SetPoint Medical Received FDA Approval for Novel Neuroimmune Modulation Therapy for Rheumatoid Arthritis
On July 31, 2025, SetPoint Medical, a company focused on developing therapies for individuals with chronic autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) approved its SetPoint System. This groundbreaking device is the first neuroimmune modulation system designed to treat adults with moderate-to-severe rheumatoid arthritis (RA) who have not responded adequately to or cannot tolerate current advanced RA treatments, including biologics and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).
“The approval of the SetPoint System, the first-in-class neuroimmune modulation platform, represents a transformative milestone in the management of autoimmune diseases,” said Murthy V. Simhambhatla, Ph.D., CEO of SetPoint Medical. “We are committed to improving the health of people living with RA, and look forward to working with providers and payers to make our innovative therapy accessible to their patients. We plan to introduce the SetPoint System in targeted U.S. cities this year, followed by expansion across the country starting in early 2026.”
The SetPoint System is an implantable, integrated neurostimulation device that delivers targeted electrical stimulation to the vagus nerve once daily. This stimulation activates the body’s natural anti-inflammatory and immune-regulating pathways. As a novel therapeutic approach, it offers the potential to significantly improve RA management without the immune-suppressing risks associated with conventional treatments.
The device received FDA approval based on the RESET-RA study a randomized, double-blind, sham-controlled trial involving 242 patients. The study confirmed the safety and efficacy of the SetPoint System in individuals with moderately to severely active RA who had shown inadequate response or intolerance to one or more biologic or targeted synthetic DMARDs.
“This is a landmark study in the treatment and care of rheumatoid arthritis,” said John Tesser, MD, FACP, FACR, MACR, a leading rheumatologist and national rheumatology principal investigator of the RESET-RA study. “The study met its primary efficacy endpoint of ACR20 at three months, with improvements observed in ACR response rates and disease activity metrics through 12 months of follow-up. 75% of patients in the study were free of biologic or targeted synthetic DMARDs at 12 months.”
The device placement and stimulation therapy were well-tolerated, with a low incidence of related serious adverse events (1.7%), and no reported cases of malignancies, major cardiac events, or serious infections associated with SetPoint Therapy.
“The approval of the SetPoint System highlights the potential of neuroimmune modulation as a novel approach for autoimmune disease, by harnessing the body’s neural pathways to combat inflammation,” said Mark Richardson, MD, PhD, Director of Functional Neurosurgery at Massachusetts General Hospital and Professor of Neurosciences at Harvard Medical School, and national surgical principal investigator in the RESET-RA study. “After implantation during a minimally invasive outpatient procedure, the SetPoint device is programmed to automatically administer therapy on a predetermined schedule for up to 10 years, simplifying care for people living with RA.”
The SetPoint System has been granted breakthrough device designation by the FDA, a program aimed at supporting technologies that may provide more effective treatment or diagnosis for serious conditions. Additionally, the company plans to explore the use of its platform for other autoimmune disorders, including multiple sclerosis and Crohn’s disease.
As per DelveInsight’s “Neuromodulation Devices Market Report”, the neuromodulation devices market was valued at USD 5.71 billion in 2023, growing at a CAGR of 8.95% during the forecast period from 2024 to 2030 to reach USD 9.56 billion by 2030. The demand for neuromodulation devices is primarily driven by the growing prevalence of neurological disorders and the increasing number of patients suffering from chronic pain. Additionally, increasing research and development activities, along with collaborations among key players, are significantly contributing to market growth. The rising aging population further compounds this demand, as older adults are more susceptible to neurological conditions and chronic pain. These factors collectively position the neuromodulation devices market for positive growth during the forecast period from 2024 to 2030.
Body Vision Medical Received Pre-Market Approval for LungVision® in Singapore, Advancing AI-Powered Imaging for Early Lung Cancer Diagnosis
On August 5, 2025, Body Vision Medical, a leading provider of AI-driven intraoperative imaging solutions, has announced that its LungVision advanced imaging platform had received Pre-Market Approval from Singapore’s Health Sciences Authority (HSA). This regulatory clearance paves the way for the full commercial launch of LungVision in Singapore and marks a major step forward in the company’s mission to enhance the early and accurate detection of lung cancer on a global scale.
“Receiving HSA’s Pre-Market Approval is an important milestone for physicians and patients in Singapore,” said Benny Krauz, Vice President of Regulatory and Quality at Body Vision Medical. “Physicians will now be able to improve the success of their diagnostic bronchoscopy procedures with real-time three-dimensional imaging, which can lead to a meaningful stage shift in lung cancer diagnostics.”
“Bringing LungVision to Singapore represents an important step forward in enhancing diagnostic accuracy for pulmonary care,” said Daniel Soh, Managing Director for Scanmed Technology. “This platform aligns with our mission to offer high-quality, innovative solutions that improve patient care. LungVision’s ability to enhance early detection and biopsy accuracy is an important advancement for pulmonary care in the region.”
LungVision converts any conventional 2D fluoroscopic imaging system into an AI-driven 3D imaging platform, providing physicians with real-time navigation and improved visualization for more accurate bronchoscopic biopsies. This technology enables earlier and more precise diagnosis of pulmonary nodules, enhancing patient outcomes while maintaining low procedural costs.
As per DelveInsight’s “Cancer Diagnostics Market Report”, the global cancer diagnostics market was valued at USD 125.13 billion in 2023, growing at a CAGR of 9.43% during the forecast period from 2024 to 2030, to reach USD 214.88 billion by 2030. The increase in demand for cancer Diagnostics products and services is predominantly attributed to the spike in cancer cases reported worldwide. In addition, growing manufacturers’ focus on developing advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and rising government initiatives to raise awareness regarding early detection and management of cancer among patients, and others, are anticipated to drive the global cancer diagnostics market during the forthcoming years.
BioLab Holdings, Inc. Launched its Largest Clinical Trial to Date Evaluating Human Placental Membrane Products
On July 31, 2025, BioLab Holdings, Inc., a Phoenix-based medical manufacturer focused on regenerative wound care, launched its most extensive clinical trial to date. This multicenter, prospective, randomized controlled study aims to assess the effectiveness of four human placental membrane (HPM) products combined with standard of care (SOC), compared to SOC alone, in treating nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs).
Officially titled “A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers (BIOCAMP),” the trial will recruit 650 participants across up to 30 clinical sites nationwide.
“This study represents a major milestone in our commitment to advancing wound care through rigorous clinical research,” said Dr. Marshall Medley, chief medical officer at BioLab. “By evaluating our full suite of amnion-based products in a real-world setting, we aim to provide clinicians with robust data to guide treatment decisions for patients with chronic wounds.”
Participants will be randomly assigned to receive either standard of care (SOC) alone or SOC in combination with one of four BioLab products: Tri-Membrane Wrap™ (HPM-1), Membrane Wrap™ (HPM-2), Membrane Wrap-Lite™ (HPM-3), or Membrane Wrap-Hydro™ (HPM-4). Treatments will be administered weekly for up to 12 weeks or until full wound closure is achieved and verified two weeks thereafter. Optional weekly visits will be available in both groups for dressing changes. The study aimed to reflect real-world clinical outcomes and contribute to the expanding evidence base supporting placental-derived allografts in the treatment of chronic wounds.
According to DelveInsight’s “Wound Debridement Devices Market Report”, the wound debridement devices market was valued at USD 4,993.72 million in 2024, growing at a CAGR of 5.53% during the forecast period from 2025 to 2032 to reach USD 7,660.46 million by 2032. The growing prevalence of chronic and non-healing wounds, such as diabetic foot ulcers, pressure sores, and venous leg ulcers, is significantly boosting the demand for wound debridement devices. These conditions require regular and effective wound management to prevent infections and promote healing. Additionally, the rising number of traumatic injuries from accidents and surgeries has led to an increased need for timely wound cleaning and tissue removal. Additionally, increasing R&D activities and product launches by key players are factors that are expected to drive the wound debridement devices market significantly during the forecast period from 2025 to 2032.
Concept Medical Announced First Patient Enrollment in MAGICAL-SV IDE Trial, Expanding its Coronary Clinical Program Across the U.S. and Europe
On August 1, 2025, Concept Medical Inc., a global leader in drug-delivery technologies, has announced the enrollment of the first patient in the MAGICAL-SV trial (MAGIcTouch™ Sirolimus-Coated Balloon for the Treatment of Coronary Artery Lesions in Small Vessels). This U.S. Investigational Device Exemption (IDE) study is designed to evaluate the safety and efficacy of the company’s MagicTouch™ sirolimus-coated balloon (SCB) in treating small coronary vessels. This milestone represents a significant advancement in Concept Medical’s goal to transform coronary artery disease (CAD) treatment and marks the expansion of its clinical program into both the United States and Europe.
The inaugural patient was enrolled at Mount Sinai Hospital in New York by Dr. Samin Sharma, Director of Interventional Cardiology, an important step forward in enhancing treatment options for patients with small-vessel coronary artery disease. “Today marks a great feat for us and for the MAGICAL-SV trial,” said Dr. Samin Sharma. “My team at Mount Sinai is privileged to be the first to begin this study. This is a proud moment for all of us, especially knowing what the trial signifies and aims to achieve by evaluating MagicTouchas a potential alternative for treating small vessels in the U.S.”
The first U.S. enrollment marked a key milestone following the FDA’s Investigational Device Exemption (IDE) approval of Concept Medical’s MagicTouch sirolimus-coated balloon (SCB), strengthening the company’s expanding coronary clinical program. Concept Medical is now simultaneously enrolling patients in three IDE trials across the U.S., covering both coronary and peripheral interventions, highlighting its ongoing commitment to delivering cutting-edge therapies to patients globally.
MAGICAL-SV is a prospective, multicenter, single-blind randomized clinical trial (2:1 randomization) designed to compare Concept Medical’s MagicTouch SCB with drug-eluting stents (specifically Everolimus-eluting stents [EES] or Zotarolimus-eluting stents [ZES]) for the treatment of small coronary artery lesions. Randomization is stratified by site and the presence of medically-managed diabetes mellitus. A total of 1,605 patients will be enrolled across the U.S. and Europe to assess the primary endpoint of target lesion failure (TLF) at 12 months.
The trial was led by a distinguished international team of cardiologists. Dr. Martin B. Leon (USA) serves as Study Chair, with Dr. Azeem Latib (USA), Dr. Ajay Kirtane (USA), and Prof. Antonio Colombo (Europe) as principal investigators (PIs).
Dr. Azeem Latib, a U.S. PI for MAGICAL-SV, noted, “The first U.S. patient enrollment in the MAGICAL-SV study marks an exciting step forward in building robust evidence for sirolimus-coated balloon technology in the treatment of small-vessel coronary disease. As we explore metal-free PCI strategies, this study brings renewed hope for safer, more effective options for our patients.” Prof. Antonio Colombo, who leads the European arm of the study, added, “Starting small and going big! MAGICAL-SV represents an important step in building evidence for sirolimus-coated balloons.”
According to DelveInsight’s “Drug Eluting Balloons Market Report”, the drug-eluting balloon market is estimated to grow at a CAGR of 8.31% during the forecast period from 2024 to 2030. The demand for drug-eluting balloons is primarily being boosted by the increasing prevalence of numerous heart diseases, including peripheral and coronary artery diseases. Furthermore, the increasing preference for minimally invasive procedures, the advantages of balloon catheters over drug-eluting stents, the rising elderly population base, and others will propel the demand for drug-eluting balloons in the upcoming years. In addition, growing healthcare spending, especially in emerging countries, rising product launches and approvals, and surging research and developmental activities by the key players, among others, are thereby contributing to the overall growth of the drug-eluting balloon market during the forecast period from 2024-2030.
Fresenius Medical Care’s Third-Party Clinical Research Organization Frenova Announced Strategic Collaboration Advancing Genomics-Driven, Precision Kidney Disease Care
On July 31, 2025, Fresenius Medical Care announced a new collaboration involving its third-party clinical research organization, Frenova, alongside Nephronomics, a renal precision medicine company, and GENEWIZ by Azenta Life Sciences. The partnership was set to enhance genomic analysis efforts within Frenova’s groundbreaking My Reason® genomics research program. This strategic alliance aimed to harness advanced technologies to deepen the understanding of kidney, cardiovascular, and metabolic diseases, ultimately advancing the field of precision medicine for patients around the globe.
Genomics-based or precision medicine, also referred to as personalized medicine, relies on an individual’s genetic profile to guide healthcare decisions. By analyzing a person’s genome, this approach enables more precise and effective diagnostics, treatments, and preventive care tailored to each patient’s unique biological characteristics.
“Kidney disease affects each individual differently, shaped by their unique biology and genetic makeup,” said Frank Maddux, M.D., Global Chief Medical Officer and member of the Management Board at Fresenius Medical Care AG. “These differences influence not only how the disease manifests, but also which treatments and therapies are most effective. By harnessing advanced genetic and molecular insights, we can transform kidney care—making it more personalized, precise, and responsive to each patient’s distinct needs. This collaboration paves the way for innovative diagnostics and therapies, enabling truly individualized clinical interventions and redefining what it means to be patient centric.”
Frenova’s My Reason® genomics research program is a kidney-centric data registry that integrates genomic and clinical patient data to explore the genetic foundations of kidney disease. To date, over 35,000 individuals have enrolled and contributed biospecimens, with the program aiming to reach 50,000 participants within the next two years. Through this collaboration, advanced gene sequencing and data analysis are conducted to unlock valuable genetic insights.
“This large-scale whole genome sequencing initiative marks a pivotal milestone in our journey to build the most comprehensive genotype-phenotype database for patients with cardiovascular, kidney, and metabolic diseases,” said Jan Walter, President of Frenova. “We are excited to collaborate with Nephronomics on the interrogation of the Nephronomics Atlas to unlock unprecedented insights that could transform patient care.”
“The My Reason® dataset, built through Frenova’s unparalleled reach and expertise in nephrology care, represents the world’s most robust end-stage kidney disease cohort, where many genetic signals are strongest,” said James Sietstra, Founder of Nephronomics. “This collaboration will enable us to unlock new insights that not only advance scientific understanding but also translate into genetically informed therapeutics in the cardio-kidney-metabolic field.”
“We are thrilled to partner with Frenova and Nephronomics and contribute to the My Reason® research program,” said Ginger Zhou, President, GENEWIZ. “This collaboration represents a significant step forward in our shared mission to advance precision medicine and improve outcomes for patients.”
Nephronomics holds exclusive commercial rights to the My Reason® dataset, which forms the foundation of the Nephronomics Atlas, a comprehensive repository of clinical and genomic data focused on cardio-kidney-metabolic (CKM) diseases. The company is dedicated to advancing targeted therapies and transforming CKM care by harnessing precision medicine insights. Through the use of proprietary AI and machine learning models trained on this rich dataset, Nephronomics uncovers new disease subtypes, protective genetic variants, and potential therapeutic targets.
In this collaboration, GENEWIZ will utilize its proven DNA sequencing technologies and specialized expertise to generate large-scale genomic data from biospecimens collected via Frenova’s expansive nephrology research network. Additionally, Azenta will support the initiative by offering long-term sample storage through its global biorepository infrastructure. With more than 25 years of experience in DNA sequencing and multiomics, Azenta brings end-to-end capabilities to support complex research programs.
According to DelveInsight’s “Artificial Kidney Market Report,” the artificial kidney market was valued at USD 2.33 billion in 2024, growing at a CAGR of 12.80% during the forecast period from 2025 to 2032 to reach USD 6.09 billion by 2032. The demand for artificial kidneys is being significantly driven by the rising prevalence of kidney failure and end-stage renal disease (ESRD), coupled with an increasing incidence of risk factors such as diabetes, hypertension, and aging. These health concerns are contributing to the growing need for more advanced renal care solutions. Additionally, the rising demand for home-based dialysis treatments and continuous technological advancements and product launches in artificial kidney development are playing a key role in propelling market growth. Together, these factors are expected to positively influence the artificial kidney market throughout the forecast period from 2024 to 2032.
Demetra Acquired OrthoFundamentals, LLC and Launched a New Global Spine Division
On July 31, 2025, Demetra, a pioneering and independent global medical company specializing in bone cements, spacers, and biomaterials for orthopedic applications and PJI infection control, announced the full acquisition of OrthoFundamentals, LLC, a US-based innovator known for its advanced implants and sterile-packed, single-use instrument kits for SI Joint Fusion procedures. Alongside this acquisition, Demetra has launched Demetra Spine, a new global business unit dedicated to advancing spinal surgery with progressive, value-driven solutions.
This acquisition builds on two recent strategic initiatives that further strengthen Demetra’s clinical and technological capabilities in spine surgery: the majority acquisition of GetSet Surgical, a Swiss-based leader in sterile-packed, single-use kits for spine procedures, and the acquisition of key assets from Bespoke Technologies, including state-of-the-art, sterile-packed 3D-printed titanium implants designed for ACDF procedures.
For over four decades, Demetra has been a trusted partner to healthcare professionals worldwide, improving the lives of nearly three million people through innovative solutions in infection control, prosthesis fixation, and orthobiologics. Its reputation is bolstered by the success of technologies from Tecres, OSARTIS, and OsteoRemedies.
Now, building on this strong legacy, Demetra is poised to expand its influence into spinal surgery. Through these strategic acquisitions, Demetra Spine is equipped with a solid engineering, scientific, and technological foundation, positioning it to address current market demands and meet emerging challenges in the spine care landscape.
Matthew Palmer, Founder and CEO of OrthoFundamentals, stated: “There was a natural synergy and shared vision between OrthoFundamentals and Demetra to differentiate in the market by addressing the primary pain points experienced by providers of spine surgical solutions, particularly in the outpatient ASC settings. We are excited to join the Demetra Spine team and accelerate this vision to lead by being fundamentally different with single-use solutions that are Always Sharp, Always Sterile and Always Ready.”
The Demetra Spine Unit was established with a clear and ambitious mission: to alleviate pain and revitalize lives. This division is dedicated to revolutionizing spinal surgery through value-driven solutions that are minimally invasive, reduce the risk of infection, and promote environmental sustainability. It marks a significant step in Demetra’s broader strategy to lead in infection prevention and enhance clinical outcomes across orthopedics, neurosurgery, and interventional pain management.
Given the United States’ status as one of the most dynamic, technologically advanced, and high-potential healthcare markets, the launch of a US-based division reinforces Demetra’s dedication to expanding its presence in North America and sets the stage for sustained international growth.
“This move represents a bold step in Demetra’s strategy to revolutionize spinal care through innovation, sustainability, and clinical effectiveness. Our ambition is to become the company of choice also in spinal care by developing breakthrough technologies that lower infection risk and set new standards for surgical innovation, commented Michele Perrino, CEO of Demetra. The appointment of Ted Bird to lead the Demetra US Spine Division is a powerful statement of intent — his extensive global commercial leadership experience and deep expertise across orthopedics, spine, neurosurgery, and musculoskeletal care make him the ideal person to drive this next chapter of growth”.
The Spine division represents a transformative approach to spinal surgery, with every element from implants to instruments engineered to minimize complications, simplify procedures, and significantly improve patients’ quality of life. With this initiative, Demetra strengthens its long-term vision of becoming a global leader in advancing surgical outcomes through a focus on prevention, innovation, and sustainability.
According to DelveInsight’s “Spinal Fusion Devices Market Report”, the spinal fusion devices market was valued at USD 7,139.71 million in 2024, growing at a CAGR of 5.31% during the forecast period from 2025 to 2032 to reach USD 10,762.88 million by 2032. The spinal fusion devices market is experiencing steady growth is driven by the rising instances of spinal disorders along with the growing global prevalence of chronic pain. Additionally, conditions such as degenerative disc disease, spondylolisthesis, and spinal stenosis are becoming increasingly common, particularly among the aging population. The surge in road traffic accidents further highlights the urgent need for effective spinal fusion solutions to restore mobility and reduce long-term disability. Additionally, the increase in product development activities among the key market players is further escalating the overall market of spinal fusion devices. Collectively, these factors are anticipated to fuel the expansion of the spinal fusion devices market over the forecast period from 2025 to 2032.
