TransMed7, LLC Announces First Clinical Use of SpeedBird Breast Biopsy Devices for Commercial Launch

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August 10, 2022 – TransMed7, LLC announced that the first clinical cases of the final commercial production version of the Sparrow device (a member of the new SpeedBird family of vacuum-assisted single insertion/multiple collection (SIMC) breast biopsy devices ) were successfully performed by Dr. Edgar Staren, distinguished surgeon and past president of the American Society of Breast Surgeons (ASBrS).

Dr. Staren commented: “Image-guided breast biopsy using TransMed7 SpeedBird SIMC devices involves minimal setup, is very easy to perform due to their extreme ultrasound visibility, is very well tolerated by patients and took only a few minutes for each clinical case. The core samples were simply exceptional in every case I performed and provided exactly what our team needed to plan the therapy management of each patient. He added: “I can even say that these early cases covered the spectrum of what I know to be some of the most difficult breast biopsy cases that doctors can encounter, and the devices worked brilliantly.”

Dr. James W. Vetter, Co-Founder and President of TransMed7, said, “We specifically designed and developed our SpeedBird and Concorde breast biopsy platforms to address and overcome the many problematic issues associated with current decades-old biopsy devices, including their difficulty visualizing the needle tip with real-time imaging modalities, sharp and potentially traumatic needle tips, limitations on the quantity and quality of biopsy specimens, and restrictions on type of fabric that can be collected by them.

The SpeedBird and Concorde device platforms are based on TransMed7’s patented Zero5 working element consisting of a single fused element constructed from 3 hypotubes, laser cut and welded to form articulating twin cutting blades to the end of a rotating open tube. This element gently penetrates, digs, cuts and provides a pathway for transporting multiple tissue samples through a closed circuit vacuum and fluid handling system in a removable chamber. Zero5 forward coring technology enables these devices to reliably and consistently obtain full core, uniform diameter specimens with intact architecture from all different soft tissues. It was developed as an entirely new mechanism intended to deliver superior results while reducing costs, and to facilitate ease of use for a quick learning curve and adoption.

“We are delighted to announce the successful clinical use of our production level, minimally invasive breast biopsy devices as we officially roll out our commercial launch,” said Dr. Vetter. “The real significance of reaching this milestone is that it unequivocally demonstrates that our core Zero5 technology has now been clinically confirmed to be transformational in the care and benefit of patients worldwide. This result proves that our plan to apply Zero5 technology to all of our next-generation biopsy device platforms, suitable for various full-body applications, is an achievable benchmark. These include our Heron, ThunderBird, Cardinal, and Phoenix platforms, among others yet to come, and the robotic instrument applications we derive from each of them.

The SpeedBird platform of breast biopsy devices includes four models of handheld, ultrasound-guided, vacuum-assisted, full-fluid-management SIMC devices with simple and extremely cost-effective designs based on Zero5 forward coring technology common with 10, 12 and 14 -gauge basic needle sizes. SpeedBird 38 is designed for a fully automated cycle (coring, tissue separation and transport); SpeedBird Universal and SpeedBird Universal 99 are designed for manual coring length control and automatic tissue transport (SpeedBird Universal 99 additionally features a reusable handle and replaceable needles, resulting in an ideal lower cost for emerging international markets); and the new Sparrow device, which is designed for manual coring length control and automatic tissue transport and is intended to become the ultimate “terminator” of the single insertion – single sample (SISS – limited to one) “snapgun”. single sample for each insertion) devices used on the majority of patients today.

The Concorde™ platform of two rig models, also based on adapted Zero5® technology, are fully automated, selective direct coring or combined forward and shielded side coring, vacuum-assisted, full fluids, 10-14 gauge. The Concorde ST device is designed for stereotaxic breast biopsy and 2D/3D tomosynthesis guided procedures with full built-in capabilities (console replacement). The Concorde US device is designed either for ultrasound guidance for handheld use or with an optional reusable stage mount adapter for stereotaxic use and 2D/3D tomosynthesis.

Eugene H. Vetter, Co-Founder and CEO of TransMed7, said, “The successful use of these devices now proves that we can adapt and apply our patented Zero5 technology to provide the world’s broadest range of transformational devices, new generation and minimally invasive. platforms for biopsy procedures and interventional solutions in the near future. Patients will finally be able to look forward to this new generation of devices replacing the decades-old technologies currently used on them. Expect announcements of early clinical case results from the Concorde™ family of breast biopsy devices in the coming weeks. »

TransMed7 plans to attend the upcoming Radiological Society of North America (RSNA) meeting in Chicago, IL; the upcoming meeting of the American Society of Breast Surgeons (ASBrS) in Boston, MA; and the upcoming Society of Breast Imaging (SBI) meeting in Washington, DC, where we will report expanded clinical results from multiple centers using our FDA-cleared SpeedBird and Concorde biopsy devices for breast health.

For more information: www.transmed7.com


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