Industry news
Boston Scientific reports initial data from ACURATE neo2 system study
28 November | Trials
Boston Scientific has reported the initial data from the study of the ACURATE neo2 Aortic Valve System, which supports its clinical procedural success and safety. The findings from the ACURATE neo2 Post Market Clinical Follow-up (PMCF) study included a 98.4% high procedural success rate along with low mortality and paravalvular leak (PVL) rates.
In the European single-arm, prospective ACURATE neo2 PMCF study of the system, 0.8% was the primary safety endpoint of all-cause mortality at 30 days.
Additionally, the findings demonstrated that no subjects experienced greater than moderate PVL, with 1.9% and 18.9% experiencing moderate and mild PVL rates, respectively.
A low 6.5% rate of new pacemaker implantation 30 days after a procedure was another observation from the study, with no incidence of acute kidney injury or disabling stroke reported.
The study includes 250 severe aortic stenosis patients from 18 centres in Europe and will assess the outcomes for five years after procedures. A primary imaging endpoint, also included in the study, will evaluate the visually apparent thickening of the prosthetic valve leaflets (HALT).
Boston Scientific global chief medical officer Dr Ian Meredith said: “These trial data confirm the success of meaningful and differentiated enhancements included in the design of the ACURATE neo2 valve, from low rates of PVL and first-time pacemaker implantation to excellent hemodynamic performance and high rates of procedural success and safety.
“We look forward to reviewing longer-term results from this trial and bringing this differentiated transcatheter aortic valve replacement (TAVR) technology to more patients and their physicians.”
In 2020, the ACURATE neo2 Aortic Valve System secured CE Mark. It is being assessed in the US and Canada, where patients are currently being enrolled, in the ACURATE IDE trial.
Main image: Boston Scientific, Silicon Valley. Credit: Sundry Photography/ Shutterstock
29 November| Deals
Halo and Ikonopedia partner to provide genetic testing for breast cancer
Halo Diagnostics has announced a partnership with Ikonopedia , a breast imaging reporting and tracking solution, to offer genetic testing for breast cancer. The collaboration aims to improve the detection of early-stage breast cancer, as well as patient outcomes.
Under the partnership, Halo’s genetic lab and precision diagnostic software services will be integrated with Ikonopedia’s mammography software for follow-up tracking and one-click radiology reporting. This integration is anticipated to lead to a 40% increase in follow-up imaging compliance, which will aid in early detection and lead to less invasive treatments.
Additionally, the partnership will use Halo’s Hereditary Gene Panel Tyrer-Cuzick 8 and Polygenic Risk Score to increase the identification of patient risk. Halo Diagnostics founder and chief product officer Brian Axe said: “We’re proud to partner with Ikonopedia and their robust breast imaging reporting and risk-assessment tools. “Our combined solution will save lives by improving early detection through fast, accurate diagnosis and personalised care.”
21 November | Trials
Johns Hopkins finds new AI blood test detects liver cancer in study
Johns Hopkins University School of Medicine in Maryland, US, has announced that a new artificial intelligence (AI)-based blood testing technology was found to detect more than 80% of liver cancers in a study.
The new blood test, dubbed DNA evaluation of fragments for early interception (Delfi ), was developed and used by researchers at the Johns Hopkins Sidney Kimmel Cancer Center.
It has been designed for the detection of fragmentation changes that occur among DNA shed from cancer cells into the bloodstream, known as cell-free DNA (cfDNA).
In the recent study, which was conducted last year, the researchers used the DELFI technology on blood samples obtained from 724 people to detect hepatocellular cancer (HCC ), a type of liver cancer. Of the total plasma samples, 501 were collected in the US and the European Union (EU).
They also included samples from 75 HCC patients for training and validating the machine learning model, a type of AI that leverages data and algorithms to improve accuracy. The remaining 223 samples were collected from Hong Kong and included samples from 90 HCC patients, 35 HBV-related liver cirrhosis patients, 66 hepatitis B virus (HBV) patients, and 32 individuals with no underlying risk factors.
2 December | DEALS
Integra LifeSciences to acquire Surgical Innovation Associates
Integra LifeSciences has signed a definitive agreement to buy Surgical Innovation Associates (SIA ), a spin-out from Northwestern University , Illinois, US. Under the deal terms, Integra will pay $50m at the closing of the deal, as well as up to $90m more upon achieving certain revenue and regulatory milestones.
SIA develops advanced solutions for reconstructive and aesthetic surgery to improve the experience of both surgeons and patients. The company develops, markets and sells the DuraSorb resorbable synthetic matrix for plastic and reconstruction surgery.
DuraSorb is a completely-resorbable knitted mesh that has been designed to address the limitations of current soft tissue support products in reconstructive and aesthetic surgery. Integra LifeSciences expects the deal to advance its global strategy in breast reconstruction.
30 November | Regulation
Health Canada approves Novocure’s Optune to treat glioblastoma
Health Canada has granted approval for the treatment of recently diagnosed and recurrent glioblastoma (GBM) using Optune from Novocure. Optune is a wearable, portable medical device that creates Tumor Treating Fields (TTFields), which are electric fields for disrupting the division of cancer cells.
Using four adhesive patches called transducer arrays, it provides the TTFields therapy to the location of the tumour without increasing the chemotherapy-related side effects. TTFields may destroy some of the cancer cells completely and have not been shown to affect healthy cells. The small and lightweight Optune allows individuals to receive continuous treatment almost anywhere. It is claimed to be the first treatment approved for GBM in Canada in more than 12 years.
30 November | Covid-19
FDA grants EUA for Lucira Health’s COVID-19 & Flu Test
The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Lucira Health ’s COVID-19 & Flu Test for use in point-of-care settings. The nucleic acid amplification test (NAAT)/molecular test has been developed for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B viral RNA.
It uses a single anterior nasal swab sample collected from people aged two years and above, who are suspected of having a respiratory viral infection by their healthcare provider, to test for Covid-19 and all its variants of concern as well as Flu A and Flu B. The PCR Lab-quality test provides positive results in as little as 11 minutes, while a negative result takes 30 minutes.
2 December | Devices
WISE obtains FDA approval for new neuromonitoring device
Medical device firm Wise has received US Food and Drug Administration (FDA) approval for its WISE Cortical Strip, a single-use device for neuromonitoring. The new device has been designed for Intra Operative Neurophysiological Monitoring (IONM) from the surface of the brain. It is claimed to be the first product in the company’s WISEneuro Monitoring product portfolio to receive FDA clearance.
The latest move comes after the WISE Cortical Strip received CE mark approval in May 2021. Developed using Supersonic technology, the new strip can be used for intraoperative use with monitoring, recording and stimulation equipment to record the brain’s spontaneous electrical activity (ECoG) and somatosensory evoked potentials (SEPs).
It can also be used for brain stimulation to elicit motor-evoked potentials (MEPs). The strip is composed of stretchable platinum electrodes, which are embedded in a soft and thin film of medical-grade silicone.
WISE CEO Luca Ravagnan said: “The FDA clearance is a crucial milestone for our commercial development, allowing to expand the distribution of the WISE Cortical Strip from Europe to the US and fuelling the development of the WISEneuro Monitoring product family.
“European clinicians are already demonstrating strong appreciation for the benefits of our product, we are looking forward to starting commercialisation also in the US.” The performance of the WISE Cortical Strip was validated in a multicentric pre-market clinical study in Europe.
In the WIN study, the strip demonstrated better performance in terms of electrical impedance in physiological conditions compared to the conventional cortical electrodes that are currently available on the market.
In brief
Adaptive Biotechnologies rolls out clonoSEQ Assay for DLBCL patients
Adaptive Biotechnologies has introduced its new clonoSEQ Assay for detecting minimal residual disease (MRD) in the blood of diffuse large B-cell lymphoma (DLBCL) patients. The new assay can evaluate the MRD status in a DLBCL patient by measuring the circulating tumour DNA (ctDNA), the DNA fragments released into the blood by dying cancer cells that can be used as a measure of tumour burden.
It uses the company’s immune medicine platform to find and quantify specific DNA sequences that are found in malignant cells to evaluate and monitor MRD during and after treatment. The assay also provides accurate, standardised and sensitive MRD measurement that helps clinicians predict patient outcomes, monitor patients during remission, study response to therapy over time, and also predict potential relapse.
The company stated that ClonoSEQ is available as a Clinical Laboratory Improvement Amendments (CLIA )-validated laboratory-designed test (LDT) for DLBCL, and that the company will start accepting DLBCL blood samples in Streck tubes from this week.
Brainomix and Pixyl partner to offer multiple sclerosis solution
Brainomix has unveiled a new collaboration with French medical neurology imaging company Pixyl to expand its offering with the latter’s multiple sclerosis (MS) treatment. Under the partnership deal, the company will be responsible for distributing Pixyl’s software-as-a-Service (SaaS) solution, Neuro.MS.
The Neuro.MS SaaS solution has been designed for the diagnosis and treatment of MS patients. It leverages advanced deep-learning technology to provide clinicians and radiologists with clinically relevant information regarding neurological disorders such as MS.
The solution automatically analyses MRI images of the brain to identify, quantify and track abnormalities within five minutes. It offers access to quantified and classified white matter hyperintensities along with quantified measures of lesion volumes and brain atrophy.
AnchorDx enrols first participant for UriFind assay trial in US
Chinese cancer early detection solutions developer AnchorDx has enrolled the first participant in the clinical trial of its UriFind bladder cancer assay in the US.
The registrational, prospective clinical trial aims to assess the non-invasive assay’s performance in more than 1,000 targeted patients, across multiple sites, including ten Urology clinics and three CAP/CLIA laboratories. UriFind is a quantitative real-time PCR (qPCR) assay that has been designed for detecting two DNA methylation biomarkers in urine specimens from patients suspected of having bladder cancer.
The company stated that its urine-based molecular test is intended to accurately detect bladder cancer.
The assay is said to offer superior sensitivity and specificity compared to cytology and other assays, as well as advantages in detecting early, micro, residual and recurrent bladder cancer.
Yale School of Medicine researchers identify ADHD biomarkers in children
Researchers at the Yale School of Medicine have identified biomarkers of attention-deficit/hyperactivity disorder (ADHD) by analysing the data from magnetic resonance imaging (MRI) exams on approximately 8,000 children.
They have also identified the role of neuroimaging machine learning to assist in diagnosing, treating and observing the disorder. The findings from the new study are planned to be presented at the Radiological Society of North America’s (RSNA) next annual meeting. The researchers used MRI data obtained from the Adolescent Brain Cognitive Development (abcd ) study of brain development and child health, which was conducted in the US.
Lunit’s AI-based radiology solutions receive CE mark and UKCA certification
South Korean artificial intelligence (AI)-powered cancer solutions provider Lunit has obtained CE marking for Lunit INSIGHT, its suite of AI solutions for radiology, under the latest Medical Device Regulation (MDR) of Europe.
The company has also secured the UK Conformity Assessed (UKCA) marking for its Lunit INSIGHT product line. The two markings represent commercial approval for the products across both the UK and Europe.
Lunit has become the first software as a medical device (SaMD) company in the Asia Pacific region to obtain CE and UKCA certification. Lunit CEO Brandon Suh said: “Our MDR CE and UKCA certifications clearly show Lunit’s high product power and advanced regulatory compliance capabilities.
“We will continue our proactive response to European market trends to accelerate our business expansion.”
Two products in the Lunit INSIGHT suite, Lunit INSIGHT CXR and Lunit INSIGHT MMG, received the CE marking under the MDR as well as the UKCA certifications.
