Arthroplasty

Centinel Spine® PMA Application for First-of-its-Kind 2-Level prodisc® C Vivo and prodisc C SK Match-the-Disc™ Cervical Total Disc Replacement System Filed and Proceeding with Substantive Review

Retrieved on: 
Thursday, October 26, 2023
Anatomy, FDA, Arthroplasty, Investigational device exemption, Food, TDR, Health, PMA, WEST, IDE, Clinical trial, Surgeon, Samuel Bryan, Safety, SK, Food and Drug Administration Amendments Act of 2007, Pharmaceutical industry, Medical device

The clinical trial evaluated the safety and effectiveness of the prodisc C Vivo and prodisc C SK system by comparing it with an approved total disc replacement (TDR) product as a control for 2-level indications.

Key Points: 
  • The clinical trial evaluated the safety and effectiveness of the prodisc C Vivo and prodisc C SK system by comparing it with an approved total disc replacement (TDR) product as a control for 2-level indications.
  • The filing date for the Company's PMA application was September 27, 2023 and the submission is now under substantive review by the FDA.
  • "The prodisc C Vivo and prodisc C SK 2-level cervical disc clinical trial was unique in two ways," said Centinel Spine CEO Steve Murray.
  • The prodisc C Vivo system has been in clinical use internationally since 2009 and is currently one of the most frequently implanted TDR devices in the world.

Peptilogics Reports Positive 180-Day Top-Line Interim Data From Phase 1B Trial of PLG0206 in Patients With Periprosthetic Joint Infection (PJI)

Retrieved on: 
Tuesday, September 19, 2023
Biotechnology, FDA, Other Health, Health, Clinical Trials, Infection, CARB-X, Obesity, Surgeon, Biomedical Advanced Research and Development Authority, Failure, Prevalence, Diabetes, Aftercare, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Human services, Office of Inspector General, U.S. Department of Health and Human Services, Wellcome Trust, Overalls, Administration for Strategic Preparedness and Response, Quality of life, Risk, AMR, Implant, Administration, Development, Journal, TKA, Patient, Thomas Jefferson University Hospital, Low-dose naltrexone, UPMC, Debridement, Research, Orthopedic surgery, Recurrence, Biofilm, Pharmaceutical industry, Arthroplasty

Peptilogics, a clinical-stage biotechnology company, today announced new top-line interim data for PLG0206 in periprosthetic joint infection (PJI) patients from their ongoing Phase 1b trial.

Key Points: 
  • Peptilogics, a clinical-stage biotechnology company, today announced new top-line interim data for PLG0206 in periprosthetic joint infection (PJI) patients from their ongoing Phase 1b trial.
  • At 180-days following treatment with PLG0206 administered during a DAIR (Debridement, Antibiotics, and Implant Retention) surgery, no treatment-related serious adverse events were reported in either cohort.
  • One recurrence was observed in the trial (one of 14 patients, 7%), which was in the Low Dose cohort at Day-180; no recurrences were observed in the High-Dose cohort.
  • “Most of the patients in this trial have a very high risk of failure due to their comorbidities including obesity, diabetes, and prior joint surgeries, making them some of the hardest patients to treat.

Exactech Presents New Shoulder Research Studies at Global Conference

Retrieved on: 
Thursday, September 14, 2023
Health, Medical Devices, Surgery, Other Health, General Health, Clinical Trials, Biotechnology, Shoulder, Arthroplasty, Male, Deformity, Surgeon, Medical University of South Carolina, FRSC, Instability, Risk, Senior counsel, Medical school, Research, Incidence, Correlation, Patient, Osteoarthritis, International Congress on Tuberculosis, Équinoxe, Female, Dentistry, Birth control, Nursing, MD, Extremities

Exactech , a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, presented 21 new scientific and clinical studies on the company’s Equinoxe® shoulder at the 2023 International Congress on Shoulder and Elbow Surgery (ICSES) annual meeting Sept. 5-8 in Rome.

Key Points: 
  • Exactech , a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, presented 21 new scientific and clinical studies on the company’s Equinoxe® shoulder at the 2023 International Congress on Shoulder and Elbow Surgery (ICSES) annual meeting Sept. 5-8 in Rome.
  • One of the podium presentations, Clinical Outcomes Based on Final Baseplate Version in Reverse Total Should Arthroplasty, evaluated clinical outcomes of reverse shoulder patients with baseplates in varying degrees of deformity.
  • Another podium presentation, Correlation of Risk Factors with Odds of Instability after Reverse Shoulder Arthroplasty, evaluated the impact of multiple risk factors on the incidence rate of instability after reverse shoulder arthroplasty.
  • “Data drives everything we do at Exactech, and these 21 new clinical research studies contribute meaningful, and generalizable, new findings that are helpful to shoulder surgeons worldwide as they treat their patients using shoulder arthroplasty.”

EmergeOrtho-Triangle Region Welcomes Dr. Rhett Hallows, Joint Replacement Surgeon

Retrieved on: 
Monday, August 28, 2023
Bachelor of Science, University, Hip, University of Utah School of Medicine, ABMS, Elective surgery, Arthroplasty, Wilson, Triangle, MD, Patient, Wake Forest, Faculty, Health, Knee, Injury, Medical device, Nursing, Southern Utah University, Science, Adult

DURHAM, N.C., Aug. 28, 2023 /PRNewswire/ -- Dr. Rhett Hallows, a renowned Joint Replacement Specialist joins EmergeOrtho-Triangle Region's team of orthopedic surgeons, with a focus on the anterior-based muscle-sparing (ABMS) hip replacement approach.

Key Points: 
  • DURHAM, N.C., Aug. 28, 2023 /PRNewswire/ -- Dr. Rhett Hallows, a renowned Joint Replacement Specialist joins EmergeOrtho-Triangle Region's team of orthopedic surgeons, with a focus on the anterior-based muscle-sparing (ABMS) hip replacement approach.
  • Dr. Hallows has also become proficient in the ABMS approach to hip replacement, which offers a rapid hip replacement recovery, similar to anterior total hip arthroplasty.
  • "Having Dr. Rhett Hallows on our team is truly a privilege," Medical Director of EmergeOrtho-Triangle Region, Dr. Will Silver said.
  • Since 1952, EmergeOrtho–Triangle Region has been providing comprehensive subspecialty orthopedic care to address a diverse variety of injuries and conditions.

Shoulder Innovations Announces Securing of a $45M Debt Facility

Retrieved on: 
Tuesday, August 22, 2023
Shoulder, SI, Partnership, Arthroplasty, History, Journal, Traction, Investment, Journal of Shoulder and Elbow Surgery, Growth, Renewable energy, Management

(SI), a Grand Rapids, Michigan-based leader in the shoulder replacement implant market, announced securing of a $45M debt facility in partnership with Trinity Capital.

Key Points: 
  • (SI), a Grand Rapids, Michigan-based leader in the shoulder replacement implant market, announced securing of a $45M debt facility in partnership with Trinity Capital.
  • Matthew Ahearn, Chief Operating Officer of Shoulder Innovations, said, "The Trinity Capital debt facility provides Shoulder Innovations flexibility to make additional investments into the team, systems infrastructure and InSet™ technology to further accelerate the growth and scale of the business."
  • Shoulder Innovations has developed the InSet™ Shoulder Replacement Platform leveraging the extensive experience and history of innovation of SI's technical, commercial, and clinical teams.
  • Dave Blue, Chief Commercial Officer of Shoulder Innovations said, "We are very excited to have secured these additional financial resources to help support our robust growth, expansion, and development that is happening here at Shoulder Innovations."

HSS Announces Leadership Successions in Specialties of Joint and Pediatric Surgery

Retrieved on: 
Wednesday, August 9, 2023
Surgeon, Pediatrics, Hip, Elective surgery, Arthroplasty, Spine, Osteochondritis dissecans, MBA, Research, Associate, MS, Hospital for Special Surgery, Dislocation, Mayman, Patient, HSS, Hospital, Health, ACL, Sports medicine, Trauma, Dentistry, Nursing, DRS, Green, MD

NEW YORK, Aug. 9, 2023 /PRNewswire/ -- Hospital for Special Surgery (HSS), the world's leading academic medical center focused on musculoskeletal health, today announced the appointments of David J. Mayman, MD, as chief of the Adult Reconstruction and Joint Replacement (ARJR) Service and Daniel W. Green, MD, MS, as chief of the Pediatric Orthopedic Surgery Service.

Key Points: 
  • Dr. Widmann will continue to care for pediatric patients with spine and limb deformities and will lead a new center of excellence dedicated to robotic-assisted surgery at HSS.
  • Bostrom and Widmann for their steadfast leadership over the years," said Bryan T. Kelly, MD, MBA , president, surgeon-in-chief and medical director of HSS.
  • These appointments will allow us to continue to advance excellence for our joint replacement and pediatric surgical patients."
  • A member of the Hip and Knee Societies, Dr. Mayman is a leader in the field of robotic and navigated joint replacement surgery.

Spinal Stabilization Technologies, LLC, a Leading Developer and Manufacturer of Spinal Medical Devices, to be Publicly Listed through a Proposed Business Combination with BlueRiver Acquisition Corp.

Retrieved on: 
Monday, July 24, 2023
Professional Services, Medical Devices, Health, Surgery, Other Health, Finance, Spinal fusion, SST, Investigational New Drug, PIPE, PLLC, Arthroplasty, I Am the Moon, Back pain, Prospectus, Acquisition, Degenerative disc disease, Patient, Investigational device exemption, Clinical, Spinal disc herniation, Ides, Security (finance), IDE, FDA, NYSE, Medical device

Spinal Stabilization Technologies (“SST” or the “Company”), a medical device company, and BlueRiver Acquisition Corp. ("BlueRiver") (NYSE AM: BLUA), a publicly traded special purpose acquisition company, have entered into a definitive business combination agreement.

Key Points: 
  • Spinal Stabilization Technologies (“SST” or the “Company”), a medical device company, and BlueRiver Acquisition Corp. ("BlueRiver") (NYSE AM: BLUA), a publicly traded special purpose acquisition company, have entered into a definitive business combination agreement.
  • Upon the closing of the proposed transaction between SST and BlueRiver, the combined company will operate as Spinal Stabilization Technologies and be listed on an approved stock exchange.
  • The PerQdisc is an investigational device in the U.S. and has not been approved by the FDA.
  • SST's pioneering work has positioned it to be at the forefront of the market for Augmented Discectomy and Degenerative Disc Disease treatments.

Solenic Medical, Inc. Announces $5.1M Series A Funding Round Led by Johnson & Johnson Innovation - JJDC, Inc.

Retrieved on: 
Tuesday, June 20, 2023
Infection, Field line, USB On-The-Go, Arthroplasty, Quality of life, Catheter, Therapy, Patient, Risk, Immune system, Disease, AMF, Bacteria, Health, FDA, Trauma, Knee, Dentistry, Pharmaceutical industry

ADDISON, Texas, June 20, 2023 /PRNewswire-PRWeb/ -- Solenic Medical, developer of a device that uses alternating magnetic fields (AMF) to treat a prosthetic joint infections (PJI) announced today it has raised a $5.1 million Series A funding round. The syndicated round was led by Johnson & Johnson Innovation – JJDC, Inc., and joined by other major medical device investors such as ShangBay Capital and Highpoint Ventures. The patent-pending technology offers a complete non-invasive approach for the eradication of biofilm on metallic implants for the treatment of PJI. Initially targeting the metallic components of knee implants, this product is the first in the company's pipeline of treatments for most metallic medical implants including knees, hips, elbows, trauma devices and more.

Key Points: 
  • The syndicated round was led by Johnson & Johnson Innovation – JJDC, Inc., and joined by other major medical device investors such as ShangBay Capital and Highpoint Ventures.
  • The patent-pending technology offers a complete non-invasive approach for the eradication of biofilm on metallic implants for the treatment of PJI.
  • James Y. Lancaster, CEO of Solenic Medical, said, "Our team has been working diligently to prepare this technology for patient treatments.
  • Thanks to our FDA Breakthrough Device designation we expect rapid progress to treat knee implant patients suffering from PJI in early 2024."

Premia Spine TOPS™ System Achieves FDA Premarket Approval with Superiority-to-Fusion Label

Retrieved on: 
Tuesday, June 20, 2023
Injection, Spine, Journal, Failure, Stenosis, Arthroplasty, Index, Pain, Control, Back pain, Food and Drug Administration Amendments Act of 2007, Motion, PMA, Gold, Patient, Oswestry Disability Index, Lumbar spinal stenosis, Premia, Decompression, IDE, FDA, Treatment, Food, Spinal stenosis, Safety, Pharmaceutical industry, Lithium, Spondylolisthesis

NORWALK, Conn., June 20, 2023 /PRNewswire-PRWeb/ -- Premia Spine, a medical technology company revolutionizing the treatment of chronic leg and back pain, proudly announces the Food and Drug Administration (FDA) approval of its Total Posterior Spine (TOPS) facet joint replacement system. The TOPS System previously earned the FDA's Breakthrough Designation status and has now successfully completed its Premarket Approval (PMA) application. Premia Spine undertook rigorous testing to receive FDA approval, including an Investigational Device Exemption (IDE) study to confirm the safety and efficacy of the system. The company's pivotal FDA trial demonstrated that, at two years post-operation, the TOPS System outperformed fusion in treating grade 1 degenerative spondylolisthesis with stenosis. This accomplishment marks the TOPS System as the first lumbar spine implant to receive a superiority claim over lumbar fusion.

Key Points: 
  • NORWALK, Conn., June 20, 2023 /PRNewswire-PRWeb/ -- Premia Spine , a medical technology company revolutionizing the treatment of chronic leg and back pain, proudly announces the Food and Drug Administration (FDA) approval of its Total Posterior Spine (TOPS) facet joint replacement system.
  • The TOPS System previously earned the FDA's Breakthrough Designation status and has now successfully completed its Premarket Approval (PMA) application.
  • Premia Spine undertook rigorous testing to receive FDA approval, including an Investigational Device Exemption (IDE) study to confirm the safety and efficacy of the system.
  • This accomplishment marks the TOPS System as the first lumbar spine implant to receive a superiority claim over lumbar fusion.

Top Neurosurgeon, Dr. Albert Wong, will be Speaking at the 20th Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference June 15-17, 2023

Retrieved on: 
Wednesday, June 14, 2023
Surgeon, Elective surgery, Education, Neoplasm, University, Health, Arthroplasty, Suite, Stanford University School of Medicine, Pain, Hospital, Ortho, MISS, Knowledge, Artificial intelligence, LOS, Next Generation, Northwestern University, Conference, Medical device, Dentistry, Spine, Swissôtel

LOS ANGELES, June 14, 2023 /PRNewswire-PRWeb/ -- A world-renowned leader in orthopedic and spinal care, Dr. Albert Wong, will be sharing his extensive knowledge on two different panels at this year's Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference. The event is taking place at the Swissotel in Chicago, Illinois, where topics such as new technologies, business regulations of outpatient surgery centers, optimizing outpatient surgeries and the next spine and orthopedic procedures to transition to the outpatient surgery setting will be shared. Dr. Albert Wong's first speaking event on the topic of "The Next Spine, Orthopedic Procedures to Go Outpatient" will take place at 8:45 - 9:25 AM on Friday, June 16th. This talk will focus on where the industry is headed and what forward-looking surgeons are doing today to prepare. Later that same afternoon, from 3:55 - 4:35 PM, Dr. Wong will lead a second panel to discuss "Technologies That Will Define the Next Generation of Spine" where he and fellow experts will elaborate on the newest technologies, including robotic navigation, arthroplasty, augmented reality, endoscopic surgeries and artificial intelligence.

Key Points: 
  • At this first-rate conference, participants can learn from and network with over 118+ surgeons and 190+ ASC, ortho and spine professionals from leading hospitals and healthcare systems.
  • LOS ANGELES, June 14, 2023 /PRNewswire-PRWeb/ -- A world-renowned leader in orthopedic and spinal care , Dr. Albert Wong, will be sharing his extensive knowledge on two different panels at this year's Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference.
  • Dr. Albert Wong 's first speaking event on the topic of "The Next Spine, Orthopedic Procedures to Go Outpatient" will take place at 8:45 - 9:25 AM on Friday, June 16th.
  • For more details on the conference please visit:
    "I always look forward to speaking at and collaborating with my peers at this premier spinal conference," says Dr. Albert Wong.