University of Minnesota Medical School

New Velentium Medical Facility Providing Neuromodulation Device Design & Manufacture EDEN PRAIRIE, Minn., March 21, 2025 /PRNewswire/ -- To follow up on the completion of its clinical proof-of-concept study, SynerFuse™ and its partner, Velentium Medical, today announced plans to scale the patented SynerFuse™ e-TLIF™ procedure implant device. "With the completion of our proof-of-concept study, we advanced our mission to improve patient quality of life," said Zenanko. "The SynerFuse™ proof-of-concept study demonstrated the safety and feasibility of integrating direct nerve stimulation with open lumbar or lumbosacral decompression and instrumented fusion. And now we move on to the next phase in our quest to bring our therapy to the many patients who could benefit from it." "The SynerFuse™ e-TLIF™ technique will be a new treatment approach of integrating neuromodulation with spinal decompression and fusion for the 500,000-plus patients who undergo traditional spinal fusion surgery in the United States each year," said Velentium Medical Chairman & Cofounder Dan Purvis. "We are excited about the potential of this therapy and about moving forward with SynerFuse™." "We are pleased to have been selected by SynerFuse™ as their strategic development and manufacturing partner, showcasing our industry-leading design, development, and manufacturing capabilities for both devices and leads. From our new flagship facility in Houston, Texas, our experienced team will Change Lives for a Better World as we scale production for SynerFuse™," said Velentium Medical Cofounder Tim Carroll. "Our custom-designed device was conceived by our medical team—that is, by surgeons for surgeons addressing neuropathic and mechanical pain," said Rohan Lall, M.D., SynerFuse™ chief medical officer and former investigator at MHealth Fairview. "With the SynerFuse™ DRG system (implantable pulse generator and custom leads) designed and manufactured by Velentium Medical, the SynerFuse™ e-TLIF™ procedure incorporates insights from our 15-patient proof-of-concept clinical trial that was completed with our collaborators at the University of Minnesota and South Bend Orthopaedics." "Requiring only a single incision and involving direct visual placement of the neurostimulation device will make the SynerFuse™ e-TLIF™ procedure better in terms of patient safety," said University of Minnesota Associate Professor of Neurosurgery Michael C. Park, M.D., Ph.D.*, SynerFuse™ proof-of-concept study principal investigator. "Our data indicate that we should maintain the therapy we used in the proof-of-concept trial." "The SynerFuse™ e-TLIF™ therapy represents a novel integration of next-generation stimulation and monitoring with spinal decompression and instrumented fusion. Our initial experience has found this to aid in post-operative treatment of back and leg pain," said Deepak Reddy, M.D., South Bend Orthopaedics and SynerFuse™ proof-of-concept study principal investigator. "The therapy unlocks an additional safe modality to treat surgical, neuropathic and mechanical back and leg pain whilst reducing the patients' exposure to opioids." More information about SynerFuse™ is available at . More information about Velentium Medical is available at . About Chronic Lower Back Pain (cLBP) cLBP is defined as lower back pain that continues for 12 weeks or longer, even after an initial injury or underlying cause of acute lower back pain has been treated.1 With more than 500,000 procedures performed annually, spinal fusion remains a common treatment for spinal instability, albeit with a high incidence of residual neuropathic pain.2 Up to 40% of patients who undergo spinal fusion end up with Failed Back Surgery Syndrome (FBSS), a condition resulting in significant, lingering neuropathic pain, costing the U.S. healthcare system $20B per year and significantly affecting the quality of life of patients.3 About SynerFuse™ SynerFuse™ is a Delaware corporation based in Minnesota—the heart of Medical Alley and the cradle of neuromodulation and medical device innovation. SynerFuse™ believes that individuals with cLBP/FBSS and their providers deserve an alternative option than spinal fusion alone. Even when spinal fusion is successful, it can often result in residual chronic neuropathic pain and use of addictive opioids. The company is working to create a non-narcotic pain management for chronic low back pain with a patented therapy that integrates spinal fusion hardware and an active neuromodulation system. More information about the company is available at . This communication contains information about an investigational product. This product is limited by Federal (U.S.) law to investigational use only. SynerFuse™ makes no claims regarding the safety or effectiveness of the unapproved investigational product. The intent of providing this information is to convey research and development initiatives underway at SynerFuse™. SynerFuse™ Milestones July 2018: SynerFuse™ founded July 2019: FDA approves feasibility study December 2019: University of Minnesota Institutional Review Board approves feasibility study March 2020: Clinical trial agreement finalized with University of Minnesota Medical School January 2022: First patient implanted—Dr. Michael C. Park implanted stimulator and leads, Dr. Rohan Lall implanted fusion January 2023: South Bend Orthopaedics activated as second clinical site June 2023: First solo procedure performed by former investigator Dr. Rohan Lall (implanted fusion with stimulator and leads) August 2023: Second solo procedure performed by principal investigator Dr. Deepak Reddy, showing solo surgeon can learn and implement procedure outside University of Minnesota October 2023: 15th patient implanted October 2024: Final 12-month patient follow-up completed *Dr. Park holds stock options from SynerFuse. About Velentium Medical Velentium Medical is a Richmond, Texas-based professional engineering firm that exists to transform IP into the design and manufacture of safe and secure medical devices that will change lives and create a better world. More information about the company is available at . 1 See "Low Back Pain Fact Sheet." National Institute of Neurological Disorders and Stroke, , accessed 3 March 2025. 2 Karen L. Saban et al., "Health-Related Quality 3 Marchof Life of Patients Following Selected Types of Lumbar Spinal Surgery: A Pilot Study," Health and Quality of Life Outcomes 5 (2007), , accessed 17 October 2023. 3 Farber SH, Han JL, Elsamadicy AA, Hussaini Q, Yang S, Pagadala P, Parente B, Xie J, Lad SP. Long-term Cost Utility of Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome. Pain Physician. 2017 Sep;20(6):E797-E805. PMID: 28934786; PMCID: PMC8358894. SOURCE SynerFuse WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

--Study Evaluated Safety and Tolerability of Simultaneous Spinal Fusion and Implant of Neuromodulation Devices in Chronic Lower Back Pain Patients EDEN PRAIRIE, Minn., March 3, 2025 /PRNewswire/ -- SynerFuse™ and its collaborators at the University of Minnesota, South Bend Orthopaedics, and RQM+ today announced the completion of the SynerFuse™ proof-of-concept study to evaluate the safety and tolerability of the novel Electric Transforaminal Lumbar Interbody Fusion (e-TLIF™) procedure integrating spinal fusion with direct nerve stimulation, which is designed to treat chronic lower-back pain (cLBP) and neuropathic leg pain. To bring the proof-of-concept study to completion, the team conducted one-year follow-up assessments of the study's 15 surgery patients. Continue Reading Data from the SynerFuse™ proof-of-concept study will be used to support the publication of peer-reviewed journal articles and to support the company's application for breakthrough status with the FDA. With this milestone, we advance our mission to improve patient quality of life and address the opioid crisis head on. Post this "I want to thank our principal investigators: Michael C. Park, M.D., Ph.D.*, associate professor of neurosurgery at the University of Minnesota, and Deepak Reddy, M.D., South Bend Orthopaedics," said Justin Zenanko, SynerFuse™ CEO and co-founder. "I'd also like to thank our co-investigators leading the study: Rohan Lall, M.D., our chief medical officer and a spine surgeon with M Health Fairview University of Minnesota Medical Center; Jonathan Sembrano, M.D., associate professor of orthopedic surgery at the University of Minnesota; and Matthew A. Hunt, M.D., MHA, FRCS, FAANS, M Health Fairview University of Minnesota Medical Center." "I am also grateful to our regulatory consultants, Sew-Wah Tay, Ph.D., and Ming-Cheng Chew at RQM+, who have been with us since the beginning of our study in 2020, ensuring our compliance and assisting us with our application for breakthrough status with the FDA," said Zenanko. "Currently, if patients have persistent chronic back and leg pain after a successful fusion, they may eventually become candidates for neuromodulation therapy, but typically only several years after surgery, during which time they may suffer disabling pain and opioid medication use," said Lall. "If the SynerFuse™ e-TLIF™ procedure proves effective at lowering post-operative pain levels, as early indications have suggested, we may have a new treatment strategy that potentially dramatically improves patient quality of life and pain outcomes." "With this milestone, we advance our mission to improve patient quality of life and address the opioid crisis head on," said Zenanko. "The SynerFuse™ proof-of-concept study demonstrated the safety and feasibility of integrating direct nerve stimulation with open lumbar or lumbosacral decompression and instrumented fusion," said Park. "The direct placement of the electrode on the nerve also demonstrated no device-related significant adverse events. This technique could be a new treatment approach of integrating neuromodulation with spinal decompression and fusion." "Our experience with Synerfuse™ e-TLIF™ procedure was very positive," said Reddy. "We saw improvement in acute postoperative pain scores as well as reduced medication usage in the first six weeks. The patient certainly found the therapy an essential part of their postoperative care and was still using it at their one-year follow-up." "We are pleased to be able to help SynerFuse™ in its regulatory compliance journey with the FDA and other agencies," said Sew-Wah Tay, Ph.D., regulatory, clinical, and QA consultant at RQM+. "We look forward to the next phases of compliance and regulatory approvals with SynerFuse™ and to realizing the team's dream of bringing the company's novel therapy to the market so spinal fusion patients can experience superior outcomes." More than 93 million Americans (28 percent) report suffering from chronic low back pain.(1) With more than 500,000 procedures performed annually, spinal fusion remains a common treatment for spinal instability, albeit with a high incidence of residual neuropathic pain.(2) It has been estimated that up to 40 percent of patients who undergo spinal fusion end up with failed back surgery syndrome (FBSS), a condition resulting in significant, lingering neuropathic pain, costing the U.S. healthcare system $20B per year,(3) significantly affecting the quality of life of patients, and contributing to the opioid crisis (more than half of opioid users report back pain).(4) More information about SynerFuse™ is available at . About Chronic Lower Back Pain (cLBP) cLBP is defined as lower back pain that continues for 12 weeks or longer, even after an initial injury or underlying cause of acute lower back pain has been treated.(5) With more than 500,000 procedures performed annually, spinal fusion remains a common treatment for spinal instability, albeit with a high incidence of residual neuropathic pain.(6) Up to 40% of patients who undergo spinal fusion end up with Failed Back Surgery Syndrome (FBSS), a condition resulting in significant, lingering neuropathic pain, costing the U.S. healthcare system $20B per year and significantly affecting the quality of life of patients,(7) About SynerFuse™ SynerFuse™ is a Delaware corporation based in Minnesota—the heart of Medical Alley and the cradle of neuromodulation and medical device innovation. SynerFuse™ believes that individuals with cLBP/FBSS and their providers deserve an alternative option than spinal fusion alone. Even when spinal fusion is successful, it can often result in residual chronic neuropathic pain and use of addictive opioids. The company is working to create a non-narcotic pain management for chronic low back pain with a patented therapy that integrates spinal fusion hardware and an active neuromodulation system. For more information on the company, please visit . This communication contains information about an investigational product. This product is limited by Federal (U.S.) law to investigational use only. SynerFuse™ makes no claims regarding the safety or effectiveness of the unapproved investigational product. The intent of providing this information is to convey research and development initiatives underway at SynerFuse™. SynerFuse™ Milestones July 2018: SynerFuse™ founded July 2019: FDA approves feasibility study December 2019: University of Minnesota Institutional Review Board approves feasibility study March 2020: Clinical trial agreement finalized with University of Minnesota Medical School January 2022: First patient implanted—Dr. Michael C. Park implanted stimulator and leads, Dr. Rohan Lall implanted fusion January 2023: South Bend Orthopaedics activated as second clinical site June 2023: First solo procedure performed by former investigator Dr. Rohan Lall (implanted fusion with stimulator and leads) August 2023: Second solo procedure performed by principal investigator Dr. Deepak Reddy, showing solo surgeon can learn and implement procedure outside University of Minnesota October 2023: 15th patient implanted October 2024: Final 12-month patient follow-up completed *Dr. Park holds stock options from SynerFuse. About South Bend Orthopaedics South Bend Orthopaedics provides specialized care for all musculoskeletal surgery and Orthopaedic rehabilitation patients, as well as those suffering from work-related and sports injuries. Founded on the principle of providing excellence in Orthopaedics, SBO has been serving the needs of northern Indiana and southern Michigan since 1947 and functions as the Orthopaedic Surgeons for The University of Notre Dame Athletics Department since 1949. Dr. Reddy has become a leader in complex spine surgery with specific areas of interest including robotics, minimally invasive spine surgery, 3D printing, and other emerging technologies. Please visit . About RQM+ RQM+ accelerates medical innovation by streamlining the lifecycle of devices, diagnostics, and biotechnology products. Our expertise transforms innovative ideas into market-ready solutions, ensuring life-changing technologies reach patients faster and more efficiently. The RQM+ portfolio of services enables the delivery of end-to-end solutions across the complete product lifecycle: Regulatory and Quality Consulting Lab Services and Materials Consulting via Jordi Labs Clinical Trials Reimbursement Statista. (2024, January 29). Share of U.S. adults with chronic low back pain 2022, by age. . Karen L. Saban et al., "Health-Related Quality of Life of Patients Following Selected Types of Lumbar Spinal Surgery: A Pilot Study," Health and Quality of Life Outcomes 5 (2007), , accessed 17 October 2023. Farber SH, Han JL, Elsamadicy AA, Hussaini Q, Yang S, Pagadala P, Parente B, Xie J, Lad SP. Long-term Cost Utility of Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome. Pain Physician. 2017 Sep;20(6):E797-E805. PMID: 28934786; PMCID: PMC8358894. Deyo, R. A., Von Korff, M., & Duhrkoop, D. (2015). Opioids for low back pain. BMJ, 350, g6380. . See "Low Back Pain Fact Sheet." National Institute of Neurological Disorders and Stroke, , back%20pain%20has%20been%20treated, accessed 17 October 2023. Karen L. Saban et al., "Health-Related Quality of Life of Patients Following Selected Types of Lumbar Spinal Surgery: A Pilot Study," Health and Quality of Life Outcomes 5 (2007), , accessed 17 October 2023. Farber SH, Han JL, Elsamadicy AA, Hussaini Q, Yang S, Pagadala P, Parente B, Xie J, Lad SP. Long-term Cost Utility of Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome. Pain Physician. 2017 Sep;20(6):E797-E805. PMID: 28934786; PMCID: PMC8358894. SOURCE SynerFuse WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Safety and initial activity of autologous human B cells genetically engineered to express human iduronidase using the Sleeping Beauty transposon system. Results from a first-in-human clinical trial in subjects with MPS I SAN FRANCISCO, CA, USA I January 27, 2025 I Immusoft of CA, a cell therapy company dedicated to improving the lives of patients with rare diseases, today announced that it will feature oral and poster presentations at the upcoming WORLDSymposium™ 2025, held in San Diego, February 3-7, 2025. Immusoft will present the following: Oral Presentation: Friday, February 7 th , 9:00 AM PST, Dr. Paul Orchard, MD. Title: Safety and initial activity of autologous human B cells genetically engineered to express human iduronidase using the Sleeping Beauty transposon system: Results from a first-in-human clinical trial in subjects with MPS I Presenter: Paul J. Orchard, MD., Professor, Division of Pediatric Blood and Marrow Transplantation & Cellular Therapy University of Minnesota Medical School Poster Presentation: Wednesday, February 5 th , 2026, 3:30-5:30 PM PST, Kiosk 27-B. Title: Safety and initial activity of autologous human B cells genetically engineered to express human iduronidase using the Sleeping Beauty transposon system: Results from a first-in-human clinical trial in subjects with MPS I Presentation Category: Translational Research & Late-Breaking Science Posters (LB-35 to LB-62) Immusoft is developing B cells as biofactories for therapeutic protein delivery. This new modality has the potential to be both durable and redosable. The Company’s lead drug candidate, ISP-001, is the first ever engineered B cell in a human clinical trial and a first-in-class investigational treatment for mucopolysaccharidosis type I (MPS I), a rare lysosomal storage disease. ISP-001 is an autologous B cell product engineered to express human alpha-L-iduronidase (IDUA) for the treatment of MPS I. In this first-in-human clinical trial, the patient was dosed without the need for a preconditioning regimen (required for gene-modified stem cells) or immunosuppression (required for most systemic virus-delivered gene therapy), both of which can be associated with severe toxicities. The trial is supported by an $8 million award from the California Institute for Regenerative Medicine (CIRM), one of the world’s largest institutes dedicated to regenerative medicine. There is a significant unmet need for new therapies with improved efficacy and convenience in MPS I, where the current standard of care is enzyme replacement therapy (ERT) or hematopoietic stem cell transplant (HSCT). Due to their capacity for high-level protein production, their natural ability to engraft in the bone marrow without the need for toxic preconditioning, and their ability to manufacture a multitude of protein types, B cells have the potential to address unmet needs across numerous therapeutic indications. Additional information regarding the WORLDSymposium ™ presentation can be found at: https://worldsymposia.org/ . About Immusoft Immusoft is a cell therapy company focused on developing novel approaches to treat rare diseases by sustained delivery of protein therapeutics from a patient’s own B cells. The company is developing a technology platform called Immune System Programming (ISP ™ ), which modifies a patient’s B cells and instructs the cells to produce gene-encoded medicines. The B cells that are reprogrammed using ISP become miniature drug factories that are expected to survive in patients for many years. The company is based in Seattle, WA. For more information, visit www.immusoft.com . About the California Institute for Regenerative Medicine (CIRM) At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast-track the development of today’s most promising stem cell technologies. With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality. SOURCE: Immusoft