Aleks Cukic - Vice President, Business Development and Strategic Planning
Analyst
Thank you, Marshall. During the second quarter, we sold 85 da Vinci systems; 66 in the United States, 14 in Europe and five in rest of world markets. A total of 6 systems were part of sales, trading transactions. The net 79 new system installs brings to 946, the cumulative number of da Vinci systems worldwide; 710 in the U.S., 159 in Europe and 77 in rest of world markets. 18 of the 79 net systems installed during the quarter represented repeat systems sales to existing customers, which brings to 110 the total number of customers which own 2 or more da Vinci systems. 70 of the 85 total system sold were da Vinci S HD systems. Internationally, we had another solid quarter, which included 3 more da Vinci placements into Switzerland, 2 into Sweden and our first da Vinci placements into the countries of Argentina, Cyprus and Qatar. Additionally, we were notified by the State Food and Drug Administration in the Peoples Republic of China that da Vinci S has been granted regulatory clearance which allows us to begin marketing the S system throughout China. Clinically, we had an excellent quarter, a quarter in which we experienced strong sequential procedure growth within all of our targeted surgical specialties both in the U.S. and internationally. And for the first time, our overall gynecologic procedure business registered both the largest sequential percentage growth as well as the largest absolute procedure growth for the quarter. This growth was led by da Vinci Hysterectomy and sacral colpopexy. Our urology business showed solid growth, exceptionally so with in our Kidney and Bladder business mainly da Vinci Nephrectomy and partial nephrectomy and da Vinci Cystectomy. We also saw solid growth within our dVP business, particularly so internationally. Our da Vinci cardiac revascularization and Mitral Valve Repair business were also strong. In Q2, there are approximately 100 da Vinci related clinical papers published within various peer reviewed Journals throughout several surgical specialties. In addition, there were multiple scientific abstracts, clinical posters and podium presentations delivered within the various conferences we attended. The annual American Urology Association conference or AUA took place in May and was attended by nearly 13,000 urologists from around the world. da Vinci's imprint on the AUA has grown over the years to the point where dVP is now the most popular treatment for men with Prostate Cancer in the United States, and arguably, it's the most enabling product used within all urologic cancers, prostate, kidney, and bladder. At the AUA conference, 76 da Vinci presentations, abstracts, and posters were featured, 40 of which were focused on dVP alone, the remaining 36 reported on da Vinci Nephrectomy and partial nephrectomy, cystectomy, pyeloplasty as well as sacral colpopexy for Uro/GYN conditions. In parallel with these presentations were five AUA da Vinci post graduate or instructional courses, a pre-AUA advanced robotics course, a da Vinci satellites symposium and an international robotics cystectomy consortium program. Two of our fastest growing procedures are da Vinci Partial Nephrectomy and da Vinci Cystectomy. Though they are relatively new opportunities, multiple presentations focused on these complex cancer procedures. Due to the technical challenges, traditional laparoscopic approaches within these procedures are rarely performed, therefore the gold standard remains open surgery. The group headed by Dr. Raul O. Parra from Coopers Medical Center in New Jersey presented their initial 20 patients comparing da Vinci Partial Nephrectomy to open Nephrectomy. The author's introduction was as follows and Laparoscopic partial nephrectomy requires experience and a lengthy learning curve to successfully accomplish tumor excision. The advent of robotic assisted laparoscopic surgery has proven successful in Prostate Cancer surgery, encouraging a growing number of centers in adapting this technology in complex renal surgery. The study compared blood loss, operating time, pathologic outcomes and length of hospitalization. In their results, they reported that over time was a bit longer in their initial da Vinci cases, but their blood loss was reduced by over 50% and hospitalization was reduced by 43% with similar pathologic results. It's important to note that these were the group's initial cases, learning curve cases, but through their learning curve, they showed strong clinical results. Two of the cystectomy presentations at AUA caught our attention and both were by Dr. Doug Scherr and his group out of Cornell University Hospital in New York. The first study prospectively compared perioperative and pathologic outcomes in 70 consecutive patients undergoing open radical cystectomy and da Vinci Cystectomy. The study compared operating time, blood loss, transfusion rates, length of hospitalization, and cancer outcomes. The authors had this to say about their results. Our initial experience with robotic cystectomy suggests potential advantages compared to standard open approach, although operative duration was greater in the robotic group. Blood loss, transfusion requirement, and hospital stay were all decreased compared to the open cohort. The robotic method also demonstrated comparable early pathologic outcomes. Their second prospective study measured cost differences, both direct and indirect between open cystectomy and da Vinci Cystectomy. Their study compared cost within three distinct urinary diversion procedures. First, a cystectomy with an ileal conduit; second, a cystectomy with an Indiana pouch; and third, a cystectomy ileal neobladder. Despite the increased materials cost, da Vinci Cystectomy was shown to be less expensive than the open cystectomy across all three groups. The da Vinci ileal neobladder procedures registered an 8% cost savings, compared to open. da Vinci Indiana pouch, a 32% savings. And for da Vinci ileal conduits, a 42% cost savings. The largest cost driver in the study was hospital length of stay, where da Vinci patients systematically demonstrated shorter length of stay compared to open patients. The author's conclusion, and I quote Robotics cystectomy appears to be more cost efficient than open cystectomy as a treatment for muscle invasive bladder cancer at a high volume tertiary care referral center despite an increase in materials cost. The cost benefit obtained from reduced length of stay with Robotics cystectomy is significant. On June 26th and 27th, the first worldwide robotic renal symposium was held at Washington University, in St. Louis. 115 surgeons from around the world attended this first ever event exclusively devoted to da Vinci renal surgery. The course was dedicated to offering practical techniques to enable surgeons to incorporate da Vinci renal surgery, into their practice, and included lectures and cases on a wide range of renal applications for robotics in radical nephrectomy, partial nephrectomy, pyeloplasty and adrenalectomy. The course featured four complete live surgery broadcast and during one of them Dr. Sam Biani [ph], the course director performed a da Vinci Partial Nephrectomy with one ischemic time of only 13 minutes. The patient left the hospital in two days and reported to have gone dancing one week later, and also reported to have used no pain medication once sent home. On the advantages of da Vinci renal surgery, Dr. Sam Biani [ph] had this to say, and I quote robotic renal surgery offers so many advantages over open and laparoscopic approaches. We are able to do more complex surgery and with fewer side effects such as shorter ischemic times and quicker return to normal activity. It is a revolution. As many of you know sacral colpopexy is a procedure performed by gynecologists, uro-gynecologist, and urologist to correct vaginal vault prolapse. The condition is very common and the gold standard corrective procedure is an open sacral colpopexy. The group out of the Mayo Clinic Rochester led by Doctors Chow and Siddique [ph] presented data on their first 42 da Vinci patients; 35 patients in their study had a minimum of a 12 month follow up with a mean follow up period of 36 months. All but one of their patients were released on post operative day one and one was released on post op day two. This compares very favorably to the open sacral colpopexy published by Richard which suggest a two to three day hospitalization. More important than hospitalization is procedure durability, which is one of the reasons that traditional laparoscopy is infrequently performed. The Mayo series show that the da Vinci Sacral Colpopexy is not only less invasive, but also highly durable. The author summarized by saying and I quote The robotic assisted laparoscopic sacral colpopexy is a minimally invasive technique for vaginal vault prolapse repair combining advantages of open sacral colpopexy with the decreased morbidity of laparoscopy. We found a decreased hospital stay, low complication rates, and high patient satisfaction with a minimum of one year follow up. But most importantly, the long term results of the robotic repair mirror those of the open repair with significantly less morbidity. In last month's edition of the Journal of Minimally Invasive Gynecology doctors Payne and Daugherty [ph] from the Ochsner Clinic published a study comparing outcomes of total laparoscopic Hysterectomy to da Vinci Hysterectomy or dVH for benign conditions. The construct was a 200 consecutive patient retrospective analysis of their 100 most recent Hysterectomies prior to establishing the robotics program compared to their first 100 hysterectomies following the establishment of their robotics program. I would reference Dr. Payne and Dr. Daugherty's [ph] work in the past, but until now it had not been published within a leading clinical journal. There is seven page paper details of very key findings. For example, the number of patients that required an exploratory laparotomy with a total abdominal hysterectomy was 11 in the pre-robotic cohort and zero in the da Vinci cohort. These 11 were patients that upon initial review could not be treated either laparoscopically or vaginally. This resulted in an exploratory laparotomy and subsequent abdominal hysterectomy. There were zero similar events within the da Vinci cohort. In addition, intra-operative conversation were significantly reduced, 9% laparoscopically, 4% with da Vinci. Worth noting is the size of the uterus within the conversions. In the 20 laparoscopic conversions, the average uterus weighed 359 grams, whereas the four da Vinci conversions had average uterine weights of 1387 grams, a pretty significant difference. The authors offered a number of perspectives in their study that supported the following findings. A significant decreased exists in operative time with surgeons and teams experienced with robotic cases. A two-fold decrease in blood loss exists among robotic hysterectomies compared to laparoscopic hysterectomies. After implementation of a robotics program, hospitals may... hospitals stay may be shortened by half a day. They went on to say and I quote this difference may seem trivial, but when we one looks at the overall exploratory rate combined with intra-operative conversion rate in the pre-robotic cohort, it is five fold higher than the robotic cohort. Also the average hospital stay for an abdominal hysterectomy is two to three days with an associated recovery time of six to eight weeks. When one considers the 600,000 hysterectomies performed in United States, up to 63% of these cases are done as total abdominal hysterectomies. The societal impact of virtually eliminating the abdominal approach translates into an annual reduction of 800,000 inpatient hospital stays. Additional benefits would include a decrease in hospital complications This is certainly a long and large... a long term and a large view, but it is a view driven by the results within their own practice, which speaks to why a da Vinci Hysterectomy adoption is growing at such a rapid rate. This concludes my overview and I'll turn the time over to Ben.