Cellmax™ Wound Spray

Indication:
For healthcare professionals as an adjuvant to standard wound care in the management of chronic, non-healing wounds in adult patients, including:

• Diabetic Foot Ulcers (DFU)
• Venous Leg Ulcers (VLU)
• Postoperative wounds
• Trauma wounds
• Other chronic non-healing wounds classified as HSPC Class 2 and Class 3
  (Harikrishna Peri-wound Skin Classification)

Contraindications:
Cellmax™ Wound Spray is contraindicated in the following conditions:

• Ischemic wounds prior to effective revascularization
• Neoplastic wounds (wounds associated with malignancy or neoplastic procedures)
• Active infections requiring surgical intervention, such as underlying abscesses and fasciitis requiring incision and drainage
• Underlying osteomyelitis
• Chronic wounds classified as HSPC Class 4 or Class 5, as these types of wounds require more aggressive treatments

Direction for use:
Cellmax™ Wound Spray must be prepared and administered under sterile conditions by trained healthcare professionals.

Administration Guidelines:

1. Perform standard wound debridement to remove necrotic tissue or slough before product administration.
2. Ensure the spray bottle is intact and the nozzle is clean.
3. Shake gently before use to ensure uniform dispersion of active ingredients.
4. Use aseptically, avoiding direct contact between the nozzle and the wound or other surfaces to prevent contamination

Application Method: Spray the product to cover the entire wound bed evenly post-debridement.

Dosage: Apply sufficient solution to coat the wound surface, typically 1–2 sprays per cm², as directed by a healthcare professional. Adjust based on wound size and condition.

Treatment Schedule: Administer 2–3 times per week for up to 12 weeks or until wound closure, with wound assessments at each visit.

After Initial Use: Store at 2–8°C and use within 28 days. Discard after 28 days from first opening.

Precautions:

• Consultation: Consult a provider before use if pregnant, breastfeeding, or for pediatric patients (safety not established).
• Geriatric: Clinical data primarily from adult patients; no specific precautions beyond general wound care.
• Infection Control: Do not apply to wounds with uncontrolled local or systemic infection. Appropriate infection management should be instituted before application.
• Sterility: Reconstitution and administration must be carried out using aseptic technique by trained healthcare professionals.
• Multi-patient Use: Cellmax™ Wound Spray is intended for multi-patient use. After initial use, keep tightly closed and handled aseptically. Do not allow the nozzle to come into direct contact with wounds or other surfaces.
• Allergies: Patients with known hypersensitivity to any components should not be treated. Discontinue use if signs of local or systemic allergic reaction occur.
• Adjunct Use: Intended as an adjunct to standard wound care. There is no data available for the safety of concurrent use with other advanced wound products.

Safety & Quality:

• Biocompatibility: Evaluated under ISO 10993 standards. Testing for cytotoxicity, irritation, and sensitization demonstrated that the product is non-irritant and non-sensitizing. Detailed biocompatibility reports available upon request.
• Adverse Reactions: No adverse side effects, including irritation, sensitization, or allergic reactions, have been reported. Rare cases of hypersensitivity may occur. Discontinue if adverse reactions are observed.
• Drug Interactions: No known drug interactions. The product contains soluble proteins designed for local action and is not intended for mixing with other medicinal products.
• Quality Standards: Compliant with ISO 13485 and GDPMD standards. Donor materials certified negative for HIV-1/HIV-2, HBV, HCV, and syphilis.

Recommended Storage:

• Storage: Store unopened bottles at 2–8°C in a dry, dark place. After first opening, use within 28 days and handle aseptically. Keep the bottle tightly closed to prevent contamination.
• Shelf Life: 24 months from the manufacturing date.
• Protect from light and moisture. Do not use if packaging is damaged or beyond the expiration date. Discard any product not stored under recommended conditions.

Ingredients:
Aqua, Lactobacillus Ferment, Glycerin, Centella Asiatica Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Extract, Rosmarinus Officinalis (Rosemary) Extract, Colloidal Silver, Phenoxyethanol, Caprylyl Glycol, Bioprotein from Mesenchymal Stromal Cell Secretome, Mannitol, Sodium Chloride.