Manchester-based Woven Orthopedic Technologies is bringing its surgical screw sleeves, in development since 2013, to the U.S. market.
The U.S. Food & Drug Administration granted a so-called “de novo classification” to Woven’s OGmend Implant Enhancement System (pronounced similarly to “augment”) over the summer, allowing it to market the product for use during long-bone trauma surgeries.
OGmend is a special sleeve made of biotextile that provides surgical screws with a better grip into bones,
It’s a significant milestone for Woven, which has been navigating surgery postponements and other challenges caused by COVID-19 in Europe, where OGmend has been in use for spine surgeries since 2019.
“It’s been difficult, to say the least,” President and co-founder Brandon Bendes said in a recent interview. “Like the rest of the world, we’ve had to get creative and implement a number of countermeasures to drive progress.”
Bendes said he’s uncertain about exactly how rising coronavirus infection rates stateside might impact Woven’s timeline for getting OGmend into U.S. operating rooms. It can take months under normal circumstances to get hospital purchasing committees to approve a new product. The pandemic has forced some committees to meet virtually, while other hospitals have frozen new product approvals.
Though there are challenges and uncertainty caused by the pandemic, all things considered, Woven is having an amazing year overall, Bendes said. Besides the FDA win, the company has also raised more financing, added additional markets, and completed a clinical study of OGmend in European patients, the results of which will be announced in December in Germany.
“We’ve been really lucky with what we’ve accomplished this year and considering that demand is not going away because people are still going to need orthopedic surgery, we’re in an unbelievable position to take off when things open up again,” he said.
Last week, Woven put another feather in its cap for 2020, when the Orthopedics This Week, which bills itself as the most widely read publication in the orthopedics industry, included Woven on its list of winners for its 12th annual Spine Technology Awards.
”We are very proud to be acknowledged that the industry has taken note of the results we have achieved,” said Bendes, who gave a brief winner’s speech during the virtual event last Thursday.
Millions of people fracture their bones each year in the U.S. Not all will need surgery, and not all surgeries will use OGmend, but the market potential is still big for Woven, especially if it can win additional approvals to expand its product to more categories of orthopedic surgery.
OGmend has performed well so far in Europe, according to Bendes, who reported “a 100% success for every unit implanted with no device-related complications, adverse events, or revisions.”
“If we can replicate the results we achieved in our first year in Europe, then profitability will occur in the not-so-distant future,” he said.
