Editors’ Choice: 2024 in Review

The MedTech industry has evolved faster than ever in 2024, with groundbreaking advancements reshaping healthcare delivery and patient outcomes. From artificial intelligence transforming diagnostics and personalised medicine to cutting-edge robotics redefining surgical precision, the year is marked by innovations which are setting new benchmarks for efficiency and outcomes. The convergence of technology, regulation, and patient-centric care is creating a dynamic landscape where every breakthrough holds the potential to revolutionise healthcare as we know it. In our editors’ recap, we are celebrating the notable milestones reached by some of the key players in the industry.  

Funding

In March, Carlsmed raised $52.5m in a Series C funding round co-led by B Capital and U.S. Venture Partners. The AI-enabled personalised surgery company has planned to accelerate and boost commercialisation efforts of its aprevo personalised spine surgery platform for lumbar fusion procedures.

Q2 saw Materna Medical Inc. completing the first close of a $20m Series B2 financing round led by InnovaHealth Partners. The company has reached several key milestones, including obtaining FDA clearance for its first commercial product, the Milli Vaginal Dilator. Clinical data from an expanded feasibility study of Materna’s second product, Materna Prep, shows substantial promise in the potential to reduce pelvic floor injury rates for women delivering vaginally.

Another funding round was completed in September with the Swiss spine technology company Neo Medical raised $68m to expand its portfolio of surgical technologies. Led by Gyrus Capital and existing investors Vincent Lefauconnier and Jonas Larsson, the funding will increase the Lausanne-headquartered business’ market share in key regions beyond Europe, immediately focusing on expanding its US business.

Sirona Medical, a San Francisco, CA-based provider of cloud-native radiology workflow software, also raised $42m in Series C funding in November. The company provides its flagship radiology workflow solution, Unify platform, which unifies diagnostic and clinical image viewing, radiology reporting, worklist, and AI on a single cloud-native platform. 

Mergers & Acquisitions

Q1 started with the news the Canadian surgical device manufacturer Titan Medical merged with imaging guidance company Conavi Medical. The agreement meant that Titan would acquire all the issued and outstanding shares of Conavi, with shareholders being provided equivalent common shares in the newly amalgamated company which plans to continue the development of Conavi’s Novasight Hybrid System following its 510(k) approval from the FDA.

Later on, Edwards Lifesciences agreed to sell its Critical Care product group to Becton, Dickinson and Company, in an all-cash transaction valued at $4.2b. The sale enhances Edwards’ balance sheet flexibility for disciplined investments in technologies for aortic, mitral, tricuspid and pulmonic patients, as well as new therapeutic areas for interventional heart failure. 

In August, Johnson & Johnson acquired the interatrial shunt maker V-Wave for up to $1.7b. The newly acquired company develops cardiovascular implant technology that specifically targets heart failure with reduced ejection fraction. V-Wave designed its Ventura interatrial shunt with a nitinol hourglass frame to decrease elevated left atrial pressure seen in congestive heart failure.

Q4 saw DHG boost its market-leading pressure ulcer prevention portfolio with the Sumed International acquisition. Beginning trading in 1987, Sumed has a well-established reputation as a manufacturer and service provider of pressure ulcer prevention surfaces, accessories and wheelchairs, driven by a dedicated team and backed by high-quality solutions.

Clinical trials

At the beginning of the year, Cognito Therapeutics enrolled the first patient in a biomarker substudy within its HOPE pivotal trial evaluating sensory stimulation devices in Alzheimer’s disease patients. The study assessed the efficacy of Cognitio’s GammaSense Stimulation system in subjects with mild to moderate Alzheimer’s disease. The randomised, double-blind, sham-controlled, adaptive-design trial aimed to administer the therapy to 530 subjects with Alzheimer’s for 12 months.

In Q2, MiRus reported positive results from the first-in-human trials of its Siegel transcatheter aortic heart valve, conducted at the Instituto Nacional Del Torax in Santiago, Chile. The trial, involving five patients with severe symptomatic aortic stenosis, showed no mortality or stroke at 30 days, and none of the patients required a permanent pacemaker or experienced vascular complications.

Soon after, the robotics company Medical Microinstruments announced it had completed a preclinical study evaluating its Symani surgical robot in neurosurgical procedures. As part of the study, Dr Adnan Siddiqui successfully repaired a blood vessel in the brain in an animal model. The study aimed to assess the feasibility of using the system to obtain user feedback, from a neurosurgeon.

In Q4, Sonablate enrolled its first patient into its HIFIVE U.S. clinical trial, which is testing high-intensity focused ultrasound (HIFU) for the non-invasive treatment of incompetent veins. The Sonablate HIFU system ablates incompetent peripheral veins, offering an alternative to invasive treatments that typically require needle penetration, catheter insertion and extensive anaesthetic preparations. Unlike these procedures, HIFU is an extracorporeal method, delivering therapeutic ultrasound energy externally without instruments entering the body.

Innovation

A notable innovation from earlier this year involves the US-based medical technology company Accelus, which launched a linesider modular-cortical system, used in spinal implant surgeries. The technology allows surgeons to place screw shanks early in the procedure and customise the construct with modular tulips and rods. The system comes in open modular and cortical modular sets, catering to different surgical approaches.

Molli Surgical also launched its OncoPen surgical tool for breast cancer imaging. The company said the precision of the OncoPen and Molli system allows for more targeted lesion removal, smaller surgical incisions, conservation of healthy tissues, and potentially improved cosmesis.

In August, Enovis unveiled its new total ankle replacement system with new e+ Polyethylene. The implant’s new, vitamin E-blended e+ Polyethylene insert offers improved durability, stability and longevity, marking the company’s efforts in continuous improvement toward enhancing patient satisfaction and outcomes.

Later on, the US-based brain-computer interface company, Science Corporation revealed results from its preliminary trial of its PRIMA retina implant, announcing the device can restore real-form vision in patients who had lost their central visual field. The study examined 38 patients suffering from geographic atrophy in a bid to obtain a CE mark for European market approval for the implant.

Regulatory Approvals

Q1 started with the news that Magstim, a key player in neuroscience research and treatment for mental health, has been awarded FDA clearance for Horizon 3.0 with StimGuide Pro. The approval provides physicians, nurse practitioners, clinicians, and researchers with the most advanced transcranial magnetic stimulation technology available to treat patients diagnosed with depressive or obsessive-compulsive conditions.

Another approval involved the early-stage Freyja Healthcare, which has received 510(k) FDA clearance for its VereSee device, used in laparoscopic surgery in women’s health. Founded in 2017, the company has raised almost $8m in seed funding, with $1m in a Series A funding round in April 2019.

Soon after, Asensus Surgical won FDA nod for a surgical robot used to treat adult and paediatric urology patients. The company originally designed Senhance for use in general laparoscopic and laparoscopic gynaecological procedures. Since winning FDA clearance for the system in 2017, Asensus secured expanded indications, deals with Google and Nvidia, and hospital placements around the world.

More recently, Momentis Surgical’s Anovo robotic surgical platform has secured 510(k) clearance for use in single-site, abdominal access ventral hernia repair. The device features humanoid robotic arms, which the company says are designed to provide human-level dexterity.

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