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Epi-Stop™ Nasal Gel/Epistaxis Pack is a sterile, single use in patients suffering from anterior epistaxis to: - Help control minimal bleeding following trauma by barrier function, blood absorption and platelet aggregation; - Act as an adjunct to aid in the natural healing process. Epi-Stop™ Nasal Gel/Epistaxis Pack is indicated for use as a nasal packing to treat anterior epistaxis. Epi-Stop™ Nasal Gel/Epistaxis Pack is intended for use under the direction of a licensed healthcare provider.

Epi-Stop™ Nasal Gel/Epistaxis Pack is a single use, hemostatic, and injectable gel, made of crosslinked gelatin and hyaluronic acid, indicated for the treatment of anterior epistaxis. Epi-Stop™ Nasal Gel/Epistaxis Pack creates a moist environment for healing and the ability of absorbing and stopping nose bleeding within minutes. Due to its viscoelasticity and low extrusion force, Epi-Stop™ Nasal Gel/Epistaxis Pack can be injected into the anterior nasal cavity and the gel must be left in the nose for at least 72 hours. Afterwards, the gel can be removed by using safe water for gentle irrigation (either sterile or boiled water) or using safe lukewarm water.

The SPIWay Endonasal Access Guide is indicated for use in endoscopic transnasal sphenoid sinus and skull base surgery.

The SPIWay Endonasal Access Guide is a sterile, single patient use device placed within the nostril/nasal cavity during endoscopic transnasal sphenoid sinus and skull base surgery to facilitate visualization of the surgical site and smooth manipulation of introduced instruments. It is made of a thermoplastic elastomer.

The Novapak Nasal Sinus Packing and Stent is intended for use in patients undergoing nasal/sinus surgery as a space occupying packing to: - · Separate tissue or structures compromised by surgical trauma. - · Separate and prevent adhesions between mucosal surfaces in the nasal cavity. - · Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption, and platelet aggregation. - · Act as an adjunct to aid in the natural healing process. Novapak is indicated for use as a nasal packing to treat epistaxis.

Novapak™ is a single use, nasal packing and stent for use following sinus surgery to prevent adhesions, control mild bleeding and provide a level of antibacterial effectiveness. Novapak™ is composed of formulated chitosan and cellulose ingredients in a sponge can be compressed for insertion into anatomy and can be cut to size. Novapak™ hydrates with sterile saline and forms a gel. The sponge dissolves within the nasal cavity with daily irrigation and natural mucus flow over several days. Residence time is typically 7-14 days with adequate irrigation. Alternately, the dressing may be removed through gentle aspiration at the discretion of the physician.

Indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to: - Separate tissue or structures compromised by surgical trauma - Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity - Help control minimal bleeding following surgery or trauma - Help control minimal bleeding following surgery or nasal trauma by tamponade effect blood absorption and platelet aggregation - Act as an adjunct to aid in the natural healing process Indicated for use as a nasal hemostat to treat epistaxis. Intended for use under the direction of a licensed healthcare provider.

Intranasal splints are utilized to stop nasal hemorrhage and for the prevention of tissue adhesion in the nasal and/or sinus cavities. It is often used after FESS, nasal/sinus surgery, or surgical trauma in the event of excessive epistaxis. Splints are gently inserted into the nasal cavity. The device is designed to swell within the nasal cavity in order to exert pressure on the bleeding sites. The splint material is dissolvable. Splints can also be used following sinus surgery in order to hold cartilage and membranes in their proper places during healing following surgerv. The Chitosan Intranasal Splint is made from Carboxymethyl Chitosan, mixed with Methyl Cellulose, and Hydroxyethyl Cellulose to make an absorbent porous sponge that is flexible and dissolvable. The device acts as a nasal splint and temporary spacer.

The SPIWay® Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.

The SPIWay®Endonasal Access Guide is a temporary working channel sheath for use in endoscopic sphenoid sinus and transsphenoidal surgery. The device consists of a single piece of thermoplastic polymer with a low friction coating, which creates a working channel sheath in the natural orifice of the nose to facilitate visualization of the surgical site and smooth manipulation of introduced instruments during transnasal endoscopic surgery. The shape of the SPIWay Endonasal Access Guide contains a flared portion at the proximal end of the device which remains outside the nasal passage and a conical body that sits within the nasal cavity. The flared proximal end and conical body act to anchor the device, preventing migration once inserted and allow simple removal. The device has an elliptical shape, and the major axis of the ellipse is oriented vertically with the nostril. The device is supplied in several lengths that are selected based upon the surgeon's needs. It is provided sterile and for single use in a pack of two, one for each nostril. A pair of devices is sealed in a Tyvek pouch and 5 pouches are placed into a labeled carton.

The Composite Removable Sinus Stent is intended for use in adult patients following ethmoid sinus surgery, to maintain patency and reduce the need of post-operative intervention surgery. The composite stent is intended to be left inside the ethmoid sinus cavity for up to 28 days. The composite sinus stent provides steady support of nasal walls against swelling mucosa, middle turbinate stabilization and prevents obstruction by adhesions. The stent can be removed at any time within 28 days by cooling and self-crimping.

The subject device is supplied sterile for single use. The composite removable sinus stent provides sinus wall support following functional endoscopic sinus surgery. A delivery system is provided to insert the implant. The system contains the following components: Stent: The stent is balloon expandable and composed of an outer polyurethane and inner Nitinol alloy bodies. The stent is designed to accommodate the size and variability of the post-surgical ethmoid cavity anatomy. Once expanded the stent is designed to support the walls of ethmoid cavity, in order to prevent adhesions and middle turbinate lateralization into the septum. Stent can be removed within 4 weeks by cooling and self-crimping. Delivery System: The delivery system is designed to insert, position and deploy the stent, following functional endoscopic sinus surgery, guided by endoscopic direct vision. The delivery system consists of a water filled syringe connected to high compliance low pressure balloon via rigid shaft. The balloon is supplemented with color marker.

The Chitogel Endoscopic Sinus Surgery Kit is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to: - Separate tissue or structures compromised by surgical trauma - Separate and prevent adhesions between mucosal surfaces in the nasal cavity and minimize ostial stenosis following endoscopic sinus surgery - Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation - Act as an adjunct to aid in the natural healing process The Chitogel Endoscopic Sinus Surgery Kit is indicated for use as a nasal packing to treat epistaxis.

The Chitogel Endoscopic Sinus Surgery Kit consists of the following components: - Sealed vial containing 300mg Dextran Aldehyde Powder - Sealed vial containing 10ml Sodium Phosphate Buffer Solution - Sealed vial containing 10ml Chitosan Succinaamide Solution - 12cc control syringe - Fluid dispensing connector - Two (2) mixing cannulae - Malleable cannula The Chitogel Endoscopic Sinus Surgery Kit is used during nasal surgery. The components in the Chitogel Kit are mixed by the physician using the syringe and cannulae provided. The pre- measured components mix to form the biodegradable gel. Once the components are mixed and create the gel, the physician applies the gel to the target area using the malleable cannula and thereby creating a nasal packing. All components are provide sterile and are for single use only.

The SPIWay Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.

The SPIWay Endonasal Access Guide is a sterile, single patient use device placed within the nostril/nasal cavity during endoscopic sphenoid sinus or transsphenoidal surgery to facilitate visualization of the surgical site and smooth manipulation of introduced instruments. It is made of a thermoplastic elastomer.

HEMOPORE® is intended for use in patients undergoing nasal/simus surgery as a temporary wound dressing. HEMOPORE® functions as a topical hemostatic aid to control mild bleeding by tamponade effect, blood absorption, platelet activation and aggregation. It acts as an adjunct to aid in the natural healing process as a space occupying stent to separate and support tissues. It prevents adhesions and minimizes edema.

HEMOPORE® is a sterile fragmentable nasal dressing of 8 cm composed of poly(DL-lactide-cos-caprolactone) urethane and blended with a chitosan derivate and a violet color additive. After insertion of HEMOPORE®in the nasal cavity, fluids will be absorbed by the dressing, which helps to control bleeding after surgery. The dressing fragments within several days by hydrolyzing ester bonds, whereafter it is drained from the nasal cavity via the natural mucus flow. The HEMOPORE® is sterilized in a blister package. The device is single-use, cannot be resterilized, and is a prescription product.