International Forum of Allergy & Rhinology

New 12-month Results from the VATRAC Trial Confirm Durable Efficacy of Aerin Medical’s VivAer® in Patients with Nasal Valve Collapse

Retrieved on: 
Tuesday, September 6, 2022

This study demonstrates that treatment with VivAer is a compelling non-invasive alternative for NAO patients and reinforces physician confidence in the consistent and lasting results of this treatment.

Key Points: 
  • This study demonstrates that treatment with VivAer is a compelling non-invasive alternative for NAO patients and reinforces physician confidence in the consistent and lasting results of this treatment.
  • After primary endpoint analysis and unblinding, 31 patients were eligible for crossover, and all elected to undergo active VivAer treatment.
  • The VATRAC study outcomes demonstrate ongoing effectiveness and safety of VivAer, with treated patients reporting durable improvement from baseline at 12 months post-procedure.
  • 1 Silvers et al., Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial.

Xlear Provides New RCT Study on COVID-19 to the Dept. Of Justice in Ongoing Lawsuit; More Clinical Data Than FDA Relying on to Approve New Vaccines; Study Confirms Prior Studies on Effects of Nasal Hygiene on COVID-19

Retrieved on: 
Wednesday, August 31, 2022

Most importantly, the new RCT pilot study found no anosmia (loss of sense of smell) among the outpatients who used Xlear.

Key Points: 
  • Most importantly, the new RCT pilot study found no anosmia (loss of sense of smell) among the outpatients who used Xlear.
  • Theyre relying on information that isnt even from these specific vaccines to approve them.
  • At the same time, Xlear has been used by millions of Americans for 20-plus years without a single adverse effect report.
  • The FDA is about to approve these vaccines for millions of Americans with no data.

New 12-month Results from RHINTRAC Randomized Controlled Trial Demonstrate Durable Safety and Efficacy of Aerin Medical’s RhinAer® for Treatment of Chronic Rhinitis

Retrieved on: 
Wednesday, July 6, 2022

These results for the trials active treatment arm showed that chronic rhinitis symptoms continued to improve through 12 months after treatment with RhinAer.

Key Points: 
  • These results for the trials active treatment arm showed that chronic rhinitis symptoms continued to improve through 12 months after treatment with RhinAer.
  • Chronic rhinitis is a condition where symptoms such as nasal congestion and runny nose last more than four consecutive weeks.
  • RHINTRAC, a multi-center, single-blind study, enrolled 117 patients seeking treatment for chronic rhinitis symptoms of at least six months duration.
  • 1 Stolovitzky JP, Ow RA, Silvers SL, Bikhazi NB, Johnson CD, Takashima M. Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial.

Four-Year Results Show Aerin Medical’s VivAer® Treatment Provides Significant, Sustained Relief of Nasal Obstruction Symptoms

Retrieved on: 
Wednesday, June 29, 2022

The results showed the long-term durability of VivAer treatment for those with nasal airway obstruction (NAO) due to nasal valve collapse (NVC).

Key Points: 
  • The results showed the long-term durability of VivAer treatment for those with nasal airway obstruction (NAO) due to nasal valve collapse (NVC).
  • In the follow-up study, patients experienced significant and sustained improvement in symptoms of NAO through four years following a single treatment of NVC with VivAer.
  • View the full release here: https://www.businesswire.com/news/home/20220629005192/en/
    Following treatment with VivAer, published data demonstrate significant and sustained improvement in symptoms of nasal airway obstruction due to nasal valve collapse through four years.
  • VivAer, a non-invasive technology developed by Aerin Medical Inc., uses temperature-controlled radiofrequency energy to provide long-term relief from nasal obstruction symptoms.

Aerin Medical’s RhinAer® Demonstrates Long-term Safety and Efficacy for Treatment of Chronic Rhinitis in Newly Published Two-year Study

Retrieved on: 
Tuesday, June 7, 2022

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20220607005151/en/
    Two-year data published online in Allergy & Rhinology confirms that treatment with RhinAer provides significant and lasting improvement of chronic rhinitis symptoms.
  • RhinAer, a non-invasive technology developed by Aerin Medical Inc., uses temperature-controlled radiofrequency energy to provide long-term relief from chronic rhinitis.
  • Treatment of the PNN using RhinAer has been shown to be an effective, patient-friendly option to treat both chronic allergic and non-allergic rhinitis.
  • RhinAer provides ENTs a compelling alternative with lasting benefits for appropriate chronic rhinitis patients whether they suffer from allergic or non-allergic rhinitis.

Xlear Files Legal Response to Government’s Lawsuit

Retrieved on: 
Wednesday, December 22, 2021

Today, Xlear Inc. filed the companys response to a Department of Justice lawsuit alleging violations of the Federal Trade Commission Act, among other allegations.

Key Points: 
  • Today, Xlear Inc. filed the companys response to a Department of Justice lawsuit alleging violations of the Federal Trade Commission Act, among other allegations.
  • The company denied all the Governments allegations and leveled a series of affirmative defenses at the Government, including violations of Xlears First Amendment right to free speech.
  • Xlears Response outlines a series of studies, including two randomized clinical trials (RCTs)* and other clinical and lab data, that more than substantiate Xlears statements regarding COVID-19.
  • The Response we filed also includes a new in vitro study done at Utah State Universitys Institute for Antiviral Research.

Recent Peer-Reviewed Publication Confirms Patient Satisfaction with Multiple Allergy Immunotherapy Options

Retrieved on: 
Wednesday, November 17, 2021

Sarita S. Ballakur MD, et al, conducted a one-time, real world survey assessing patient satisfaction of adults with prescribed allergy immunotherapy (IT) via their chosen delivery method -- either Subcutaneous Immunotherapy (SCIT), also known as allergy shots, Sublingual Immunotherapy (SLIT) using liquid drops, or Oral Mucosal Immunotherapy (OMIT) using a specially designed toothpaste delivery system.

Key Points: 
  • Sarita S. Ballakur MD, et al, conducted a one-time, real world survey assessing patient satisfaction of adults with prescribed allergy immunotherapy (IT) via their chosen delivery method -- either Subcutaneous Immunotherapy (SCIT), also known as allergy shots, Sublingual Immunotherapy (SLIT) using liquid drops, or Oral Mucosal Immunotherapy (OMIT) using a specially designed toothpaste delivery system.
  • Overall, 85 percent of the study participants found allergy IT either extremely helpful, very helpful or somewhat helpful.
  • SCIT has been the gold standard for allergy immunotherapy for decades, but people now have more choices.
  • We hope that results from this survey will help patients become aware of their options, particularly of Allerdent,our OMIT toothpaste.

Nathan Jones, CEO of Xlear, Inc. Statement in Response to a Lawsuit Filed by the Department of Justice, on Behalf of the United States, Alleging That Certain Statements Made by Xlear Violated the FTC Act and the Consumer Protection Act

Retrieved on: 
Monday, November 1, 2021

This is real sciencedone and published by independent medical experts.

Key Points: 
  • This is real sciencedone and published by independent medical experts.
  • We believe so strongly in the science we are providing links to these studies here.
  • In sharp contrast to trying to protect the American public, the Government is doing all in its power to stop Xlear from simply telling the public about the science.
  • We will vigorously defend against the Governments case, and, in doing so, defend the science against politics, paternalism, and dogmaticism.

Luoxin Pharmaceutical signs licensing agreement with Austria-based Marinomed Biotech AG for Budesolv® Budesonide Nasal Spray

Retrieved on: 
Thursday, October 21, 2021

SHANGHAI, Oct. 21, 2021 /PRNewswire/ -- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. (''Shandong Luoxin''), a subsidiary of Luoxin Pharmaceutical Group Stock Co., Ltd. ("Luoxin Pharmaceutical" or "the company") , signed a licensing agreement with Austria-based Marinomed Biotech AG ("Marinomed"), whereby Shandong Luoxin will gain the exclusive rights for the development, manufacture, and commercialization of Budesolv (Budesonide Nasal spray) in China (including Chinese mainland, Hong Kong and Macao SAR, Taiwan region).

Key Points: 
  • SHANGHAI, Oct. 21, 2021 /PRNewswire/ -- Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. (''Shandong Luoxin''), a subsidiary of Luoxin Pharmaceutical Group Stock Co., Ltd. ("Luoxin Pharmaceutical" or "the company") , signed a licensing agreement with Austria-based Marinomed Biotech AG ("Marinomed"), whereby Shandong Luoxin will gain the exclusive rights for the development, manufacture, and commercialization of Budesolv (Budesonide Nasal spray) in China (including Chinese mainland, Hong Kong and Macao SAR, Taiwan region).
  • Budesolv, a new formulation of the glucocorticoid budesonide, which is a steroid nasal spray and is not yet available for domestic and overseas market.
  • The recently completed pivotal clinical trial successfully demonstrated non-inferiority of the Budesonide nasal spray when compared to Rhinocort Aqua 64.
  • Once budesonide nasal spray suspension has been launched, Shandong Luoxin will pay to Marinomed tiered royalties based on net sales.

Lyra Therapeutics Presents New Positive Phase 2 LANTERN 6-Month Follow-Up and LYR-210 Pharmacokinetic Data, and LANTERN Manuscript Wins Award at the 67th Annual Meeting of the American Rhinologic Society

Retrieved on: 
Monday, October 4, 2021

The PK study was selected as a top clinical presentation at the meeting; additionally, the LANTERN Phase 2 manuscript won the ARS Annual Meeting 2021 Clinical Science Maurice Cottle Award.

Key Points: 
  • The PK study was selected as a top clinical presentation at the meeting; additionally, the LANTERN Phase 2 manuscript won the ARS Annual Meeting 2021 Clinical Science Maurice Cottle Award.
  • "A lack of strong rebound in CRS symptoms post-treatment and removal is very exciting, with potential long-term benefit for CRS patients.
  • "This release profile is exactly what I would want in an anti-inflammatory implant and the symptom improvement observed with LYR-210 is quite meaningful.
  • The LANTERN study, winner of the 2021 American Rhinology Society 2021 Maurice Cottle Award, has been published in the International Forum of Allergy & Rhinology.