Treatment has begun on the first patients in Origin Inc.'s U.S. dose-ranging GENESIS trial. The Princeton, N.J.-based company has developed a technology to produce and deliver plasma-generated nitric oxide for the treatment of chronic diabetic foot ulcers (DFU).
Origin, which was formed in 2010 and was formerly called Advanced Plasma Therapies Inc., has developed a device with a hand-held, computer-guided system that generates nitric oxide from ambient room air within a defined plasma stream. From there, nitric oxide is generated and targeted toward the patients wound for about six to 12 minutes.
"From an external source, we're able to deliver a critical mechanism to the body, to allow healing to begin," Betsy Hanna, chief operating officer of Origin, told Medical Device Daily.
In the GENESIS study, the company will recruit up to 100 patients across 15 clinical sites in the U.S. After a two-week run-in period, patients will be randomized into one of four different dosing regimens or a standard of care treatment arm to assess efficacy and safety. Patients will be treated over 12 weeks and monitored for 12 weeks post treatment.
Standard for care treatment for chronic wounds includes dressing changes, wound cleansing, pressure relief (off-loading) and wound debridement.
Effectiveness will be measured by wound closure rate and wound closure percentage. Safety will be measured by wound-related adverse events, which include adverse events of all causes that affect the wound. The company said it would provide an update and initial readout of the interim results in 4Q17.
"We're going to do an analysis of the data at the mid-point of the trial to see the differences of the arms and the efficacy vs. the standard of care," Hanna said. "That data will [determine] the time in which we file for a new IDE for a pivotal trial."
Because of the nitric oxide component, the technology is being treated like a combination product by the FDA.
"The FDA has put us in the device division," Hanna said. "But because of the mode of action of nitric oxide, we do have in our review process and our regulatory process members from the [Center of Drug Evaluation and Research] are also involved in the discussions of the safety and efficacy of the therapy."
Plans eventually call for the company to seek approval in Europe.
"Our target initially is going to be looking at wounds that have failed the standard of care," Hanna said. "There are a number of different products out ... [but] nothing with an overwhelming clinical success in treating these kinds of ulcers. You've got a market out there for advanced wound treatment products and the market is more than $13 billion."
She added, "We see this as a wide open opportunity, and our job is to get the first use and indication approved for our device, to demonstrate we can make a difference in that healing."
Origin isn't alone in its goal to get secure FDA approval for a diabetic foot ulcer technology.
One of the most notable companies in the space is Sanuwave Inc. The Alpharetta, Ga.-based firm has been vying to gain FDA approval for its Dermapace technology for a number of years. The device has CE mark approval and uses a noninvasive, biological response for the repair and regeneration of skin, musculoskeletal tissue and vascular structures.
Sanuwave initially hit a major snag in its plans to bring the device to market back in 2011, after it was revealed in the 206-patient trial that there was no statistically significant difference regarding wound closure after 12 weeks between the sham treatment and the treatment with Dermapace. Sanuwave has been notably quiet with its progress in the U.S., but last month it launched a blog on its website to update key developments with its product line.
Integra Lifesciences Holdings Corp. also has applications in soft tissue repair and regeneration applications. The Plainsboro, N.J.-based company broadened its strength in the space when it acquired Tei Biosciences and Tei Medical for $312 million. (See Medical Device Daily, June 30, 2015.)