brand strategy, the creation of “buzz” from potential investors and customers, and strategic hiring and board appointments. The Frost & Sullivan Award-recognized company must demonstrate sound decision-making and outstanding creativity on all business fronts in order to be recognized.
“We are gratified to have this important recognition bestowed on our company,” said Janet Campbell, Chairman and CEO of Seno. “This public acknowledgement from such a recognized institution as Frost & Sullivan in the medical industry is further validation of the value of our platform technology, our management team, and the future of Seno and its products. “We are honored to receive this prestigious Award.”
Frost & Sullivan presents the Award for Emerging Company each year to organizations that display world class performance in their industry. In order to qualify, companies are asked to demonstrate outstanding management, superior market growth, exceptional customer service and the ability to combine technology and successful strategic initiatives. In the Award presentation Frost & Sullivan said Seno Medical Instruments distinguished itself in 2008 as the only company to commercially offer an opto-acoustic imaging device for preclinical imaging. This achievement, along with the establishment of research partnerships and licensing agreements with notable market participants and research centers (such as Yale, MIT, NIH, and NCI) — hallmarks the company’s impressive rapid advancement since its inception in 2005.
“Highlighting the outstanding progress Seno Medical exhibited in 2008 was the company’s assembling of a talented senior management team with the experience and vision needed to drive growth and financial success in the company’s future,” said Frost & Sullivan Industry Analyst Travis Chong. “The company is expected to leverage its collected expertise as it explores potential growth engines in 2009 including various clinical applications within cardiology and oncology.”
Since Q3 2008 Seno Medical Instruments has announced an exclusive licensing agreement with the world leader in high frequency ultrasound VisualSonics for the rights to Seno’s opto-acoustic small animal imaging (preclinical) technology; the hire of a new Chief Medical Officer, Dr. William Keane; the appointment of imaging pioneer, Dr. Walter Robb to their Scientific Advisory Committee; and the initiation of clinical studies for their breast application at the University of Texas Health Science Center, San Antonio and the CTRC. “Over the past six months we have accomplished a great deal and achieved important goals,” said CEO Campbell. “I am proud to add to our list of scientific and management accomplishments, this important award from Frost & Sullivan. This is a tremendous recognition of achievement for Seno Medical and for cancer researchers. We look forward to further development of our platform opto-acoustic technology products in 2009.”
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