StatSeal®

Don’t Just Cover It…Seal It.

With the Family of Products That Stop Bleeding and Help Protect Wounds and Procedural Sites

StatSeal® DISCStatSeal®

StatSeal®

Seal the Site. STAT.TM

For Large-Bore Catheters and Arterial Access Sites

For Wounds and ProceduresFor Venous Access Sites

StatSeal® medical devices, in powder or disc form, are made of a hydrophilic polymer and potassium ferrate. When placed on an external bleeding wound or procedural site, in com-bination with manual pressure, StatSeal® forms a seal that stops bleeding and helps protect the site from contamination.

Seal formation is independent of the clotting cascade.

StatSeal® quickly forms a seal to stop the flow of blood and exudates, and protect the site from contamination.

The mechanism of action is a simultaneous two-step action:1. The polymer rapidly dehydrates the blood, stacking up the solid components.2. The potassium ferrate agglomerates the blood solids, creating a seal or physical barrier.

Beneath the seal, the blood clots naturally.

In-Vitro studies* show that on the distal side of the seal, pH is low (~2) while on the proximal side of the seal, pH is neutral.

StatSeal® is not contraindicated for patients of any age.

Scanning Electron Microscopy (SEM) photo of seal

StatSeal® (unactivated powder)

Illustration of seal formation

(Manual pressure is applied on top of powder to strengthen seal.)

“The Seal”

What is StatSeal®?

How Do StatSeal® Products Work?

* Study report on file at Biolife, LLC

What Is It?StatSeal® Powder quickly forms a seal to stop external bleeding and oozing from wounds and procedures. The powder’s ingredients are a hydrophilic polymer and potassium ferrate.

StatSeal® Powder is effective for: •Vascularaccesssitebleedingandoozing •Skintears •Lacerations •Avulsions •Biopsiesandexcisions •Wounddebridement •Othernon-suturablewounds •Bleedingfromsutures

Patented Technology That Stops External Bleeding

From Wounds and Procedures

StatSeal

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The Benefits of StatSeal® Powder Controls Bleeding and Oozing •Sealformsinstantlyuponcontactwithbloodorexudate,strengthening with pressure and time •Doesnotrelyonthebody’sclottingcascadetocreateaseal •Worksforpatientsofanyage

Improves Outcomes •Increasespatientcomfortandsatisfaction •Hypo-allergenic,notbiologicallyderived

•Fewerdressingchangesandoccurrencesofrebleeds

Efficient and Cost-effective •Fasthemostasisandfewerdressingchangessavesvaluablenursingtime •Lessexpensivethanotherhemostats

®

1-800-722-7559 www.statseal.com

Instructions for Use - Skin Tears, Avulsions and Other Non-Suturable woundsApplication includes 1 bottle, 1 Powder Containment Device (PCD) and 1 product description label.

StatSeal®

Use of the PCD is optional. The PCD and foam insert can help contain powder when applied tovertical surfaces.

1. Clean wound and ensure blood or exudate is present.

2. Tap bottom of bottle to pour powder directly onto blood or bloody exudate. Cover bleedingareacompletely.Occasionallyuponapplication,atemporarywarmingorstingingsensationisfelt.

3. Apply pressure for 30 seconds to 2 minutes to form the protective seal. (Holding pressure with gauze is not recommended). If bleeding continues, repeat application.

4. Dress the wound with non-adherent dressing. The protective seal is safe to leave in place until it falls off naturally.

Instructions for Use – Vascular Access Sites

Before applying powder, secure catheter near access site. Catheter movement after powder is applied can disrupt newly-formed seal.

1. Place PCD around site, pour powder into PCD. Place foam center in PCD to cover powder.

2. Hold continuous pressure for 2 minutes to form seal; increase hold times as clinically necessary.

3. If bleeding continues, reapply more powder and hold manual pressure until bleeding stops.

4. Cover with transparent dressing following normal protocol; press and form transparent dressing around powder to help contain powder around access site.

Site should remain dry and intact until next scheduled dressing change.

You may feel a slight warming from the powder as it forms the seal.

To remove StatSeal®: If StatSeal® Powder must be removed, as determined by a healthcare professional, brush away loose powder then wet the seal with sterile water/saline until seal starts loosening from the wound. Gently scrape off loosened seal with gloved finger. Repeat as needed.

1-800-722-7559 www.statseal.com

What Is It?StatSeal® ADVANCED is a manual pressure adjunct that controls external bleeding from large-bore venous catheters, arterial access procedures, and other diagnostic or interventional procedures. Available in both powder and disc (compressed powder) form, the ingredients are a hydrophilic polymer and potassium ferrate.

Disc/Powder + Pressure = SealAs an adjunct to manual pressure, StatSeal® ADVANCED forms a physical seal through agglomeration of blood solids and proteins along with simultaneous rapid dehydration of the blood.

StatSeal® ADVANCED achieved hemostasis in less than two minutes for venous access and four minutes for arterial procedures based on results from a randomized controlled clinical study. StatSeal®effectively reduced time to hemostasis with minimal associated complications (hematoma, rebleeds). StatSeal® is superior to the control (D-Stat®) in reducing time to hemostasis.*

*Michael D. Kuo, MD et al. Comparative Evaluation of Noninvasive Compression Adjuncts for Hemostasis in Percutaneous Arterial, Venous, and Arterio-venous Dialysis Access Procedures; Journal of Vascular and Interventional Radiology. Vol. 19, Number 1, January 2008.

Patented Technologyto Seal Access Sites Following Sheath and Catheter Removal

StatSealadvanced

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The Benefits of StatSeal® ADVANCED Reduces hold times •Doesnotrelyonthebody’sclottingcascade •Sealformsinstantlyandstrengthenswithpressureandtime •Thesealstayswiththepatient

Improves outcomes •Increasespatientcomfortandsatisfaction •Allowsforre-accessofthesite •Hypo-allergenic,non-irritant

Improves facility throughput •EfficientandCost-effective •Lessexpensivethanpads,patchesandclosuredevices •Versatile–usefulinthecontrolofanyexternalbleeding •Savesvaluablestafftime

Powder and Disc®

1-800-722-7559 www.statseal.com

StatSeal®

Instructions for Use - StatSeal® ADVANCED Powder

1. 2. 4. 5.3.

TOPICAL HEMOSTATIC POWDER

HP

S01

r3

Leave scab in place as directed

StatSeal®

6.

Application includes 1 bottle, 1 Powder Containment Device (PCD) and 1 product description label.

2. Pour powder into PCD* - lift sheath gently to ensure powder gets under sheath, then create a pile of powder around the sheath and completely fill the PCD.

6. Place transparent dressing per protocol; Apply product description label on top of dressing to identify powder. Follow your normal ambulation protocol.

4. StatSeal® Advanced is a manual pressure adjunct. For initial uses, start at current manual pressure hold times then gradually adjust down toward 5 to 10 minutes of continuous pressure. Extend hold times as clinically necessary.

5. Release pressure slowly; Roll fingers off PCD**.

3. Place PCD center (foam insert) over powder. Pull sheath slowly while applying pressure over the arteriotomy and the insertion site.

* Fill PCD completely; don’t overfill; the bottle contains excess powder in case of a rebleed.** If bleeding continues, reapply more powder (if necessary) with manual compression until bleeding has stopped. You may feel a slight warming from the powder as it forms the seal.

To remove Statseal® Advanced: If Statseal® Advanced Powder must be removed, as determined by a healthcare professional, brush away loose powder then wet the seal with sterile water/saline until seal starts loosening from the wound. Gently scrape off loosened seal with gloved finger, cotton swab or tongue depressor. Repeat as needed.

1. Clean and dry the area around the site. Withdraw sheath leaving at least 3 to 4 centimeters (2-3 cms for fistula/grafts) under the skin. Remove PCD from package, peel paper backing and center (PCD) around sheath.

Instructions For Use: StatSeal® ADVANCED DiscApplication includes 1 StatSeal® ADVANCED Disc.

1.Opensterilepackagingandremovedisc.2. Place disc over the sheath at access site. Pull sheath slowly while applying pressure directly over the arteriotomy and puncture site. Allow a small amount of blood to come in contact with the disc in order to form a seal.3. Hold continuous semi-occlusive pressure over disc and arteriotomy site for >=5 minutes (Extend hold times as necessary for larger sheaths or anticoagulated patients).4. Release pressure slowly to check for hemostasis. Apply additional pressure as necessary.5. Place transparent dressing per protocol. Apply product description label.6. Leave disc in place for 24 hours or as directed by clinician.

2. 4.

TOPICAL HEMOSTAT

Leave scab in place as directed

5.3.

Benefits of StatSeal® Disc:Creates a seal that prevents bleeding and oozing •Sealformsinstantly,strengtheningwithmanualpressureandtime

•Doesnotrelyonthebody’sclottingcascade

•Workswithanyprotein-filledfluid

Helps minimize dressing changes •Sealssitesfrominsertionto7days,virtuallyeliminating24or48-hour dressing changes

•Helpsminimizeunplanneddressingchangesduetobleedingandoozing

•HelpsfollowCDCguidelinesbykeepingsitesdryandintact

Helps improve outcomes for patients and staff •Lessexposureofsite-Improvesdeliveryofatraumaticcare

•Savesnursingtimeandcosts

The Solution: StatSeal® DiscThe patented technology of StatSeal ® (BioSeal) Powder, now in an easy-to-use disc! StatSeal® Disc is a topical disc, made of compressed powder (hydrophilic polymer and potassium ferrate) that forms a seal over an access site to keep it dry and intact. StatSeal® Disc is available in various sizes to fit securely around different sizes of catheters (1.9-14 Fr).

The Challenge: How to Protect an Access Site•“Soiled,wetorloosedressingsmustbechanged”sincethey provide an optimum environment for bacterial growth according to CDC Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011.

•SoiledgauzeorCHG-impregnatedspongeshavebeenclinicallyshown to result in frequent dressing changes.1

•Dressingchangesrequirevaluablenursingtime,addedmaterialcost and expose the site.

•Dressingdisruptionisamajorriskfactorforcatheter-relatedinfections.*

“The StatSeal® disc is a game changer! For PICC and central line insertions, the disc keeps sites dry and intact. It is truly the future of hemostasis and vascular access site care.”

Louis Guzzi, MD – Critical Care Medicine, Florida Hospital

1Timsit, et al, JAMA, March 25, 2009, “Chlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes for Prevention of Catheter-Related Infections in Critically Ill Adults”.

*”Timsit JF, Bouadma L, Ruckly S, et al, Crit Care Med. 2012;40:1707-1714 ”Dressing Disruption Is a Major Risk Factor for Catheter-Related Infection,”

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Seal the Site. STAT.

Access site with soiled CHG sponge

StatSealDisc

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The Difference is the SealHow does StatSeal® Disc Work?StatSeal® quickly forms a seal to stop the flow of blood and exudates.The mechanism of action is a simultaneous two-step action:1. The polymer rapidly dehydrates the blood, stacking up the solid blood components.2. The potassium ferrate agglomerates the blood solids creating a physical barrier.Beneath the seal, the blood clots naturally.

With StatSeal® Disc, it’s ONE and DONE!

Instructions For Use:Application includes 1 StatSeal® Disc.StatSeal® Disc is intended for use under the care of a health care professional for the temporary external control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.

1. Prepare the skin around insertion site according to facility protocol.2. Opensterilepackagingandremovedisc.3. Place the disc by sliding it down the catheter until it touches skin at the catheter site. The brown side should be towards the patient’s skin and the slit perpendicular to the catheter. The edges of the slit should approximate one another to the extent possible. The foam side is facing up. Tip: Don’t stretch the disc apart too much upon application.4. Apply a continuous hold on top of the foam for at least 2 minutes to form the seal; increase the hold time as clinically necessary.5. Secure the catheter per protocol.6. Cover with transparent dressing following facility protocol.7. Remove disc with next dressing change and resume regular dressing protocol.Site should remain dry and intact until next scheduled dressing change.

DISCStatSeal®

1-800-722-7559 www.statseal.com

Close up of underside of foam showing

compressed powder

PROVIDES BETTER PATIENT OUTCOMESA peer-reviewed clinical trial published in the Journal of the Association for Vascular Access** showed that when used for all PICC line insertions (418) and occasional bleeding during dressing changes at Florida Hospital, StatSeal®(formerly BioSeal):

•Showeda40%decreaseinCatheter-RelatedBloodstreamInfections (CRBSIs) during and post-trial

•Eliminatedthe48-hourdressingchange;initialdressingchange performed at 7 days

•Achievedfasthemostasis,evenforpatientswithclottingdifficulties(≤2min.in96%ofapplications)

•Resultedinnoreportedcomplications.

** Lauren Blough, RN, BS, CRNI, Kathy Hinson, BS, RN, MN, MPH, MBA, John Hen, PhD, “The Science of a “Seal” for PICC Line Management: BIOSEAL CVC Powder As An Alternative Hemostatic Agent That Keeps Sites Dry And Intact,” Journal of the Association for Vascular Access, Summer 2010, 15:2, 66-73.

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ACHIEVES RAPID HEMOSTASIS, STOPS OOZINGIn a peer-reviewed clinical trial published in the Journal of Vascular and Interventional Radiology (January 2008) comparingtheefficacyoftwocompressionadjunctsin176percutaneousvascularaccessprocedures,StatSeal®(formerly known as QR Powder) was twice as fast in achieving hemostasis as the control with no differences in infections or adverse events.

StatSeal® Powder applied to a Mohs site

StatSeal® in Clinical and Laboratory Studies

Results: StatSeal® reduced mean time to hemostasis to under 4 minutes for arterial procedures.*

PROCEDURE TyPEMean Time to Hemostasis (min.)

StatSeal® Control (D-Stat)

Arterial - Therapeutic 3.56 9.99

Arteriovenous Dialysis Access 3.41 7.26

*Hold times may vary due to anticoagulation levels, sheath sizes or clinical techniques.Michael D. Kuo, MD, et al, Comparative Evaluation of Noninvasive Compression Adjuncts for Hemostasis in Percutaneous Arterial, Venous, and Arteriovenous Dialysis Access Procedures; Journal of Vascular and Interventional Radiology. Vol. 19, Number 1, January 2008.

InastudyofMohsMicrographicSurgery,StatSeal®showedgreaterefficacyand more rapid onset of action in second intention healing compared with the control compressed foam sponge (at week 12). StatSeal® reduced erythema and produced fewer incidents of scarring.

LeonKircik,MDandJamesQ.DelRosso,DO. Journal of Drugs in Dermatology (JDD), February 2010, Vol. 9, Issue 2: 137-140,

Size Extra Small~1.9-4 Fr

Small~4-6 Fr

mEdium~6-9 Fr

largE~10-14 Fr

Extra lg.~15-18 Fr advancEd

item number:

carton dt613 dS614 dm615 dl616 dx617 da618 case dt623 dS624 dm625 dl626 dx627 da628# of applications:

carton 6 6 6 6 6 6 case 24 24 24 24 24 24

DISCStatSeal®

Underside of foamshowing compressed

powder disc

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StatSeal® Product Ordering Information

StatSeal® ADVANCED PowderSeals arterial access sites

Manufacturer Item Number Description Number of Applications

LP607 Carton 6

LP637 Case 24

StatSeal® PowderStops external bleeding from wounds and procedures

Manufacturer Item Number Description Number of Applications

LP606 Carton 6

LP636 Case 24

StatSeal®

StatSeal®

StatSeal® Disc - Extra Small to Extra Large size: For temporary external control of bleeding from percutaneous cathetersStatSeal® ADVANCED Disc - For temporary external control of bleeding from sheath and catheter removals

Size Extra Small~1.9-4 Fr

Small~4-6 Fr

mEdium~6-9 Fr

largE~10-14 Fr

Extra lg.~15-18 Fr advancEd

item number:

carton dt613 dS614 dm615 dl616 dx617 da618 case dt623 dS624 dm625 dl626 dx627 da628# of applications:

carton 6 6 6 6 6 6 case 24 24 24 24 24 24

DISCStatSeal®

Underside of foamshowing compressed

powder disc

StatSeal® Product Ordering Information

StatSeal® ADVANCED PowderSeals arterial access sites

Manufacturer Item Number Description Number of Applications

LP607 Carton 6

LP637 Case 24

StatSeal® PowderStops external bleeding from wounds and procedures

Manufacturer Item Number Description Number of Applications

LP606 Carton 6

LP636 Case 24

StatSeal®

StatSeal®

StatSeal® Disc - Extra Small to Extra Large size: For temporary external control of bleeding from percutaneous cathetersStatSeal® ADVANCED Disc - For temporary external control of bleeding from sheath and catheter removals

Biolife,LLC•816325thCourtEast,Sarasota,FL342431-800-722-7559•www.statseal.com

StatSeal®

SSPF01r1

Seal the Site. STAT.TM