NELA BioDynamics
Offering Innovative Joint Replacement Implant

Today, younger people are facing early joint problems, especially due to the increase of amateur’s sports activities. To elucidate, in the population over 60 years, osteoarthritis is the main cause of joint replacements affecting 10 percent of men and 18 percent of women. On the other hand, in a younger population (<60 years), the main cause of these injuries is traumatic, derived from sports practice and increased physical activity.

Currently, there are two types of implants for joint replacements: cemented, which emerged in the 1950s, and press-fit, which emerged in the ’80s with porous coatings. These implants are fixed by pressure, inserting the implant by impacts. In both cases, before inserting the implant, the bone must be machined by hammering rasps to obtain the implant housing, which is very traumatic. Although results obtained with these implants are good, there are still some improvements to be made in terms of traumatic reduction, increased implantation control, and quality of remodelled bone.

That’s where NELA BioDynamics comes in.

NELA BioDynamics presents a disruptive joint replacement implant that solves the current limitations present in the implantation, service and replacement phases, reducing intervention time, traumatic damage, post-operative time, and the cost of the process. “With NELA implant, we are addressing current challenges, by having an intramedullary modular system that allows adaptation of the initial fixation force to bone condition of the patient and its lifestyle, reducing the traumatic damage and improving adaptation of the implant to the bone due to the use of less rigid materials than those used in current implants on the market,” says Mr. José Expósito-Ollero, the CEO of NELA BioDynamics.

NELA implant is inserted into the canal with clearance and expanded in a controlled manner using a torque wrench, allowing precise control of the fixation force exerted on the bone. The implant eliminates the need to fix the stem by impacts or using bone cement, thus providing a safer and precise method of fixation. “We present a disruptive intramedullary device, with an innovative expandable modular structure combining polymeric and metallic materials. It is a patented modular mechanism, composed by conical bolts in contact with expansion cylinders, joined by a central screw and a pre-stressing nut that generates the compression of the system thus achieving radial expansion,” states Mr. Expósito-Ollero.

We present a disruptive intramedullary device, with an innovative expandable modular system that reduce the global rigidity and enhance the tolerability of the patient to the implant

“This level of control and precision allows the implant to be adjusted or “tailored-fit” as we call it, to a wide range of patients with different lifestyles and levels of activity. However, it is particularly beneficial to the older population, which represents the highest percentage of cases in these interventions, especially derived from osteoarthritis.”

The hip replacement implant is the first application being developed by NELA; however, the company has the exclusive license of two patents that protect a wide range of applications. The intramedullary implant patent has already been granted in the U.S. (US-10568670-B2), and it is in national phases in Europe (EP-3476320-A1). In addition, this patent can be combined with a percutaneous collar also protected by another patent in its portfolio (EP-3517079-A1). The intramedullary implant patent protects all applications that require an intramedullary stem:

1. Endoprosthesis for joint replacement: Replacement of long bone joint after osteoarthritis, fracture, necrosis, etc. Applications: hip, knee, shoulder, elbow prosthesis.

2. Nail for fractures: Stabilization of the long bone fracture zone.

3. Exoprosthesis for limb amputation: Direct fixation of the external prosthesis to the bone.

For the latter application of exo-prosthesis, the implant can be combined with the percutaneous collar patent to reduce stoma infections. In addition, the collar patent has application in colostomies and cystotomies. “We are currently focused on bringing up to the market the hip replacement solution and we intend to develop a complete catalog of applications in the next 8 years in a phased manner,” informs Mr. Expósito-Ollero.

Currently, NELA is at the pre-clinical stage, having performed in silico models, fixation tests on synthetic bone, preliminary mechanical tests, and a pilot test in sheep. Preliminary histological results exhibited a significant improvement in the host’s tolerability to the implant due to a decrease in the peri-implant granulocytic reaction, associated with lower fibrosis and less inflammatory response. During this year and the beginning of 2022, they intend to complete the pre-clinical phase by performing all the required biomechanical and biocompatibility tests and initiate productive validations. By the last quarter of 2022, NELA wants to start a Clinical Trial to obtain FDA approval and CE Mark by 2024-25. “Our international market development plan is focused on countries with the highest volume of potential sales in the application sector. Apart from the U.S., we are currently targeting Europe and Latin America. We also intend to bring to the market other applications protected by our patents in the next 8 years,” concludes Mr. Expósito-Ollero.