TransMed7, LLC Announces First Revenue from Concorde Family of Devices

PORTOLA VALLEY, Calif.--(BUSINESS WIRE)-- TransMed7, LLC announced today the first sales of Concorde (Single Insertion / Multiple Collection (SIMC®)) Soft Tissue Biopsy devices, to the Margaret West Comprehensive Breast Center in Germantown, TN. Dr. Michael Berry, distinguished surgeon and former Board of Directors member of the American Society of Breast Surgeons (ASBrS), explained his excitement about the purchase of these devices. “After performing a series of breast biopsies using SpeedBird and Concorde devices, I examined all these patients in a standard follow up consultation. Each patient shared that the procedure was pain free and quicker than they had anticipated. Additionally, I found that none of these patients had any bruising from the procedure. I look forward to using SpeedBird and Concorde devices for my patients in the future.”

Both the SpeedBird device platform for Breast Health and the Concorde family of devices are based on TransMed7’s patented Zero5® work element that is formed into a fused, laser cut and welded single component comprising articulable twin cutter blades at the end of a rotating open tube. Concorde devices include an outer scoopula-shaped shield that adds an additional directionality capability and an easily recognizable reference structure for exceptional ultrasound and stereotactic/tomosynthesis accuracy. In both Concorde and SpeedBird devices, the unique work element gently penetrates, cores, severs, and opens its 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 obtain full-core, large diameter samples with intact architecture regardless of tissue type.

Dr. James W. Vetter, TransMed7 Co-Founder and Chairman, stated, “Our purpose from the beginning was to develop SpeedBird and Concorde around an entirely new mechanism for advanced breast biopsies with extensive patent protection. Through patient innovation, we achieved our goal of creating a full line of revolutionary soft tissue biopsy systems, efficient to produce for interventional radiologists and surgeons to quickly adopt. To maximize patients’ benefits we diligently worked to reduce bleeding and procedure time, and to eliminate pain and the bruising normally associated with these procedures, producing devices that allow physicians to complete biopsies in 3-5 minutes when typically, they take up to 30 minutes or more with other devices. Critically, we have achieved our main goal to maximize the information contained within each tissue sample. To that end we have already heard from pathologists, excited by the size and exceptional quality of our tissue samples.”

The SpeedBird™ and Concorde platforms include six models of hand-held, ultrasound and Stereotactic/Tomosynthesis guided, vacuum assisted, full fluid management, SIMC® devices with simple, cost-effective designs based on the common Zero5® forward coring technology available in 10, 12, and 14-gauge core needle sizes.

The Concorde ST device is designed for stereotactic and 2D/3D tomosynthesis guided breast biopsy procedures with full, built-in (console-replacing) capabilities. The Concorde US device can be either handheld for ultrasound guidance or used with an adapter for Stereotactic and 2D/3D Tomosynthesis.

Dr. Berry commented on the incredible visibility of SpeedBird and Concorde under ultrasound guidance, saying, “When teaching physicians, one of the more difficult aspects of a procedure is keeping track of the needle image on the ultrasound screen. SpeedBird and Concorde devices have a proprietary flashing image which makes it nearly impossible to lose sight of the biopsy needle. I believe these devices will make training much easier for all physicians who are doing ultrasound, Stereotactic and 2D/3D Tomosynthesis guided biopsies. With these devices it’s like you are turning on the lights in a dark room.”

Eugene H. Vetter, TransMed7’s Co-Founder and CEO, stated, “Physicians who have used our devices in their different forms and combinations have confirmed we have met our goal to create and provide the world’s most extensive group of transformational, next generation, minimally invasive device platforms for biopsy procedures and interventional solutions. Patients can look forward to procedures that take less time, deliver bigger, better samples, and will vastly upgrade their overall experience.”

TransMed7 is ramping up training for surgeons and radiologists while also increasing production of SpeedBird and Concorde devices for sale. We anticipate strong growth in the adoption of our SpeedBird and Concorde devices by surgeons and radiologists.

About TransMed7, LLC

TransMed7, LLC is a medical and technology-based organization focused on the highly efficient development of innovative, minimally invasive medical devices aimed at providing new solutions for doctors and their patients. With particular emphasis on oncology, regenerative medicine, and cardiovascular disease, TransMed7 and its team of clinicians, scientists, and engineers have developed a portfolio of next-generation platform devices that are expected to be market leaders in their targeted fields of medicine. TransMed7 accomplishes this through application of a wholly new approach in its business plan and structure, enabling these new transformational technologies to move from rapid development through commercial manufacturing and market deployment, or where appropriate, handoff to our Strategic Partners. For more information about TransMed7, please visit our website at www.transmed7.com.

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