XCelliStem Wound Powder
XCelliStem is a prescription wound powder made by Stemsys. Clinicians order it through a medical distributor.
Updated . Edited by: Ilyass Ben Hakim.
Where to buy
- MD Biologix, national distributorLink · mdbiologix.health
- Search Google for XCelliStem wound care providersLive search · google.com
Patients get XCelliStem through a doctor or wound care clinic. The clinic orders it from the distributor. Ask your wound care team whether it suits your wound.
Professional insight
Wound care nurses check sterility, lot and wound type. They apply single-use dressings once, then discard the rest.
- It is a collagen matrix, not a stem cell product.
- FDA cleared it through 510(k), not full approval.
- Porcine origin matters for some patients' beliefs or allergies.
- Insurers may ask for documented medical necessity.
Check the label
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XCelliStem product facts
- FDA clearance
- 510(k) K172593
- Cleared March 2018.
- Material
- Porcine extracellular matrix
- Classed as a dressing with animal-derived material.
- Status
- Prescription use, single use
Common uses
The FDA record lists partial and full thickness wounds. Examples include pressure, diabetic and venous ulcers. Some surgical and trauma wounds are listed too. A clinician decides if it fits.
Questions for the seller
- Is the product supplied through the authorized distributor?
- Which pack sizes can the clinic order?
- Will insurance or Medicare cover this dressing?
- What documentation does the payer need?
Red flags
- Sold to the public with no prescription.
- Marketed as stem cells or a cure.
- Repackaged powder in plain jars.
- No lot number or sterile packaging.
Common questions
- Can I buy XCelliStem over the counter?
- No. Its device record lists it as prescription use only.
- Does XCelliStem contain stem cells?
- The FDA record describes a porcine collagen matrix. It does not describe stem cells.
- Who makes XCelliStem?
- Stemsys of Sunrise, Florida. MD Biologix calls itself the national exclusive distributor.