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.