David Cash, ZKR Orthopedics - Minimally Invasive Surgical Alternatives | LSI USA '24

David Cash  0:04  
Good afternoon, Dave cash CEO ZKR Orthopedics. Our mission's to create a minimally invasive treatment for patellofemoral cartilage degeneration and osteoarthritis. Talk about what we'll cover today in the presentation. Sore kneecaps. The number one reason patients visit an orthopedist in the United States. Our founder Dr. Jeff haubrich, invented a treatment for unloading the patellofemoral compartment to treat very sore kneecaps. At a conservative price point. These patients represent an annual revenue opportunity of about $2 billion existing codes provide lucrative reimbursement for the surgery center and physician. Data from the first inhuman trial 18 patients conducted by Dr. Conrad xlnr ski in Warsaw, Poland demonstrated improvements in pain and function. This data was sufficient to get an approval from the agency last month to enroll a 250 patient IDE trial. We have subsequently signed up Kayo wells and invest investigators coast to coast we'll talk about that. Lastly, we are raising $20 million Series B to finance the IDE trial, conduct pre market activities and expand the technology platform pediatrics and patellar instability. All right. Kandra Malaysia patella. It's a Latin term mean sore kneecaps? No, I'm just kidding. softening of the cartilage. It's a very prevalent disease. 70 million Americans have reported pet Phantom Pain, approximately a million treated annually. Our specific focus is on later stage cartilage degeneration specifically Outerbridge grades three and for said differently and in an analogy we like to use. When the cracks and potholes show up in the pavement, we have an elegantly simple repair that extends the life of the native joint current treatment paradigm. Nearly a million patients a year are treated conservatively starts with Advil, ice bracing, progresses to injection therapies. Kandra plasti is cleaning up the edges of the potholes. microfracture. And then the late stage is obviously knee replacement. Our specific focus is between conservative care and late stage. The lift implant is an elegantly simple technology which unloads the compartment by elevating and realigning. patellar tracking. I'll say that one more time, we unload tele femoral compartment by elevating and realigning. patellar tracking. The mechanism of action is fairly simple. We unload the compartment by proximal proximally by elevating the tendon. Further the geometry of the implant realigns it from lateral to medial damage image here, the red represents the lesion. It's the same lesion and multiple planes represented here. In the second image, you can see the implant elevates the tracking of the patella up above the lesion. In the axial plane which represented by the third again same lesion location 90 to 95% of the time we tend to see lesions manifest and pet femme disease on the lateral set and the geometry of the implant. In addition to elevating slopes lateral to medial it mimics the effect of a Fulkerson osteotomy. A couple of renderings here I like the one on the far right, that shows the geometry inflection again elevation and lateral to medial realignment. Okay, evidence that it works. We conducted an 18 patient trial, Warsaw, Poland, all patients received the lift implant and we measured follow up out to two years. The graphs on the right, we improved pain 62% from baseline. We improved function 29% from baseline. Further, we saw the most amplified clinical effect in the second sickest Patients those with full blown osteoarthritis great for Outerbridge. Importantly, two things. One, the number one safety metric we need to evaluate is influence on the tendon. We saw no evidence of necrosis, lengthening, shortening Alta or Baja. So from a tendons safety point of view, there were no issues reported. Second, none of the 18 patients progressed to total knee or partial knee replacement. Most of them are out to three years at this point. Market summary, we'll dive into the details in subsequent slides. We believe there are 600,000 existing surgeries in the United States annually on patients with patellofemoral disease. We forecast an ASP of approximately $4,000 representing gross margin profile of 95%. inclusive of a single use instrument set existing codes provide reimbursement. Here are the details of our market quantification work. It's worth noting that of the earlier stage intervention, the lift technology may be used can competently with Kandra plasti graft procedures and microfracture. Additionally, we believe that lift will become standard of care prior to Unicompartmental knee replacement. As we think about ASP, we position slightly above the osteotomy sets that are available in the marketplace and well below primary knee implants. Interesting note, the Misha device which recently gained approval is out there between eight and $10,000. ASP it's a very similar device and that it unloads the neighboring compartment of the knee. Listed here are the existing reimbursement codes 27422 For patellar realignment is a long standing code attach there are the fees are shown there are the fees for the physician in the surgery center. It's worth noting the physician fee associated with that code substantively equal to the much longer and more invasive near arthroplasty. Our ID trial was approved last month. It's a 250 patient trial non inferiority design. propensity matched where we will compare the lift technology to tibial tubercle osteotomy. Interesting, very high probability of success based on the revision rate associated with DTOs. We've signed up the institutions displayed a nice mix of brand name institutions academic centers with various community hospitals. We are enrolling the treatment arm in the US and the TT o RM in the EU. From a timeline it'll take us six to seven quarters to enroll the trial and then two year follow up. We have breakthrough designation accelerating the approval process. The differentiation from the IDE data coupled with a very strong IP portfolio positions as well for an exit prior to commercialization if we have to go it alone 95% gross margins and a $3,000 price point provide sufficient momentum to commercialize independently. We'll get into the details but we have a strong and growing IP portfolio. strong management team and the series B raise $20 million to finance the IDE the approval pre market activities and expand the product platform to teller instability in pediatrics. Don't hesitate to comment contact me with any questions. Thanks