Press Releases

SAN ANTONIO, August, 8 2016 – Seno Medical Instruments, Inc., the leader in improving the process of diagnosing breast cancer through the development of an opto-acoustic (OA) imaging device, today announced the appointment of Eric Davis as Chief Financial Officer.  Mr. Davis previously served as the Chief Financial Officer and Corporate Treasurer at CeloNova BioSciences, Inc.  Mr. Davis brings more than 20 years of financial and operational leadership with extensive domestic and international experiences.

“Eric is an accomplished financial executive with significant accounting and operational proficiencies, and will be an exceptional addition to our team,” said Tom Umbel, CEO of Seno Medical.  “Eric brings global business and healthcare finance and accounting experience, which is invaluable in our preparation to launch our products and services in Europe next year.”

During his tenure at CeloNova, a medical device manufacturing company in San Antonio, Mr. Davis was responsible for global finance/accounting, treasury and investor relations in 58 different countries.  Prior to that, Mr. Davis was the CFO and Operating Officer at Genesis Networks Enterprises, LLC where he led finance and accounting operations of a $1 billion network integrations and supply chain management company.  He has extensive experience in securing investments, improving EBITDA, and implementing quality processes to improve margins.  Mr. Davis has his Masters of Science in Finance from Madison University and a BS in Business Administration in Management from University of Tulsa.

“It’s truly an exciting opportunity to join an innovative company like Seno Medical, especially at this juncture in their product life cycle,” said Mr. Davis. “The commitment by this passionate team and the company’s novel technology to improve cancer diagnosis non-invasively and without additional ionizing radiation, make it an exciting time to join such a dynamic organization.”

The Imagio^® OA breast imaging system was designed to facilitate the identification of 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 the Imagio system is non-invasive and does not require patient exposure to contrast agents, ionizing radiation (x-ray) or radio-isotopes, which are required for other modalities that are capable of functional imaging, including magnetic resonance imaging (MRI) or positron emission tomography (PET).

SAN ANTONIO, August 1 , 2016 – Seno Medical Instruments, Inc., the leader in improving the process of diagnosing breast cancer through the development of an opto-acoustic (OA) imaging device, today announced the appointment of Tammy Garcia as Senior Vice President of Sales & Marketing.  Ms. Garcia previously served as the General Manager, Breast Imaging for GE Healthcare.  Ms. Garcia brings more than 25 years of commercial and marketing leadership in medical devices and diagnostic imaging with a significant part of her passion and career focused on women’s health and improving cancer detection.

“Tammy’s track record of success in commercializing new technologies will be invaluable as we move closer to bringing the Imagio™ breast imaging system to market,” said Tom Umbel, CEO of Seno Medical.    “We are very excited for Tammy to join our company as we prepare to launch our products in Europe early in 2017.”

During her 13-year tenure at GE Healthcare, Ms. Garcia held several leadership roles where she established commercial teams focused on double-digit growth in Orthopedics and Breast Imaging.  Additionally, Ms. Garcia led the sales and marketing efforts in the launches of disruptive technologies with MAKO Surgical, an orthopedic robotic device and implant company, and InSightec, a magnetic resonance imaging (MRI) guided focused ultrasound non-invasive surgical therapy company.  Ms. Garcia has an MBA from University of Phoenix, Phoenix, AZ.

“I am thrilled to be joining the Seno Medical family–the creators of the revolutionary Imagio™ breast imaging system,” said Ms. Garcia.  “The Imagio™ opto-acoustic technology fuses functional and anatomical information real time, with the ultimate goal of improving the accuracy of cancer diagnosis non-invasively.  This novel technology has the potential to give clinicians another tool in their arsenal to analyze a breast lesion, co-registering the functional/metabolic information with sonographic images.  We believe this will provide the radiologist with more confidence to rule out malignancy without exposing patients to additional radiation.  I can’t wait to further expand this technology in Europe and eventually introduce this technology to patients and clinicians in the United States.”

The Imagio™ OA breast imaging system was designed to facilitate the identification of 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 the Imagio™ system is non-invasive and does not require patient exposure to contrast agents, ionizing radiation (x-ray) or radio-isotopes, which are required for other modalities that are capable of functional imaging, including MRI or positron emission tomography (PET).

SAN ANTONIO, Feb. 1, 2016 /PRNewswire/ — Seno Medical Instruments, Inc., the leader in improving the process of diagnosing breast cancer through the development of an opto-acoustic (OA) device, today announced the appointment of Tom Umbel as Chief Executive Officer. Mr. Umbel previously served as the Vice President of Business Development for Bioventus, a privately held ortho-biologics company. Mr. Umbel brings more than 30 years of medical device and diagnostic leadership experience to the company, including extensive expertise in advancing solutions for women’s health. Mr. Umbel takes the helm from Tom Miller, Seno Medical’s President, who was serving as interim CEO following the departure of founder Janet Campbell.

“Tom is an acknowledged leader in the medical device industry with a strong track record in women’s health and diagnostic imaging,” said Dr. Harry Jacobson, Chairman of MedCare Investment Funds. “Tom’s track record of success in commercializing imaging technologies will be invaluable as we move closer to bringing the Imagio™ breast imaging system to market.”

Mr. Umbel was a key executive at Hologic, the largest dedicated women’s health company in the U.S. During his 15-year tenure he helped Hologic grow from a small, single-product company with $100 million in revenue to a large diversified company with more than $2.5 billion in sales. Prior to Hologic, Mr. Umbel was President of Direct Radiography Corp., where he led the development and commercialization of digital x-ray detector technology, which was sold to Hologic and became the core product for Hologic’s market-leading digital mammography system. Mr. Umbel has also held senior management positions at Sterling Diagnostic Imaging and DuPont. He earned a Bachelor of Science degree in Chemical Engineering from Grove City College in Pennsylvania.

“I am enthusiastic to be joining Seno at this time and have the opportunity to help deliver to clinicians and patients a tool that will allow for more precise and earlier diagnosis of breast cancer,” said Mr. Umbel. “The team at Seno has done a tremendous job developing this innovative opto-acoustic technology. This technology has the potential to provide clinicians with the information needed to determine whether a suspicious breast mass is malignant or not, while potentially helping patients avoid undergoing negative biopsy procedures. I am confident that we have the pieces in place to bring this non-invasive method for diagnosing breast cancer to market.”

The Imagio™ OA 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 the Imagio™ system is non-invasive and does not require patient exposure to contrast agents, ionizing radiation (x-ray) or radio-isotopes, which are required for other modalities that are capable of functional imaging, including magnetic resonance imaging (MRI) or positron emission tomography (PET).

SAN ANTONIO, Nov. 3, 2014 /PRNewswire/ — 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 that the use of the Seno Imagio breast imaging system and the associated predictive model appear to have the potential to significantly improve the physicians’ ability to accurately rule out breast cancer compared to traditional ultrasound alone.

“Diagnostic specificity, or the ability to accurately identify benign masses, remains disappointingly low for imaging methodologies optimized to identify all cancerous lesions with near 100% sensitivity,” said A. Thomas Stavros, MD, Medical Director, Seno Medical Instruments. “We believe that by training Imagio readers with this real-time predictive model, they may be able to accurately reclassify benign breast lesions to a lower BI-RADS score so the patient can confidently avoid a biopsy on benign masses. If confirmed by Seno’s prospective, multicenter PIONEER Pivotal Study of Imagio, the predictive model may improve the image reader’s ability to accurately characterize solid breast masses as cancerous or benign and to spare women with benign lesions from the biopsy process beyond the standard-of-care today.”

The predictive model is based on key opto-acoustic features of breast masses obtained by Imagio during a 79 subject pilot study. Seno completed active enrollment of 2,100 subjects in the U.S.-based PIONEER study in September. The results of the study will serve as the basis for the company’s Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA).

Dr. Stavros presented results of the parallel reader study, which was designed to prospectively test the predictive model, at the 18th SIS World Congress on Breast Healthcare. The meeting, hosted by the American Society of Breast Disease and by the Senologic International Society, took place in Orlando, Fla. from October 16 to 19, 2014.

To develop the real-time predictive model, an expert radiologist blinded to histologic outcomes evaluated traditional diagnostic breast ultrasound and the 5 different Imagio opto-acoustic features of 79 masses (41 benign, 38 cancer) classified BI-RADS 4 prior to biopsy. Linear regression was used to model and predict the probability of malignancy, while logistic regression was used to model and to predict whether a mass was benign or malignant.

Three independent radiologist readers analyzed the gray scale ultrasound images and assigned BI-RADS categories and percentage risk of malignancy (POM) to each mass. They then scored the 5 individual Imagio opto-acoustic features and assigned BI-RADS categories and POM to each mass based upon OA without the predictive model applied. Finally, the readers repeated the Imagio OA feature analysis and assignment of BI-RADS category and POM with the aid of the predictive model. All three independent radiologists identified all of the cancerous lesions with Imagio images, generating 100% sensitivity across all readers, while one cancer was missed on gray scale ultrasound. With Imagio OA without the predictive model the IRs achieved 11%, 24%, and 25% better specificity than with conventional gray scale ultrasound. With the predictive model added, each independent radiologist was able to improve his/her ability to accurately classify a suspicious breast mass as benign by 28%, 36% and 38% achieving better specificity than with conventional gray scale ultrasound, respectively. Incremental improvements in specificity attributable to the predictive model (over subjective assignment) were 17%, 12%, and 13%.

“We are dedicated to improving the standard care for women after a suspicious mass is identified in one of their breasts. This new predictive model showed the increased potential of opto-acoustic images to help physicians confidently classify breast masses as benign, possibly eliminating the need for biopsies on certain breast masses,” said CEO Janet Campbell. “We are completing the follow-up of all subjects who participated in our U.S. pivotal study and will submit these additional promising data sets to the FDA as part of Seno’s PMA data package.”

Imagio was designed to identify two functional hallmarks of a potential malignancy: the presence of abnormal blood vessels (angiogenesis) and the relative reduction in oxygen content of hemoglobin. The technology is non-invasive and does not require contrast agents or radio-isotopes, which are required for other modalities such as magnetic resonance imaging (MRI) or positron emission tomography (PET), nor does it use ionizing radiation (x-ray).

According to the American Cancer Society’s estimates, 232,340 new cases of invasive breast cancer and an additional 64,640 cases of in situ breast cancer were diagnosed and approximately 39,620 women in the U.S. died from the disease during 2013. Only lung cancer accounts for more cancer deaths in women.

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 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 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 chemotherapy or hormonal treatments of breast cancer. To learn more about Seno Medical’s opto-acoustic imaging technology and applications, visit www.SenoMedical.com

SAN ANTONIO, Oct. 23, 2014 /PRNewswire/ — 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 Janet Campbell-Clark, Chief Executive Officer, will be presenting a corporate overview at the Cleveland Clinic’s 2014 Medical Innovation Summit to be held October 26-29 in Cleveland, OH.

The presentation will take place on October 29 at 8:00 am ET at the Cleveland Convention Center in Room 26.

About the Cleveland Clinic’s 12th Annual Medical Innovation Summit

The summit will convene over 1,500 great thinkers and leaders for a candid exchange on new medical technology, its future, recent breakthroughs and continuing challenges.

The Trout Group [www.troutgroup.com] has teamed up with The Cleveland Clinic to create Ground Waves – an exciting two day showcase that will present a wide array of companies making waves in cancer treatment and personalized medicine. The Summit is renowned for thought-provoking panels, lively 1-on-1 discussions with influential CEOs, and the discovery of the latest market-ready technologies poised to shake up the status quo.

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 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 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 chemotherapy or hormonal treatments of breast cancer. To learn more about Seno Medical’s opto-acoustic imaging technology and applications, visit www.SenoMedical.com

Medical Innovation Summit Contacts
Lee M. Stern / lstern@troutgroup.com
Emily Present / epresent@troutgroup.com

SAN ANTONIO, TX – September 23, 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 it has completed active enrollment of subjects in its U.S.-based PIONEER Pivotal Study of Imagio™. The study was designed to determine if this technology will provide information to the physician to determine if a woman may avoid negative biopsies. This information will serve as the basis for the company’s Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA). “There is a significant unmet medical need for more accurate diagnostic imaging technologies to help physicians confirm and rule out breast cancer before the patient has to undergo an invasive procedure. More information at the imaging stage could help us make more informed decisions regarding whether we should send the patient for a surgical or needle biopsy,” said Reni Butler, MD, Assistant Professor of Diagnostic Radiology at the Yale School of Medicine in New Haven, Conn. and the co-principal investigator for the study.

Imagio™ was designed to identify two functional hallmarks of a potential malignancy: the presence of abnormal blood vessels (angiogenesis) and the relative reduction in oxygen content of hemoglobin. The technology is non-invasive and does not require contrast agents or radio-isotopes, which are required for other modalities such as magnetic resonance imaging (MRI) or positron emission tomography (PET), nor does it use ionizing radiation (x-ray).

“Earlier data from a feasibility study of Imagio™ led to encouraging results and we look forward to seeing the outcomes from this pivotal study. If the results are consistent with the earlier, smaller studies, we believe this could be an important new technology to help improve the diagnosis of breast cancer and allow many women with benign lesions to have short-interval Imagio™ follow-up and avoid a biopsy,” said co-principal investigator Erin Neuschler, MD, Northwestern Medicine® Radiologist and Assistant Professor of Radiology at Northwestern University Feinberg School of Medicine in Chicago.

The Imagio™ study was conducted in 16 leading institutions throughout the U.S. with more than 2,100 subjects enrolled. The study was designed to measure the sensitivity and specificity of Imagio™ compared to Imagio™ grayscale ultrasound imaging in breast lesions using the probability of malignancy (POM). Subjects who enrolled in the study underwent a traditional ultrasound and an Imagio™ scan. Physicians only used traditional ultrasound findings to determine if the subject should advance to the biopsy phase. The Imagio™ results were later interpreted by an independent reader panel. Subjects who had a negative diagnostic ultrasound will be re-evaluated 12 months after their initial examination to confirm the negative results as a true negative.

“Completing active enrollment is a significant milestone in Seno’s efforts to commercialize Imagio™. We developed Imagio™ with the goal of reducing the number of imaging tests and invasive procedures women currently have to undergo to learn if a suspicious breast mass is cancerous or not. We would like to thank our investigators and their dedicated teams for participating in this important study. We hope Imagio™ will have a significant impact on the diagnosis of breast cancer in the future,” said Janet Campbell, CEO of Seno Medical Instruments.

According to the American Cancer Society’s estimates, 232,340 new cases of invasive breast cancer and an additional 64,640 cases of in situ breast cancer were diagnosed and approximately 39,620 women in the U.S. died from the disease during 2013. Only lung cancer accounts for more cancer deaths in women.

Seno’s Imagi™o fuses opto-acoustics, a technology based on “light-in and sound-out,” with diagnostic 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. 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.

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 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 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 chemotherapy or hormonal treatments of breast cancer. To learn more about Seno Medical’s opto-acoustic imaging technology and applications, visit www.SenoMedical.com