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PARSIPPANY, N.J., Jan. 9, 2025 /PRNewswire/ -- Onkos Surgical, a leading provider of innovative solutions for complex orthopaedic procedures, today announced that its revolutionary NanoCept Antibacterial Technology has been used successfully in multiple surgical procedures. NanoCept is a novel antibacterial coating applied to orthopaedic implants to help address intraoperative bacterial contamination. Continue Reading NanoCept™ Antibacterial Technology "Limb salvage and revision procedures are challenging, and the rate of complication is much higher than most index orthopaedic procedures," said Steven Gitelis, MD, Director of Musculoskeletal Oncology at Rush University Medical Center and Chief Medical Officer of Onkos Surgical. "The risk of implant infection is on my mind every time I take a patient to the operating room, and this is especially true for patients with bone cancer, as they are more susceptible. The NanoCept Technology represents a significant advancement in the preventative measures my colleagues and I use to mitigate the potentially devastating complications related to intraoperative bacterial contamination of implants. It has the potential to create a paradigm shift in implant selection and is a valuable tool surgeons will now have that may help address an unsolved clinical problem." Orthopaedic implant-related infections are clinically challenging and have significant negative effects on patients. Periprosthetic joint infection (PJI) has a lower survival rate than several forms of cancer1 and is expected to cost the U.S. healthcare system up to $1.8 billion dollars by 2030.2 It is estimated that 60-70% of all early and delayed-onset PJI (<3 months and 12-24 months post-surgery) are initiated at the time of the procedure through intraoperative contamination.3 Onkos received De Novo market authorization from the Food and Drug Administration (FDA) in April of 2024 for its NanoCept Antibacterial Technology. Data submitted to support the De Novo application showed that NanoCept has up to a 99.999% (5-log reduction) kill rate in standardized in-vitro testing of bacteria that are commonly found in the operating room environment. The initial FDA authorization for NanoCept was for the Company's ELEOS™ Limb Salvage System, which is a modular total joint system used for patients with bone loss. "The successful completion of these initial surgeries is a key achievement and significant milestone in our strategy to deploy the NanoCept Technology across our portfolio," said Patrick Treacy, Onkos CEO and Co-founder. "We believe NanoCept is a platform technology that will substantially extend our reach and capability in broad orthopaedic markets, and we are actively working to expand regulatory clearances beyond ELEOS to include implants used in orthopaedic reconstruction due to tumor, trauma and other orthopaedic revision procedures." About Onkos Surgical Onkos Surgical is a leader in innovative solutions for complex orthopaedic conditions. With our novel product portfolio, surgeons are better informed about patient-specific clinical challenges and are able to plan and implement more precise reconstructions. Our personalized approach supports improved patient outcomes and experiences using the latest innovations in antibacterial implant coatings, virtual surgical planning, 3D anatomic modeling and printing, implant design, and workflow optimization. More than 350 of the leading academic medical institutions in the US choose Onkos for their complex revision and tumor orthopaedic cases. For more information on Onkos Surgical and its products and services, please visit . Forward Looking Statements Certain statements made in this release that are not statements of historical or current facts are forward-looking statements which involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance, or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "future," "believes," "expects," "may," "will," "should," "potential," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management's beliefs, assumptions and current expectations but are subject to known and unknown risks and uncertainties including, without limitation, launch delays and the possibility that post-market clinical results may be inconsistent with the in-vitro preclinical test results. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not and should not be relied upon as a guarantee of future performance or results. The forward-looking statements included are made only on the date of this release. The company assumes no obligation to update any information or forward-looking statement contained herein, save for any information required to be disclosed by law. Media Contacts: Sean P. Curry Chief Commercial Officer Onkos Surgical [email protected] 973.264.5400 Alyssa Paldo Vice-President, Media Relations Specialist FINN Partners [email protected] 847.791.8085References1,2 – Premkumar et.al. Projected economic burden of periprosthetic joint infection of the hip and knee in the United States. The Journal of Arthroplasty. Volume 36, Issue 5 P1484-1489.E3May 20213 - Tande AJ, Patel R. Prosthetic joint infection. Clin Microbiol Rev. 2014 Apr;27(2):302-45. doi: 10.1128/CMR.00111-13. PMID: 24696437; PMCID: PMC3993098. SOURCE Onkos Surgical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Updated guideline establishes guidance based on latest in evidence-based recommendations ROSEMONT, Ill., Dec. 17, 2024 /PRNewswire/ -- The American Academy of Orthopaedic Surgeons (AAOS) issued an updated Clinical Practice Guideline (CPG) for the Prevention of Total Hip and Knee Arthroplasty Periprosthetic Joint Infection (PJI) in Patients Undergoing Dental Procedures, which replaces the previous guideline from 2012. The CPG supports patients who are scheduled for or have undergone total joint arthroplasty (TJA) and may need dental procedures by addressing antibiotic use and the timing of dental procedures before or after joint replacements, such as total knee arthroplasty (TKA) or total hip arthroplasty (THA) to help prevent infection. To view the full guideline, click here. "Dental procedures are believed to possibly allow bacteria to enter the bloodstream and attach themselves to hip or knee implants, potentially causing PJI in a patient," said Yale Fillingham, MD, FAAOS, co-chair of the AAOS' guideline development group. "PJI is one of the most devastating complications for patients following TJA, and we must do everything possible that is supported by evidence to prevent these infections. Given the large number of annual TJA procedures and that most of these patients undergo a dental cleaning at least twice a year, this CPG is relevant to nearly every TJA patient." THA and TKA are two of the most common surgical procedures performed worldwide. In the United States, over 1 million THAs and TKAs are performed each year, and these cases are estimated to increase by 659% and 469%, respectively, by 2060. Unfortunately, PJI is associated with increased mortality (up to 250% greater than patients who do not have PJI, along with the risk of a higher incidence of mental health disorders). The workgroup studied the latest data to provide clinically backed evidence for orthopaedists and dentists aimed at prevention but also weighed it against potential patient harm. The updated guideline includes two limited-strength options and three consensus options. Options are developed when little or no evidence exists on a particular topic. The group issued a limited-strength option stating that routine use of a systemic prophylactic antibiotic before a dental procedure in patients with a hip or knee replacement may not reduce the risk of a subsequent PJI. "The committee took a close look at the data on the administration of antibiotics before a dental procedure after both hip and knee replacement to see if it mitigated the potential risk of a PJI associated with that dental procedure," said Charles Hannon, MD, FAAOS, co-chair of the AAOS' guideline development group. "Based on the best available data, no study found that administering antibiotics before a dental procedure changed a patient's risk of getting a parasitic joint infection. With that said, it is important to recognize there may be other considerations that may lead a provider to prescribe antibiotics for an individual patient. This decision should be made with the patient, and the unique risks and benefits for the patient should be considered." The second limited-strength option states that screening patients who have received certain dental procedures before their hip or knee replacement may not reduce the risk of subsequent PJI. However, the workgroup recognizes that patients should be aware of the potential risks of poor oral hygiene. Guidelines At-A-Glance Desk Reference The workgroup also developed a new resource with suggested time intervals between dental procedures and TJA that supports two consensus statements. These statements address whether to delay an arthroplasty after a dental procedure or delay a dental procedure after TKA or THA. "It was important to create an at-a-glance tool for orthopaedic surgeons, dentists and their healthcare teams that provides guidance on the timing of dental procedures before and after TKA and THA. The tool outlines suggested timing based on the risk of transient bacteremia, the occurrence of an invasive surgical procedure that can lead to higher bacterial loads/increased infection risk, or the treatment of an active dental infection," said Dr. Hannon. Highlights from the chart include: Noninvasive dental procedures and minimally invasive dental care procedures such as dental examinations (without probing), oral hygiene procedures, and orthodontic procedures can be performed safely until the day before elective TJA surgery. Oral surgery procedures and dental extractions, which can take up to three weeks to heal, should be completed at least three weeks before elective TJA. The majority of dental procedures should be delayed for up to three months after TJA based on the type of procedure performed. The updated CPG was jointly developed by the AAOS and the American Association of Hip and Knee Surgeons, with contributions from the Infectious Disease Society of America, the Musculoskeletal Infection Society, and the American Dental Association. Intended CPG Use CPGs are not meant to be stand-alone documents but rather serve as a point of reference and educational tool for orthopaedic surgeons and healthcare professionals managing patients presenting with PJI that may be related to TKA and THA. CPGs recommend accepted approaches to treatment and/or diagnosis and are not intended to be a fixed protocol for treatment or diagnosis. Patient care and treatment should always be based on a clinician's independent medical judgment and the individual patient's specific clinical circumstances. The guideline is not intended for use as a benefits determination document. The full Clinical Practice Guideline for the Prevention of Total Hip and Knee Arthroplasty Periprosthetic Joint Infection in Patients Undergoing Dental Procedures is intended for reference by orthopaedic surgeons and dentists and is available through AAOS' OrthoGuidelines website and free mobile app. For more information on the development process for AAOS clinical practice guidelines, please view the Clinical Practice Guideline Methodology. About the AAOS With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world's largest medical association of musculoskeletal specialists. The AAOS is the trusted leader in advancing musculoskeletal health. It provides the highest quality, most comprehensive education to help orthopaedic surgeons and allied health professionals at every career level to best treat patients in their daily practices. The AAOS is the source for information on bone and joint conditions, treatments and related musculoskeletal healthcare issues; and it leads the healthcare discussion on advancing quality. Follow the AAOS on Facebook, X, LinkedIn and Instagram. SOURCE American Academy of Orthopaedic Surgeons WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Outcomes at 12 months demonstrate a statistically significant net treatment effect of 19% compared to the standard of care two-stage exchange arthroplasty and highlight a 71% reduction in PJI burdenDALLAS, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Osteal Therapeutics, Inc. (“Osteal”), a clinical-stage biopharmaceutical company developing a new category of combination drug/device therapies for orthopedic infections, announced positive 12-month results from the two APEX (Abbreviated Protocol for Two Stage Exchange) clinical trials of VT-X7 KIT (vancomycin hydrochloride for irrigation; tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) in patients with periprosthetic joint infections (“PJI”) of the hip or knee. The two prospective, randomized, comparative studies evaluated the efficacy of a rapid (7-day) exchange arthroplasty with intra-articular antibiotic irrigation versus the current standard of care, two-stage exchange arthroplasty. Results were featured at the 2024 American Association of Hip and Knee Surgeons (AAHKS) annual meeting and were presented by Dr. Nicolas S. Piuzzi, MD, of the Cleveland Clinic Foundation in Cleveland, Ohio. The APEX clinical program enrolled 152 patients across 23 centers in the U.S., with 76 patients treated in each study arm. Results demonstrated a statistically significant net treatment effect at 12-months of 19% (MSIS Tier 1, VT-X7: 71% vs. Control: 52%). Additionally, the median time to revision arthroplasty was significantly shorter at 7 days in VT-X7 patients compared to 98 days in patients with standard two-stage exchange. Of those patients completing revision arthroplasty (VT-X7: 100% vs. Control: 82%), patients treated with VT-X7 had a shorter overall procedure time by 62 minutes compared to patients treated with two-stage exchange. When considering the overall burden of PJI to the patients during the study follow-up period (i.e. time spent without a permanent implant and/or time spent as a failure), VT-X7 reduced PJI burden by 71% compared to standard two-stage exchange. Overall, the 12-month results demonstrated both a statistically significant and clinically meaningful treatment effect with VT-X7 compared to standard two-stage exchange. “A periprosthetic joint infection presents a significant challenge, with treatment often requiring multiple surgeries and prolonged rounds of antibiotics, which can profoundly disrupt a patient’s life. The APEX clinical program results are impressive, demonstrating a clinical advantage of rapid exchange arthroplasty with target site irrigation and providing surgeons with a promising, transformative approach to treating PJI, one that addresses the need to expedite infection eradication and allow patients to reclaim their lives.” says Dr. Piuzzi, Principal Investigator for the APEX-2 clinical study. About Periprosthetic Joint Infection (PJI) Affecting over 40,000 people in the U.S. annually, PJI is a rare and potentially devastating complication of joint replacement surgery in which pathogenic bacteria colonize the joint prosthesis, forming difficult-to-remove structures called biofilms. Biofilm infections are challenging to resolve, requiring long, invasive and expensive treatments that are often unsuccessful, resulting in high rates of permanent disability and early death. Recent retrospective analyses demonstrate that the current gold standard for treatment of PJI, two-stage exchange arthroplasty, takes an average of 16 weeks and has a success rate under 50% after 12 months, highlighting the unmet need for faster and more efficacious treatment options. About VT-X7 KIT VT-X7 KIT (vancomycin hydrochloride and tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin, two well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a 7-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these challenging infections. In clinical studies of VT-X7, 100% of patients were treated and received a new permanent joint prosthesis in seven days with >90% remaining infection-free after one year. The US Food and Drug Administration has granted VT-X7 Breakthrough Therapy, Orphan Drug, Fast Track and Qualified Infectious Disease Product designations. This initial application of VT-X7 represents a first-of-its-kind, multibillion-dollar opportunity to dramatically improve outcomes for a serious unmet medical need in PJI. About Osteal Therapeutics, Inc. Osteal Therapeutics is a privately held, clinical-stage biopharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences. The company is leveraging the ability of concentrated, locally delivered antimicrobials to treat the bacterial biofilms typically responsible for musculoskeletal infections while minimizing off-target tissue exposure and associated adverse effects. Osteal employs a low-risk development strategy by using approved drugs with long histories of safety and efficacy as candidates for new routes of local delivery. The company’s lead candidate, VT-X7 KIT, is in late-stage clinical development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com Corporate Contact: Todd SaundersVice President of MarketingOsteal Therapeutics, Inc.Phone: 469-809-2630Email: info@ostealtx.com