Friday Five: The medtech week in review (1 May 2020)

Boston Scientific, Edwards Lifesciences give more colour on post-COVID-19 recovery; digital therapeutics dial into COVID-19 tackling efforts; antibody tests proliferate; cell deformability diagnostic tech gets evaluated in COVID-19 setting.

Boston Scientific highlights a mixed bag for recovery...

Boston Scientific was among the swell of companies reporting quarterly results this week as earnings season went into full swing. The firm’s 3% organic revenue decline in Q1 was to be expected and consistent with what’s been seen so far from its medtech peers, particularly those whose core products are affected by halt in elective procedures. While it did not provide guidance for the year due to the uncertainties of the pandemic, Boston Scientific did give detailed insight into how its different businesses have fared in April, which CEO Michael Mahoney and others believe will be the toughest month in the toughest quarter yet. Overall, businesses hardest hit, like neuromodulation, have the highest mix of deferrable procedures, while those like interventional oncology, particularly its BTG-acquired Therasphere radioactive bead therapy, has shown to be more resilient due to the higher acuity, critical nature of the treatment. 

To take a deeper dive into Boston Scientific’s recovery forecasts for its different franchises, go to The Wider View: Boston Scientific’s Insights Point To Where Faster Recovery Could Happen

...and Edwards underlines issues to iron out post-COVID-19

Edwards Lifesciences, Boston Scientific’s rival and leader in the structural heart market, also provided some commentary during its Q1 earning call on how it sees normalisation of healthcare procedures play out once the COVID-19 situation starts to ease. CEO Michael Mussallem noted that while recovery will likely happen in the second half of the year, there are issues like kick-starting the referral system and getting patients ready and willing to come back into the hospital for their procedures that need to be addressed. He conceded that the disruption to the referral system caused by COVID-19 is "very real" and that patients were "scared and afraid of COVID, which meant that they have, in many cases, decided to stay home. This, and many factors, will influence the recovery", said the CEO.

Go to The Wider View: Serious Revving Needed To Get Procedural Engine Back To Full Recovery, Edwards Indicates to learn more. 

Digital therapeutics coming to fore in COVID-19 response

The last week has seen a couple of notable launches in the digital therapeutics space, following the US FDA’s relaxation of its policy on the distribution of these products to help manage mental health and psychiatric disorders during the COVID-19 pandemic. Akili Interactive, which has been awaiting FDA clearance of its digital therapy for attention-deficit hyperactivity disorder (ADHD), ENDEAVOR, has now made the therapy available to children temporarily under the FDA emergency policy. Akili is making ENDEAVOR available at no cost and without a physician prescription (the app is designed to be a prescription-only therapy and will be regulated as such when it finally gets FDA clearance). Pear Therapeutics, another player in the prescription digital therapeutics space, is doing a limited launch of one of its pipeline products to help people living with schizophrenia during the COVID-19 crisis. Pear-004, which the company is developing and evaluating in partnership with pharma giant Novartis, is designed to improve core symptoms and depression in people living with schizophrenia by providing multimodal neurobehavioral interventions in combination with standard of care antipsychotic medication. 

Antibody tests grow in numbers in FDA EUA list

With an increasing number of countries looking to move into the next phase of its COVID-19 pandemic response and start easing restrictions, antibody testing has been hitting the headlines with more ferocity than ever before. The FDA has ramped up authorisation of these serology tests, which are designed to detect if an individual has developed immunity to the SARS-CoV-2 virus. As of April 30, the US regulator has given emergency use authorisation to eight serology tests for antibodies to COVID-19, including two from Ortho Clinical Diagnostics (OCD) alone. OCD, which was formerly Johnson & Johnson’s IVD-focused business before it was carved out of the group, had its first serology test authorised on April 14 detects total antibodies, including IgG and IgM, whereas the second test that was authorised on April 24 detects IgG only. The company claims its second test has 100% specificity [a claim which Roche Diagnostics CEO Thomas Schinecker might dispute, based on his comments during the Swiss firm’s Q1 conference call - Ed]. Abbott also has an EUA for its lab-based serology test and said it has a lateral flow serology test, for use in point of care setting, on the way. 

Cytovale evaluates cell-based tech to detect sepsis in potential COVID-19 cases 

One technology that is still in development but could have the potential to help healthcare systems in their fight against COVID-19 is Cytovale’s rapid diagnostic system for early signs of sepsis. The Bay Area start-up recently received funding from the US Biomedical Advanced Research and Development Authority (BARDA) to support a pilot study evaluating the use of its technology for triaging patients with potential respiratory infections, including those related to COVID-19. Cytovale’s technology is designed to measure and analyse immune cell activity, by looking at the cells’ biophysical properties, specifically cellular deformability. It is said to be able to produce results in less than 10 minutes. The pilot study will be conducted in Louisiana, considered to be a COVID-19 hotspot in the US. Initial data from the study is expected to be available before the end of Q2, depending on enrollment, said Cytovale.

To get a low down on the technology, read One To Watch: Cytovale’s Cell-based Diagnostic Could Filter Out Sepsis Cases Fast.

The Wider View and One To Watch articles are part of our premium MedTech PLUS service. To find out more, email info@firstwordmedtech.com 

 

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