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, today announced the expansion of its leadership team with the appointments of Kathy Burke as Vice President of Market Access, Clay Cohorn as Vice President of Clinical Affairs, Trey Putnam, PhD, RAC as Vice President of Regulatory Affairs and Quality Assurance, and Todd Saunders as Vice President of Marketing. All four will report to Osteal’s Chief Executive Officer (CEO), David Thompson. Each of these seasoned leaders bring over twenty years of experience in the development, approval, or commercialization of complex biopharmaceutical products. These appointments come at a critical time as Osteal accelerates its clinical, regulatory and product development programs.
“I am excited to welcome Kathy, Clay, Trey and Todd. It is remarkable how quickly the team coalesced around the goal of lifting the burden of musculoskeletal infections for patients, providers and payers. We are executing like a group that has worked together for years not months,” said Mr. Thompson. “We now have the right leadership and expertise to deliver on our ambitious 2023 plan and build a world-class organization bringing change to a condition that hasn’t seen significant outcome improvements in two decades.”
About Periprosthetic Joint Infection (PJI)
Affecting over 40,000 people in the U.S. annually, periprosthetic joint infection (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 evidence demonstrates 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 more reliable treatment options.
About VT-X7
VT-X7 (VT-X7 irrigation system, vancomycin hydrochloride for irrigation and tobramycin sulfate for irrigation) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin, well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a seven-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these rare challenging infections. In a Phase 2 clinical study of vancomycin and tobramycin delivered by irrigation, 100% of patients were treated and received a new permanent joint prosthesis in seven days with 93% remaining infection free at one year. Osteal recently completed enrollment of the Phase 2 “APEX” clinical study, a randomized controlled trial of VT-X7 compared to the current standard of care for treatment of PJI, two-stage exchange arthroplasty. The US Food and Drug Administration granted VT-X7 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 an underserved patient population.
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, is in Phase 2 development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com
Corporate Contact:
Todd Saunders
Vice President of Marketing
Osteal Therapeutics, Inc.
Phone: 469-809-2630
Email: info@ostealtx.com
