Digital Health company ResApp Health Limited (ASX: RAP) submits its CE Mark Technical File to the British Standard Institution (BSI) for a first-of-its-kind smartphone application, ResAppDx, developed for the diagnosis and management of respiratory disease. The news sent the ResApp shares to jump up 4.762% to stand at $0.110 in the morning trade on 2 January 2019.
CEO and Managing Director of ResApp Health, Tony Keating stated that the preparation and filing of the CE Mark Technical file for the company’s flagship ResAppDx-EU, a diagnostic tool for acute respiratory disease, outlines the last step to complete the commercialization of its first product.
CE mark certification is required to confirm with the protection standards relating to the safety, health, and environmental conditions and impact of the goods sold within the European Economic Area. The receipt of CE Marking approval from European Notified Body would enable ResApp to commence the commercial sale of ResAppDx-EU in the European Economic Area and facilitate commercialization in other markets such as Canada, Australia, and Singapore.
Mr. Keating added Europe represents an attractive market as the major part of continent’s six billion annual general practitioner visits are related to respiratory disease.
This mobile software application, ResAppDx-EU is designed to be used by clinicians by which they can take the rapid test for the most commonly-observed acute pediatric respiratory disease. It includes lower respiratory tract disease, asthma/reactive airway disease, pneumonia, croup, and bronchiolitis in infants and children.
Going forward, the company intends to file a De Novo premarket submission with the US Food and Drug Administration by the first quarter of this calendar year 2019. Also, ResApp is in talks with German private hospitals to quantify its application’s healthcare system benefits in this European winter.
The company told two other significant clinical programs are underway. The first one includes an acute adult respiratory disease diagnosis study in the US, SMARTCOUGH-C-2. In respect to this study, The technical issues raised earlier have been reportedly resolved, and the adjudication is expected to be completed this quarter. Whereas, the second major program is an at-home obstructive sleep apnea study in which recruitment is said to nearing completion.
On the financial front, ResApp posted a net loss of $6.53 million for the year ended 30 June 2018, compared to a net loss of $10.03 million reported in the previous corresponding period. The company explained that the loss for the prior year is mainly attributable to research and development costs which accounts for approximately 49% of total expenses incurred during that year.
The market capitalization of ResApp Health Limited is $82.62 million as at 2 January 2019. In the past 12 months, RAP has witnessed a positive market change of 28.05%. But over the last three months, it has fallen massively by 53.33%.
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