FAQ

Frequently Asked Questions

Frequently Asked Questions

Who is Molecular Biologicals?

A biotechnology company based on a broad and solid therapeutic keratin platform that provides therapeutic prescription-only keratin products for dermatological, regenerative, and woundcare markets.

What are Keragel® and KeragelT®?

Keragel® and KeragelT ® are hydrogels enriched with pharmaceutical-grade keratin protein that deliver Replicine™ Bioactive Keratin to the wound while maintaining a moisture-rich environment. Keragel® and KeragelT® are indicated for acute/chronic superficial and partial thickness wounds with dry-to-medium exudate, such as:

  • Venous leg ulcers
  • Arterial ulcers
  • Diabetic ulcers
  • Pressure ulcers
  • Skin graft donor sites
  • First- and second-degree burns
What is the difference between Keragel® and KeragelT®

KeragelT® has the same ingredients as Keragel® but with a thinner viscosity that is faster drying, ideal for patients with delicate skin.

What is Keramatrix®?

Keramatrix® is an absorbable matrix enriched with pharmaceutical-grade keratin protein that delivers Replicine'" Bioactive Keratin as it dissolves into the wound. Keramatrix® is presented sterile in peel-open packages for single use. Keramatrix® is indicated for:

  • Acute surgical wounds
  • Chronic vascular ulcers
  • Partial and full thickness wounds
  • Venous ulcers
  • Donor sites/grafts
  • Pressure ulcers
  • Podiatric wounds
  • Traumatic wounds
  • Wound dehiscence
  • First- and second-degree burns
  • Diabetic ulcers
What patient types can benefit from Molecular Biological's keratin-based products?

Clinical efficacy with Molecular Biological's keratin products has been demonstrated in:

  • Acute surgical wounds
  • Chronic wounds
  • Diabetic foot ulcers
  • Pressure ulcers
  • Venous stasis ulcers
  • Arterial ulcers
  • Vascular ulcers of mixed etiology
  • Improving skin condition and quality of life for those living with Epidermolysis Bullosa (EB)
  • Skin graft donor sites
  • First- and second-degree burns
  • Skin tears
  • Superficial injuries, cuts, abrasions, and surgical wounds
How are Molecular Biologicals' products different?

Molecular Biologicals has developed 3 advanced wound-healing products that deliver pharmaceutical-grade Replicine'" Bioactive Keratin to the wound bed, facilitating a moist wound-healing environment and effectively managing wound exudates. All 3 products have been observed to:

  • Increase the rates of proliferation and migration of keratinocyte cells to jumpstart the healing process
  • Accelerate epithelialization and wound closure
  • Stimulate critical collagens (IV and VII) for wound healing
  • Provide an optimum healing environment while promoting tissue healing
  • Improve healing in surgical wounds, cuts, or abrasions
What is Replicine'" Bioactive Keratin?

Replicine'" Bioactive Keratin is derived from a proprietary manufacturing process that carefully extracts the keratin protein from sheep's wool, fully intact. By maintaining the form and function of the protein, as well as its bioactivity-the main factor needed for healing, this technology controls the molecule, creating a versatile biopolymer material that can be formed into a liquid, gel, or a solid.

How do you apply Keragel®?
INSTRUCTIONS FOR USE
  1. Cleanse and debride the wound in accordance with normal procedures.
  2. Ensure that the skin surrounding the wound is dry.
  3. To open the tube, use the piercer cap to break the nozzle seal. To ensure sterility, sanitize the piercer cap before use.
  4. Apply a 3mm to 6mm (1/8inch to 1/4inch "thickness of a dime") layer of Keragel® to cover the entire wound surface.
  5. Cover with an appropriate secondary dressing if needed.
RECOMMENDED CARE
  • The wound should be inspected daily or as indicated by a physician. For wounds that appear dry, more gel should be applied to the area
How do you apply KeragelT®?
INSTRUCTIONS FOR USE
  1. Cleanse and debride the wound in accordance with normal procedures.
  2. Ensure that the skin surrounding the wound is dry.
  3. To open the tube, use the piercer cap to break the nozzle seal. To ensure sterility, sanitize the piercer cap before use.
  4. Apply a 1mm to 3mm (1/8inch to 1/4inch) layer of KeragelT ® to cover the entire wound surface daily or as indicated by a healthcare professional.
  5. Cover with an appropriate secondary dressing if needed.
RECOMMENDED CARE
  • The wound should be inspected daily or as indicated by a physician. For wounds that appear dry, more gel should be applied to the area

For additional information about using KeragelT with patients who have EB, please call:
1-844-793-9933 or visit www.molecularbiologicals.com

How is Keramatrix® applied?

Keramatrix® should only be applied by a health care provider (Note: always handle using aseptic technique).

WOUND BED PREPARATION AND APPLICATION
  1. Prepare the wound area using standard debridement methods; the wound may be surgically debrided to ensure the wound edges contain viable tissue.
  2. Cut the dry Keramatrix® sheet into a piece slightly larger than the outline of the wound area. If the wound is larger than a single sheet, multiple sheets may be used, overlapping edges as necessary.
  3. For a wound with a low level of exudate, hydrate the matrix by soaking it in sterile saline solution for 2 minutes prior to application.
  4. Place the edge of the sheet in contact with intact tissue and smooth the matrix so that it contacts the underlying wound bed. If multiple sheets are used, overlap adjoining sheets to provide coverage of the entire wound. Secure with physician's preferred method of fixation (steri-strips, sutures, staples, clips).
  5. After application, use an appropriate non-adherent, occlusive secondary dressing to maintain a moist environment. Ensure the dressing is well restrained.
REAPPLICATIONS
  1. Change Keramatrix® as necessary every 4 to 5 days or as determined by the healthcare provider. Do not remove existing gel or matrix areas. The matrix will caramelize into a gel and have an off-white or light brown color.
  2. Once cleansed with a sterile saline solution, Keramatrix® may be reapplied. Ensure that there are no bleeding areas and the wound edges are clean.
  3. For a wound with a medium to high level of exudate, place the edge of the sheet in contact with intact tissue and smooth the dressing so it contacts the underlying wound bed. Small openings can be cut into the sheet prior to application to allow adequate drainage and ensure tissue matrix contact with the wound bed.
  4. Carefully document healing progression using customary healing parameters. Proceed with reapplication of appropriate non-adherent occlusive secondary dressing and maintain a moist environment.
  5. If infection, excessive redness, blistering, or allergic reaction occurs, the matrix material should be removed.
What type of adverse events (AEs) have been seen with the use of these products?

No AEs have been reported.

How can I obtain samples of Keragel®, KeragelT®, or Keramatrix®?

Please call 1-844-793-9933 or email: info@molecularbiologicals.com to request a representative visit

Who should not use these products?

These products should not be used in patients with known sensitivity to keratin.

Where can I get more information?

Please call 1-844-793-9933 or visit http://www.molecularbiologicals.com