Medical Device Network

Immunotherapy drugs continue to gain momentum across a growing range of disease areas with blockbusters such as MSD’s Keytruda (pembrolizumab) and BMS’s Opdivo (nivolumab) generating billions in annual revenue since their US Food and Drug Administration (FDA) approval in 2014. Amid this sustained growth, British biotech IMU Biosciences is working to make immunotherapy drugs safer and more effective. Spun out from King’s College, London and the Francis Crick Institute in 2021, the UK company has designed a platform to assess how an individual’s immune system influences their responsiveness to immunotherapy treatments. Medical Device Network sat down with IMU's CEO, John Baker, to learn more about the company’s mission to reshape the understanding of the immune system, and why. #immunology #immunotherapy #cancer #assay #AI #machinelearning Read the full interview below: https://lnkd.in/e8CGNAKS

Ampa has raised $8.5m and initiated the US rollout of its transcranial magnetic stimulation (TMS) system for treating major depressive disorder (MDD), months after emerging from stealth. The US-based company’s Pre-A funding round was led by Nexus NeuroTech Ventures, with participation from other VCs, including Satori Capital and Morningside Ventures, as well as Ampa’s existing investors, which include individual entrepreneurs. Ampa CEO Don Vaughn said: “Ampa One was built to give clinicians a practical, portable, affordable tool that expands patient access to this lifesaving technology.” #depression #neurmodulation #brainstimulation #FDA Read the full report below: https://lnkd.in/ewTByysq

Boston Scientific has lifted its fiscal year 2025 (FY25) profit outlook to between $3.02 and $3.04 per share amid continued strong performance in its third quarter (Q3), largely driven by growth in its cardiovascular business. The company now expects profits of $3.02 and $3.04 per share for FY25, up from $2.95 to $2.99 previously. Following the Q3 result’s announcement, Boston’s share price on the New York Stock Exchange (NYSE) rose by more than 4% to around $104 per share, up from $103.10 at market open on 22 October. Boston has a market cap of around $153bn. During a post-earnings conference call, Boston’s CEO Mike Mahoney shared that 500,000 patients to date have been treated with Farapulse, with “consistent and reproducible real-world results”. He commented: “Continued strong double-digit growth in Farapulse is supported by ramping adoption of our OPAL HDx Mapping System, with one in three Farapulse accounts now utilising our integrated FARAWAVE NAV PFA catheter and OPAL device.” #medicaldevice #PFA #Farapulse #cardiovascular #healthcare Read the full report below: https://lnkd.in/e6ESymj7

Germany-based roclub has raised $11.7m to fuel the US launch of its platform for the remote operation (teleoperation) of medical devices in healthcare settings where practitioner shortfalls exist. The Series A funding round was led by Smedvig Ventures and YZR Capital, and saw participation from existing investor Speedinvest and a range of angel investors. roclub’s cloud-based platform facilitates the teleoperation of any medical equipment with a front-end monitor, allowing operators who are part of the company’s technologist marketplace to remotely manage multiple machines simultaneously. Roclub’s co-founder and managing director André Glardon highlights that staff shortages are being felt globally across public and private sector healthcare providers in both rural and urban locations. Glardon told Medical Device Network: “We have customers in areas spanning hospital, outpatient, radiology, and orthopaedics. With cost-effectiveness in mind, the company is developing scalable pricing models, offering flexible partnership structures, and emphasising measurable ROI. “Our goal is to make remote operations both accessible and sustainable for every healthcare provider, regardless of size or location.” #radiology #FDA #medtech #healthcare #startups Read the full report below: https://lnkd.in/e6U_suuq

Hologic, Inc. is set for acquisition by alternative asset management entities Blackstone and TPG for up to $18.3bn in enterprise value, as part of a definitive agreement. The transaction is valued at a potential $79 per share. Stockholders of Hologic are poised to receive $76 per share in cash, with the possibility of an additional $3 per share through a contingent value right (CVR), which will be distributed in two potential payments of up to $1.50 each. Hologic CEO, chairman and president Stephen MacMillan said: “With their resources, expertise and commitment to women’s health, Blackstone and TPG will help accelerate our growth and enhance our ability to deliver critical medical technologies to customers and their patients around the world.” #womenshealth #medtech #healthcare Read the full report below: https://lnkd.in/esrGv9Uw

Biocomposites has launched its SYNICEM range of spacers for hip, knee, and shoulder revision surgery in the US. The launch of the British medtech company’s SYNICEM range in the US follows a UK release in 2023. Biocomposites gained full control of the product range following its buyout of the remaining shares in French engineering firm Synergie Ingénierie Médicale in September 2024. Biocomposites’ CEO, Michael Harris highlighted that its SYNICEM spacers’ precision-engineered, uniform structure, local antibiotic delivery, and wide size range result in a “faster, simpler, more dependable” alternative to handmade spacers. #medtech #revisionsurgery #spacers #SYNICEM Read the full report below: https://lnkd.in/eC_bZTWu

US-based Adaptyx Biosciences has secured $14m to scale its bio-wearable that translates molecular data into actionable healthcare insights. Bringing the clinical stage company’s total funding to around $23m, the seed financing round was led by Los Angeles-based tech investment company Interlagos, with participation from entities such as Overwater Ventures and Stanford University. Adaptyx’s bio-wearable is a skin patch with a minimally invasive dermal probe that monitors biomarkers in interstitial fluid. Adaptyx’s CEO Vijit Sabnis said healthcare currently suffers from a “data deficit”. Laboratory tests only provide “snapshots” of health that don’t account for the body’s changing physiology, thereby resulting in blind spots that “prevent addressing many of today’s health challenges”. Sabnis added: “Our mission is to expand continuous monitoring beyond glucose to include the many molecules that drive human health, creating a rich data pipeline that guides patients and clinicians to make the best decisions at the right time.” #molecularmonitoring #healthcare #wearables Read the full report below: https://lnkd.in/egQwCevk

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The US Food and Drug Administration’s (FDA) recent clearance of Roche’s blood-based Alzheimer’s disease test will boost therapeutic intervention options for the disease and clinical trial enrolment, an expert has said. This availability will open up diagnostic testing to vast numbers of people in need of “good early assessment” of their cognitive function, Gary Zammit, CEO of blood testing provider Clinilabs, told Medical Device Network. “Up to now, people would need to have imaging, or have cerebrospinal fluid (CSF) samples taken, which is a particularly invasive procedure. With this simple blood test, it makes the procedure much more convenient, accessible, and tolerable for patients,” Zammit said. Zammit goes on to highlight Roche’s test’s value in ruling out whether an individual is likely to have Alzheimer’s disease – a factor that will likely benefit Alzheimer’s disease clinical trials, which research indicates have a 98% failure rate. “One of the reasons that drugs fail is because it can be difficult to confirm the diagnosis of Alzheimer’s disease,” Zammit explained. “With a test like Elecsys available, researchers can now more confidently exclude certain people from clinical trials by doing the test in advance; then if it’s not Alzheimer’s disease, they wouldn’t be put into the trial for Alzheimer’s disease. “Therefore, the availability of Elecsys will help to better define the patient populations that we’re testing, which should in turn help to reduce the failure rate in Alzheimer’s disease clinical trials,” Zammit noted. #FDA #Alzheimers #pTau #clinicaltrials #drugdevelopment Read the full report below: https://lnkd.in/e3bY55id

Boston Scientific has acquired Nalu Medical, Inc. for around $533m, broadening the therapeutic scope of the medtech giant’s neuromodulation portfolio. California-based Nalu’s Neurostimulation System is designed to address chronic pain in regions such as the shoulder, lower back and knee via peripheral nerve stimulation (PNS). Driven by an implantable pulse generator powered by a small wearable disc that can be controlled via a smartphone app, the system delivers mild electrical pulses to interrupt pain signals before they reach the brain. “Peripheral nerve stimulation is an exciting field with a significant unmet patient need,” said Jim Cassidy, president of neuromodulation at Boston Scientific. “Adding the highly differentiated Nalu Medical technology complements our existing therapies—including spinal cord stimulation, basivertebral nerve ablation and radiofrequency ablation—enabling us to deliver advanced pain relief options to a wider variety of patient populations,” Cassidy added. #FDA #neuromodulation #medtech #chronicpain #peripheralnervestimulation #neurology Read the full report below: https://lnkd.in/eFJUxMzV