Press Releases

–  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.
Tel: +1 917-497-2867
Email: esandoval@lazarpartners.com

–  Publication in AJR defines advanced statistical methods that can be used with diagnostic imaging output to downgrade breast mass risk classification –

SAN ANTONIO, May 3, 2018 – The American Journal of Roentgenology recently published findings on statistical methods for downgrading the risk classification of breast masses to reduce the need for unnecessary breast biopsies. Clinicians from Seno Medical and medical center collaborators from The University of Texas co-authored the report.¹  

“The perceived risk of missing a breast cancer diagnosis with breast imaging studies is much higher than the risk of a false-positive diagnosis, leading to breast imagers recommending a breast biopsy whenever the risk of cancer is greater than 2%. Sometimes ancillary diagnostic breast imaging studies are performed to reduce risk to less than 2%, but it is difficult to know exactly how much risks are reduced even after a negative ancillary diagnostic imaging examination,” said Thomas Stavros, MD, Chief Medical Officer of Seno Medical and a co-author of the report. “However, the use of the Negative Likelihood Ratio (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.”

The report explores the use of a statistical calculation known as the Negative Likelihood Ratio (NLR). It shows how NLR can be calculated from a diagnostic test’s sensitivity and specificity and also show the NLRs of some currently available diagnostic imaging modalities. It outlines how the BI-RADS (Breast Imaging and Reporting Data System, or BR) 4A sub-category has low enough and narrow enough range of pre-test probabilities (see Table 1) to allow downgrading to a post-test probability of 2% or less after a negative diagnostic imaging test with an adequately low NLR.

Each BI-RAD category is associated with a specific risk of breast cancer. Briefly, the approach includes the following steps:

1. Classify lesions according to BI-RADS category 4 subcategories. Subcategory 4A is important as it represents the subcategory where the range of PPVs is both low enough and narrow enough to allow downgrading to BI-RADS category 3 is most possible when a diagnostic imaging test result is negative.
2. Confirm that the Positive Predictive Value (PPV) is within the American College of Radiology (ACR) benchmark PPV range for BI-RADS subcategory 4A (>2% to 10%).
3. Ensure the NLR is adequate for a negative test finding to reduce the post-test probability to 2% or less.

“Reducing the number of unnecessary breast biopsies is an essential advancement toward improving women’s healthcare and protecting breast health,” said Pam Otto, M.D., Department of Radiology, The University of Texas Health Science Center at San Antonio and co-author. “I would encourage breast imagers to consider using BI-RADS 4 subcategories and NLR as important tools for helping them minimize false positive studies with minimum adverse effect on sensitivity, optimizing their patients’ breast health. The availability of web-based programs for automating the NLR calculations should help to facilitate routine use of this important statistical tool.”

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.

[1] 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.

-2017 award recognizes a novel optical imaging modality that provides high molecular contrast of
important biomarkers throughout the body –

SAN ANTONIO, January 30, 2018 – 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, today announced the winner of the 2017 Best Paper Award at the International Society for Optics and Photonics (SPIE) “Photons Plus Ultrasound: Imaging and Sensing” annual conference. This year’s award was given to a team of researchers from California Institute of Technology, Washington University in St. Louis, Duke University and Tsinghua University, Beijing who have developed a novel photoacoustic technology. Seno Medical has sponsored the award for the past eight years, which includes a Certificate of Accomplishment and a $3,000 cash prize.

The conference, held under the auspices of the SPIE/BIOS Photonics West symposium, is the largest international forum for the biomedical opto-acoustics research community, held this week in San Francisco January 27th – 31st. More than 250 papers representing the latest results in imaging and sensing technologies, including both clinical and pre-clinical applications, are presented.

The field of biomedical opto-acoustic (photoacoustic) imaging continues to experience rapid growth. In 2017, the total number of research papers published in peer-reviewed literature on the subject of opto-acoustic imaging exceeded 500, and the total number of papers published on the technology now exceeds 5,000. The number and sophistication of papers reporting on opto-acoustic clinical applications and commercial grade systems have been increasing since the beginning of the 21st century, a trend that became even more prominent at this year’s conference. There are approximately 1,000 attendees at the symposium, and the clinical application sessions achieved standing-room-only attendance.

“As a leader in applying opto-acoustic imaging to advance the diagnosis of breast cancer, we know firsthand that these technologies have tremendous potential in improving patient care and outcomes,” said Steven Miller, Senior Vice President of Engineering at Seno Medical. “Seno Medical is committed to fostering innovation that helps advance patient care, and we are excited about the increased number and sophistication of papers reporting on opto-acoustic clinical applications and commercial grade systems at this year’s conference. The technology described in the award-winning paper has the potential to significantly improve the resolution of whole-body dynamic imaging for small animals used in many areas of medical research from pathology to oncology.”

The 2017 Best Paper Award was given to the team for their work on the study Imaging Small-animal Wholebody Dynamics by Single-impulse Panoramic Photoacoustic Computed Tomography. Seno Medical congratulates the papers’ authors, Lei Li, Liren Zhu, Cheng Ma, Li Lin, Junjie Yao, Lidai Wang, Konstantin Maslov, Ruiying Zhang, Wanyi Chen, Junhui Shi, and Lihong V. Wang. The company also thanks the Organizing Committee and the contributors to this conference for their ongoing efforts to support the transformation of biomedical opto-acoustics and photoacoustics into clinical applications that can address real unmet needs within the healthcare system.

The Single-impulse Panoramic Photoacoustic Computed Tomography (SIP-PACT) technology substantially enhances imaging performance to complement existing modalities for small animal whole-body imaging. This technology non-invasively images mouse anatomy real-time, with clearly viewed sub-organ vasculature and structure. SIP-PACT as a whole-body imaging tool for small animals will enable widespread applications in fundamental biology, pathology, oncology and other areas.

Two other papers were selected as finalists for the 2017 award:

• Photoacoustic analysis of thyroid cancer in vivo: A pilot study, by Jeesu Kima, Min-Hee Kimb, Kwanhoon Jo, Jeonghoon Hab, Yongmin Kim, Dong-Jun Lim, and Chulhong Kim
• Possibility of transrectal photoacoustic imaging-guided biopsy for detection of prostate cancer, by Miya Ishihara, Masayuki Shinchib, Akio Horiguchi, Hiroshi Shinmotoc, Hitoshi Tsudad, Kaku Irisawae, Takatsugu Wadae, and Tomohiko Asanob.

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’s Imagio™ breast imaging system fuses opto-acoustic technology with ultrasound to generate functional and anatomical images of the breast. The opto-acoustic images provide a unique color map in and around suspicious breast masses while the ultrasound provides a traditional anatomic image. Through the appearance or absence of the two hallmark indicators of cancer – angiogenesis and deoxygenation – Seno believes that Imagio™  images 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. Seno’s platform technology may also address other disease applications in organs other than the breast, as well as assessing other breast problems, such as early response to neoadjuvant chemotherapy or hormonal treatments of breast cancer. To learn more about Seno’s opto-acoustic imaging technology and applications, visit www.SenoMedical.com

–  Prospective clinical study presented at the San Antonio Breast Cancer Symposium suggests Imagio findings may help clinicians tailor patient treatment regimens –

–  Functional Imaging provides important information about the growth and location of blood vessels around breast masses as compared to anatomical imaging-

SAN ANTONIO, December 8, 2017 – 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 clinical data from their clinical study demonstrating that its Imagio^™ breast imaging system achieved significant differentiation among prognostic subtypes of breast cancer (PSBC). These prognostic subtypes provide important information about the genes that each patient’s cancer expresses. The data are being presented today at 5:00 p.m. during a poster presentation [#P5-02-04] at the San Antonio Breast Cancer Symposium taking place December 5 – 9.

“Confirming a diagnosis of breast cancer is just the first step in understanding the pathology of a patient’s tumor,” said study presenter Stephen Grobmyer, M.D., Director, Breast Surgical Oncology, Cleveland Clinic. “Determining a patient’s prognostic subtype of breast cancer is essential for understanding how tumors will respond to specific therapies and selecting a treatment regimen that offers the patient the best chance of a positive outcome. The findings that OA/US may differentiate among several breast cancer subtypes suggest that this novel imaging methodology could potentially provide a non-invasive alternative to biopsy without sacrificing information about the molecular pathology of the tumor. This could be an important advance for women with breast cancer.”

The prospective, multi-center study was conducted at 16 centers in the United States. A total of 1,808 breast masses in 1,739 subjects assessed as BI-RADS (Breast Imaging and Reporting Data System, or BR) category 3, 4 or 5 were imaged with OA/US, resulting in the identification of 678 malignant lesions. Eight blinded readers scored these 678 lesions based on three internal features of the tumor and two external features of the tumor boundary and surrounding tissue. An experienced central breast pathologist who was blinded to the OA/US assessment confirmed the pathologic diagnoses. Biopsy specimens were obtained and assessed for the expression of four genes that comprise the PSBC: estrogen receptor (ER), progesterone receptor (PR), HER2-neu (HER2) and Ki-67. The PSBCs are defined as follows:

• Luminal A (LUM-A): ER/PR (+) and Ki-67 and HER2 (-). These tumors are often low grade, with slow tumor growth and are associated with the most positive prognosis.
• Luminal B (LUM-B): ER (+), PR (+/-), Ki-67 (+) and HER2 (+/-). These tumors are also low grade but grow more quickly than LUM-A.
• Triple-negative breast cancer (TNBC): ER/PR (-), Ki-67 (+/-) and HER2 (-). These tumors are aggressive and typically associated with poor prognosis.
• HER2-enriched (HER2): ER/PR (-), Ki-67 (+/-) and HER2 (+). These tumors tend to grow quickly but are responsive to anti-HER2 targeted therapies.

Tumors not meeting the definition of any of these categories were deemed unclassified.

Key findings from the study include:

• There was a significant difference in the sum of the three internal OA/US features between LUM-A and TNBC subtypes (p = 0.0256) and borderline significance between LUM-A and LUM-B (p = 0.0831) and LUM-A and HER2 (p = 0.0707).
• There was a significant difference in the sum of the two external OA/US features between LUM-A and TNBC subtypes (p = 0.0001) and LUM-B and TNBC subtypes (p = 0.0020) and borderline significance between LUM-A and HER2 (p = 0.0617).
• TNBC tumors showed mainly internal findings consisting of polymorphic intensely deoxygenated vessels.
• LUM-A tumors showed a paucity of internal findings and abundant external findings consisting of short perpendicularly oriented tumor vessels in the boundary zone (BZ whiskers), partial BZ deoxygenated blush, and peripheral radiating deoxygenated vessels.

“The results of this study underscore the clinical benefits that can be achieved with Imagio’s functional imaging technology,” said Tom Umbel, CEO of Seno Medical Instruments. “Unlike anatomical imaging techniques, such as mammography or conventional ultrasound, functional imaging provides important information about the growth and location of blood vessels in and around breast masses. These findings show that not only does this functional imaging data allow for more accurate diagnosis of breast cancer, it also correlates with existing prognostic breast cancer subtypes. This data may suggest that OA/US has the potential to provide physicians with a powerful tool for gaining insight into the molecular pathology of each patient’s tumor without the need for invasive biopsy procedures. Seno Medical is committed to improving the care and outcomes of women with breast cancer through improved non-invasive diagnostic approaches.”

The Imagio™ OA/US breast imaging system was designed and is being studied to identify two functional hallmarks of cancer: the presence of abnormal blood vessels (tumor angiogenesis) and the relative reduction in oxygen content of blood that occurs in cancer compared to benign masses and normal tissues.   The technology 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™ 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 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.

About Breast Cancer

According to the American Cancer Society, an estimated 246,660 new cases of invasive breast cancer, along with 61,000 new cases of non-invasive (in situ) breast cancer, will be diagnosed in U.S. women in 2016. An estimated 40,450 women in the U.S. are expected to die in 2016 from breast cancer. Only lung cancer accounts for more cancer deaths in women.[1]

[1] U.S. Breast Cancer Statistics | Breastcancer.org. (2016). Breastcancer.org. http://www.breastcancer.org/symptoms/understand_bc/statistics