Tiger BioSciences Announces Publication of Interim TIGERCAMP Randomized Controlled Trial Data Demonstrating caregraFT™ Plus Standard of Care Outperformed Standard of Care Alone Across Key Interim Wound-Healing Measures
PR Newswire
CONSHOHOCKEN, Pa., May 28, 2026
CONSHOHOCKEN, Pa., May 28, 2026 /PRNewswire/ — Tiger BioSciences announced the publication of interim data from the ongoing TIGERCAMP randomized controlled trial (RCT), now publicly available through ClinicalTrials.gov under Identifier NCT06826339. The findings are planned for publication in the Journal of Chronic Wound Care Management and Research (CWCMR).
The TIGERCAMP trial is a multicenter, prospective, randomized controlled platform study evaluating caregraFT™, a full-thickness placental membrane allograft, as an adjunct to standard of care (SOC) in patients with non-healing diabetic foot ulcers (DFUs).
In this interim analysis, caregraFT™ plus standard of care outperformed standard of care alone across the key wound-healing measures evaluated, demonstrating stronger closure and wound reduction outcomes compared with traditional standard of care alone, which primarily consists of conservative wound management techniques such as debridement, moisture-retentive dressings, offloading, and compression. SOC often remains insufficient for achieving timely closure in many non-healing diabetic foot ulcers. caregraFT in combination with SOC meaningfully shifts the trajectory of chronic diabetic foot ulcer healing from passive wound management to active tissue regeneration.
Key interim findings demonstrate that the caregraFT™ study arm outperformed SOC alone:
- Higher complete wound closure: 46% of patients receiving caregraFT™ plus SOC achieved complete wound closure compared with 28% of patients receiving SOC alone.
- Greater wound area reduction: Patients treated with caregraFT™ plus SOC demonstrated a 61% mean percent area reduction (PAR) compared with 39% for SOC alone.
- Strong Bayesian probability of benefit: Interim Bayesian analysis showed a 96% probability of wound closure benefit with caregraFT™ plus SOC compared with SOC alone.
- Approximately 1.8x greater likelihood of closure: Patients treated with caregraFT™ plus SOC were approximately 1.8X more likely to achieve wound closure compared with receiving SOC alone.
- Favorable safety profile at interim analysis: No product-related adverse events or serious adverse events were observed in the caregraFT™ treatment group during this interim stage.
Across every reported interim wound-healing measure, caregraFT™ plus standard of care demonstrated stronger outcomes than SOC alone, including higher complete closure, greater percent area reduction, and an approximately 1.8X greater likelihood of wound closure.
These TIGERCAMP interim results align with large-scale evidence reviews, including a 2,000+ patient meta-analysis of 12 modern randomized controlled trials and a systematic review of 35 prior RCTs included in Medicare’s 2025 LCD evidence review.1
“The interim TIGERCAMP data are clear: caregraFT™ plus standard of care outperformed standard of care alone across the wound-healing measures evaluated,” said Garrett Grinsfelder, President of Tiger Wound Care. “Patients treated with caregraFT™ plus standard of care achieved higher complete wound closure, greater percent area reduction, and an approximately 1.8x greater likelihood of closure compared with standard of care alone. These findings reinforce our confidence in caregraFT™ and our commitment to advancing evidence-based solutions for patients with hard-to-heal wounds.”
Sponsored by Tiger BioSciences, the ongoing Phase IV study is taking place across multiple clinical sites throughout the United States. Primary study endpoints include complete wound closure at 12 weeks, with secondary endpoints evaluating percent area reduction, time to closure, pain reduction, adverse events, and patient quality of life metrics.
Additional information regarding the TIGERCAMP study, including enrollment criteria and participating sites, is available at ClinicalTrials.gov under Identifier NCT06826339.
Reference
1. Medicare 2025 LCD: Systematic review of evidence from the 2024 final LCD, which included 35 prior RCTs (2024 and before).
About Tiger BioSciences
Tiger BioSciences, headquartered in Conshohocken, PA, is a vertically integrated tissue engineering company specializing in the recovery, processing, development, research, and distribution of cellular, acellular, and matrix-like products (CAMPs) and aesthetic technologies. Built on a deep heritage of human cell and tissue processing expertise, the company functions as a tissue recovery agency, processing innovator, aesthetics device manufacturer, and commercial partner to clinicians, delivering cutting-edge solutions that meet the evolving needs of providers and their patients and enabling life-changing, head-to-toe treatment options across a wide range of applications. Tiger BioSciences remains steadfast in its commitment to patients, providers, and donor families.
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