The leading digital healthcare company, ResApp Health Limited (ASX: RAP) declared the top-line outcomes for croup and primary upper respiratory tract disease (URTD) attained from the study of SMARTCOUGH-C-2.
SMARTCOUGH-C-2 is a double-blind, prospective study, which concentrates on evaluating the effectiveness of the ResAppDX smartphone application, for the diagnosis of severe respiratory disease detected during childhood. The conducted study registered around 1,667 patients, between the age of 29 days- 12 years. All these patients involved with the study represented 1 among 3 of the participating sites in the USA region, reflecting the symptoms of severe respiratory disease.
While providing cough recordings to the clinical adjudicators, the company came across the technical issues. Therefore, the croup outcomes were not available in the preliminary results. The results were overdue until the time adjudicators heard every cough recording and were engaged with the re-review process of individual patient’s medical records.
A 74% of positive per cent agreement i.e. PPA and 74% of negative per cent agreement i.e. NPA was accomplished for ResAppDx, when the comparison was made with the clinical diagnosis for croup. ResAppDx’s PPA surpassed that of the individual treating team clinicians and had a 65% PPA when the comparison was made to the final adjudicated result. The team clinicians were engaged with observing and treating participants involved in the study, forming a part of routine standard care. According to the study, out of the 29 patients on whom the study was conducted, around 2% were clinically diagnosed with croup.
Source: Company news on ASX
Tony Keating, CEO and Managing Director of ResApp commented that the lesser incidence of croup in the study population demonstrated the relative rarity of croup in the setting. Further, it prohibited the company from the inclusion of it in its FDA submission report.
Recently, the company announced that it had obtained the nod from AusIndustry regarding its application for R&D advanced overseas finding.
Also, the company released its half-year financial results ended 31 December 2018 recently. Wherein the company recorded revenues from ordinary activities down by 38.66% to $34,742 as on 31 December 2018. The loss from ordinary activities after tax attributable to members was up by 4.5% to $ 3,330,307.
On 29 January 2019, the company notified the market about the Ractivities during the second quarter of the financial year ended 31 December 2018. During December, the company submitted its CE Mark Technical File for ResAppDx-EU, which is a mobile software application, supposed to be used by the clinicians to diagnose lower respiratory tract disease like croup, pneumonia, asthma etc., detected among children. During the second quarter of the financial year, the company recorded positive results from double-blind, prospective obstructive sleep apnoea study.
During the period, the company made progress while working with its US and Australian-based consultants on a De Novo premarket submission for its acute paediatric respiratory disease diagnostic smartphone application. The company expected to file the submission to FDA for three of the most clinical indications. As on 31 December 2018, RAP had cash of $6.8million and was well-funded to execute its clinical and commercialisation strategy.
The stock of the company closed at A$0.085, down by 3.409% from its previous close. Its market capitalization is A$69.25 million with circa 786.88 million shares outstanding.
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