Breast Biopsy Site Marker

BreastMed has developed a patented implantable soft tissue marker.  Our initial product, intended for use in a variety of clinical applications, including as breast biopsy site marker and as implantable fiducial marker, was conceived and developed by co-inventors Patrick Bolan, Ph.D., Michael Garwood, Ph.D., Michael T. Nelson, MD, and Daniel A. Halpern.

Our initial product focus has been breast biopsy site marking applications, including minimally-invasive procedures, and is intended to be compatible with and well-visualized under all key imaging modalities, including x-ray based methods such as conventional mammography, computed tomography (“CT”) and fluoroscopy, as well as other imaging approaches that do not involve x-rays, such as ultrasound, magnetic resonance imaging (“MRI”), MR spectroscopy, and nuclear medicine SPECT and positron emission tomography (“PET”).  We believe it can play important role in the continued paradigm shift from invasive open surgical to minimally-invasive biopsy procedures.

Breast-Med intends commercialize its proprietary implantable tissue marker, with potential to dramatically improve patient diagnosis, staging, therapy and follow-up of breast cancer and other cancers. Key applications include use as breast biopsy-site marker, as implantable fiducial marker to improve localization in radiotherapy and various image-guided ablation methods, and other soft tissue oncology applications.   As a fiducial marker, Breast-Med's marker is intended to optimize therapeutic targeting and reduce collateral damage to adjacent healthy tissue. 

Medical imaging procedures play important role in diagnosis, staging, treatment and follow-up of breast cancer and other tumors, which often involves use of radiographic markers (small devices implanted during biopsy or surgery).  Conventional markers typically consist of solid objects, which often interfere with imaging procedures and which generally are not permanently visible. Breast-Med’s device is a permanent, fully-implantable, hermetically-sealed tissue marker.  The marker produces a change in signal intensity under magnetic resonance imaging (MRI) to enable the marker to be permanently well-visualized under all tumor types and all tissue types, which is not possible with conventional markers. Alternative configurations may also improve visibility under other imaging modalities, such as computed tomographic (CT) imaging or ultrasound imaging (ULS). This device does not interfere with imaging methods and remains well-visualized for isolating the biopsy site tissue.

The Breast-Med marker was specifically designed to avoid interference with either MR imaging or MR Spectroscopy (MRS), a recognized form of molecular diagnostic imaging (metabolites, such as choline peaks are closely  associated  with breast cancer).  Co-Inventors of the Breast-Med marker are experts in MRS, particularly as relates to breast MRS. 

Breast-Med is currently in the pre-clinical development phase of development of its initial breast marker.  Breast-Med to date has been privately funded.  Breast-Med is currently engaged in discussions with multiple leading industry participants and investor groups regarding possible joint clinical research as well as strategic investment, licensing, distribution or sale of the company’s marker products.

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