SD Biosensor, SJL Partners to acquire Meridian Bioscience for $1.53bn
8 July | M&A
A consortium formed by SD Biosensor (SDB) and SJL Partners signed a definitive merger agreement to acquire diagnostic products manufacturer Meridian Bioscience in an all-cash deal valued at approximately $1.53bn.
According to the deal terms, the shareholders of Meridian Bioscience will receive $34 per share in cash, which represents a 16% premium based on the one-month average price per share of common stock starting 7 June.
Meridian Bioscience develops, produces, markets, and distributes a range of diagnostic products in areas that include upper respiratory infections, gastrointestinal and blood lead level testing.
SDB and SJL will fund the transaction through a combination of cash on hand and additional financing. The transaction is anticipated to conclude in the fourth calendar quarter of the year.
Once the deal closes, SD Biosensor is expected to hold about 60% of Meridian while the remaining 40% will be held by SJL.
15 July | Approvals
DYANSYS RECEIVES US FDA APPROVAL FOR FIRST RELIEF NEUROSTIMULATION DEVICE
DyAnsys received US FDA approval for its percutaneous electrical neurostimulation (PENS) device, called First Relief, to treat diabetic neuropathic pain.
First Relief is for symptomatic relief of chronic, intractable pain related to diabetic peripheral neuropathy through multiple treatments for up to 56 days.
Placed behind the ear, the wearable device provides continuous pulses of low-level electrical current for several days.
The regulatory approval was based on data obtained from a randomised, double-blind prospective study, which was conducted with 63 participants aged between 30 and 74 years.
In the study, First Relief was evaluated against a placebo, as well as another device that had previously been approved by the US FDA.
12 July | Diagnostics
FDA GRANTS BREAKTHROUGH DEVICE DESIGNATION FOR T2 BIOSYSTEMS’ T2LYME PANEL
The US FDA granted breakthrough device designation for T2 Biosystems’ T2Lyme Panel.
A direct-from-blood molecular diagnostic test, the T2Lyme Panel was designed to detect the Borrelia burgdorferi, B. afzelii, and B. garinii bacteria, which cause Lyme disease, directly from a patient’s blood.
It runs on the FDA-cleared T2Dx Instrument and was developed to support early diagnosis.
Early diagnosis allows appropriate treatments to be provided quickly, which helps prevent or reduce complications and significant costs associated with the disease.
According to preclinical data, the device provides superior accuracy compared to other diagnostics used for detecting Borrelia infections in patients that are suspected of having Lyme disease.
11 July | Clinical Trials
NYXOAH RECEIVES FDA APPROVAL TO BEGIN GENIO SYSTEM TRIAL
Medical technology firm Nyxoah secured an investigational device exemption (IDE) approval from the US FDA to carry out the ACCCESS clinical study of its Genio system.
Genio is a next-generation neurostimulation solution developed to for moderate-to-severe obstructive sleep apnoea (OSA) in adults. Genio is a battery-free, leadless, and single-incision neurostimulator.
The device keeps the upper airway open while the user is asleep by stimulating the hypoglossal nerve bilaterally.
Previously, Genio received Breakthrough Device Designation from the US FDA for the treatment of complete concentric collapse (CCC) patients.
ACCCESS is designed to assess the use of Genio to treat moderate-to-severe OSA and CCC of the soft palate in adult patients.
1 July | Wearables
LIVEMETRIC SECURES FDA 510(K) CLEARANCE FOR LIVEONE BP MONITORING SYSTEM
LiveMetric received 510(k) clearance from the US FDA for LiveOne, a blood pressure monitoring technology.
LiveOne is a non-invasive, wrist-worn device that provides real-time measuring of blood pressure in patients with hypertension and cardiovascular diseases.
Without the need for any external calibration, the cuff-free device continuously extracts the pressure waveform from the radial artery.
It combines microelectromechanical system (MEMS) nanosensors with AI algorithms to provide blood pressure measurements.
Developed using a unique technological approach, the device uses a range of high-frequency nanosensors that help to process and sense actual pressure.
LiveOne uses machine learning to extract blood pressure values from the pulse waveform shape.
6 July | Diagnostics
BLOOM DIAGNOSTICS INTRODUCES NEW INFLAMMATION TEST TO MEASURE CRP
Bloom Diagnostics introduced its Bloom Inflammation Test, which measures the C-Reactive Protein (CRP) in the bloodstream to detect inflammation.
Depending on sample CRP levels, the single-use, semi-automated testing kit gives five different classifications, ranging from normal to high-grade inflammation.
The test is designed to be used by professional clinicians. It allows testing for different ranges of CRP using a single drop of blood, with results obtained in minutes.
The process involves the collection of a pin-prick blood sample on a test strip, which is sent to the Bloom lab.
Cloud-based algorithms and AI technology combine results with other information, such as medical history, lifestyle, health status, and symptoms.
14 July | Artificial Intelligence
ANUMANA PARTNERS WITH NOVARTIS FOR AI-DRIVEN HEART DISEASE DETECTION
Health technology company Anumana and Novartis Pharmaceuticals entered a partnership to use AI for the detection of heart diseases.
Under the multi-year collaboration, the companies will seek to deploy multiple AI-powered software solutions that will be able to identify hidden cardiovascular conditions.
They will deliver electrocardiogram (ECG) AI algorithms that will enable physicians to improve the detection of heart diseases in patients with no prior history.
1 July | Clinical Trials
JUSTLIGHT LAUNCHES CLINICAL TRIALS OF SUNFLOWER RX FOR ALZHEIMER’S DISEASE
JustLight launched clinical trials to evaluate its Sunflower Rx medical device, designed to provide photobiomodulation (PBM) treatment for Alzheimer’s disease. PBM is the medicinal use of red or near-infrared light for repairing and energising cells.
The device uses specific wavelengths of near-infrared light to bypass the skull and be directly absorbed by the brain. It uses high-efficiency LEDs with four wavelengths for precision dosing according to scientific references.
20 January | Covid-19
WALGREENS LAUNCHES INTERACTIVE TOOL TO TRACK COVID-19 VARIANTS
Walgreens has launched a new interactive tracking tool, the Walgreens Covid-19 Index, to advance the rapid detection of Omicron and track variant activity. It says the index can track the spread of the omicron variant within 24 to 48 hours.
The tool uses testing data from Aegis Sciences Corporation and uniquely identifies the spread of current and emerging virus variants in real-time.
The tool offers a snapshot of data for the past seven days based on positive tests analysed at more than 5,000 Walgreens locations across the nation.
According to the data collected and tracked by the tool, more than 95% of all positive cases of Covid-19 nationally are presumed to be the Omicron variant.
VIOME LIFE SCIENCES INTRODUCES FULL BODY INTELLIGENCE TEST
Viome Life Sciences launched its Full Body Intelligence Test for at-home testing. The test is designed to provide nutrition recommendations to optimise the user’s health.
Using microbial and human gene expression, the at-home test helps to study the oral microbiome, gut microbiome, blood transcriptome, and broader human-microbe interactions throughout the body.
MEDTRONIC ENTERS PARTNERSHIP WITH CATHWORKS WITH $585M BUYOUT OPTION
Medtronic formed a strategic partnership with Israel-based cardiovascular disease-focused medical technology company CathWorks.
According to the agreement, Medtronic will make an investment of up to $75m and immediately begin co-promotion of CathWorks’ FFRangio System in the US, Europe, and Japan, where it is currently available commercially.
BILLIONTOONE LAUNCHES NORTHSTAR SELECT AND NORTHSTAR RESPONSE ASSAYS
BillionToOne launched Northstar Select and Northstar Response, its first liquid biopsy products for oncology.
A pan-cancer somatic mutation profiling panel, Northstar Select provides a prioritised list of mutations present in a tumour. It uses the company’s molecular counting technology which allows the panel to identify actionable alterations.
MOLECULIGHT’S DEVICE BOOSTS HEALING BY 204% IN DIABETIC FOOT ULCER TRIAL
MolecuLight reported its MolecuLight i:X device designed to view the presence of increased bacterial burden in wounds raised 12-week healing rates by 204% in a trial recruiting diabetic foot ulcer patients.
The 56-patient trial assessed the use of point-of-care bacterial autofluorescence imaging to manage diabetic foot ulcers versus standard-of-care.