Sequence LifeScience Enrolls First Patient in Clinical Trial Evaluating Placental Membrane Grafts for Diabetic Foot Ulcers

Sequence LifeScience Inc., a leader in allograft tissue processing, has announced a key milestone in its clinical development program, the first patient has been enrolled and treated in its multicenter, prospective, matched-controls clinical trial evaluating the safety of the company’s placental membrane grafts for diabetic foot ulcers (DFUs).

About the Trial

This study represents the first prospective clinical trial evaluating Sequence LifeScience’s proprietary placental membrane allografts for chronic DFUs. These grafts have been previously utilized in the treatment of both acute and chronic wounds.

• Study Type: Prospective, multicenter, matched-controls clinical trial
• Primary Objective: To evaluate safety and wound closure outcomes in patients with hard-to-heal diabetic foot ulcers
• Condition Overview: DFUs affect more than 4 million people globally and are among the leading causes of lower limb amputation
• Enrollment Status: Ongoing across select clinical research sites in the U.S.
• Preliminary Data: Expected by mid-2026

A Novel Matched-Control Design

The trial employs a matched controls design that leverages patient data from the U.S. Wound Registry instead of using a traditional untreated control group.

This Institutional Review Board (IRB)-approved approach allows researchers to:

• Use matched control data from patients with similar characteristics
• Reduce total patient enrollment needs, speeding up trial completion
• Accelerate patient access to therapies demonstrating clinical benefit

Expert Commentary

“Enrolling and grafting our first patient is a significant achievement not only for Sequence LifeScience but also for patients and clinicians who continue to face the devastating consequences of chronic, non-healing diabetic wounds. These placental membrane grafts leverage the body’s own biological signals to stimulate healing in tissues that are resistant to conventional therapies.”

• Dr. Serena, Founder & CEO of SerenaGroup, Inc. and lead investigator for the study.

About the Investigational Product

The investigational placental membrane grafts are derived from human placental tissue and processed using the company’s proprietary AlloKleen™ Process.

• The process is designed to preserve structural and biochemical integrity of the extracellular matrix, maintaining the biological cues necessary for tissue repair.
• Clinical use since 2022 has already shown promising outcomes in real-world applications.

“We know our products are safe and effective — over 38,000 grafts have been distributed over the past three years. This controlled study is designed to demonstrate effectiveness and support Medicare reimbursement for patients receiving these products. We are committed to addressing the urgent unmet need in diabetic wound care.”

• Brian Kieser, President & CEO of Sequence LifeScience, Inc.

About Sequence LifeScience, Inc.

Sequence LifeScience is a biomedical company focused on developing advanced regenerative therapies using ethically sourced human allograft tissues. The company’s proprietary processing technologies support a new generation of biologics aimed at improving clinical outcomes in:

• Wound care
• Surgical repair
• Tissue regeneration

With a strong commitment to clinical excellence, Sequence LifeScience continues to advance regenerative medicine solutions for conditions with high unmet medical need.

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