Olympus joins biliary stent sector – market predicted to be $1bn by 2030

12 December | Deals

On February 24th, 2023, Olympus Corporation announced it had agreed to acquire Taewoong Medical, a South Korea-based manufacturer specialising in gastrointestinal (including biliary tract) metallic stents. According to GlobalData predictions, the pancreatic and biliary metal stent market will be worth $1bn by 2030, up from $500m in 2015 and $700m in 2021. 


Olympus already dominate market share in endoscopy devices and the acquisition of Taewoong Medical not only widens the Japanese company’s endotherapy portfolio, but also increases its share in the pancreatic and biliary stent market, which was at 0.9% in 2021 according to GlobalData. 


The deal, expected to be completed in June 2023, will see Taewoong receive $370m in cash – $255.5m of which will be paid at closing and $114.5m will be paid depending on future milestones. 


The incidence of biliary cancers is rising as global populations age. Stenosis – a narrowing of structures and ducts – is an effect of biliary cancer. Metallic stents are frequently used to manage this and can be applied non-invasively in the biliary duct, oesophagus, colon, and duodenum to help clear the occlusion. Biliary tract obstruction is frequent in biliary cancer and metallic stents are often a primary treatment path. 


Despite the potential of the metallic stent market, GlobalData predicts that, although there has been increased adoption due to their improved patient outcomes, rising costs and reimbursement policies of metal stents (compared to plastic alternatives) may hamper its growth. 


According to an Olympus spokesperson speaking to Medical Device Network, gastrointestinal disease is one of the key disease states it is targeting in future business strategies. Gaining primacy in the gastrointestinal stent market will help Olympus achieve its financial outlook. In its full year forecast for fiscal 2023, the Japanese company expects revenue of $6.37bn (871bn yen) with 16% YoY growth. 

Main image credit: JHVEPhoto / Shutterstock.com

16 March | Deals

Medtronic’s Affera Mapping and Ablation System receives CE Mark 

Medtronic has secured CE Mark for its Affera Mapping and Ablation System to treat atrial arrhythmias. The Affera system uses the Sphere-9 Catheter and the Affera Prism-1 Mapping Software. It has been designed to both map and ablate atrial arrhythmias, as well as provide real-time feedback through its intuitive mapping and navigation software. 


 The company stated that with the integration of the Sphere-9 pulsed field ablation (PFA), radiofrequency (RF) and high-density (HD) mapping catheter, the complete system creates a new paradigm in electrophysiology. 

  

Together with the integrated mapping and navigation system, the Sphere-9 Catheter rapidly generates complex electro-anatomical maps. This allows physicians to provide wide-area focal ablation lesions of choice between RF or PFA, based on the patient and procedure requirements. 


The nitinol 9mm ablation tip of the catheter requires fewer focal ablation lesion applications, which reduces the procedure times compared to standard irrigated ablation catheters. Meanwhile, the mapping software offers an optimised user experience through streamlined insights and feedback. 


Medtronic Cardiac Ablation Solutions business vice-president, chief medical officer Khaldoun Tarakji said: “The revolutionary Affera Mapping and Ablation System combined with the novel Sphere-9 Catheter represent a great advancement in the field of HD mapping and focal ablation. 

“Current technologies require the use of separate HD mapping and ablation catheters. The ability to map, ablate and validate with the Sphere-9 Catheter enables the physician to eliminate the need to exchange catheters and empowers them to choose the energy source, whether RF or PF, based on the patient’s needs.” 


The CE Mark is supported by data obtained from clinical trials evaluating the performance and safety of the Sphere-9 Catheter and Mapping System. Last December, the company completed participant enrolment in the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) randomised, pivotal Affera SPHERE Per-AF clinical trial. The trial was designed to assess the Affera Mapping and Ablation System’s effectiveness and safety to treat persistent atrial fibrillation. Furthermore, Medtronic plans to commercialise the Affera Mapping and Ablation System in Europe from the first half of the year. 

16 March | Approvals

TruDiagnostic and NADMED launch new blood diagnostic in US

Health data company TruDiagnostic has entered a new partnership with Finnish nicotinamide adenine dinucleotide (NAD) diagnostic company NADMED to launch a new NAD+ blood diagnostic test for patients in the US. Claimed to be the only CE-marked NAD+ testing product, the Q-NADMED Blood Kit can measure NAD+ and NADH from a small blood sample for several clinical applications.

NADMED testing kits are said to facilitate precise and quantitative detection of metabolites in a sample using knowledge of standards for the preparation and preservation of NAD. 


The kits use an extraction technique that is suitable for all blood samples and apply a safe detection method, stated the company. NAD+/NADH is a metabolite that is related to ageing and several other diseases. Unusual levels of these metabolites have been connected to improper immune function, metabolic disease, dementia and neurodegeneration, and heart disease. 


NAD+/NADH is essential to sustaining optimal function in the body. NADMED CEO and co-founder Jari Närhi said: “We appreciate TruDiagnostic’s agile, yet diligent approach to introducing novel technology to their customers in the US market. 


“We foresee a fruitful cooperation to continuously develop business and service models to meet the needs for NAD testing of the varied customer base.” 


With expertise in understanding and interpreting the fluid epigenome, TruDiagnostic is involved in various clinical trials that assess the effectiveness of products that claim to provide anti-ageing benefits. Furthermore, it is engaged in research projects to create and validate other algorithms for tracking ageing and disease. 

16 March | Approvals

US CDC researchers develop test to screen HCU in newborns 

Researchers at the Centers for Disease Control and Prevention (CDC) in the US have developed a new test that could ensure newborns with homocystinuria (HCU) receive essential treatment. HCU impedes the ability of an infant to metabolise the amino acid methionine, a component of several proteins, including those found in breast milk. 


The test measures the rise in levels of homocysteine, which almost always rise within the first few days of birth in infants with HCU. Furthermore, homocysteine levels usually rise before methionine levels. 


In the study, which was published in the American Association for Clinical Chemistry’s (AACC) Clinical Chemistry journal, the researchers’ team used the new test on residual newborn screening specimens obtained from infants who had received diagnoses. The samples included 50 from HCU-negative infants receiving total parenteral nutrition (TPN), two from HCU-positive patients, and 100 from healthy patients. 


The new test distinguished between the healthy and HCU-positive samples and accurately classed the TPN samples as HCU-negative. Centers for Disease Control and Prevention researcher Konstantinos Petritis said: “Here we present the only flow injection analysis–tandem mass spectrometry first-tier newborn screening method that directly quantifies total homocysteine from dried blood spots. 


“The ability to screen total homocysteine during first-tier newborn screening is a significant step toward reducing HCU false-negative rates, which will enable early identification and intervention to reduce HCU-associated morbidity and mortality.” 


HCU is a congenital disease that causes serious complications if it is not treated early. The complications range from eye and skeletal issues to vascular abnormalities and intellectual disabilities. 

16 March | Diagnostics

Visby Medical’s Sexual Health Test gets 510(k) clearance in US 

Visby Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its second-generation Sexual Health Test. 

  

The Sexual Health Test is a fast polymerase chain reaction (PCR) diagnostic test that aims to uncover sexually transmitted infections (STIs) in women caused by Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis. Visby also secured a Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA for the point of care (POC) test. 


Said to be an ‘instrument-free’ platform that fits in the palm of the user’s hand, the CLIA-waived, Sexual Health test provides results in less than 30 minutes for clinicians in POC settings. Visby Medical Operations senior vice-president Mark Medlen said: “We are excited that the clearance of the second-generation Sexual Health Test will enable us to move production to our fully automated lines, allowing us to deliver more tests to eagerly waiting customers.” 


Featuring a sleeker design, the new single-use, fast PCR platform is said to offer significant improvements in workflow and reliability compared to its predecessor. Henderson, Nevada, CareNow Urgent Care market medical director Lamont Tyler said: “Visby innovation has become essential for maintaining quality urgent care and positive patient experience in our practice. 


“The Visby test is a win-win, helping fight antibiotic resistance as well as the spread of untreated infection while empowering patients to engage health services with greater confidence.” In January, the US FDA granted Visby Medical emergency use authorization (EUA) for its new Respiratory Health POC test, a rapid PCR device, for use in CLIA-waived settings. 

15 March | Approvals

Sophia Genetics and Agilent collaborate on cancer analysis solution 

Cloud-native software company Sophia Genetics has collaborated with Agilent Technologies to deliver a comprehensive solution for cancer analysis. 


The partnership will see the SOPHiA DDM Platform integrated with Agilent’s SureSelect Cancer Comprehensive Genomic Profiling (CGP) Assay Kit, which is intended for research use only. This will allow clinical researchers to precisely detect multiple biomarkers, thereby helping to reduce the risk of missing significant information in cancer samples. 


SOPHiA DDM is a cloud-based software-as-a-service platform that helps analyse data from multiple modalities and supports the adoption of data-driven medicine. Sophia Genetics business development and marketing vice-president Kevin Puylaert said: “Working with Agilent means combining best-in-class profiling practices with rich data and insights. 


“Together, we can break traditional barriers that often limit new discoveries, democratising access to data-driven medicine around the world.” 

  

Leveraging the SOPHiA DDM Platform, users will have access to an integrated solution that is aligned with information from the latest guidelines and features reporting tools that are more advanced than readouts. 


This partnership will enable labs of varying sizes to bring cancer analysis in-house, removing the need to send samples or output data to other vendors and labs. Italy-based research and genetics laboratory TomaLab is also involved in an early-access programme that is presently underway. 


Agilent integrated genomics division general manager and vice-president Kevin Meldrum said: “We chose to partner with Sophia Genetics to leverage their analytical and reporting capabilities, which complements our SureSelect Cancer CGP panel, to drive toward providing clinical researchers with a complete set of tools that will make comprehensive tumour profiling possible in their own labs.”  


In January, Agilent joined forces with Akoya Biosciences for the development of immunohistochemistry diagnostic products for tissue analysis. 

15 March | Partnerships

MedAlliance recruits more than 1,000 patients in Selution DeNovo trial 

Swiss medical technology firm MedAlliance has completed the recruitment of more than 1,000 patients in its Selution DeNovo coronary randomised trial. 


The trial is designed to compare the use of the new sirolimus drug-eluting balloon (DEB Selution) against a limus drug-eluting stent (DES) treatment strategy. Selution Sustained Limus Release (SLR) features an angioplasty balloon coated with MicroReservoirs that contain a mixture of the anti-restenotic drug sirolimus and biodegradable polymer. 


These MicroReservoirs offer controlled and sustained release of the drug for more than 90 days in a manner similar to a DES but without leaving a metal scaffold behind. Claimed to be the largest DEB study ever undertaken, the Selution DeNovo trial is being conducted at around 70 participating sites across 15 countries. 


To reflect present medical practice and lower bias, patients in the trial were randomised prior to any vessel preparation. The study’s objectives include the demonstration of non-inferiority at both one and five years, as well as superiority for target vessel failure (TVF) at five years, stated the company. 


MedAlliance chairman and CEO Jeffrey Jump said: “This trial has the potential to change medical practice, not only in Europe but also in the US, China and Japan, benefitting patients around the globe. 


“We are currently enrolling US patients in our coronary ISR IDE and BTK studies in the US and Europe.” 


In May 2020, the company received CE mark approval for the Selution SLR to treat coronary artery disease. 

  

MedAlliance is claimed to be the first DEB company to receive breakthrough designation status from the US Food and Drug Administration (FDA). Besides the below-the-knee (BTK) and superficial femoral artery (SFA) indications for which the firm received FDA investigational device exemption (IDE) approval in May and August last year, MedAlliance secured coronary in-stent restenosis (ISR) IDE approval in October last year and de novo coronary artery lesions approval in January. 

In brief

Spectrum Healthcare selects Proscia’s Concentriq Dx platform 

Spectrum Healthcare Partners (SHCP), a multispeciality, physician-owned healthcare practice, has selected the Concentriq Dx software platform from digital and computational pathology solutions provider Proscia. 


SHCP intends to implement Proscia’s advanced digital pathology platform to modernise its operations and increase access to high-quality diagnostic services across the states of Maine and New Hampshire in the US. Spectrum Healthcare Partners Pathology Division managing director Bilal Ahmad said: “Concentriq Dx is critical to decentralising our diagnostic services. It will enable us to seamlessly transition to digital pathology at scale so that we can reimagine our day-to-day operations beyond the confines of our physical laboratory spaces.” 


The Concentriq Dx platform is designed to drive diagnostic workflows for laboratory networks and offers interoperability with scanners and image analysis applications. Furthermore, the platform streamlines collaboration by allowing remote image viewing, thus providing subspecialist experts with faster and broader access. 


Proscia CEO David West said: “Our organisations share a strong commitment to the patient, and we are thrilled that SHCP sees the value of modern digital pathology in democratising diagnosis and helping to improve treatment decisions.”  


Proscia said that the platform, which is CE-marked under the in vitro diagnostic regulation (IVDR), helps to realise pathology’s artificial intelligence (AI)-powered future to address growing needs. Spectrum Healthcare comprises 200 physicians who practice in the areas of anesthesiology, orthopaedics, pathology, radiation oncology, radiology, and vascular and interventional radiology. 


Concentriq Dx has been made available by the firm for primary diagnosis in the US during the Covid-19 public health emergency. 

El Camino Health deploys Flosonics’ FloPatch ultrasound technology 

El Camino Health has deployed Flosonics Medical’s FloPatch advanced ultrasound system for sepsis management. 


It is said to be the first health system in the world to use the new technology for real-time monitoring of blood flow. FloPatch is claimed to be the first wireless and wearable Doppler ultrasound system. It enables clinicians to better manage intravenous (IV) fluid therapy in the early stages of the sepsis care pathway. 


El Camino Health chief nursing officer Cheryl Reinking said: “We are proud to be the first hospital in the world to adopt this advanced technology and have been working with Fogarty Innovation and Flosonics Medical for the past year piloting FloPatch. 


“Our nurses immediately loved it and helped decide where in the hospital the technology would be the best fit.” 


Designed to offer a consistent method for measuring changes in heart function, FloPatch is an easy-to-use, hands-free device that can be implemented in one minute. The US Food and Drug Administration (FDA)-approved device is placed on the neck to continuously evaluate blood flow in the carotid arteries, the blood vessels responsible for the supply of blood to the brain, neck and face. It wirelessly transmits this data to a secure iOS mobile application, which enables clinicians to receive actionable and real-time data at the bedside. 

Novosound, PAVmed partner for ultrasound technology   

Novosound has entered into a commercial partnership agreement with medical technology company Pavmed to advance intravascular imaging technology. The company stated that the new deal furthers its move into healthcare, as well as its regional expansion into North America.  

  

It is specialised in designing and producing ultrasound sensors using a thin-film technique to address the conventional ultrasound limitations. The company uses its in-house design and manufacturing capabilities in engineering a thin-film core material which is lightweight, compact, extreme temperature resistant, flexible, low profile, and also capable of producing high resolution images.  

  

Novosound CEO and co-founder Dave Hughes said: “PAVmed has a strong track record in delivering commercial stage medical technology across medical devices, diagnostics, and digital health – the group is the ideal partner for Novosound as we increasingly gain traction in the international healthcare sector.”  

  

Recently, the company secured $4.49m (£3.7m) in a financing round, which was led by investment services provider Par Equity.  

Somavedic reports positive data from ABE and EEMT trial 

Somavedic and BrainTap have reported positive data from a pilot study of Audio Brainwave Entrainment (ABE) and electromagnetic field (EMF) effects mitigation technology (EEMT). 


The six-week trial included 20 subjects aged 34 to 65 years who underwent two daily BrainTap sessions, which involved using a BrainTap headset near a Somavedic device. According to the findings, participants had a statistically significant improvement in their sleep and mood quality, as well as a reduction in stress and depressive mood, after the ABE and EEMT introduction. 


All participants also experienced more restful sleep, while 90% of them had an improvement in their happiness and overall disposition. The Profile of Mood States (POMS) questionnaire, Pittsburgh Quality of Sleep Index, and The Depression, Anxiety and Stress Scale (DASS-21) assessments were used to evaluate the results and effectiveness. 


Somavedic noted that the study participants did not use analgesics, anti-inflammatories or sleep aids for at least seven days before, as well as throughout, the study. The company expects that the trial will encourage more extensive use of ABE and EEMT to improve overall well-being.  

Argon Medical introduces Traveler Portal Vein Access Series 

US-based Argon Medical Devices has launched the TRAVELER Portal Vein Access Series, which serves as the latest addition to the company’s portal vein access product portfolio. 


TRAVELER has been designed to improve the visualisation and durability of components, helping to address some of the common challenges faced during Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedures. 


The new product line aids physicians in accessing the portal vein through the liver during these procedures. 

Now available in Canada and the US, the new TRAVELER Series includes TRAVELER16, TRAVELER21 and TRAVELER38.  


The company stated that the launch of the TRAVELER series is the first of multiple new product launches planned for this year. It also noted that the new Portal Vein Access Series supplements its Scorpion Series, which was launched in 2021 and also supports TIPS procedures. Including the Scorpion and ScorpionX products, the Scorpion Series provides improved navigation control, visualisation and durability for current procedural methods. 


It uses a patented curve-in-curve system to provide a 360-degree range of motion for the needle or stylet that is used to access the portal vein.