reports
- Andy Smith
Interim Results: Financials reflect increased investment
RUA Life Sciences interim results demonstrated the continued investment in the business and its new products. The highlight of the interims was the 33% increase in third-party contract revenues that were a result of a recovery in elective surgical procedures, particularly in the US. Clouding the interims were the implications of the regulatory delay to the 510(k) review of RUA’s large-bore vascular graft medical device, which we explore more in this note. The deferral of RUA Vascular product r...
- Andy Smith
Regulatory hiccup
RUA Life Sciences have announced a regulatory update on the 510(k) submission for its vascular graft products that was filed on November 3rd, 2021. The FDA appears to have questions about the products that will almost certainly take longer to resolve than the normal review window. RUA and the FDA have converted the application into a pre-notification process and RUA does not now expect its first commercial sales in the first quarter of 2022. We are leaving our valuation unchanged at £122.9m or...
- Andy Smith
Significant milestone and trading update
RUA Life Sciences released a well-received announcement on an important milestone in the commercialisation of its large bore vascular graft and its related product, the vascular patches. The release also included a trading update on group businesses. As a result of this positive development on RUA’s vascular graft product, we have updated our valuation of the product itself and RUA’s cash position at the end of September 2021. The manufacturing hiccup that had held up the US FDA’s medical devic...
- Andy Smith
Confident AGM And Trading Update
RUA Life Sciences’ AGM statement and trading update demonstrated good progress across its businesses since the FY 2021 results announcement earlier in the summer. RUA’s product that is closest to the market – the large bore vascular graft – is back on track for a Q1 2022 commercial launch. The 510(k) approval and agreements with distribution partners will likely result in an increase in our valuation when they occur. RUA’s expectation of a six-fold increase in production capacity as a result of...
- Andy Smith
Investing in Growth
While RUA Life Sciences’ FY 2021 results echoed some of the challenges from last year’s pandemic, largely in the well-flagged revenue shortfall stemming from RUA’s customers that was a result of fewer elective surgeries, RUA’s focus now is on investing the proceeds of last year’s share offering in its vascular and heart valve products. Our forecasts and valuation have been updated for this increased pace of investment. Reminder we are hosting a presentation with management on Friday at 2pm. Re...
- Andy Smith
Minor bump in the road to 510k submission
RUA have released a precautionary announcement noting a minor delay to the 510k submission for its large bore vascular graft. This was almost certainly due to the handling of the batch of un-implanted grafts, and we share RUA’s frustration with the resulting delay. Since we had not yet updated our valuation for a June 2021 510k submission, our fair value remains unchanged. RUA announced a delay to their 510k medical device submission to the FDA for their large bore vascular graft. Surprisingly,...
- Andy Smith
RUA Life Sciences: Fundraising completed
On 30th December 2020, RUA reported that shareholders had approved resolutions regarding the placing along with a strongly oversubscribed Open Offer. RUA now start 2021 with the resources and mandate to accelerate the development of its products, where we anticipate reports of progress during the year. We have slightly increased our R&D and CapEx spend for FY 2022 to reflect this investment and the cash utilization. We have updated the valuation for revised share count, the full £7.0m amount r...
- Andy Smith
Christmas comes early – Fundraising and Interims
RUA have announced a Placing and Open Offer conditional on shareholder approval at a General Meeting (GM) – our financials assume the full amount of £7m, less costs, is raised. Since acquiring RUA Medical, RUA Life Sciences has become a fully integrated medical device designer and manufacturer. When the fundraising completes, RUA will have the resources to accelerate the development of its products on which much of our valuation has been based. We have updated our valuation for the expectation...
- Andy Smith
Heart valve progress
RUA have announced an earlier than expected update on the testing of its Elast-Eon-coated tri-leaflet artificial heart valve from its pilot pulsatile flow program. This testing is meant to simulate not just the flow of blood through the valve, but the viscous patterns that occur during the opening and closing of the valve, in the simulation of typical natural conditions. Not only have the minimum ISO Standard performance requirements been easily surpassed, but there were indications of reproduci...
- Andy Smith
‘A fully formed medical device manufacturer’
RUA Life Sciences announced its trading update for the six months to 30 September 2020. The global pandemic and the reduction in the number of elective surgeries had a (previously announced) impact on RUA Medical Device’s revenues. There was also a slight reduction in RUA Biomaterial’s licensing income, but in both divisions there has been a recent recovery and catch-up. Our valuation remains unchanged as our model had included these delays, and those divisions comprise minor components of our t...
- Andy Smith
Graft progress reflected in new valuation
RUA Life Sciences has announced that their graft products have moved into the final long-term animal testing stage. This is the point that proceeds the submission and then FDA approval (during which the graft could be partnered). We have therefore modified the risk-adjustment in our valuation to reflect a 5% higher probability of success. This tangible progress in the development of RUA’s most advanced products validates the acquisition of RUA Medical as all the value from these products now res...
- Andy Smith
Positive AGM Statement
RUA have provided a recent flurry of positive news, including an update on RUA Vascular division’s products and the recovery in elective surgical procedures in the US and Europe. The AGM update paints a recovering picture of the orders and therefore revenues at its RUA Medical Devices division. The recovery in elective surgical procedures and orders from its largest customer are expected to result in shipments that will average around 90% of pre-pandemic levels over the next three months. R...
- Andy Smith
'The transformation continuum’
Following the acquisition of RUA Medical Devices Limited by AorTech International plc, the combination has released their first set of final results under the company’s new banner of ‘RUA Life Sciences plc’. The name change has not been the only transformation as RUA is now a fully integrated medical device company with FY 2020 revenues of £489k, a cash balance as at 7 July 2020 of £1.5m, plus much more to come in product development news in FY 2021. FY 2020 Results Licence fees and ro...
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