Introducing FibulaXpand: An Innovative Solution Revolutionizing Bone Repair
With FibulaXpand, we have developed a groundbreaking approach to repair severely injured limbs, potentially saving them from amputation. Our innovative system enlarges the diameter of a bone and grows an autologous bone graft within the patient's leg, enabling a faster recovery and return to daily activities.
Vadim's Story: One Fate Among Many Others
Meet Vadim, a 21-year-old Ukrainian soldier who sustained a severe leg injury during the Russian invasion. Despite surviving, his right shinbone was shattered, leading to a severe infection. Conventional treatments suggested amputation, devastating news for someone so young.
There are methods to spare him from amputation. However, for many patients like Vadim, the traditional method of bone lengthening presents significant challenges. This method requires a metal frame to be placed outside the leg fixed to the bone with wires that penetrate the skin.
The Main Drawbacks:
- Extended Healing Time: Vadim would need to live with the external frame for approximately two years until his bone fully heals.
- High Complication Risk: The metal frame significantly restricts movement and increases the risk of new infections.
- Daily Discomfort: The frame would prevent Vadim from wearing normal pants and force him to spend most of his time in a wheelchair.
Understandably, Vadim was appalled by the prospect of this cumbersome and restrictive treatment, which would greatly impact his quality of life for an extended period.
However, with the FibulaXpand technology, there is hope for Vadim to regain full use of his leg quickly.
Innovative System for Fibula Expansion
To perform the FibulaXpand procedure, a specialized system is required to expand the fibula, a non-weight-bearing bone next to the tibia in the lower leg. This system, developed exclusively by us, addresses a significant gap in current medical technology. The core of our design is a cylindrical balloon that gradually expands by introducing small amounts of liquid with a syringe through a port.
We have successfully implemented this concept in physical prototypes and proved its viability and effectiveness by rigorous mechanical and biomechanical testing.
The FibulaXpand Process
Now, let us see how the expansion system is applied. As mentioned, our method known as "Fibula Expansion" leverages the body's own fibula. By expanding the fibula within the patient’s leg, we can increase its diameter allowing for the creation of a robust bone graft.
This is how it works:
- Insertion: The whole system is implanted in the leg and the balloon, initially without any liquid, is inserted into the bone gap created by first halving the fibula.
- Bone Formation: As new bone tissue forms in the gap, similar to the healing of a broken bone, the balloon remains in place.
- Expansion: Afterwards, over 10 days, the balloon is gradually expanded by adding liquid in several steps each day, stretching the formed bone tissue (callus) and increasing the fibula's diameter.
During the expansion a spacer is placed in the to be constructed bone gap (here in the tibia). After expansion, the fibula is resected, the spacer is removed and the graft is trimmed to the defect length and then implanted into the bone defect. Stabilization is achieved with an intramedullary nail. The reconstructed bone can heal afterwards to reach its original strength after a few months.
This completely internal procedure significantly reduces treatment time and complications, promoting faster and more comfortable healing in comparision to external procedures. The whole procedure, from resection of the affected avital bone segment due to infections or tumors to full reconstruction, is illustrated in the following:
Explore the Scientific Background
For those interested in the scientific foundation of FibulaXpand, explore my PhD thesis and related publications via the following links:
Key Benefits of FibulaXpand
Patient Advantages
- High comfort and early mobilization
- Quick return to daily routine
- Short hospitalization and low reinfection rate
- Minimal external disturbances avoiding bulky fixators
Medical Procedure Benefits
- 100% internal procedure using the patient’s own bone material
- Standardized and streamlined operation
- Reduced medication requirements
Product and Operational Efficiency
- Cost-effective off-the-shelf products with high margins
- Low development and usability risk
Market and Financial Advantages
- Secured international patents
- Additional reimbursement opportunities
- Niche market with strong connections among leading experts
Hospital and Surgical Efficiency
- High throughput rate and predictable surgeries
- Cost-effective with reduced per-case expenses
Expert Endorsements
FibulaXpand is recognized by clinical experts as a highly promising device within a specialized niche market. Strong networking among surgeons internationally ensures rapid dissemination and adoption of our innovation.
Achievements and Milestones
We have made significant strides in the development and validation of our innovative bone repair technology. We have successfully secured intellectual property rights ensuring our unique technology is protected. Rigorous testing has been conducted with positive results in both initial and advanced animal models. We have developed prototypes designed for human use and validated them through comprehensive testing and biomechanical simulations. Our collaboration with leading experts in the medical field has been instrumental in refining surgical techniques and enhancing the application process. Additionally, we have thoroughly evaluated suppliers to ensure the availability of high-quality components necessary for the next phases of development.
Next Steps
We are poised to begin pilot series manufacturing followed by thorough testing and validation. Preparing detailed technical documentation for regulatory submissions will pave the way for clinical studies essential for real-world medical application and subsequent certification and market entry.
Market Potential
Our market research indicates a potential annual market size of €250M - €500M across the EU, US, and Japan. Similar technologies such as InSpace by OrthoSpace have achieved significant market success, with Stryker acquiring OrthoSpace for $220M in 2019.
Investment Opportunity
We are seeking investors to fund the next phases of our project, including clinical studies to establish clinical evidence and achieve market entry.
Join Us in Revolutionizing Bone Repair
Ready to invest in the future of bone defect treatment? Contact us today to learn more about this unique opportunity to transform lives, including the clinical & technical background, the market, and the business case behind it.
Invest in FibulaXpand and be part of a revolutionary change in orthopedic surgery, offering hope and enhanced quality of life to countless patients like Vadim.
Reach out to us and make a lasting impact by investing in something meaningful with a promising return on investment.
Best regards,
Andy