Press Releases
Seno Medical Launches CONFIDENCE Registry Study for Imagio® Breast Imaging System
October 20, 2021Prospective, controlled multi-center observational registry will include ~12 sites and 600 patients to collect data on opto-acoustic/ultrasound (OA/US) system.
[SAN ANTONIO, TX – October 21, 2021] Texas-based Seno Medical Instruments, Inc. (Seno) has launched its CONFIDENCE registry to evaluate the efficacy of imaging with opto-acoustic/ultrasound (OA/US) to diagnose breast abnormalities including cancer using its groundbreaking Imagio® Breast Imaging System.
Approximately twelve sites will participate in the international registry, with a target of over 600 total patients participating through the study’s timeframe, ending in 2024.
Several international sites in the Netherlands are currently recruiting for the study. The study’s intent is to obtain real-life, post-market data on the use of the Imagio® System and to provide evidence on the general use and performance of the system in a real-world setting.
“We believe, much like other hybrid imaging modalities such as PET/CT, the sum of opto-acoustics and ultrasound together provide greater sensitivity and specificity than either of the imaging modalities individually,” says Shaan Schaeffer, VP of Clinical Operations at Seno.
CONFIDENCE registry endpoints to be analyzed include:
- Specificity, negative-likelihood ratio, sensitivity, and positive-likelihood ratio for the Imagio® System versus other standard-of-care imaging modalities,
- Use of the Imagio® System in comparison to, and in combination with, other imaging modalities in impacting the decision to biopsy,
- Quality of Life Assessment – Testing Morbidity Index,
- In malignant masses, assessment of the roles of OA/US as a prognostic biomarker,
- Characteristics of lymph node lesions/masses the device is used for.
Breast biopsy procedures caused by false-positive diagnostic assessments in the United States cost the healthcare system more than $2 billion per year.[i] Seno’s Imagio® technology could mitigate that with its non-invasive OA/US technology to help physicians better differentiate between benign and malignant breast lesions in real time, helping providers characterize and differentiate masses that may—or may not—require more invasive diagnostic evaluation.
Seno’s Chief Executive Officer, Tom Umbel, commented, “This registry study will help us substantiate the efficacy of the Imagio® System in a real-world setting and the ability for OA/US to benefit physicians and patients around the world.”
The company’s OA/US technology combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The opto-acoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno Medical has shown that the Imagio® OA/US Breast Imaging System will be a more effective tool to help radiologists confirm or rule out malignancy compared to traditional diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. In addition to the novel imaging provided by the Imagio® System, Seno includes an artificial intelligence (AI) decision-support tool (the SenoGram®) to aid physicians in interpreting the new images that, along with training and certification, helps radiologists make the transition from ultrasound alone to OA/US imaging.
The system is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.
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. Approved by the US FDA in January 2021, Seno Medical’s Imagio® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.
[i] Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of utilization patterns and associated costs of the breast imaging and diagnostic procedures after screening mammography. Clinicoeconomics Outcomes Res 2018;10:157-167.
Contact:
Tammy Garcia, 210.615.6501, tgarcia@senomedical.com
FDA Approves Seno Medical’s Ground-Breaking Breast Cancer Diagnostic Technology
January 18, 2021Seno’s Imagio® Breast Imaging System helps physicians differentiate between benign and malignant breast lesions using a novel combination of ultrasound and opto-acoustic technology.
[SAN ANTONIO, TX – January 19, 2021] The Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA) has granted Texas-based Seno Medical Instruments, Inc. (Seno) premarket approval (PMA) for its groundbreaking diagnostic breast cancer imaging technology that helps physicians better differentiate between benign and malignant breast lesions. The company’s Imagio® Breast Imaging System uses non-invasive opto-acoustic ultrasound (OA/US) technology to provide information on suspicious breast lesions in real time, helping providers characterize and differentiate masses that may – or may not – require more invasive diagnostic evaluation.
Breast biopsy procedures caused by false-positive diagnostic assessments in the United States cost the healthcare system more than $2 billion per year.[i] Seno’s Imagio® technology could mitigate that by giving providers additional real-time information regarding suspicious breast masses and increased confidence to make a better decision regarding the need for diagnostic breast biopsies.
The company’s OA/US technology combines laser optics and grayscale ultrasound to provide fused functional and anatomical breast imaging. The opto-acoustic images provide a unique blood map in and around breast masses, while the ultrasound provides a traditional anatomical image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno Medical has shown that the Imagio® OA/US Breast Imaging system will be a more effective tool to help radiologists confirm or rule out malignancy compared to traditional diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. In addition to the novel imaging provided by the Imagio system, Seno includes an AI physician decision support tool (the SenoGram®) to aid in interpreting the new images that, along with training and certification, help radiologists make the transition from ultrasound alone to OA/US Imaging.
The system is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast work-up following clinical presentation or other imaging examinations such as screening mammography.
Seno’s Chief Executive Officer Tom Umbel commented, “We are thrilled to have reached this milestone and are looking forward to moving our technology platform forward in the U.S. with this FDA approval. Our internal team and our faithful investigators and clinical trial sites have worked diligently to bring Imagio® to market and improve care for patients and providers with the precise diagnostic capabilities and enhanced decision-making support that our novel OA/US imaging provides.”
Seno’s Chief Medical Officer, A. Thomas Stavros, MD, FACR, FSBI, believes that Imagio® is establishing a better standard for how diagnostic modalities should be judged. “Optimizing the diagnosis of breast masses requires a combination of very high sensitivity (≥98%) while simultaneously maximizing specificity and minimizing false positives and biopsies of benign masses. Other modalities have reported improvements in specificity, but these have often come at the expense of the desired high ≥98% sensitivity. The data from the PMA study shows that OA/US successfully achieved improved specificity at a fixed sensitivity of 98%, the part of the ROC curve where clinical decisions about whether or not to biopsy a mass are actually made.”
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 Medical’s Imagio® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.
[i] Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of Utilization Patterns and Associated Costs of the Breast Imaging and Diagnostic Procedures After Screening Mammography. ClinicoEconomics and Outcomes Research 2018:10 157-167.
Seno Medical and “Know Your Lemons” Highlight Importance of Education and Self-Exam for Early Breast Cancer Detection
November 13, 2019New survey demonstrates women play a critical role in symptom(s) discovery
SAN ANTONIO, Nov. 14, 2019 /PRNewswire/ — A recent survey of women in the Netherlands found that 79 percent of respondents diagnosed with breast cancer noticed symptoms prior to being diagnosed.
Seno Medical Instruments, Inc. (Seno Medical), a Texas-based medical imaging company developing breakthrough breast cancer diagnostic technology, teamed up with the Know Your Lemons campaign to conduct the survey in the Netherlands, which has one of the highest incidence rates in the world, during October’s Breast Cancer Awareness Month.
Sponsored by the international breast cancer charity, the Know Your Lemons Foundation focuses on breast health education to overcome taboos, fears, and literacy issues. The most famous image of their campaign uses 12 lemons in an egg carton that illustrate 12 signs of breast cancer. The study found that the image improved early detection.
When patients were asked about their symptoms, initially just 11 percent thought they had more than one symptom. However, when patients were shown the 12 symptoms of breast cancer image, 41 percent identified that they had two or more symptoms of breast cancer. Sixty-eight percent of women who had a noticeable symptom said the image would have helped them had they seen it before they were diagnosed.
Only one-third of patients surveyed were old enough for routine mammogram screening (age 50 or older), so symptom awareness was particularly critical for this population. Importantly, self-exam helped one out of five patients find breast cancer. For those that reported not performing a regular self-exam, 44 percent said the reason was simply forgetting to do it.
Through the partnership with Know Your Lemons, Seno Medical supports educational activities focused on healthcare providers across the Netherlands where its opto-acoustic ultrasound imaging technology is already in use providing more information about the abnormal blood vessels and oxygen content of potential tumors.
“Doing whatever we can to diagnose breast cancer early is the mission of our company,” said Tammy Garcia, the senior vice president of sales and marketing at Seno Medical. “We’re thrilled to be making a difference by educating and empowering women and men so they can take care of themselves and seek help early.”
“When a woman is diagnosed at the earliest stage, survival rates are nearly 100 percent,” says Dr. Corrine Ellsworth-Beaumont, founder and designer of Know Your Lemons. “Our charity has reached over half a billion women (and men) around the world, but we won’t rest until we reach everyone. Awareness is something that goes beyond October—it’s a year-round effort. We hope to send out hundreds of posters this November to make a difference in the Netherlands.”
One of the survey respondents, Amanda Menno, age 46 from Hoogland, knew she had a symptom because of the campaign. “Once I saw all the different symptoms of breast cancer, the image got stuck in my mind, which was a good thing since I discovered a dimple in my breast a short time later. Because of Know Your Lemons, I knew that I had to see my doctor as soon as possible.”
With the support of Seno Medical, Know Your Lemons is offering a free poster, while supplies last, to patients and healthcare providers in the Netherlands who visit https://knowyourlemons.com/nederlands to boost educational efforts.
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 Medical’s Imagio® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – the opto-acoustic images provide a unique blood map in and around breast masses while the interleaved and co-registered ultrasound provides a traditional anatomic image.
Know Your Lemons Foundation is a global charity focused on early detection for breast cancer. In partnership with organizations around the world, they provide education in a friendly, memorable way to improve understanding, confidence, and promote screening in an effort to save lives.
Contact:
Bryan Fisher, 202.868.4825, bfisher@messagepartnerspr.com
Additional Research Published In Radiology Demonstrates Application Of Ground-Breaking Breast Cancer Diagnostic Technology
September 18, 2019Seno Medical’s opto-acoustic technology could differentiate between breast cancer types
SAN ANTONIO, Sept. 19, 2019 /PRNewswire/ — An article recently published in Radiology highlights the groundbreaking use of a new imaging technology introduced by Seno Medical Instruments, Inc.® (Seno Medical) to diagnose breast cancer. The technology may offer physicians a new, non-invasive tool to not only better differentiate between benign and malignant breast cancers, but may also help differentiate between breast cancer molecular subtypes.
The analysis of 652 malignant masses concluded that Seno Medical’s opto-acoustic combined with ultrasound (OA/US) technology has the potential to depict characteristics that differentiate luminal cancers from those classified as triple negatives and HER2+.
“The clinical implications of accurately identifying molecular subtypes of cancer non invasively with imaging could be very significant for patients,” said Basak E. Dogan, MD, Director of Breast Imaging Research at UT Southwestern Medical Center. “Molecular subtypes help determine the treatment of more than two million women diagnosed with breast cancer worldwide each year.”
Biopsy specimens don’t always represent the tumor in its entirety and are therefore subject to sampling selection errors. Imaging could allow a better evaluation of the whole tumor and further improve pre- and post-surgical treatment strategies.
Researchers observed 2,055 breast masses in 1,972 women who underwent pre-biopsy OA/US examination using Seno Medical’s Imagio® Breast Imaging System. Of those, 652 masses in 629 women showed invasive cancer at final pathology.
Physicians most commonly use the grayscale ultrasound modality to diagnose cancer, but ultrasound alone has limited ability to determine prognosis. By pointing to morphological and functional features like internal blood vessels, blush, and hemoglobin, OA/US significantly contributed to differentiating between breast cancer subtypes and identifying the cancers that have the highest likelihood for aggressive growth and metastasis.
“Although this is an emerging technology, these results show that OA/US technology could help deliver more timely, actionable cancer diagnoses for millions of women,” said Gisela Menezes, MD, PhD, medical director at Seno Medical. “When time is of the essence, this technology could give physicians and their patients the information they need to develop the right treatment plan.”
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 Medical’s Imagio® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – the opto-acoustic images provide a unique blood map in and around breast masses while the interleved and coregistered ultrasound provides a traditional anatomic image.
Contact:
Bryan Fisher, 202.868.4825, bfisher@messagepartnerspr.com
European Radiology Profiles Seno Medical’s Ground-Breaking Breast Cancer Diagnostic Technology
June 18, 2019Seno Medical’s opto-acoustic technology could reduce false positives and identify cancer sub-types
SAN ANTONIO, June 19, 2019 /PRNewswire/ — Additional research appearing in the June online issue (open access) of European Radiology features the groundbreaking diagnostic breast cancer imaging technology introduced by Seno Medical Instruments™, Inc. (Seno Medical). This technology might not only help physicians better differentiate between benign and malignant breast lesions, but also discriminate between breast cancer molecular subtypes.
The retrospective European post-marketing surveillance analysis corroborates previous studies, which concluded that opto-acoustic ultrasound (OA/US) technology might increase specificity and the ability to rule out disease, potentially reducing the number of false positive examinations and biopsies of benign masses. Researchers observed results from five centers in the Netherlands, where the technology has been introduced commercially using Seno Medical’s Imagio® Breast Imaging System. In this study, 67 biopsy-proven malignant masses were reviewed to compare OA/US characteristics and histopathological prognostic indicators.
OA/US technology creates a “blood map” that gives functional and anatomical information in and around the mass using hemoglobin as a natural contrast agent. The study results showed that OA/US can also help identify different subtypes of cancer by measuring the emergence of angiogenesis (newly created blood vessels which indicate the presence of malignant activity within and around the mass). Other key factors (e.g. histologic grade, continuous number of mitosis, HER2 and hormone receptor status, and Ki-67 poliferation index) might also be identified with the aid of this technology.
According to the study results, the combination of functional and morphologic information provided by OA/US showed promise in differentiating Luminal A, Luminal B, HER2-enriched, and Triple Negative cancers. These tumors have a different prognosis and require different treatment paths that physicians and patients must consider. Molecular analysis requires specialized equipment and expertise, making this process lengthy and expensive. Breast tumors are heterogeneous and biopsy may be insufficient to assess the complete tumor heterogeneity. Therefore, OA/US features that suggest an aggressive tumor subtype that is potentially conflicting with histopathologic biomarkers might suggest the need for more extensive review and inspection of the pathologic specimen.
“Successful breast cancer treatment relies on detecting the cancer and its subtype as quickly as possible,” said Gisela Menezes, MD, PhD, Medical Director at Seno Medical and the article’s lead author. “This promising data using a non-invasive diagnostic approach with OA/US molecular bioimaging could potentially give patients a better chance of getting more accurate and timely prognosis and treatment.”
“Although this is a new emerging technology, these encouraging results show that Seno Medical’s OA/US technology could impact the course of cancer diagnosis for millions of women,” said Ruud Pijnappel, MD, PhD, Professor at University Medical Center, Utrecht, Netherlands and one of the study’s authors. “This technology could give physicians the information needed to make a more confident diagnosis in less time, improve their patient’s experience, and potentially reduce biopsies of benign masses.”
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 a molecular partner to ultrasound. Seno Medical’s Imagio® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – the opto-acoustic images provide a unique blood map in and around breast masses while the interleved and coregistered ultrasound provides a traditional anatomic image.
Contact:
Bryan Fisher, 202.868.4825, bfisher@messagepartnerspr.com
Seno Medical and “Know Your Lemons” Team Up For Breast Cancer Education
May 11, 2019Partnership emphasizes breast health education and empowers women
SAN ANTONIO, May 12, 2019 – Seno Medical Instruments, Inc. (Seno Medical), a Texas-based medical imaging company developing breakthrough breast cancer diagnostic technology, announced an educational partnership supporting Worldwide Breast Cancer’s “Know Your Lemons” campaign starting with the Netherlands, which has one of the highest breast cancer incidence rates in the world.
Through the partnership with Know Your Lemons, Seno will support educational activities focused on healthcare providers across the Netherlands.
Sponsored by Worldwide Breast Cancer, an international breast cancer charity, Know Your Lemons focuses on breast health education. The Seno Medical partnership will boost efforts to overcome taboos, fears, and literacy issues that stymie discussion about breast cancer by using a series of powerful lemon images as blunt stand-ins for breasts.
“More than two million women worldwide received a breast cancer diagnosis last year, and early detection is an important key to their survival,” said Tammy Garcia, senior vice president of sales and marketing at Seno Medical. “Know Your Lemons is kickstarting life-saving conversations about breast cancer. We’re proud to be part of this groundbreaking campaign to educate women and empower them to get screened.”
Seno Medical uses opto-acoustic ultrasound imaging to provide more information about the abnormal blood vessels and oxygen and de-oxygen content in and around the tumor.
Because many people do not know the symptoms, risks, and detection options for breast cancer worldwide, this new campaign focuses entirely on increasing conversations about breast health. Seno Medical leaders say the use of lemon imagery for the breast bypasses cultural barriers in a friendly, familiar, and engaging way.
Since 2014, Know Your Lemons has educated more than 500 million people in more than 20 languages. Community health workers and medical personnel use its educational resources in more than 90 countries.
“A lemon doesn’t have gender, or ethnicity or cultural taboos, so it can represent anything,” said Corrine Ellsworth-Beaumont, the founder of Know Your Lemons. “The campaign creates a new way of looking at the breast that is not sexual, gory, or censored. This partnership with Seno Medical brings us closer to our goal of educating all women.”
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 Medical’s Imagio® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation.
Contact:
Bryan Fisher, 202.868.4825, bfisher@messagepartnerspr.com
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