Endoscopic hemostatic powder spray: Current evidence and clinical applications

Table 1 Characteristics of commercially available and investigational hemostatic powders

	Composition	Mechanism of action	Delivery system	Biodegradability and clearance	Advantages	Limitations
TC-325 (Hemospray®)	Inert mineral powder	Absorbs liquid, concentrates clotting factors, and forms a mechanical barrier	High-pressure CO2 cartridge	Non-absorbable and excreted	Broad coverage; effective for diffuse bleeding	Perforation risk with high CO2 pressure; catheter clogging
EndoClot®	Absorbable modified polymer	Absorbs liquid and accelerates the physiological coagulation cascade	Air compressor	Absorbable and degrades within 3 days	Low delivery pressure	Slow spraying; catheter clogging
Ankaferd Blood Stopper®	Standardized plant extracts	RBC aggregation, largely independent of classic coagulation	Syringe via catheter	Absorbable and excreted	Plant-derived; animal data suggest anti-infective, wound-healing-promoting, and antitumor activity	Limited clinical evidence
UI-EWD (NexPowder™)	Oxidized dextran and amino acid derivative	Forms highly adhesive hydrogel upon hydration	Integrated low-pressure air pump	Non-absorbable; excreted in about 66 hours	Employing liquid coating technology via a fluidized bed granulator; strong adhesion and good durability	Evidence primarily from Korean cohorts
CEGP-003 (CG-Bio)	Absorbable macromolecule with EGF	Forms gel and releases EGF	Alto-shooter gun system	Absorbable	Combined hemostatic and wound-healing functions	Limited clinical evidence
Self-Propelling Thrombin Powder	CaCO3, thrombin, tranexamic acid	CO2-bubble propelled; activates coagulation	CO2 pump	Absorbable	Self-propelled; against blood flow; suitable for pulsatile bleeding	Just preclinical and early-stage research
Polysaccharide Hemostatic Powder	Plant starch and carboxymethyl chitosan	Absorbs liquid and activates intrinsic coagulation factors	Air compressor	Absorbable	Rapid hemostasis; simple operation	Catheter clogging reported

EGF: Epidermal growth factor; RBC: Red blood cell; CO₂: Carbon dioxide; CaCO₃: Calcium carbonate.

Table 2 Summary of reported hemostasis and rebleeding rates of hemostatic powders by clinical scenario

	Indication	Highest hemostasis rate, %	Lowest rebleeding rate, %	Reported study designs	Remarks
TC-325 (Hemospray®)	NVUGIB	100	2.1	Prospective[22,26], retrospective[19,20,21,34]	Hemostatic rate varies slightly across studies but remains generally high
	Variceal Bleeding	100	0	Prospective[15,16,18,48], case[13,17]	Demonstrates high hemostatic success rates as bridging therapy in emergency settings
	Peptic Ulcer Bleeding	95	15	Prospective[14,23,24], retrospective[25]	Not recommended as monotherapy, particularly to be avoided in Forrest Ia lesions
	Tumor Bleeding	100	2.1	Prospective[32,33], retrospective[28,35], case[29,30,43,44,46]	Highly effective for tumor oozing in palliative or bridging therapy, but limited sample size
	GIB in children	100	12	Prospective[38], retrospective[39], case[40]	Just performs well in small-scale studies but requires confirmation in larger trials
	Post-procedural Bleeding	100	0	Case[31,41,42,45]	Performs well in small-scale studies, requires confirmation in larger trials
	Diverticular bleeding	100	0	Retrospective[47]	Limited evidence but effective in selected cases
EndoClot®	GIB	86	11.4	Prospective[50,52], retrospective[53]	Hemostatic rate is stable
	Post-EMR Bleeding	78	4.7	Prospective[55]	Applicable in both prophylaxis and treatment of procedure-related bleeding
	Diverticular bleeding	100	0	Case[56]	Performs well in small-scale studies but requires confirmation in larger trials
Ankaferd Blood Stopper®	GIB	100	0	Prospective[61], retrospective[62], case[65]	Existing studies involve small sample sizes, although reported hemostatic rates are high
UI-EWD (NexPowder™)	NVUGIB	97	3.7	Prospective[71], retrospective[70,74]	High immediate hemostasis in a large Korean cohort
	LGIB	100	5.5	Retrospective[72,73]	Immediate hemostasis is high, but evidence is limited
	Tumor Bleeding	100	26.1	Retrospective[68], case[69]	Limited sample size but reported hemostatic rates are high
CEGP-003 (CG-Bio)	UGIB	100	8.6	Prospective[75,76]	Existing studies have relatively small sample sizes, but reported hemostasis rates are high
Polysaccharide Hemostatic Powder	GIB	100	0	Prospective[81,82,83]	Higher hemostatic rates achieved in Forrest IIa lesions
	Post-procedural Bleeding	100	0	Prospective[84,87,88,89], retrospective[86], case[80]	Well-documented and highly effective for post-ESD/EST bleeding

EMR: Endoscopic mucosal resection; ESD: Endoscopic submucosal dissection; EST: Endoscopic sphincterotomy; GIB: Gastrointestinal bleeding; LGIB: Lower gastrointestinal bleeding; NVUGIB: Non-variceal upper gastrointestinal bleeding; UGIB: Upper gastrointestinal bleeding.

Table 3 Regional availability of hemostatic powders used in gastrointestinal bleeding, European Conformity

Product (manufacturer, origin)	Region(s) where marketed	Notes
TC-325 (Hemospray®; Cook Medical, United States)	United States, Canada, Europe, and other regions	Approved for endoscopic hemostasis in non-variceal upper GI bleeding; CE marking also reported for pediatric use
EndoClot® Polysaccharide Hemostatic System (EndoClot Plus, United States)	Europe, Türkiye, Malaysia, Australia	Country-level availability varies; no product-specific approval data identified for other regions
Ankaferd Blood Stopper® (ABS; AND Pharmaceuticals, Türkiye)	Türkiye (predominantly); limited availability elsewhere	Reported by the manufacturer as the first original locally licensed hemostatic medicinal product in Türkiye
UI-EWD (NexPowder™; Next Biomedical, Republic of Korea)	Republic of Korea, United States, Europe	FDA-cleared since 2022; most clinical evidence originates from Korean cohorts
CEGP-003 (CG Bio, Republic of Korea)	Republic of Korea	Availability and regulatory status outside the Republic of Korea not reported
Self-propelling thrombin powder (experimental agent)	None	Preclinical animal studies only
Polysaccharide hemostatic powder (multiple products)	China, Republic of Korea	Regulatory status differs according to the specific product

Regulatory information was compiled from the open United States Food and Drug Administration 510(k) database, manufacturer information, and published reviews. European Conformity marking is required for marketing in the European Union where a product is reported as marketed in Europe. “None” indicates that no reliable information was identified in the reviewed sources. ABS: Ankaferd Blood Stopper; CE: European Conformity; FDA: United States Food and Drug Administration; GI: Gastrointestinal.