Chronic rhinitis

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Spirair™, an early-stage company pioneering minimally invasive solutions that help ENTs advance care for their patients, today announced the appointment of Benjamin Bishop as its chief executive officer. The company is developing a novel therapy for symptomatic nasal septal deviation (NSD) that supports and straightens minor deviations in the septum with a bioabsorbable implant. Septal deviation is one of the most common causes of nasal airway obstruction (NAO), a condition that makes it difficult to breathe through the nose. 1 Despite advancements in techniques, treatments and technologies in the otolaryngology (ENT) field broadly, NSD correction has remained stagnant for years. Treatment options for symptomatic NSD have been limited to either over-the-counter medications to alleviate symptoms or invasive surgical techniques to address the structural issues that cause these symptoms. Traditional septoplasty or septorhinoplasty are the most common surgical treatment options for NSD. Septoplasty can require significant time away from work, with approximately 40% of patients requiring two or more weeks off for recovery. 2 “ Our team is partnering with leading ENT advisors and industry veterans to develop minimally invasive solutions that provide strong outcomes and a better experience for their patients,” said Bishop. “ I’m proud to join this team of innovators who are working to add treatment options to physicians’ toolkits to help them continue supporting their patients.” Bishop joins Spirair with two decades of commercial leadership experience across the medical, surgical and aesthetic industries. He has a proven track record for successfully launching disruptive technologies and establishing new markets, playing a key role in developing high-growth companies like Revelle Aesthetics, Revance Therapeutics, and Access Closure. Bishop also led sales and marketing at Arrinex – the company that developed ClariFix ® , an ENT technology for chronic rhinitis – prior to its acquisition by Stryker in 2019. Spirair got its start in the Stanford Biodesign Innovation Fellowship, a program that equips aspiring innovators with a proven, repeatable process to identify important health-related needs, invent novel health technologies to address them, and prepare to implement those products into patient care. Founders James Kintzing, Ph.D. and Brandon McCutcheon, M.D. were co-fellows in the program and identified an opportunity in the ENT space when they discovered the unmet need for a minimally invasive nasal septal deviation correction therapy to help address nasal airway obstruction. “ As an alumna of the Stanford Biodesign Innovation Fellowship myself, I’ve seen firsthand how this program successfully supports groundbreaking ideas in healthcare technology – and Spirair is a shining example of this innovation,” said Kate Garrett, managing partner at Sonder Capital, assistant director of the Stanford Biodesign Innovation Fellowship and chair of Spirair’s board of directors. “ Benjamin Bishop has an outstanding track record as a commercial leader and I’m thrilled to welcome him to Spirair as its chief executive officer as we begin this exciting next stage of growth.” Spirair’s nasal septal deviation therapy is currently being investigated as part of two IRB-approved nonsignificant risk (NSR) U.S. clinical trials. The company expects to begin a Series B fundraising round and initiate its commercialization efforts in 2024. 1 Clark DW, Del Signore AG, Raithatha R, Senior BA. Nasal airway obstruction: Prevalence and anatomic contributors. Ear Nose Throat J. 2018 Jun;97(6):173-176. doi: 10.1177/014556131809700615. PMID: 30036414. 2 Chidambaram A, et al. Anticipated absence from work ('sick leave') following routine ENT surgery: are we giving the correct advice? A postal questionnaire survey. Clin Otolaryngol Allied Sci. 2001 Apr;26(2):104-8. doi: 10.1046/j.1365-2273.2001.00433.x. PMID: 11309049. About Spirair Spirair is an early-stage company pioneering minimally invasive solutions that help ENTs advance care for their patients by providing strong outcomes and a better patient experience. Spirair is committed to developing new therapies that can easily integrate in any ENT’s treatment algorithms so they can help more of their patients breathe better. Its first product is a novel minimally invasive option for symptomatic NSD that supports and straightens minor deviations in the septal cartilage and can be conveniently and safely performed under local anesthesia in any site of service as part of standard septoplasty techniques. The company got its start through the Stanford Biodesign Innovation Fellowship, a program that equips aspiring innovators with a proven, repeatable process to identify important health-related needs, invent novel health technologies to address them, and prepare to implement those products into patient care.

Durable results are consistent with other studies of RhinAer MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Aerin Medical Inc., a company dedicated to providing Ear, Nose and Throat (ENT) physicians with non-invasive solutions for the treatment of chronic nasal conditions, today announced the publication of positive 24-month results from RHINTRAC, a randomized, sham-controlled clinical trial, in the International Forum of Allergy & Rhinology (IFAR). These results demonstrate the durable treatment effect of RhinAer® for treating chronic rhinitis, showing a significant improvement in symptoms through two years. These findings build on the previously published results of two separate studies that also demonstrated significant, sustained improvement with RhinAer treatment.1,2 This press release features multimedia. View the full release here: Results of the RHINTRAC randomized controlled trial published in the International Forum of Allergy & Rhinology (IFAR) confirmed that treatment with RhinAer® resulted in a significant improvement in chronic rhinitis symptoms through two years. RhinAer uses temperature-controlled radiofrequency energy to provide long-term relief from chronic rhinitis. (Photo: Business Wire) “Chronic rhinitis treatment has been a longstanding challenge due to the limitations of medical therapy and the historical lack of minimally invasive, comprehensive procedure options,” said Pablo Stolovitzky, M.D., Adjunct Assistant Professor, Department of Otolaryngology, Emory University; CEO of ENT of Georgia North, Atlanta; and principal investigator of the RHINTRAC trial. “It is significant to add high-level evidence reinforcing the efficacy and durability of RhinAer, which provides a well-studied solution for those enduring the burdens of chronic rhinitis.” ENTs use RhinAer to directly interrupt overactive nerve signals which contribute to symptoms that can be difficult to treat with medications alone in patients suffering from chronic rhinitis. RHINTRAC, a multi-center randomized study, enrolled 117 patients with chronic rhinitis symptoms of at least six months duration, commonly with a poor response to medical therapy. This publication reports patient outcomes through two years, including treatment response, chronic rhinitis symptom burden, quality of life, medication use and adverse events for all treated patients. More than 87% of patients responded to treatment and patients showed sustained improvement in chronic rhinitis symptoms at two years. Additional findings published in IFAR included: Eighty-one percent of patients reported improvements in quality of life, as assessed by the Mini-Rhinoconjunctivitis Quality of Life questionnaire, compared to baseline. Patient treatment response, including symptom reductions, improved through two years, with a 64.6% improvement over baseline in reflective total nasal symptom score (rTNSS). All individual symptom scores (runny nose, congestion, sneezing and nasal itching) were significantly improved over baseline through two years. “Three separate studies have consistently shown long-term benefit from a single procedure with RhinAer,” said Scott Wolf, M.D., co-founder and Chief Medical Officer of Aerin Medical. “We sincerely thank the dedicated physicians who have significantly advanced understanding of RhinAer’s treatment effect on behalf of the otolaryngology community.” Rhinitis, or inflammation of the mucous membranes of the nose, can include symptoms such as runny nose, congestion, itching, sneezing, coughing, and post-nasal drip. Chronic rhinitis, when symptoms last more than four consecutive weeks, can be challenging to treat and may significantly lower a person’s quality of life. About RhinAer Using temperature-controlled, radiofrequency technology, RhinAer features a thin, wand-like stylus that is inserted via the nostril to deliver precise therapeutic benefits, while sparing surrounding tissues. RhinAer directly disrupts the posterior nasal nerve (PNN) that triggers excessive mucus production, treating an underlying cause of chronic rhinitis. RhinAer provides ENT physicians with a comprehensive solution for the treatment of chronic rhinitis, addressing sources of rhinorrhea (runny nose) and congestion. The procedure can be performed with a local anesthetic during an office visit, with no incisions, minimal to no downtime, and little discomfort. RhinAer initially received FDA 510(k) clearance in December 2019 and CE Mark in 2020. For more information, visit . About Aerin Medical Aerin Medical is a privately held, venture-backed company, with U.S. offices in California and Texas. Aerin’s mission is to expand access to meaningful relief for millions of patients suffering from chronic ENT conditions. The company’s products, VivAer® for nasal airway obstruction and RhinAer® for chronic rhinitis, leverage Aerin’s proprietary temperature-controlled technology, which allows ENT physicians to reliably improve patients’ symptoms with unique technologies that are appealing alternatives to invasive surgery. More than 100,000 patients have been treated with Aerin Medical products to date. For more information, please visit and follow Aerin Medical on Facebook, X, Instagram, LinkedIn and YouTube. 1 Ehmer D, McDuffie CM, McIntyre JB, et al. Long-term Outcomes Following Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Chronic Rhinitis. Allergy & Rhinology. (2022);13. doi:10.1177/21526575221096045. 2 Lee, J.T., Abbas, G.M., Charous, D.D., Cuevas, M., Göktas, Ö., Loftus, P.A., Nachlas, N.E., Toskala, E.M., Watkins, J.P. and Brehmer, D. Two-Year Outcomes After Radiofrequency Neurolysis of Posterior Nasal Nerve in Chronic Rhinitis. The Laryngoscope. (2023) .

MOUNTAIN VIEW, Calif.--( BUSINESS WIRE )-- Aerin Medical Inc. , a company dedicated to providing Ear, Nose and Throat (ENT) physicians with non-invasive solutions for the treatment of chronic nasal conditions, today announced that Rhinology Journal has published positive two-year outcomes from the VATRAC trial. The study showed a single in-office treatment with VivAer ® resulted in sustained improvement in symptoms of nasal airway obstruction (NAO) caused by nasal valve collapse, and reduced both daytime sleepiness and the use of medications and mechanical aids. Previously published three-month results of the randomized controlled trial demonstrated that treatment with VivAer was safe and superior to a sham procedure. 1 “These data demonstrating the significant and lasting improvements in nasal airway obstruction symptoms mark a breakthrough in addressing a common and often-challenging cause of the condition,” said Joseph K. Han, M.D., professor, chief of the division of rhinology and endoscopic sinus and skull base surgery, and chief for the division of allergy at Eastern Virginia Medical School, who served as the co-principal investigator of the VATRAC clinical trial. “VivAer offers lasting relief to patients with nasal airway obstruction symptoms and creates new options for complete treatment of the nasal valve.” VATRAC, a prospective, multi-center randomized control trial, enrolled 119 patients who had extreme or severe NAO based on the validated Nasal Obstruction Symptom Evaluation (NOSE) Scale score, with nasal valve collapse as a primary or significant contributor to NAO symptoms. The most common symptoms of NAO include nasal congestion or stuffiness, trouble breathing through the nose, trouble sleeping and difficulty breathing well during exercise or exertion. After primary endpoint analysis, 31 control patients were eligible for crossover and elected to undergo active VivAer treatment. The data in this two-year post-procedure publication includes 73 patients receiving VivAer treatment, including these crossovers. The long-term follow up from VATRAC confirmed the sustained effectiveness of VivAer, with treated patients reporting durable improvements from baseline through 24 months post-procedure, including in those with documented septal deviation. Key findings included: The responder rate at two years was 90.4%, sustained across all time periods. Patient NAO symptoms significantly improved over baseline at all follow-up timepoints; at two years post-treatment, patients maintained a 54.7% improvement in NOSE scores compared to baseline. The presence of septal deviation did not significantly affect treatment outcomes. Treatment with VivAer was well-tolerated, and there were no serious adverse events related to the procedure or device. “This publication adds to the deep dossier of clinical evidence for VivAer, with three separate studies now confirming multi-year benefit and with comparable responder rates,” said Matt Brokaw, CEO of Aerin Medical. “We extend our gratitude to the clinical investigators whose dedication has been instrumental in demonstrating that VivAer is a practical and effective innovation changing how and where nasal airway obstruction patients are treated.” NAO takes a heavy toll on daily life. Nasal valve collapse contributes to nasal obstruction for 73% of highly symptomatic individuals, 2 but is often under-diagnosed and left untreated. This can have a significant impact on a person’s quality of life, as the nasal valve is the narrowest part of the nasal airway and even small obstructions can create an exponential reduction in airflow. VivAer offers ENT physicians a unique, non-invasive and office-friendly option that durably remodels tissue in the nasal valve to address NAO in appropriate patients. About VivAer VivAer is a non-invasive technology that uses patented, temperature-controlled radiofrequency energy and is clinically demonstrated to provide long-term relief from nasal obstruction. VivAer features a thin, wand-like stylus that attaches to a console. The stylus is inserted via the nostril to gently remodel the nasal tissue and improve airflow. VivAer does not involve any cutting, removal of nasal tissue or bone, or the use of an implant. Treatment with VivAer may be performed during an office visit with local anesthesia. Patients typically experience little discomfort with minimal to no downtime and are often able to return to normal activities following treatment. The VivAer Stylus received CE Mark in 2016 and FDA 510(k) clearance in December 2017. For more information, visit www.VivAer.com . About Aerin Medical Aerin Medical is a privately held, venture-backed company, with U.S. offices in California and Texas. Aerin’s mission is to expand access to meaningful relief for millions of patients suffering from chronic ENT conditions. The company’s products, VivAer ® for nasal airway obstruction and RhinAer ® for chronic rhinitis, leverage Aerin’s proprietary temperature-controlled technology, which allows ENT physicians to reliably improve patients’ symptoms with unique technologies that are appealing alternatives to invasive surgery. More than 100,000 patients have been treated with Aerin Medical products to date. For more information, please visit www.aerinmedical.com and follow Aerin Medical on Facebook , X , Instagram , LinkedIn and YouTube . ____________________________ 1 Silvers et al., Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial. International Forum of Allergy and Rhinology. July 2021. https://doi-org.libproxy1.nus.edu.sg/10.1002/alr.22861 2 Clark, David; Del Signore, Anthony; Raithatha, Roheen; Senior, Brent; 2018. Nasal airway obstruction: Prevalence and anatomic contributors; 2018 ENT Ear Nose & Throat Journal ; 97(6).