Rhinomed snoring product receives regulatory approvals

THE ROADHOUSE PHARMACY: Rhinomed (ASX: RNO) has completed testing and technical documentation allowing its new snoring and sleep quality product Mute™ to gain acceptance with the US Food and Drug Administration(FDA), European authority (CE Mark) and the Australian Therapeutic Goods Association (TGA).

Rhinomed described Mute to be an internal nasal dilator that increases airflow, allowing people to breathe more and snore less.

The company claims a recently independently conducted trial achieved the primary endpoints of reduction in snoring severity, volume, frequency and duration.

The trial exceeded pre-specified criteria showing clear improvement in reported sleep quality in both snorer and partner.

Rhinomed said registering the Mute with the US FDA as a Class 1, 510(k) exempt medical device product allows it to be sold online and in store within the United States.

Conforming to the regulatory and manufacturing requirements necessary to receive a CE Mark also enables the Mute to be marketed directly to European consumers, and to consumers in the four member states of the European Free Trade Association and in Turkey.

Australian TGA registration ensures the company can commence its test-marketing program immediately.

“The testing, process and steps we put in place for the testing of our first product – the Turbine – ensured that our second technology – Mute was right from the start designed, tested and manufactured to fully comply with the most rigorous of regulatory requirements,” Rhinomed CEO Michael Johnson said in the company’s announcement to the Australian Securities Exchange.

“Our internal team and regulatory advisors have done a great job of ensuring that we built the required testing and quality control processes that have enabled the Mute to comply with ISO Standard 13485 for the development of medical devices and to be successfully registered with the European, US and Australian Authorities.”

Website: www.rhinomed.com.au