CleraFlexTM
GelSana is redefining wound healing with proven technology designed to optimize the wound healing cascade. Overactive inflammation impairs the body’s natural healing process.
Normal Healing
Non-Healing
Backed by Science and Preclinical Studies.
CleraFlex Supports Wound Healing with Decreased Inflammation
Inflamed macrophages co-cultured with CleraFlex exhibit reduced expression of IL-6, IL-1β, and TNF-α.
*p<0.05 for CleraFlex vs. Inflammation
CleraFlex Promotes Faster Healing in Diabetic Wounds Compared to a Leading Biologic Drug
CleraFlex healed more diabetic wounds at 14 days in a large animal (porcine) model compared to an FDA-approved biologic drug.
Reduced Bacterial Burden in Infected Burn Wounds Treated with CleraFlex
In infected burn wounds in a large animal (porcine) model, CleraFlex was found to significantly decrease bacterial load.
*p<0.05 for CleraFlex vs. Saline
Single Solution. Treat Chronic, Surgical and Burn Wounds Across the Wound Cascade.
GelSana’s novel polymer technology supports the natural wound healing process with reduced inflammation at the wound site, and has been shown to improve healing in animal trials. Improved healing reduces the risk of infection and amputation. Our polymers can be applied to wounds more readily then current dressings: they are extrudable yet highly elastic and stretchable. They gently adhere to the surrounding healthy tissue while not adhering to a moist wound bed. As a partially hydrated material, they donate moisture to wounds and they are also able to accept moisture from wounds.
CleraFlex™ is a non-sterile, single-patient, single-use wound dressing intended for the management of wounds. The device is intended to create and maintain a moist wound environment to support the wound healing process.
CleraFlex™ is intended for use under the direction or supervision of a healthcare professional in clinical or home care settings.
CleraFlex™ is indicated for use on wounds, including:
- Diabetic foot ulcers
- Leg (arterial and venous) ulcers
- Pressure sores (bed sores)
- Malignant or fungating wounds
- Surgical wounds and incisions
- Second-degree burns
CleraFlex™ is not intended to be implanted inside the body.
- Single use only. Do not reuse the syringe after it has been opened.
- Do not swallow.
- Keep out of reach of children and animals.
- Use with caution near the eyes. If the product gets in your eyes, rinse thoroughly with water.
- Use caution in deep wounds with narrow openings (e.g., fistulas).
- CleraFlex should not be used on infected wounds unless directed by a healthcare professional.
Although uncommon, the following adverse reactions may occur:
- Localized hypersensitivity or allergic reaction (e.g., redness, itching, rash)
- Skin maceration due to excessive moisture
- Mild, transient irritation at the application site
When Should I Contact My Healthcare Provider?
Contact your healthcare provider immediately if:
- Your wound worsens
- You notice signs of infection
- You develop an allergic reaction (e.g., rash, itching, swelling)
- You experience unexpected pain or discomfort
For serious issues related to CleraFlex, contact your healthcare provider and report the incident to GelSana Therapeutics, Inc.
Publications
- Stager MA, Adhikari B, Raichart A, Krebs MD. Self-Initiated Photopolymerization of Anti-Inflammatory Hydrogels with Sustained Release. ACS Macro Letters, 12(1), 65-70, Jan. 2023.
- Stager M, Bardill J, Raichart A, Osmond M, Niemiec S, Zgheib C, Seal S, Liechty K, Krebs MD. Photopolymerized Zwitterionic Hydrogels with Sustained Delivery of Cerium Oxide Nanoparticle-miR146a Conjugate Accelerates Diabetic Wound Healing. ACS Applied Bio Materials, 5(3), 1092-1103, March 21, 2022.
- Bardill JR, Laughter MR, Stager M, Liechty KW, Krebs MD, Zgheib C. Topical Gel-Based Biomaterials for the Treatment of Diabetic Foot Ulcers. Acta Biomaterialia, 138, 73-91, Jan 2022.
- Sener G*, Hilton SA*, Osmond MJ, Zgheib C, Newsom JP, Dewberry L, Singh S, Sakthivel TS, Seal S, Liechty KW*, Krebs MD*. Injectable, Self-Healable Zwitterionic Cryogels with Sustained MicroRNA-Cerium Oxide Nanoparticle Release Promote Accelerated Wound Healing.Acta Biomaterialia, 101, 262-72, January 1, 2020.
- Sener G, Krebs MD. Zwitterionic cryogels for sustained release of proteins.RSC Advances, 2016, 6, 29608-11.