A Paradigm Shift in Skeletal Reconstruction

Product and Market Opportunities

The TRS technology platform is ideally suited for a variety of important clinical applications. Our long term objective is to partner with major medical device and pharmaceutical companies to develop comprehensive skeletal reconstruction product lines targeted at four distinct markets, including craniomaxillofacial (CMF) surgery, orthopedic surgery, spine fusion surgery, and bone growth factor delivery.

CMF Surgery

This has been the focus of our research and product development efforts for the last several years. Working with our world class Surgeon Advisory Board, TRS has conceptualized a family of advanced bioresorbable implants to address several challenging clinical indications in CMF surgery. For complex CMF skeletal repair or reconstruction, the current surgical gold standard is the use of metal plate and screw systems or the harvest and implantation of autologous bone graft taken from the patient's hip, fibula or scapula. Other indications, such as cranioplasty and dental implant surgery, are currently addressed by the use of harvested bone graft, bone substitutes, or expensive bone growth factor products. TRS implants offer compelling advantages to CMF surgery.

  • For more complex cases, they eliminate the need for autologous bone graft harvest, a secondary surgery that is time consuming, costly, and frequently associated with complications.
  • They do not require the use of metal plates and screws, which are often associated with poor aesthetic and functional outcomes in CMF anatomy.
  • Unlike metal implants, they are bioresorbable and never require a second surgery for hardware removal and the associated costs.
  • They are differentiated by their osteoconductive coating that actively promotes natural bone formation, reducing the need to use bone growth factor products.
complex-cranial-bone-trauma excised-mandible-tumor
Complex Cranial Bone Trauma Excised Mandible Tumor

 

Orthopedic Surgery

In addition to CMF surgery, TRS technology is an ideal platform for the development of differential products in the orthopedic surgery market.

  • For orthopedic surgical procedures to reconstruct large skeletal defects resulting from significant and complex trauma or tumor removal, similar to CMF surgery, TRS implants offer compelling advantages over the use of metal plate and screw products. They have similar structural integrity but, unlike metal implants, they directly promote rapid bone formation and are fully bioresorbable over time, eliminating the need for hardware removal surgery.
  • Soft tissue injury repair is another orthopedic surgery procedure where TRS technology can advance patient care. In this procedure the clinical challenge is to restore a strong attachment of soft tissue structures to bone, a common requirement in rotator cuff repair surgery as well as reconstructive surgery for knee ligament repair. TRS implants are perfectly suited for this application given the accelerated bone growth and integration promoted by their unique osteoconductive coating.
  • TRS coating technology can also be applied to metallic hip and knee replacement implant systems to accelerate bone formation around their fixation stems and strengthen permanent attachment.
long-bone-tumor-resulting-in-fracture rotator-cuff-re-attachment-to-bone hip-replacement-implant-anchored-in-femur
Long Bone Tumor
Resulting in Fracture
Rotator Cuff
Re-Attachment to Bone
Hip Replacement
Implant Anchored in Femur

 

Spine Fusion Surgery

Although the last decade has witnessed the development of new implant technologies intended to displace conventional spine fusion surgery, fusion remains the gold standard therapy for serious degenerative conditions of the cervical and lumbar spine. There are a variety of implant technologies and products currently marketed for insertion into the disc space as part of the spine fusion procedure. These include metallic cages, spacers made of inert, non-metallic materials, and dowels constructed from cadaveric bone. While fusion implant technologies and insertion procedures may differ, their common purpose is to stabilize the disc space and maintain proper spacing between vertebral bodies while bone growth occurs to form a solid bony bridge that fuses the two vertebra together. Spine fusion implants constructed from TRS technology have several important advantages.

  • Like current metallic ages and spacers, they are strong enough to maintain proper vertebral body spacing and can readily be constructed into any desired shape in order to optimize ease of insertion.
  • Unlike metallic cages and spacers. they are bioresorbable over time, so no foreign material remains in the disc space once the fusion process is complete.
  • As opposed to current cages and spacer products constructed from inert materials, they are differentiated by their osteoconductive coating and ability to bind and time-release bone growth factors to actively promote bone formation, which is the key to achieving successful and permanent spine fusion.
  • They deliver bone growth factors locally, and in a more controlled fashion, lessening problematic side effects such as heterotopic bone formation and systemic dispersion of the growth factor.
  • They closely resemble cadaveric bone dowels in both form and function, but are synthetic and do not have the sourcing, variations in quality, processing challenges, or expense associated with the use of cadaveric material.
interbody-spine-fusion-cage
Interbody Spine Fusion Cage

 

Bone Growth Factor Delivery

Bone growth factors offer important clinical advantages and patient care benefits. However, they are also associated with problematic side effects. Most of these side effects stem from the use of direct application or collagen sponges to deliver the growth factor. These delivery techniques result in dosage variances and bolus release which can lead to unwanted dissipation of the growth factor outside of the desired delivery location. To make growth factors safer, there is an urgent need for improved delivery techniques that eliminate bolus release, lower dosage requirements, contain delivery to the target area, and prevent systemic dissipation. Another limitation of current growth factor delivery strategies, like the use of collagen sponges, is the lack of structure. Structural implants that carry and deliver growth factors have the potential to significantly expand the opportunities for their use as well as optimize outcomes.

Our research has clearly demonstrated that coated TRS scaffolds serve as an excellent substrate for adhesion and local, controlled release of bone growth factors. TRS technology can be used to construct structural carriers uniquely and specifically suited for a wide variety of clinical applications. TRS also has research experience with, and patents covering "microsphere" technology that binds growth factors and delivers them via injection with the same controlled release advantages. In summary, TRS technology represents a significantly improved and safer delivery vehicle for bone growth factors that can expand their indications and market adoption.