Arch Therapeutics (OTC:ARTH) is looking to bring advanced material technology to wound care, and in July, the company got one step closer by submitting its application to the FDA for 510(k) clearance for its 1st commercial product, a topical gel based on its AC5 wound care platform.
The company’s products are designed around technology out of the Massachusetts Institute of Technology called self assembling peptidomimetics. The technology, developed by company co-founder Rutledge Ellis-Behnke, is at the core what makes the company’s AC5 product stand out.
The AC5 self-assembling peptide technology is designed to be applied as a liquid or a spray and self-assembles into a nano-fiber structure that acts as a physical barrier on the tissue, sealing the wound to stop fluids from leaking.
Early testing of the technology platform has shown that it excels at both stopping bleeding and promoting hemostasis, Dr. Terrence Norchi told MassDevice.com in an interview.
“It’s very different on a number of fronts. On the one hand, the underlying technology is pretty special, but on the other hand, it’s very easy to use. Based on the work that we have done, we have seen good data in allowing wounds to heal normally,” Dr. Norchi said. “What we’ve noticed is that the other products on the market don’t have this sort of hemostasis data that we have.”
For 11 years, Dr. Norchi has been at the head of Arch Therapeutics, joining Ellis-Behnke and his vision for the technology.
Prior to its founding in 2006, Dr. Norchi was living in Boston, positioned at the head of the 2nd largest healthcare mutual fund in the world. But Norchi, and Ellis-Behnke before him, were driven by an interest in the concept of wound management, and how they could utilize technology to improve it.
“We were interested in this concept of what happens when you have a wound – you have a hole in the body, you have bleeding, leaking, contamination and the need for normal healing. Rutledge was working with these propositions at MIT,” Dr. Norchi told MassDevice.com in an interview.
The Arch Therapeutics team saw an opportunity to create a better product for wound management with the self-assembling peptide technology – one that could quickly create barriers and stop bleeding.
With the technology, Dr. Norchi and co-founders Steve Kelly, a serial entrepreneur that had previously founded Myomo, and Ellis-Behnke, set out to commercialize the tech.
The initial FDA 510(k) submission is just the 1st step for the company – but one that has been a long time coming. Working with advanced materials, especially ones as novel and new as self-assembling peptides, has meant the company is subject to slow progress at times, Dr. Norchi said.
“We decided to start this company and spent a lot of years figuring out all of the various stuff one has to figure out in the early days of what is a …very novel new technology. Very few people had experience with self-assembling peptides. There was a lot of learning going on,” Dr. Norchi said. “How do you make it? How do you not make it? Whats the lead sequence?”
Years of development later, and Arch Therapeutics is preparing to release it’s 1st product – the AC5 topical gel – contingent on its FDA approval.
But the initial external use isn’t the endpoint for the technology. The AC5 platform holds promise for other applications, including internal use, Dr. Norchi said.
“We think that these compositions have great potential in a range of applications, from surgical to trauma to other types of wound care. to some specialty applications in various organs in the body. We have a lot of opportunity in front of us in terms of product to develop. We’re pretty excited to do it,” Dr. Norchi said.
For its topical gel product, Dr. Norchi said that the company was hopeful for a launch within the 2nd half of the year, but said there is no exact timeline. The company also has plans to do more trials of the device, including a trial for an internal application, though such a trial could be a ways off, Dr. Norchi added.
“We do plan to do an internal trial at some point. We expect that to be a PMA application with the US FDA for use inside the body,” Dr. Norchi said.
As for other applications and products, Dr. Norchi said that the topical gel, and even the AC5 line, was just the beginning for the company.
“The AC5 happens to be the 1st line of applications and products that we’re looking at but we’re pretty excited by the possibility for … the potential for a series of additional products to follow. Another way of saying it is, we’re not a 1 product company, in terms of what we expect from our future,” Dr. Norchi said.
