Tuesday, February 07, 2023
TransMed7, LLC announced today that the “First in Human” series of clinical cases using commercial production Concorde US devices (a member of the new Concorde family of vacuum-assisted, Single Insertion / Multiple Collection (SIMC®) Soft Tissue Biopsy devices) have been successfully performed by Dr. Michael Berry, distinguished surgeon and member of the American Society of Breast Surgeons (ASBrS), performing breast biopsy cases at the Margaret West Comprehensive Breast Center in Germantown, TN. These cases demonstrated Concorde’s combined forward and side coring action, which is unique to the Concorde family of advanced breast biopsy devices, and is designed to add a vital layer of precision, control, efficiency and confidence for biopsy procedure under advanced imaging modalities.
Dr. Berry commented, “I was delighted to perform the first clinical cases using TransMed7’s new Concorde US ultrasound-guided soft tissue breast biopsy devices. Just a few coring passes were all that I needed for complete diagnosis in all of my Concorde cases - the core specimens were immense, full diameter and of surgical quality, and provided all of the lesion’s genomic marker information our team needed to provide a definitive diagnosis and plan for each of these patient’s therapeutic management.” He added, “Although the Concorde US device has a lot of advanced capabilities that allow us to imagine new procedures with its unique tissue shielding scoopula feature, I found it to be very intuitive and easy to use from the first time I picked it up - and I predict that it will give physicians great confidence in approaching difficult cases just as it has in the cases I performed. I finished these biopsy procedures in an average of less than 5 minutes, which represents significant cost savings as well. This is my new favorite instrument!”
Similar to the SpeedBird device platform for Breast Health, the Concorde family of devices is based on TransMed7’s patented Zero5® work element composed of a fused, single element constructed from 3 hypotubes, laser cut and welded to form articulable twin cutter blades at the end of a rotating open tube, with the addition of an outer scoopula shield for the Concorde devices. This element gently penetrates, cores, severs, and provides a pathway to transport multiple tissue samples via a closed-circuit fluid management and vacuum system into a detachable chamber. Zero5® forward coring technology enables these devices to reliably and consistently obtain full-core, uniform-diameter samples with intact architecture from all of the various soft tissues.
The Concorde platform of devices was developed by Dr. James Vetter and his R&D team as an entirely new mechanism for advanced breast biopsies, and consists of two device models which are fully automated, selectively forward coring or combined forward and shielded side coring, vacuum-assisted, full fluid management, 10-14-gauge devices using our proprietary tissue shielding technology at the working end of the coring needle. The Concorde ST device is designed for stereotactic and 2D/3D tomosynthesis guidance breast biopsy procedures with full, built-in (console-replacing) capabilities. The Concorde US device is designed for either ultrasound guidance for handheld use or with an optional, reusable, stage mount adapter for Stereotactic and 2D/3D Tomosynthesis use.
Dr. James W. Vetter, TransMed7 Co-Founder and Chairman, stated, “We are delighted to announce the successful clinical utilization of our production level, minimally invasive Concorde breast biopsy devices as we formally roll out our commercial launch in this first quarter of 2023,” stated Dr. Vetter. “The real importance of achieving this new milestone is that it demonstrates unequivocally that our Zero5® core technology in both the SpeedBird and Concorde platforms of next generation biopsy devices has now been clinically confirmed with advanced benefits for the care of breast health patients in both United States and international markets.”
TransMed7 plans participating in the next American Society of Breast Surgeons (ASBrS) meeting in Boston, MA and the next Society of Breast Imaging (SBI) meeting in Washington, D.C. where we expect to report expanded clinical results from multiple centers using our FDA-cleared SpeedBird and Concorde biopsy devices for Breast Health.