#United States #Phoenix #Clinical Trials #BioLab Holdings #Chronic Wounds

BioLab Holdings Inc. and Its Latest Clinical Trials

BioLab Holdings Inc., a prominent medical manufacturer situated in Phoenix, has recently announced a series of clinical trials aimed at revolutionizing care for chronic wounds. This initiative primarily focuses on non-healing wounds, including diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). The company’s commitment to advancing wound care through innovative solutions is exemplified in its development of Cellular, Acellular, and Matrix-like Products (CAMPs), which are intended to effectively cover and protect problem wounds.

The Drive for Clinical Trials

The implementation of these clinical trials comes in response to urgent requests from the Medicare Administrative Contractors (MAC) region, which are seeking solid evidence to affirm the efficacy of wound care products. Effective January 1, 2026, the MAC is set to implement a Local Coverage Determination (LCD) for DFUs and VLUs, requiring robust clinical data to support product validation and coverage.

The BIOCAMP Trial

A centerpiece of these efforts is the BIOCAMP trial, a multicenter, prospective, randomized controlled study. This trial aims to assess the effectiveness of human placental membrane products when used in conjunction with standard of care (SOC) compared to the SOC alone. Notably, this innovative trial design allows for a simultaneous evaluation of various products over diverse wound types against a SOC reference arm. Dr. Marshall Medley, Chief Medical Officer at BioLab, emphasized the significance of this study, stating that it marks a pivotal moment for rigorous clinical research in wound care. Preliminary outcomes from the trial will be presented at the upcoming TRES conference on October 30.

CAMP RWE Trial

In addition to the BIOCAMP trial, the CAMP RWE trial is being conducted. This multifaceted study compares the results of patients treated with either a tri-layer or a single-layer amnion graft against a matched retrospective control cohort. The hybrid study design integrates both retrospective SOC and prospective real-world evidence (RWE) treatment arms, thereby enhancing the reliability of its findings. Dr. Windy Cole, who is involved with the publication of the results, will assist in sharing these significant findings.

Real-World Data Collection

BioLab is also taking steps to gather real-world data through an ongoing study that evaluates the effectiveness of amniotic membranes on various types of wounds, including diabetic foot ulcers and post-operative wounds. This real-world assessment involves patients who have previously received treatment with BioLab’s products. The findings will complement ongoing randomized trials, aiming to provide a comprehensive understanding of product efficacy. Dr. Carlos Encinas, Chief Science Officer at BioLab, highlighted the importance of these studies in adhering to the MAC region's stringent data demands and ensuring patients benefit from advanced wound care solutions.

Supportive Meta-Analyses

Additionally, BioLab is actively backing meta-analyses spearheaded by the Serena Group, including a substantial mega-meta-analysis. The primary objective of this analysis is to illustrate that membrane products can yield similar healing rates regardless of the brand, which can bolster providers’ confidence in the efficacy and safety of amniotic products. This effort substantiates BioLab's mission of prioritizing high-quality outcomes in wound treatment.

Future Directions

The prospective LCD set to take effect on January 1, 2026, will be limited to treatments for DFUs and VLUs specifically, while other types of wounds must conform to established care standards prior to application. For BioLab Holdings, this array of clinical trials not only underscores a proactive approach to chronic wound management but also signifies an unwavering dedication to validating wound care products through scientific rigor and clinical excellence.

To discover more about the innovative wound care solutions offered by BioLab Holdings Inc., visit biolabholdings.com.