Press Releases

Results Presented at the American Roentgen Ray Society (ARRS) Annual Meeting

San Antonio, May 10, 2017 – Seno Medical Instruments, Inc. (Seno Medical), the leader in new technology for breast cancer diagnosis, is using opto-acoustic (OA/US) imaging to differentiate benign from malignant masses. Seno Medical announced that its Imagio^™ breast imaging system results correlate with the histopathological findings of benign and malignant breast masses. These data were highlighted during an oral presentation at the American Roentgen Ray Society (ARRS) Annual Meeting, which took place from May 1-5 in New Orleans.

The basis for this presentation is the institutional review board (IRB)-approved Phase III pilot study, which was designed to determine the histopathologic basis of OA/US breast imaging and investigate its ability to differentiate benign and malignant masses. A total of 92 patients with 94 solid or complex cystic and solid breast masses assessed as BI-RADS 3, 4 or 5 on conventional diagnostic ultrasound (CDU) were imaged with OA/US. For each mass, five pre-determined OA features – three internal features and two external features – were evaluated. The three internal features (internal vessels, blush and hemoglobin) and two external features (boundary zone vessels and peripheral zone vessels) were scored and correlated with benign and malignant histopathology.

Mean OA scores were higher for malignant masses compared to benign masses for all individual internal and external features, as well as for combined internal and external OA features. Statistical analysis showed that these differences were highly statistically significant. External features were more predictive of malignancy than internal features, with greater differences in their means and 99% confidence intervals between benign and malignant masses.

“These data reinforce previous findings suggesting that opto-acoustic diagnostic imaging may improve our ability to differentiate between benign and malignant breast masses. This could help us decrease the number of unnecessary breast biopsies performed for benign findings, reducing patient anxiety, discomfort and health care cost,” said Reni Butler, MD, principal study investigator and Assistant Professor of Radiology and Biomedical Imaging at Yale University School of Medicine. “Unlike previously investigated functional modalities, opto-acoustic imaging provides real-time anatomic and functional information without ionizing radiation or the need for IV contrast injection, making it a potentially safer and more convenient option for patients.”

“We are encouraged by these promising study results, further underscoring the clinical utility of the Imagio OA/US breast imaging system as an effective tool to aid in the assessment of breast masses,” said Tom Umbel, CEO of Seno Medical Instruments. “We are confident that OA/US imaging has the potential to address significant unmet needs in the characterization and diagnosis of breast lesions and look forward to announcing the results of PIONEER, our pivotal U.S. study of more than 2,000 patients, later this year.”

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.

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.

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, were diagnosed in U.S. women in 2016. An estimated 40,450 women in the U.S. died 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

SAN ANTONIO, April 24, 2017 /PRNewswire/ — Seno Medical Instruments, Inc. (Seno Medical), the leader in improving the process of diagnosing breast cancer through the development of an opto-acoustic (OA/US) imaging device, today announced the appointment of Ann Waterhouse as Vice President of Quality Assurance and Regulatory Affairs. Ms. Waterhouse previously served as the Director of Regulatory Affairs at Hill-Rom in Batesville, IN. Ms. Waterhouse brings 18 years of regulatory and quality experience across a broad range of medical devices. She has been involved in Fortune 500 international expansion, start-up companies and developing and growing quality and regulatory functions.

“Ann has made an immediate impact in our organization and is joining Seno Medical at a critical stage in our FDA approval and commercialization process. We are pleased to have this type of talent join our leadership team,” said Tom Umbel, CEO of Seno Medical. “Ann’s regulatory knowledge and reputation within the FDA will be an important asset as we embark on our final phase in this process for the Imagio™ OA/US breast imaging system.”

Ms. Waterhouse has been part of successful leadership teams who worked on closure of FDA warning letters, 510(k) and PMAs, international registrations and expanding global footprint, as well as mergers and acquisitions. Most recently at Hill-Rom, she was integral to working through many regulatory matters and implemented a Regulatory Intelligence program focused on the directional and dedicated design of innovative products. Ms. Waterhouse has been dedicated to the education and retention of employees at both a company level and as part of the Indiana Medical Device Manufacturers Council (IMDMC).

“I am excited to join Seno Medical. There is an energy at this company to do innovative work that is not often felt in larger organizations. The passion and teamwork are also more evident, and this technology will have an effect on patient quality of life that is immeasurable,” said Ms. Waterhouse.

The Imagio™ OA/US breast imaging system was designed to identify the 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 used by Seno Medical’s OA/US is non-invasive and does not require patient exposure to contrast agents, ionizing radiation (x-ray) or radioisotopes, which are required for other modalities that are capable of functional imaging, including magnetic resonance imaging (MRI) or positron emission tomography (PET). The Imagio breast imaging system is currently an investigational device in the United States.

The technology currently has CE mark outside the U.S. and is targeting Premarket Approval submission to the FDA in 2017.

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 functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map 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 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.

SAN ANTONIO, Jan. 18, 2017 /PRNewswire/ – Seno Medical Instruments, Inc., the leader in improving the process of diagnosing breast cancer through the development of an opto-acoustic (OA/US) imaging device, today announced the appointment of Steve Miller as SVP of Engineering. Mr. Miller previously served as the Vice President of Product Realization at FUJIFILM SonoSite, with headquarters in Bothell, Washington. Mr. Miller has dedicated the majority of his 30-year career to the development of innovative medical imaging products that affect patients and customers. He is personally an inventor on more than 30 patents, while leading teams that received more than 200 patents.

“Steve has led international engineering teams in the development of innovative and high performance ultrasound imaging systems. His customer centric approach to product development addressing customer needs at major imaging companies is why he will be an exceptional addition to our leadership team,” said Tom Umbel, CEO of Seno Medical. “Steve brings the ultrasound system knowledge and experience from top global imaging companies.”

Mr. Miller was responsible for taking new concepts to volume production, including engineering, manufacturing, supply chain, and product management at SonoSite. FUJFILM SonoSite is the global leader in ultrasound products designed specifically for point-of-care markets. Prior to SonoSite, Steve held several leadership roles at GE Healthcare; his last role at GE was the Engineering General Manager for GE Healthcare’s Global Ultrasound Probe division, where he managed engineering teams in seven countries.

Commenting on his appointment, Mr. Miller said, “I am very excited about the possibilities of opto-acoustic imaging. I was extremely impressed when I saw clinical results and heard feedback from several recognized expert clinicians. The Seno team is clearly very passionate about the realization of this innovative breakthrough technology and its ability to improve the care for so many affected by the risk of cancer – as many close to me have been impacted.”

The Imagio® OA/US breast imaging system was designed to identify the 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 used by Seno’s OA/US is non-invasive and does not require patient exposure to contrast agents, ionizing radiation (x-ray) or radioisotopes, which are required for other modalities that are capable of functional imaging, including magnetic resonance imaging (MRI) or positron emission tomography (PET). The Imagio breast imaging system received CE mark approval in 2015 and is currently an investigational device in the United States.

The technology currently has CE mark outside the U.S. and is currently targeting Premarket Approval submission to the FDA, in early 2017.

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 (OA/US) to generate functional and anatomical images of the breast. The opto-acoustic images provide a unique blood map 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 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: +1 213-908-6226
Email:  esandoval@lazarpartners.com

Additional Data Validates Potential of Imagio™ Opto-Acoustic Breast Imaging System to Reduce Negative Biopsies

NEWS PROVIDED BY Seno Medical Instruments, Inc. Dec 09, 2016, 07:00 ET SAN ANTONIO, Dec. 9, 2016 /PRNewswire/ — Seno Medical Instruments, Inc., the company pioneering the development of opto-acoustic (OA) technology as a new tool to improve the process of diagnosing breast cancer, today announced results from two analyses of the company’s European MAESTRO post-market surveillance study. The two analyses were presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.

MAESTRO, a controlled, multi-center, observational, post-market surveillance and clinical follow-up study, was designed to assess the diagnostic value (specificity and sensitivity) of OA to conventional diagnostic ultrasound (CDU) in suspicious masses classified as BI-RADS 4a and 4b. Investigators first performed CDU to reach a diagnosis and decision to biopsy followed by an Imagio™ OA examination. Two hundred female subjects with undiagnosed suspicious masses enrolled in the study.

The first analysis evaluated the correlation between OA imaging results and histologic data of breast masses and found that there was a statistically significant correlation between the OA breast imaging results and those based on histopathologic analysis.

“These studies are an important step forward in the development of noninvasive breast imaging technology. Evaluation of the Imagio™ system significantly included an independent analysis of the patient’s pathology, unparalleled in the pre-release development of any breast imaging technology,” said F. Lee Tucker, MD, FCAP and pathologist for the PIONEER study in the U.S. “The findings indicate the Imagio™ system can provide an accurate and noninvasive differentiation of benign from cancerous breast masses and will be an important means of reducing the number of benign breast biopsies.”

The histopathological examination revealed 146 benign masses and 67 malignant masses. For each mass, five pre-determined OA features, three internal features, and two external features were evaluated. The three internal scores (vessels, blush, and hemoglobin) and two external features (capsular boundary zone and peripheral boundary zone) were summed together and separately for testing relationships utilizing traditional histopathology measures. The OA feature scores statistically significantly differentiate between benign and malignant masses and appear to correlate to histologic grade.

The second study, an interim analysis from the MAESTRO study, presented OA imaging downclassification and upclassifciation data, which showed that the Imagio™ system improved physicians’ ability to accurately classify breast masses as malignant or benign compared to using traditional ultrasound. Results from this study were first presented at the Annual Scientific Meeting of the European Society of Breast Imaging (EUSOBI), the second largest conference in the world dedicated to breast cancer imaging, in September 2016 in Paris.

“The interim results from the MAESTRO study provide further evidence in a real-world setting, that the Imagio breast imaging system is a viable diagnostic tool to more accurately assess breast masses for malignancy compared to diagnostic ultrasound,” said Ruud Pijnappel MD, PhD, Professor Breast Radiology at UMC Utrecht, Netherlands and CEO of LRBC – Dutch Reference Centre for Screening. “We believe the final results of the MAESTRO study to be presented in 2017 will confirm these interim results.”

“Together, the two data presentations presented at the San Antonio Breast Cancer Symposium reinforce our belief that the Imagio breast imaging system will be an important tool to clinicians to evaluate suspicious masses while providing greater comfort to the patient,” said Tom Umbel, CEO of Seno Medical Instruments. “We will soon launch the Imagio system in Europe and look forward to the presenting the MAESTRO final results and the results of our pivotal trial in the US – PIONEER – in 2017.”

Seno Medical Instruments expects to announce the final results from the MAESTRO study in early 2017. Results from the company’s PIONEER study in the U.S. of more than 2,000 patients are expected to be announced in the second half of 2017. Seno Medical is targeting their PMA submission for the Imagio system to the U.S Food and Drug Administration in early 2017.

Seno’s Imagio system co-registers and fuses opto-acoustics, a technology based on “lightin and sound-out,” with diagnostic ultrasound – (OA/US). The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Cancerous tumors grow relatively quickly and require significant amounts of blood and oxygen, so a network of blood vessels grows around cancerous masses. Imagio OA/US breast imaging system provides real-time images of these networks and a map of relative oxygen-rich or oxygendepleted blood. Unlike other functional fusion technologies, Imagio uses no x-rays (ionizing radiation) or injectable contrast agents or radio-isotopes to obtain its information, thereby reducing the patient’s exposure to any potentially harmful aspects of imaging.

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 optoacoustic imaging technology and applications, visit http://www.SenoMedical.com

About the San Antonio Breast Cancer Symposium

The San Antonio Breast Cancer Symposium is an international symposium directed primarily towards academic and private physicians and researchers involved in breast cancer in medical, surgical, gynecologic, and radiation oncology, as well as other appropriate health care professionals. Approximately 7,500 attendees from more than 90 countries are expected to attend.

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. Additionally, there are over 1.6 million biopsies performed annually and recent reported data noted an 81% “false positive” rate of biopsy procedures – the portion of biopsies that do not lead to breast cancer surgery.   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. \

Media Contact

Erich Sandoval Lazar Partners Ltd.  Tel: +1 213-908-6226 Email:  esandoval@lazarpartners.com

1.J Womens Health, September 2014, Vol. 23:S1,

2.An Actuarial Analysis of Breast Cancer Screening and Follow-on Diagnostics in a Commercially Insured Population.(2014).Millman, Inc., NY. http://www.milliman.com/uploadedFiles/insight/2014/actuarial-analysis-breast-cancer-screening.pdf

3.U.S. Breast Cancer Statistics | Breastcancer.org. (2016). Breastcancer.org. http://www.breastcancer.org/symptoms/understand_bc/statistics SOURCE Seno Medical Instruments, Inc. Related Links http://www.senomedical.com

Seno Medical Instruments to Present Updated Data from Pivotal European Study at 2016 San Antonio Breast Cancer Symposium

SAN ANTONIO, Dec. 5, 2016 — Seno Medical Instruments, Inc., the company pioneering the development of opto-acoustic technology as a new tool to improve the process of diagnosing breast cancer, today announced that it will present data from its European MAESTRO post-market surveillance and clinical follow-up study at the 2016 San Antonio Breast Cancer Symposium (SABCS) taking place from December 6-10, 2016 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

Seno Medical Instruments will present two poster presentations on Friday, December 9:

Breast Biopsy Histology Relationships with Opto-Acoustic Imaging of Breast Masses, Poster Session 4, 7:30 a.m. – 9:00 a.m. CST, Hall 1
Opto-Acoustic Imaging of the Breast: Downclassification and Upclassification of Suspicious Breast Masses, Poster Session 4, 7:30 a.m. – 9:00 a.m. CST, Hall 1
Thomas Stavros, MD, FACR, FSRU, FRANZCR, Medical Director of Seno Medical Instruments, will present the histological analysis on behalf of Marc van de Vijver, MD, PhD, Department of Pathology at the Netherlands Cancer Institute, Amsterdam, while the MAESTRO study’s principal investigator, Ruud Pijnappel, MD, PhD, Radiologist, University Medical Center, Utrecht, NL, will present the opto-acoustic imaging downclassification and upclassifciation data.

“The Imagio™ breast imaging system represents a significant advance to improve the diagnoses of breast cancer by helping to determine the appropriate classification of breast masses,” said Thomas Stavros, MD and Medical Director of SENO Medical. “The presentation of the histological data will be of particular interest to the oncology community as it will identify a correlation between the opto-acoustic imaging findings and histologic grade of the breast masses.”

“We believe the new data from the MAESTRO study will provide additional clinical evidence to validate our Imagio™opto-acoustic breast imaging system and allow radiologists to make more precise and accurate diagnoses when assessing suspicious breast masses in patients,” said Tom Umbel, CEO of Seno Medical Instruments.

Seno Medical Instruments expects to announce the final results from the MAESTRO study in early 2017. Results from the PIONEER study – the company’s U.S. trial of more than 2,000 patients — are expected to be announced in the second half of 2017.

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 http://www.SenoMedical.com.

About the San Antonio Breast Cancer Symposium

The San Antonio Breast Cancer Symposium is an international symposium directed primarily towards academic and private physicians and researchers involved in breast cancer in medical, surgical, gynecologic, and radiation oncology, as well as other appropriate health care professionals. Approximately 7,500 attendees from more than 90 countries are expected to attend.

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. Additionally, there are over 1.6 million biopsies performed annually and recent reported data noted an 81% “false positive” rate of biopsy procedures – the portion of biopsies that do not lead to breast cancer surgery. 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.

Media Contact

Erich Sandoval
Lazar Partners Ltd.
Tel: +1 213-908-6226
Email: esandoval@lazarpartners.com

1 J Womens Health, September 2014, Vol. 23:S1,
2 An Actuarial Analysis of Breast Cancer Screening and Follow-on Diagnostics in a Commercially Insured
3 Population.(2014).Millman, Inc., NY. http://www.milliman.com/uploadedFiles/insight/2014/actuarial-analysis-breast-cancer-screening.pdf
4 U.S. Breast Cancer Statistics | Breastcancer.org. (2016). Breastcancer.org. http://www.breastcancer.org/symptoms/understand_bc/statistics

SOURCE Seno Medical Instruments, Inc.

Related Links
http://www.senomedical.com

New Interim Results Support Imagio™ Opto-acoustic (OA) Breast Imaging System’s

Potential to Reduce Negative Biopsies

SAN ANTONIO, Sept. 24, 2016 — Seno Medical Instruments, Inc. (Seno), the company pioneering the development of opto-acoustic technology as a tool to improve the process of diagnosing breast cancer, announced today interim results from the company’s multicenter, European MAESTRO post-market surveillance and clinical follow-up study.  The results demonstrate the potential of its Imagio™ opto-acoustic (OA)   breast imaging system to provide physicians with vital information needed to determine whether or not a suspicious mass is cancerous, with the goal of reducing the rate of negative biopsies. The data were presented at a clinical symposium at the Annual Scientific Meeting of the European Society of Breast Imaging (EUSOBI), the second largest conference in the world dedicated to breast cancer imaging, on September 24, 2016 in Paris.

“The interim results from MAESTRO add to the growing body of clinical evidence showing that the Imagio™ opto-acoustic diagnostic tool increases physicians’ confidence when differentiating and classifying malignant and benign breast tissue,” said the study’s principal investigator Ruud Pijnappel, MD, PhD, Radiologist, University Medical Center, Utrecht, NL, who presented the interim analysis. “The improved accuracy that is possible with this technology could help women avoid painful biopsy procedures that sometimes follow false-positive diagnoses.”

There are over 1.6 million biopsies performed annually[1] and recent reported data noted an 81% “false positive” rate of biopsy procedures – the portion of biopsies that do not lead to breast cancer surgery.[2]   Seno’s Imagio™ breast imaging system, which received its CE Mark in 2014, has the potential to reduce negative biopsies by 43%. Seno Medical is targeting their PMA submission for the Imagio™ system to the U.S Food and Drug Administration by the end of 2016.

MAESTRO, a controlled, multi-center, observational, post-market surveillance and clinical follow-up study, was designed to assess the diagnostic value (specificity and sensitivity) of Opto-Acoustics to conventional diagnostic ultrasound (CDU) in suspicious masses classified as BI-RADS 4a and 4b. Investigators first performed CDU to reach a diagnosis and decision to biopsy followed by an Imagio™ OA examination. Two hundred female subjects with undiagnosed suspicious masses enrolled in the study.

The interim analysis of 78 subjects found that following the use of Imagio™ system, radiologists downgraded BI-RADS categories of the internal ultrasound control-classified BI-RADS 4a masses to BI-RADS 3 or 2 in 75% of cases, and BI-RADS 4b masses to either BI-RADS 3 or 2 in 37.5% of cases. The interim results also showed that Imagio™ OA also increased specificity to over 43%, with no significant loss in sensitivity. Importantly, clinicians were able to reduce the rate of false-positive diagnoses by 20% for the last 48 subjects evaluated in the study.

“The interim results of the MAESTRO study are promising and could help physicians reliably and safely assess suspicious masses to deliver optimal treatment for each patient,” said Tom Umbel, CEO of Seno Medical Instruments. “We look forward to the delivery of the first Imagio™ OA/US systems in the Netherlands, UK and Germany early next year.”

Final results from the MAESTRO study are expected to be announced in early 2017. Enrollment for a U.S. trial of more than 2,000 patients has been completed and results will be announced in the latter half of 2017.

Seno’s Imagio™ system co-registers and fuses opto-acoustics, a technology based on “light-in and sound-out,” with diagnostic ultrasound – (OA/US). The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Cancerous tumors grow relatively quickly and require significant amounts of blood and oxygen, so a network of blood vessels grows around cancerous masses. Imagio™ OA/US breast imaging system provides real-time images of these networks and a map of relative oxygen-rich or oxygen-depleted blood. Unlike other functional fusion technologies, Imagio™ o uses no x-rays (ionizing radiation) or injectable contrast agents or radio-isotopes to obtain its information, thereby reducing the patient’s exposure to any potentially harmful aspects of imaging.

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

About EUSOBI Annual Scientific Meeting

The EUSOBI Annual Scientific Meeting consists of plenary lectures, workshops, symposia, poster sessions and technical exhibitions.  The conference attracted renowned international speakers who shared their latest information and perspectives on emerging technologies in the breast cancer imaging space.

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.[3]

SOURCE Seno Medical Instruments, Inc.

[1] J Womens Health, September 2014, Vol. 23:S1,

[2] An Actuarial Analysis of Breast Cancer Screening and Follow-on Diagnostics in a Commercially Insured Population.(2014).Millman, Inc., NY. http://www.milliman.com/uploadedFiles/insight/2014/actuarial-analysis-breast-cancer-screening.pdf

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