Press Releases

[SAN ANTONIO, TX – March 29, 2022] Seno Medical’s Imagio^® Breast Imaging System has been named a finalist in the 2022 Medical Device Excellence Awards, in the Radiological, Imaging, and Electromechanical Devices category.

The Medical Design Excellence Awards (MDEA) is the premier awards program for the medtech industry. Since its inception in 1998, the mission of the MDEAs has been to recognize significant achievements in medical product design and engineering that improve the quality of healthcare delivery and accessibility. Final winners will be announced in April.

“Innovation and passion are the foundational building stones of Seno Medical, and we are so honored to be a finalist in this prestigious program that celebrates these qualities in medtech,” Tom Umbel, Seno’s Chief Executive Officer, commented.

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 reduce those costs 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.

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 hypoxia – 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.

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[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.

[SAN ANTONIO, TX – February 8, 2022] Seno Medical’s Imagio^® Breast Imaging System has been named a finalist in the 2022 Edison Awards competition in the Science and Medical category and Diagnostics sub-category.

The Edison Awards program is an annual competition honoring excellence in new product and service development, marketing, human-centered design, and innovation. Past winners have included Fortune 500s, small start-ups, and everything in between, and the program celebrates the spirit of extraordinary innovator Thomas Edison. Expert reviewers from around the world, in conjunction with the Edison Award Steering Committee, reviewed over 350 nominations and determined Imagio® to be among the most elite submissions to be considered for the annual competition. Final winners will be announced in April.

Seno’s Chief Executive Officer, Tom Umbel, commented, “We are honored to be considered amongst some of the greatest innovating companies of our time.  We truly believe that Imagio® can make a difference in both diagnostic confidence and patient experiences.”

Breast biopsy procedures caused by false-positive diagnostic assessments in the United States cost the healthcare system more than $2 billion per year.  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.

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.

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[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.

[SAN ANTONIO, TX – December 1, 2021] A study presented at the Radiological Society of North America (RSNA)’s annual meeting showed Texas-based Seno Medical Instruments, Inc. (Seno)’s Imagio^® opto-acoustic ultrasound (OA/US) breast imaging provides significantly better specificity than ultrasound alone. The poster, “Performance of Optoacoustic Ultrasound with an Artificial Intelligence-based Decision Support Tool vs Ultrasound Alone to Classify Benign Versus Malignant Breast Masses: A Pivotal Reader Study,” was presented by Stephen Seiler, MD, Associate Professor, Breast Imaging Division, Department of Radiology at UT Southwestern (Dallas, TX) on November 30.

The study intended to evaluate the gain in specificity using opto-acoustic ultrasound images and an AI-based decision support tool verses ultrasound alone.  The study found that OA/US, when used with a decision support tool, has statistically significant better specificity compared to conventional ultrasound alone.

• Fifteen readers with a wide range of experience in breast imaging from both private practice (8) and academic (7) were involved with the reader study.
• Opto-acoustic ultrasound achieved the primary endpoint in this reader study with specificity significantly higher for OA/US (47.2%) compared to ultrasound alone (38.2%), a difference of 9 percent.
• The observed specificity was 50.1 percent for IUS+OA and 36.6 percent for US. At fixed 98 percent sensitivity, there was a 13.5 percent observed specificity advantage.
• There were 1510 BI-RADS 4A reads of benign masses based on review of US alone.  IUS+OA resulted in the appropriate downgrading of 753 (49.8%) reads to either BI-RADS 2 or BI-RADS 3.

“OA imaging provides different, yet complementary, diagnostic information not provided by conventional ultrasound or its submodalities of Doppler and elastography,” concluded Seiler.

“When used alongside the AI decision support tool, OA imaging has the potential to reduce false positives and thus biopsies of benign masses, versus ultrasound alone, without sacrificing sensitivity.”

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, “The findings by Dr. Seiler and his collaborators further validate the potential for our Imagio^® Breast Imaging System to improve patient care by reducing unnecessary biopsy procedures and supporting clinical decision making confidence.”

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.

Prospective, 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

Seno’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.

New 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