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COVID-19 test offering swells; Orexo capitalises on demand surge for mental health digital therapeutics; Zimmer Biomet gives insight on medtech procedure rebound; vascular robotics innovator poised to tap into major opportunity; Boston Scientific’s subcutaneous ICD proves its mettle.
Abbott pushes ahead in growing throng of COVID-19 tests
Every week sees a new batch of COVID-19 tests join the list and several of the big players are now offering more than one test, though none as many as Abbott who this week capped an FDA Emergency Use Authorisation for its fifth test. This most recent test is a molecular diagnostic for SARS-CoV-2 that runs on its Alinity m molecular laboratory instrument; it joins Abbott’s two other FDA-authorised molecular diagnostics (one that runs on the lab-based m2000 platform, the other on the point-of-care ID NOW platform) and two antibody tests (both are lab-based and run on the Architect and Alinity i systems). However, Abbott's tests are coming under fire with questions raised about how sensitive and specific they are, particularly its ID NOW test. As this article went to press, it was reported that New York University researchers claim the test may miss as many as half of COVID-positive cases and the FDA issued a statement warning about "accuracy concerns" over ID NOW.
Orexo catches rising wave of mental health DTx
Swedish specialty pharma firm Orexo will be joining this rising swell of companies offering mental health digital therapeutics with the launch of deprexis, a digital therapy for depression, in the US this summer. The latter is the third addition to Orexo’s growing DTx portfolio, which also houses vorvida, a DTx for alcohol use disorder which will be launched in parallel with deprexis, and OXD01, a new DTx designed for managing opioid use disorder. Deprexis is already cleared by the US FDA but Orexo is capitalising on the FDA’s emergency policy for the distribution of DTx by moving forward the launch of vorvida and OXD01. The company had initially planned to launch vorvida in Q3 and OXD01, which is still in clinical trials, would not have come to market before 2022 but is now expected to be available this autumn. The pandemic has not only helped to bring these products to users much quicker, Orexo CEO Nikolaj Sørensen said COVID-19 has accentuated the importance and need for DTx.
More insights into how medtech procedures will rebound
As the earnings season starts to tail off, the biggest orthopaedics pure-play Zimmer Biomet acknowledged that it has been hit harder than most by the impact of the COVID-19 pandemic with more than 80% of its revenue being dependent on elective procedures. The firm released its Q1 2020 results this week which saw revenue declines across the board. CEO Bryan Hanson agreed with his medtech peers that a rebound will ultimately happen, as these elective procedures cannot be deferred indefinitely, but was more cautious about the timing of the recovery due to the many variables involved. He was optimistic nonetheless that when the recovery process is in full swing and patients "come back into the funnel", revenue will return "beyond 100% of pre-COVID numbers". [See The Wider View: Zimmer Biomet Cautious On Timing But Bullish On Magnitude Of Recovery to get more of Hanson’s insights.]
Newly cash-fuelled Robocath ready to hit cath labs with robotic system
One thing COVID-19 does not look to have derailed is interest in robotics, as evidenced by French firm Robocath’s recent success in raising its largest financing round yet. The €40 million ($43.2 million) series C is intended to ramp up commercialisation of Robocath’s R-One robotic system for performing interventional vascular procedures. The company conceded that the current COVID-19 pandemic had put a slight delay on its commercial plans but it believes it will be back interacting with physicians in June as hospitals start opening up to take on elective procedures once more. Robocath has very little competition in this space, with its only key rival being Corindus, which was acquired by Siemens Healthineers last year for $1.1 billion - an impressive multiple of 100 times that of Corindus’ annual revenue. [To find out more about R-One and Robocath’s strategy to take its system to market, read One To Watch: Robocath poised to ramp-up and tap into vascular robotics opportunity]
Boston Scientific touts heartening data on SICD use in "real-world" candidates
Boston Scientific released positive data from two large-scale studies of its EMBLEM subcutaneous implantable cardioverter defibrillator (S-ICD) at the virtual Heart Rhythm Society 2020 meeting last Friday. The PRAETORIAN study - the first randomised controlled trial to pit an S-ICD against conventional transvenous defibrillators (TV-ICDs) - aimed to assess the incidence of major ICD-related adverse events between these two types of devices and results showed that S-ICD therapy is non-inferior to TV-ICD, "with significantly less lead-related complications in patients treated with the S-ICD," said Reinoud Knops, lead investigator of PRAETORIAN. The UNTOUCHED study, on the other hand, was designed to see how well S-ICDs performed in patients who are much sicker than the current patient pool for these devices ie younger patients with fewer comorbidities. Results showed that at one year, the rate of adverse incidents like inappropriate shocks were much lower than in comparable studies - even in this sicker population - helped by newer algorithms and novel programming. [To dig deeper into the results of these two studies and understand their implications, read The Wider View: Boston Scientific’s S-icd Proves Its Mettle But It’s Not Without Complications].
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