Over at Israel’s newspaper Globes we read about a start-up EnzySurge Ltd., a company working on novel chronic wound treatment technology. According to the newspaper, “EnzySurge is now completing the effectiveness clinical trial of its product in Israel, which shows that the product produces a significant improvement in wounds. The believes that it has a strong likelihood of obtaining US Food and Drug Administration (FDA) approval for its product as a “combined product” without the need for additional clinical trials. The FDA has already approved a device that EnzySurge has developed but not the combined product with chemical solution.”
Indeed, according to this FDA 501(k) summary (.pdf), the device has been cleared by the FDA in 2006, but it is still pending European CE Mark of approval.
More about the EnzySurge technology, as it is presented by the company:
DermaStream is a multi-patented, multi-disciplinary treatment for chronic wound care. Developed by a combined team of bio-technology, medical device and wound care specialists, DermaStream combines a unique device with bio-active formulae to rapidly and painlessly treat and control the wound environment. With CST™ (Continuous Stream Therapy) technology at its core, it streams an ongoing supply of fresh, bio-active solution to trigger the desired reaction while actively and selectively draining, suctioning and washing away bacteria, necrotic tissue and other undesirable exudates…
The easy-to-use DermaStream™ device designed for hospital and home treatment continuously streams fresh doses of highly active solutions into the controlled wound environment. DermaStream actively drains, dissolves and washes away bacteria, necrotic tissue and other undesirable exudates.
DermaStream™ device features:
Three innovative actions operate in refined concert to expedite treatment of chronic wounds with unprecedented efficacy, safety and patient comfort:
1. Continuous streaming of fresh solution
This unique irrigation system ensures uniform flow of highly active ingredients over the entire wound surface and a continuously moist wound environment.
2. Ongoing removal of bacteria, necrotic tissue & excess exudates
An innovative combination of three cleansing actions uniquely responsive to the controlled wound environment:
Continuous drainage of excess exudates Mild negative pressure achieves faster, proactive removal of necrotic burden in addition to enhanced active ingredient’s efficacy and tissue regeneration Hypertonic medium for biochemical extraction of excess fluid
3. Controlled wound environment
The durable yet flexible, water-tight protective streaming device minimizes wound exposure to damaging elements while providing a controlled, moist environment for optimal receptiveness to active ingredients.
The versatile DermaStream device is available with highly active yet safe solutions specially developed for the debridement, regeneration and closure phases of wound management.