Press Releases

IHE SHARAZONE Hits Major Milestone with 15 Participants, Empowering 37 Creators and 24 Consumers

[May 17, 2024] IHE-Europe is thrilled to report a major milestone for the IHE SHARAZONE, a groundbreaking initiative aimed at boosting digital interoperability and the exchange of health information. This innovative platform now proudly supports 15 participating organizations, each committed to enhancing the standardization of healthcare technologies, comprising 37 creators and 24 consumers systems with more than 150 touch points successfully tested.

The following vendors are currently participating: AGFA HealthCare*, AGFA Radiology Solutions, AZmed, Carl Zeiss Meditec*, Delphinus Medical Technologies, Inc., GE HealthCare*, Gentuity, MedicalCommunications*, Olympus Europa*, Philips*, Seno Medical, Siemens Healthineers*, Synedra Information Technologies*, VISUS Health IT* (*Founding members).

The IHE SHARAZONE's success is attributed to its dynamic, continuous testing environment, which complements well-established events, like the IHE Connectathon. This platform allows for ongoing, asynchronous testing, making it invaluable for handling the content complexities of DICOM objects in a real-world setting. Through the IHE SHARAZONE, participants engage in robust peer-to-peer information content testing, which is critical for advancing the interoperability of medical imaging and healthcare IT systems across various providers.

Charles Parisot, Chair of the IHE SHARAZONE Task Force at IHE-Europe, emphasized: "The enthusiastic participation and rapid growth within the SHARAZONE underscore the dedication of our members to improve technology integration, directly impacting patient care and provider efficiency".

A significant aspect of the SHARAZONE is its unique operational model. Creators upload shared test inputs including test items and suites, while consumers download these inputs, execute tests, and provide detailed feedback on both the produced content and its ingestion. This iterative process not only enhances product functionalities but also ensures that products and solutions can seamlessly integrate.

With the aim of expanding its impact, IHE-Europe is actively inviting more organizations and industry stakeholders world-wide to join the IHE SHARAZONE. Participants benefit from access to a rich network of expertise, the latest developments in health IT, and the opportunity to shape the future landscape of healthcare technology.

For more information on how to join or engage with the IHE Sharazone, please visit our website: https://www.ihe-europe.net/IHE_SHARAZONE

IHE-Europe contact: secretariat@ihe-europe.net

About IHE-Europe: The mission of IHE-Europe is to improve patient care by advancing the interoperability of healthcare IT systems and the appropriate sharing of relevant information. Towards that end, IHE-Europe conducts education, testing, demonstrations and other activities promoting the deployment within Europe of systems compliant with the IHE Technical Frameworks developed by IHE International. IHE-Europe interacts with relevant governmental and non-governmental organisations in Europe. It also maintains close contacts with similar initiatives around the world.

CPT Code 0857T Enables a Pathway for Reimbursement When Using Seno’s Imagio^® Breast Imaging System to Diagnose Breast Cancer.

[San Antonio, TX — February 13, 2024] The American Medical Association (AMA) has issued a new Category III Current Procedural Terminology (CPT*) code for the use of Imagio^® (OA/US) Breast Imaging System, a new modality in breast cancer imaging and diagnosis by Seno Medical. The Category III code, 0857T (Under OptoAcoustic Imaging Procedures), issued late 2023 and effective January 1, 2024, provides physicians, facilities, and other qualified healthcare providers a means to seek coverage and reimbursement for utilizing opto-acoustic technology to diagnose breast cancer.

This new modality, Imagio^® OA/US technology combines laser optics, sound, and artificial intelligence to offer 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.

Said Tom Umbel, CEO of Seno Medical, "This CPT code will enable hospitals and imaging centers using the Imagio^® System to submit claims directly and incorporate opto-acoustic diagnostic imaging into their patient-care pathway.” Seno Medical is collaborating with The Pinnacle Health Group to provide coding and claims support within the breast imaging and diagnostics space for CPT 0857T code to enable precise and professional support for healthcare professionals and patients.

About Seno Medical

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 U.S. FDA in January 2021, with additional approval in June 2022 to include its latest 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. The company was recently recognized by Frost & Sullivan with its 2023 Enabling Technology Leadership award for its innovative approach to diagnostic imaging. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.

* CPT^® copyright 2024 American Medical Association. All rights reserved. CPT^® is a registered trademark of the American Medical Association.

Seno Medical offers highly differentiated opto-acoustic/ultrasound (OA/US) exam to diagnose breast cancer and significantly reduce unnecessary breast biopsies.

San Antonio, TX — January 17, 2024 — Frost & Sullivan recently recognized Seno Medical with the 2023 US Enabling Technology Leadership Award. Seno Medical is a groundbreaking company founded in 2005 that revolutionized the breast cancer imaging sector with its innovative opto-acoustic/ultrasound (OA/US) technology, integrating laser optics with ultrasound to enhance cancer diagnosis.

Seno Medical's trendsetting approach lies in the ability of its advanced breast cancer diagnosis technology to address critical industry challenges, such as staff shortages and the high rate of unnecessary biopsies. Its Imagio^® Breast Imaging System, which received Pre-Market Approval (PMA) from the US Food and Drug Administration (FDA) in 2021, seamlessly combines opto-acoustics and ultrasound to provide clinicians with real-time results. Seno Medical's solution is more effective and patient-friendly than traditional breast cancer diagnosis technologies as it provides clinicians with functional information about the oxygenation and deoxygenation in and around a suspicious mass to better determine likelihood of malignancy earlier in the care pathway and non-invasively.

Seno’s technology also employs the body's hemoglobin as a natural contrast agent, making it safe and accurate. This system dramatically boosts clinicians' confidence in distinguishing malignant and benign breast masses, thereby reducing biopsies and exams and enhancing patient care. Furthermore, Seno Medical's strategy extends beyond just technology development. By collaborating with experts in artificial intelligence (AI) and deep learning, the company aims to refine its diagnostic capabilities in the next few years. This forward-thinking approach demonstrates Seno Medical's commitment to providing efficient, patient-centered solutions in breast cancer diagnosis.

“Seno Medical’s opto-acoustic technology for breast imaging is non-invasive, has no ionizing radiation, does not use contrast agents or radionuclides, and does not require the compression that is used in mammography,” said Sudhakar Mishra, senior director of growth advisory for health and life sciences at Frost & Sullivan.

Seno Medical sets itself apart in the opto-acoustic imaging field by emphasizing practical clinical applications over purely research-focused endeavors. While many organizations in the photoacoustic community concentrate on the theoretical aspects of photonics, Seno Medical has uniquely directed its efforts toward tangible clinical applications. This practical orientation toward real-world medical challenges underlines Seno Medical's pioneering role in the industry and its leadership role in delivering increasingly sophisticated solutions for the ever-evolving demands of the global medical marketplace.

“In the photoacoustic or opto-acoustic community, most organizations focus more on the research aspects of photonics and not on clinical applications, such as the breast, thyroid, or prostrate, unlike Seno Medical,” noted Mishra.

Each year, Frost & Sullivan presents this award to a company that develops a pioneering technology that enhances current products and enables new product and application development. The award recognizes the high market acceptance potential of the recipient’s technology.

Frost & Sullivan Best Practices awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry.

About Frost & Sullivan

For six decades, Frost & Sullivan has been world-renowned for its role in helping investors, corporate leaders, and governments navigate economic changes and identify disruptive technologies, Mega Trends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. Contact us: Start the discussion.

Contact:

Christine Savoie
E: christine.savoie@frost.com

About Seno Medical

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.

Contact:

Tammy Garcia
E: tgarcia@senomedical.com

Study evaluates feasibility of leveraging Seno’s Imagio^® System to detect response earlier during breast cancer therapy.

[San Antonio, TX – December 8, 2023] A limited feasibility study presented at this year’s San Antonio Breast Cancer Symposium (SABCS) found that Seno Medical’s Imagio^® Breast Imaging System using opto-acoustic/ultrasound (OA/US) shows promise in detecting vessel and oxygenation changes preceding tumor volume decrease in patients who are in a trajectory to achieve a tumor pathologic complete response (pCR). Similarly, an increase in OA/US scan scores after cycle 1 may be an important indicator of poor response to chemotherapy, allowing for intervention earlier in the course of therapy.

The poster Changes in Breast Cancer Opto-Acoustic Imaging Features During Neoadjuvant Therapy and Correlation with Pathologic Response: A Feasibility Study was presented on Friday, December 8, by Basak Dogan, MD, director of breast imaging research at the University of Texas Southwestern Medical Center, Department of Radiology, Harold C. Simmons Comprehensive Cancer Center.

The analysis highlights the role OA/US can play in predicting response to neoadjuvant therapy (NAC) by evaluating the OA/US imaging feature changes. The objectives included but were not limited to: (1) identify complete responders (patients who had no residual cancer left after chemotherapy, i.e., pCR) before ultrasound (US) volume changes occur and (2) detect non-responders early in the course of therapy.

Key results of the study include:

• At the end of cycle 1 chemotherapy, the OA/US percentage change in internal hemoglobin (Hb) score (76.4% vs 108.8% in complete vs non-complete responder groups, respectively, p=0.01) had the highest correlation with pCR at surgery
• Changes in all mean OA/US scores from baseline to pre-surgery except peripheral zone radiating vessel score significantly correlated with pCR (p<0.05)
• Multiple individual and total OA/US scores at cycle 1 predicted poor response (RCB-III) status; percent decrease in OA/US Mean Deoxygenated Blush Score at cycle 1 scan was significantly lower in cancers that showed RCB-III (117.8%) vs. complete to moderate response (RCB 0-II) (64.8%), p=0.03 at pathology
• Tumor volume change was not significantly different in pCR vs. non-pCR at cycle 1, mid therapy time points, while there was a significant difference at pre-surgery scan (p<0.003)
• No scan-related Serious Adverse Effects were reported.

The authors concluded, “Our preliminary findings indicate that OA/US-detected vessel and oxygenation changes precede tumor volume decrease in patients who are in a trajectory to achieve pCR (complete response). OA/US shows promise to identify exceptional responders as early as post-cycle 1 therapy. In addition, several OA/US scores at cycle 1 scan significantly correlated with poor response (RCB-III) status, indicating that in vivo tumor oxygenation assessed by OA/US can be used to predict chemotherapy resistance. The I-SPY 2 Trial utilizes a new predictive tool, ‘PreRCB,’ which includes mid-treatment MRI and core biopsy responses to identify patients likely to have a pCR¹. OA/US imaging eliminates the need for contrast use or an invasive biopsy procedure; therefore, may have better acceptance by patients compared to MRI or needle biopsy.”

Imagio^® OA/US technology combines laser optics and grayscale ultrasound to offer 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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^{1 Park JW, Liu MC, Yee D, Yau C, van 't Veer LJ, Symmans WF, Paoloni M, Perlmutter J, Hylton NM, Hogarth M, DeMichele A, Buxton MB, Chien AJ, Wallace AM, Boughey JC, Haddad TC, Chui SY, Kemmer KA, Kaplan HG, Isaacs C, Nanda R, Tripathy D, Albain KS, Edmiston KK, Elias AD, Northfelt DW, Pusztai L, Moulder SL, Lang JE, Viscusi RK, Euhus DM, Haley BB, Khan QJ, Wood WC, Melisko M, Schwab R, Helsten T, Lyandres J, Davis SE, Hirst GL, Sanil A, Esserman LJ, Berry DA; I-SPY 2 Investigators. Adaptive Randomization of Neratinib in Early Breast Cancer. N Engl J Med. 2016 Jul 7;375(1):11-22. doi: 10.1056/NEJMoa1513750. PMID: 27406346; PMCID: PMC5259558.}

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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