Portola Valley, CA, August 8, 2022 – TransMed7, LLC announced
today 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, a
distinguished surgeon and former President of the American Society of
Breast Surgeons (ASBrS).
Dr. Staren commented, “Image-guided
breast biopsy using TransMed7’s SpeedBird™ SIMC® devices involves
minimal setup, is very easy to perform because of their extreme
ultrasound visibility, is very well tolerated by the patients, and has
taken only a few minutes to complete for each clinical case. The core
specimens were simply outstanding in all the cases I performed, and
provided exactly what our team needed to plan for each patient’s
therapeutic management.” He added, “I can even say that these first
cases spanned the spectrum of what I know to be some of the most
challenging breast biopsy cases that can be encountered by physicians,
and the devices performed brilliantly.”
Dr. James W. Vetter,
TransMed7 Co-Founder and Chairman stated, “We specifically designed and
developed our SpeedBird™ and Concorde™ Breast Biopsy platforms to
address and overcome the many problematic issues associated with the
current decades-old biopsy devices, including their 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 that can be
collected by them.”
The SpeedBird™ and Concorde™ device platforms
are 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. 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. It was developed as an entirely new
mechanism intended to deliver superior results while also lowering
costs, and to facilitate ease of use for rapid learning curve and
adoption.
“We are delighted to announce the successful clinical
utilization of our production level, minimally invasive breast biopsy
devices as we formally roll out our commercial launch,” stated Dr.
Vetter. “The real importance of achieving this milestone is that it
demonstrates unequivocally that our Zero5® core technology has now
clinically confirmed its transformational nature for the care and
benefit of patients world-wide. This result proves that our plan to
apply Zero5® technology to all of our next generation biopsy device
platforms, adapted for various applications all over the body, is an
achievable benchmark. These include our Heron™, ThunderBird™, Cardinal™,
and Phoenix™ platforms among others still to come, as well as the
robotic instrument applications that we derive from each of them.”
The
SpeedBird™ platform of Breast Biopsy devices includes four models of
hand-held, ultrasound guided, vacuum assisted, full fluid management,
SIMC® devices with simple, extremely cost-effective designs based on the
common Zero5® forward coring technology with 10, 12, and 14-gauge core
needle sizes. SpeedBird 38 is designed for fully automated cycling
(tissue coring, part-off, and transport); SpeedBird Universal and
SpeedBird Universal 99 are designed for manual coring length control and
automatic tissue transport, (SpeedBird Universal 99 further features a
reusable handle and replaceable needles, resulting in a lower cost ideal
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 only one sample for
each insertion) “snapgun” devices being used on a majority of patients
today.
The Concorde™ platform of two device models, also based on
adapted Zero5® technology, are fully automated, selectively forward
coring or combined forward and shielded side coring, vacuum-assisted,
full fluid management, 10 -14-gauge devices. 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.
Eugene H. Vetter,
TransMed7’s Co-Founder and CEO, stated, “The successful use of these
devices now proves that we can adapt and apply our patented Zero5®
technology to provide the world’s most extensive range of
transformational, next generation, minimally invasive device platforms
for biopsy procedures and interventional solutions in the near future.
Patients will finally be able to look forward to this next generation of
devices replacing the decades-old technologies currently being used on
them. Look for announcements of first clinical case results of the
Concorde™ family of Breast Biopsy devices in the coming weeks.”
TransMed7
anticipates participating in the next Radiological Society of North
America (RSNA) meeting in Chicago, IL; 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 will report
expanded clinical results from multiple centers using our FDA – cleared
SpeedBird™ and Concorde™ biopsy devices for Breast Health.
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.
Contact Information:
Jonathan J. Coyne, Vice President Administration
jcoyne@transmed7.com
TransMed7, LLC
117 Solana Rd., Portola Valley, CA, 94028
TransMed7, LLC Announces First Clinical Use of SpeedBird™ Breast Biopsy Devices for Commercial Launch

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