Arch Therapeutics has developed a technology it says is able to control bleeding and leakage during surgery and trauma.
The technology, known as the AC5 surgical hemostatic device, is able to stop bleeding immediately, with a elapsed time of 10 seconds. Other methods of hemostasis take anywhere between 180 and 300 seconds.
Dr. Terrence Norchi, CEO and president of Arch Therapeutics, described the technology and said that it uses peptides that are unlike normal peptides. He said that it is like a vial of liquid, similar to hand sanitizer, that contains peptides. When the peptides hit a wound, they become “briefly unhappy” by themselves. So they begin to assemble themselves into a very dense nanofiber structure that stops bleeding, leaking and mitigates containment.
A wound is a highly charged environment with ionic charges. The peptides in the topical liquid are able to conform to any parts of the outside and inside of wounds that may be irregular in size and allows for normal healing.
Its non-sticky chemistry makes it ideal for use in a laparoscopic setting. The liquid is also clear, allowing doctors to be able to see through the liquid as they work around it. So far, the technology has been tested in non-human animal clinical work in the U.S.
Arch Therapeutics is a biotech company, and this technology is being regulated as a device. The material uses no metabolic or chemical effects on the body and relies on the rearrangement of peptides, which makes it have to be regulated like a device.
The AC5 Surgical Hemostatic Device has not been tested on humans in the U.S. yet, but it did complete its first trial on humans in Europe.
“The product was safe and it was effective,” said Norchi.
Arch Therapeutics has begun the process to file for CE Marking to sell the device in Europe.
The company also plans to commercialize and file for 510k notification in this coming calendar year.
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