Press Releases
Using a Real-Time Predictive Model to Interpret Images from Seno Medical Instruments Imagio Breast
November 02, 2014SAN ANTONIO, Nov. 3, 2014 /PRNewswire/ — Seno Medical Instruments, Inc., the company pioneering the development of opto-acoustic technology as a new tool to improve the process of diagnosing breast cancer, announced that the use of the Seno Imagio breast imaging system and the associated predictive model appear to have the potential to significantly improve the physicians’ ability to accurately rule out breast cancer compared to traditional ultrasound alone.
“Diagnostic specificity, or the ability to accurately identify benign masses, remains disappointingly low for imaging methodologies optimized to identify all cancerous lesions with near 100% sensitivity,” said A. Thomas Stavros, MD, Medical Director, Seno Medical Instruments. “We believe that by training Imagio readers with this real-time predictive model, they may be able to accurately reclassify benign breast lesions to a lower BI-RADS score so the patient can confidently avoid a biopsy on benign masses. If confirmed by Seno’s prospective, multicenter PIONEER Pivotal Study of Imagio, the predictive model may improve the image reader’s ability to accurately characterize solid breast masses as cancerous or benign and to spare women with benign lesions from the biopsy process beyond the standard-of-care today.”
The predictive model is based on key opto-acoustic features of breast masses obtained by Imagio during a 79 subject pilot study. Seno completed active enrollment of 2,100 subjects in the U.S.-based PIONEER study in September. The results of the study will serve as the basis for the company’s Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA).
Dr. Stavros presented results of the parallel reader study, which was designed to prospectively test the predictive model, at the 18th SIS World Congress on Breast Healthcare. The meeting, hosted by the American Society of Breast Disease and by the Senologic International Society, took place in Orlando, Fla. from October 16 to 19, 2014.
To develop the real-time predictive model, an expert radiologist blinded to histologic outcomes evaluated traditional diagnostic breast ultrasound and the 5 different Imagio opto-acoustic features of 79 masses (41 benign, 38 cancer) classified BI-RADS 4 prior to biopsy. Linear regression was used to model and predict the probability of malignancy, while logistic regression was used to model and to predict whether a mass was benign or malignant.
Three independent radiologist readers analyzed the gray scale ultrasound images and assigned BI-RADS categories and percentage risk of malignancy (POM) to each mass. They then scored the 5 individual Imagio opto-acoustic features and assigned BI-RADS categories and POM to each mass based upon OA without the predictive model applied. Finally, the readers repeated the Imagio OA feature analysis and assignment of BI-RADS category and POM with the aid of the predictive model. All three independent radiologists identified all of the cancerous lesions with Imagio images, generating 100% sensitivity across all readers, while one cancer was missed on gray scale ultrasound. With Imagio OA without the predictive model the IRs achieved 11%, 24%, and 25% better specificity than with conventional gray scale ultrasound. With the predictive model added, each independent radiologist was able to improve his/her ability to accurately classify a suspicious breast mass as benign by 28%, 36% and 38% achieving better specificity than with conventional gray scale ultrasound, respectively. Incremental improvements in specificity attributable to the predictive model (over subjective assignment) were 17%, 12%, and 13%.
“We are dedicated to improving the standard care for women after a suspicious mass is identified in one of their breasts. This new predictive model showed the increased potential of opto-acoustic images to help physicians confidently classify breast masses as benign, possibly eliminating the need for biopsies on certain breast masses,” said CEO Janet Campbell. “We are completing the follow-up of all subjects who participated in our U.S. pivotal study and will submit these additional promising data sets to the FDA as part of Seno’s PMA data package.”
Imagio was designed to identify two functional hallmarks of a potential malignancy: the presence of abnormal blood vessels (angiogenesis) and the relative reduction in oxygen content of hemoglobin. The technology is non-invasive and does not require contrast agents or radio-isotopes, which are required for other modalities such as magnetic resonance imaging (MRI) or positron emission tomography (PET), nor does it use ionizing radiation (x-ray).
According to the American Cancer Society’s estimates, 232,340 new cases of invasive breast cancer and an additional 64,640 cases of in situ breast cancer were diagnosed and approximately 39,620 women in the U.S. died from the disease during 2013. Only lung cancer accounts for more cancer deaths in women.
About Seno Medical Instruments, Inc.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno’s Imagio breast imaging system fuses opto-acoustic technology with ultrasound to generate functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around suspicious breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of the two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno believes that Imagio images will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. Seno’s platform technology may also address other disease applications in organs other than the breast, as well as assessing other breast problems, such as early response to chemotherapy or hormonal treatments of breast cancer. To learn more about Seno Medical’s opto-acoustic imaging technology and applications, visit www.SenoMedical.com
Seno to Present at the Cleveland Clinic’s 12th Annual Medical Innovation Summit
October 22, 2014SAN ANTONIO, Oct. 23, 2014 /PRNewswire/ — Seno Medical Instruments, Inc., the company pioneering the development of opto-acoustic technology as a new tool to improve the process of diagnosing breast cancer, today announced that Janet Campbell-Clark, Chief Executive Officer, will be presenting a corporate overview at the Cleveland Clinic’s 2014 Medical Innovation Summit to be held October 26-29 in Cleveland, OH.
The presentation will take place on October 29 at 8:00 am ET at the Cleveland Convention Center in Room 26.
About the Cleveland Clinic’s 12th Annual Medical Innovation Summit
The summit will convene over 1,500 great thinkers and leaders for a candid exchange on new medical technology, its future, recent breakthroughs and continuing challenges.
The Trout Group [www.troutgroup.com] has teamed up with The Cleveland Clinic to create Ground Waves – an exciting two day showcase that will present a wide array of companies making waves in cancer treatment and personalized medicine. The Summit is renowned for thought-provoking panels, lively 1-on-1 discussions with influential CEOs, and the discovery of the latest market-ready technologies poised to shake up the status quo.
About Seno Medical Instruments, Inc.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno’s Imagio breast imaging system fuses opto-acoustic technology with ultrasound to generate functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around suspicious breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of the two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno believes that Imagio images will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. Seno’s platform technology may also address other disease applications in organs other than the breast, as well as assessing other breast problems, such as early response to chemotherapy or hormonal treatments of breast cancer. To learn more about Seno Medical’s opto-acoustic imaging technology and applications, visit www.SenoMedical.com
Medical Innovation Summit Contacts
Lee M. Stern / lstern@troutgroup.com
Emily Present / epresent@troutgroup.com
Seno Completes Patient Enrollment in U.S. Pivotal Study of Imagio™ Breast Imaging System
September 22, 2014SAN ANTONIO, TX – September 23, 2014 – Seno Medical Instruments, Inc., the company pioneering the development of opto-acoustic technology as a new tool to improve the process of diagnosing breast cancer, announced today it has completed active enrollment of subjects in its U.S.-based PIONEER Pivotal Study of Imagio™. The study was designed to determine if this technology will provide information to the physician to determine if a woman may avoid negative biopsies. This information will serve as the basis for the company’s Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA). “There is a significant unmet medical need for more accurate diagnostic imaging technologies to help physicians confirm and rule out breast cancer before the patient has to undergo an invasive procedure. More information at the imaging stage could help us make more informed decisions regarding whether we should send the patient for a surgical or needle biopsy,” said Reni Butler, MD, Assistant Professor of Diagnostic Radiology at the Yale School of Medicine in New Haven, Conn. and the co-principal investigator for the study.
Imagio™ was designed to identify two functional hallmarks of a potential malignancy: the presence of abnormal blood vessels (angiogenesis) and the relative reduction in oxygen content of hemoglobin. The technology is non-invasive and does not require contrast agents or radio-isotopes, which are required for other modalities such as magnetic resonance imaging (MRI) or positron emission tomography (PET), nor does it use ionizing radiation (x-ray).
“Earlier data from a feasibility study of Imagio™ led to encouraging results and we look forward to seeing the outcomes from this pivotal study. If the results are consistent with the earlier, smaller studies, we believe this could be an important new technology to help improve the diagnosis of breast cancer and allow many women with benign lesions to have short-interval Imagio™ follow-up and avoid a biopsy,” said co-principal investigator Erin Neuschler, MD, Northwestern Medicine® Radiologist and Assistant Professor of Radiology at Northwestern University Feinberg School of Medicine in Chicago.
The Imagio™ study was conducted in 16 leading institutions throughout the U.S. with more than 2,100 subjects enrolled. The study was designed to measure the sensitivity and specificity of Imagio™ compared to Imagio™ grayscale ultrasound imaging in breast lesions using the probability of malignancy (POM). Subjects who enrolled in the study underwent a traditional ultrasound and an Imagio™ scan. Physicians only used traditional ultrasound findings to determine if the subject should advance to the biopsy phase. The Imagio™ results were later interpreted by an independent reader panel. Subjects who had a negative diagnostic ultrasound will be re-evaluated 12 months after their initial examination to confirm the negative results as a true negative.
“Completing active enrollment is a significant milestone in Seno’s efforts to commercialize Imagio™. We developed Imagio™ with the goal of reducing the number of imaging tests and invasive procedures women currently have to undergo to learn if a suspicious breast mass is cancerous or not. We would like to thank our investigators and their dedicated teams for participating in this important study. We hope Imagio™ will have a significant impact on the diagnosis of breast cancer in the future,” said Janet Campbell, CEO of Seno Medical Instruments.
According to the American Cancer Society’s estimates, 232,340 new cases of invasive breast cancer and an additional 64,640 cases of in situ breast cancer were diagnosed and approximately 39,620 women in the U.S. died from the disease during 2013. Only lung cancer accounts for more cancer deaths in women.
Seno’s Imagi™o fuses opto-acoustics, a technology based on “light-in and sound-out,” with diagnostic ultrasound. The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Cancerous tumors grow relatively quickly and 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 relative oxygen-rich or oxygen-deprived blood. Unlike other functional fusion technologies, Imagio™ uses no x-rays (ionizing radiation) or injectable contrast agents to obtain its information, thereby reducing the patient’s exposure to any potentially harmful aspects of imaging.
About Seno Medical Instruments, Inc.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno’s Imagio™ breast imaging system fuses opto-acoustic technology with ultrasound to generate functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around suspicious breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of the two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno believes that Imagio™ images will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. Seno’s platform technology may also address other disease applications in organs other than the breast, as well as assessing other breast problems, such as early response to chemotherapy or hormonal treatments of breast cancer. To learn more about Seno Medical’s opto-acoustic imaging technology and applications, visit www.SenoMedical.com
Seno Medical Instruments receives CE Mark for Imagio® breast imaging system
April 09, 2014SAN ANTONIO, TEXAS – April 10, 2014 – Seno Medical Instruments, Inc., the company pioneering the development of opto-acoustic technology as a new tool to improve the process of diagnosing breast cancer, announced today that it has received the CE Mark for Imagio®, a new opto-acoustic imaging system, in Europe. Seno is in the middle of its Pivotal Study whose purpose is to determine if this technology will provide new information to the physician to decide if a woman may avoid negative (unnecessary) biopsies.
“I am very pleased that we have achieved this important milestone for Seno,” said Seno CEO, Janet Campbell. “Experts recently presented data from the Imagio feasibility study at the European Congress of Radiology in Vienna, and it was enthusiastically received by European key opinion leaders. The CE Mark means we can now commercialize this important new breast imaging system in Europe and gives us the opportunity to continue developing our relationships with physicians and regulators in the EU.”
Seno’s Imagio fuses opto-acoustics, a technology based on “light-in and sound-out,” with traditional ultrasound. The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Cancerous tumors grow relatively quickly and 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 relative oxygen-rich or oxygen-deprived blood. Radiologists believe that Imagio images depicting significant vascular structures and low oxygen levels are likely to indicate cancers. Unlike other functional fusion technologies, Imagio uses no x-rays (ionizing radiation) or injectable contrast agents to obtain its information, thereby reducing the patient’s exposure to any potentially harmful aspects of imaging.
In 2012, The European Journal of Cancer estimated that 464,000 new cases of breast cancer were diagnosed in Europe. Each year millions of women around the world undergo core needle or surgical breast biopsies after a suspicious mass is found through breast imaging or self-exams. Studies show that more than 80% of these biopsies reveal benign pathology after they are analyzed in a laboratory.
The Imagio Pivotal Study is ongoing in the U.S. and includes 16 leading hospitals and imaging centers throughout the country. The study will form the basis of the company’s pre-market approval application (PMA) to seek U.S. approval from the U.S. Food and Drug Administration (FDA).
Data Show Seno Medical Instruments’ Imagio™ Could Potentially Allow Doctors to Eliminate the Need for a Breast Biopsy and Monitor Early Response to Treatment
March 09, 2014VIENNA, AUSTRIA – March 10, 2014 – Seno Medical Instruments, Inc., the company pioneering development of opto-acoustic (OA) imaging as a tool to improve the process of diagnosing breast cancer, today announced that two analyses of outcomes from a U.S. Feasibility Study of its investigational Imagio™ breast imaging device were presented at the annual meeting of the European Congress of Radiology 2014.
The first statistical analysis is of the Feasibility Study data (Abstract C-0926), 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. This will be verified in the ongoing U.S. Pivotal Study which has already enrolled more than half of the 2,000 subject target. Imagio™ may be a useful tool to help physicians reduce the need for biopsy in patients with benign but suspicious appearing breast masses on conventional diagnostic breast ultrasound.
“We are encouraged by these findings, which demonstrate the biopsy-sparing potential of Imagio™,” said Thomas Stavros, MD, FACR, FSRU, FRANZCR, Medical Director, Seno Medical Instruments. “While surgical and core needle biopsies are considered the gold standard for breast cancer diagnosis, biopsies are the most expensive part of the diagnostic process and over 80% of U.S. biopsies are negative. Imagio™ has the potential to contribute to the way that breast cancer is diagnosed and to optimize the decision to biopsy.”
The second statistical analysis is of pre-defined histopathology findings relative to the specific features of benign and malignant lesions. This information was captured in the Imagio™ opto-acoustic images during the Feasibility Study. It 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 diagnostic work-up, which will also be verified in the ongoing Pivotal Study.
Separate analysis of the feasibility data showed that OA findings could potentially correlate with molecular subtypes of breast cancer (Abstract C-1528). “If confirmed in a larger series of breast cancer patients, this analysis suggests that OA findings might be useful in differentiating and monitoring early response to medical oncologic treatments,” said lead biostatistician Philip Lavin, PhD, FASA, FRAPS, who is a consultant to Seno Medical Instruments. “Our ongoing Pivotal Study will continue to elucidate the potential Imagio™ may have in both classifying breast masses and determining molecular subtypes.”
Imagio™ fuses 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.
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, more than 80% of these biopsies reveal benign pathology .
About the European Congress of Radiology (ECR)
The European Congress of Radiology (ECR) represents the medical specialty of radiology throughout Europe and the Mediterranean. The ECR comprises a Congress Committee, a Programme Planning Committee, and 17 Scientific Subcommittees. The next ECR congress will be held from March 5–9, 2015, in Vienna, Austria.
Seno Medical Instruments Raising $39 Million in Series C Funding Round
February 24, 2014SAN ANTONIO, TEXAS – February 25, 2014 – Seno Medical Instruments, Inc., the company pioneering opto-acoustic imaging as a tool to improve the process of diagnosing breast cancer, today announced that it has sold $34.6 million of a $39 million Series C equity funding round from existing investors with the lead investment from MedCare Investment Funds.
The new funding will support Seno’s ongoing U.S. Pivotal Study of the Imagio® breast imaging device, as well as activities to obtain the CE Mark in Europe, which the company seeks to receive by the end of the first quarter of 2014. There are currently 16 leading hospitals and imaging centers throughout the U.S. enrolling patients in the Imagio Pivotal Study.
“We believe Seno Medical’s opto-acoustic imaging platform has the potential to answer a significant unmet need in the diagnosis of breast cancer,” said Harry Jacobsen, M.D., Chairman of MedCare Investment Funds. “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. We look forward to seeing the results of the company’s ongoing Pivotal Study.”
Imagio fuses an imaging technology based on light-in and sound-out called “opto-acoustics” with conventional 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.
“We owe MedCare and our other loyal investors so much gratitude for their years of support as we have worked towards our goal of offering women a more effective, safe diagnostic imaging option for breast cancer,” said Janet Campbell, CEO of Seno Medical Instruments. “We currently have all 16 of the sites in the Imagio Pivotal Study enrolling subjects and currently over half have been enrolled. In the meantime, we are actively seeking our CE Mark clearance, which we expect sometime during the first quarter of 2014.”
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.
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