Seno Medical said Tuesday it completed the final phase of the pivotal trial of its Imagio opto-acoustic breast imaging platform designed to help prevent unnecessary biopsies.
The Imagio system combines traditional ultrasound with light-based imaging, providing physicians with a closer look at “suspicious” breast masses without subjecting patients to radiation, injectable contrast agents or invasive biopsies.
“In light of the fact that a large majority of biopsies reveal benign pathology, we believe that Imagio could potentially help reduce the number of procedures generated by false positives by providing physicians with more information and thus be more confident in their imaging assessments. Data from prior Seno studies demonstrated Imagio’s potential to achieve clinically-meaningful diagnostic sensitivity and specificity for breast cancer beyond those delivered by traditional, diagnostic ultrasound. It is our hope and belief that the results of this study will confirm these earlier findings,” co-principal investigator Dr. Erin Neuschler of Northwestern University’s Feinberg School of Medicine said in a press release.
The pivotal 2,100-patient Pioneer study is investigating the Imagio’s sensitivity and ability to determine whether suspicious breast masses are cancerous or not and will serve as the basis for the company’s premarket approval application with the FDA, Seno said.
“We started doing basic research with opto-acoustics back in 2005 and it is noteworthy to see this rigorously conducted trial of this technology completed. We await the final analysis now that all of the patients have enrolled in the trial. Based on our clinical experience to date, it appears this breast cancer imaging technology could enhance both the physician and the patient experience by reducing the number of the false positive cases, which we currently face assessing patients with abnormal breast imaging,” principal investigator Dr. Stephen Grobmyer of the Cleveland Clinic said in prepared remarks.
Seno said it plans on releasing data from the Pioneer study at the Radiological Society of North America’s annual meeting in late November.
“We are pleased to have completed the final phase for the Pioneer Study. I would like to thank our sites and readers for their commitment to this important milestone. This represents an important achievement in Seno’s mission to help improve the diagnostic process for breast cancer. This product shows promise for improving the diagnosis of suspicious breast lesions in hundreds of thousands of women across the U.S.,” CEO Tom Miller said in prepared remarks.
Last month, Seno Medical said its founder and CEO Janet Campbell is stepping down from her role to pursue a new role with startup Dominion Medical. The company said Campbell will stay on to advise the company as it hunts for a new CEO.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.