At that moment, the expanding spine cage family was born.

Overview of the path to the current cause – A Brief History

PFD/iOI has determined that a legal cause can be entered into because of patent infringements by a large publicly traded medical device company to PFD/iOI’s Universally Expanding Cage ™ (UEC) technology. The path from the invention’s beginning to the possible infringement is a two-decade-long story. Here is a brief look at how PFD/iOI has evolved to this point.

Later that evening, after the lecture, Dr. Grotz shared with Dr. Berven some of his history including how he had earned three Stabilizer for Human Joint patents along with three FDA 510k clearances and had performed the first-in-human studies for the Stabilizers at St. Francis Memorial Hospital. This work set his orthopedic inventions’ commercialization precedent and launched Dr. Grotz on his path to finding ever better orthopedic device technologies to help patients; a passion that continues to this day.

Dr. Grotz further shared that his wife, who was also his office manager, had helped him create his beautiful office in the penthouse suite of a nearby building on Van Ness in San Francisco, California and it was there that he and his staff of ten cared for patients, scheduling more limb reconstructive surgeries than most other SF orthopedic surgeons combined.

Intrigued by this, Dr. Berven asked if he might visit the office sometime to which Dr. Grotz replied, “How about right now?” They proceeded to the office and a conversation ensued that lasted well into the early morning hours. The two discussed many things,

• Dr. Berven was curious about how Dr. Grotz had made it to the top with his San Francisco practice, and his passion for inventing.

• Dr. Grotz was equally curious about how Dr. Berven had become the top spine surgeon at UCSF, which so happened to be Dr. Grotz’s alma mater.

One area of questioning was Dr. Grotz’s curiosity about why Dr. Berven liked spine surgery as it seemed to him that success was minimal as half the patients still had post-operative pain.

Example of a BAK Cage

This is when the conversation turned to how spine patients with disc pathology were treated. Dr. Berven explained how patients with ruptured discs were treated by removing the bad disc and then inserting a metal spacer along with a bone graft to replace the injured area. This technique used what was called a spacer as the BAK cage, which in essence was a metal conduit with external threads.  Though sometimes successful, if too small, the cage would move around which minimized the chances of it effecting healing, because it did not fuse into place. Conversely, if the BAC or evolving yet static cage implant were too big, the device could cause nerve or vertebral endplate subsidence. At this point, Dr. Grotz asked what may happen if one could insert something that “gets big” filling the space precisely. Such a device, once implanted, would immediately press against the opposing vertebral endplates, and create a better fit, and a higher potential for proper fusing known as arthrodesis. It is worth noting at this point that with any boney fracture, osteotomy, or fusion when any type of hardware is inserted, either the hardware/bone interface heals, or the operative treatment fails. In essence, the principle is, “No motion, no pain”. Dr. Grotz postulated that holding the bones together with an expanding implant device would lead to a better fusion potential, and therefore no pain. At that moment, the expanding spine cage family was born. A solution that would combine dynamic physics, engineering, and clinical need toward better patient outcomes.

2007 Patent for the LEC

Dr. Grotz spent the next few months with a bright prototype engineer named Rudy Pretti developing and trying out many expansion ideas. These trials included taking the standard BAK cage and cutting it at every other end so that it resembled a Chinese finger trap. It was from this work that the first device, called the Linear Expanding Cage (LEC) was created. The first patent for this expanding spine cage was filed and granted but development beyond this prototype stage was never commercialized. Dr. Grotz and his team, under the banner of his Innvotech Surgical company, then moved toward creating the next generation of a better spine cage. This device was called the Selectively Expanding Spine Cage (SEC) and is built upon a hydraulically controllable mechanism that allowed tiny pistons that when injected with saline during the surgery, would elevate up a circular stairwell allowing the spine cage to expand into a tight fit position. An additional patent on the SEC was filed and granted and after a year of testing, John Barrett, the CEO of Innvotech Surgical, was able to get the attention of Casey McGlynn, Esq.,  the top patent attorney at Wilson Sonsini, one of the largest law firms in the United States that specialized in business, securities, and intellectual property law patent, to refer the work on the SEC to Alloy Ventures, Inc.  Alloy Ventures, Inc, was a venture capital firm that invested primarily in early-stage information technology, cleantech, and life sciences. Alloy was immediately interested and arranged for one of their principals, Doug Kelly, MD, along with John Barrett to go to UCSF to talk with Dr. Berven. During this meeting in surgery, Dr. Berven concurred that the efficacy of the SEC device was merit worthy. Over the next several years, the development of the SEC continued, and the first-in-human trials were done in South Africa, followed by 1000 successful patient surgeries around the world, using the SEC implant. The results of these trials were clinically impressive, and the SEC began to draw the attention of several large players in the orthopedic hardware space. Innvotech Surgical, which held the intellectual property rights for the SEC was renamed CoAlign Innovations and the SEC was rebranded as AccuLif.  Medtronics had invested in the R&D. Soon thereafter a deal was negotiated that allowed Stryker Corporation, a multinational medical technology company based in Kalamazoo, Michigan to purchase CoAlign along with all its IP including the AccuLIf cage.

After the sale, Dr. Grotz was invited to discuss in an industry magazine, OrthoKnow, Strategic Insights into the Orthopaedic Industry, what further improvements might be made for an ideal orthopedic spine device to maximally correct and control spinal deformities. In the article, Dr. Grotz discussed the concept of a Universally Expanding Cage (UEC) that could be inserted at any angle and be adjustable to precisely change spine angulations to correct issues such as scoliosis and kyphosis. A provisional UEC patent had been filed. In addition to this article, Dr. Grotz also entered into a conversation with K2M Stryker where he presented several ideas and offered to partner with them. The company however was not interested in pursuing a relationship. Dr. Grotz went ahead and pursued the development of this spine cage with his new company called iOrthopedics, Inc. (iOi). The next-generation development of the SEC was realized, and Dr. Grotz and iOi pursued new IP protections for what they called the Universally Expanding Cage (UEC). A patent was filed and granted that described a spinal arthrodesis implant to manage pathologic anatomy in deformity and scoliosis, wherein a spine cylindrical or rectangular spine cage could expand at either or both ends, axially controlled, for best surgical results within the three-dimensional human construct. It was this advancement of thinking, with the UEC expanding in variable planes to match patients’ needs, that evolved from a simple up or down Acculif disc space arthrodesis implant to a UEC multi-directional fixation device and surgical method, for improving patient outcomes.

.Dr. Grotz attended an American Academy of Orthopedic Surgeons convention in Las Vegas, Nevada where he saw a spine cage produced by K2M called Mojave which used very similar designs to the UEC. Dr. Grotz built upon his own UEC invention, to create the latest iteration now called Gobi™. iOI began to make plans for its commercialization. In 2018, Stryker purchased K2M and introduced to the market the Mojave technology as the Stryker PL 3D Expandable Interbody System. The device, which had received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) in June 2017, was touted as “The first-of-its-kind fusion device designed to allow for independent control of the anterior and posterior heights in the lumbar spine.” In discussion with reps at the Orthopedic meeting, Dr. Grotz learned that although there was a 510k, no patents had been issued for the Mojave Cage, moving toward the Stryker PL 3D Expandable Interbody System.

STRYKER’s Mojave spine cage next to the iOrthopedics GOBI™ Spine Cage.

—- Per K2M

“The launch of the MOJAVE PL 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology marks a significant advancement in expandable interbody technology,” said K2M Chairman, President, and CEO Eric Major. “Its infinite adjustment and comprehensive height and lordotic expansion capabilities provide surgeons with a more flexible means to facilitate 3D sagittal balance in their patients. We are proud to reiterate our commitment to excellence in 3D spinal innovation by inventing new solutions, that when supported by our Balance ACS platform, allow spine surgeons worldwide to facilitate quality outcomes in their patients.”

Thus, Dr. Grotz’s ideas, which had been patent pending since 2014, had been commercialized by K2M/Stryker. It was at this point that PFD/iOI began investigating whether K2M/Stryker’s Mojave/PL 3D Expandable Interbody System had constructively utilized the key differentiator of a spine cage applying intervertebral space expansion at either or both ends, controlled by an axial inserter through a proximate wound, in their technology.

PFD/iOI believes there is patent infringement by at least one of the offending company’s devices.

To the extent the PFD/iOI legal team can prove this and show damages, the case will be awarded in our favor. PFD/iOI owns the patents covering the expandable spine cage designs and methods of surgery for the market even beyond the UEC technology and believes it has been damaged for approximately five years by K2M, and the offending company.

PFD/iOI’s intent is to seek recovery of those damages and/or to sell the IP.