EXCLUSIVE: FDA says ReShape Medical can skip advisory panel for obesity balloon device

April 7, 2015 By Brian Johnson Leave a Comment

ReShape Medical, which is developing a balloon system to combat obesity, notched a significant victory in its path to commercialization, CEO Richard Thompson told MassDevice.com today.

Regulators at the FDA waived a requirement that the San Clemente, Calif.-based company appear before an advisory committee for its premarket approval application, Thompson told us. That removes a significant amount of uncertainty from the arduous PMA process for the ReShape Duo device, he said.

Medical device advisory panel meetings are typically convened at the FDA’s request for 2 key reasons: Premarket submission advice and/or regulatory issues. The panels, which are made up of members of the medical community, are typically held over 2 days and feature presentations from sponsors and FDA representatives. The FDA is not bound by its panels’ decisions when approving a product, but often follows their lead.

"I consider [bypassing the advisory panel] to be a major risk reduction for the company, as well as a schedule reduction," Thompson told us.

ReShape, which filed its PMA application last June, is on pace to get a decision from the agency during the 1st half of 2015, he said. A positive decision would clear the pathway for a U.S. launch of the obesity balloon system.

The ReShape Dual Balloon system is designed to be inserted endoscopically and remain in the stomach for 6 months. The balloon takes up space in the stomach and helps patients feel full. While the stomach-filling balloons are in place, patients are counseled by healthcare professionals on nutrition, exercise and behavior modification to help them develop a healthier lifestyle, according to ReShape.

Last fall ReShape released results from its Reduce US pivotal trial that it said showed patients with the device lost 2.3 times more weight than patients using just diet and exercise.

The Duo, which has been available commercially in Europe since 2007, is a non-reimbursed cash procedure.

Thompson told MassDevice.com that the company is likely seek another round of financing on the private markets to fund commercialization. In February, the company closed on nearly $7 million through existing internal investors, according to a filing with the federal Securities & Exchange Commission. ReShape Medical has raised more than $46.5 million since its inception.

Hospital survey reveals front-line needs, desperate measures
Hospitals across the U.S. have begun resorting to unorthodox means of replacing or sanitizing personal protective equipment (PPE) and atypical sourcing of PPE and other supplies needed to fight the coronavirus pandemic, according to a government survey. The Department of Human Services’ Office of the Inspector General (OIG) conducted the random survey of 323 hospitals… […]
CDRH gives medtech manufacturers employee coronavirus safety tips
As certain medtech companies continue ramping up production of devices and components to fight the coronavirus, the FDA’s Center for Devices and Radiological Health (CDRH) on Sunday announced several tips to help protect medtech manufacturing employees from contracting COVID-19. In addition to frequent and thorough hand-washing, maintaining social distancing and avoiding face-touching, the agency urged… […]
Lin Engineering hastens manufacture of DC motors for fight against COVID-19
Lin Engineering — a designer and manufacturer of precision electric motors and motion systems — is prioritizing the production and supply of motors to support companies making medical devices critical in the treatment of COVID-19 patients. Morgan Hill, Calif.-based Lin Engineering said last week its highest priority is supplying motors to the makers of medical… […]
Nortech, Minnetronix may start building ventilators
Two Minnesota medtech contract manufacturers are taking a hard look at producing ventilators, including one from the plans that Medtronic made public last week to address the coronavirus outbreak. Maple Grove-based Nortech Systems (NSDQ:NSYS) told Medical Design & Outsourcing it is seriously considering starting to produce the machines based on the design specifications of Medtronic’s… […]
Materialise touts 3D-printed oxygen mask that could free up ventilators
Materialise announced today that it developed a 3D-printed device to convert standard hospital equipment into a mask to help patients breathe by creating positive pressure in the lungs. The Leuven, Belgium-based company’s Materialise NIP Connector is designed to give clinicians the ability to reduce the time that patients need access to ventilators and relieve the… […]
Plastikos implements bio-contamination testing and compliance under ISO 14698
Plastikos (Erie, Pa.) recently announced that it has implemented a formal bio-contamination testing and compliance system that’s in full compliance with ISO 14698-1 and ISO 14698-2 — a move the company described as paramount amid the COVID-19 pandemic. Plastikos and Plastikos Medical presently mold medical devices and parts within multiple ISO-7 certified cleanrooms. The new… […]
How 3D printing is enabling ventilator splitting
Amid the shortage of ventilators due to the COVID-19 pandemic, researchers are finding success using 3D printing to enable “ventilator splitting.” The search continues to go on for more machines, but there have already been government actions taken to increase amounts, while researchers have taken it into their own hands to create homemade-style ventilators. However,… […]
How R&D departments are coping with coronavirus
Hardly anyone’s R&D workplace has been spared all the repercussions of the COVID-19 crisis. People are working remotely, staggering their hours in laboratories to avoid too many coworkers, and relying heavily on conference calls and video meetings. Our WTWH Media sister site R&D World spoke to a few industry people to see how they’re coping… […]
Europe waives tariffs, import taxes on COVID-19 medtech
The European Commission has decided to waive tariffs and value-added taxes (VAT) on certain medical devices and personal protective equipment (PPE) coming from outside the EU during the coronavirus pandemic. The measure includes testing kits, ventilators and other medical equipment and will remain in force for six months, the commission said today. “In this emergency,… […]
FDA eases mask regulations, seeks to boost decontamination of used masks
The FDA yesterday further relaxed regulations on medical and surgical masks and face shields to ease shortages during the coronavirus pandemic, and invited companies that decontaminate masks to submit proposals for emergency authorizations. In a new guidance, the agency also gave its blessing to healthcare providers to use improvised masks during the public health emergency when… […]
BARDA opens research portal to fight COVID-19
By James Keller, Emergo Group The Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response, is seeking information from stakeholders on available medical countermeasures in development. It is particularly interested in products and technologies that have progressed into… […]