innova® OSTEOSYNTHESIS IMPLANT

This innovative osteosynthesis is created using metal sheets molded around the fractured bone to maintain the broken parts in position and secure them with clamps. It differs from the current method of screwing plates into the broken bone. This new approach is more cost-effective, reduces surgery time, and minimizes trauma.

What makes this implant apart?

The metal sheets are custom-molded to precisely fit the dimensions and shape of the frac-tured bone. Channels and bas-reliefs are integrated into the sheets to enhance resistance to bending, torsion, and shear stresses. The number, position, and orientation of channels are determined based on stress vectors specific to each type of bone and fracture. Clamps are then inserted into the channels around them to keep both the bone and metal in place dur-ing the healing process, eliminating the need for screws.

The strength and stability of the broken bone parts are optimized for each bone type and fracture through a combination of channels, clamps, positioning, orientation, and the caliber of the sheet metal.

The metal sheets contain openings that allow for viewing of the fracture during surgery and follow-up checks. Micro-support protrusions are used to prevent direct contact between the sheets and the bone. The contact area of the new implant and the bone is smaller compared to traditional implants with plates and screws, allowing the bone to maintain its physiological properties.

This personalized approach ensures an exact fit and superior mechanical performance. Var-ious methods and computer applications are available to achieve optimal mechanical per-formance using minimal implant material. This innovation paves the way for algorithms that can provide a standardized pattern for each bone type and fracture.
The physical mechanical advantages incorporate advanced technologies in design, manu-facturing, surgery planning, and operation. Imageology, finite element and optimization methods, and 3D modeling are utilized from the initial image of the fractured bone and sur-gery planning to assist the surgeon during the surgery, displaying on a screen the effect of clamps, the appropriate tension of each, and the position. The surgeon can visualize the entire procedure and make adjustments until an optimal outcome is achieved. While it may sound like magic all the tools incorporated are readily available nowadays.

In summary, this new implant additionally features:

1. CAD, FEM (breakage, torsion, bending); optimization methods, algorithms, and imaging for design, manufacturing, and during surgery. Also, Artificial Intelligence and robotics.
2. Assists surgeons in planning and during surgery in aligning fracture and tensioning clamps using real-time images.
   

Business Potential

This new implant has significant market potential due to its lower production cost, lack of screws, reduced invasiveness, and shorter surgery time. Attaching this implant to a fractured bone is easier and quicker with clamps than with screws, saving 30 to 50% time in the oper-ating room. The molding process provides an exact fit to the bone and fracture; it is a simple computerized process and implants can be categorized by bone type and fracture, similar to current plates.
This implant has the potential to reduce costs by 50% compared to screw implants because it uses less material, has a simpler manufacturing process, and requires lower investment in machinery, materials, and labor. The machines used for cutting and forming metal sheets are simple, inexpensive, and compact. Mass production does not require large investments. Additionally, being lighter than plates and screws, it is more cost-effective to transport and distribute.

The market for this type of implant generates approximately US$12.5 billion in sales annual-ly and is expanding. Factories in various countries airship their products to customers, while smaller producers supply local clients and also engage in export. The current plates and screws system is dominated by major companies such as Johnson & Johnson with Depuy, Zimmer Biomet, Stryker, Medtronic.

Manufacturing and Distribution of the New Osteosynthesis Implant

The production of the new osteosynthesis implant is simpler than casting and polishing plates, making holes, and machining screws, and it costs less. Manufacturing requires small, simple, low-cost machines, initially manual and later can be automated. Like the current implants, there will be options for each type of bone and fracture, delivered in appropriate packaging to surgeons, hospitals, clinics, and health centers. The metal sheets needed to produce the new osteosynthesis are available in the marketplace, and the clamps are made of surgical steel, also readily available.

Development Status

Epic has designed and developed the implant, prototypes, machines, and construction drawings, and will provide all this information to interested investors or companies for nego-tiation. Research on the manufacturing process is currently being conducted by universities.

Status of IP Protection

A patent has been granted in Colombia (2021-2041) and patent applications are in progress in China and the United States.

Investment Opportunity

We are seeking investors and companies to capitalize on the commercial potential of this new implant. We are open to joint ventures, production licenses, and partial property sales. We will share designs of machines, production and marketing strategies, construction plans, and cost estimates.
Contact Us. We would be happy to provide more information