ThorafiX is developing a patented rib fixation system designed to prevent Proximal Junctional Kyphosis (PJK)—one of the greatest unsolved challenges in modern spine surgery.
The minimally invasive rib hook and implant system anchors spinal constructs to the ribs, redistributing stress and preventing mechanical collapse that leads to junctional failure.
ThorafiX addresses Proximal Junctional Kyphosis (PJK), a debilitating complication affecting up to 46% of adult spinal deformity cases. PJK causes structural breakdown at the top of long spinal fusions, leading to vertebral collapse, severe pain, and costly revision surgeries.
Current approaches—pedicle screw-only constructs or soft-tissue preservation—fail to provide lasting biomechanical protection.
ThorafiX’s innovative solution creates a “soft landing” at the fusion’s upper end by adding two levels of rib fixation above the uppermost instrumented vertebra using low-profile rib hooks or flexible rib bands.
This approach:
- Preserves key posterior ligaments, paraspinal muscles, and facet joints
- Acts as a natural tether
- Creates a less rigid, load-sharing transition zone
- Reduces stress concentration at the upper instrumented vertebra (UIV)
By combining structural support with preserved soft tissues, ThorafiX delivers a balanced biomechanical solution that maintains spinal correction and significantly lowers junctional failure risk. Supported by biomechanical testing and early clinical data, the technology offers the first practical, minimally invasive method for durable junctional protection in both adult and pediatric deformity surgery—addressing a multi-billion-dollar unmet need.
Core Team & Advisors
- Dr. Daniel Bonthius, MD-PhD
CEO/President of Apex Orthopaedic Technologies and ThorafiX; physician-innovator leading clinical, business, and regulatory strategy. - Dr. Hai Yao, PhD
Co-Inventor; Vice President for Biomedical Innovation at Clemson University; NIH-funded expert in spine biomechanics. - Dr. Stephen Kalhorn, MD
Clinical Advisor; Professor of Neurosurgery at MUSC; national expert in complex spine and deformity correction. - Kelly Ammann, MS
Lead Engineer; mechanical and systems design lead for next-generation rib hook and instrumentation. - Mike Wentz
Development Engineer; CAD modeling, prototype iteration, and tolerance analysis. - BAAT Medical
Development and manufacturing partner with 20+ years of regulatory and engineering experience in orthopaedic devices.
This cross-functional team combines deep clinical insight, proven engineering execution, and regulatory expertise—advancing ThorafiX from concept to regulatory-ready status with strong KOL and institutional support.
ThorafiX will pursue a targeted, surgeon-driven commercialization strategy focused on early adoption by top academic and high-volume deformity centers.
Key Elements
- Seamless Integration
System integrates with existing pedicle screw and rod constructs—no major workflow changes or capital equipment required. - Manufacturing & Regulatory Partnership
BAAT Medical ensures scalable, ISO 13485-compliant production. - KOL Network
Leading U.S. spine surgeons actively engaged in design refinement, testing, and first-in-human protocols. - Strategic Relationships
Building alliances with major spine companies (DePuy Synthes, NuVasive, Globus, Medtronic) for future licensing or acquisition. - Long-Term Expansion
Pediatric scoliosis, minimally invasive applications, and integration with Apex Orthopaedic’s Saturn SI decorticating screw system.
This unified platform addresses junctional instability from top (rib-spine) to bottom (sacroiliac joint), positioning ThorafiX to reshape the spine fixation market.
ThorafiX will generate revenue through direct implant sales, distribution partnerships, and eventual licensing or acquisition by strategic spine companies.
Revenue Model
- Initial Sales
Direct sales to hospitals and academic centers post-FDA clearance; compatible with standard systems for rapid uptake. - High Gross Margins
Expected >80%, supported by outsourced manufacturing via BAAT Medical. - Strategic Exit Path
Licensing/acquisition discussions as clinical data accumulates. - Portfolio Expansion
Pediatric applications, minimally invasive variants, and integration with Saturn SI system targeting >$12 billion global spine markets.
Investment Opportunity
ThorafiX is seeking a $700K–$1M bridge round to achieve FDA clearance and early clinical validation for two synergistic technologies:
- ThorafiX rib fixation system (R-FIX) for PJK prevention
- Saturn SI decorticating screw system for sacroiliac fusion
Use of Proceeds
| Purpose | Details |
|---|---|
| Verification & Validation + 510(k) Submission | Complete final testing and regulatory submissions for both systems. |
| Cadaveric & Pilot In-Human Studies | Conduct usability studies and small pilot trials with surgeon partners. |
| Pilot Manufacturing & Quality Systems | Establish scalable production through BAAT Medical. |
| Regulatory Clearance Preparation | Prepare both products for clearance and limited clinical launch. |
This bridge positions ThorafiX for a Series A focused on commercialization, expanded trials, and strategic partnerships—offering a de-risked, capital-efficient path backed by $2.4M non-dilutive funding and a world-class KOL network.
ThorafiX has reached regulatory-ready status with significant de-risking milestones achieved.
Key Achievements
- Design & Testing
Final CAD designs, manufacturing drawings, and bench testing showing significant reductions in junctional strain. - Regulatory Pathway
Acquired predicate device; 510(k) strategy finalized; Breakthrough Device Designation application prepared. - Manufacturing Partnership
BAAT Medical developing ISO 13485-compliant documentation and production. - Funding & Support
$2.4M non-dilutive grants (NIH SBIR, SCRA, NASS); ~$1.4M remaining + $300K pending. - KOL Network
Leading surgeons (Drs. Kalhorn/MUSC, Whang/Yale, Kim/San Diego) preparing cadaveric validation and early human use.
Next steps: final verification testing, documentation, and FDA submission—positioning for first-in-human evaluation within the next year.
ThorafiX and affiliated entities have raised over $2.6 million in non-dilutive funding:
- NIH SBIR grants
- SCRA grants
- NASS grants
~$1.4 million remaining + $300,000 pending. Funds have supported design, engineering, IP, prototypes, and testing. No commercial revenue generated yet.
