Friday Five - The medtech week in review (19 September 2019)

Healthtech-pharma partnering escalates in diabetes, MS and other chronic diseases; CMR Surgical bulks up coffers; first Class III device clears new EU MDR hurdle

Abbott and Medtronic snap up insulin partners for digitising diabetes management

The diabetes market saw two of the leading blood glucose device players announce, on the same day, but separately, news of partnerships with two of the world's three biggest insulin manufacturers. Abbott scored a deal with Sanofi to make its FreeStyle Libre blood glucose sensing technology compatible with the French pharma company's smart insulin pens, which are still under development, so that data from the devices can be shared on the same digital platform and allow more seamless diabetes management. Medtronic also struck a similar data-sharing agreement with Novo Nordisk, which would pair up the Guardian Connect continuous glucose monitor with the Danish firm's insulin pens, expected to be available next year. This is Medtronic's first partnership with an insulin supplier, while Abbott already has made some headway with Sanofi being its third insulin delivery partner. Medtronic has already made some noise to signal its commitment towards more partnerships like this in diabetes, so we could be hearing more announcements from the medtech giant soon. 

[See The Wider View: Medtronic plays catch up in CGM-insulin pairings, but Novo Nordisk deal moves it in the right direction]

Happify Health strikes first digital therapeutic deal with Sanofi

Sanofi looks to be going in all guns blazing with its digital health strategy as it hit the headlines again this week with another partnership that will further strengthen its digital offering. The company is teaming up with Happify Health to develop a prescription digital therapeutic (PDT), based on the latter's app for reducing stress and anxiety, that will be targeted specifically at multiple sclerosis patients. Sanofi currently markets two MS drugs, Aubagio and Lemtrada, and this PDT will be a third product that complements the medication and address the estimated 60% of MS patients who suffer from depression and anxiety, Chris Wasden, head of Happify’s digital therapeutics division, told FirstWord MedTech. It won't be for another two years before the PDT could be ready to enter the market, we learnt, but here's why Sanofi should still benefit from adding a digital element to its MS portfolio. 

[See The Wider View: Can Happify’s mental well-being app help boost Sanofi’s MS sales downer?]

Bayer invests in new digital tech partner One Drop

Yet another announcement in the flurry of healthtech-pharma partnerships this week is Bayer's collaboration with One Drop to apply the latter's AI-driven diabetes management programme and develop it for other disease areas, such as oncology, cardiovascular disease and women's health. One Drop's platform draws data from several connected devices that track information across different health metrics, and it uses this data to recommend personalised health programmes to bring about behavioural change for promoting better disease management. The company already has partners in diabetes and it looks like this partnership with Bayer, which also comes with a substantial investment from the German company, is the first for One Drop outside of diabetes. 

CMR Surgical's hefty capital injection fuels Versius' path to commercial expansion

Emerging surgical robotics company CMR Surgical has raised what is its biggest round to date, and also said to be the biggest fundraise ever within the European medtech sector. The $240-million series C financing will be the last venture round for the company, according to CEO Martin Frost, as it clears the path for scaling up commercialisation of its Versius robotic system. This latest capital injection also brings the Cambridge, UK company's valuation to over $1 billion, giving CMR unicorn status. The size of its valuation is not the most important thing though, Frost told FirstWord MedTech, but the fact that it can deliver on its mission quickly "without having to go out again to raise more money." 

[See The Wider View: Medtech unicorn CMR Surgical readies itself for new commercial heights]

Another MDR-certified device in the bag and it's a high-risk device

Heart device specialist Biotronik has obtained what is the first MDR certification for a Class III device, the highest risk category under the EU MDR's classification system. The news comes just a week after Novartis bagged the accolade of having the first device ever to be certified under the new and more stringent regulatory framework; Novartis' Concept1 inhaler was previously a Class I device under the outgoing Medical Devices Directive (MDD), but is now up-classified to Class IIa under the MDR. Biotronik did not provide more details of the product that was MDR-certified, nor whether it was a new device or one that was already on the market. Gary Slack, senior vice-president of BSI, the notified body that certified Novartis' inhaler, had told FirstWord MedTech that he foresees an uptick in MDR applications over the next few months, but a large part of notified bodies' work will be on renewing CE certificates under the MDD instead, in the run up to the May 2020 deadline. 

[See The Wider View: Novartis gets MDR ball rolling but avalanche of applications under new EU reg not likely]

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