SoundHealth (a medical technology company utilizing the power of AI and medical science to improve patient outcomes) has introduced SONU. SONU is the world’s first FDA De Novo authorized, AI-enabled, and wearable medical device for treating moderate to severe nasal congestion due to allergic and non-allergic rhinitis for at-home use by individuals 22 years of age and older.
SONU offers a new non-pharmaceutical treatment option for patients and clinicians. And the US Food and Drug Administration (FDA) issued a De Novo classification for the SONU product, which includes the SONU device and the SONU app.
In parallel with the official launch of SONU, SoundHealth received $7 million of seed funding. And SoundHealth will use the funding to enhance the commercialization and marketing of SONU and to seek regulatory authorization for additional indications for pediatric use and insomnia.
Moai Capital and J4 Ventures led the funding round with additional funding from TeleSoft Partners, Tau Ventures, TechU Ventures and Rhythm Venture Capital. And Peter Moran (an early-stage investor in digital health and wellness companies, a former long-time managing partner at DCM Ventures, and a seed investor in SoundHealth) will join the SoundHealth board of directors.
SONU is an AI-enabled patented drug-free medical device that utilizes acoustic vibrational energy for providing personalized relief for nasal congestion. And acoustic vibration associated with humming has been shown to decrease symptoms of nasal congestion, potentially 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.
SONU is easy, convenient and pleasant to use for patients. And using SoundHealth’s proprietary AI technology, the SONU app scans their face using a smartphone, creates a digital map of their sinuses and calculates 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 SONU band delivers frequencies tailored to the patient based on the app’s calculations. And thensymptom relief begins in minutes.
Patients do not need to change their activities while using SONU. And they can use SONU anytime at home just for 15 minutes twice a day, for example, while online, brushing their teeth, drinking their morning coffee, exercising or watching TV.
The SONU band provides resonant sound waves that gently vibrate the nasal cavity. And these micro vibrations are so small they may not even be noticeable, and they stimulate nasal nerves, which may result in vasoconstriction (reducing swelling and opens nasal passages); sonication (dilutes accumulated dense mucus); and mucociliary clearance (drains healthy mucus). 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 pharmaceutical treatment options.
KEY QUOTES:
“We are delighted to announce the close of our seed-round investment — the proceeds of which will be used for product launch and advancing our pipeline of indications for the SONU device. Our groundbreaking technology provides the first FDA authorized, non-pharmaceutical medical device treatment option for nasal congestion due to allergic and non-allergic rhinitis. SoundHealth’s mission is to provide personalized, intelligent wearables to help people breathe and sleep better!”
- Dr. Paramesh Gopi, founder and CEO, SoundHealth
“SONU is using the latest medical science to provide a game-changing and liberating alternative treatment for nasal congestion. Investors are increasingly looking for high-efficacy solutions to many maladies without the side effects of pharmaceutical approaches. I look forward to working with SoundHealth’s tenured team in helping many people find relief from nasal congestion with this simple yet powerful, non-invasive device without the side effects often associated with pharmaceuticals.”
- Peter Moran
“We were especially struck by how quick and easy SONU can bring relief to allergies, without using a drug. Future applications could include helping with sleep and stress.”
- Amit Garg, managing partner of Tau Ventures
“SONU’s vibroacoustic therapy offers an innovative drug-free treatment option for my patients suffering from allergic and non-allergic nasal congestion. The prospect of replacing medications with a scientifically proven non-invasive therapy is truly exciting.”
- Dr. Cecelia Damask, DO, FAOCO-HNS, FAAOA, a physician at Orlando and Lake Mary ENT & Allergy, board-member-at-large for the American Osteopathic Colleges of Ophthalmology and Otolaryngology-Head and Neck Surgery (AOCOO-HNS), coordinator of education for the American Academy of Otolaryngic Allergy (AAOA), chair-elect of the Allergy, Asthma, and Immunology Committee for the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) and assistant professor in the Department of Otolaryngology at the University of Central Florida College of Medicine.
“SONU is a really interesting technology. It’s based on the really old understanding that when we hum or sing or whistle, our sinuses open, and we also feel very relaxed. The vibration relaxes the sympathetic and parasympathetic parts of our autonomic nervous system; it opens our sinuses with resonance, improves the flow of mucus in the nose and promotes ciliary action. SONU was designed based on what we know about vibrations and acoustic resonance, without any medications, and the patient can do whatever else they want while using the SONU band. We’ve waited a long time in our field for a product that can help manage nasal congestion, sinus pressure and tension in the head and neck in such an elegant way, so that the whole experience is wonderful for our patients. It’s a very good alternative to the other options of medications, allergy management, surgery and office procedures. So, I’m excited to add SONU to the toolkit for patients with nasal congestion.”
- Dr. Jacob Johnson, MD, president, San Francisco Audiology, ENT specialist, San Francisco Otolaryngology Medical Group, and associate clinical professor, University of California, San Francisco
