Biotectix Announces Launch of GLP Preclinical Trial with Strategic Partner
07-Jun-2010
Ann Arbor, Michigan - Biotectix, LLC is pleased to announce the initiation of a three month GLP chronic animal study funded by a co-development partner in the medical device field. The study represents a continuation of a previously announced strategic research collaboration agreement.
The objective of this study is to validate the safety and efficacy of an implantable electrostimulation device that serves a $1 billion worldwide market with a projected compound annual growth rate exceeding 20%. The undisclosed partner is a leading manufacturer in this market. “We are very excited to continue to work with our partner on this technology, the entire Biotectix team is pleased by this demonstration of confidence in the company and its products,” indicated Jim Arps, Biotectix Vice President & General Manager. “All work is based on Biotectix’s proprietary technology and coating methods on bioactive, electrically conductive biomaterials that improve electrical performance as well as the biological integration and stability of implantable biomedical devices,” added Jim.
The study was initiated after in vitro and in vivo testing demonstrated that Biotectix BT DOT coated implants were stable for more than 6 months in vivo and maintained improved electrical conductivity compared to uncoated electrodes, specifically:
• BT DOT-coated electrodes reduced electrical variability between electrodes in vivo
• The coatings reliably increased the charge storage capacity by over 350 %
• Voltage excursion under of biphasic stimulation were reduced by over 40 % in vitro
• BT DOT electrode coatings provided faster response and better signal fidelity than uncoated electrodes
• The coated electrodes exhibited a lower impedance than uncoated electrodes in the range of 1 – 100,000 Hz by up to 98 %
Dr. Sarah Richardson-Burns, Director of R&D at Biotectix, was present during the surgical procedures and noted, “The coated samples performed identically to the unmodified devices during implantation, initial tests performed shortly after treatment confirmed the performance gains that we had previously observed. If the devices function as we anticipate, we are hopeful that our partner will initiate first-in human clinical trials within the next 18-24 months.”
About Biotectix
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, 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.
About Allied Minds
Allied Minds is a U.S. capital investment firm with offices in Boston, Los Angeles, and Washington, DC. The Company creates spin out businesses based on early-stage technology developed at renowned U.S. Universities and National Labs and serves as a holding company that supports these businesses with capital, management, and shared services. Allied Minds is the premier firm to utilize this novel and fully integrated approach to technology investing. The Company’s subsidiary investments span multiple business sectors and offer an attractive risk-return profile, a deliverable timeline, and potential products that will be groundbreaking in their respective fields. These subsidiaries include AXI, BA Logix, Biotectix, Cephalogics, CryoXtract, GliaGen, Illumasonix, ProGDerm, Precision Biopsy, Purtein, RF Biocidics, SaltCheck, SiEnergy Systems, SoundCure and Spin Transfer Technologies. For more information please visit www.alliedminds.com
For more information;
James Arps, Vice President & General Manager
Biotectix, an Allied Minds Company
jim.arps@biotectix.com
The objective of this study is to validate the safety and efficacy of an implantable electrostimulation device that serves a $1 billion worldwide market with a projected compound annual growth rate exceeding 20%. The undisclosed partner is a leading manufacturer in this market. “We are very excited to continue to work with our partner on this technology, the entire Biotectix team is pleased by this demonstration of confidence in the company and its products,” indicated Jim Arps, Biotectix Vice President & General Manager. “All work is based on Biotectix’s proprietary technology and coating methods on bioactive, electrically conductive biomaterials that improve electrical performance as well as the biological integration and stability of implantable biomedical devices,” added Jim.
The study was initiated after in vitro and in vivo testing demonstrated that Biotectix BT DOT coated implants were stable for more than 6 months in vivo and maintained improved electrical conductivity compared to uncoated electrodes, specifically:
• BT DOT-coated electrodes reduced electrical variability between electrodes in vivo
• The coatings reliably increased the charge storage capacity by over 350 %
• Voltage excursion under of biphasic stimulation were reduced by over 40 % in vitro
• BT DOT electrode coatings provided faster response and better signal fidelity than uncoated electrodes
• The coated electrodes exhibited a lower impedance than uncoated electrodes in the range of 1 – 100,000 Hz by up to 98 %
Dr. Sarah Richardson-Burns, Director of R&D at Biotectix, was present during the surgical procedures and noted, “The coated samples performed identically to the unmodified devices during implantation, initial tests performed shortly after treatment confirmed the performance gains that we had previously observed. If the devices function as we anticipate, we are hopeful that our partner will initiate first-in human clinical trials within the next 18-24 months.”
About Biotectix
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, 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.
About Allied Minds
Allied Minds is a U.S. capital investment firm with offices in Boston, Los Angeles, and Washington, DC. The Company creates spin out businesses based on early-stage technology developed at renowned U.S. Universities and National Labs and serves as a holding company that supports these businesses with capital, management, and shared services. Allied Minds is the premier firm to utilize this novel and fully integrated approach to technology investing. The Company’s subsidiary investments span multiple business sectors and offer an attractive risk-return profile, a deliverable timeline, and potential products that will be groundbreaking in their respective fields. These subsidiaries include AXI, BA Logix, Biotectix, Cephalogics, CryoXtract, GliaGen, Illumasonix, ProGDerm, Precision Biopsy, Purtein, RF Biocidics, SaltCheck, SiEnergy Systems, SoundCure and Spin Transfer Technologies. For more information please visit www.alliedminds.com
For more information;
James Arps, Vice President & General Manager
Biotectix, an Allied Minds Company
jim.arps@biotectix.com
