Portola Valley, CA, August 16, 2022 – TransMed7, LLC announced
today that the “First in Human” clinical case of the commercial
production version of a Heron™ XPS device (a member of the new Heron™
family of vacuum-assisted, Single Insertion / Multiple Collection
(SIMC®) Soft Tissue Biopsy devices) was successfully performed by Dr.
Edgar Staren, a surgical oncologist with the US Oncology network and a
Clinical Professor of Surgery at the University of Arizona Phoenix,
College of Medicine.
Dr. Staren commented, “I was confident
to perform the first clinical biopsy procedure using TransMed7’s new
Heron™ XPS ultrasound-guided soft tissue biopsy device on a challenging
case that otherwise would have required an open surgical biopsy
procedure because of the proximity to major blood vessels and other
sensitive structures as well as the need to obtain adequate tissue for
histopathologic, molecular and other studies. The forward coring Heron™
device allowed me to precisely position the device in relation to the
lesion because of its clear ultrasound visibility all along the path
from the skin, to and through the lesion, and ensure that the samples
taken were just what I was targeting. Three coring passes were all that I
needed for complete diagnosis – the core specimens were immense, full
diameter, high quality, and provided all of the lesion’s relevant
information for our team to provide a definitive diagnosis and plan for
the patient’s therapeutic management.” He added, “I predict that the
ease of use and performance of the Heron™ devices will give physicians
great confidence in approaching biopsies of the liver, kidney, prostate,
lymph nodes and others, as well as difficult cases that otherwise would
require open surgical biopsy procedures. The whole biopsy procedure was
finished in less than 5 minutes, which represents a significant cost
savings as well.”
Similar to the SpeedBird™ and Concorde™ device
platforms for breast health, the Heron™ platform of devices for soft
tissue biopsies and interventional procedures for nearly all organs
(excluding lung at present) and soft tissue outside of the breast is
based on and adapted from 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.
Dr. James W.
Vetter, TransMed7 Co-Founder and Chairman stated, “We specifically
designed and developed our Heron™ platform to provide the most extensive
breadth of advanced capabilities available in the world, for soft
tissue biopsy and interventional procedures across many clinical
applications. Each of the Heron™ platform devices is capable of
accepting any of the drop-in needle sets in the full range of 12, 14,
16, and 18 gauge needles matched to any of four standard needle lengths
to provide a full range of options for procedures involving highly
vascular organ systems, and where complex neuro-vascular bundles located
along the pathway to the target sites are present such as in the
prostatic capsule region, and likewise in organs and other sensitive
soft tissue structures, particularly where ease of guidance and ease of
device manipulation are considered essential, enabling capabilities. We
intended from the start to make the Heron™ platform the most universal
set of biopsy devices in the world, enabling interventionists all over
the globe to quickly expand the scope for minimally invasive
alternatives to organs and areas within organ systems that simply would
not have been advisable prior to the introduction of the Heron line of
instruments.”
The Heron™ platform of soft tissue biopsy devices
includes three models of hand-held, ultrasound guided, vacuum assisted,
full fluid management, SIMC® devices. The Heron™ XP device model is
designed for fully automated cycling (tissue coring, part-off, and
transport), and features an optional side shielding scoopula in short or
long version. The Heron™ XPK and XPS full featured models are designed
for manual coring length control and automatic tissue transport.
The
Heron™ platform also includes a new device model, the Heron™ RO model,
designed for direct integration into a robotic surgical system for
advanced surgical procedures of the future, including robotic prostate
BPH symptom relief interventions. Similar to the Heron™ XP model, it is a
fully automated, selectively forward coring or combined forward and
shielded side coring, vacuum-assisted, full fluid management, biopsy or
tissue debulking device. The Heron™ RO model features full remote
control capabilities through the use of a Remote Control Unit (RCU) or
Wireless Control Unit (WCU) for maximum adaptability to an advanced
robotic surgical system.
Eugene H. Vetter, TransMed7’s Co-Founder
and CEO, stated, “The Heron Platform of devices was originally
developed to target the need for advanced biopsy capabilities and other
procedures for the prostate, kidney and liver. We’ve expanded that
indication to match its FDA granted 510k clearance for all soft tissue
outside of lung, but also deliberately excluding breast interventions
for which our SpeedBird™ and Concorde™ devices were specifically
developed and are superbly matched. The Heron™ devices are currently
510k cleared for 10 to 14 gauge needles, and we expect to receive FDA
clearance for 16 and 18 gauge needle sizes as well before year end. The
Heron™ platform devices will provide the most advanced capabilities for
biopsy devices featuring needle sizes from 12 to 18 gauge. Our next
generation Cardinal™ devices, currently under development, will complete
the advanced biopsy device spectrum with 19 to 23 gauge needles, thus
providing the first true Fine Needle Core Biopsy (FNCB) capabilities
anywhere in the world.”
TransMed7 anticipates participating in
the next Radiological Society of North America (RSNA) meeting in
Chicago, IL where we will report expanded clinical results from multiple
centers using our FDA – cleared Heron™ soft tissue biopsy devices for
prostate, liver, kidney and other soft tissue biopsies outside of the
field of breast health, as well as for Prostate BPH symptom relief
procedures.
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 Heron Soft Tissue Biopsy Devices for Commercial Launch

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