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Hugo on the way to market; FTC déjà-vu for Illumina; Oxford Nanopore eyes billion-dollar IPO; Cognito CEO on DTx; polling physicians on ADHD DTx.
Medtronic’s Hugo robot one step closer to market
Medtronic has submitted its Hugo soft tissue robotic surgical system for CE mark and US IDE approval, narrowly hitting the Q1 target deadline it had set itself. In a March 31 filing with the US Securities and Exchange Commission, the company also indicated that it was partnering with several hospitals and healthcare systems in the EU and other CE mark jurisdictions to install Hugo systems and deliver training. Surgical robotics has often been highlighted as one of the main drivers that will help it achieve its goal of 5% annual growth. Hugo’s path to regulatory submission had been prolonged due to COVID-19, with lockdown restrictions last year causing some delays in the development work. The company is hoping to get the EU marketing green light within this fiscal year, which closes at the end of April.
Antitrust watchdog hounds Illumina over Grail acquisition
It’s déjà-vu for Illumina, as the next-generation sequencing (NGS) leader finds itself once again at loggerheads with the US antitrust authority, the Federal Trade Commission. The FTC is taking Illumina to court over its proposed $2.2 billion acquisition of multi-cancer early detection (MCED) test specialist, Grail, claiming the merger to be anticompetitive. Unlike the FTC’s objection to Illumina’s previous attempt to acquire Pacific Biosciences - a deal which was eventually abandoned by Illumina, the bone of contention is to do with Illumina being the main supplier of NGS systems that are used to perform the MECD test. Grail might be the furthest ahead in this market, but there are other MECD companies that also rely on Illumina’s NGS systems for their tests. The FTC is concerned Illumina may impede these MECD rivals’ journey to market through anticompetitive practices around the sale of its NGS systems. To find out more, read Wider View: Second round in the ring with FTC may not be easier for Illumina.
Oxford Nanopore gears up for IPO
While Illumina wrangles with the FTC, its NGS competitor Oxford Nanopore Technologies is prepping for a potential initial public offering that analysts say could value the company between $5.5 billion and $9.6 billion. Oxford Nanopore was a very vocal opponent to the Illumina/PacBio merger; the company’s mission is to make gene sequencing affordable and accessible and its handheld MinION DNA sequencer - based on its proprietary nanopore sequencing platform - has been used since the start of the COVID-19 pandemic in more than 85 countries, including China, to track the emergence of new SARS-CoV-2 variants. To date, Oxford Nanopore has received over $825 million in venture financing. Pending appropriate market conditions, the firm expects the IPO to take place in the second half of the year.
Why new-gen digital therapeutics need to prove their mettle against drugs
If digital therapeutics represent a new category of products, should they not be measured against a different benchmark to traditional pharmacotherapy? No, according to Brent Vaughan, CEO of Alzheimer’s digital therapeutics firm Cognito. The chief exec strongly believes if digital therapeutics want to have label claims like a drug, and demonstrate that they can have a disease-modifying impact even in tough-to-crack diseases like Alzheimer’s, then they need to show they can move endpoints just like a drug and use some of the same instruments. FirstWord HealthTech’s chat with Vaughan follows Cognito’s recent presentation of data from the phase II study of its GammaSense neurostimulation therapy. To get more insights on why and how digital therapeutics like GammaSense can carve themselves a space in the marketplace alongside drugs, see Spotlight On: Why DTx musn’t cut corners - especially for serious indications like Alzheimer’s.
Polling: what are physicians’ attitudes to digitised ADHD solutions?
Digital therapeutics are also making strides in attention deficit and hyperactivity disorder (ADHD), using different approaches such as neuromodulation and video-game based interventions like Akili Interactive’s EndeavorRx. Full data from the STARS-Adjunct study of EndeavorRx was just published last week, comparing the efficacy of using the digital therapeutic as standalone therapy or as an adjunct to pharmacotherapy. Results showed significant improvement in ADHD symptoms in both cohorts - but is this enough to convince physicians to adopt this innovative therapy? We are running a poll to find out what US and EU GPs’ attitudes are to this and other digitised ADHD solutions. Look out for our results next week [For details of the questions asked, see Physician Views: Are digital therapies for ADHD getting physicians’ attention?]
In other news...
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