Freiburg, Germany, August 31, 2026
Kazia Therapeutics has announced plans to expand its ongoing paxalisib clinical trial into hormone receptor-positive (HR+)/HER2-negative breast cancer, following new preclinical findings showing significant antitumor activity and a favorable safety profile in combination with standard-of-care therapies. The company said the data also indicate that paxalisib may help resensitize treatment-resistant tumors, including tumors that have developed resistance to CDK4/6 inhibitors. Based on these findings, Kazia is amending its ongoing triple-negative breast cancer (TNBC) clinical trial protocol to establish a new three-arm expansion for patients with pre-treated HR+/HER2- metastatic breast cancer. The first patient is expected to be enrolled before the end of 2026, with full enrollment anticipated by the end of 2027.
Second FDA Designation Expands BCI Applications
The new FDA designation focuses on the potential use of Brain Interchange to establish a direct communication pathway between the brain and digital devices. For people living with non-progressive quadriplegia, the technology is being developed to interpret neural activity and enable users to control a computer cursor using their thoughts. This capability could potentially provide an independent channel for interacting with digital environments when conventional physical movement is severely restricted. CorTec said the second designation places Brain Interchange among the limited number of BCI platforms worldwide to receive more than one FDA Breakthrough Device Designation. Importantly, the new designation concerns the platform’s communication application, while the earlier designation covers therapeutic cortical stimulation intended to support motor recovery following chronic ischemic stroke. The FDA Breakthrough Devices Program is intended for certain medical devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. The designation facilitates more frequent interaction with the FDA during development and can help sponsors address regulatory questions as clinical evidence and device development progress. For CorTec, the second designation provides additional regulatory engagement as it advances Brain Interchange toward future clinical development in communication restoration. The company is also participating in the FDA’s Total Product Life Cycle Advisory Program (TAP) for the stroke rehabilitation application, further supporting its regulatory strategy for the investigational platform.
Brain Interchange Combines Neural Recording and Stimulation
Brain Interchange is a fully implantable, wireless, bidirectional closed-loop BCI designed to both record neural signals and deliver adaptive cortical stimulation. Its platform architecture allows the system to read brain activity and respond through stimulation, creating a closed-loop interface between neural signals and therapeutic or assistive functions. CorTec is developing the same underlying implant for multiple neurological applications, with stroke rehabilitation serving as its lead therapeutic program and communication representing an additional assistive direction. The company’s broader clinical pipeline also includes investigations involving epilepsy, while potential applications in depression and severe paralysis are being developed. The communication potential of the platform has already been demonstrated in an ongoing clinical setting. In April 2026, CorTec reported that a participant in its University of Washington stroke clinical study successfully controlled a computer through thought alone using the implanted Brain Interchange system. The demonstration included computer interaction and showed that the same implanted hardware being evaluated for stroke rehabilitation could also capture neural signals relevant to computer control. CorTec emphasized that this demonstration illustrated the platform’s versatility and was separate from the scope of its existing stroke Breakthrough Device Designation.
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Clinical Development Continues Across Neurological Conditions
Brain Interchange remains an investigational medical device and is not approved for commercial use. CorTec is continuing clinical development of the system while evaluating its capabilities across different neurological conditions. The company previously received FDA authorization for clinical evaluation of the platform in stroke rehabilitation, with patients implanted at Harborview Medical Center in Seattle as part of the study. CorTec has reported stable operation of the system over extended periods, while its clinical programs are intended to generate additional evidence on neural recording, stimulation, safety, and functional performance. The second Breakthrough Device Designation represents a significant step in the development of implantable BCI technology for communication restoration. By pursuing therapeutic and assistive applications through the same bidirectional platform, CorTec aims to establish Brain Interchange as a multi-indication neurotechnology system. Further clinical evidence and regulatory evaluation will be required to determine whether the technology can ultimately deliver safe and effective benefits for people with severe paralysis, stroke-related disabilities, and other neurological disorders.
Source: CorTec press release
