Licensing Opportunities

Organogenesis has developed regenerative medicine technology in the areas of cell culture devices and media, tissue regeneration and cell therapy, collagen biomaterials and bio-remodelable graft constructs available for co-development and licensing. These technologies consist of:

FortaFlex^® Collagen Biomaterial Technology

There is a trend in surgical procedures to replace the use of synthetic materials with natural biomaterials. Natural biomaterials are used in applications ranging from urology to neurosurgery to orthopedics. These natural biomaterials are either allogeneic (another human, usually cadaveric) or xenogeneic (animal) derived. Long-term persistence of a material may be required, while other applications need a durable but remodelable material which allows host infiltration and tissue regeneration.

Organogenesis Inc. has developed FortaFlex^® Technology to fulfill this demand. The ability to create natural biomaterials optimized for strength and the in situ tissue interaction needed for specific surgical applications represents a major advance.

By controlling the chemical and physical properties of the material, FortaFlex^® Technology can be tailored for specific indications. There are three key components to this process: purification to ensure biocompatibility; lamination to achieve desired physical characteristics; and improved collagen matrix bonding with carbodiimide to control in vivo persistence.

FortaFlex^® is unique in that it is:

1. Strong: Highest strength per unit thickness in class
2. Pure: High level of purity due to proprietary chemical cleaning process
3. Customized: Customized remodeling through innovative crosslinking technology
4. Ready to Use: Delivered hydrated

FortaFlex^® Technology has the following FDA 510(K) clearance:

• FortaPerm^®
  • Pubourethral support
  • Prolapse repair (urethral, vaginal, rectal and colon)
  • Reconstruction of the pelvic floor
  • Bladder support
  • Sacrocolposuspension
  • Reconstructive procedures and tissue repair
  • Treatment of stress urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency

• FortaGen^®
  • Defects of the abdominal and thoracic wall
  • Muscle flap reinforcement
  • Rectal and vaginal prolapse
  • Reconstruction of the pelvic floor
  • Hernias
  • Suture-line reinforcement
  • Reconstructive procedures

• FortaGen^® for Tendon Repair: The first collagen biomaterial to be cleared by the FDA for all tendon repair including:
  • All rotator cuff tendons
  • Patellar tendon
  • Achilles tendon

Thousands of patients have been treated in the US and abroad with FortaFlex^® products in clinical trials and with commercial product. Clinical trials with the FortaFlex^® material have been (or are being) conducted in e.g. Stress Urinary Incontinence, Vaginal Prolapse, and closure of the patent foramen ovale PFO in the heart.

All the above-mentioned indications are currently available for licensing.

More information on our FortaFlex^® technology can be found here.

Liver Assist Device

Each year in the US, approximately 300,000 people are hospitalized for liver disease; over 25,000 die from liver failure. Currently, the only way to provide liver function is via a transplant. Today, many patients die before a suitable donor liver becomes available.

The Organogenesis liver assist device (LAD) was developed as a "bridge to transplant" to keep a patient alive until a liver becomes available. The device could also be used in some situations as an alternative to transplantation, keeping a patient alive for the few weeks needed for his or her own liver - a highly regenerative organ - to recover. This approach would be beneficial as liver transplantation is risky, invasive and expensive, and requires lifelong immunosuppressant drug therapy.

Our approach is based on utilizing hepatocytes encased in a bioreactor to process patient blood (plasma) using a dialysis-type procedure. As the largest organ in the body, the liver requires many active cells to perform its challenging functions. To achieve sufficient clinical benefit without diverting too much blood from the patient, maximal function must be obtained from each cell. The device design is engineered to permit the liver cells to function as they would in the organ. Obtaining a safe, reliable source of cells is also a critical consideration. Thus a key focus of our program includes cell procurement and culture.

Organogenesis acquired intellectual property and brought the technology forward using in-house expertise to optimize hepatocyte cell growth and metabolic functionality.

Vascular Graft

Approximately 350,000 coronary artery bypass grafting (CABG) procedures are performed annually in the US alone. These procedures are performed to channel blood around blockages in the arteries that keep the heart alive. CABG procedures typically require several grafts, as patients generally have multiple blockages. The material used for most bypass grafts is vein harvested from the patient's leg. Unfortunately, the patient may not have sufficient vein material available. Additionally, the use of patient vein adds to the surgical complexity and, thus, cost of the procedure, as well as increases the risk of post-surgery complications, including pain and infection at the harvest site.

The vascular graft is designed to be an off-the-shelf product that would replace the need to use patient vein as a source for graft material. As inclusion of living blood vessel cells would cause rejection, our vascular graft does not contain cells when implanted. It is designed to become populated with the patient's own cells after implantation. In November 1999, Organogenesis published significant data showing that, in small animals, our non-living vascular graft had been converted to living tissue within 90 days of implantation. The graft had gained the hallmark cells of an artery - the endothelial cells which line the blood flow channel, providing a smooth flow surface and avoiding clot formation, and smooth muscle cells that enable an artery to constrict and dilate. The study found that the cells were functional - the now-living graft constricted and dilated in response to stimulus. Vitally, the graft had stayed unblocked since implantation, which meant that it had avoided causing immediate clotting reactions and longer term disruptions to blood flow.

For licensing inquiries, please contact:

	Hugh Keeping, PhD, MBA
	Senior Technology Assessment Officer
	Organogenesis Inc.
	150 Dan Road
	Canton, MA 02021
	Telephone: ( 781) 401-1123
	Email: hkeeping@organo.com