The MedTech world experienced a wealth of pioneering breakthroughs during the third quarter of 2023. With the start of November, let’s take a moment to review the key highlights across funding, innovations, clinical trials, mergers, acquisitions, and regulatory approvals in our quarterly editors’ recap.
Innovations
In an effort to provide reliable in vitro diagnostics, Siemens Healthineers unveiled the Atellica CI Analyzer, offering improved turnaround time predictability, advanced reporting functionality, and stringent safety measures. The Atellica CI Analyzer makes it possible for both standalone labs and satellite labs of wider health networks to have the same reagents, consumables, and intelligent software as the company’s flagship Atellica Solution—now condensed into a 1.9 square meters footprint ideal for smaller laboratories.
Meanwhile, researchers from Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, designed a device that can help test treatments in patients with gliomas, a type of tumor that originates in the brain or spinal cord. The device, which is designed to be used during standard-of-care surgery, provides unprecedented insight into the effects of drugs on glioma tumors and caused no adverse effects on patients in a phase 1 clinical trial.
Regulatory Approvals
The third quarter of the year got off to a strong start as MediView XR received FDA 510(k) clearance for its augmented reality surgical navigation platform, XR90, which allows physicians to view a patient’s anatomical structures in 3D for preoperative and intraoperative use.
The Ohio-based MedTech company’s XR90 combines CT imaging with ultrasound, allowing 3D holographic images to be displayed anatomically underneath the patient’s skin, enabling providers to perform minimally invasive procedures, such as tumor ablations and biopsies.
More recently, Tyber Medical achieved regulatory approval for its implantable K-Wires and Steinmann Pins from both the US Food and Drug Administration (FDA) and the European Union Medical Device Regulation (EU MDR). Available in sterile and non-sterile options, the approved K-Wires and Steinmann Pins are offered in several configurations, including combinations of trocar tip, diamond tip, fluted tip, partial thread, full thread, ball end and flat end.
Tyber Medical CEO Jeff Tyber said: “Our focus has always been on developing products that are innovative, efficient and deliver unparalleled performance. Receiving the FDA and MDR clearance for these platforms is a testament to our rigorous pursuit of advancing patient care while helping our customers expand their brand.”
Two more regulatory approvals that took center stage during Q3:
Johnson & Johnson’s Atrial Fibrillation Ablation Devices without Fluoroscopy: The US Food and Drug Administration (FDA) granted its approval to Johnson & Johnson’s catheter-based atrial fibrillation ablation devices, and notably, these devices can now be used without the need for fluoroscopy. This milestone represents a significant enhancement in cardiac care, promising a safer environment for both patients and medical practitioners during these procedures.
DermaSensor’s positive results for skin cancer detection device across multiple skin tones: DermaSensor’s handheld elastic scattering spectroscopy (ESS) device has made a remarkable impact by demonstrating a high level of sensitivity in the detection of all types of skin cancer, achieving an impressive 96% accuracy rate. Equally remarkable is its consistent performance across various Fitzpatrick skin type subgroups. This regulatory approval signifies a groundbreaking development in the realm of dermatology and skin cancer detection, offering the potential for improved diagnostic accuracy and accessibility for a broader range of patients.
Clinical Trials
Just a month ago, Medidata unveiled the Medidata Diversity Program, a forward-thinking initiative focused on promoting diversity, equity, and inclusion within clinical trials. The program seamlessly integrates the expertise from Medidata’s AI and Patient Cloud portfolios, culminating in a comprehensive strategy tailored to meet regulatory requirements and boost inclusivity within clinical trials.
Zooming out to the broader landscape of clinical trials and medical advancements, July marked a significant milestone in Alzheimer’s Disease research. Cognito Therapeutics made significant progress with recent MRI data showcasing lobe-specific changes in white matter volume and myelination in Alzheimer’s Disease patients.
The company presented new imaging data at the Alzheimer’s Association International Conference 2023 from the Phase 2 OVERTURE study, that reported its proprietary gamma sensory stimulation therapy reduced the decline in white matter/grey matter (WM/GM) contrast in the entorhinal region. The entorhinal region of the brain is of particular interest in the early stages of AD, and early intervention with Cognito’s therapy may result in enhanced tissue preservation and reduced neurological damage.
Funding
CMR Surgical marked a significant milestone, completing over 15,000 global surgical procedures using their Versius® system. To fuel their expansion, they secured $165 million in funding.
CMR was established in 2014 with a mission to transform lives by making minimal access surgery (MAS) more accessible and affordable with Versius, a small, modular, and versatile surgical robotic system. The surgical cases span more than 130 complex and benign procedure types including colectomies, hernia repairs, hysterectomies, sacrocolpopexies, and lobectomies across seven surgical specialties. The funding round of $165 million (£133m), which was increased from the initial base size due to strong internal demand, was led by all of its major existing investors, including Ally Bridge Group, Cambridge Innovation Capital, Escala Capital, LGT, Lightrock, RPMI Railpen, SoftBank Vision Fund 2, Tencent and Watrium.
In a similar context, SpineX managed to secure essential funding for advancing the SCiP device’s pivotal clinical trial aimed at children with cerebral palsy (CP), a childhood movement disorder. This crucial funding comes from the National Institutes of Health, facilitated through the Small Business Innovation Research Awards.
The data gathered during the trial will play a central role in the company’s pursuit of US Food and Drug Administration (FDA) approval, paving the way for marketing and further development of the device.
Mergers & Acquisitions
Abbott announced a definitive agreement to acquire Bigfoot Biomedical, a leader in developing smart insulin management systems for people with diabetes. This move aims to further develop connected solutions for making diabetes management more personal and precise.
Enovis Corp agreed to acquire Italian surgical implant manufacturer LimaCorporate for about 800 million euros ($850 million), including debt. This acquisition will bolster the US company’s reconstructive business and expand its international footprint.
Inogen completes its acquisition of PhysioAssist, a leading provider of innovative medical devices. This strategic move aligns with Inogen’s strategy to diversify its portfolio and expand market opportunities imminently.
The third quarter of 2023 has proven to be a period of groundbreaking advancements and transformative shifts in the MedTech landscape, setting the stage for a future where healthcare is safer, more accessible, and patient-centric. These developments reflect the relentless pursuit of innovation and the commitment to improving patient care on a global scale.
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