The company also said it is in talks with the FDA as it seeks a regulatory pathway for approval in the U.S., and is continuing to work towards winning reimbursement for its device in Germany and the UK.
“We are pleased with the progress toward the company’s goals of reducing and stabilizing cash burn and re-establishing important regulatory relationships. Although disappointed that we are no longer able to serve patients and clinicians in Australia, we have decided not to appeal the decision but rather to focus our resources on our efforts in other key geographies,” prez & CEO Scott Schorer said in a press release. “We believe that EndoBarrier is safe and effective. Our expanded team of clinicians and dedicated employees are fully committed to making GI Dynamics succeed and delivering on the promise of EndoBarrier.”
GI Dynamics said it plans to file its quarterly earnings report with the SEC before November 14.
“We have addressed and resolved many of the legacy issues at GI Dynamics and are focused on moving this company forward. We will continue to concentrate on building our clinical data portfolio, securing reimbursement in targeted international markets, and working to establish a good working relationship with FDA and other regulatory bodies,” Schorer said in prepared remarks.
Last week, GI Dynamics said that Australia’s Therapeutics Goods Administration removed the EndoBarrier weight loss device from the Register of Therapeutic Goods, effectively stopping commercialization of the device in the region.
The company said it will continue to support ongoing trials, including a randomized, controlled trial exploring the treatment of nonalcoholic steatohepatitis which has been enrolling patients for 14 months.
GI Dynamics said its sales in Australia constituted approximately 15% of its worldwide revenue.
The post GI Dynamics updates on Australian market removal, release of Q4 earnings appeared first on MassDevice.
from MassDevice http://ift.tt/2exj0lu
Cap comentari:
Publica un comentari a l'entrada