about

PFD iOrthopedics (PFD/iOI ) is the developer of a unique spine cage technology called the Universally Expanding Cage (UEC) and has developed its first product candidate utilizing the technology named the GOBI™ Spine Cage. The GOBI™ Spine Cage is one of the first to have the ability to be adjustable on both the distal and proximal ends of the cage in order to allow a surgeon to provide an exacting fit to a patient suffering from lumbar spinal issues such as a ruptured or compressed vertebra.

about

PFD iOrthopedics (PFD/iOI ) is the developer of a unique spine cage technology called the Universally Expanding Cage (UEC) and has developed its first product candidate utilizing the technology named the GOBI™ Spine Cage. The GOBI™ Spine Cage is one of the first to have the ability to be adjustable on both the distal and proximal ends of the cage in order to allow a surgeon to provide an exacting fit to a patient suffering from lumbar spinal issues such as a ruptured or compressed vertebra.

background

PFD/iOI developed a proprietary technology for orthopedic spine cages utilizing a patented technology called the Universally Expanding Cage (UEC). The technology was created in 2015 to meet the need for a better orthopedic hardware device that could provide patients suffering from lumbar back issues due to damaged vertebrae, a greater chance of healing in order to relieve pain and regain mobility. Their first product candidate, the GOBI™ Spine Cage, is the result of this work. In 2018 it was discovered a competing orthopedic hardware company had gone to market with a device that seemed to incorporate some of the key differentiating aspects of the PFD/iOI patented designs. Because this seems to be an infringement of the patent portfolio IP, PFD/iOI has begun to investigate a potential remedy for relief by filing an infringement cause of action against this company. If successful, PFD/iOI hopes to gain a judgment for the lost market revenue since the infringing company began to sell its product. In addition, PFD/iOI hopes that a successful outcome in such a cause will clear the path forward for them to finish development and either sell or market their GOBI™ Spine Cage technology.

vision

The UEC technology and the GOBI™ Spine Cage product candidate are the results of the innovative vision of Dr. Thomas Grotz. Dr. Grotz is a noted orthopedic surgeon who has developed several novel inventions for advancing orthopedic care for a variety of patient issues. The UEC and the GOBI™ Expandable Cage are just two of those inventions that were created to provide an orthopedic surgeon a better alternative than current similar hardware provides.

The current expenditure for back surgery in the US exceeds $11 billion annually in which the spine cage hardware market is a large participant. As the UEC and the GOBI™ Spine Cage offer a distinct advantage it is PFD/iOI’s desire to finalize its development, regulatory, and validation work in order to be able to position the IP for either purchase by a large player already in the industry or to pursue commercialization of the resultant product technologies.

The current infringement issues pose some challenges to this goal as PFD/iOI needs to make sure its IP is secure prior to moving to a purchase agreement or market strategy.

In addition, PFD/iOI feels it has suffered a significant loss due to the sales of the infringing company’s product and wishes to seek a remedy for such loss.

innovation

The UEC and the GOBI™ Spine Cage are unique in their product category as they are one of the first to provide both distal and proximal end adjustments for the positioning of the spine cage. They are the first technology to utilize the key mechanical differentiators that Dr. Grotz has created to make this technology workable. It is estimated that up to 40% of back surgeries fail because the implant does not create a solid connection between damaged vertebrae in order for proper fusion to take place. The UEC and the GOBI™ Spine Cage have the potential to dramatically lower this high failure rate percentage and provide patients with lumbar spine issues with a much better outcome.

The UEC and the GOBI™ Spine Cage

The UEC provides a novel innovative advance for expandible spine cages. The technology for the UEC is the first to use unique mechanical design features that allow a surgeon to adjust both the upper and lower lifting plates of the cage at both ends independently in order to provide a precision fit specific to a lumbar spine patient’s needs. This innovation promises to provide better potential for fusion and bone growth to occur in order to provide long-term relief for the patient.

OVERVIEW

Expandable Spine Cages offer orthopedic surgeons a vertebral body reconstruction solution that combines rigid anterior (front) spinal column support, excellent fixation into the vertebral endplate, adequate room within the cage for bone graft, and generally unmatched ability for distraction (surgically created space) and sagittal (lordosis, standing upright) alignment. Though there are many expandable spine cages on the market, none have the ability for complete independent fine-tuning of the adjustment height of the distal and proximal ends of the device. 

The UEC and the GOBI™ Spine Cage have incorporated a mechanism that allows the lower lifting plate to have a proximal lower angled lifting portion along with an upper lifting plate having a proximal upper angled lifting portion that can be independently adjusted to correct deformities in the spine in order to stabilize the spine and allow solid fusion of the vertebrae to occur.

FEATURES

The UEC technology IP has the following unique patented differentiators in its design:

  • An expandable lower lifting plate and an upper lifting plate
  • A distal and proximal lifting block
  • A rotational block with a lifting screw, and a locking nut.
  • The implant is configured so that the lower lifting plate and the upper lifting plate can be closed in both a proximal end and a distal end, opened at only the proximal end or distal end, or opened in both the proximal and the distal end.
  • The implant is configured to allow up to 50% expansion between the lower lifting plate and the upper lifting plate.
  • The implant utilizes a method for dis­tracting adjacent bone segments having opposing surfaces comprising inserting one or more of the expandable medical implant of the first embodiment between the opposing surfaces of the bone segments.

PFD/iOi and PFD

PFD Management has identified the PFD/iOI UEC technology infringement matter as one of the five Medical Technology companies to include in the PFDMOF3001 Opportunity Fund, LLC. PFD Management believes that PFD/iOI will be successful in their action against the infringing medical hardware company and their subsequent move to a commercialization event with the UEC technology and the GOBI™ Spine Cage product candidate will occur within the fund’s time frame. To learn more about the specifics of this component of the fund, register for access at our Membership Portal.