Notizia - Recent Pharma, Healthcare and Biotech Happenings
Jan 08, 2026
Table of Contents
On January 06, 2026, W. L. Gore & Associates’ medical business (Gore) announced that it had received FDA approval for the GORE® VIABAHN® FORTEGRA Venous Stent, formerly known as the GORE® VIAFORT Vascular Stent, marking it as the first device approved for the treatment of deep venous disease in the inferior vena cava (IVC), iliac, and iliofemoral veins.
The FORTEGRA Venous Stent, which became the latest addition to the VIABAHN® Device family, was specifically designed to treat patients with deep venous disease. The device featured an open-structure, self-expanding wire-wound nitinol frame combined with an expanded polytetrafluoroethylene (ePTFE) polymer lattice, engineered to deliver conformability, strength, and resistance to fracture.
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This innovative technology was developed to provide an optimal balance by enabling the stent to conform to natural venous anatomy while maintaining compression resistance along its entire length. With its broad range of available sizes, the FORTEGRA Venous Stent was suitable for a wide variety of patient anatomies, supporting its use across diverse clinical scenarios.
“The FORTEGRA Venous Stent represents a significant advancement in the treatment of patients with the most difficult-to-treat venous obstructive pathology; occlusion of the inferior vena cava, iliac veins and inflow femoral veins.
Patients will benefit from a device that is designed specifically for this disease and its unique anatomic and physiologic challenges, including preservation of optimal flow dynamics through iliocaval confluence and side branch preservation,” says Kush Desai, MD, and National Primary Investigator.
As per DelveInsight’s “Peripheral Vascular Devices Market Report,” the global peripheral vascular devices market size is expected to increase from USD 9,853.30 million in 2024 to USD 15,544.32 million by 2032, growing at a CAGR of 5.92% during the forecast period from 2025 to 2032. The market for peripheral vascular devices is primarily driven by the growing incidence of Peripheral Artery Disease (PAD) and vascular disorders, their associated risk factors, the increasing preference for minimally invasive procedures, technological advancements in product design, and an increase in product development activities among key market players.
On January 06, 2026, Stereotaxis, a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, announced that it had received U.S. Food and Drug Administration (FDA) approval for the MAGiC™ Magnetic Interventional Ablation Catheter.
“FDA approval of MAGiC is a significant milestone for Stereotaxis and the community of physicians pioneering robotics in electrophysiology. It ensures the benefits of Robotic Magnetic Navigation can support patients with complex and critical heart rhythm disorders, represents a major advance in robotic cardiac ablation technology, and provides a foundation for continued technological and clinical progress,” said David Fischel, Stereotaxis Chairman and CEO. “We want to thank and recognize the team members, partners, clinicians and reviewers who made this milestone possible. We look forward to seeing MAGiC serve as a key pillar in our effort to continue making robotics broadly impactful and beneficial in electrophysiology.”
The MAGiC catheter, developed by Stereotaxis, was a robotically navigated magnetic ablation catheter intended for cardiac ablation procedures to treat heart rhythm disorders. The device was designed to broaden access to minimally invasive cardiac ablation therapy, particularly for complex and underserved patient populations. It was guided by highly precise, computer-controlled magnetic fields, enabling levels of catheter maneuverability, precision, and stability that were often difficult to achieve with conventional manual catheters.
“Robotic Magnetic Navigation has played a central role in the treatment of complex arrhythmias, and FDA approval of MAGiC is a critical milestone in the advancement of the technology and ensuring its continued positive impact on the care of challenging electrophysiology patients,” said Dr. J. Peter Weiss, Cardiac Electrophysiologist and Associate Professor of Medicine at Banner University of Arizona Medical Center.
“The MAGiC catheter is an important innovation in the robotic treatment of arrythmias, and will support our efforts to offer safe and effective therapy to otherwise underserved patients,” said Dr. J. David Burkhardt, Cardiac Electrophysiologist, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. “We look forward to using MAGiC, and its unique advantages, to continue pioneering the leading edge of electrophysiology.”
The MAGiC Magnetic Interventional Ablation Catheter was indicated for cardiac electrophysiological mapping, delivery of diagnostic pacing stimuli, and the creation of endocardial lesions to treat supraventricular tachycardia, including macroreentrant atrial tachycardia, focal atrial tachycardia, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia in patients with congenital heart disease. It was specifically intended for patients in whom conventional manual catheter navigation was limited due to anatomical abnormalities and/or prior surgical interventions.
As per DelveInsight’s “Ablation Devices Market Report,” the global ablation devices market size is expected to increase from USD 8,090.31 million in 2024 to USD 15,347.69 million by 2032, growing at a CAGR of 8.38% during the forecast period from 2025 to 2032. The market of ablation device solutions is being primarily driven by the rising prevalence of chronic diseases such as cancer and cardiovascular diseases, and increasing technological advancements globally.
On January 06, 2026, StimLabs®, a leading regenerative medicine company, announced the launch of Allacor P, the first medical device derived from human umbilical cord extracellular matrix (ECM). Allacor P received an A Code in 2025, which enabled StimLabs to commercialize the product across expanded sites of service.
Allacor P was indicated for the management of a broad range of acute and chronic wounds. The device retained key structural ECM components and was rich in hyaluronic acid and collagen I. Its unique particulate format enabled versatile application and allowed the product to conform to irregular and complex wound geometries.
Allacor P was cleared by the U.S. Food and Drug Administration (FDA) in February 2024, alongside the company’s umbilical cord-derived hospital solution, Corplex P®. Following FDA clearance, StimLabs worked to generate supporting scientific evidence and collect real-world clinical feedback to guide appropriate product use as the company expanded into additional sites of care.
Commenting on the device, leading wound care clinician Dr. R. Daniel Davis stated, “the dehydrated human umbilical cord particulate device has the potential to impact so many patients in the same way it did for a recent complex case of mine. The dramatic improvement after just one application brought hope to my patient during a challenging time. I’m an advocate for this device; it’s something providers need to try.”
StimLabs expanded access to Allacor P into additional care settings, aiming to provide a greater number of patients and healthcare professionals with advanced solutions to support diverse wound care needs.
As per DelveInsight’s “Wound Closure Devices Market Report,” the global wound closure devices market is expected to increase from USD 15,831.38 million in 2024 to USD 28,128.89 million by 2032, growing at a CAGR of 7.52% during the forecast period from 2025 to 2032. The market for wound closure devices is primarily driven by the rising prevalence of chronic and acute wounds, the growing number of surgical procedures worldwide, and the increasing number of product launches and regulatory approvals by key market players.
On January 05, 2026, W. L. Gore & Associates, Inc. (Gore), a global materials science company focused on transforming industries and improving lives, announced that it had entered into a definitive agreement to acquire Conformal Medical, Inc., an innovative medical device company developing the investigational CLAAS® AcuFORM™ System, a next-generation left atrial appendage occlusion (LAAO) technology. The transaction was expected to close in early 2026, subject to regulatory approvals.
“The investigational CLAAS AcuFORM System represents the kind of transformative, science-driven innovation that reflects our long-term commitment to improving patient care,” said Bret Snyder, board chair and CEO of W. L. Gore & Associates. “It is an ideal fit with our endovascular portfolio and a strong complement to our existing cardiac products. As a privately held company founded on scientific innovation, Gore continues to thoughtfully pursue opportunities and partnerships that expand our ability to improve lives through the work of all our businesses, including expanding our ability to serve clinicians and improve patient outcomes.”
The investigational Conformal CLAAS AcuFORM System featured a nitinol endoskeleton combined with a proprietary foam matrix implant, engineered to conform to a broader range of left atrial appendage (LAA) anatomies while requiring fewer device sizes. Designed in two sizes, the system had the potential to enable same-day LAAO procedures, supporting a shift away from general anesthesia and overnight hospital stays. At the time of the announcement, the CLAAS AcuFORM System was undergoing clinical testing and was not available for commercial use.
LAAO was described as a one-time procedure for patients with non-valvular atrial fibrillation (AFib), intended to reduce the risk of stroke-causing blood clots forming in the LAA and to eliminate the need for long-term daily oral anticoagulant therapy. AFib was projected to exceed 12 million cases in the United States by 2030, according to estimates from the American Heart Association.
The acquisition supported Gore’s strategy to expand into adjacent endovascular therapies and reflected its long-term commitment to developing and investing in breakthrough medical technologies. Over the past 50 years, Gore had introduced numerous innovations across its cardiac, vascular, and surgical solutions portfolios.
“We are pleased to join forces with a partner that reflects our belief that the investigational CLAAS AcuFORM Device can prove to be a transformative solution for stroke prevention. Our stakeholders will realize the value of this partnership as we bring this therapy through the clinical and regulatory process and eventually make it available to patients worldwide,” said James Reinstein, President and CEO of Conformal Medical. “This partnership combines Conformal’s deep expertise in LAAO with Gore’s world-class capabilities in technology development, distribution and operations. It will enable us to leverage Gore’s global presence, accelerating our mission of shaping the future of stroke prevention.”
Gore had established itself as a medical technology innovator for more than five decades, engineering devices to treat a wide range of cardiovascular and other health conditions. With over 50 million medical devices implanted worldwide, the company continued to build on its legacy of improving patient outcomes through research, education, and quality initiatives. Its focus on product performance, ease of use, and service quality helped deliver sustainable cost savings for physicians, hospitals, and insurers.
BDT & MSD Partners served as the exclusive financial advisor, and Davis Polk acted as legal counsel to W. L. Gore & Associates. Piper Sandler served as exclusive financial advisor, and Gunderson Dettmer acted as legal counsel to Conformal Medical.
According to DelveInsight’s “Endovascular Aneurysm Repair Devices Market Report”, the endovascular aneurysm repair devices market was valued at USD 2,937.61 million in 2024, growing at a CAGR of 5.85% during the forecast period from 2025 to 2032, to reach USD 4,613.26 million by 2032. The rising incidence of abdominal and thoracic aortic aneurysms (AAA and TAA) is significantly driving the Endovascular Aneurysm Repair (EVAR) market. As the aging population grows, demand for effective, minimally invasive treatments like EVAR increases, given its benefits of reduced hospitalization, lower complication rates, and quicker recovery compared to traditional surgery. Additionally, continuous advancements in EVAR device technology, such as more flexible stent grafts and improved imaging for precise placement, are expanding its applicability to a broader range of patients, further boosting market growth. Together, these factors are expected to increase the demand for endovascular aneurysm repair devices across the globe during the forecast period from 2025 to 2032.
On January 07, 2026, CornerLoc™ announced the publication of 6-month interim results from the SPARTAN Study, a prospective, multicenter clinical trial designed to evaluate patient-reported pain and functional outcomes following lateral-oblique sacroiliac (SI) joint fusion using the TransLoc 3D™ System. The interim findings were published in the Pain Physician Journal (December 2025; Volume 28, Issue S7). The analysis showed clinically meaningful improvements in pain and function at six months post-procedure, with no device- or procedure-related adverse events reported during the interim follow-up period.
At the time of the interim data cutoff, 114 patients had undergone the procedure, and 72 patients had completed their six-month follow-up visit. Outcomes were evaluated using validated patient-reported outcome measures collected at baseline and through six months post-procedure. During the interim analysis period, all patients were treated with the TransLoc 3D™ System in a dual-screw configuration, consisting of two 3D-printed titanium compression screws placed across the sacroiliac joint from the ilium to the sacrum using a lateral-oblique trajectory.
According to the published interim results, significant improvements in pain and function were observed within the first three months following the procedure, with continued and durable improvement through six months across all patient-reported outcome measures. At six months, 91.67% of patients reported improvement in both pain and function. In addition, 70.83% of patients achieved at least a 50% reduction in pain, with an average pain reduction of 59.90% at six months, as measured by the Numerical Rating Scale (NRS). Functional outcomes demonstrated an average improvement of 49.01% on the Oswestry Disability Index (ODI).
“The publication of these interim SPARTAN results represents an important step in building high-quality clinical evidence around the TransLoc 3D™ procedure and the lateral-oblique approach for SI joint fusion,” said Bob Compton, Founder and Chief Executive Officer of CornerLoc™. “The interim findings support a favorable safety profile alongside meaningful improvements in pain and function associated with the lateral-oblique approach.”
The study’s prospective, multicenter design captured outcomes across a diverse patient population and routine clinical practice, supporting its relevance for physicians considering SI joint fusion as a treatment option.
The SPARTAN Study remained ongoing, with continued follow-up planned through 12 months to further assess long-term safety and clinical outcomes.
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.
On January 05, 2026, TYBR Health, a regenerative medicine and medical device company focused on improving post-surgical soft-tissue healing, announced the first U.S. clinical use of the B3 GEL™ System. The initial procedure was performed by Dr. Hanna Tammam, a fellowship-trained hand, elbow, and shoulder surgeon based in Lubbock, Texas, and marked an important milestone in translating advanced biomaterial science into routine clinical practice.
The B3 GEL™ System was designed to improve post-operative tendon mobility through an intuitive and precise proprietary delivery mechanism, enabling surgeons to achieve improved functional outcomes while integrating seamlessly into existing surgical workflows.
B3 GEL™ was a collagen-based tissue protector derived from extracellular matrix (ECM). Unlike traditional physical barrier products that could be challenging to deploy in confined anatomical spaces, the B3 GEL™ System was flowable, conformed to tissue surfaces, and maintained biomechanical separation during the critical healing period, after which it was naturally resorbed. Recently published research on ECM-based hydrogels suggested these materials may positively interact with the early healing environment, supporting the body’s natural repair processes. TYBR Health continued to evaluate the clinical performance of the B3 GEL™ System through post-market surveillance and real-world clinical use.
“In a complex second-stage flexor tendon reconstruction where balancing tissue protection with early rehabilitation is critical I applied B3 GEL™ directly over the repair,” said Dr. Hanna Tammam. “The gel set within minutes, maintained excellent visualization, and allowed smooth tendon gliding without restricting motion. I subsequently used it in two additional flexor tendon repair cases, and across these early cases I observed consistently favorable early range of motion, minimal stiffness, and no complications—findings that are very encouraging in this patient population.”
“The first cases in the United States with the B3 GEL™ System represent a pivotal milestone for TYBR Health and for patients undergoing musculoskeletal surgeries”, said Chris Wright, Chief Commercial Officer of TYBR Health. “These initial procedures mark the transition from regulatory clearance to real-world clinical application, allowing surgeons to directly address post-surgical tissue tethering a complication that too often limits patient mobility and extends recovery times. By protecting healing tissues during the critical early phase, B3 GEL™ helps bridge the gap between surgical repair and functional success, enabling patients to regain movement faster and more completely. We’re excited to see these early outcomes that support our mission of improving quality of life for millions affected by tendon, ligament, and muscle procedures.”
TYBR Health continued to expand the clinical adoption of the B3 GEL™ System in collaboration with surgeons and conducted post-market surveillance studies to collect real-world evidence on the system’s performance and patient outcomes across a variety of surgical settings.
According to DelveInsight’s “Surgical Sealant and Adhesives Market Report”, the global surgical sealant and adhesives market was valued at USD 2.18 billion in 2023, growing at a CAGR of 7.58% during the forecast period from 2024 to 2030 to reach USD 3.39 billion by 2030. The surgical sealant and adhesives market is slated to grow owing to the rising prevalence of chronic health conditions, including cardiovascular, kidney, and neurological disorders. The rise in road accidents requiring urgent surgeries is another factor in the growth of the surgical sealant and adhesives market. The continuous rise in cosmetic surgeries and growing focus on improving the safety, affordability, and usability of surgical sealants and adhesives are further expected to result in appreciable revenue growth in the Surgical Sealant and Adhesives Market during the forecast period 2024 to 2030.
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Jan 08, 2026
Table of Contents
On January 06, 2026, W. L. Gore & Associates’ medical business (Gore) announced that it had received FDA approval for the GORE® VIABAHN® FORTEGRA Venous Stent, formerly known as the GORE® VIAFORT Vascular Stent, marking it as the first device approved for the treatment of deep venous disease in the inferior vena cava (IVC), iliac, and iliofemoral veins.
The FORTEGRA Venous Stent, which became the latest addition to the VIABAHN® Device family, was specifically designed to treat patients with deep venous disease. The device featured an open-structure, self-expanding wire-wound nitinol frame combined with an expanded polytetrafluoroethylene (ePTFE) polymer lattice, engineered to deliver conformability, strength, and resistance to fracture.
This innovative technology was developed to provide an optimal balance by enabling the stent to conform to natural venous anatomy while maintaining compression resistance along its entire length. With its broad range of available sizes, the FORTEGRA Venous Stent was suitable for a wide variety of patient anatomies, supporting its use across diverse clinical scenarios.
“The FORTEGRA Venous Stent represents a significant advancement in the treatment of patients with the most difficult-to-treat venous obstructive pathology; occlusion of the inferior vena cava, iliac veins and inflow femoral veins.
Patients will benefit from a device that is designed specifically for this disease and its unique anatomic and physiologic challenges, including preservation of optimal flow dynamics through iliocaval confluence and side branch preservation,” says Kush Desai, MD, and National Primary Investigator.
As per DelveInsight’s “Peripheral Vascular Devices Market Report,” the global peripheral vascular devices market size is expected to increase from USD 9,853.30 million in 2024 to USD 15,544.32 million by 2032, growing at a CAGR of 5.92% during the forecast period from 2025 to 2032. The market for peripheral vascular devices is primarily driven by the growing incidence of Peripheral Artery Disease (PAD) and vascular disorders, their associated risk factors, the increasing preference for minimally invasive procedures, technological advancements in product design, and an increase in product development activities among key market players.
On January 06, 2026, Stereotaxis, a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, announced that it had received U.S. Food and Drug Administration (FDA) approval for the MAGiC™ Magnetic Interventional Ablation Catheter.
“FDA approval of MAGiC is a significant milestone for Stereotaxis and the community of physicians pioneering robotics in electrophysiology. It ensures the benefits of Robotic Magnetic Navigation can support patients with complex and critical heart rhythm disorders, represents a major advance in robotic cardiac ablation technology, and provides a foundation for continued technological and clinical progress,” said David Fischel, Stereotaxis Chairman and CEO. “We want to thank and recognize the team members, partners, clinicians and reviewers who made this milestone possible. We look forward to seeing MAGiC serve as a key pillar in our effort to continue making robotics broadly impactful and beneficial in electrophysiology.”
The MAGiC catheter, developed by Stereotaxis, was a robotically navigated magnetic ablation catheter intended for cardiac ablation procedures to treat heart rhythm disorders. The device was designed to broaden access to minimally invasive cardiac ablation therapy, particularly for complex and underserved patient populations. It was guided by highly precise, computer-controlled magnetic fields, enabling levels of catheter maneuverability, precision, and stability that were often difficult to achieve with conventional manual catheters.
“Robotic Magnetic Navigation has played a central role in the treatment of complex arrhythmias, and FDA approval of MAGiC is a critical milestone in the advancement of the technology and ensuring its continued positive impact on the care of challenging electrophysiology patients,” said Dr. J. Peter Weiss, Cardiac Electrophysiologist and Associate Professor of Medicine at Banner University of Arizona Medical Center.
“The MAGiC catheter is an important innovation in the robotic treatment of arrythmias, and will support our efforts to offer safe and effective therapy to otherwise underserved patients,” said Dr. J. David Burkhardt, Cardiac Electrophysiologist, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. “We look forward to using MAGiC, and its unique advantages, to continue pioneering the leading edge of electrophysiology.”
The MAGiC Magnetic Interventional Ablation Catheter was indicated for cardiac electrophysiological mapping, delivery of diagnostic pacing stimuli, and the creation of endocardial lesions to treat supraventricular tachycardia, including macroreentrant atrial tachycardia, focal atrial tachycardia, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia in patients with congenital heart disease. It was specifically intended for patients in whom conventional manual catheter navigation was limited due to anatomical abnormalities and/or prior surgical interventions.
As per DelveInsight’s “Ablation Devices Market Report,” the global ablation devices market size is expected to increase from USD 8,090.31 million in 2024 to USD 15,347.69 million by 2032, growing at a CAGR of 8.38% during the forecast period from 2025 to 2032. The market of ablation device solutions is being primarily driven by the rising prevalence of chronic diseases such as cancer and cardiovascular diseases, and increasing technological advancements globally.
On January 06, 2026, StimLabs®, a leading regenerative medicine company, announced the launch of Allacor P, the first medical device derived from human umbilical cord extracellular matrix (ECM). Allacor P received an A Code in 2025, which enabled StimLabs to commercialize the product across expanded sites of service.
Allacor P was indicated for the management of a broad range of acute and chronic wounds. The device retained key structural ECM components and was rich in hyaluronic acid and collagen I. Its unique particulate format enabled versatile application and allowed the product to conform to irregular and complex wound geometries.
Allacor P was cleared by the U.S. Food and Drug Administration (FDA) in February 2024, alongside the company’s umbilical cord-derived hospital solution, Corplex P®. Following FDA clearance, StimLabs worked to generate supporting scientific evidence and collect real-world clinical feedback to guide appropriate product use as the company expanded into additional sites of care.
Commenting on the device, leading wound care clinician Dr. R. Daniel Davis stated, “the dehydrated human umbilical cord particulate device has the potential to impact so many patients in the same way it did for a recent complex case of mine. The dramatic improvement after just one application brought hope to my patient during a challenging time. I’m an advocate for this device; it’s something providers need to try.”
StimLabs expanded access to Allacor P into additional care settings, aiming to provide a greater number of patients and healthcare professionals with advanced solutions to support diverse wound care needs.
As per DelveInsight’s “Wound Closure Devices Market Report,” the global wound closure devices market is expected to increase from USD 15,831.38 million in 2024 to USD 28,128.89 million by 2032, growing at a CAGR of 7.52% during the forecast period from 2025 to 2032. The market for wound closure devices is primarily driven by the rising prevalence of chronic and acute wounds, the growing number of surgical procedures worldwide, and the increasing number of product launches and regulatory approvals by key market players.
On January 05, 2026, W. L. Gore & Associates, Inc. (Gore), a global materials science company focused on transforming industries and improving lives, announced that it had entered into a definitive agreement to acquire Conformal Medical, Inc., an innovative medical device company developing the investigational CLAAS® AcuFORM™ System, a next-generation left atrial appendage occlusion (LAAO) technology. The transaction was expected to close in early 2026, subject to regulatory approvals.
“The investigational CLAAS AcuFORM System represents the kind of transformative, science-driven innovation that reflects our long-term commitment to improving patient care,” said Bret Snyder, board chair and CEO of W. L. Gore & Associates. “It is an ideal fit with our endovascular portfolio and a strong complement to our existing cardiac products. As a privately held company founded on scientific innovation, Gore continues to thoughtfully pursue opportunities and partnerships that expand our ability to improve lives through the work of all our businesses, including expanding our ability to serve clinicians and improve patient outcomes.”
The investigational Conformal CLAAS AcuFORM System featured a nitinol endoskeleton combined with a proprietary foam matrix implant, engineered to conform to a broader range of left atrial appendage (LAA) anatomies while requiring fewer device sizes. Designed in two sizes, the system had the potential to enable same-day LAAO procedures, supporting a shift away from general anesthesia and overnight hospital stays. At the time of the announcement, the CLAAS AcuFORM System was undergoing clinical testing and was not available for commercial use.
LAAO was described as a one-time procedure for patients with non-valvular atrial fibrillation (AFib), intended to reduce the risk of stroke-causing blood clots forming in the LAA and to eliminate the need for long-term daily oral anticoagulant therapy. AFib was projected to exceed 12 million cases in the United States by 2030, according to estimates from the American Heart Association.
The acquisition supported Gore’s strategy to expand into adjacent endovascular therapies and reflected its long-term commitment to developing and investing in breakthrough medical technologies. Over the past 50 years, Gore had introduced numerous innovations across its cardiac, vascular, and surgical solutions portfolios.
“We are pleased to join forces with a partner that reflects our belief that the investigational CLAAS AcuFORM Device can prove to be a transformative solution for stroke prevention. Our stakeholders will realize the value of this partnership as we bring this therapy through the clinical and regulatory process and eventually make it available to patients worldwide,” said James Reinstein, President and CEO of Conformal Medical. “This partnership combines Conformal’s deep expertise in LAAO with Gore’s world-class capabilities in technology development, distribution and operations. It will enable us to leverage Gore’s global presence, accelerating our mission of shaping the future of stroke prevention.”
Gore had established itself as a medical technology innovator for more than five decades, engineering devices to treat a wide range of cardiovascular and other health conditions. With over 50 million medical devices implanted worldwide, the company continued to build on its legacy of improving patient outcomes through research, education, and quality initiatives. Its focus on product performance, ease of use, and service quality helped deliver sustainable cost savings for physicians, hospitals, and insurers.
BDT & MSD Partners served as the exclusive financial advisor, and Davis Polk acted as legal counsel to W. L. Gore & Associates. Piper Sandler served as exclusive financial advisor, and Gunderson Dettmer acted as legal counsel to Conformal Medical.
According to DelveInsight’s “Endovascular Aneurysm Repair Devices Market Report”, the endovascular aneurysm repair devices market was valued at USD 2,937.61 million in 2024, growing at a CAGR of 5.85% during the forecast period from 2025 to 2032, to reach USD 4,613.26 million by 2032. The rising incidence of abdominal and thoracic aortic aneurysms (AAA and TAA) is significantly driving the Endovascular Aneurysm Repair (EVAR) market. As the aging population grows, demand for effective, minimally invasive treatments like EVAR increases, given its benefits of reduced hospitalization, lower complication rates, and quicker recovery compared to traditional surgery. Additionally, continuous advancements in EVAR device technology, such as more flexible stent grafts and improved imaging for precise placement, are expanding its applicability to a broader range of patients, further boosting market growth. Together, these factors are expected to increase the demand for endovascular aneurysm repair devices across the globe during the forecast period from 2025 to 2032.
On January 07, 2026, CornerLoc™ announced the publication of 6-month interim results from the SPARTAN Study, a prospective, multicenter clinical trial designed to evaluate patient-reported pain and functional outcomes following lateral-oblique sacroiliac (SI) joint fusion using the TransLoc 3D™ System. The interim findings were published in the Pain Physician Journal (December 2025; Volume 28, Issue S7). The analysis showed clinically meaningful improvements in pain and function at six months post-procedure, with no device- or procedure-related adverse events reported during the interim follow-up period.
At the time of the interim data cutoff, 114 patients had undergone the procedure, and 72 patients had completed their six-month follow-up visit. Outcomes were evaluated using validated patient-reported outcome measures collected at baseline and through six months post-procedure. During the interim analysis period, all patients were treated with the TransLoc 3D™ System in a dual-screw configuration, consisting of two 3D-printed titanium compression screws placed across the sacroiliac joint from the ilium to the sacrum using a lateral-oblique trajectory.
According to the published interim results, significant improvements in pain and function were observed within the first three months following the procedure, with continued and durable improvement through six months across all patient-reported outcome measures. At six months, 91.67% of patients reported improvement in both pain and function. In addition, 70.83% of patients achieved at least a 50% reduction in pain, with an average pain reduction of 59.90% at six months, as measured by the Numerical Rating Scale (NRS). Functional outcomes demonstrated an average improvement of 49.01% on the Oswestry Disability Index (ODI).
“The publication of these interim SPARTAN results represents an important step in building high-quality clinical evidence around the TransLoc 3D™ procedure and the lateral-oblique approach for SI joint fusion,” said Bob Compton, Founder and Chief Executive Officer of CornerLoc™. “The interim findings support a favorable safety profile alongside meaningful improvements in pain and function associated with the lateral-oblique approach.”
The study’s prospective, multicenter design captured outcomes across a diverse patient population and routine clinical practice, supporting its relevance for physicians considering SI joint fusion as a treatment option.
The SPARTAN Study remained ongoing, with continued follow-up planned through 12 months to further assess long-term safety and clinical outcomes.
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.
On January 05, 2026, TYBR Health, a regenerative medicine and medical device company focused on improving post-surgical soft-tissue healing, announced the first U.S. clinical use of the B3 GEL™ System. The initial procedure was performed by Dr. Hanna Tammam, a fellowship-trained hand, elbow, and shoulder surgeon based in Lubbock, Texas, and marked an important milestone in translating advanced biomaterial science into routine clinical practice.
The B3 GEL™ System was designed to improve post-operative tendon mobility through an intuitive and precise proprietary delivery mechanism, enabling surgeons to achieve improved functional outcomes while integrating seamlessly into existing surgical workflows.
B3 GEL™ was a collagen-based tissue protector derived from extracellular matrix (ECM). Unlike traditional physical barrier products that could be challenging to deploy in confined anatomical spaces, the B3 GEL™ System was flowable, conformed to tissue surfaces, and maintained biomechanical separation during the critical healing period, after which it was naturally resorbed. Recently published research on ECM-based hydrogels suggested these materials may positively interact with the early healing environment, supporting the body’s natural repair processes. TYBR Health continued to evaluate the clinical performance of the B3 GEL™ System through post-market surveillance and real-world clinical use.
“In a complex second-stage flexor tendon reconstruction where balancing tissue protection with early rehabilitation is critical I applied B3 GEL™ directly over the repair,” said Dr. Hanna Tammam. “The gel set within minutes, maintained excellent visualization, and allowed smooth tendon gliding without restricting motion. I subsequently used it in two additional flexor tendon repair cases, and across these early cases I observed consistently favorable early range of motion, minimal stiffness, and no complications—findings that are very encouraging in this patient population.”
“The first cases in the United States with the B3 GEL™ System represent a pivotal milestone for TYBR Health and for patients undergoing musculoskeletal surgeries”, said Chris Wright, Chief Commercial Officer of TYBR Health. “These initial procedures mark the transition from regulatory clearance to real-world clinical application, allowing surgeons to directly address post-surgical tissue tethering a complication that too often limits patient mobility and extends recovery times. By protecting healing tissues during the critical early phase, B3 GEL™ helps bridge the gap between surgical repair and functional success, enabling patients to regain movement faster and more completely. We’re excited to see these early outcomes that support our mission of improving quality of life for millions affected by tendon, ligament, and muscle procedures.”
TYBR Health continued to expand the clinical adoption of the B3 GEL™ System in collaboration with surgeons and conducted post-market surveillance studies to collect real-world evidence on the system’s performance and patient outcomes across a variety of surgical settings.
According to DelveInsight’s “Surgical Sealant and Adhesives Market Report”, the global surgical sealant and adhesives market was valued at USD 2.18 billion in 2023, growing at a CAGR of 7.58% during the forecast period from 2024 to 2030 to reach USD 3.39 billion by 2030. The surgical sealant and adhesives market is slated to grow owing to the rising prevalence of chronic health conditions, including cardiovascular, kidney, and neurological disorders. The rise in road accidents requiring urgent surgeries is another factor in the growth of the surgical sealant and adhesives market. The continuous rise in cosmetic surgeries and growing focus on improving the safety, affordability, and usability of surgical sealants and adhesives are further expected to result in appreciable revenue growth in the Surgical Sealant and Adhesives Market during the forecast period 2024 to 2030.
