Press Releases

SAN ANTONIO, TEXAS – April 10, 2014 – 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, announced today that it has received the CE Mark for Imagio®, a new opto-acoustic imaging system, in Europe. Seno is in the middle of its Pivotal Study whose purpose is to determine if this technology will provide new information to the physician to decide if a woman may avoid negative (unnecessary) biopsies.

“I am very pleased that we have achieved this important milestone for Seno,” said Seno CEO, Janet Campbell. “Experts recently presented data from the Imagio feasibility study at the European Congress of Radiology in Vienna, and it was enthusiastically received by European key opinion leaders. The CE Mark means we can now commercialize this important new breast imaging system in Europe and gives us the opportunity to continue developing our relationships with physicians and regulators in the EU.”

Seno’s Imagio fuses opto-acoustics, a technology based on “light-in and sound-out,” with traditional ultrasound. 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 provides images of these networks and a map of relative oxygen-rich or oxygen-deprived blood. Radiologists believe that Imagio images depicting significant vascular structures and low oxygen levels are likely to indicate cancers. Unlike other functional fusion technologies, Imagio uses no x-rays (ionizing radiation) or injectable contrast agents to obtain its information, thereby reducing the patient’s exposure to any potentially harmful aspects of imaging.

In 2012, The European Journal of Cancer estimated that 464,000 new cases of breast cancer were diagnosed in Europe. Each year millions of women around the world undergo core needle or surgical breast biopsies after a suspicious mass is found through breast imaging or self-exams. Studies show that more than 80% of these biopsies reveal benign pathology after they are analyzed in a laboratory.

The Imagio Pivotal Study is ongoing in the U.S. and includes 16 leading hospitals and imaging centers throughout the country. The study will form the basis of the company’s pre-market approval application (PMA) to seek U.S. approval from the U.S. Food and Drug Administration (FDA).

VIENNA, AUSTRIA – March 10, 2014 – Seno Medical Instruments, Inc., the company pioneering development of opto-acoustic (OA) imaging as a tool to improve the process of diagnosing breast cancer, today announced that two analyses of outcomes from a U.S. Feasibility Study of its investigational Imagio™ breast imaging device were presented at the annual meeting of the European Congress of Radiology 2014.

The first statistical analysis is of the Feasibility Study data (Abstract C-0926), suggests that information from Imagio™ may have the potential to achieve clinically-meaningful sensitivity and specificity for breast cancer beyond those achievable with traditional, standalone diagnostic ultrasound. This will be verified in the ongoing U.S. Pivotal Study which has already enrolled more than half of the 2,000 subject target. Imagio™ may be a useful tool to help physicians reduce the need for biopsy in patients with benign but suspicious appearing breast masses on conventional diagnostic breast ultrasound.

“We are encouraged by these findings, which demonstrate the biopsy-sparing potential of Imagio™,” said Thomas Stavros, MD, FACR, FSRU, FRANZCR, Medical Director, Seno Medical Instruments. “While surgical and core needle biopsies are considered the gold standard for breast cancer diagnosis, biopsies are the most expensive part of the diagnostic process and over 80% of U.S. biopsies are negative. Imagio™ has the potential to contribute to the way that breast cancer is diagnosed and to optimize the decision to biopsy.”

The second statistical analysis is of pre-defined histopathology findings relative to the specific features of benign and malignant lesions. This information was captured in the Imagio™ opto-acoustic images during the Feasibility Study. It suggests that Imagio™ may have the potential to provide additional information that could help clinicians grade the aggressiveness of cancerous breast tumors during the imaging phase of a woman’s diagnostic work-up, which will also be verified in the ongoing Pivotal Study.

Separate analysis of the feasibility data showed that OA findings could potentially correlate with molecular subtypes of breast cancer (Abstract C-1528). “If confirmed in a larger series of breast cancer patients, this analysis suggests that OA findings might be useful in differentiating and monitoring early response to medical oncologic treatments,” said lead biostatistician Philip Lavin, PhD, FASA, FRAPS, who is a consultant to Seno Medical Instruments. “Our ongoing Pivotal Study will continue to elucidate the potential Imagio™ may have in both classifying breast masses and determining molecular subtypes.”

Imagio™ fuses an imaging technology based on light-in and sound-out called “opto-acoustics” with traditional ultrasound. The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Unlike other imaging modalities, Imagio™ doesn’t expose patients to potentially harmful ionizing radiation (x-rays) or injectable contrast agents.

Each year in the U.S. 1.7 million women undergo core needle or surgical breast biopsies after a suspicious mass is found through breast imaging or self-exams. However, more than 80% of these biopsies reveal benign pathology .

About the European Congress of Radiology (ECR)

The European Congress of Radiology (ECR) represents the medical specialty of radiology throughout Europe and the Mediterranean. The ECR comprises a Congress Committee, a Programme Planning Committee, and 17 Scientific Subcommittees. The next ECR congress will be held from March 5–9, 2015, in Vienna, Austria.

SAN ANTONIO, TEXAS – February 25, 2014 – Seno Medical Instruments, Inc., the company pioneering opto-acoustic imaging as a tool to improve the process of diagnosing breast cancer, today announced that it has sold $34.6 million of a $39 million Series C equity funding round from existing investors with the lead investment from MedCare Investment Funds.

The new funding will support Seno’s ongoing U.S. Pivotal Study of the Imagio® breast imaging device, as well as activities to obtain the CE Mark in Europe, which the company seeks to receive by the end of the first quarter of 2014. There are currently 16 leading hospitals and imaging centers throughout the U.S. enrolling patients in the Imagio Pivotal Study.

“We believe Seno Medical’s opto-acoustic imaging platform has the potential to answer a significant unmet need in the diagnosis of breast cancer,” said Harry Jacobsen, M.D., Chairman of MedCare Investment Funds. “Breast biopsies, the current standard of care for diagnosing or ruling out cancer, are the most expensive part of the breast cancer diagnostic process. By providing a real-time blood map co-registered with ultrasound images, we believe that opto-acoustics can provide radiologists more information than ever before to help them confidently rule out cancer so that fewer women with benign lesions will have to undergo biopsies and the worry that can come from the process. We look forward to seeing the results of the company’s ongoing Pivotal Study.”

Imagio fuses an imaging technology based on light-in and sound-out called “opto-acoustics” with conventional ultrasound. The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Unlike other imaging modalities, Imagio doesn’t expose patients to potentially harmful ionizing radiation (x-rays) or injectable contrast agents.

“We owe MedCare and our other loyal investors so much gratitude for their years of support as we have worked towards our goal of offering women a more effective, safe diagnostic imaging option for breast cancer,” said Janet Campbell, CEO of Seno Medical Instruments. “We currently have all 16 of the sites in the Imagio Pivotal Study enrolling subjects and currently over half have been enrolled. In the meantime, we are actively seeking our CE Mark clearance, which we expect sometime during the first quarter of 2014.”

Each year in the U.S. 1.7 million women undergo core needle or surgical breast biopsies after a suspicious mass is found through breast imaging or self-exams. However, up to four out of five of these biopsies reveal benign pathology.

SAN ANTONIO, TEXAS – December 17, 2013 – Seno Medical Instruments, Inc., the company pioneering opto-acoustic imaging as a tool to improve the process of diagnosing breast cancer, today announced new statistical analysis of outcomes from a Feasibility Study of its investigational Imagio™ breast imaging device.

The analysis of data from the Feasibility Study, presented at the San Antonio Breast Cancer Symposium (SABCS) 2013 (Abstract P4-01-14) on December 13, 2013, suggests that information from Imagio may have the potential to achieve clinically-meaningful sensitivity and specificity for breast cancer beyond those achievable with traditional, standalone diagnostic ultrasound. If confirmed in a larger Pivotal Study – currently underway in the U.S. – Imagio may be a useful tool to help physicians rule out the need for a biopsy in patients with benign breast masses.

“These preliminary findings are encouraging and may support the biopsy-sparing potential of Imagio,” said lead biostatistician Philip Lavin, PhD, FASA, FRAPS, who is a consultant to Seno Medical Instruments. “Surgical and core needle biopsies are considered the gold standard for breast cancer diagnosis, yet are the most expensive part of the diagnostic process. While existing breast imaging technologies are successful at positively identifying cancerous masses, it is very difficult to rule out cancer during the imaging phase and a large majority of biopsies come back negative for cancer.”

This new statistical analysis of various features of benign and malignant lesions captured in the Imagio opto-acoustic images during the Feasibility Study also suggests that Imagio may have the potential to provide additional information that could help clinicians grade the aggressiveness of cancerous breast tumors during the imaging phase of a woman’s diagnosis, if verified in the ongoing Pivotal Study.

Imagio combines an imaging technology based on light-in and sound-out called “opto-acoustics” with traditional ultrasound. The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Unlike other imaging modalities, Imagio doesn’t expose patients to potentially harmful ionizing radiation (x-rays) or injectable contrast agents.

For this study, proposed classification guidelines were developed to help identify features that differentiate images of benign and cancerous lesions, as well as the aggressiveness of the tumor. To develop the proposed classification guidelines, images of each tumor were assessed using three internal and two external features, which were scored on an ordinal scale from zero to five. The results were then summed to get a total internal score, total external score, and a total score. These results were then analyzed with five statistical classification methods.

“We are encouraged to see a high correlation between pathology results and classified features of masses captured in Imagio opto-acoustic images as part of this Feasibility Study,” said Thomas Stavros, MD, FACR, FSRU, FRANZCR, Medical Director, Seno Medical Instruments. “Our ongoing Pivotal Study will hopefully provide evidence to confirm our hypothesis and this early data.”

Each year in the U.S. 1.7 million women undergo core needle or surgical breast biopsies after a suspicious mass is found through breast imaging or self-exams. However, up to four out of five of these biopsies reveal benign pathology .

About San Antonio Breast Cancer Symposium (SABCS)

For thirty-six years, the Symposium’s mission has been to provide state-of-the-art information on breast cancer research. From a one-day regional conference, the Symposium has grown to a five-day program attended by a broad international audience of academic and private researchers and physicians from over 90 countries. The Symposium aims to achieve a balance of clinical, translational, and basic research, providing a forum for interaction, communication, and education for a broad spectrum of researchers, health professionals, and those with a special interest in breast cancer.

CHICAGO, ILLINOIS – December 4, 2013 – Seno Medical Instruments, Inc., the company pioneering opto-acoustic imaging as a tool to improve the process of diagnosing breast cancer, today announced preliminary information from a feasibility study of its Imagio™ breast imaging device. Results from the feasibility study suggest that information from Imagio, beyond that available from traditional breast ultrasound, may be helpful in assisting physicians in their decisions whether to recommend biopsies for women with suspicious breast masses. The data were presented at the annual meeting of the Radiological Society of America (RSNA), which concludes here this Friday.

Imagio combines an imaging technology based on light-in and sound-out called “opto-acoustics” with traditional ultrasound. The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Unlike other imaging modalities, Imagio doesn’t expose patients to potentially harmful ionizing radiation (x-rays) or injectable contrast agents.

“Given these early results, I believe that opto-acoustics could potentially spare some BI-RADS 4a cases and some BI-RADS 4b cases from needing to undergo biopsies,” said study investigator Kenneth Kist, M.D., Associate Professor of Radiology at UT Health Science Center in San Antonio, Texas. “This could represent a significant advance in the diagnostic path for breast cancer and I look forward to seeing the results of the ongoing U.S. Pivotal Study.”

The BI-RADS classification is used by radiologists to predict the probability of malignancy of a breast mass based on imaging results. A BI-RADS 3 mass only carries up to a 2% chance of being cancerous. Patients with masses in the BI-RADS 3 category can safely wait to see if the mass changes or grows. A BI-RADS 4a mass is considered to have more than a 2% but less than or equal to 10% chance of being cancerous, and a BI-RADS 4b mass is considered to carry from greater than 10% to less than or equal to 50% risk of malignancy. Patients whose masses are deemed BI-RADS 4a or higher will almost always undergo a core needle or surgical biopsy.

For this study (Abstract LL-BRS-WE5B), five blinded readers independently assessed Imagio images from 73 patients with 74 breast masses. All of the masses were biopsied to provide a gold-standard comparator. Readers were blinded to the subjects’ medical history, biopsy report, histology report, clinical records and follow-up. All 34 detected cancer masses remained at their original BI-RADS classification.

In the 40 remaining benign masses, downgrades to BI-RADS 3 were achieved in 12 of 22 original BI-RADS 4a diagnoses as a result of opto-acoustics. Three of 13 BI-RADS 4b masses were downgraded to BI-RADS 3.

Each year in the U.S. 1.7 million women undergo core needle or surgical breast biopsies after a suspicious mass is found through breast imaging or self-exams. However, up to four out of five of these biopsies reveal benign pathology.

A separate electronic exhibit (Abstract LL-BRE2487) providing an overview of opto-acoustic technology was also displayed throughout the meeting.

“These early results underscore the potential of opto-acoustic imaging technology which we believe represents a significant step forward in cancer diagnosis,” said Thomas Stavros, MD, FACR, FSRU, FRANZCR, Medical Director, Seno Medical Instruments. “This feasibility study shows that Imagio has potential to lead to better outcomes for women and fewer biopsies. We are working diligently with 16 leading breast imaging centers across the U.S. to complete our Imagio Pivotal Study that will form the basis of our Premarket Approval Application with the U.S. Food and Drug Administration.”

About the Radiological Society of North America(RSNA)

The Radiological Society of North America (RSNA®) is an international society of radiologists, medical physicists and other medical professionals with more than 51,000 members from 136 countries across the globe. RSNA hosts the world’s premier radiology forum, drawing approximately 55,000 attendees annually to McCormick Place in Chicago, and publishes two top peer-reviewed journals: Radiology, the highest-impact scientific journal in the field, and RadioGraphics, the only journal dedicated to continuing education in radiology. www.rsna.org

SAN ANTONIO, TEXAS – November 25, 2013 – Seno Medical Instruments, Inc., the company pioneering opto-acoustic imaging as a tool to improve the diagnosis of cancer, announced today that the first 100 patients have been enrolled into its Pivotal Study of Imagio™, a new opto-acoustic imaging system that may help women with benign breast masses avoid negative, invasive biopsies.

Each year in the U.S. 1.7 million women undergo core needle or surgical breast biopsies after a suspicious mass is found through screening mammograms or self-exams and a series of diagnostic imaging tests are performed. However, four out of five of these biopsies reveal benign pathology.

Imagio™ combines traditional ultrasound with an imaging technology based on light in and sound out called “opto-acoustics.” The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Unlike other imaging modalities, Imagio™ doesn’t expose patients to potentially harmful ionizing radiation (x-rays) or injectable contrast agents.

“Although breast cancer is one of the most prevalent causes of death in women, the tools used to diagnose this disease have certain limitations that can make the process intrusive, costly and potentially harmful to patients,” said Thomas Stavros, M.D., Medical Director, Seno Medical Instruments. “Breast biopsies, the current standard of care for diagnosing or ruling out cancer, are the most expensive part of the breast cancer diagnostic process. By providing a real-time blood map co-registered with ultrasound images, we believe that opto-acoustics can provide radiologists more information than ever before to help them confidently rule out cancer so that fewer women with benign lesions will have to undergo biopsies and the worry that can come from the process.”

Because cancerous tumors grow relatively quickly, they require significant amounts of blood and oxygen, so a network of blood vessels grows around cancerous masses. Imagio™ provides images of these networks and a map of oxygen-rich or oxygen-deprived blood. Radiologists believe that Imagio™ images depicting significant vascular structures and low oxygen levels are likely to indicate cancer.

The Imagio™ Pivotal Study will include 16 leading hospitals and imaging centers throughout the United States.

“Scanning the first 100 patients and starting the active enrollment phase is an important milestone for us in our mission to deliver a new standard in breast cancer diagnosis,” said Janet Campbell, CEO of Seno Medical Instruments. “We believe Imagio™ can offer a better diagnostic alternative for women who have suspicious breast masses, and can help physicians more confidently rule out cancer with a less invasive test. Based on conversations with some of the top minds in radiology, we are encouraged that this new modality could have a significant impact breast cancer diagnosis.”

The American Cancer Society estimates that there were more than 2.9 million women with a history of invasive breast cancer living in the U.S. in 2012, with 226,870 of them diagnosed during the year.