Mainstay Medical Published Post-Market Clinical Trial Data from Ongoing ReActiv8®-C Study 

On November 22, 2022, Mainstay Medical, a medical devices company, announced that the data from the ReActiv8®-C study, a single-centre, real-world study with a one-year clinical follow-up of selected patients, is published. 

ReActiv8 is an implantable medical device designed to treat adults suffering from chronic low back pain (CLBP) caused by multifidus muscle dysfunction. Imaging or physiological testing may reveal multifidus muscle dysfunction in adults who have failed therapy, including pain medications and physical therapy and are not candidates for spine surgery.

The study was conducted in Klinikum Itzehoe, a hospital in Germany. The study involved patients with back pain ≥6 and no prior lumbar surgery. The patients implanted with ReActiv8 demonstrated that most of the patients around 44 showed statistically significant improvements in pain (NRS), disability (ODI) and quality of life (EQ-5D-5L). 

This study also indicates that the patient’s response to ReActiv8 is consistent with both a restorative mechanism of action and the ReActiv8-B randomized clinical trial results.

“These real-world results further validate ReActiv8’s restorative mechanism of action, which treats a primary underlying cause of mechanical chronic lower back pain, multifidus dysfunction. German physicians have been some of our foremost implanters of ReActiv8, and we look forward to continuing to make the therapy more broadly available to patients in this region,” said Jason Hannon, CEO of Mainstay Medical. 

“These favourable real-world data are consistent with the ReActiv8-B study, which is extremely important for me in adopting new technologies. I am excited to continue offering restorative neurostimulation with ReActiv8 for my patients with multifidus dysfunction resulting in chronic axial low back pain,” commented Dr. Med. Ardeshir Ardeshiri, Head physician of the Spine Surgery Section of the Clinic for Trauma Surgery and Orthopedics, Klinikum Itzehoe. 

As per DelveInsight’s “Neurostimulation Devices  Market” report, the global neurostimulation devices market was valued at USD 5.82 billion in 2021 and is expected to grow at a CAGR of 11.77% to reach USD 11.34 billion by 2027. The factors driving the market for neurostimulation devices include the increasing prevalence of various chronic diseases such as epilepsy and others, escalating product demand as add-on therapy, adoption of technologically advanced products, and the increasing geriatric population across the globe, among others. As per DelveInsight’s analysis, in the device type segment, the spinal cord stimulators category is expected to hold the largest market share in the neurostimulation devices market. This can be attributed to the increased usage of spinal cord stimulators for treating neuropathic pain and spinal injuries. In addition, an upsurge in minimally invasive procedures and an increase in healthcare spending are expected to drive further market growth for spinal cord stimulators across the globe.

Sony Announces the Launch of a Cloud-based Solution for Flow Cytometry Data Analysis 

On November 17, 2022, Sony Corporation launched a flow cytometry data analysis cloud solution named SFA – Life Sciences Cloud Platform. Using the data from flow cytometers, SFA – Life Sciences Cloud Platform can identify rare cells, including cancer and stem cells, from a wide variety of cell populations. 

The SFA – Life Sciences Cloud Platform can efficiently perform a wide array of analysis protocols, ranging from conventional analysis, including gating, in which only specific cell populations are selected for analysis and quantification based on differences in scattered light and fluorescence signal intensity, to advanced analysis such as dimensionality reduction, which enables a two-dimensional view of multi-dimensional information, and clustering, which automatically classifies cell populations. 

The solution is compatible with Sony’s flagship ID7000™ spectral cell analyser that delivers streamlined multicolour cell analysis with more than 44 colours. In addition, this solution features BL-FlowSOMiv, a newly developed algorithm that speeds up FlowSOM, one of the clustering methods. Furthermore, because each algorithm is pre-installed in the cloud environment, immediate analysis is possible, and results from the data analysis can be managed and shared among users.

Moreover, the SFA – Life Sciences Cloud Platform has various features, such as machine-learning-based advanced analysis for rapid identification of cell populations and survey of multi-dimensional information, easy data management and sharing, and an advanced analysis system to support deeper insights. 

Taisuke Kawasaki, Senior General Manager, Life Science Division, Sony Corporation, said, “The SFA – Life Sciences Cloud Platform is Sony’s first cloud service for life sciences, which was developed based on the needs of research sites and the knowledge gained from providing advanced flow cytometers such as the ID7000.” He further added, “Through our solution, the data obtained from the ID7000 can be directly imported and efficiently used in both conventional analysis with a high degree of freedom and for advanced analysis, which enables researchers to gain deeper insights easily and quickly by analysing a large amount of data at high speed.”

According to DelveInsight’s  “Flow Cytometry Market”  report, the global flow cytometry market was valued at USD 4,942.02 million in 2021, growing at a CAGR of 7.52% during the forecast period from 2022 to 2027, to reach USD 7,587.63 million by 2027. The flow cytometry market is estimated to register positive revenue growth primarily due to rising research and development activities in the life sciences and healthcare sector. Moreover, the increasing prevalence of chronic and immunological ailments like HIV and cancer, among others, is likely to propel the flow cytometry market in the upcoming years. As per DelveInsight’s analysis, in the technology type segment in the flow cytometry market, cell-based flow cytometry is estimated to hold a significant share in the overall flow cytometry market during the forecast period 2022-2027. This can be ascribed to the advantages associated with it. Cell-based flow cytometry has the advantage of testing the effects of compounds against molecular targets within the context of living cells.

FDA Approved the Empatica’s Health Monitoring Platform 

On November 22, 2022, Empatica, a digital health and AI company involved in developing medical-grade wearables and algorithms for health monitoring and diagnostics, has received the U.S. Food and Drug Administration (FDA) approval for Empatica Health Monitoring Platform. 

Based on data gathered by Empatica’s medical-grade, CE-certified EmbracePlus wearable, the Empatica Health Monitoring Platform is a full-stack remote health monitoring and data-gathering solution for research and healthcare practitioners. The Platform also has clinically verified digital biomarkers, a secure cloud architecture, and Empatica’s exclusive Care software package.

The Empatica Health Monitoring Platform is intended to collect physiological data from a diverse set of patients and clinical trial participants in a continuous, seamless manner. All collected data is easily accessible via the Empatica Cloud, and the Care Portal facilitates study management and patient onboarding.

Major pharmaceutical firms utilise the Empatica Health Monitoring Platform to continuously collect and analyse physiological data for clinical trials testing the effectiveness of innovative treatments. 

The Platform from Empatica has received approval for continuous data collection to track electrodermal activity, peripheral skin temperature, movement-associated activity during sleep, and blood oxygen saturation (SpO2) during rest (EDA). 

“We are excited to team up with Empatica, their investors and partners on this journey,” commented Cris De Luca, Partner at Sanofi Ventures and newly-appointed Empatica board member. He remarked, “By gaining higher resolution into disease symptomology through novel digital measures and digital biomarkers in clinical and real-world settings, Empatica is unlocking the possibilities of early disease detection, enhanced treatment decisions, and improving quality of life for patients around the world.”

According to DelveInsight’s “Patient Monitoring Devices Market” report, the global patient monitoring devices market was valued at USD 35.21 billion in 2021, growing at a CAGR of 8.20% during the forecast period from 2022 to 2027, to reach USD 56.46 billion by 2027. The increase in demand for patient monitoring devices is predominantly attributed to the rising prevalence of chronic and lifestyle-associated disorders, increasing preferences for remote patient monitoring systems among patients and healthcare providers, and the rising number of technological advancements in patient monitoring devices, among others. As per DelveInsight’s analysis, among all the regions, North America is expected to hold the largest market share in the overall patient monitoring devices market during the forecast period. This domination is due to the increasing prevalence of chronic diseases, increasing product approval and launches, the presence of key market players, and government support in the region.

Swing Therapeutics Announced Positive Results from Studies of Stanza

On November 21, 2022, Swing Therapeutics, a digital therapeutics company involved in the development of evidence-backed treatments for autoimmune and chronic pain conditions, presented research at the American College of Rheumatology (ACR) annual meeting on positive results reported from a prospective single-arm clinical trial (REACT-FM) for Stanza, a Digital Therapeutic for Fibromyalgia Treatment. 

Stanza is a prescription smartphone-based digital therapeutic designed to help adult patients manage the psychological symptoms associated with fibromyalgia, including anxiety, depression, and sleeplessness. 

The Patient Global Impression of Change (PGIC) Scale was used to assess participants in this study. The Revised Fibromyalgia Impact Questionnaire (FIQ-R) was also collected, as well as instruments that measure pain intensity and interference, sleep interference, depression, anxiety, pain acceptance, mindfulness, and quality of life (QoL). 

After 12 weeks of using the app, outcomes were measured and compared to baseline scores for all completed participants. Participants with fibromyalgia improved in all areas measured at the end of a 12-week therapy course. After Stanza treatment, 84% of participants reported improvement in their fibromyalgia symptoms. 

Swing Therapeutics also revealed the findings of usability testing on Stanza as part of the REACT-FM trial. The participants in this study used the mHealth App Usability Questionnaire (MAUQ) at the end of the 12-week treatment to rate Stanza’s ease of use, interface, and overall satisfaction. The participants who were currently or previously using FDA-approved pharmacological treatments for fibromyalgia were asked to rate their preference for the digital therapeutic application versus medication management. 

At the end of the 12-week programme, 84% and 88% of participants, respectively, reported positive ratings in the MAUQ domains of ‘Ease of Use” and ‘Interface and Satisfaction.’

“This real-world data expands the growing body of clinical evidence supporting the use of digital therapeutics for the management of fibromyalgia, and reinforces the positive outcomes observed from a previous randomized controlled trial,” said Mike Rosenbluth, PhD, founder and CEO of Swing Therapeutics. She added, “As we gather additional compelling evidence, our mission is to make digital behavioral therapeutics like Stanza become more accessible to people with fibromyalgia. The launch of Swing Care is an exciting step toward broadening the reach of telemedicine and digital health to a wider population of patients.” 

Andrea Chadwick, M.D., a globally recognized expert on the treatment of fibromyalgia and Medical Director of Swing, commented, “People living with fibromyalgia often fall through the cracks of healthcare, and better solutions are needed to improve the quality of their lives. This clinical data demonstrate the power of digital behavioural therapeutics to make a meaningful difference. Swing Care has partnered with Swing Therapeutics to expand access through telehealth to specialized, clinically proven fibromyalgia treatment that otherwise has only been available from a limited number of providers.” He further added, “With Swing Care, patients will receive personalized treatment plans that meet their unique needs, including access to behavioural therapies like Stanza and medication management as needed.”

According to DelveInsight, the global digital therapeutics market is expected to grow in the coming years owing to the increased smartphone penetration in both developed and developing nations and the associated cost-effectiveness of digital technology for providers and patients. Moreover, the increasing prevalence of chronic diseases, increasing healthcare expenditure, and continuous research and development activities with respect to digital therapeutics, among others, are expected to drive market growth for the digital therapeutics market. 

ClariPi Joins Siemens Healthineers Digital Marketplace 

On November 22, 2022, ClariPi Inc. declared that its ClariCT.AI software would be released on Siemens Healthineers’ Digital Marketplace, facilitating a wide range of healthcare stakeholders with an open and secured environment for sharing, accessing, and analysing data. 

ClariCT.AI is an innovative CT image denoising solution that produces superior CT images by removing noise and enhancing image clarity based on deep-learning technology for a more efficient workflow. The Clarity Engine preserves a natural image texture while clearing quantum noises, thereby providing a comfortable observation with enhanced image clarity.

Also, the FDA-cleared and CE-marked ClariCT.AI offers superior CT images by removing noise and enhancing image clarity based on deep-learning technology for a more efficient workflow.

“We are pleased to announce that our ClariCT.AI solution is now available through Siemens Healthineers’ partnership. With the launch on the Digital Marketplace, we are one step closer to our vision – implementation is simplified, providing easy access to ClariPi’s AI innovations”, commented Jong Hyo Kim, CEO/CTO of ClariPi Inc.

“ClariCT.AI has gone through a rigorous integration process that gives its users the ability to produce noise-cleaned images without repeated scanning. By requiring lower radiation doses than typically needed for scanning, CT exams paired with ClariCT.AI is safer for patients’ health, particularly for paediatric and oncology patients. It also is a good complement to annual ultra-low-dose lung cancer screenings,” said Harry Park, President of ClariPi USA Inc.

According to DelveInsight, the Digital Health Market is observing remarkable market growth due to the factors such as the growing awareness and adoption of digital healthcare and the rising demand for IoT, AI, and others in the healthcare industry. Further, the increasing patient pool suffering from chronic disease and the rising burden of the global geriatric population will increase the need for remote and virtual patient care, leading to the increased demand for digital health. Additionally, the growing demand for remote patient monitoring and mobile health applications, increasing penetration of smartphones in the healthcare industries, increasing product or service launches and approvals, the presence of key players in the market, and other factors will create a requisite for digital health in the market. 

Zimmer Biomet Received FDA Clearance of Persona® OsseoTi® Keel Tibia

On November 21 2022, Zimmer Biomet Holdings, Inc., a global medical technology company, received the US Food and Drug Administration (FDA) 510(k) clearance for the Persona® OsseoTi® Keel Tibia for cementless knee replacement expanding the Persona® Knee System Portfolio of the company. 

The Persona OsseoTi Knee System is the newest addition to the clinically successful Persona Knee System. It includes a new porous version of the Persona anatomic tibia made with Zimmer Biomet’s OsseoTi Porous Metal Technology, which combines anatomical information with 3D printing to create a structure that closely resembles the structure of human cancellous, or spongey, bone. To provide stable initial fixation and biological fixation, this material is paired with a keeled design.

“With an increasing number of surgeons opting for cementless procedures for their patients, we are excited to expand our market-leading Persona Knee portfolio with the Persona OsseoTi Keel Tibia, a versatile and surgeon-centered solution for performing a cementless total knee replacement,” commented Ivan Tornos, Chief Operating Officer at Zimmer Biomet. He further added, “Adding the Persona OsseoTi Keel Tibia to our well-established and clinically proven Persona Knee System allows surgeons to better address the needs of their patients with a comprehensive single system solution for a cementless or cemented application. We’re proud to close out the year with another advancement in our portfolio, thanks to the strong execution of our team members and our commitment to fueling growth with innovation.”

According to DelveInsight’s “Knee Reconstruction/Replacement Devices Market” report, the knee reconstruction/replacement devices market was valued at USD 7.87 billion in 2021, growing at a CAGR of 4.52% during the forecast period from 2022 to 2027 to reach USD 10.27 billion by 2027. The demand for knee reconstruction devices is primarily attributed to the growing burden of the geriatric population. In addition, the increasing prevalence of various knee-associated musculoskeletal disorders, such as osteoarthritis, rheumatoid arthritis, and others, are anticipated to drive the knee reconstruction market during the forecast period from 2022 to 2027.