Press Releases

Imagio^® System’s unique hybrid modality helps doctors better characterize suspicious breast lesions to avoid unnecessary invasive biopsies and improve patient care.

[San Antonio, TX – November 30, 2023]  A study presented at RSNA and published in Academic Radiology has found that Seno Medical’s Imagio^® Breast Imaging System with opto-acoustic ultrasound (OA/US) imaging is more cost effective when compared to ultrasound alone in evaluating suspicious breast lesions.ⁱ Imagio’s^® non-invasive opto-acoustic ultrasound (OA/US) technology provides functional real-time information about suspicious breast lesions, helping physicians characterize and differentiate masses that may — or may not — require more invasive diagnostic evaluation. 

The presentation, Supplemental Optoacoustic Imaging of Breast Masses: A Cost-Effectiveness Analysis, was presented at RSNA on Thursday, November 30, by B. Bersu Ozcan, M.D. (Research Fellow, Department of Radiology, UT Southwestern), and discusses the need to improve diagnostic performances of imaging studies to reduce the significant medical and economic burdens of benign biopsies. The presentation was awarded the 2023 RSNA Trainee Research Prize.

The analysis highlights the cost effectiveness of the OA/US modality compared to ultrasound (US) alone, taking into consideration incremental cost effectiveness ratio (ICER) compared to willingness to pay (WTP) and how that affects the incremental net monetary benefit (NMB) and quality of life benefits for a comparative technology. 

Key takeaways:

• The model indicated that the net monetary benefit (NMB) of OA/US was $1,495.36 per patient, the value that is obtained from the money invested in the technology, which the study found to be greater value than ultrasound alone.
• The calculated incremental cost effectiveness radio (ICER) from the model analytics is $-31,715.82/QALY (quality adjusted life year) for OA/US. Comparatively anything lower than $100,000/QALY is considered cost effective. The ICER comparison show OA/US as significantly more cost effectiveness than US.
• The probabilistic sensitivity analysis was run on over 10,000 iterations and OA/US remained as the more cost-effective strategy in 98.69% of the iterations.

The authors concluded, “OA/US is more cost-effective than US to differentiate benign or malignant breast masses in the diagnostic setting. It can reduce costs while improving patients’ quality of life, primarily by reducing false-positive results with consequent benign biopsies.”

Mammograms are an essential part of preventive healthcare, and when an initial review reveals a suspicious lesion, additional imaging and/or invasive breast biopsies could be the next step in diagnosis. However, breast biopsy procedures caused by false-positive assessments in the United States cost the healthcare system more than $2 billion per yearⁱⁱ and cause millions of women unnecessary stress and anxiety. 

Imagio^® OA/US technology combines laser optics and grayscale ultrasound to offer 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 — the Imagio^® OA/US Breast Imaging System is a more effective tool to help radiologists confirm or rule out malignancy compared with traditional diagnostic imaging modalities. And it does this without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. 

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Approved by the US FDA in January 2021 with additional approval in June 2022 including its state-of-the-art ultrasound technologies, 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 Ozcan BB, Xi Y, and Dogan BE. Supplemental Optoacoustic Imaging of Breast Masses: A Cost-Effectiveness Analysis. Acad Rad 2023;08.042.

ⁱⁱ 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 – SEPTEMBER 22, 2023] Alex Hamlow has joined Seno Medical Instruments, Inc. as Chief Revenue Officer.  Seno Medical is the leader in improving the process of diagnosing breast cancer and the pioneer of the Imagio^® Breast Imaging System with opto-acoustic/ultrasound (OA/US) imaging technology. 

Hamlow has over 20 years of experience in the healthcare space developing and implementing customer-centric vision, strategy, processes, and systems for commercial growth. He joins Seno after serving as President of A. Hamlow Servant Leadership (AHSL), an advisory consultancy and new venture incubator where he worked with early-stage start-up and Fortune 100 companies to plan and implement strategies for growth. Prior to that, he served as Chief Commercial Officer at Kheiron Medical Technologies Limited, a start-up focused on AI breast cancer detection software, where he built the commercial program, launched the first platform of products, and closed $20 million in deals to scale the business globally. 

He holds a BS in Electronic Engineering from DeVry University and serves on the board of the Candi Hamlow Foundation, a healthcare foundation in honor of his late wife supporting education and care pathway guidance for women diagnosed with cancer who also suffer from underlying autoimmune disorders. 

“Alex’s experience scaling businesses and cementing global growth is a perfect fit for Seno Medical,” said Tom Umbel, CEO of Seno Medical. “His background in AI technologies in breast cancer will also help us position our Imagio^® Breast Imaging System and accompanying SenoGram^® technology to our best advantage.” 

“Seno’s OA/US technology, in combination with its AI capabilities, has great potential as a new imaging modality to improve breast cancer diagnosis and reduce false positives,” commented Hamlow. “I am thrilled to be part of the team and look forward to helping grow Seno into a global powerhouse.”

Seno’s Imagio^® OA/US system combines laser optics and grayscale ultrasound to provide fused functional, morphological, and anatomical breast imaging. The optoacoustic 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 with traditional diagnostic imaging modalities. And it does this 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 decision-support tool (SenoGram^®) to help physicians interpret the new images. This AI tool, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging to more precisely assign the likelihood of malignancy. 

The Imagio^® System was cleared by the US FDA in 2021 and received Supplemental PMA Approval for its market-ready device in June 2022. 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 developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Approved by the US FDA in January 2021 with additional approval in June 2022 including its state-of-the-art ultrasound technologies, 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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[SAN ANTONIO, TX – SEPTEMBER 14, 2023] Seno Medical Instruments, Inc., the leader in improving the process of diagnosing breast cancer and the pioneer of the Imagio^® Breast Imaging System with opto-acoustic/ultrasound (OA/US) imaging technology, has added Agnes Berzsenyi to its Board of Directors, effective immediately. 

Ms Berzsenyi spent over 27 years at General Electric, where she held prominent leadership positions driving disruptive innovation, global growth and profitability. In her most recent role, Ms Berzsenyi was the President and CEO, Women's Health & X-ray, for GE Healthcare. In this role, she was responsible for driving the global strategic and commercial direction for the Women's Health & X-ray portfolios inclusive of mammography, bone densitometry, X-ray and services.  Her responsibilities included product innovation, commercial growth, and customer collaboration to reshape the mammography experience for women all around the world with innovative products such as Senographe Pristina, SenoBight HD (Contrast-enhanced mammography) and Pristina Dueta, the industry's first wireless remote that allows women to manage their own compression during their mammogram. 

“Agnes brings passion with a deep and vast background in Women's Health to her new role on Seno Medical's Board.  Her time spent at GE Healthcare as a senior executive leading the company's efforts in Women's Imaging will be invaluable to our company.” said Tom Umbel, CEO of Seno Medical. “We welcome Agnes and look forward to her contributions to the future of Seno Medical.”

Commenting on her appointment, Ms. Berzsenyi said, “I am very excited about the possibilities of what OA/US imaging can do to improve breast cancer diagnosis. I was extremely impressed when I saw clinical results and heard feedback from several recognized expert clinicians. The Seno team is clearly very passionate about the realization of this innovative breakthrough technology and its ability to improve the care for so many affected by the risk of cancer – as many close to me have been impacted.”

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Approved by the US FDA in January 2021 with additional approval in June 2022 including its state-of-the-art ultrasound technologies, 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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Seno’s Imagio^® System Uses Photoacoustic (Opto-acoustic) and Ultrasound Imaging to help doctors better characterize suspicious breast lesions to avoid unnecessary invasive biopsies and improve patient care.

[San Antonio, TX – July 20, 2023] Seno Medical’s technology platform for the Imagio^® Breast Imaging System - which includes Photoacoustic imaging - has been added to the Digital Imaging and Communications in Medicine (DICOM^®) Standards update version 2023c (Supp 229). The DICOM Standard is managed by the Medical Imaging & Technology Alliance - a division of the National Electrical Manufacturers Association.

This inclusion in the internationally-accepted standards enables photoacoustic images to be accepted as part of a best practice standard for medical imaging providers.

Imagio^® opto-acoustic/ultrasound (OA/US) technology combines laser optics (photoacoustic imaging) and grayscale ultrasound to offer 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 — the Imagio^® OA/US Breast Imaging System is a more effective tool to help radiologists confirm or rule out malignancy compared with traditional diagnostic imaging modalities. And it does this without exposing patients to ionizing radiation (x-rays) or contrast agents. 

DICOM^® — Digital Imaging and Communications in Medicine — is the international standard for medical images and related information. It defines the formats for medical images that can be exchanged with the data and quality necessary for clinical use. DICOM^® is implemented in almost every radiology, cardiology imaging, and radiotherapy device (X-ray, CT, MRI, ultrasound, etc.), and increasingly in devices in other medical domains such as ophthalmology and dentistry. With hundreds of thousands of medical imaging devices in use, DICOM^® is one of the most widely deployed healthcare messaging Standards in the world. 

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Approved by the US FDA in January 2021 with additional approval in June 2022 including its state-of-the-art ultrasound technologies, 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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[SAN ANTONIO, TX – March 23, 2023] The Artificial Intelligence Excellence Awards program has selected Seno Medical’s AI platform, SenoGram^® — exclusively available in conjunction with the company’s Imagio^® Breast Imaging System — as a winner in its first annual program. SenoGram^® is an artificial intelligence (AI) decision-support tool that helps physicians interpret new images from the Imagio^® System.  The SenoGram^®, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging to more accurately determine the likelihood of malignancy of breast lesions.

The Artificial Intelligence Excellence Awards recognizes those organizations, products, and people who bring AI to life and apply it to solve real problems. Awards are broken down by categories; the SenoGram^® AI decision-support tool was recognized in the Diagnosis category. 

“We are delighted to be included among these groundbreaking leaders in the artificial intelligence stratosphere,” Tom Umbel, Seno’s Chief Executive Officer, commented. “The use of the SenoGram^® is a tremendous benefit to clinicians in interpreting the images from Imagio^®. Our AI advancements improve outcomes for patients and increase diagnostic confidence of providers.”

“We are so proud to name Seno Medical as a winner in our inaugural Artificial Intelligence Excellence Awards program”, said Maria Jimenez, Chief Nominations Officer for Business Intelligence Group. “It was clear to our judges that Seno was using AI to improve the lives of their customers and employees. Congratulations to the entire team!”

Recently honored with a Gold Edison award, a Gold Medical Design Excellence Award and as a semifinalist in the 2022 Minnies for its medical innovation, Seno’s pioneering diagnostic breast cancer imaging system helps physicians differentiate between benign and malignant breast lesions using non-invasive opto-acoustic/ultrasound (OA/US) technology to provide information on breast lesions in real time, helping providers to characterize masses that may — or may not — require more invasive diagnostic evaluation. 

Breast biopsy procedures caused by false-positive diagnostic assessments cost the US healthcare system more than $2 billion per year.ⁱ Seno’s Imagio^® technology could significantly reduce those costs with its patient-centric OA/US innovation.

Seno’s OA/US system combines laser optics and grayscale ultrasound to provide fused functional, morphological, 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 with traditional diagnostic imaging modalities. And it does this 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 decision-support tool (SenoGram^®) to help physicians interpret the new images. This AI tool, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging to more precisely assign the likelihood of malignancy. 

The Imagio^® System was cleared by the US FDA in 2021 and received Supplemental PMA Approval for its market-ready device in June 2022. 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.

About Business Intelligence Group www.bintelligence.com
The Business Intelligence Group was founded with the mission of recognizing true talent and superior performance in the business world. Unlike other industry award programs, these programs are judged by business executives having experience and knowledge. The organization’s proprietary and unique scoring system selectively measures performance across multiple business domains and then rewards those companies whose achievements stand above those of their peers.

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Originally approved by the US FDA in January 2021 with a Supplemental PMA Approval for its latest device in June 2022, 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 – January 13, 2023) Seno Medical has entered into an exclusive distributor agreement with Genetik, Inc., to market, sell and service the company’s groundbreaking Imagio^® Opto-Acoustic/Ultrasound (OA/US) Breast Imaging System. This distributor agreement – a first for Seno – will enable Genetik to regionally distribute the Imagio^® System in Singapore, where the distributor is headquartered.

“We are thrilled to be partnering with a reputable organization such as Genetik to stimulate commercial adoption of the Imagio^® System into Southeast Asia,” commented Tom Umbel, CEO and President of Seno Medical. “This agreement represents a major milestone for Seno Medical and the continued acceptance and adoption of our new fusion modality in breast imaging.”

“We are proud to work with innovative and highly accurate technologies that can change the standard of care for patients. We look forward to representing this state-of-the-art product for diagnosing breast cancer – the only global FDA-approved technology based on photoacoustic fused with ultrasound,” commented Genetik CEO V. B. Balrai Singh.

Recently honored with a Gold Edison award, a Gold Medical Design Excellence Award and as a semi-finalist in the 2022 Minnie’s for its medical innovation, Seno’s groundbreaking diagnostic breast cancer imaging system helps physicians differentiate between benign and malignant breast lesions using non-invasive opto-acoustic/ultrasound (OA/US) technology to provide information on breast lesions in real time, helping providers to characterize masses that may — or may not — require more invasive diagnostic evaluation.

Breast biopsy procedures caused by false-positive diagnostic assessments cost the US healthcare system more than $2 billion per year.ⁱ  Seno’s Imagio^® technology could significantly reduce those costs with its patient-centric OA/US innovation.

Seno’s OA/US system combines laser optics and grayscale ultrasound to provide fused functional, morphological, 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 with traditional diagnostic imaging modalities. And it does this 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 (SenoGram^®) to help physicians interpret the new images. This AI tool, along with training and certification, helps radiologists transition from ultrasound alone to OA/US imaging to more precisely assign the likelihood of malignancy.  

The Imagio^® System was cleared by the US FDA in 2021 and received a supplemental PMA approval for its market-ready device in June 2022. 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 developing and commercializing a new modality in cancer diagnosis: opto-acoustic imaging. Originally approved by the US FDA in January 2021 with a Supplemental PMA Approval for its latest device in June 2022, 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.