Thank you, I'd like to present these results to you, and I'd like to acknowledge all my colleagues and co-authors in this presentation. We're all very well aware of the fact that the dysfunctional meniscus or absence of the meniscus leads to an increased load concentration of the joint, which ultimately can lead to an early need for replacement of the affected compartment of the knee joint. We're also very well aware that a lot of patients do not want to have a joint replacement, and there exists a treatment gap in between having a meniscectomy and having the need for a unicompartmental or total knee replacement, with younger patients having a higher lifetime risk of revisions. So the question becomes, what do you do for patients who have pain after meniscus surgery that are too young and don't have enough articular cartilage injury to have knee replacement, or yet are too old for cartilage repair or allograft treatment? A new solution to this old problem is the new surface artificial meniscus. This meniscus implant is designed to mimic the function of the natural meniscus by dampening loads transmitted through the knee joint. It is an interpositional, non-anchored implant, and therefore is free to translate as the knee moves and is anchored between the compression forces of the femur on the tibia. It is also made of cartilage-friendly material and is designed that closely mimics the natural meniscus, as can be seen in these MRI images. The surgical procedure for insertion is very straightforward and involves a preparation of the joint arthroscopically of the meniscal rim, a small medial arthrotomy with placement of the implant. You can see here on fluoroscopy how you can see the meniscal implant moving as the knee translates through flexion and extension. Our study combined two studies, the SUN study, which was a single-arm study, and the VENUS, which was a randomized controlled study. We created then the MERCURY study. The inclusion criteria were knee pain post-mendiscectomy that failed prior to surgery. Exclusion was grade four cartilage lesions or increased varus deformity of the knee joint. We had various time points for follow-up and was done at 23 clinical sites. The key endpoints were the COOS pain and COOS overall score at 24 months, with a 20-point improvement defined as clinically significant for FDA purposes. This is an outline of where the studies were done. The combined study group you can see here, the average patient was a 50-year-old male with two-plus knee arthroscopies, had previously used oral anti-inflammatories, had intra-articular injections, and had grade two to three cartilage damage. When we looked at the COOS pain score, we could see a compelling statistically superior result starting at six months between the implant group in the MERCURY study and the control group that was sustained over 24 months. In the COOS overall score, we also saw the same type of improvement, again, starting at six months and continuing on through the course of 24 months. Interestingly, heavier patients reported a greater pain relief, ranging up into 30 points in some patients. And also, this was distributed throughout a complete age group ranging from the 30s to the 60s, with all demonstrating significant improvement in COOS pain scores. Very importantly, the implant itself maintained the articular cartilage while reducing pain. At 24 months, the control group had an increased percentage of exposed bone by MRI, while the new surface implant group had actually slightly less bone exposed by MRI at 24 months. This was confirmed both by MRI and when needed, intraoperative findings of the chondroprotective effect, as can be seen here. Interesting patients with multiple arthroscopies represented probably the largest unmet need. And you can see that patients that had one previous meniscectomy versus more than one all maintained statistically significant improvement, ranging out to 24 months. Patient accountability in the implant group, 90% of the new surface subjects completed their 24-month follow-up. Our key clinical findings, 84% of the new surface patients experienced at least a 10-point improvement, 69% of these patients met the 20-point improvement threshold as well, 89% of the new surface patients finished their 20-month follow-up, and 70% of the patients required the use of only one implant. In addition, some clinically unique findings that statistically superior pain relief beginning at six months, that obese and older patients had a higher response rate, that patients with replacement implants were able to repeat their superior results the second time after their revision surgery. And finally, that the MRI evidence of the new surface preserved the femoral articular cartilage, noted in MRI as the superiority in cartilage condition, decreased bone marrow edema, and maintenance of joint space as compared to controls at two years. Thank you.

surface artificial meniscus

treatment

pain relief

knee joint

implant