• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Intersect ENT touts meta-analysis of steroid-releasing sinus implant

September 11, 2017 By Sarah Faulkner

Intersect ENTIntersect ENT (NSDQ:XENT) touted data today from a meta-analysis of two studies assessing the safety and efficacy of its investigational steroid-releasing sinus implant, Sinuva.

The studies evaluated Sinuva in patients with recurrent and medically refractory nasal polyps. The meta-analysis, which was presented at the American Rhinologic Society’s annual meeting, included data from the Resolve and Resolve II trials – both randomized, prospective clinical studies that enrolled adult chronic sinusitis patients who had undergone prior endoscopic sinus surgery.

“The results of this meta-analysis affirm our excitement about the potential of the Sinuva implant, if approved, to improve care for patients who suffer from nasal obstruction and polyps with treatment via a less invasive solution,” president & CEO Lisa Earnhardt said in prepared remarks.

The meta-analysis showed that patients receiving implants had a greater improvement in nasal obstruction/congestion score from baseline after 90 days compared to the control group.

The company also reported that patients with Sinuva had a greater reduction in bilateral polyp grade from baseline after 90 days compared to the control group.

All patients were candidates for revision sinus surgery at the start of the study and 59% of Sinuva patients were no longer indicated for revision surgery after 90 days, Intersect ENT said.

Adverse event rates were similar between the treatment and control groups, although the company observed one serious implant-related adverse event.

“The results of the 400-patient meta-analysis indicate that Sinuva may reduce clinical symptoms, polyp burden and the need for revision surgery,” Dr. Pablo Stolovitzky, CEO of ENT of Georgia, added. “The potential of an in-office solution backed by rigorous clinical evidence is exciting for ENTs managing this challenging patient population.”

The FDA is slated to make a decision regarding Intersect ENT’s new drug application for Sinuva by January next year.

XENT shares were trading at $32.95 in morning activity today, up 3.1%.

See the best minds in medtech live at DeviceTalks Boston on Oct. 2. 

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Implants, Wall Street Beat Tagged With: Intersect ENT Inc.

IN CASE YOU MISSED IT

  • Glucotrack to effect a reverse stock split
  • Medtronic unveils ‘MiniMed’ as name for soon-to-be separated Diabetes unit
  • Insulet, Marvel collab to unveil comic book hero with type 1 diabetes
  • Insulet rolls out new Omnipod 5 iPhone app for use with Dexcom G7
  • Tandem, Abbott strike deal to pair insulin pumps with glucose-ketone monitor

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS