Brad Hancock
Analyst · Craig-Hallum Capital. Your line is open
Thank you, Mark, and good morning. Our commercial strategy which continues to gain traction is centered on three critical areas. First, trained surgeons and certified centers to leverage the strong physician enthusiasm we are seeing for vBloc Therapy; second, accelerate the growth of our patient base; third, help patients gain access to vBloc Therapy through a number of programs such as financing and reimbursement support. We have 51 centers certified and 77 surgeons trained to implant our vBloc Therapy, which has surpassed our initial objective of 20 to 25 centers for the year. This increase in the number of surgeons trained is due to the positive response we have seen from physicians who believe vBloc Therapy is an important weight loss options for their practice. Immediately after approval we began the process of identifying and certifying centers of excellence and training surgeons and their support staff on vBloc. Next, we introduce the technology to these centers and to the Value Analysis Committee or VAC at each center. This is an administrative process that includes an evaluation of the technology by a team of internal experts, contract negotiations and accounting procedures. In most cases the VAC process takes a minimum of two to three months per center. To-date nearly half of our certified centers have completed this internal approval process. Following these approvals, the center and EnteroMedics can start to collaborate on activity to recruit patients, schedule them for a surgeon consultation, and finally, moved to the implant procedure. This is a lengthy required process with the new technology and we are pleased with our progress to-date, including the first U.S. commercial implant in May at Tufts Medical Center. This very positive initial experience gives us confidence that more centers and physicians will be coming online and that this adoption will translate into a growing number of implants as the year progresses. Our goal for the remainder of 2015 is to continue to certify new centers and train physicians while maintaining a controlled rollout of the technology, so as to fully support initial adopters and patients who want access to vBloc Therapy. The second part of our commercial strategy is growing our patient base to a robust direct-to-consumer marketing program and public relations effort often in collaboration with our implanting centers. We have had tremendous support from these vBloc centers to recruit patients through localized radio and television campaigns, as well as more targeted, measurable and interactive digital marketing activities. The voices of these campaigns come from our strongest advocates, our patients. These individuals repeatedly tell us that vBloc Therapy allows them to fearful changing their relationship with food, which has allowed them to start living the life they always wanted. The third component of our commercial strategy is developing a number of partnerships to support access to vBloc Therapy for patients through financing options and reimbursement coverage. EnteroMedics has partnered with Prosper Healthcare Lending, formerly American HealthCare Lending to provide funding for patients access to vBloc Therapy. Prosper Lending is known for providing innovative, affordable, and patient friendly options for healthcare-related expenditures. Last week we announced the launch of vBloc Access, a comprehensive patient and provider support program administered by an exceptional group of reimbursement experts that helps individuals consider navigating through the insurance benefits and claims process. Once patients have decided on vBloc, this team will assist them with the prior authorization and claims appeal process for payment and coverage. An equally important component of the program is to collaborate with physicians on providing the necessary documentation to support the medical necessity of vBloc for their patients. The vBloc Access team has a great track record of successful prior authorizations and claim appeals with other new technologies. We expect them to have a similar success with vBloc. Using the prior authorization to support patient access to vBloc Therapy also contributes to our longer-term strategy of establishing third-party reimbursement and private insurer markets. As we are demonstrating patient demand through the prior authorization process, we will work with the same payers to educate them about the overall value of vBloc Therapy to achieve a coverage policy decision. And a second but parallel effort in our reimbursement strategy, we are focused on creating broader scale adoption of our technology through public and societal support channels and by participating in technology assessment evaluations. vBloc Therapy was evaluated at the most recent California Technology Assessment Forum. CTAF evaluated the comparative effectiveness and value of several current approaches to obesity management including medications, devices, and surgical procedures. The panel, which was made up of leading healthcare industry experts, including bariatric surgeons, insurance providers, and patient advocates, voted favorably on vBloc Therapy’s net health benefit when compared to conventional therapy in adult patients with a BMI greater to or equal than 35. CTAF will take the panel’s vote into account when issuing their updated report in the next few weeks. These types of assessments are often used by insurers as a resource when they evaluate new technologies for patient coverage. We will continue to publish clinical and economic evidence that supports the long-term clinical and cost benefit of vBloc Therapy to support our reimbursement and surgeon outreach programs. Last month vBloc’s long-term durability was further confirmed by the publication of the 18-month results from the ReCharge study in the Journal of Obesity. We had a number of additional publications in process to further support the safety and efficacy of vBloc Therapy and the meaningful effect that this technology has on the treatment of people with moderate obesity and comorbidities. In addition through the publication of clinical data from our ReCharge study, we will begin to gather data in our post-approval registry called the ENGAGE registry, which will allow us to collect and publish data from patients in a commercial setting. To complement the clinical data publication initiative, we are working with experts in the bariatric field to publish the results of an economic modeling report that supports the cost benefit of vBloc Therapy, which we look forward to seeing submitted by these experts to a peer-reviewed journal. We are currently using our six Category 3 CPT codes, which are cross-walked to other neuromodulation payment codes. These codes are well established and are favorably reimbursed. Our early success in using these codes will determine if and when we consider conversion of a Category 3 codes. And finally, we are looking at several innovative options for partnerships with vBloc centers, such as risk sharing arrangements with payers where performance and outcomes are the determining principals. We believe vBloc Therapy holds a very strong position compared to other bariatric procedures based on our low complication rates, which will allow us to develop meaningful risk sharing contracts with Integrated Delivery Networks or IDNs. We are exploring how our technology can be incorporated into these IDNs where there is continuum of care that includes reimbursement. The VA is a prime example of the success of the strategy. We recently had our first vBloc Therapy procedures conducted at the VA in Dallas. There are number of types of self-insured programs across the country and we will be exploring more of these opportunities as the year progresses. We believe all of these efforts show the strength and the robustness of our long-term commercial strategy. So in summary, we are executing on a commercial strategy that is focused on recruiting vBloc centers of excellence. We have initiated influential marketing strategies designed to attract ever-growing number of patients’ joint therapy and we are providing support to those patients with financing and reimbursement resources, which will allow them to enjoy the benefits of improved health and lifestyle as a result of our unique therapy. With that, I'll now turn the call over to Greg. Greg?