FUTURE OF HEALTHCARE
SpineGuard | June 08, 2022
pineGuard an innovative company that deploys its DSG sensing technology to secure and streamline the placement of bone implants, announces the launch of a new three-year collaboration program with two labs of Sorbonne University CNRS and Inserm: the ISIR.
DSG is based on the local measurement of electrical conductivity of tissues in real time without X-ray imaging, with a sensor located at the tip of the drilling instrument. Its efficacy was proven by more than 90,000 surgeries across the globe and 19 scientific publications. SpineGuard has entered in 2017 a collaboration with ISIR for the application of DSG to surgical robots and the enhancement of their safety, accuracy, and autonomy.
SpineGuard and ISIR capitalize on first order outcomes published so far…
At the close of a first collaboration phase, SpineGuard announced sub-millimetric accuracy experimental outcomes in bone boundary detection and automatic stop of a vertebral drilling performed by a robot using the DSG technology. These impressive outcomes were presented as they were produced successively at the Hamlyn medical robotics conference in London in May 2019, receiving the first price for best scientific paper, then in plenary session at the SMISS minimally invasive spine surgery (SMISS) in Las Vegas in November 2021, and lastly during the CRAS conference in Naples in April 2022.
… and join forces with the LIB laboratory in order to add ultrasound to the project.
Encouraged by this success, the research and development teams wish to go even further in surgical robots advancement: the guidance technologies that allow the robot to position itself properly relative to the patient to find the drilling entry point rely today on X-Ray imaging, dangerous for health, in combination with space-consuming optical registration. SpineGuard has long explored the possibility to use ultrasound complementarily to DSG for this preliminary step, before the tool is penetrating bone, and was granted two families of international patents on that topic. The LIB laboratory, who features an international level expertise in the field of ultrasound imaging, answered with enthusiasm the invitation to join the project. SpineGuard, ISIR and LIB thus start a new 3-year collaboration that is expected to produce breakthrough results in the field.
“We are happy to launch this partnership that will allow us to go even further in improving surgical robots in orthopedics. This new phase of the project aims at enabling robots to perform bone drilling and cutting, as well as implant placement, in a secured and more autonomous manner in the human skeleton. Our goal is to implement first-class collaboration between French Research and Industry and trigger commercial ventures in the orthopedic field via strategic agreements with industry partners.”
Stéphane Bette, co-founder and Deputy CEO of SpineGuard
Guillaume Morel, Professor at Sorbonne University and ISIR Director, and Brahim Tamadazte, Researcher at CNRS and member of ISIR, added: “We are delighted to continue the close and dynamic collaboration initiated in 2017 with SpineGuard. The entry of robotics and associated new technologies in operating room is no doubt one of the biggest medical advances of the last twenty years. Robotic approaches often allow the surgical gesture to be less invasive, more accurate, safe and intuitive in numerous surgical procedures. The first outcomes from the previous collaboration gave us more visibility on the clinical added value that a robot with original and effective sensors can bring to Orthopedic Surgery in general and Spine in particular. This new collaboration will be about ultrasonic sensors coupled with robotics. This original and promising association will allow the surgeon to define the entry point and the pedicle screw trajectory accurately and non-invasively, without relying on ionizing or costly preoperative imaging (scanner, MRI). The association of two prestigious labs of Sorbonne University (ISIR and LIB), whose competencies are highly complementary to SpineGuard’s industrial vision constitute a stimulating work environment favorable to innovation. The journey with SpineGuard goes on for three more years with a target of several technologic and scientific innovations to serve patients and care providers.”
Quentin Grimal, Professor at Sorbonne University and Manager of the team “Ultrasound and imaging for bone quality characterization” at LIB, concludes: “Using ultrasound to position a surgical tool is particularly relevant. Ultrasounds are danger free and provide real time information about interfaces, bone anatomy, even bone mechanical quality. The use of an ultrasound probe should allow to position the robotic arm in an optimal manner to place pedicle screws. In general, echography does not allow to see beyond the bone surfaces because ultrasounds are strongly reflected at the surface and strongly attenuated when propagating in bone. Low amplitude signals coming from inside bone can however be exploited through specific treatments which are a specialty of our team. Our team, pioneer in ultrasound utilization to probe bone, has introduced several approaches that offer an alternative to X-Rays for characterization of trabecular or cortical bone health. For our team, this partnership with SpineGuard and ISIR is a great fit: it will accelerate methodology and instrument developments for a broader utilization of ultrasound in orthopedic surgery. We are very happy to participate in this innovation rich project.”
Founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard is an innovative company deploying its proprietary radiation-free real time sensing technology DSG® (Dynamic Surgical Guidance) to secure and streamline the placement of implants in the skeleton. SpineGuard designs, develops and markets medical devices that have been used in over 90,000 surgical procedures worldwide. Nineteen studies published in peer-reviewed scientific journals have demonstrated the multiple benefits DSG® offers to patients, surgeons, surgical staff and hospitals. Building on these strong fundamentals and several strategic partnerships, SpineGuard has expanded the scope of its DSG® technology in innovative applications such as the « smart » pedicle screw, the DSG Connect visualization and registration interface, dental implantology and surgical robotics. DSG® was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. SpineGuard has engaged in multiple ESG initiatives.
ISIR is one of the largest French Research institutions in robotics and intelligent systems, reporting mainly to Sorbonne University, CNRS (National Center for Scientific Research) and Inserm (National institute for health and medical research). It regroups more than 50 teaching researchers and permanent researchers and approximately 80 PhD ad post-doc students. ISIR is structured around 6 research teams focused on artificial intelligence and machine learning, mobile robotics, small scale robotics, assistance robotics (physical therapy and mobility support), human-robot interaction and surgical gesture assistance. ISIR has a rich expertise in the design of innovative robotic architectures, simulation and control, clinical validation and transfer of high industrial potential results. Over the last 5 past years, 10 pre-clinical or clinical studies were conducted at ISIR. 8 patents were granted, and 2 start-up companies created.
The Laboratory for biomedical imaging (LIB) is specialized in Fundamental and Applied Research for biomedical morphologic imaging methods, functional and molecular on small animal and human. It reports to Sorbonne University, CNRS and INSERM. It regroups 35 permanent researchers and teaching researchers, of whom half are also hospital practitioners, approximately 10 engineers and technicians and more than 30 PhD students and post-docs. LIB is structured around 6 teams whose focuses correspond to key priorities of 21st century Public Health: cancer, cardiovascular and neurologic diseases, bone quality. LIB develops new diagnostic and treatments methods exploiting various modalities: ultrasound, MRI, CT, SPECT-PET, etc. LIB has a strong commitment to technology transfer. Over the last 5 years, 6 patents were granted, 7 software were filed, and 5 startup companies launched.
FUTURE OF HEALTHCARE
BD (Becton, Dickinson and Company) | April 23, 2022
BD a leading global medical technology company, announced the formation of the Sustainable Medical Technology Institute, a model of practice within the organization that will bring together BD researchers and engineers, as well as quality, regulatory, policy and operational expertise, to focus on reducing the environmental impact of the company's product portfolio in three areas, including adopting sustainable product design strategies, developing and deploying sustainable sterilization technologies, and addressing materials of concern.
The Institute will serve as an example of how the company continues to advance the world of health by prioritizing high-quality, safe products for patients, while furthering its environmental, social and governance strategy.
"As part of our ESG strategy, we made commitments in specific areas where we see the most opportunity for BD to create meaningful, measurable change over the next decade. In order to achieve these commitments, we established a set of goals to track and measure our success, and this includes how to reduce the environmental impact of our product portfolio and address our customers' sustainability needs. These priorities led us to form the Sustainable Medical Technology Institute."
Maureen Mazurek, vice president, sustainability and environmental health and safety at BD
Dr. Amit Limaye, director of the Sustainable Medical Technology Institute and director of sustainability research and development at BD, added, "By empowering our teams to tap into deep expertise in areas like engineering and materials science, coupled with access to breakthrough research, technologies, and government and academic partnerships, we are well-positioned to be the best environmental stewards of our portfolio. It is our vision to create a strategic roadmap that will be integral across the organization, demonstrating how an ethical and sustainable company can drive growth, while meeting patient and customer needs in the most environmentally sustainable way possible."
The Institute will operate in North America, Europe and Asia, and will collaborate with cross-functional teams within the company's business units, inclusive of research and development, regulatory, quality, policy and operations roles, with the goal of ensuring accountability and a streamlined approach to sustainability efforts, as well as further address sustainability needs within the industry and global regulatory bodies. Key initial efforts include reestablishing a set of minimum environmental and human health criteria for new products and product changes aligned with the company's 2030+ ESG commitments and goals, and identifying new ways to reduce, reuse, recycle or replace materials. These efforts will inform the company's product life cycle roadmap and enable adoption of a sustainable-by-design product development process.
is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
FUTURE OF HEALTHCARE
Medicago | May 06, 2022
Medicago announced the publication of the results from the Phase 3 study of COVIFENZ®, COVID-19 vaccine recombinant, adjuvanted, in the New England Journal of Medicine. The Phase 3 trial studied the two-dose regimen of COVIFENZ® given 21 days apart versus placebo in over 24,000 subjects aged 18 and above. Common side effects in the vaccine group included injection site pain, headache, fatigue, fever, muscle aches, and chills.
COVIFENZ® is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 in individuals 18 to 64 years of age. The safety and efficacy of COVIFENZ® in individuals younger than 18 years of age or 65 years and older have not been established. COVIFENZ® has not yet received approval in other jurisdictions.
“We are proud to have our Phase 3 clinical trial published in the esteemed New England Journal of Medicine to be shared with the larger scientific community. Medicago’s scientific team has dedicated decades to the development of our proprietary plant-based vaccine manufacturing platform, and we are thrilled to see our results disseminated in this way. We hope that this exchange of research and knowledge will encourage and inspire future innovation in biomedical science and clinical practice.”
Marc-André D’Aoust, Executive Vice President, Innovation, Development and Medical Affairs at Medicago
COVIFENZ® was authorized for use by Health Canada on February 24, 2022. This is the first authorized COVID-19 vaccine developed by a Canadian-headquartered company, and the first that uses a plant-based protein technology.
“The world needs a diverse range of vaccine options to continue to fight COVID-19, and we are proud to be able to contribute,” said Toshifumi Tada, CEO and President at Medicago.
Medicago is on a mission to help improve global public health using the power of plants. Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare, Medicago is a pioneer in plant-based therapeutics. We are proudly rooted in Quebec, with manufacturing capacity in both Canada and the US. Our passionate and curious team of over 500 scientific experts and employees are dedicated to using our technology to provide rapid responses to emerging global health challenges, and to advancing therapeutics against life-threatening diseases worldwide. Medicago is an affiliated company of Mitsubishi Tanabe Pharma Corporation.
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation, the majority parent company of Medicago, is one of the large Japanese pharmaceutical companies, with its headquarters in Osaka, Japan. It positions vaccines as one of its key R&D areas and is also working to develop new modalities of vaccines. MTPC will further contribute to the prevention of infectious diseases which is one of the world’s important social issues, by delivering a new option of plant-based VLP vaccine as a new type of vaccine. MTPC is a member of Mitsubishi Chemical Holdings Group.
Ivenix | April 01, 2022
Ivenix, Inc. announced that it has entered into a definitive agreement to be acquired by Fresenius Kabi, a global health care leader specializing in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Ivenix’s advanced infusion system combined with Fresenius Kabi’s intravenous fluids and infusion therapy offerings will bring a comprehensive portfolio of infusion products to U.S. hospitals. The purchase price will be a combination of US$240 million upfront payment and milestone payments linked to achievements of commercial and operating targets.
The transaction is subject to regulatory approvals and other customary closing conditions and is expected to close by mid-2022.
The transaction is designed to
Create a comprehensive portfolio that joins the industry’s most advanced infusion pump technology with the newest source of intravenous fluids, infusion supplies and accessories.
Accelerate operational and commercial growth and scale providing a platform for rapid expansion.
Build on a shared culture of exceptional customer service.
Establish Fresenius Kabi as a leader in the approximately $5 billion infusion segment.
This pivotal transaction will accelerate innovation, expand our combined infusion therapy portfolio and enhance our infusion capabilities, resulting in improved medication safety and operational efficiency.
“We’re very pleased to partner with Fresenius Kabi, a leading global health care company. Together, we intend to transform the standard of care for North American health care providers and patients by providing the highest level of safe and effective integrated infusion care,”
Jorgen B. Hansen, Ivenix’s Chief Executive Officer
The Ivenix Infusion System includes a large-volume infusion pump with administration sets, infusion management tools, and analytics to inform care and advance efficiency. Ivenix centered the system around the patient and clinician and designed it to reduce infusion-related errors and drive down the total cost of ownership. After receiving U.S. Food and Drug Administration (FDA) clearance, Ivenix successfully launched the infusion system in 2021.
“Combining Ivenix’s expertise in pump technology and software with our infrastructure, portfolio, and presence in hospital settings represents an ideal opportunity. We intend to scale the launch of Ivenix’s next-generation infusion system while driving growth opportunities in the United States. With today’s announcement, Fresenius Kabi expects to create a leading, comprehensive infusion therapy offering,” said Michael Sen, President and CEO, Fresenius Kabi.
Ivenix, Inc. is a medical technology company with a vision to eliminate infusion-related patient harm. The company was founded to develop innovative solutions that transform infusion delivery. Ivenix designed an infusion system from the ground up to streamline medication delivery and bring infusion technology into the digital age. The Ivenix Infusion System includes a large-volume infusion pump supported by a robust infusion management system designed to set new standards in simplicity, intelligence, and reliability. For more information, visit ivenix.com. The Ivenix Infusion System is cleared by the FDA.