Press Releases

[SAN ANTONIO, TX – April 25, 2022] Seno Medical’s Imagio ^® Breast Imaging System has been selected by the Edison Awards program as a GOLD award winner in the Science & Medical category. The award was presented at the program’s annual gala on April 21, 2022.

The Edison Award’s Gold, Silver and Bronze Winners are chosen as the "best of the best" within their respective categories by some of the world's top senior business executives, designers, academics, and innovation leaders. Being recognized with an Edison Award is one of the highest accolades a company can receive in the name of innovation and business success. The Edison Awards honor excellence in new product and service development, marketing, human-centered design, and innovation.  A full list of winners can be found here.

“We are simply elated to be honored with an Edison award,” Tom Umbel, Seno’s Chief Executive Officer, commented. “This recognition for our Imagio® technology truly validates all the work that the team at Seno has passionately persevered toward to improve the patient and provider experience.”

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.

###

[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 – April 8, 2022] The 2022 Medical Device Excellence Awards program has selected Seno Medical’s Imagio^® Breast Imaging System as a GOLD award winner 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.

“These medtech innovations demonstrate excellence in design & engineering as well as improve healthcare delivery & accessibility,” according to the MDEA media partner, MD+DI.

“What an incredible honor to be recognized as a GOLD award winner by MDEA for our innovation,” Tom Umbel, Seno’s Chief Executive Officer, commented. “The entire team at Seno Medical has worked tirelessly to improve patient care through the use of Imagio, and we are proud to be in the company of all of these groundbreaking award winners.”

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.

###

[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 – 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.

###

[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.

###

[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