FBC Device
Cost-Effective and Hassle-Free ALIF Implants

To this day, lower back pain (LBP) remains one of the leading causes of global disability with high social, economic, and individual effects on people. In the U.S. alone, LBP is the second most common cause of disability in adults and a common reason for lost workdays.

One of the major reasons for lower back pain is disc problems along the lumbosacral joint (L5-S1 disc) of the spine. The lumbosacral joint provides cushioning and shock-absorbing functions to protect the vertebrae during spinal movements. Therefore, it is a vulnerable spot and is often susceptible to traumatic injuries, degeneration, disc herniation, and nerve pain.

Even though the advancements in the medical field have brought forth different treatment options for LBP, the results are often less than satisfactory. Despite the best efforts, treatment options such as spinal fusion (bone grafting), electrotherapy, or traction remain a complicated and excruciating process for patients. For instance, one of the widely accepted treatments for damage to the L5-S1 disc is anterior lumbar interbody fusion (ALIF). However, clinical research have shown that secondary subsidence (collapse of the spinal discs) and the loss of balance are significant complications associated with the lumbar interbody fusion procedure.

So, is there no effective treatment for the lumbosacral joint injury?

Enter FBC Device. The company has developed—FBC 921—a 3D printed titanium implant to help surgeons in re-establishing the individual spinal balance and minimizing the risk of secondary implant collapse. A two-piece component, FBC 921, is the new generation of anterior interbody implant which gives surgeons the ability to continuously adjust the lordosis angle (the inward curving of the lower back) and optimize the correct posture for patients. “The recent trends in lumbosacral biomechanics are rapidly moving in the direction of ‘expandable’ implant designs. Our implant is unique in this category as it focuses on re-establishing the individual lordosis angle,” underscores Prof. Finn Bjarke Christensen, an MD, a Ph.D., and DMSc within orthopedics, and the founder and CEO of FBC Device.

How it all started…

It is important to note that Prof. Christensen was involved in spinal research for more than 20 years before founding FBC Device.

We find excellent performance at follow-ups with regard to both balance correction and functional outcomes in our European product. Furthermore, patients required no revision surgery within five years

Prof. Christensen was also the recipient of the prestigious International Society for the Study of the Lumbar Spine (ISSLS) Volvo Award for his lumbar spine research in 1997 and low back pain research in 2007.

According to Christensen, the idea of FBC Device’s ALIF implant stemmed from the detailed study of the traditional ALIF treatment and post-surgery recovery pattern. In 2005, he attended a scientific conference in New York, where a long-term outcome study of the lumbar total disc replacement (TDR) procedure was discussed. The experts of spinal research revealed a study that, in the long run, almost 60 percent of the patients’ spinal discs ended up fusing after the treatment. Those particular patients eventually showed a better clinical outcome. “This revelation kindled the idea of an implant that could increase the chances of re-establish the natural balance of the spine and thereby also optimise bone fusion,” says Prof. Christensen.

Driven by this understanding, Prof. Christensen founded FBC Device while continuing his professorship and medical practice. In 2010, the early success of the prototype implant in LBP treatment encouraged Prof. Christensen to move ahead with his ground breaking innovation in both EU and the U.S. Today, FBC 921 holds a 510(k) approval, and its IP is protected by 5 U.S. patents.

Creating a New Treatment Opportunity

Most of the expandable spinal implants introduced in the market have complex designs and focuses on height adjustment. While some expandable implants allow re-establishment of the disc height and moderate correction in the lower back curvature, these treatment options can be an expensive affair for both the surgeon and the patient. “When surgeons change the height of the implant, they need to simultaneously find the right curvature angle to support that height. And that’s where many of the implants that are available right now are incapable of correcting the long-term angulation in relation to the height,” states Prof. Christensen.

In contrast, the FBC 921 implant is an articulated two-piece device that offers a full range lordotic angle, where surgeons can determine the optimum curvature of the lower back. A single implant can cover 95 percent of the normal lordosis range. The top component can move freely relative to the bottom until they are locked in place without changing the critical posterior height. Therefore, surgeons can personalize the curvature of the lower back between 9 and 21 degrees, which broadens the scope and feasibility of ALIF. The implant technology allows for improved contact between vertebrae and implant. It enables better load distribution, reduce subsidence, and potentially accelerate fusion. “By offering ample space for a bone graft, our innovative implant brings back the ‘touch’ to the surgeon,” mentions Prof. Christensen. Surgeons can simply adjust the alignment of the device for each patient’s need and lock the two pieces relative to each other. And even after the implant is placed, surgeons would still have the freedom of correcting the lordosis angle. “So far, we find excellent performance at follow-ups with regard to both balance correction and functional outcomes in our European product.

”FBC 921 implant is an articulated two-piece device that offers a full range lordotic angle, where surgeons can determine the optimum curvature of lower back”

Supporting it with Strong Engineer- Surgeon Collaboration

One of the crucial determining factors in FBC Device’s success is the close surgeon-engineer relationship it maintains. FBC Device works with the clients at every step of the design process right from the start, the company’s engineers can reduce the risk of that the implants defects.

The Journey Ahead

FBC Device has already witnessed extraordinary long-term results in its usage in Europe. The surgeons who have used the implant have given extremely favourable reviews of the device and its usefulness. Propelled by this success, FBC Device is now looking to make its presence felt in the U.S. market. Interestingly, Prof. Christensen is now making the company strategy and ownership more open for the U.S. market.

Additionally, FBC Devices is working on a prototype for lateral and oblique spinal implant design based on the FBC 921 implant technology. The company is also looking at a number of other implant prototypes for cervical spine surgery. “Once finalized, these implants will be available in the U.S. through coming partners,” shares Prof. Christensen. With such innovative implants in the pipeline, FBC Device is well on its way to usher into a new era of LBP treatments by progressively redefining the current paradigm.