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VENOUS ULCERS

Transform Your Venous Ulcer Treatment Results

VenoHeal™ technology combines advanced compression and bioactive materials to achieve 35% faster healing rates for even the most challenging venous leg ulcers.
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Clinically Proven

Medicare Approved

94% Success Rate

Leg Wound Healing

Complete Venous Ulcer Solution​

Our comprehensive approach addresses every aspect of venous leg ulcer treatment, from initial assessment to complete healing and prevention of recurrence.

Rapid Healing Technology

Our innovative multi-component compression system shows a remarkable 35% wound closure rate after just six weeks, with 87% of patients showing significant improvement.

Simple Application System

Efficient, effective treatment delivery optimized for the high-throughput environments of outpatient wound care clinics, for optimal clinical results and maximum productivity.

Cost-Effective Care

Reduces overall treatment costs by up to 3x compared to traditional methods. Studies show the potential savings of substantial savings with our advanced therapy.

Evidence-Based Protocol

Developed from extensive clinical research and real-world data from 81 U.S. wound care centers, ensuring optimal outcomes across all patient populations.

Enhanced Patient Comfort

Designed for maximum patient comfort and adherence with flexible materials that conform perfectly to the leg with minimal slippage, even during regular activities.

Advanced Cellular Technology

Incorporates cellular and tissue-based products (CTPs) that work synergistically with compression therapy to accelerate healing in challenging chronic wounds.

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Wound Closure Rate in Only 6 Weeks
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Overall Clinical Improvement Rate
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More Cost-Effective Than Standard Care
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Clinician Satisfaction With Therapy
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Advanced Treatment

VenoHeal™ Advanced Treatment System

Our flagship product combines innovative compression technology with bioactive materials to create the optimal healing environment for venous leg ulcers.

Intelligent Pressure Distribution

Provides consistent 40mmHg compression with graduated pressure distribution to maximize venous return while remaining comfortable for patients.

Visual Application Indicators

Unique pattern guides proper application technique, ensuring consistent compression with each application regardless of caregiver experience level.

Moisture Management Technology

Advanced materials actively manage wound exudate while maintaining optimal moisture levels, creating the ideal environment for cellular healing.

Antimicrobial Protection

Built-in silver ion technology provides continuous antimicrobial protection without cytotoxicity, reducing bioburden and infection risk.

Why Focus on These Products?​

65% of wounds encompass three main conditions – Diabetic, Pressure, and Venous Ulcers.
The estimated annual cost burden for care of diabetic foot disease is $18.7 billion for Medicare recipients, and approximately $80 billion for overall treatment across all age groups.
Amnion-Chorion Membranes

Measurable Clinical Outcomes

VenoHeal™ has demonstrated exceptional results in clinical settings, significantly outperforming traditional venous ulcer treatments across all key metrics.

Superior Healing Rates

In comparative studies, VenoHeal™ has consistently demonstrated accelerated healing rates and improved patient outcomes compared to standard compression therapy alone.
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Faster healing times across all wound types compared to standard compression
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Reduction in wound-related complications when following VenoHeal™ protocols
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Success rate with challenging ulcers of >10cm² and >12 months duration

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Reduction in recurrence rates over 24-month follow-up period

Antimicrobial Protection

Antimicrobial peptides such as defensins and elafin in amniotic fluid confer intrinsic antibacterial properties, reducing infection rates in chronic wounds. 

Dehydration and cryopreservation techniques preserve these biological attributes while extending shelf life, enabling off-the-shelf availability for clinical use.

Clinical Effecacy

Across Wound Types

Evidence-based outcomes have been established for a variety of chronic wounds, highlighting the importance of employing biomedical research and clinical studies to guide effective treatment strategies.

DFUs, characterized by impaired angiogenesis and persistent inflammation, benefit uniquely from amnion-chorion substitutes.

The hypoxic wound microenvironment in diabetes is ameliorated by placental membranes’ oxygen-carrying capacity, while angiogenic factors like vascular endothelial growth factor (VEGF) stimulate capillary formation.

  • Rapid Closure: 85% of DFUs heal within 4 weeks when dHACM is applied weekly
  • Superior Results: 65% closure at 12 weeks versus 41.1% for standard care
  • Refractory Wounds: 66% of previously treatment-resistant DFUs achieve complete closure within 77 days

VLUs, often complicated by edema and fibrinous exudate, require therapies that withstand mechanical stress while modulating inflammation.

CTPs provide the mechanical strength and biological signaling needed to address these complex wounds.

  • Enhanced Compression Therapy: 60% closure rates versus 35% for compression alone
  • Faster Resolution: Reduction in healing times by 42 days compared to standard treatments
  • Cost Reduction: 31% lower total treatment costs over 6 months due to fewer dressing changes and visits
Research Studies

Key Clinical Trials Overview

Comprehensive analysis of randomized controlled trials and comparative studies supporting the efficacy of amnion-chorion products

DEBTAL Trial

n=168 • 24-week

  • Objective: Compare acellular dermal matrices (ADMs) against standard care for DFUs
  • Methods: Multicenter RCT with 24-week follow-up period
  • Key Finding: Single applications of DermACELL® (amnion-chorion matrix) achieved 65% closure at 12 weeks versus 41.1% for standard care
  • p-Value: p<0.001
  • Walters et al. (2016), Int Wound J, 13(6):1111-1120

Snyder VLU Study

n=109 • 12-week

  • Objective: Evaluate dHACM as an adjunct to compression therapy for venous leg ulcers
  • Methods: 12-week randomized clinical trial with standard compression
  • Key Finding: dHACM plus compression therapy achieved 60% closure rate versus 35% for compression alone
  • Significance: Attributed to membrane's metalloproteinase inhibition and TGF-β3-mediated fibrotic regulation
  • Snyder et al. (2016), J Wound Care, 25(7):S22-S28

Zelen Comparative Study

n=100 • Multi-center

  • Objective: Compare dehydrated human amnion/chorion membrane (dHACM) with bilayered living cellular construct (BLCC)
  • Methods: Prospective, randomized, controlled multicenter clinical trial
  • Key Finding: 97% DFU closure with weekly dHACM versus 73% for BLCC, with median closure times of 23.6 versus 34 days
  • p-Value: p=0.0498
  • Zelen et al. (2014), Int Wound J, 13(6):1271-1277

Tettelbach DFU Study

n=110 • RCT

  • Objective: Evaluate efficacy of dHACM allograft for chronic DFUs
  • Methods: Prospective, randomized, controlled, multi-center clinical trial
  • Key Finding: dHACM showed 70% complete healing at 12 weeks vs. 50% for standard care alone
  • Hazard Ratio: 2.15 (95% CI 1.30-3.57)
  • Tettelbach et al. (2019), Int Wound J, 16(1):122-130

Meta-Analyses

  • Haugh et al. (2017)
  • Studies Included: 16 RCTs
  • Total Patients: 1,021
  • Pooled Results: Amnion-chorion products demonstrated 32% greater probability of complete healing compared to standard care (RR = 1.32, 95% CI 1.22-1.43)
  • Corallo et al. (2023)
  • Studies Included: 24 studies
  • Quality Assessment: High methodological quality using GRADE approach
  • Key Finding: dHACM showed statistically significant advantage over conventional treatments for wound healing rate, time to heal, and area reduction

Cost-Effectiveness Evidence

Comparative Cost Analysis

Methodology: 2019 cost-utility analysis (n=120 VLUs)

Result: SIS-amnion composite grafts reduced total treatment costs by 31% over 6 months due to fewer dressing changes and outpatient visits

ICER: $18,450 per QALY for dHACM in DFUs (below $50,000/QALY threshold)

Long-Term Economic Impact

Reduction in:

  • Hospital readmissions
  • Amputation rates
  • Nursing time
  • Overall treatment duration

Ongoing Clinical Trials

AMSC-Seeded Matrices (NCT04889213)

Status: Phase II, Recruiting

Focus: Evaluating AMSC-seeded chorion matrices for neuropathic DFUs

Preliminary Data: 89% closure at 16 weeks vs. 52% for acellular grafts

AI-Driven Customization        (MultiTech-034)

Status: Pre-registration

Design: Adaptive platform trial using machine learning algorithms

Innovation: Matching dHACM variants to ulcer microenvironments based on proteomics

Expected Completion: Q4 2025

Strength of Evidence Assessment

Application
Evidence Level
Key Findings
Recommendation
Diabetic Foot Ulcers
Level I (High)
Multiple RCTs demonstrate superior healing rates (70-97%) and faster closure times
Strong recommendation for use in non-healing DFUs after 4 weeks of standard care
Venous Leg Ulcers
Level II (Moderate)
RCTs show 60% closure with adjunctive use; particularly effective for ulcers >12 weeks duration
Moderate recommendation as adjunct to compression therapy for refractory VLUs
Pressure Ulcers
Level II-III (Limited)
Small RCTs and cohort studies show promising results; larger studies needed
Conditional recommendation for Stage III-IV pressure ulcers after standard care failure
Surgical Wounds
Level III (Limited)
Case series show accelerated healing in complex surgical defects; limited comparative data
Consider for complex surgical wounds with exposed structures

Evidence Level Definitions:

Level I: Multiple high-quality RCTs with consistent findings

Level II: Single high-quality RCT or multiple lower-quality RCTs

Level III: Non-randomized controlled trials, cohort studies, or case series

Approximately 6.5 million people in the United States, or about 1 in 38 adults, are affected by chronic wounds each year.

* Chronic Wound Management: From Gauze to Homologous Cellular Matrix

1:38

adults have a chronic wound

Our advanced skin and tissue solutions accelerate healing, reduce recovery time, and help people return to a higher quality life.
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