RefleXion Medical's SCINTIX biology-guided radiotherapy platform (BgRT) has demonstrated remarkable efficacy in treating lung and bone cancer patients, achieving 100% local disease control in the US-based PREMIER trial (NCT05406167). Nine-month follow-up scans post-treatment revealed that all patients with lung and bone metastases experienced local disease control, defined as either complete response (CR), partial response (PR), or stable disease (SD).
Clinical Outcomes and Safety Profile
The PREMIER trial results showed that 41% of patients experienced complete or partial responses, with notably higher response rates observed in bone metastases patients (47%) compared to those with lung tumors (35%). These positive outcomes were observed across patients with both localized and metastatic cancer, demonstrating the platform's broad therapeutic potential.
Treatment with SCINTIX BgRT proved highly tolerable, with no patients experiencing treatment-related adverse events (TEAEs) higher than Grade 2 during the study period. This safety profile supports the platform's potential for widespread clinical adoption.
"We are beginning to see the clinical translation of a technology that can autonomously guide radiation based on real-time biology," stated Sean Shirvani, RefleXion's Chief Medical Officer. "Achieving 100% local control in both lung and bone tumours with imaging up to nine months after treatment represents an important step forward in expanding the reach of radiotherapy for patients with advanced cancer."
Revolutionary Technology Platform
SCINTIX distinguishes itself as the first and only precision radiotherapy system to combine positron emission tomography (PET) imaging with a linear accelerator (LINAC). This unique integration enables the system to precisely administer radiation doses to cancer cells while minimizing impact on surrounding healthy tissues.
The platform differs from other next-generation radiotherapy products such as intensity-modulated radiation therapy (IMRT) and stereotactic body radiation therapy (SBRT) by incorporating individual patient biological information into treatment planning. RefleXion claims this approach helps address both tumor heterogeneity and motion management challenges during treatment delivery.
Regulatory and Market Position
The SCINTIX BgRT platform received FDA approval in 2023, following its breakthrough device designation in late 2021. Since market introduction, RefleXion has installed the technology at Beverly Hills Cancer Center, marking the first freestanding cancer center to incorporate the equipment.
The Centers for Medicare and Medicaid Services (CMS) has announced reimbursement coverage for patients receiving SCINTIX therapy, including novel codes for freestanding cancer centers and physician reimbursement. This coverage decision removes a significant barrier to patient access.
Competitive Landscape
While SCINTIX BgRT represents a first-in-class device, it faces potential competition from established players. Siemens Healthineers-owned Varian's TrueBeam incorporates advanced imaging, precision dosing, and image acquisition for treatment planning. Similarly, Elekta's precision radiotherapy units operate with continuous, anatomy-specific magnetic resonance imaging and motion management capabilities.
Future Development Plans
Following these positive topline outcomes, RefleXion plans to expand registry enrollment and continue monitoring patients to determine long-term treatment-related outcomes. The company positions SCINTIX as a potential "first-in-class treatment option for localized and metastatic disease," based on the trial's promising results.
