industry news

05 JUNE 2019

Medline completes AngioDynamics’ NAMIC portfolio acquisition

Healthcare company Medline has completed the proposed acquisition of NAMIC fluid management portfolio from medical devices firm AngioDynamics for $167.5m.

The portfolio includes cardiac catheterisation solutions, and the transaction covers the NAMIC brand, contrast management and closed fluid systems, guidewires, disposable transducers and interventional accessories.

Proposed in April this year, the deal also comprises AngioDynamics manufacturing facility at Glens Falls, New York, US, that produces injection moulded components and kits.

AngioDynamics has used a portion of the approximate $160m net proceeds to pay off all of its outstanding debt.

The company plans to combine its approximately $80m post-transaction cash balance with an additional $125m revolving line of credit for organic and inorganic investments to support growth and future profitability.

AngioDynamics president and CEO Jim Clemmer said: “We are very pleased to have completed the divestiture of the NAMIC fluid management business, which is a critical step in our ongoing portfolio optimisation efforts.

“The proceeds from this transaction enable us to further accelerate our strategic investments in key therapeutic areas and to advance our propriety medical technologies, including AngioVac, BioFlo, and the NanoKnife System, to address the unmet needs of patients around the globe.”

Medline noted that the transaction combines its customer base, distribution scale and medical kitting experience with the brand presence of NAMIC.

Following completion of the transaction, the NAMIC business will run as a new unit of Medline with a focus on Cath Lab products and solutions.

The acquisition will see the transition of around 330 AngioDynamics employees to Medline. In addition, 14 sales reps across the US, Canada and Europe will become part of the Medline sales team.

05 JUNE 2019

UK researchers create early stage blood test for heart failure

A research team at Queen’s University Belfast in Northern Ireland has developed a blood test to detect heart failure at earlier stages.

The new test is designed to measure the B-type natriuretic peptide (BNP) protein, as well as other proteins in the blood to enable better diagnosis of heart failure. It will simultaneously measure 25 proteins from blood samples of heart failure patients.

To assess whether the proteins would identify patients with heart failure, the test was then applied to more than 400 blood samples obtained from people with and without the condition.

Based on the study results, the researchers concluded that measurement of the 25 proteins provides a more accurate detection of heart failure compared to BNP alone.

Commonly, clinicians measure levels of the BNP protein in the blood using a standard test. Increased levels of this protein in heart disease patients are considered an indication of heart failure risk.

However, the protein can be elevated because of a variety of heart problems and blood levels can change due to certain medications, obesity and with age. This impacts the accuracy and reliability of BNP testing for the presence or severity of heart failure.

Currently, the team is collecting samples from multiple hospital sites across the UK, Ireland, France, Greece and the US in order to validate the accuracy of these proteins in diagnosis.

Researchers also aim to gain better insights into the potential benefit of the test for patients.

Queen’s University Belfast research fellow Dr Claire Tonry said: “There’s an urgent need to develop tests that can diagnose heart failure at an earlier stage and with greater accuracy in order to improve outcomes for patients with the disease.

“It’s difficult to measure multiple biomarkers in blood in a single test but, through our method, we were able to quickly measure multiple proteins from a small amount of blood that’s routinely collected by clinicians for measurement of BNP.”

Heart failure is a chronic condition known to affect approximately 920,000 people in the UK.

It is characterised by shortness of breath and a feeling of unusual tiredness or weakness. However, some people do not experience symptoms until after the condition has progressed.

04 JUNE 2019

Home-based brain stimulation treatment for depression launches in the UK

An at-home, medical-grade brain stimulation headset has launched in the UK, and claims to offer an alternative to pharmacological treatment for depression. The system is used in conjunction with a therapy app,

Medical device company Flow, which has had its treatment approved as a Class II medical device in Europe, is now in conversation with the NHS to make the headset available on prescription.

Patients diagnosed with depression often have reduced neural activity in their left frontal lobe, part of the brain involved in the regulation of cognitive skills and emotional expression. The Flow headset uses transcranial direct current stimulation (tDCS), a form of neurostimulation that delivers a constant, low direct current via electrodes on the head to this area of the brain to help rebalance activity.

Clinical trials published in the New England Journal of Medicine and the British Journal of Psychiatry have demonstrated that brain stimulation of this nature had a similar impact to antidepressants but with fewer and less severe side effects.

The former trial found that 24% of patients using tDCS completely overcame their depression and 41% found at least half of their symptoms disappeared after six weeks, while the latter recorded these same statistics at 23% and 34% respectively.

tDCS was also found to not produce any serious side effects or irreversible injuries. As it is a less expensive treatment than transcranial magnetic stimulation, electroconvulsive therapy or psychotherapy, this finding is particularly relevant for policymakers who might consider tDCS as a clinical therapy outside the research setting.

Flow co-founder and CEO Daniel Mansson said: “We want to support the improvement of the current standard of care for people living with depression by increasing treatment choice and empowering patients to self-manage their symptoms at home with effective, non-pharmacological alternatives.”

The typical course of treatment with the Flow headset lasts for 30 minutes per brain-stimulation session, with 18 sessions over six weeks. Continued treatment will then take place once or twice a week.

During brain stimulation, patients engage with a virtual therapist via an app, which features videos and advice about depression and how to reduce symptoms. This is informed by expert knowledge in sleep, nutrition, fitness and medication.

One in three workplace sick notes handed out by GPs are for mental health reasons, including depression, the economic costs of which are estimated at £105.2bn annually in England.

03 JUNE 2019

Warwick Uni mass spectrometry spin-out secures seed funding

University of Warwick spin-out Verdel Instruments has raised seed funding of over £230,000 from Longwall Ventures and British public innovation agency Innovate UK to develop a new two-dimensional mass spectrometry (2DMS) technology.

Mass spectrometry technology is used in analytical laboratories to identify key components and impurities in biopharmaceuticals, as well as in food, chemical products and the environment.

These instruments rely on a process of chromatography before the spectrometry analysis actually begins, separating the molecules of the substances analysed so they can enter the mass spectrometer one by one. It will then measure each molecule’s mass, fragment the molecule and measure the masses of the fragments, from which the molecular structure can be deduced.

The problem with the mass spectrometry devices currently in use across the world is that they cannot analyse more than one component at a time, meaning a scientist must accept a loss of information about impurities or parts of the entire structure. They also require very long runtimes for accurate results, in the region of 90 – 180 minutes.

Using 2DMS, only a single 20-minute analysis is required, Verdel said. The new technique allows researchers to analyse multiple complex samples simultaneously, with all data produced in parallel.

To date, 2DMS has only been used in academia, where large, slow and expensive instruments have been modified to introduce the 2D capacity. Verdel is now working with industry to develop this new technology and make it available in commercial facilities.

Director of Verdel Instruments and University of Warwick professor of analytical chemistry Pete O’Connor said: “We have done analysis of small pharmaceutical and agrichemical molecules, sequenced multiple complex protein or peptides, complex polymer distributions, monoclonal antibodies, proteomics samples, and whole proteins, and are currently working to expand the capabilities into environmental testing, petroleum analysis, food safety, and clinical analysis.”

The technology works by employing electrical pulses to manipulate ions in a linear ion trap before fragmentation to enable parallel acquisition of mass spectra. This operates in combination with UV laser-based fragmentation and a fast mass analyser.

The company said the technology offers improved specificity, sensitivity and speed compared to traditional mass spectrometry techniques.

31 MAY 2019

Nemaura gets European approval for SugarBEAT CGM

UK-based technology company Nemaura Medical has secured the European CE-Mark for the SugarBEAT continuous glucose monitor (CGM).

The marketing authorisation covers predictive alerts that provide visual indication in case glucose levels are falling or rising above minimum and maximum thresholds.

For use by diabetics and pre-diabetics, SugarBEAT comes with a non-invasive, needle-free, disposable and adhesive skin-patch connected to a rechargeable transmitter. It provides an ambulatory glucose profile (AGP) chart to help users spend more time in range (TIR).

Audible alerts or physical vibration of the mobile phone connected to SugarBEAT can also be enabled, alerting the user when glucose levels are estimated to decrease to dangerously low levels.

Nemaura Medical CEO Dr Faz Chowdhury said: “Given these benefits, we look forward to aggressively entering both the multi-billion-dollar diabetic (insulin and non-insulin dependent) and pre-diabetic markets.

“In addition, we plan to target the wearable health tech market for health-conscious consumers, which is experiencing explosive growth.”

Initially, the company intends to target the type II diabetes market, which makes up 95% of diabetics. This group commonly depend on periodic A1c readings every three to six months in order to manage their glucose levels.

A1c measurements are obtained from a lab blood test and offer a single value indicating the average glucose level over the past 60-90 days.

Meanwhile, CGM offers a time in range’ (TIR) metric, which measures the time per day when glucose is kept within the normal range.

The SugarBEAT smartphone app provides glucose readings every five minutes for the duration of wear. The CGM is expected to cut the number of daily finger prick tests.

Nemaura intends to launch the device in the UK and Germany in the coming months. The company is also planning to seek US regulatory approval this year.

31 MAY 2019

Thrive raises $110m to support cancer detection platform

Thrive Earlier Detection has been launched with $110m series A funding to advance and commercialise its liquid biopsy test CancerSEEK.

The test was developed by cancer research experts at Johns Hopkins University, US, for the identification of multiple cancer types at early stages. It combines DNA analysis with protein measurements from blood to detect tumours.

In a retrospective study, CancerSEEK showed more than 99% specificity.

The company intends to add real-world data and machine learning to further improve the test over time and provide a comprehensive primary care solution.

Thrive Earlier Detection co-founder and chief innovation officer Christoph Lengauer said: “We envision a future where routine preventative care includes a blood test for cancer, just as patients are now routinely tested for early stages of heart disease. We know that if cancer is caught early enough, it can often be cured.”

Currently, the test is being studied in the prospective DETECT study involving 10,000 healthy individuals.

Being conducted in alliance with Geisinger, the study is designed to gain better insights into the test’s performance and the implementation of its findings into patient care.

The company is planning additional studies to collect evidence for supporting regulatory approvals, inclusion in cancer screening guidelines and extensive reimbursement.

CancerSEEK has obtained the US Food and Drug Administration (FDA) breakthrough device designation to identify genetic mutations and proteins related to pancreatic and ovarian cancers.

“We know that if cancer is caught early enough, it can often be cured.”

Thrive Earlier Detection CEO Steven Kafka said: “With the help of experts and strategic partners, Thrive is launching today to advance a novel test for the earlier detection of multiple cancers, which we aim to augment with an integrated service that helps patients manoeuvre the often confusing path that follows a cancer diagnosis.”

The company’s series A funding round was led by Third Rock Ventures, and joined by Section 32, Casdin Capital, Biomatics Capital, Invus, Gamma 3, Exact Sciences, Cowin Venture, BlueCross BlueShield Venture Partners and Camden Partners among others.

30 MAY 2019

Australian patient data vulnerable to cyber attacks, audit finds

An audit has concluded that patient data in the Australian state of Victoria’s public health system could easily be breached.

Victoria’s auditor general Andrew Greaves and his office were able to hack into some of the state’s biggest health databases. They used basic hacking tools to access patient data at five different organisations – Barwon Health, the Royal Children’s Hospital, the Royal Victorian Eye and Ear Hospital, as well as the department’s Digital Health and Health Technology Solutions – to demonstrate what Greaves described in a report as a “a significant and present risk” to Australian citizens’ patient data.

The auditors were able to access the restricted administration and corporate offices of all the parties examined. For two of the five they were also able to gain access to areas storing critical technology infrastructure.

Some of the organisations were still using default manufacturer account names and passwords on key devices such as servers, details of which are easily available online.

Overall, they were ruled to not have been proactive enough in taking a whole-of-hospital approach to security.

RSA Security regional director of UK & Ireland Chris Miller said: “Attacks on healthcare organisations are becoming increasingly common, so it’s imperative that organisations take the necessary steps to manage their digital risk very carefully.

“Some of the errors that the auditors have picked up on here are pretty basic, which suggests that security hasn’t become embedded into these organisations – instead being treated as a bolt-on, or worse, a hurdle.”

The auditor general’s offices also investigated the security infrastructure surrounding the Department of Health and Human Services and the Department of Justice and Community Safety. It found that while the infrastructure was adequate, its effectiveness was undermined by a laissez-faire approach to safety culture.

All of the audited health services accepted the auditor general’s recommendations to tighten security around patient hospital data.

Due to their storage of huge amounts of personal data, hospitals are growing targets for hackers, and medical records can sell for thousands of dollars on the dark web.

In 2017 the WannaCry ransomware attack caused global chaos, costing the British NHS £92m and resulting in 19,000 appointments being cancelled.

Miller said: “Many hackers out there are opportunists; if you are not even doing the basics, then you could fall victim to a hacker who is simply rattling doorknobs to see which one is unlocked.”

29 MAY 2019

3D-printed artificial corneas could replace donor transplants

A 3D-printed artificial cornea made of decellularised corneal stroma and stem cells may eventually replace the use of donated corneas in eye surgery.

A group of researchers at the Pohang University of Science & Technology and the Kyungpook National University School of Medicine in South Korea worked together to 3D print an artificial cornea using tissue-derived bioink. Their research has been published in Biofabrication.

Because the 3D-printed cornea is composed of materials deriving from corneal tissue it is biocompatible, with 3D cell printing technology recapitulating the corneal microenvironment so that its transparency is similar to the human cornea.

There are roughly 2,000 patients awaiting cornea donation in South Korea, who wait an average of six years for surgery. While artificial corneas are available for patients who cannot find a suitable donor, those currently on the market are made up of recombinant collagen or chemical substances such as synthetic polymer. This means they can often resist full incorporation into the eye or are not transparent after the cornea implant.

This is because the cornea is organised in a lattice pattern of collagen fibrils, which directly impacts the transparency of the cornea. Many researchers have tried to replicate this structure via a synthetic artificial cornea but have struggled to do so.

The researchers at Pohang and Kyungpook were able to solve this problem through the shear stress generated by the frictional force of the 3D printing process when the bioink passed through the nozzle. Regulating the shear stress to control the pattern of the collagen fibrils manufactured the necessary corneal lattice pattern, demonstrating that corneal stroma-derived decellularised extracellular matrix bioink was biocompatible and could be transplanted into a human eye.

The research team also observed that the collagen fibrils remodelled along with the printing path create a lattice pattern similar to the structure of native human cornea after four weeks in vivo.

A 3D-printed artificial cornea derived from real corneal tissue could help to bypass both the difficulties of finding a donor match and the complications associated with synthetic corneas for patients with cataracts and other ocular complications.

Pohang University of Science & Technology professor Jinah Jang said: “The suggested strategy can achieve the criteria for both transparency and safety of engineered cornea stroma. We believe it will give hope to many patients suffering from cornea-related diseases.”