• Safety of QV’s novel stimulation regimes demonstrated in large animal studies for up to three months of implantation.
• Pre-clinical data demonstrates QV’s breakthrough proprietary stimulation methodology outperforms that of the industry leader in its effectiveness against advanced patient derived models.
• Positive response from FDA pre-submission, providing clear guidance that de-risks the path to first-in-human trials

 

30th August 2024, Cheshire, UK

QV Bioelectronics, the creator of the world’s first implantable Electric Field Therapy (EFT) device for the treatment of brain tumours, is excited to announce significant advances in the development of this first-in-class therapy. Glioblastoma Multiforme (GBM) is the most common primary brain cancer in adults, and one of the most aggressive types of cancer generally, with an average life expectancy of only 18 months after treatment.

Recent preclinical studies have yielded promising data that validate the efficacy of QV’s proprietary technologies, paving the way for first-in-human trials and creating a paradigm shift in GBM treatment. QV’s data supports the potential for significantly increased longevity and quality of life compared to the first and only approved GBM electric field therapy currently generating over $0.5Bn revenue.

Large Animal & In-vitro Studies Confirm Safety

A robust three-month study on large animals has demonstrated the safety of QV’s novel Electrical Field Therapy stimulation regime. Importantly, there were no significant adverse events, neurological side effects, gross abnormalities, nor tissue damage. Additionally, in vitro studies have shown that QV’s proprietary stimulation parameters, which are effective in killing patient-derived glioblastoma cells, have no negative impact on the health of state-of-the-art human neuronal models.

Breakthrough in Targeting Resistant GBM Subtypes

QV’s proprietary “QV6” stimulation paradigm has been shown to be highly effective against multiple tumour genetic profiles. Different genetic groupings within an individual glioblastoma tumour have been shown to drive resistance to current treatments. This scientific breakthrough demonstrates the potential for significantly improved efficacy compared to existing treatment modalities. Further development of QV’s proprietary stimulation regimes will enable a precision medicine approach.

Positive Feedback from the FDA

In a recent pre-submission meeting, the FDA provided positive feedback on QV’s validation plan, offering a clear pathway to first-in-human trials, significantly de-risking the development process.

Disrupting a Multi-Billion Dollar Market with Single Incumbent

QV’s target market is a validated multi-billion-dollar opportunity, currently occupied by but under penetrated by a single incumbent. The innovative technology developed by QV aims to disrupt this space with a ground-breaking therapy that could significantly improve patient outcomes. Beyond GBM, QV plans to expand their platform into other associated indications, increasing their addressable population by 20-fold, with a broader addressable market worth over $30 billion. QV’s approach enjoys wide support from clinical KOLs and patient groups from around the globe.

Fund Raise
QV Bioelectronics is now raising Series A investment in order to complete development and deliver the first-in-human clinical trial in GBM patients, having achieved critical technological de-risking of this innovative product.

About QV Bioelectronics
QV Bioelectronics is striving to deliver longer, better quality lives for brain tumour patients. They are developing an implanted electric field therapy device, GRACE, aims to address the unmet clinical need of malignant brain tumours by extending survival without impacting quality of life. GRACE is currently in preclinical development and not yet licenced for use by regulatory agencies. GRACE will not be marketed or otherwise available to patients until it has met regulatory requirements.