industry news

04 September 2018

CMR Surgical unveils surgical robotic system Versius

UK-based medical equipment maker CMR Surgical has unveiled a next-generation surgical robotic system, called Versius, to provide a portable option for minimal access surgery.

The robotic system is designed to address the complexities and offer improved access during minimal access surgeries.

Versius comes with a small form and individually cart-mounted arms, which enable its transportability between operating rooms and hospitals. The portability is said to also allow easy setup and patient access.

According to CMR Surgical, the new surgical robotic system bio-mimics the human arm and offers freedom of port placement with benefits of small fully-wristed instruments.

In addition, Versius features 3D HD vision, easy instrument control and various options for working positions.

CMR Surgical CEO Martin Frost said: “We believe Versius represents a paradigm shift in surgery. The ground-breaking design, coupled with genuine affordability, means that patients everywhere have the potential to benefit from the advantages of minimal access surgery.”

Founded in 2014, the company primarily focuses on developing robotic systems to make minimal access surgery accessible and affordable.

According to Accuray Research, the current $4bn global annual revenues of robot-assisted minimal access surgery market are estimated to reach $20bn by 2025.

In June this year, CMR Surgical raised $100m in a series B financing round. The company said that the funds would be used to support the preparation of Versius for commercialisation.

Currently, the company is working on validation studies required for regulatory approval in Europe. The Versius system is expected to be launched for use in the UK and continental Europe hospitals next year.

CMR Surgical is also planning for an international expansion.

We spoke to CMR last year about the development of the Versius. You can read the full feature here.

04 September 2018

New REVOLVER technique can predict how cancer will advance

A team of scientists at the Institute of Cancer Research, London and the University of Edinburgh has developed a new technique, called repeated evolution of cancer (REVOLVER), which predicts the evolving nature of cancer tumours.

Developed using artificial intelligence (AI), REVOLVER uses data gathered from patterns in DNA mutation within cancers to predict future genetic changes.

Scientists analysed the data in 768 tumour samples from 178 patients, reported in previous studies for lung, breast, kidney and bowel cancer, to detect and compare changes in each tumour.

According to the study, repeating patterns of DNA mutations can serve as an indicator of prognosis in developing future treatments.

The study also noted that the ever-changing nature of tumours enabling cancers to evolve to a drug-resistant form and the new technique will assist doctors to provide personalised treatment for each patient.

ICR evolutionary genomics and modelling team leader Andrea Sottoriva said: “We’ve developed a powerful artificial intelligence tool which can make predictions about the future steps in the evolution of tumours based on certain patterns of mutation that have so far remained hidden within complex data sets.

“With this tool we hope to remove one of cancer’s trump cards the fact that it evolves unpredictably, without us knowing what is going to happen next. By giving us a peek into the future, we could potentially use this AI tool to intervene at an earlier stage, predicting cancer’s next move.”

Wellcome Trust, the European Research Council and Cancer Research UK funded the study.

04 September 2018

Biocartis and Wondfo partner to market Idylla platform in China

Belgian molecular diagnostics company Biocartis Group has entered a joint venture (JV) agreement with Guangzhou Wondfo Biotech to commercialise the fully automated molecular diagnostics (MDx) Idylla platform in mainland China.

The JV, which will be equally owned by both companies, will acquire a license to the Idylla platform from Biocartis.

The partners will invest a total of €14m in the JV over several tranches.

The proposed venture will initially focus on local manufacturing, commercialisation, and registration of the products in IdyllaMDx oncology test menu with the Chinese Regulatory Authorities (CFDA).

Biocartis chief executive officer Herman Verrelstsaid: “With Wondfo, we team up with a partner that has deep knowledge and experience of the Chinese diagnostics market.

“The current size and expected growth of this market provide significant opportunities for Idylla, whose features are an excellent fit with local market needs.

“Furthermore, we see great interest from pharma and test content partners to extend existing collaborations into China. The announcement today is as such a first important step in unlocking Idylla’s commercial potential in China that will provide a broader cancer patient population with access to personalized medicines.”

In the next phase, the JV will focus on developing new Idylla assays for the Chinese market.

The JV is currently subject to certain customary closing conditions and is expected to commence its operational activities by the end of this year.

Wondfo board chairman Jihua Wang said: “Through our collaboration with Biocartis, Wondfo will be the first to introduce the rapid, high precision MDx testing concept into the precision medicine field in China.

“Additionally, with a focus on developing companion diagnostic tests, Wondfo will be able to expand its footprint to the therapeutic area and as such, close the loop.”

03 September 2018

NICE approves new treatment for severe asthma for NHS use

The National Institute for Health and Care Excellence (NICE) has approved the new procedure, called bronchial thermoplasty, offered to adults with severe asthma for wider use on the NHS network.

In its draft guidance, NICE noted that the procedure is safe and can reduce the severity and frequency of attacks.

It will be offered to patients with asthma that cannot be controlled with inhaler medication.

Asthma is a long-term condition that causes inflammation and constriction of the smooth muscle in the airway walls with symptoms such as recurring episodes of wheezing, breathlessness, chest-tightness and coughing.

The treatment involves the application of short pulses of radiofrequency energy to the airway wall under sedation or general anaesthetic.

It needs two sessions over a period of three weeks intervals to complete.

Bronchial thermoplasty is said to lower the ability of the airways to constrict by removing the smooth muscle mass lining them and reduce the severity and frequency of severe asthma attacks.

NICE interventional procedures programme director and clinical advisor Kevin Harris said: “If you are frequently admitted to hospital with severe asthma which cannot be controlled with drugs, this is a procedure which people may wish to consider after discussions with their clinician.

“Asthma is a common disease and the vast majority of patients won’t require this treatment. But for people with severe asthma this procedure could be life-changing.

“The committee was convinced it was safe enough and works well enough for use with standard arrangements in the NHS.”

Additionally, the independent committee recommends this procedure to be carried out under standard arrangements and will take place only in specialist centres with intensive care.

03 September 2018

ResMed files patent infringement claim against Fisher & Paykel

US-based medical device company ResMed has filed a patent infringement action against New Zealand-based medical device maker Fisher & Paykel Healthcare.

The petition has been submitted to the United States International Trade Commission and US District Court for the Southern District of California.

ResMed seeks a ban on import and sale of Fisher & Paykel’s Simplus full face, Eson nasal and Eson 2 nasal masks in the US.

The company complaint alleged that these masks infringe five of its patents covering mask system and cushion design.
It is claimed that the Simplus full face mask infringes all the five asserted patents, while Eson and Eson 2 infringe three of them.

Through the filing, ResMed expects monetary damages for the infringement of patent technology, along with an injunction preventing sales of infringing masks in the future.

ResMed global general counsel and chief administrative officer David Pendarvis said: “We will defend our intellectual property wherever necessary to ensure that patients worldwide continue to receive the high-quality care they deserve, and are confident that when the ITC and the District Court hear all the evidence, ResMed will prevail in these cases.”

Commenting on the lawsuit, Fisher & Paykel said that the company will contest the allegations.

Fisher & Paykel Healthcare managing director and CEO Lewis Gradon said: “Fisher & Paykel Healthcare respects the valid intellectual property rights of others, and we are confident in our position with respect to ResMed’s patents given the rigorous clearance we conduct before any product is released to market.”

Since August 2016, Fisher & Paykel and ResMed have been in litigation over patent infringement allegations in the US, Europe, New Zealand and Australia by both companies.

Last year, ResMed is said to have withdrawn its petition against the same Fisher & Paykel products, with plans to re-file it in the ITC.

03 September 2018

Researchers develop tool to identify disease-carrying mosquitoes

A research team at the University of Texas has developed a new diagnostic tool to identify a species of mosquito that carries harmful viruses such as Zika, dengue, chikungunya and yellow fever.

The tool comprises a smartphone camera, 3D-printed box and simple chemical test to assess if a dead mosquito is of the Aedes aegypti species.

This species is known to be a carrier for dangerous diseases and is associated with the rapid increase in mosquito-borne diseases since 2004 in the US.

University of Texas at Austin Molecular Biosciences department research associate Sanchita Bhadra said: “Many of these diseases are spreading in areas where they weren’t common before.

“Having surveillance is important in conjunction with any kind of outbreak, and this method allows a rapid test in the field.”

In addition to disease-carrying mosquitoes, the new diagnostic tool can also identify the presence of a biopesticide called Wolbachia.

Wolbachia is a type of bacteria that can prevent mosquitoes from spreading diseases. It is being used by public health agencies to infect mosquitoes in order to control the transmission of viruses.

The new tool can be used to track Wolbachia effectiveness. It is expected to provide a better alternative for existing tests that are considered hard-to-read, costly and not logistically convenient.

It is designed to analyse the nucleic acid of mosquitoes and delivers results as a yes or no readout on a smartphone. The tool is said to detect the target with more than 97% accuracy.

Bhadra added: “This test can happen without involving a lot of staff and equipment to make sure Wolbachia is effective and spreading as anticipated.”

Apart from identifying disease-carrying mosquitoes and Wolbachia, the researchers are working towards the application of this technology to easily detect if trapped mosquitoes are carrying pathogens.

31 August 2018

Implantable electronic device could stop epileptic seizures

A team of British and French researchers has conducted a study that assessed the use of an implantable electronic device in identifying, stopping and preventing epileptic seizures.

The team comprised researchers from the UK’s University of Cambridge and France’s École Nationale Supérieure des Mines and INSERM.

During the study, the researchers directly implanted a neurotransmitter into the brain of mice.

The device was tuned to deliver a native brain chemical to stop the progression of the seizure, upon detection of the first signals of a seizure.

The thin, organic films of the implantable electronic device were said to cause minimal damage to the brain, while their electronic properties allow medical applications.

Commonly, epilepsy is treated with drugs. However, the medications may lead to serious side effects and are known to fail at preventing seizures in three out of ten patients.

The implantable electronic device used in the latest research is designed to target the source of the seizure and send signals to the neurons to stop firing.

Meanwhile, the delivery of the brain chemical drug to the affected region is carried out using a neural probe, which is fitted with an ion pump and electrodes to track neural activity.

When the electrodes detect the seizure neural signal, the ion pump gets activated and generates an electric field.

The electric field results in electrophoresis, where the drug moves across an ion exchange membrane and leaves the device. This field’s strength can regulate the amount of drug released.

It was observed that relatively small doses of the drug are required to prevent the seizure, allowing operation of the device without requiring a refill for longer durations.

University of Cambridge Department of Engineering postdoctoral researcher Christopher Proctor said: “In addition to being able to control exactly when and how much drug is delivered, what is special about this approach is that the drugs come out of the device without any solvent.

“This prevents damage to the surrounding tissue and allows the drugs to interact with the cells immediately outside the device.”

While the approach is yet to be tested in humans, the researchers expect it to be useful in treating other conditions such as brain tumours and Parkinson’s disease.

The study results were published in the Science Advances journal.

31 August  2018

Stryker to acquire K2M Group in $1.4bn deal

Stryker has entered into a definitive agreement to acquire 100% of the issued and outstanding stake in spine solutions maker K2M Group in an all-cash deal valued at about $1.4bn.

Founded in 2004, K2M Group focuses on developing complex and minimally invasive spine technologies and techniques designed to achieve three-dimensional Total Body Balance.

The K2M portfolio will complement Stryker’s spine business while also providing support with an established footprint in the complex spine market.

Stryker expects the acquired business to bolster its Spine offerings in the core spinal segment and expand its additive manufacturing capabilities.

Stryker chairman and CEO Kevin Lobo said: “This acquisition underscores our commitment to the spinal market, which is the largest segment of Orthopaedics with significant unmet needs.

“We believe K2M will significantly enhance our presence with surgeons, patients and employees in both the spine and related neurotechnology markets.”

Subject to customary closing conditions and approvals, the acquisition is set to be completed in the fourth quarter of this year.

After closing of the deal, K2M will become a wholly-owned subsidiary of Stryker. Furthermore, K2M Group chairman, CEO and president Eric Major is expected to be appointed as Stryker Spine division president.

Major said: “Stryker’s established leadership in the orthopaedic and neurosurgical market, combined with K2M’s culture of innovation and leadership in complex spine and minimally invasive solutions, represent a powerful opportunity for Stryker to strengthen its leadership in the $10bn global spine market.”