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510K Products

Kytogenics represents an attractive, late stage investment opportunity. During the next 2 years the Company intends to bring to market six products in important therapeutic areas to include:

NOCC™ Hydrophilic Wound Dressing

Kytogenics' first 510K to receive FDA clearance was its NOCC™ Hydrophilic Wound Dressing on March 14, 2008. The Company has expertise in the preparation of sterile solutions and gels of NOCC from its experience in developing products for the surgical adhesion prevention markets, which can be used as hydrophilic solutions for wound fillers. The advantage of this product over most other wound fillers is that it is bioresorbable and does not have to be irrigated out of the wound.

Lubricants for Transurethral Surgical Instruments

KYTO filed this 510K premarket notification for its solution-based product to be used as an aid in the insertion of transurethral surgical instruments.

Super-Absorbent Wound Dressing

KYTO has filed a 510K for its NOCC-based super absorbent gels for the development of haemostatic bandagesKYTO has developed NOCC-based super-absorbent gels that absorb 98X their weight of fluid demonstrating their potential as hemostats.

Hemostatic Particles

This 510K filed with the FDA for NOCC Hemostatic particles is used for leg ulcers, pressure ulcers and surgical wounds to provide moist wound healing and allow non-traumatic removal of the dressing.  The dressing incorporates high wound exudate absorbing chitosan based powders, similar to those used in the Kytogenics Super-Absorbent Wound Dressing.

There are two additional 510K applications being prepared that pertain to the indications shown below.  These 510K applications are expected to be filed in Q2 2008.  The Company expects to file additional 510K applications later 2008 which will include Absorbable Tendon Wraps and Cardiovascular Wraps.

Ear Nose & Throat (ENT)
Use of NOCC solutions, films or foams for void filling and adhesion prevention after ear, nose and throat reconstructive surgery is indicated for use in patients undergoing nasal/sinus/ear surgery as a void filling dressing and are intended to prevent adhesions in the nasal/ear cavity, separate mucosal surfaces compromised by surgery or trauma, minimize edema and help control bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process.

Lubricants and Adjuncts to Protect Tissues and Promote Healing
Based on Kytogenics' NOCC™ Hydrophilic Wound Dressing, this solution-based product is to be used as a healing aid in gastro-urological (endoscopic) surgical procedures inclusive of hernia repair, gall bladder and general G-U procedures.  The product serves as an aid in the insertion of endoscopes, facilitates visualization during ophthalmic and endoscopic procedures and provides a viscous coating for damaged tissue during the healing process. 

Dura-Wraps
A product to be used following neurological surgery and to protect brain tissue.