Lyphoderm consists of a total lysate derived from cultured human keratinocytes providing a natural complex of growth factor activity. In phase II clinical trials Lyphoderm demonstrated superior clinical outcome in a large group of venous leg ulcer patients. It offers a highly effective treatment for chronic wounds. Moreover, Lyphoderm has overcome the logistical, delivery and storage challenges associated with currently available (and those in clinical development) regenerative medicine products.
The current market for regenerative medicine products is in its infancy, yet it is poised for massive growth over the next decade. Well planned clinical trials, robust business models and significant delivery/logistical benefits over existing treatment options will boost this segment. The analysis of the environment reveals important opportunities for the commercial success of Lyphoderm:
- Vast patient pool in venous leg ulcers
- Significant Phase II data to indicate 80% of patient population are responders
- More than 3 times as effective as standard therapy
- Important patient population seeking medication for diabetic ulcers
- Growing patient population in both venous and diabetic ulcers
- Clinical need for an efficient therapy
- Off-the-shelf availability
- Long term ambient storage
- End sterilized for ultimate patient safety
- End-user and patient friendly
Lyphoderm, due to its biological action, will be differentiated from the existing offerings in the regenerative medicine arena. Its user-friendly delivery system differs from products currently on the market and in development. Broadly, the product will be positioned as a problem solver. It is intended to heal those 80% of wounds currently recalcitrant to standard therapies.