Cavit Sciences.IncRob@cavitsciences.com

973-278-7327

2009

PROJECT: CULTURED SKIN SUBSTITUTE

Product: The Cultured Skin Substitute (CSS) is a combination of outer and inner layers of skin cells that was developed over 20 years of research. A small (business card size) biopsy of skin is taken from the patient to begin the cell culture. The skin cells are isolated and put in a special mixture of nutrients and growth factors that support their growth. After about three weeks, the cells organize to form small sheets of CSS (3”x3”) with the physical strength of 2-3 wet paper towels. The process allows for generation of CSS of about 100 times the size of the original skin biopsy (100 business cards). From about 1% of the body, this process can generate enough CSS to cover the entire body of a burn patient. These CSS grafts are then taken to the operating room where surgeons apply them to a burn similar to the autografting method. The CSS grafts applied in the operating room are treated similarly to autografts, though somewhat more fragile until the blood supply is established. The CSS are considered full-sheet grafts, leaving few mesh marks on the skin graft and providing a better cosmetic appearance. But, the most important benefit is that CSS grafts can be made from a small amount of donor skin, for those patients with the largest burns.

OTHER CSS APPLICATIONS

CSS can also be used in reconstructive procedures for patients who have limited available donor sites. Previously grafted skin cannot be used as donor sites. The patient with a large burn originally, has no more donor sites available once the wounds are covered than he had when initially burned. Skin cells can also be cryopreserved (frozen) for later cultures, which means that multiple applications of CSS can result from a single initial skin sample.

Indication:Humanitarian Device Exemption - Full thickness burns over 50% of the body Premarket approval - Skin graft BurnsPremarket approval - Chronic woundsPremarket approval - reconstructive surgery.510k approval - Collagen Bio Materials.

Intellectual Property:Humanitarian Use Device (HUD ) designation, proprietary growth media, Proprietary collagen formulation and Manufacturing process.Proprietary Cultured Skin Substitute Manufacturing process.

Patents:WO03076604 Publication European Patent Surgical Device for Skin Therapy or Testing July 2007WO03076604 European Patent 6,905,105 Apparatus for Preparing a Biocompatible Matrix issued June 14,20055,976,878 Method and Apparatus for preparing composite skin replacement

issued November 2, 19995,711,172 Apparatus for preparing composite skin replacement issued January 27, 19985,273,900 Method and apparatus for preparing composite skin replacement issued Dec. 28, 19934,673,649 Process and defined medium for growth of human epidermal keratinocyte cells Issued June 16, 1987Most recent Patent granted by EU in April 2009.

FDA PATH:Humanitarian Device Exemption 2010510k Collagen Bio Substrate wounds 2010.Pre Market Approval for Adult indication Burns 2011Pre Market Approval Chronic wounds 2012.

Status:HUD designation Pediatric Burns. FDA sanctioned and reported trials of 124 plus Pediatric Burn Patients treated at Shriners Hospitals or affiliates Manufacturing process transferred from University of Cincinnati to GMP facility in Maryland Lonza in 2007.Pre HDE meeting completed. No outstanding issues.Compatibility trials need completed with mice or rats for HDE application submission. HDE application 85% written.PMA application being prepared for treating Military with trials scheduled to commence by January 2009.

Time to Market:1 year for HDE approval.2 years PMA burns3 Years PMA chronic wounds

US Market for HDE label use $300M US Market for PMA Burns and Wounds $11BMarket for Collagen Bio Substrate bandages and wounds $180M.

Business Plan:Available for review and audit

Financing needed:$15M for Approval HDE Pediatric burns, PMA adult burns and PMA adult chronic wounds.Investment to date $10M+ NIH and FDA sponsored research.Investment required. $5M needed for first tranche, $2M Milestone payment needed for HDE application submission$2M Milestone payment at HDE approval.$6M needed to support PMA applications Adult burns and Chronic wounds

Investment to date: $25.6M$10M+ NIH and FDA sponsored research.$2M Lonza Tech transfer and HDE and PMA support.$1,6M Connell and McCoy$7.5M 2008 Armed Forces Institute for Regenerative Medicine

$3M Ohio Third Frontier.PMA Burns Adult clinical trials being funded by Armed Forces Institute for Regenerative Medicine $0.5M granted June 18 2009, $1M additional for December 2009 adult burns.Department of Defense $5M chronic wounds pending 2010.