Obesity device firm EnteroMedics Inc. says it is on track to record the first commercial implants of its Maestro device in the next few months and is making progress towards gaining reimbursement for the neurostimulation system to control hunger cravings.

Maestro was FDA-approved to treat obesity in January. It offers first-in-class VBLOC therapy, stimulating the vagus nerve to regulate the digestive system and help suppress hunger. (See Also see "FDA Weighs Patients' Risk Tolerance in Approving Obesity Device" - Medtech Insight, 14 January, 2015..)

Since then, 15 centers have been certified and 19 physicians have been trained to perform the procedure, putting EnteroMedics well on its way to meeting its goal of training 20 to 25 centers to implant the system by the end of 2015, the firm said in an April 7 update.

Although the company is working towards broad-based reimbursement for the procedure, executives acknowledge that the first implants will be funded either by one-off, physician-initiated local coverage decisions or by self-paying patients.

"We have been focused on identifying and training centers and physicians in key self-pay markets then working to integrate vBloc Therapy into their accounting and quality-assurance systems, a process that can take two to three months per center," said Brad Hancock, chief commercial officer of EnteroMedics.

Direct-To-Patient, Reimbursement Focus

A recently hired marketing director and four regional sales directors have focused on making inroads with clinical centers and physicians. But in parallel the company says it is reaching out directly to patients via educational webinars and social media. Further, it is partnering with American HealthCare Lending to help prospective patients get payment assistance or other financing options to undergo the reversible procedure before insurance is widely available.

The Maestro system has a list price of between $15,000 and $20,000. Reimbursement will be crucial to grow the market and EnteroMedics says it is taking steps to gain support from private and public payers. On April 4, the firm appointed Tonya Dowd, formally of Quorom Consulting and Johnson & Johnson, as it VP of reimbursement to spearhead those efforts.

The first target for EnteroMedics is private insurers. "We have initiated conversations with several private payers, focusing on those with a history of adopting new technologies and those that currently offer bariatric surgery coverage," Hancock said during the firm's fourth-quarter 2014 earnings call on Feb. 18. He suggested at the time that the firm hoped to start seeing positive coverage decisions for Maestro from private payers sometime in the second quarter.

The company is also engaging the American Medical Association to upgrade its Category III Current Procedure Terminology code to a Category I CPT code. Crucial to that effort will be peer-reviewed, published data supporting the device, in addition to the company getting several commercial implants under its belt.

EnteroMedics has already published 12-month follow-up data from its pivotal trial, and it is now looking to publish longer-term data from that study as well as outcomes from other trials, including one looking at the impact of VBLOC therapy on type-2 diabetics.

To support clinical development of the system, EnteroMedics announced April 6 that Scott Shikora would be formally joining the firm as its executive VP of medical affairs and chief medical officer beginning in June. Shikora, who is a professor of surgery at Harvard Medical School, already has been acting as consulting chief medical officer for EnteroMedics.

Maestro is approved for adults 18 and older with a body mass index (BMI) of at least 40 to 45 who have been unable to lose weight through a weight loss program within the past five years, or who have a body mass index of 35 to 45 with at least one other obesity-related condition, such as type 2 diabetes, high blood pressure or high cholesterol.

EnteroMedics Eyes First Commercial Maestro Implants For Obesity After Months Of Prep

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