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Highlights:
- Rhythm Biosciences Limited (ASX:RHY) stock ended Wednesday, jumping by 95.714%.
- The company announced that its product, ColoStat®, has secured UKCA Mark.
- The UKCA Mark certification permits the marketing and selling of ColoStat® within the UK.
The Australian innovative medical diagnostics company Rhythm Biosciences Limited (ASX: RHY) rose as much as 120% intraday and ended Wednesday, 17 May 2023, jumping by 95.714% to AU$0.685 after it updated that its product, ColoStat®, has secured UKCA Mark.
Let’s get apprised of the ASX healthcare stock- RHY’s latest update.
On Wednesday, the company secured UKCA Mark for ColoStat®, which is a colorectal detection technology product and fully conforms with the European Directives for IVD Medical Devices and the UKCA requisites. This regulatory accomplishment is an outcome of analytical testing and adherence to create and advance processes according to the essential requirements.
The UKCA Mark certification permits the marketing and selling of ColoStat® within the UK. It will provide the company with a commercial pathway into international markets, with the UK alone representing an addressable population of nearly 24 million people in the age group of 45-74 years. RHY anticipates making additional growth on its market entry into the UK in the calendar year 2023.
The UKCA marking represents that the manufacturer’s product fulfils the essential requirements of the UK MDR 2002 and is a legal requirement to position a device in the UK market.
The UK CA Market is a key element of RHY’s strategic plan that forms a component of its commercial plan, along with a priority market entry strategy.
Further, in its quarterly period ended 31 March 2023, as declared in March RHY was addressing the feedback from the TGA assessment. After the withdrawal of the TGA application, RHY was positioning for a new application addressing the full list of TGA queries.
RHY was assessing its partners within each of the regions as a short-term goal to attain commercially favourable terms that will deliver solid growth in the ANZ region, the UK, the US, etc.
RHY continues to work with Biotem as its European manufacturing partner. During the reported period, RHY advanced many initiatives pertaining to product marketing, partnerships and potential customer engagement activities, which consist of RHY conducting further market surveys to provide awareness and information pertaining to ColoStat®.
As of 31 March 2023, RHY’s cash at the bank was AU$6.8 million. The company obtained an additional AU$374k refund for R&D activities in March 2023 for FY21 and FY22.
