Markets & Industry
Canada approves Leqembi for early Alzheimer’s
Canada has conditionally approved Leqembi (lecanemab), the first treatment that targets an underlying cause of early Alzheimer’s disease by removing toxic amyloid beta proteins from the brain.
Health Canada issued the Notice of Compliance with Conditions on 27 October for adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease who have confirmed amyloid build-up and carry one or no copies of the ApoE ε4 gene variant.
Leqembi works by binding to and removing amyloid beta aggregates, including soluble forms known as protofibrils and insoluble fibrils, which form amyloid plaques in the brain.
These are believed to damage neurons and disrupt communication between brain cells, driving cognitive decline.
The conditional authorisation is based on the Phase 3 Clarity AD trial, which enrolled 1,795 patients with early Alzheimer’s.
In the 18-month study, Leqembi met its primary and all key secondary endpoints, showing a statistically significant slowing of cognitive and functional decline compared to placebo.
Eisai must submit real-world data to verify the drug’s benefit to maintain the authorisation.
Leqembi, co-developed by Swedish biotech BioArctic and Japan’s Eisai, is now approved in 51 countries and regions, including Japan, the US, Europe, China, South Korea, Taiwan and Saudi Arabia, with regulatory reviews ongoing in nine others.
The antibody is given intravenously every two weeks for 18 months, with four-weekly maintenance dosing approved in some markets.
Patients are tested for the ApoE ε4 gene before treatment, as those with two copies of the variant face a higher risk of ARIA (amyloid-related imaging abnormalities) — a side effect that can cause brain swelling or small bleeds.
Professor Lars Lannfelt at BioArctic discovered the Arctic mutation linked to Alzheimer’s disease that led to Leqembi’s development.
Eisai manages global clinical development, regulatory submissions and commercialisation, while BioArctic retains co-commercialisation rights in the Nordic region.
A subcutaneous version, Leqembi Iqlik, is approved in the US for maintenance dosing. Eisai also began a rolling submission to the FDA in September 2025 for subcutaneous initiation dosing.
A long-term study, AHEAD 3-45, is testing the drug in individuals with preclinical Alzheimer’s — those with amyloid build-up but no symptoms — and is expected to continue until 2028.
Endogenex has raised US$50m to complete development of its diabetes procedure and take the technology to the FDA.
The fundraising comes shortly after the company delivered initial clinical study results showing its pulsed electric field system met safety goals and led to metabolic improvements in HbA1c, fasting glucose levels and body weight.
Founded in partnership with the Mayo Clinic, Endogenex has been targeting the duodenum, the upper section of the small intestine, with a treatment that aims to reset inflamed and dysfunctional tissue linked to type 2 diabetes and the gut’s ability to regulate blood sugar, appetite and digestion.
Its procedure delivers pulsed electric fields to the inner mucosal layers of the organ through an endoscopic electrode array, eliminating poorly functioning cells and stimulating regeneration without potentially damaging heat. The approach previously obtained breakthrough designation from the FDA.
Endogenex chief executive Stacey Pugh said: “This financing puts us in a strong position to complete our pivotal study and take the ReCET System through FDA approval.
“Type 2 diabetes continues to take a heavy toll on patients, providers, and the healthcare system. Even with the best available therapies, including GLP-1 receptor agonists and SGLT2 inhibitors, the disease often continues to progress.
“We believe that is because an important part of the disease has gone untreated: the gut. By restoring the duodenum to a healthier state, we aim to help patients do more than manage their symptoms.
“We want to potentially alter their disease progression, and this funding moves us meaningfully closer to that goal.”
Earlier this month, the Minneapolis-based company announced the publication of 48-week results from proof-of-concept programmes in the US and Australia.
More than 70 participants with poorly controlled type 2 diabetes underwent the procedure, with a 100 per cent technical success rate.
One group of 31 patients who received a double application from a second-generation, higher-energy device saw an average HbA1c reduction of 1.5 percentage points over 48 weeks, as well as weight losses of about 5.4kg, amounting to about five to six per cent of their body mass.
At the same time, glucose monitoring data showed their time in a healthy range increased from 55.8 per cent to 82.1 per cent. The trial results were published in Diabetes, Obesity and Metabolism.
The US$50m will help fund Endogenex’s pivotal trial, ReCET, which is now enrolling patients.
The proceeds, led by new backer Arboretum Ventures, come as part of an extension to a 2024 series C round that had raised US$88m.
A separate company also chasing ways to reline the duodenum, Fractyl Health, previously showed its thermal Revita rejuvenation procedure could deliver durable HbA1c benefits out to two years.
However, Fractyl later pivoted away from pursuing a type 2 diabetes indication and, following redundancies, instead directed its research towards obesity and a procedure for maintaining weight loss in people taking GLP-1 drugs.
MINNESOTA-based Medtronic has agreed to acquire neurovascular technology company Scientia Vascular for US$550m.
Scientia’s neurovascular access devices are used to navigate the brain’s complex vasculature, helping prevent cognitive decline by treating conditions such as strokes and aneurysms.
The Scientia proposal is Medtronic’s second deal of the year, after the company announced an acquisition of CathWorks for US$585m in February.
Privately held Scientia was founded in 2007 by John Lippert, its current chief technology officer. It is based in Salt Lake City, Utah, where it employs over 300 staff.
Scientia has developed a micro-fabrication technology to help address challenges in navigating the cerebral vascular system that can make it difficult for physicians to reach the site of an occlusion or aneurysm.
The acquisition builds a foundation to support procedures across both hemorrhagic and acute ischemic stroke, said Linnea Burman, Medtronic’s president of its neurovascular business.
Singapore-based Immortal True Dragon has announced plans to initiate an investment programme in ‘radical life extension technologies’.
20 longevity start-ups
It says it is committed to driving breakthroughs in longevity science and healthy lifespan research, positing that ageing and death are ‘technological challenges that can be overcome through scientific innovation’.
To date, Immortal True Dragon has invested in over 20 industry startups, with a focus on four strategic areas:
Firstly, replacement and regeneration technologies, including pioneering research such as xenotransplantation, cryopreservation, and biological tissue replacement or regeneration.
Secondly, gene therapy and delivery methods, targeting the root causes of ageing and related diseases through gene therapy
Thirdly, neural and brain ageing reversal technologies, covering cutting-edge research such as neuronal regeneration, intervention in neurodegenerative diseases, and cognitive function enhancement, aiming to fundamentally delay and even reverse the brain ageing process;
Fourthly, regulatory arbitrage and compliance paths, accelerating the transformation and implementation of innovative therapies by leveraging policy differences among different jurisdictions in the approval and clinical access of anti-aging therapies.
Boyang Wang, founder of the US$40M AUM (Assets Under Management) fund said: “Whether it’s cutting-edge scientific research or creating a better environment for scientific research, we are committed to finding investment opportunities that can bring about real impact.”
Boomer Inflexion
Research which examines mortality trends by birth cohort, or decade of birth, found that the 1950s US Baby Boomers cohort represents an inflection point transition from general improvements in earlier cohorts to deterioration across later cohorts.
Published in the Proceedings of the National Academy of Sciences (PNAS) the research showed that in general, groups born before the 1950s in the US show improving mortality rates, while those born after showed declines.
While the Baby Boomer generation represented a transition generation, the team found declining mortality patterns for subsequent generations.
There’s bad news for other generations as well. Zooming in on the data revealed troubling trends for those born since 1970, with deteriorating patterns in deaths caused by cardiovascular disease, cancer, and external causes compared with their predecessors.
The research concludes by saying ‘there is no easy answer as to why the US is struggling with mortality’.
A handful of tiny molecules circulating in the blood may help identify which older adults are most likely to survive the next two years, researchers report.
In a study of more than 1,200 people 71 and older, six small RNA molecules in the blood, called piRNAs, predicted short-term survival with up to 86%
“These RNAs are linked to survival,” and the analysis suggests they may also influence whether someone survives, says rheumatologist Virginia Byers Kraus of Duke University.
PiRNAs, short for piwi-interacting RNAs, help regulate genes involved in development, tissue repair and immune function. Research in roundworms shows that reducing piRNAs can double life span, and though widely studied in animals, their role in human aging has remained unclear.
While the results are exciting, those simulations should be interpreted cautiously, says Yale University computational biologist Raghav Sehgal.
The analysis assumes extreme changes in piRNA levels that may not be biologically feasible or safe.
At this stage, Sehgal says, the piRNA patterns probably reflect short-term health risks or frailty rather than gradual biological aging, so the test is not yet ready for clinical use.
Kraus and her team plan to explore piRNA patterns across people ages 30 to 100 and test whether interventions such as the diabetes drug metformin or GLP-1 drugs could modify RNA levels and improve health outcomes.
Mirror, mirror…on the wall
Wearables can currently help monitor your heart rate, blood oxygen and the like, but the next generation of wellness and anti-ageing devices promise to deliver something radically different from your smartwatch, highlights a gadget industry publication.
New wellness devices, such as the Withings Body Scan 2 and the NuraLogix Longevity Mirror, can check an holistic range of medical measurements, such as; arterial stiffness, vascular age, and cardiovascular risk.
These ‘longevity stations’ examine your long-term health risks by analyzing biomarkers linked to cardiovascular health, metabolic function, nerve integrity, and cellular ageing.
One of these; The NuraLogix Longevity Mirror, involves standing in front of it for 30 seconds, whilst its Transdermal Optical Imaging tech analyzes facial blood-flow patterns.
This allows it to estimate cardiovascular health, metabolic function, stress, and physiological age. This data is fed into an AI, trained on hundreds of thousands of patient records, which can then produce a Longevity Index score, along with personalized wellness suggestions.
Vision-restoration company Science Corp has closed a US$230m Series C financing round which will allow it to complete the commercialisation of its brain-computer interface, retinal implant, known as PRIMA.
The deal, which was oversubscribed, secured participation from pre-existing investors Khosla Ventures, Lightspeed Venture Partners, Y Combinator, IQT, and Quiet Capital amongst others.
It raised the total capital invested into the company to approximately $490m since it was founded in 2021.
The company says the new investment will enable it to fully see through the commercialisation of PRIMA, as well as ‘advancing its other core pipeline programs into the clinic’.
In clinical trials, PRIMA has successfully restored vision to patients blinded by late-stage macular degeneration.
Results from this European clinical trial demonstrated that the implant could restore functional central vision, effectively working as artificial photoreceptors in the retina.
Following the successful trial the California-based company has submitted a CE mark application to the European Union, as well as applying to the US Food and Drug Administration for regulatory approval.
Max Hodak, co-founder and CEO of Science Corp, said: “There is a profound sense in which the brain is the ultimate central object of medicine: it is the only organ which is not, even in principle, transplantable, and it’s becoming increasingly clear that engaging with it directly as an information processing system facilitates extraordinary effect sizes.”
Darius Shahida, Science Corp’s Chief Strategy Officer, added: “The strength and calibre of this syndicate reflects both the urgency of the problems we are addressing and the credibility of our execution so far.”
Alzheimer’s in focus
The company is now expanding its PRIMA clinical trial program to include other retinal diseases, such as Stargardt disease and retinitis pigmentosa.
Alzheimer-treatment focused US company Cognito Therapeutics has successfully completed a US $105M Series C round led by Morningside Ventures, IAG Capital Partners, and Starbloom Capital, with further investment from New Vintage, Apollo Health Ventures, Benvolio Group and others.
The new financing will allow the Massachusetts company to advance toward a regulatory submission, and commercial launch, while supporting continued clinical development of its Spectris platform, ahead of its anticipated market entry in 2027.
Christian Howell, Chief Executive Officer, Cognito Therapeutics, said: “With this financing, we are entering a pivotal moment for our company, and for the patients and families waiting for new options in Alzheimer’s disease.
“Spectris has the potential to become the world’s first physician-prescribed, at-home neuro-protective therapy for patients diagnosed with Alzheimer’s, designed to preserve cognition and daily function. This funding allows us to make this therapy accessible to those who need it most.”
Spectris is an investigational physician-prescribed, at-home therapeutic platform designed to evoke coordinated neural activity, across interconnected networks, through non-invasive visual and auditory stimulation.
By engaging neural network function through the brain’s natural sensory pathways, Spectris is being studied for its potential to preserve cognition, daily function, and brain structure in patients diagnosed with Alzheimer’s disease.
US$50m sleep boost
US business Eight Sleep has secured an additional US $50m just a few months after raising US$100in in August last year.
Founded in 2014, Eight Sleep brands itself as a ‘sleep technology’ company that combines technology, physiology and data ‘to unlock deeper sleep and better health’.
In 2025 the business achieved free cash-flow positivity and launched three new products: Pod 5, Pod Pillow Cover and Thermal Blanket.
The new capital will fund its expansion from sleep optimisation into ‘predictive, AI-driven health’, it says.
“Sleep was just the beginning,” said Matteo Franceschetti, co-founder and CEO of Eight Sleep, in a release. “We’ve built the most advanced AI-powered health sensing system in the world – one that learns your body better every night and acts on that knowledge.
“This investment gives us the resources to take that intelligence beyond the bedroom and into every dimension of personal health. … Our goal is to build the defining health technology company of this generation.”
The company started out selling a smart mattress, or Pod, that uses embedded sensors to collect data to study trends about how people sleep.
At the time of last year’s raise the company was valued at US$1bn.
Swiss wearable boost
Xsensio SA, a Swiss tech company pioneering continuous biochemical monitoring, has successfully closed a US$7m, oversubscribed, Series A financing round.
The round was led by San Francisco-based venture capital firm WI Harper, with participation from Privilège Ventures, the European Innovation Council, and private investors across the United States, Europe, and Asia.
Its Lab-on-Skin wearable biosensing platform aims to ‘deliver continuous, real-time biochemical information for personalised and preventive healthcare’.
The new funding will enable Xsensio to accelerate the development and clinical validation of its Lab-on-Skin wearable biosensing platform, designed to provide dynamic, multi-modal, biochemical information to support clinical decision-making in the hospital and beyond.
“This Series A marks a pivotal step in translating continuous biochemical monitoring into real clinical environments,” said Esmeralda Megally, CEO of Xsensio.
“For the first time, clinicians can access key continuous biochemical data in real time, information that has historically been unavailable at the point of care. This capability has the potential to fundamentally improve how patients are monitored and treated.”
Xsensio has also signed a long-term collaboration with Texas Instruments, a global leader in semiconductor technology. Xsensio was recognised by TIME as one of the World’s Top HealthTech Companies in 2025.
Paris-based Gleamer, one of Europe’s fastest-growing AI radiology platforms, has been acquired by US imaging giant RadNet in a deal valued at €230m.
The French medtech, which was founded in 2017 by Christian Allouche, Dr Alexis Ducarouge, and Dr Nor-eddine Regnard, uses AI to reduce radiology misdiagnoses.
By the end of 2025, Gleamer had reached around €30m in annual recurring revenue and built a customer base of roughly 700 clients across 44 countries.
Since its inception it has raised around €50m across three funding rounds: €27M in 2023, €7.5M in 2020, and €1.1M in 2018.
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