ANN ARBOR,
Mich.–(BUSINESS WIRE)–Biotectix, LLC, an
Allied Minds, Inc. subsidiary, is pleased to announce the first-in-human (FIH)
use of an electrostimulation device incorporating its BT DOT conductive polymer
coating technology. Last month, patients were surgically implanted with novel
gastric stimulation devices utilizing electrodes coated with Biotectixs
proprietary material. The FIH achievement represents a significant step toward
commercialization of a core Biotectix product, BT DOT. Biotectix also continues
to work with a number of partners developing the next generation of chronically
implanted electrical stimulation and recording devices for a variety of
applications.
Dr. Jeffrey L. Hendricks, Director of Engineering at
Biotectix, was present during the surgical procedures and noted that, “The BT
DOT coating allowed our partner to use a much smaller electrode and lead
assembly than they have previously implanted. The assembly was also easier and
faster for the surgeon to implant, which should result in reduced trauma to the
patient, more reproducible orientation, and better placement. Early results
also suggested the coated electrodes may enable faster and more effective
stimulation of the GI tract.”
The trial is the culmination of several months of activity
with the device partner, from initial development and demonstration of the BT
DOT coating on prototype designs in vitro to completion of stability,
sterilization, and durability testing. In the final phases, devices suitable
for human uses were prepared and necessary IRB documentation was submitted and
approved prior to initiation of the study. Treatment of additional patients is
anticipated in the coming months.
Dr. James Arps, General Manager at Biotectix, remarked, “The
first human implants of devices incorporating the BT DOT technology is a
tremendous accomplishment for Biotectix in demonstrating the safety and
efficacy of our proprietary coating materials. This is the first of a number of
successful clinical studies that we hope to complete with our various partners
in the coming year.”
About Biotectix
Biotectix is developing a new class of conductive polymer materials and
coatings for implantable devices and sensors that improve the safety, longevity,
reliability, biological integration, and function of implantable biomedical
devices. A number of benefits are driven by this platform technology without
changing device size, shape, or implant procedure, including improved
electrical performance, biocompatibility, and tissue response.
The technology addresses key limitations faced by the
medical device industry including foreign body reactions, component stability,
and long-term electrical performance in vivo. The materials are custom-designed
for the specialized mechanical, electrical, and biological environments of the
body, and provide an extremely high level of functional interfacing for medical
electrodes.
Biotectix was formed by Allied Minds (www.alliedminds.com), a private equity company, based on
technology originally developed at the University
of Michigan, Ann Arbor. The founders and inventors
continue to develop and validate the technology through research,
collaborations, and partnerships with leading companies and research
institutions. For more information please visit www.biotectix.com.
Posted by Sean Fenske, Editor-in-Chief, MDT
