“Our new Concorde and SpeedBird devices are intended to address the many problematic issues associated with current biopsy devices including difficulty visualizing the needle tip with real-time imaging modalities; sharp and potentially traumatic needle tips, limitations in biopsy specimen quantity and quality, and restrictions on tissue type and needle gauge – I’ve been there and I know what a giant step forward our devices represent,” stated Dr. Edgar D. Staren, TransMed7 President and Executive Chairman of its Clinical and Scientific Advisory Board and its Business Advisory Board.

According to recent publications, approximately 1.7 million breast biopsies are performed per year in the U.S. Nearly 1.4 million of these biopsies are performed by minimally-invasive biopsies, but over half of those biopsies still involve decades-old Single Insertion-Single Sample (SISS) biopsy device technology in an effort to lower costs. The use of SISS devices means that for each biopsy sample taken, the device must be inserted into the breast, and then withdrawn with the sample, which must be removed before the device is again inserted into the breast for a new sample. Furthermore, these devices, by virtue of their design, frequently use a spring-loaded “firing” mechanism that is designed to overcome the limitations of such device’s abilities to obtain adequate tissue for subsequent pathologic examination.

With this in mind, Dr. Staren added, “We’re also very proud to announce the addition of a new device – “Sparrow” – to the already 510(k) cleared SpeedBird family, which, like all of our devices, is a fully functioning Single Insertion-Multiple Collection (SIMC™) device, but designed specifically with the goal of eliminating all Single Insertion -Single Sample (SISS) devices from the breast biopsy market. We feel this goal is indeed realistic given the extremely efficient cost of production we can attain with all of our devices and this device in particular, so it’s time for women to finally have premium choices for minimally invasive breast biopsy procedures without being asked to make any sacrifice for cost savings.”

Eugene H. Vetter, TransMed7’s Co-Founder and CEO, stated, “The SpeedBird and Concorde devices are finally ready for rapid production scale-up and market entry for better biopsy options for women, but that’s still just the first step in our plan to provide the world’s most extensive range of transformational, and even micro-invasive device platforms for biopsy procedures and interventional solutions, including a range of new tools for robotic applications for the future. The next steps will include our new “Cardinal” Fine Needle Core Biopsy devices - which were designed for breast, lymph nodes, thyroid and pediatric procedures; along with “Heron”- a new device platform designed for far gentler, safer and more effective prostate biopsy and benign prostate hypertrophy tissue removal for men.” Mr. Vetter further added, “It’s time for the world to become aware of what we have been and are doing - the “quiet revolution” we have started is rapidly producing advanced technologies that patients should and will demand, so stay tuned for more announcements in the near future.”

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