David Cash Presents ZKR Ortho at LSI USA ‘23

Transcription  

Hi, everybody, welcome to the afternoon session. My name is Dave cash. I was hired as CEO or CEO of ZKR ortho a few weeks ago, I replaced the much beloved John Barrett, who unfortunately passed away late last year. And before I get going with the presentation, I just want to take a second to acknowledge the attendance of Ban Ki Mehta. mankini is a true med tech veteran. He also joined ZKR after John's passing and it's done the majority of heavy lifting in the C suite so thanks man, Kim. Okay, let's go ZKR on a mission to develop a minimally invasive solution for patients suffering from patellofemoral osteoarthritis

Pat faremo A is the final stage of a degenerative disease, which starts when the cartilage behind the knee that cushions movement that generates as the cartilage is worn away, the nerve endings are exposed, and the load from the joint causes the patients to experience pain. As the disease progresses, friction from bone on bone contact leads to further degen in the joint which causes more pain and invites inflammation to join the party. Bottom line, patients suffering from patfemoa experienced some or all of the symptoms listed on the slide.

So how big is the market? roughly 2% of the US population has pet FOMO a 90% of that patient set manifests the disease on the lateral side of the patella, which is our specific clinical focus set differently. There were 5 million Americans somewhere on the pet fam de Chien pathway. They start treatment with ice and Advil. They end treatment with total knee replacement.

Aging and obesity are the primary drivers of the patfemoa market. Interestingly, two thirds are women. The patient's set is getting younger, and the correlation between the sedentary lifestyle associated with the disease and comorbidities is an increasingly loud part of the conversation.The unmet need identified by the ZKR founders is there's a large gap in the patfemoa treatment paradigm between conservative care on the left and invasive surgery on the right.

Of the 5 million patients with patfemoa a more than half become clinically eligible for total knee replacement annually. But half of that half defer the TK a procedure. That's our target market. Patients looking to safely in durably extend the useful life of the native joint.

The lift procedure is the solution which fills this gap. As the animation shows. The lift implant on loads the Pat Fem joint by elevating the tendon and realigning the patella. The surgical technique was designed for extreme efficiency in an outpatient setting.

ZKR offers an elegantly simple designed to drive or efficiency. The PCAT implant is available in just a few sizes. It is positioned using one proprietary instrument and it is a fixed with three standard can sell his bone screws. The procedure was designed to be performed in conjunction with a lateral release of the patella tendon.

Our primary focus at ZKR is on women and men aged 45 Plus, looking to safely and durably extend the life of the native joint. Our first unmanned trial also suggested FFC in the earlier stages of Cartlidge Regen. But we are choosing to prioritize the patfemoa, a patient for three reasons. First, our signal was stronger. Second, the market is bigger. And third, the efficiency of the lift implant represents at least in part, a slow solution to the orthopedic capacity constraints, which garnered so much attention at double aos two weeks ago, we believe we can significantly increase patient throughput by extending the life of the native joint with a procedure performed in ambulatory surgery center in less than 20 minutes.

The graphs on the right of the slide represent the interim results from our first unmanned trial 18 patients current follow up ranging 17 to 27 months. Patient data suggests significant improvement in both pain and function.

Collectively the data was confirmatory of our clinical hypothesis. The lift implant safely and durably extends the life of the native joint by elevating and realigning the patella.

The pace of our interaction with the agency is quickened in our IDE trial is coming into focus. Most likely, we will utilize a trial which randomizes the lift procedure against tibial tubercle osteotomies.

Most likely we will pursue a PMA pathway to protect our market exclusivity.

Statistical powering and safety thresholds will likely require 180 patients randomized three to one treatment to control the timeline for corporate value achieving milestones, it's fairly clear at this point, the balance of 2023 is focused on IDE approval and a series B fundraise 2024 is all about site activation and payment patient recruiting.

I'm privileged to work with a great team. The founder Jeff Haubrich, is a renowned PET film surgeon from UCSF Ban Ki med I've already introduce we have an incredibly talented engineer named Damien Shula who runs r&d for us and Danny Shear who needs no intro runs clean reg for the company.

In summaries, ZKR offers an elegantly simple solution to expand the continuum of care for the patfemoa patient.

The lift procedure will fill the gap in the pet family treatment paradigm between conservative care and invasive surgery. Further, the efficiency of the procedure will dramatically increase orthopedic throughput capacity, and rebalance Pat Fem care from Recon to the sports medicine suite. That's it. Thanks for your time.