DALLAS, Dec. 29, 2022 (GLOBE NEWSWIRE) — Osteal Therapeutics, Inc. (“Osteal”), a clinical-stage biopharmaceutical company developing a new category of combination products for musculoskeletal infections, announced Today, we announced the expansion of the company’s leadership team. Named Kathy Burke VP Market Access, Clay Cohorn VP Clinical, Dr. Trey Putnam, RAC VP Regulatory Affairs and Quality Assurance, and Todd Sanders VP Marketing . All four will report to David Thompson, his Osteal CEO. Each of these experienced leaders has over 20 years of experience in the development, approval or commercialization of complex biopharmaceuticals. These appointments come at a critical time as Osteal accelerates its clinical, regulatory and product development programs.
“We are thrilled to welcome Cathy, Clay, Trey and Todd. “We are now delivering on our ambitious 2023 plan, and we are moving from 20 years without significant improvement,” said Thompson. We have the right leadership and expertise to build a world-class organization that delivers.”
About Periprosthetic Joint Infection (PJI)
Affecting more than 40,000 people in the United States each year, periprosthetic joint infection (PJI) is a rare complication of joint replacement surgery in which pathogenic bacteria colonize the artificial joint and are difficult to remove, called a biofilm. Can form difficult structures. Biofilm infections are difficult to resolve and require long-term, invasive and expensive treatments that are often unsuccessful and result in high rates of permanent disability and premature death. The current gold standard of treatment, two-stage arthroplasty, takes an average of 16 weeks and has a success rate of less than 50% after 12 months, indicating an unmet need for a faster and more reliable treatment option. It is embossed.
VT-X7 (VT-X7 Irrigation System, Vancomycin Hydrochloride for Irrigation and Tobramycin Sulfate for Irrigation) was designed to deliver therapeutic concentrations of the well-established broad-spectrum antibiotics vancomycin and tobramycin directly to the patient. , is a novel drug/device combination product for joint space and surrounding tissue to treat PJI. VT-X7 is a 7-day therapy designed to address the unmet clinical need for rapid, reliable treatment for these rare and difficult infections. In a phase 2 clinical trial with vancomycin and tobramycin irrigation, 100% of patients were treated in her 7 days and received a new permanent joint prosthesis, and after 1 year he remained 93% infection-free. did. Osteal recently completed enrollment in the Phase 2 “APEX” clinical trial. This was a randomized controlled trial of VT-X7 compared to PJI’s current standard of care, his two-stage replacement arthroplasty. The U.S. Food and Drug Administration has granted VT-X7 Orphan Drug, Fast Track, and Qualified Infectious Disease Product designations. This first application of VT-X7 represents a first-of-its-kind multi-billion dollar opportunity to dramatically improve outcomes for underserved patient populations.
About Osteel Therapeutics
Osteal Therapeutics is a privately held, clinical-stage biopharmaceutical company developing novel musculoskeletal therapies to treat orthopedic infections and their consequences. The company leverages the ability of concentrated, locally delivered antimicrobials to treat the bacterial biofilms responsible for musculoskeletal infections, while minimizing off-target tissue exposure and associated adverse effects. I’m here. Osteal employs a low-risk development strategy by using approved medicines with long histories of safety and efficacy as candidates for new local delivery routes. The company’s lead candidate, VT-X7, is in Phase 2 development for the treatment of periprosthetic joint infection, a serious complication of joint replacement surgery. For more information, please visit www.ostealtx.com.
Vice President of Marketing
Osteel Therapeutics, Inc.