ResApp Health Provided Update On Australian Adult Study And FDA De Novo Submission

  • Mar 29, 2019 AEDT
  • Team Kalkine
ResApp Health Provided Update On Australian Adult Study And FDA De Novo Submission

Leading digital health company, ResApp Health Limited (ASX: RAP) helps in the diagnosis and management of respiratory disease via its smartphone applications like ResAppDx-US, a smartphone application for the diagnosis of respiratory disease using cough sounds. ResAppDx-US is not available for sale in the United States as it still awaits US Food and Drug Administration (FDA) clearance.

On 29 March 2019, ResApp provided an update its Australian Breathe Easy adult prospective, double-blind clinical study and its planned De Novo submission to FDA for clearance of ResAppDx-US.

In the update, the company informed that its Australian Breathe Easy adult prospective, double-blind clinical study has completed recruitment, with 956 patients recruited. The Breathe Easy adult prospective study is focused on the diagnosis of lower respiratory tract disease, pneumonia, asthma exacerbations and chronic obstructive pulmonary disease (COPD) exacerbations. It is expected that the positive prospective adult results will greatly expand the company’s addressable market. The clinical dataset is now undergoing quality assurance. The top-line results are expected within three weeks.

The company has been working closely with Experien Group and Australian-based consultants for the documentation of De Novo submission. Today, the company announced that the documentation for its De Novo submission to the US FDA is completed. The documentation will now undergo a final two-week internal review process at Experien and at ResApp prior to its submission to the US FDA.

Recently on 18 March 2019, the company provided top-line results for croup and updated top-line results for primary upper respiratory tract disease (URTD) from its SMARTCOUGH-C-2 study which is a doubleblind, prospective study evaluating the efficacy of the ResAppDx smartphone application.

ResAppDx achieved a positive percent agreement (PPA) of 74% which exceeded that of the individual treating team clinicians who had a 65% PPA when compared to the final adjudicated outcome.

For the half year ended 31 December 2019, the company reported revenue of $34,742 which was 38.66% lower than the previous corresponding period (pcp). Further, the company reported a net loss of $3.33 million which was 4.5% higher than pcp.

Now, let’s have a glance at the company’s stock performance and the return it has posted over the past few months. The stock is trading at a price of $0.086, up by 19.444% during the day’s trade with a market capitalisation of ~$56.66 million as on 29 March 2019. The counter opened the day at $0.072 and reached the day’s high of $0.086 and touched a day’s low of $0.072 with a daily volume of ~ 1,860,481. The stock has provided a year till date return of -33.64% & also posted returns of -63.50%, -33.64% & -17.05% over the past six months, three & one-month period respectively. It had a 52-week high price of $0.280 and touched 52 weeks low of $0.069, with an average volume of ~530,930.


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