Press Releases

Seno Medical’s opto-acoustic technology could reduce false positives and identify cancer sub-types

SAN ANTONIO, June 19, 2019 /PRNewswire/ — Additional research appearing in the June online issue (open access) of European Radiology features the groundbreaking diagnostic breast cancer imaging technology introduced by Seno Medical Instruments™, Inc. (Seno Medical). This technology might not only help physicians better differentiate between benign and malignant breast lesions, but also discriminate between breast cancer molecular subtypes.

The retrospective European post-marketing surveillance analysis corroborates previous studies, which concluded that opto-acoustic ultrasound (OA/US) technology might increase specificity and the ability to rule out disease, potentially reducing the number of false positive examinations and biopsies of benign masses. Researchers observed results from five centers in the Netherlands, where the technology has been introduced commercially using Seno Medical’s Imagio® Breast Imaging System. In this study, 67 biopsy-proven malignant masses were reviewed to compare OA/US characteristics and histopathological prognostic indicators.

OA/US technology creates a “blood map” that gives functional and anatomical information in and around the mass using hemoglobin as a natural contrast agent. The study results showed that OA/US can also help identify different subtypes of cancer by measuring the emergence of angiogenesis (newly created blood vessels which indicate the presence of malignant activity within and around the mass). Other key factors (e.g. histologic grade, continuous number of mitosis, HER2 and hormone receptor status, and Ki-67 poliferation index) might also be identified with the aid of this technology.

According to the study results, the combination of functional and morphologic information provided by OA/US showed promise in differentiating Luminal A, Luminal B, HER2-enriched, and Triple Negative cancers. These tumors have a different prognosis and require different treatment paths that physicians and patients must consider. Molecular analysis requires specialized equipment and expertise, making this process lengthy and expensive. Breast tumors are heterogeneous and biopsy may be insufficient to assess the complete tumor heterogeneity. Therefore, OA/US features that suggest an aggressive tumor subtype that is potentially conflicting with histopathologic biomarkers might suggest the need for more extensive review and inspection of the pathologic specimen.

“Successful breast cancer treatment relies on detecting the cancer and its subtype as quickly as possible,” said Gisela Menezes, MD, PhD, Medical Director at Seno Medical and the article’s lead author. “This promising data using a non-invasive diagnostic approach with OA/US molecular bioimaging could potentially give patients a better chance of getting more accurate and timely prognosis and treatment.”

“Although this is a new emerging technology, these encouraging results show that Seno Medical’s OA/US technology could impact the course of cancer diagnosis for millions of women,” said Ruud Pijnappel, MD, PhD, Professor at University Medical Center, Utrecht, Netherlands and one of the study’s authors. “This technology could give physicians the information needed to make a more confident diagnosis in less time, improve their patient’s experience, and potentially reduce biopsies of benign masses.”

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 a molecular partner to ultrasound. Seno Medical’s Imagio® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – the opto-acoustic images provide a unique blood map in and around breast masses while the interleved and coregistered ultrasound provides a traditional anatomic image.

Contact:
Bryan Fisher, 202.868.4825, bfisher@messagepartnerspr.com

Partnership emphasizes breast health education and empowers women

SAN ANTONIO, May 12, 2019 – Seno Medical Instruments, Inc. (Seno Medical), a Texas-based medical imaging company developing breakthrough breast cancer diagnostic technology, announced an educational partnership supporting Worldwide Breast Cancer’s “Know Your Lemons” campaign starting with the Netherlands, which has one of the highest breast cancer incidence rates in the world.

Through the partnership with Know Your Lemons, Seno will support educational activities focused on healthcare providers across the Netherlands.

Sponsored by Worldwide Breast Cancer, an international breast cancer charity, Know Your Lemons focuses on breast health education. The Seno Medical partnership will boost efforts to overcome taboos, fears, and literacy issues that stymie discussion about breast cancer by using a series of powerful lemon images as blunt stand-ins for breasts.

“More than two million women worldwide received a breast cancer diagnosis last year, and early detection is an important key to their survival,” said Tammy Garcia, senior vice president of sales and marketing at Seno Medical. “Know Your Lemons is kickstarting life-saving conversations about breast cancer. We’re proud to be part of this groundbreaking campaign to educate women and empower them to get screened.”

Seno Medical uses opto-acoustic ultrasound imaging to provide more information about the abnormal blood vessels and oxygen and de-oxygen content in and around the tumor.

Because many people do not know the symptoms, risks, and detection options for breast cancer worldwide, this new campaign focuses entirely on increasing conversations about breast health. Seno Medical leaders say the use of lemon imagery for the breast bypasses cultural barriers in a friendly, familiar, and engaging way.

Since 2014, Know Your Lemons has educated more than 500 million people in more than 20 languages. Community health workers and medical personnel use its educational resources in more than 90 countries.

“A lemon doesn’t have gender, or ethnicity or cultural taboos, so it can represent anything,” said Corrine Ellsworth-Beaumont, the founder of Know Your Lemons. “The campaign creates a new way of looking at the breast that is not sexual, gory, or censored. This partnership with Seno Medical brings us closer to our goal of educating all women.”

Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno Medical’s Imagio® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate real-time functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation.

Contact:

Bryan Fisher, 202.868.4825, bfisher@messagepartnerspr.com

SAN ANTONIO, January 8, 2019 – Seno Medical Instruments, Inc. (Seno Medical), the leader in new technology for breast cancer diagnosis using opto-acoustic ultrasound (OA/US) imaging to differentiate benign from malignant masses, today provided a summary of key 2018 data publications and presentations that demonstrate the clinical utility and healthcare economic benefits of its proprietary, cutting-edge technology.

“Multiple publications and presentations over the course of 2018 substantially strengthen the body of evidence emphasizing the economic costs of unnecessary breast biopsies and the power of our Imagio^® Breast Imaging System to potentially reduce the number of these procedures,” said Thomas Umbel, President and CEO of Seno Medical “This growing evidence base further advances the compelling value proposition that Seno Medical offers to patients, physicians, and payers. We believe this robust body of evidence will help to position the Imagio system as a sound diagnostic tool for the breast imaging community. The selection of Imagio as a finalist for the 2018 Medtech Insight Awards in the “Best Proof-of-Value of an Innovation” category demonstrates widespread recognition of our value proposition.”

Previously unreported data publications and presentations include:

• A cover article in Radiology reporting the results of a landmark study using OA/US imaging to diagnose benign and malignant breast masses. This study, which was based on results from 2,191 breast masses in 2,105 women, found that OA/US increases the specificity of breast mass assessment compared with ultrasound (US) alone. OA/US downgraded 40.8% of benign mass reads, with a specificity of 43.0% compared with 28.1% for US alone. OA/US exceeded US in specificity by 14.9% (P< .0001). Sensitivity for biopsied malignant masses was 96.0% for OA/US and 98.6% for US (P < .0001). The negative likelihood ratio (NLR) of 0.094 for OA/US indicates a negative examination can reduce a maximum US-assigned pretest probability of 17.8% (low Breast Image Reporting and Data System [BI-RADS] 4B) to a posttest probability of 2% (BI-RADS 3).[1]
• A publication in Radiology of a European prospective, multi-center study evaluating OA/US in downgrading suspicious breast masses in 209 patients with 215 breast masses classified as BI-RADS 4a or 4b.[2] Results show that 47.9% of benign masses classified as BI-RADS 4a and 11.1% of masses classified as BI-RADS 4b were correctly downgraded to BI-RADS 3 or 2 with OA/US. Two of seven malignant masses classified as BI-RADS 4a at US were incorrectly downgraded, and one of 60 malignant masses classified as BI-RADS 4b at US was incorrectly downgraded for a total of 4.5% false-negative findings. The study authors conclude that benign masses classified as BI-RADS 4a could be downgraded in BI-RADS category with OA/US, which could potentially decrease negative biopsies for cancer and short-interval imaging follow-up examinations, with the limitation that a few masses may be inappropriately downgraded.
• A publication in Photoacoustics describing how OA/US imaging combined with US enables functional and anatomic mapping of the breast.[3] The authors conclude that the OA/US co-registration technology enables increased accuracy of radiologist assessment of malignancy by confirming, upgrading and/or downgrading US BI-RADS categorization of breast tumors.
• A publication in the American Journal of Roentgenology that compared OA/US to histology in the evaluation of potentially malignant breast masses.[4] A total of 92 masses (BI-RADS categories 3, 4 or 5) in 94 subjects were imaged with OA/US and assessed for three features internal to the tumor and two external features in the boundary zone and periphery. Mean OA/US scores were compared with histologic findings for masses that were biopsied and with benign masses. Results show that high OA/US scores, especially those based on the external features, have a high positive-predictive value (PPV) for malignancy, while low OA/US scores correlate with a low PPV for malignancy. The authors conclude that the functional component of OA/US may help address some of the limitations in discriminating between benign and malignant masses.
• A publication in the American Journal of Roentgenology that reports the outcomes of a pilot study assessing the potential of OA/US to improve BI-RADS categorization of breast masses.[5] In this study, breast masses assessed as BI-RADS category 3, 4A-C, or 5 by radiologists underwent gray scale ultrasound (US) and OA/US and were then re-categorized. Of 94 total masses, 39 were proven by biopsy to be malignant, 44 were benign and 11 BI-RADS category 3 masses were stable at 12-month follow up. The sensitivity of OA/US and US was 97.1%, while specificity, was 44.3% and 36.4%, respectively. OA/US enabled downgrading of masses stable at 12-month follow-up (41.7% downgraded from 3 to 2; 36.6% of 4A downgraded to 3 or 2; 10.1% downgraded from 4B to 3 or 2). OA/US also resulted in upgrading of 75.0% of the malignant masses classified as category 4A, 4B, 4C, or 5, and 49.4% of the malignant masses were classified as category 4B, 4C, or 5. These results demonstrate that OA/US enables the potential downgrading of benign masses and upgrading of malignant masses compared with US.

Previously reported data include:

• At the December 2018 San Antonio Breast Cancer Symposium, Seno’s Medical Director, Dr. Gisela Menezes, presented how the company’s OA/US may play a role in noninvasively offering breast cancer prognostic information at the molecular level. This prospective 5-center study was performed in the Netherlands between March 2015 and February 2016 and included 209 patients with 215 breast lesions. Study results indicated that OA/US feature scores may correlate to breast cancer molecular subtypes, with the potential of helping establish an earlier prognosis and treatment plan.[6]
• A presentation at the Radiological Society of North America 2018 Annual Meeting describing the results of a study investigating the potential role of functional OA/US imaging-derived hemoglobin de-oxygenation and angiogenesis feature scoring combined with conventional gray-scale US in non-invasively diagnosing breast cancer molecular subtypes.[7] The data demonstrate that functional OA/US features provide a non-invasive approach to helping distinguish breast cancer molecular subtypes. The study authors conclude that data from such subtype analyses may help facilitate clinical management decisions.
• A publication in ClinicoEconomics and Outcomes Research that found the annual U.S. cost of false-positive breast biopsies exceeds $2 billion.[8] The study also found that nearly $8 billion is spent annually on follow-up breast diagnostic procedures (mammograms, ultrasound and biopsies). The study authors emphasized the need for highly effective tools that can exclude patients whose suspicious breast masses are benign before they are subjected to invasive diagnostic procedures.
• A publication in the American Journal of Roentgenology describing a novel advanced statistical method for downgrading the risk classification of breast masses to reduce the need for unnecessary breast biopsies.[9] This method, the NLR, can be used with diagnostic imaging output to downgrade breast mass risk classification. The use of the NLR along with BI-RADS 4 subcategories can help to reduce the number of false-positives without experiencing excessive negative results that would lead to cancer going undiagnosed.

About Seno Medical Instruments, Inc.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno Medical’s Imagio^® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate fused real-time functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno Medical believes that the Imagio OA/US breast imaging system will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.

Media Contact

Erich Sandoval
Lazar Partners Ltd.
Tel: +1 917-497-2867
Email: esandoval@lazarpartners.com

[1] Neuschler EI, Butler R, Young CA, Barke LD, Bertrand ML, Bohm-Velez M, et al. A pivotal study of optoacoustic imaging to diagnose benign and malignant breast masses: a new evaluation tool for radiologists. Radiology. 2018:287(2):398-412.

[2] Menezes GLG, Pijnappel RM, Meeuwis C, Bisschops R, Veltman J, Lavin PT, et al. Downgrading of breast masses suspicious for cancer by using optoacoustic breast imaging. Radiology. 2018;288(2):355-365.

[3] Oraevsky AA, Clingman B, Zalev J, Stavros AT, Yang WT and Parikh JR. Clinical optoacoustic imaging combined with ultrasound for coregistered functional and anatomical mapping of breast tumors. Photoacoustics. 2018;12:30-45.

[4] Butler R, Lavin PT, Tucker FL, Barke LD, Bohm-Velez M, Destounis S, et al. Optoacoustic breast imaging: imaging-pathology correlation of optoacoustic features in benign and malignant breast masses. AJR 2018;211:1155-1170.

[5] Neuschler EI, Lavin PT, Tucker FL, Barke LD, Bertrand ML, Bohm-Velez M, et al. Downgrading and upgrading gray-scale ultrasound BI-RADS categories of benign and malignant masses with optoacoustics: a pilot study. AJR 2018;211:689-700.

[6] Menezes GLG, Mann RM, Meeuwis C, Bisschops B, Veltman J, Lavin PT, van de Vijver MJ, Pijnappel RM. Can optoacoustic imaging combined with ultrasound non-invasively offer prognosis for breast cancer molecular subtypes? SABCS 2018 Poster Presentation.

[7] Moy L, Dogan BE, Menezes GD, Neuschler EI, Butler RS, Stavros AT, et al. Optoacoustic imaging (OA) is helpful in predicting breast cancer molecular subtypes. Presented at RSNA 2018 on November 26. Abstract SPS126B.

[8] 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. ClinicoEcon Outcomes Res. 2018;10:157-167.

[9] Yang WT, Parikh JR, Stavros AT, Otto P and Maislin G. Exploring the Negative Likelihood Ratio and How It Can Be Used to Minimize False-Positives in Breast Imaging. AJR 2018;210:301-306.

–  Company’s technology, which shows promise as a clinical prognostic tool that may facilitate treatment decisions, featured as a High Impact Clinical Trial at the Radiological Society of North America Annual Meeting for second year in a row –

SAN ANTONIO, Dec. 11, 2018 /PRNewswire/ — Seno Medical Instruments, Inc. (Seno Medical), the leader in new technology for breast cancer diagnosis using opto-acoustic (OA/US) imaging to differentiate benign from malignant masses, reported results of a study demonstrating that morphologic and functional OA/US features provide a non-invasive approach to helping distinguish breast cancer molecular subtypes. The data were presented on November 26, 2018 at the Radiological Society of North America (RSNA) 2018 Annual Meeting in Chicago and the abstract was featured as one of three High Impact Clinical Trials selected for this special session.

“It has been known for some time that breast cancers with differing receptor expression and gene amplification profiles have different risk factors for disease progression, as well as different preferential organ sites of metastases and therapeutic response. Nevertheless, large-scale gene expression profiling from biopsy samples is not currently feasible,” said Thomas Stavros, MD, Chief Medical Officer of Seno Medical. “We previously hypothesized that more aggressive molecular subtypes might be detectable based on their OA/US feature scores. The results of intense comparison of our histological and OA/US imaging demonstrate and underscore the potential value of OA/US as a novel and non-invasive tool for gleaning critical information that may help to guide and optimize treatment for women with breast cancer. The importance of these data is underscored by their inclusion in the High Impact Clinical Trial category, and we are pleased that RSNA selected our OA/US technology for this honor for the second year in a row.”

There are four distinct main molecular subtypes of breast cancer, which are defined based on the presence of hormone receptors (estrogen [ER] and progesterone [PR]) with or without human epidermal growth factor receptor 2 (HER2) protein overexpression or extra copies of the HER2 gene, and elevation of the ki67 proliferation marker. The four subtypes are:

• Luminal A (LumA; ER+/HER2−negative, ki67<14%);
• Luminal B (LumB; ER+/HER2-negative, ki67≥14%, or ER+/HER2+);
• HER-2 amplified or positive (HER2+; ER-negative, HER2+) and
• Triple Negative Breast Cancer (TNBC); ER and PR-negative/HER2−negative).

The study investigated the potential role of functional OA/US imaging-derived hemoglobin de-oxygenation and angiogenesis feature scoring combined with conventional gray-scale ultrasound (US) in non-invasively diagnosing these breast subtypes.¹ A total of 2,105 women with suspicious breast masses who underwent pre-biopsy OA/US imaging using Seno’s Imagio® OA/US Breast Imaging System at 16 clinical sites between December 2012 and September 2015 were included in the study. Lesions revealing invasive breast cancer on needle biopsy were retrospectively reviewed, and seven blind readers scored the internal (OAINT) and external (OAEXT) OA/US features of identified cancers. The ratio of total internal to total external US and OA/US feature scores (RInt/Ext) was derived. Tumor hormone receptor (ER and PR), and HER2 status, and available ki67(%) labeling index were derived from pathology specimens. Key findings from the study include:

• Of 653 invasive cancers, 537 (82.2%) were ER+ and 111 (17%) were ER-negative, with ER data missing for 5 (0.8%) patients.
  ER+ cancers had significantly higher OAEXT (p<0.001), with lower OAINT (p<0.05) and RInt/Ext (p<0.001) compared with ER-negative ones.
• Of 532 patients with available pathologic molecular subtype, 186 (35.0%) were LumA, 244 (45.9%) were LumB, 79 (14.8%) were TNBC and 23 (4.3%) were HER2+.
• All OAEXT scores were lower in TNBC compared with LumA (p<0.001), whereas OAINT vessels and total scores were lower in LumA compared with TNBC (p<0.05).
• The mean RInt/Ext was significantly higher in TNBC (1.7, SD ± 0.7) compared with LumB (1.3, SD ±0.5) and LumA (1.2, SD ± 0.5) subtypes (p<0.001), but not significantly different from HER2 (1.5, SD ±0.6).
• RInt/Ext feature scores helped distinguish LumA vs. LumB (p<0.05), LumA vs. HER2+ (p<0.05, LumA vs. TNBC (p<0.001) and LumB vs. TNBC (p<0.001).
• The data demonstrate that morphologic and functional OA/US features may provide a non-invasive approach to help distinguishing breast cancer molecular subtypes. The study authors conclude that data from such subtype analyses could potentially facilitate clinical management decisions.

“The exciting finding in this study is OA/US imaging features may serve as imaging biomarkers that predict molecular phenotypes. This not only helps establish the diagnosis of breast cancer, but also distinguishes cancers with poor prognosis from those with good prognosis non-invasively – using no radiation, contrast or a need for biopsy,” said Basak E. Dogan, MD, University of Texas Southwestern Medical Center, presenter at RSNA and the first author of the study. “This is an important step forward to non-invasively optimize treatment regimens in keeping with the unique molecular profile of each woman’s cancer. Furthermore, it is a great opportunity to assess the cancer three dimensionally instead of making treatment decisions based on small biopsy samples. OA/US has the potential to improve treatment outcomes for women with invasive breast cancer.”

The Imagio® OA/US Breast Imaging System is the subject of a U.S. PMA filing with the FDA and does have European CE Mark.

About Seno Medical Instruments, Inc.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno Medical’s Imagio® OA/US Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate fused real-time functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno Medical believes that the Imagio OA/US breast imaging system will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. To learn more about Seno Medical’s OA/US imaging technology and applications, visit www.SenoMedical.com.

1. Moy L, Dogan BE, Menezes GD, Neuschler EI, Butler RS, Stavros AT, et al. Optoacoustic imaging (OA) is helpful in predicting breast cancer molecular subtypes. Presented at RSNA 2018 on November 26. Abstract SPS126B.

–  San Antonio-based technology company focuses on improving breast cancer diagnostic accuracy and ‘walking the talk’ inside the company –

SAN ANTONIO, November 12, 2018 – Local diagnostic imaging system developer, Seno Medical, is taking a serious stance against breast cancer. Not only does this innovator work toward a better imaging device beyond mammography and ultrasound with the hope of empowering breast imagers with more information for an increased diagnostic accuracy, but Seno Medical is putting breast cancer – and the patient care pathway – at the center of everything it’s doing.

Making It Personal

Earlier this fall, Seno Medical recognized that several of its employees have been touched by breast cancer, but others have not. In an effort to raise awareness of what a patient goes through when undergoing a breast exam and having a suspicious mass identified, Seno launched an employee initiative, termed “Making It Personal,” designed to match employees who want to learn more about the patient journey, with breast cancer survivors and others who are at risk of developing the disease. Employees spent time getting to know patients, their first-hand experience and the many exams they underwent, including painful biopsy procedures, to assess whether the suspicious mass was benign or malignant.

Says Making It Personal participant and Seno Finance Director, Robin Bale, “There’s a lot of learning opportunity here for me. As a man, while I understand the struggle and recognize breast cancer has been a challenging event in a patient’s life, I’ve never walked a mile in her shoes and I don’t know many that have. This program opened my eyes and helped me better understand how important it is – what we do here at Seno Medical.”

The Making It Personal program at Seno was initially a pilot project but is being rolled out across the company to help all employees keep the patient at the center of every activity and at every level in the company.

Raising Awareness

Seno Medical initiated a building-wide Breast Cancer Awareness Day at the Callaghan Tower in the medical center district of San Antonio. Seno employees were encouraged to wear pink, staff a booth in the building lobby to hand out information packets about the importance of breast cancer screening, knowing your breast density and monthly self-exams, and to fundraise for the Komen Foundation. Between donations from Seno employees and tenants throughout the building, hundreds of dollars were donated to Komen San Antonio.

Clinical Efficacy

Clinical study results have been shared at several medical conferences by breast imagers/investigators involved with Seno Medical’s opto-acoustic/ultrasound (OA/US) fused technology. One of the company’s most important international conferences is located locally in San Antonio. At the upcoming annual breast conference – San Antonio Breast Cancer Symposium, running December 4-8 – Seno’s Medical Director, Dr. Gisela Menezes, will present how the company’s OA/US may play a role in noninvasively offering breast cancer prognostic information at the molecular level.

The SA BioMed Community

Ann Stevens, president of BioMed SA, a nonprofit organization whose mission is to organize and promote San Antonio’s healthcare and bioscience assets to accelerate growth, points to cancer research and technology innovation as key strengths of the city’ biomedical sector. “I’ve followed the story of Seno Medical from its earliest days and see it as a specific example of a San Antonio company developing a promising new cancer technology,” she said.

Stevens noted that San Antonio’s biomedical sector has a rich history in cancer research, development and commercialization. “Our city is the permanent home of the world’s largest breast cancer meeting, the San Antonio Breast Cancer Symposium. Now in its 41^st year, the symposium attracts thousands of international thought leaders here every December and is known for presenting the latest breast cancer data from around the world. Seno Medical is carrying on this tradition while breaking new ground with its novel approach to cancer diagnosis.”

About Breast Cancer

Breast cancer is the most common malignancy among women worldwide and the second leading cause of cancer-related deaths in females, and it is estimated that 266,120 new cases of invasive breast cancer will be diagnosed in women in 2018.¹ Survival rates have increased steadily over recent decades as earlier detection enables treatment at earlier stages when treatment is more effective and less costly. However, many organizations differ on timing (annually, bi-annually) and ages for screening (to begin at age 40 or 50 years, screening after age 74 years), with varying opinions on how to best balance breast cancer screening costs with rates of detection, rates of false-positives or over diagnoses, and reduction in mortality.²

About Seno Medical Instruments, Inc.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno Medical’s Imagio^® Breast Imaging System fuses opto-acoustic technology with ultrasound (OA/US) to generate fused real-time functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno Medical believes that the Imagio OA/US breast imaging system will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. To learn more about Seno Medical’s OA/US imaging technology, visit www.SenoMedical.com.

¹ American Cancer Society, Current year estimates for breast cancer, January 4, 2018 http://ibm.biz/BdZJvc

² Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of Utilization Patterns and Associated Costs of the Breast Imaging and Diagnostic Procedures After Screening Mammography. ClinicoEconomics and Outcomes Research 2018:10 157-167.

Media Contact

Lisa Bichsel
Seno Medical
Tel: +1 719-640-5640
Email: lbichsel@senomedical.com

–  Publication in ClinicoEconomics and Outcomes Research estimates nearly $8 billion annually in expense for additional breast diagnostic testing, underscoring market need for improved breast diagnostic tools –

SAN ANTONIO, May 31, 2018 – False-positive breast biopsies in the United States cost the healthcare system more than $2 billion per year, according to findings released from a new study in ClinicoEconomics and Outcomes Research, conducted by a team of health outcomes research scientists at IBM Watson Health™ in collaboration with Seno Medical’s Chief Medical Officer, A. Thomas Stavros, MD.¹ 

The study analyzed recent data focusing on diagnostic breast imaging, biopsies, and other diagnostic procedures performed for patients recalled for follow-up after suspicious findings from initial screening mammography or breast examination. Such follow-up procedures are ordered by clinicians largely because current tools often cannot provide diagnostic certainty in identifying cancerous breast masses. The study looked at how often the follow-up procedures were performed, on what volume of patients, the most common sequences in which the procedures were performed, and the associated costs.

Data was collected from a nationally representative sample of 875,000 adult women using real-world encounters from health care claims data from 2011 to 2015, and then projected nationally to estimate that more than 12 million women in the US received follow-up exams each year after suspicious findings. Based on actual payer claims for the women studied, 53.3% of such patients received diagnostic mammograms, 42.4% received diagnostic breast ultrasounds, and 10.3% received biopsies after initial diagnostic procedures. Total costs for these procedures were projected at:

• $3.05 billion for diagnostic mammograms (average cost $349)
• $0.92 billion for diagnostic breast ultrasounds (average cost $132)
• $3.07 billion for biopsies (average cost $1,938)

Combined with other follow-up imaging procedures (e.g., tomosynthesis, MRI, others), the data totals nearly $8 billion spent annually for follow-up breast diagnostic procedures. [See Infographic.]

Breast cancer is the most common malignancy among women worldwide and the second leading cause of cancer-related deaths in females, and it is estimated that 266,120 new cases of invasive breast cancer will be diagnosed in women in 2018.² Survival rates have increased steadily over recent decades as earlier detection enables treatment at earlier stages when treatment is more effective and less costly. However, many organizations differ on timing (annually, bi-annually) and ages for screening (to begin at age 40 or 50 years, screening after age 74 years), with varying opinions on how to best balance breast cancer screening costs with rates of detection, rates of false-positives or over diagnoses, and reduction in mortality.¹

The study authors stressed the critical need for follow-up with patients who present with abnormal results on a screening mammogram. Standards of care and practice guidelines require further imaging studies before an invasive procedure such as breast biopsy, when the screening mammogram uncovers something suspicious.

They further recognized unmet medical need for highly effective exam tools that could exclude patients whose suspicious breast masses are benign before they are subjected to invasive diagnostic procedures. Breast biopsies have been found to show a false-positive rate following diagnostic screening procedures as high as 71 percent in the United States according to the National Cancer Institute³, translating to an annual cost of $2.18 billion in biopsy procedures that might have been avoided.

“The costs to the healthcare system are secondary to the psychological impact on women who are told that their mammogram and ultrasound were inconclusive, and that a biopsy is required to rule out cancer,” says A. Thomas Stavros, MD, FACR, FSRU, FRANZCR, Professor Specialist, Department of Radiology University of Texas Health Sciences Center and Chief Medical Officer of Seno Medical, San Antonio, TX.

Stavros continued, “Conscientious clinicians rightly want to confirm that a mass is not malignant, so the guidelines and clinical practice aren’t at fault. It’s simply that technology – as advanced as it has become – still needs further refinement to provide better specificity without sacrificing sensitivity and to engender increased diagnostic confidence for the clinician. There are significant volumes and costs of procedures required to reach a definitive, “yes,” that breast cancer does or does not exist.”

“Our findings bring a national spotlight on the current diagnostic procedure journey faced by patients and providers in order to have confidence in the evidence of a woman’s risk of breast cancer,” says Jay Margolis, PharmD, Senior Research Scientist, Life Sciences, Value Based Care at IBM Watson Health and senior author for the study. “Recalling a woman for subsequent imaging procedures that may not be truly needed places significant burdens on the patient, her family, and her career, with substantial costs to the healthcare system.”

About Seno Medical Instruments, Inc.
Seno Medical Instruments, Inc. is a San Antonio, Texas-based medical imaging company committed to the development and commercialization of a new modality in cancer diagnosis: opto-acoustic imaging. Seno Medical’s Imagio™ breast imaging system fuses opto-acoustic technology with ultrasound (OA/US) to generate fused real-time functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map around breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno Medical believes that the Imagio OA/US breast imaging system will be a more effective tool to help radiologists confirm or rule out malignancy than current diagnostic imaging modalities – without exposing patients to potentially harmful ionizing radiation (x-rays) or contrast agents. To learn more about Seno Medical’s OA/US imaging technology, visit www.SenoMedical.com.

¹ Vlahiotis A, Griffin B, Stavros AT, Margolis J. Analysis of Utilization Patterns and Associated Costs of the Breast Imaging and Diagnostic Procedures After Screening Mammography. ClinicoEconomics and Outcomes Research 2018:10 157-167.

² American Cancer Society, Current year estimates for breast cancer, January 4, 2018 http://ibm.biz/BdZJvc

³ NCI-funded Breast Cancer Surveillance Consortium (HHSN261201100031C). Downloaded from the Breast Cancer Surveillance Consortium Web site – http://breastscreening.cancer.gov/.http://www.bcsc-research.org. Accessed January 23, 2017.

Media Contact

Erich Sandoval
Lazar Partners Ltd.
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Email: esandoval@lazarpartners.com