Moncton, New Brunswick and Cambridge, Massachusetts--(Newsfile Corp. - May 5, 2026) - Breathe BioMedical, a company developing a breath analytics platform for early disease detection, today announced the addition of Weinstein Imaging Associates in Pittsburgh, Pennsylvania as a new clinical site in its large multi-center observational collection protocol study to advance the development of its breath test for the early detection of breast cancer in women with dense breasts, as an adjunct to mammography.

Weinstein Imaging Associates, with Dr. Danielle Sharek serving as Site Investigator, will collect breath samples from participants at its Pittsburgh facility. Researchers will compare the breath profiles of women with breast cancer and those without breast cancer, with the goal of identifying disease-specific patterns that can be leveraged to facilitate breast cancer detection.

Weinstein Imaging Associates is a particularly valuable addition to the study due to its focused same-day workflow for women undergoing mammography and requiring biopsy. This clinical setting provides a unique opportunity to demonstrate that Breathe BioMedical's study visit and breath sample collection can be seamlessly accommodated within this type of accelerated care pathway. It also ensures broader representation of women in the study's target population - those with dense breast tissue who are at elevated risk and actively navigating the diagnostic process.

At Weinstein Imaging, we know that the early detection of breast cancer decreases morbidity and mortality. Our goal every day is to detect breast cancers at an early stage. We are excited to take part in Breathe BioMedical's research, as we want to explore any possibility that may improve early detection and advance the care of our patients.

Preliminary analysis of Breathe BioMedical's breast cancer proof-of-concept study found 88.2% accuracy (92.9% sensitivity, 80.0% specificity), in differentiating between the breath signatures of women with early-stage breast cancer, compared to those without breast cancer, irrespective of breast density. This study compares the breath profiles of women from a diverse patient population across a range of demographics and geographic areas to further develop Breathe BioMedical's technology and enhance its machine learning algorithm's capability to differentiate between the breath profiles of women with breast cancer and those without breast cancer. The study will assess sensitivity, specificity, false negative rate and false positive rate.

"It is well understood that mammography alone is insufficient in detecting breast cancer for women with dense breast tissue, creating the need for accurate, accessible and cost-effective adjunctive detection tools," said Bill Dawes, CEO of Breathe BioMedical. "We are pleased to welcome Weinstein Imaging Associates in Pittsburgh as a valued clinical partner in our growing multi-center study. Their expertise in breast imaging makes them an ideal collaborator as we build a diverse and robust dataset to advance our breath-based detection technology."

Approximately 50% of the 70 million women in the U.S. that are eligible for breast cancer screening have dense breast tissue, making them 4 to 5 times more likely to develop breast cancer than women without dense breast tissue. Although mammography is the current gold standard for breast cancer screening, the interpretation of a mammogram can be especially challenging with dense breast tissue, because both tumors and dense breast tissue appear white on a mammogram. Evidence suggests that mammography alone fails to detect breast cancer in 30%-50% of women with dense breast tissue.

About Breathe BioMedical's Technology

Exhaled breath contains chemicals called Volatile Organic Compounds (VOCs). These VOCs are a byproduct of metabolism, travel through the blood stream, and are excreted in breath during alveolar gas exchange in the lungs. These compounds and changes in them can provide insights about the state of an individual's health, environmental exposure, and about how the body reacts to changes that may be a result of disease.

Breathe BioMedical has developed a Breath Sampler that allows individuals to provide a breath sample which can then be analyzed for combinations of biomarkers which may be indicative of disease. The sampler collects alveolar breath stored on industry standard sorbent tubes which are transported to our central laboratory. The sample is then processed using our proprietary Spectrometer, with detection capability to parts per trillion levels, producing a spectrographic data set. The Machine Learning Algorithms (MLA) are applied to the spectrographic data set to identify disease biomarkers and patterns that are associated with breast cancer.

About Breathe BioMedical

Breathe BioMedical is developing an innovative breath analytics platform to enable the early detection of disease. Our proprietary breath analytics technology is designed to collect, process and analyze breath samples to identify biomarker patterns associated with specific diseases. Breathe BioMedical is focused first on developing a breath test for breast cancer detection for women with dense breast tissue, as an adjunct to mammography, with the goal of increasing the number of breast cancer cases identified at the earliest stages. Breathe BioMedical is headquartered in Moncton, New Brunswick, with a US subsidiary in Cambridge, Massachusetts. One day, detecting disease may be as easy as breathing.

About Weinstein Imaging Associates

Weinstein Imaging is a well-established premier imaging center located in Pittsburgh, Pennsylvania with three board certified radiologists. With over 40 years of trusted service, Weinstein Imaging has built a strong reputation for excellence in women's health. The practice operates across three prime locations in the Pittsburgh area, offering comprehensive imaging services including mammography, ultrasound, bone densitometry, and same day results. Weinstein Imaging has participated in many research projects to improve imaging equipment and to advance breast cancer research.

For more information, please visit our website and follow us on LinkedIn.

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Source: Breathe BioMedical Inc.