Press Releases

Contract awarded for products that bring improvement to healthcare industry

[SAN ANTONIO, TX – November 12, 2024]– Seno Medical announced its Imagio^® Breast Imaging System has received an Innovative Technology contract from Vizient, Inc. the nation’s largest provider-driven healthcare performance improvement company. The contract was awarded based on the recommendation of the Imagio^® System by hospital experts who serve on one of Vizient’s customer-led councils, and it signifies to Vizient provider customers unique qualities that potentially bring improvement to the healthcare industry.

Innovative Technology contracts are recommended after review and interaction with products submitted through Vizient’s Innovative Technology Program. Vizient customer-led councils identify technologies that have the potential to enhance clinical care, patient safety, healthcare worker safety or improve business operations of healthcare organizations.

Seno Medical’s Imagio® Breast Imaging System, a new modality in breast cancer diagnosis, helps physicians, facilities, and other qualified healthcare providers differentiate between benign and malignant breast lesions using a novel combination of artificial intelligence (AI) – SenoGram^®, light - opto-acoustic technology, and ultrasound to characterize and differentiate masses that may — or may not — require more invasive diagnostic evaluation.

“The suite of novel technologies that Vizient’s Innovative Technology Program showcases is simply the top echelon of patient care and innovation,” commented Tom Umbel, CEO of Seno Medical. “We are honored to receive this designation from Vizient and look forward to working with its provider customers to offer the Imagio^® Breast Imaging System.”

Seno’s Imagio^® OA/US technology combines light, sound, and AI to deliver new information never before available. Opto-acoustic imaging is a category-defining technology that combines functional (opto-acoustics or photoacoustics), anatomic (ultrasound), and morphologic information using light (laser optics or opto-acoustics) and sound waves plus native artificial intelligence (SenoGram^®) decision support to produce high-resolution, high-contrast images for clinicians. The result is a diagnostic imaging modality that delivers functional information regarding suspicious breast masses, increasing confidence regarding the need for invasive breast cancer diagnostic biopsies.

Imagio^® is non-invasive, has no ionizing radiation, does not use contrast agents, and does not require the compression required in mammography. Imagio^® provides clinicians with real-time information offering same-day results. Incorporating Imagio^® into a center can improve workflow efficiency and help lower stress and anxiety in patients.

“The Innovative Technology Exchange fosters a unique opportunity for healthcare providers to interact with products and services that have the potential to impact the healthcare industry and improve clinical care or business model of organizations,” said Kelly Flaharty, senior director of contract services, Vizient. “We are pleased to invite Seno Medical to the Exchange.”

Vizient represents a diverse customer base that includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute healthcare providers and has a portfolio that represents more than $140 billion in annual purchasing volume. Through its Innovative Technology Program, Vizient works with customer-led councils and task forces to evaluate products for their potential to bring real innovation to healthcare. Vizient may award a contract to products deemed worthy of the Innovative Technology designation outside of the competitive bid cycle.

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to improving the efficiency – and reducing the complexity – of breast cancer diagnostics through its new modality: opto-acoustic imaging. Approved by the U.S. FDA in January 2021, with supplemental approval in June 2022, Seno’s Imagio^® Breast Imaging System is a new modality combining light, sound, and A.I. to provide information not previously available to the breast imager. The result is substantially improved confidence in diagnostic results that leads to real-time assessments, streamlined care pathways, and reductions in false-positive biopsies. 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 Imagio^® imaging technology and applications, visit www.SenoMedical.com.

###

[SAN ANTONIO, TX – October 31, 2024] A study published in Academic Radiology, Exploring the Utility of Optoacoustic Imaging in Differentiation of Benign and Malignant Breast Masses: Gen 2 Study, confirms that the second generation of Seno Medical’s Imagio^® Breast Imaging System, which combines light, sound, and artificial intelligence (AI), is equal to or superior to the company’s first-generation device.

The study, authored by Sammar Ghannam, MD, MPH, University Texas Health and Science Center Mays Cancer Center, San Antonio, TX - the first real-world use study of the second generation Imagio^® System - assessed palpable and non-palpable breast abnormalities in 38 patients who required diagnostic breast ultrasound workups and confirmed the clinical acceptability of modifications made to the Imagio^® System for its market-ready product as compared to its first-generation system.

The author observed that the Imagio^®’s state-of-the-art ultrasound combined with Seno’s novel opto-acoustics imaging performed equal to or better than the first-generation device, with superior image quality and increased specificity without the loss of sensitivity. In this limited imaging study, using the SenoGram^® AI decision support tool provided an observed 100 percent sensitivity and specificity at 64.3 percent. The combination of opto-acoustic imaging and AI provided by the Imagio^® System helped distinguish masses, providing functional biologic data and imaging appearance in an efficient, effective, and cost-conscious manner. According to the authors, “The functional imaging of OA/US together with the DST (SenoGram^®) does offer an objective and tightly calibrated method of predicting FNRs below 2.0% and even at and below 0.5%”.

“This is the first real world use study of the market-ready Imagio^® Breast Imaging System and confirms that in day-to-day clinical practice, OA imaging is providing breast imagers with the diagnostic confidence they’ve been seeking,” commented Tom Umbel, CEO of Seno Medical. “Our technology allows for a simplified care pathway that improves patient care and helps reduce unnecessary exams and costs of diagnosing breast cancer.”

Opto-acoustic imaging is a category-defining technology that combines functional (opto-acoustics or photoacoustics), anatomic (ultrasound) and morphologic information using light (laser optics or opto-acoustics) and sound waves plus proprietary artificial intelligence (SenoGram^®) decision support to produce high-resolution, high-contrast images for clinicians. The result is a diagnostic imaging modality that delivers functional information regarding suspicious breast masses, increasing confidence regarding the need for invasive breast cancer diagnostic biopsies.

Imagio^® is non-invasive, has no ionizing radiation, does not use contrast agents, and does not require the compression required in mammography. Imagio^® provides clinicians with real-time information and the ability to provide same-day results. Incorporating Imagio^® into a center can improve workflow efficiency and help lower stress and anxiety in patients.

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 improving the efficiency – and reducing the complexity – of breast cancer diagnostics through its new modality: opto-acoustic imaging. Approved by the U.S. FDA in January 2021, with supplemental approval in June 2022, Seno’s Imagio^® Breast Imaging System is a new modality combining light, sound, and A.I. to provide information not previously available to the breast imager. The result is substantially improved confidence in diagnostic results that leads to real-time assessments, streamlined care pathways, and reductions in false- positive biopsies. The company was 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 imaging technology and applications, visit www.SenoMedical.com.

###

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.

###

^{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.}