Siemens Healthineers Invested USD 314 Million in New MRI Manufacturing Plant

On May 15, 2024, Siemens Healthineers announced that it had invested USD 314 million in a new MRI manufacturing plant in the UK. The facility in Oxford, England, which Siemens anticipates opening in 2026, will develop technology to reduce the amount of helium needed for MRI machines.

MRI machines use liquid helium to cool their superconducting magnets. To minimize the use of helium, a nonrenewable element susceptible to supply disruptions, Siemens spent years designing a magnet with its own refrigeration system. This effort resulted in the launch of an MRI machine that uses only 0.7 liters of liquid helium, compared to up to 1,500 liters in older models.

Near Oxford, Siemens had started building a 56,000-square-meter facility dedicated to designing and manufacturing superconducting magnets. This new plant will eventually replace the current facility in the nearby village of Eynsham, which, according to Siemens, exports approximately 95% of the magnets it produces.

CEO Bernd Montag said, “In a May 7 earnings call that all the company’s MRI devices will be based on low-helium technology by 2030. The company is adding manufacturing capacity to support that ambition”.

As per DelveInsight’s PET-MRI Systems Market Report the global PET-MRI systems market is estimated to grow at a CAGR of 5.71% during the forecast period from 2024 to 2030. The PET-MRI systems market is observing substantial market growth owing to the increasing prevalence of neurological disorders such as Alzheimer’s and other dementias, strokes, migraine and other headaches, multiple sclerosis, Parkinson’s disease, neurological infections, brain tumors and the rising prevalence of various cancers around the globe. Further, the escalating burden of the geriatric population, extensive research and development activities employing PET-MRI systems, increasing approval activities by regulatory authorities for devices, the surging new device launches, and the presence of key players in the market, among others will create a requisite for PET-MRI systems in the market. Therefore, the PET-MRI systems market is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.

Samsung Medison to Buy AI Ultrasound Company Sonio

On May 08, 2024, Samsung Medison announced that it would acquire Sonio’s shares for about 126 billion.

Founded in 2020 and based in Paris, France, Sonio develops software that leverages deep learning to assist with routine fetal ultrasound examinations. The software can, for instance, identify and label ultrasound images and detect anatomical structures within those images.

Last year, Sonio obtained 510(k) clearance from the Food and Drug Administration for its Sonio Detect software. According to its website, the company’s technology is utilized by 300 care centers across 18 countries.

Samsung Medison, headquartered in Seoul, Korea, manufactures ultrasound machines and domestically distributes Samsung’s X-ray and portable CT machines. In 2010, Samsung Electronics acquired a majority stake in Medison for approximately $262 million, facilitating its entry into the medical technology market.

Sonio CEO Cécile Brosset said, “The planned acquisition creates an exciting growth opportunity for both sides.” 

According to DelveInsight’s Ultrasound Devices Market Report, the global ultrasound devices market was valued at USD 6.76 billion in 2023, growing at a CAGR of 6.82% during the forecast period from 2024 to 2030 to reach USD 10.05 billion by 2030. The ultrasound devices market is witnessing positive growth owing to the rising incidence of severe chronic diseases such as cardiovascular, urology, and others, further rapid technological developmental activities, growing awareness for early disease detection, and increasing geriatric population across the globe who are more susceptible to developing chronic disorders, and rising adoption owing to no radiation exposure, thereby contributing to the growth of the ultrasound devices market during the forecast period.

Regulatory Clearance for Leo Cancer Care’s Upright Technology for Radiation Therapy 

On May 09, 2024, Leo Cancer Care announced that its groundbreaking upright patient positioning system for radiotherapy treatment had received regulatory clearance. With this 510(K) approval, the Eve System was now authorized to provide a more human-centric approach to treating cancer patients.

The patient positioning system allows cancer patients to receive radiation treatment while seated in an upright position, offering an innovative design compared to the majority of radiotherapy devices currently available. This system, while just one component of the overall solution, holds the most potential—and most importantly, it focuses on the patient. 

CEO of Leo Cancer Care, Stephen Towe said, “Leo Cancer Care has always promised a lot; a new paradigm for radiation therapy with huge potential benefits for patients across the globe. This regulatory clearance marks a turning point for the company and our ability to deliver on those promises. This will see clinical adoption of the upright treatment approach giving patients the choice they have been waiting for.”

“This will now go from a non-clinical research solution to a fully functioning clinical device, with clinical treatments possible. With one device cleared, Leo Cancer Care has a comprehensive development pipeline to deliver further solutions within the upright technology paradigm.” added Towe.

As per DelveInsight’s Cancer Therapy Market Report the global cancer therapy market was valued at USD 169.39 billion in 2023, growing at a CAGR of 9.12% during the forecast period from 2024 to 2030, to reach USD 285.96 billion by 2030. The cancer therapy market is witnessing positive market growth owing to factors such as the rising prevalence of various cancers which are contributing in the growing demand for cancer treatment, and presence of factors like increasing aging population wherein age plays a key role in cancer development in certain cancer types namely breast cancer. Moreover, the growing focus on developing targeted therapies due to advancements in precision medicine to provide a more pronounced therapeutic effect is further driving the cancer therapy market as new products are gaining regulatory approvals for cancer treatment.

OrthoXel Received FDA 510 (k) Clearance for Their Vertex Hip Fracture Nail (HFN)

On May 09, 2024, the Vertex HFN presented a novel method for fracture fixation, to improve patient outcomes and simplify surgical procedures. Conventional approaches to treating hip fractures frequently face obstacles like instability, resulting in high rates of cutout, restricted patient mobility after surgery, ongoing pain during recovery, and complications with nonunion. OrthoXel’s Vertex HFN directly addressed these clinical challenges by providing a highly stable and adaptable solution.

Douglas R. Dirschl MD, Professor and Chairman of Orthopedic Surgery at Baylor College of Medicine said, “With the exciting news of Vertex’s FDA 510(k) clearance, I eagerly anticipate this innovative nail providing benefit to my patients and those of other fracture surgeons. The Vertex’s design offers enhanced stability as well as the flexibility to tailor treatment to individual patient and fracture needs. Like with their Apex nail, the OrthoXel team has once again demonstrated excellence and innovation in product design.”

Jason Strelzow MD, Director of Orthopaedic Trauma and Residency Program Director at The University of Chicago Medicine, said, “I am very excited to see the Vertex nail reach the market. Working with the development team they have created a one-of-a-kind system taking advantage of the existing knowledge of hip fracture nails and generated a novel, innovative design that addresses the biggest concerns around hip fracture fixation. The fluted interference fit, combined with enhanced head/neck fixation through the interdigitating screw design provides an exciting and potentially game-changing tool for these injuries.”

According to DelveInsight’s Hip Replacement Devices Market Report, the global Hip Replacement Devices Market was valued at USD 9.26 billion in 2023, growing at a CAGR of 5.06% during the forecast period from 2024 to 2030 to reach USD 12.44 billion by 2030. The rise in demand for Hip Replacement Devices is primarily due to the rising geriatric population across the globe, the increase in obesity owing to a sedentary lifestyle, the introduction of custom-made implants, and technological advancement in the product portfolio, among others.

SPR Therapeutics Reported Positive Data for PNS Pain Relief Device

On May 15, 2024, SPR Therapeutics announced encouraging findings from a trial evaluating its peripheral nerve stimulation (PNS) device designed to assist knee replacement patients dealing with chronic knee pain. The prospective study examined SPR Therapeutics’ SPRINT PNS system over a 60-day therapy period in patients experiencing postoperative pain following total knee arthroplasty, commonly known as total knee replacement surgery.

The company indicated that as many as 20% of patients undergoing total knee arthroplasty continue to experience pain beyond three months after the surgery.

SPR Therapeutics’ device utilizes a percutaneous PNS approach, which entails stimulating peripheral nerves in the area of pain. Electrical pulses are conveyed to the nerves through slender leads beneath the skin, thereby modifying the transmission of pain signals to the brain.

According to DelveInsight’s Pain Management Devices Market Report, the global pain management devices market was valued at USD 4.86 billion in 2023, growing at a CAGR of 7.90% during the forecast period from 2024 to 2030, to reach USD 7.67 billion by 2030. The demand for Pain Management Devices is primarily motivated by the rise in the prevalence of chronic pain, the high prevalence of musculoskeletal disorders, the surge in the geriatric population, the surge in awareness among people toward pain management devices, improved R&D investment to develop innovative products, and increasing cost of healthcare expenditure.

Valneva Reported Further Positive Pivotal Phase III Data in Adolescents for its Single-Shot Chikungunya Vaccine

On May 13, 2024, Valneva a specialized vaccine company announced additional positive pivotal Phase 3 results in adolescents for its single-shot vaccine against the chikungunya virus (CHIKV).

The Day 180 results validate the initial positive immunogenicity and safety data previously reported by Valneva. These findings are intended to bolster the submission for potential label extension for use in adolescents aged 12 to 17 years. Additionally, the data are anticipated to facilitate the licensure of IXCHIQ® in Brazil, marking the first potential approval for use in endemic populations.

The latest data from VLA1553-321 confirmed that a single-dose vaccination with VLA1553 triggered a robust and enduring immune response, with a seroresponse rate of 99.1% (232 out of 234 participants) at Day 180. This is compared to a seroresponse rate of 98.8% (248 out of 251 participants) at Day 29 in a subset of individuals who were CHIKV-negative at baseline, indicating sustained immunity over time.

Geometric mean antibody titers (GMTs) consistently exceeded the seroresponse threshold, as defined by the U.S. Food and Drug Administration (FDA), indicating a surrogate of protection in baseline seronegative participants who received a single dose of VLA1553.

Furthermore, the Day 180 data affirmed that a single dose of the vaccine was generally safe and well tolerated among adolescents who received VLA1553, regardless of prior chikungunya virus infection. Throughout the trial, an Independent Data Safety Monitoring Board (IDSMB) continuously evaluated safety data and did not identify any safety concerns. Most solicited adverse events observed after VLA1553 administration were mild or moderate and resolved within three days following vaccination.

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are highly encouraged by these data, as they reinforce the strong immunity and safety observed in adults and the elderly, upon which FDA approval was granted. Given the substantial risk that chikungunya presents to individuals residing in or traveling to endemic regions, it’s imperative to ensure the vaccine is available to all age groups. This broader accessibility can help provide protection and mitigate the burden of this debilitating illness.”

According to DelveInsight’s Vaccines Market Report”, the global vaccines market will grow at a CAGR of −11.47% during the forecast period from 2024 to 2030 to reach USD 65,074.86 million by 2030. The vaccines market is witnessing positive market growth owing to factors such as the rising prevalence of cancers such as liver, cervical, and others that are contributing to the growing demand for therapeutics as well as prophylactic cancer vaccines. Moreover, the growing focus on reducing childhood morbidity and mortality rates due to preventable diseases in children is another prominent factor responsible for the growth of the vaccine market.