The medical industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in numbers
Orthopedic fixation technology developer Ossio closed a $38.5 million Series C financing round. Growth equity firm MVM Partners led the funding. Current shareholders also participated in the round.
Cordis announced a deal for an $235 million agreement to buy MedAlliance. MedAlliance is the Swiss developer of SELUTION SLR, a CE-marked balloon that is coated with sirolimus.
Dutch conglomerate Royal Philips announced it is cutting 4,000 jobs after reporting lower than expected Q3 sales. In a letter to shareholders, Philips CEO Roy Jakubs said the medical device maker faces multiple challenges following the huge recall of its sleep apnea devices.
As of today, 435 COVID-19 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs).
Tuberculosis deaths and disease increase during the COVID-19 pandemic
The World Health Organization (WHO) released the 2022 Global TB Report which showed that both tuberculosis (TB) deaths and TB incidence increased during 2021. Additionally, the burden of drug-resistant TB (DR-TB) also increased by 3% between 2020 and 2021.
Medtech M&A decline poised to continue in 2023 amid ‘bumpy’ market: report
A decline in mergers and acquisitions in the medical device industry this year may continue into 2023 amid “near-term storm clouds” that include continued market uncertainties, according to a report by consulting firm EY.
Source: MedTech Dive
NIHR announces £800m for health innovation
The UK government announced more than £800m of funding for the National Institute for Health and Care Research (NIHR) to boost innovation and growth in healthcare and improve patient safety.
The NIHR will be responsible for allocating the funding, with £790m going to support breakthroughs in new treatments, diagnostics, and medical technology. A further £25m has been allocated for research into patient safety and to address health challenges such as cancer treatment and reducing medication errors.
Source: Digital Health
V-Wave concludes subject enrolment in Ventura Interatrial Shunt trial
V-Wave has concluded subject enrolment in the RELIEVE-HF pivotal clinical trial of the V-Wave Ventura Interatrial Shunt for heart failure (HF).
The sham-controlled, multi-centre, prospective, double-blinded, randomised trial has been designed to evaluate the V-Wave Ventura Interatrial Shunt’s effectiveness and safety in treating HF to reduce future hospitalisations and improve the quality of life for HF patients.
In the study, 508 advanced HF patients were enrolled in 101 hospitals from 11 countries. Patients with reduced and preserved left ventricular function etiologies for HF were also included.
The participants were randomised in a 1:1 ratio to either the Ventura Shunt treatment arm or a sham control arm.
Source: Medical Device Network
Missing data: risk of assessment bias joins the long tail of Covid-19 impact on clinical trials
It has been well reported that the Covid-19 pandemic had a direct impact on the execution of clinical trials, such as patients being unable to visit clinical sites or procedures being affected by staff shortages. Now, questions have arisen about the best way to analyse missing data due to disrupted assessments and retain statistical power without introducing bias.
Clinical trials that were using time-to-event endpoints are particularly prone to misalignment between the scientific question that the trial intends to answer and the statistical analysis. For example, progression-free survival (PFS), one of the most frequently used endpoints in oncology trials, is a major concern, state authors of a recently published research paper.
Source: Clinical Trials Arena
FDA moves to make effect on health equity part of breakthrough device considerations
The Food and Drug Administration has proposed changes to its breakthrough device program to clarify the language about technologies that benefit populations suffering from health disparities.
Through the draft document, the agency is seeking feedback on changes to two sections of the breakthrough guidance it finalized in 2018.
The sections address designation considerations and the designation review process.
If it finalizes the proposal, the FDA will expand its breakthrough program to devices that improve accessibility because they may be more effective in patients with limited or no available options.
Source: MedTech Dive
US-based company Nines is a tele-radiology and artificial intelligence startup. Its product NinesAI is FDA-cleared to triage time-critical, life-threatening indications of mass effect and intracranial hemorrhage.
Biotechnology company Lucira Health offers disposable at-home test kits to detect infectious diseases, such as Covid-19.
Source: Lucira Health
US-based company Bloomlife is using technology, data science and medical expertise to address issues in maternal health.