SONU Band by SoundHealth Receives Pediatric FDA Approval
SAN FRANCISCO--(BUSINESS WIRE)-- SoundHealth, a medical technology company harnessing the power of artificial intelligence and medical science to improve patient outcomes, announced it received United States Food and Drug Administration (FDA) approval for pediatric use of its groundbreaking SONU Band. SONU is the world's first FDA De Novo authorized, AI-enabled, wearable medical device for at-home treatment of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. This expanded approval makes SONU the first FDA-approved, drug-free solution for nasal congestion and allergies in children ages 12 and up, providing a safe alternative to pharmaceutical treatments.
SoundHealth has developed the world's first FDA-approved, wearable device for children 12 and up that offers a drug-free, safe solution for treating nasal congestion and allergies.
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'SONU offers a promising new option for children struggling with chronic nasal congestion. As a non-invasive, drug-free solution, it addresses a significant need among families looking for safe, effective alternatives to traditional therapies—particularly those involving steroids or medications with side effects,' said Dr. Alan Greene, Adjunct Professor of Pediatrics, Stanford University; Principal Investigator.
Clinically proven to be fast-acting and effective, over 80 percent of SONU patients reported improvement in their nasal symptoms. SONU represents a brand-new category of safe and rapid relief therapies for nasal congestion and spares patients from the side effects commonly associated with other treatment options.
'Nasal congestion and allergies don't have to be life-altering,' said Dr. Paramesh Gopi, founder and CEO of SoundHealth. 'Our team of scientists, engineers and medical professionals has truly revolutionized respiratory health with AI-powered sound therapy. We are thrilled to now be able to offer relief from congestion to children and will continue to work toward helping people breathe better.'
SONU is easy, convenient and pleasant to use for patients. Using SoundHealth's proprietary AI technology, the SONU app scans the patient's face using a smartphone and creates a digital map of their sinuses, calculating their optimal resonant frequencies. Following the initial one-time scan, the patient simply places the SONU Band around their head, turns it on and the band delivers frequencies tailored to the patient based on the app's calculations.
The science behind SONU:
SONU uses acoustic vibrational energy to provide personalized relief for nasal congestion. The band produces resonant sound waves that gently vibrate the nasal cavity. These micro vibrations help reduce swelling, open nasal passages and drain healthy mucus.
Acoustic vibration associated with humming has been shown to decrease symptoms of nasal congestion, possibly through modulation of autonomic inputs to the nasal mucosa or through nitric oxide activity, which may in turn exert a decongestant and anti-inflammatory effect on the nasal passages.
Using personalized, relaxing sound waves, SONU provides relief of nasal symptoms in 15 minutes or less.
SONU is the only FDA-approved device equivalent to or better than the leading nasal steroid spray, calming down symptoms of allergies, inflammation and congestion. For more information, please visit https://soundhealth.life/.
About SoundHealth
SoundHealth is a medical technology company that harnesses the power of artificial intelligence and medical science to improve respiratory and mental health. The SoundHealth team consists of experienced medical professionals, data scientists and engineers who are passionate about improving healthcare. Visit https://soundhealth.life.
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– 26% (20/77) CR+CRh rate and 48% (37/77) ORR in efficacy-evaluable pivotal R/R mNPM1 AML population – – Robust responses observed across subgroups, regardless of co-mutations, number of prior lines of therapy, or prior venetoclax, within efficacy-evaluable pivotal R/R mNPM1 AML population – – 60% (3/5) ORR in Ph 1 patients with R/R NUP98r AML – NEW YORK, June 12, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced new data from the pivotal AUGMENT-101 trial of Revuforj® (revumenib), the Company's first-in-class menin inhibitor, in patients with relapsed or refractory (R/R) mutant NPM1 (mNPM1) and NUP98-rearranged (NUP98r) acute myeloid leukemia (AML). The data are being presented in posters at the 30th European Hematology Association (EHA) Annual Congress Meeting being held June 12-15, 2025, in Milan, Italy and virtually. 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'The revumenib data in R/R mNPM1 AML presented at EHA are impressive, with 26% of patients achieving CR/CRh and nearly 50% achieving an overall response with a medicine that was generally well-tolerated. Furthermore, the 23-month median overall survival observed in responders in a subgroup analysis is very encouraging.' Additional Results from R/R mNPM1 AML Patients in the Pivotal Phase 2 Portion of the AUGMENT-101 Trial of Revumenib The Phase 2 portion of the AUGMENT-101 trial of revumenib enrolled 84 patients with R/R mNPM1 AML. As previously reported, the primary endpoint was met in the protocol-defined primary analysis population which included the first 64 adults who met the efficacy evaluable criteria. At EHA 2025, the Company will highlight consistent results from all the efficacy-evaluable R/R mNPM1 AML patients (n=77) in the Phase 2 portion of AUGMENT-101 (DCO: September 2024). 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Many factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes to Revuforj's or Niktimvo's commercial availability; changes in expected or existing competition; changes in the regulatory environment; failure of Syndax's collaborators to support or advance collaborations or product candidates; and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. 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