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After four years of work developing a small device to help orthopedic screws better grip surgery patients' bones, Manchester's Woven Orthopedics has hit a major milestone.
Starting in May, the company officially began distributing its woven biotextile devices, which are like sleeves or wall anchors for screws, in Australia and New Zealand for use in human patients. It marks the company's first revenue and the first time its product has been used in humans.
“My dream is always to get things from bench to bed,” Woven CEO Ilana Odess said in an interview. “It's so gratifying.”
In Woven's case, the idea didn't even start at a bench. A surgeon doodled the idea on a napkin one day before eventually patenting the idea. Woven acquired that patent and has been working since 2013 to develop the device.
The company's entry into Australia and New Zealand marks a shift in its initial strategy.
Woven, which has three full-time and four part-time employees, had been targeting Europe and the U.S. as its first markets, and had previously hoped to start selling in Europe by late last year.
That hasn't happened yet because Woven is still pursuing regulatory approvals, which can vary widely by country, in both places. It began a human clinical study this month in the United Kingdom with the hopes of getting approvals.
“We are absolutely continuing on U.S. and EU approvals,” said Brandon Bendes, Woven's vice president of strategy and finance. “We already submitted applications and are currently under review. Response times vary and are unknown.”
Conservatively, the company hopes for the regulatory approvals by the first quarter of next year, he added.
Woven has also gone back to the equity markets for another funding infusion. The company disclosed to the U.S. Securities and Exchange Commission in August that it had raised $4.2 million out of a total $18 million offering.
The closed funding will be used for commercial and clinical studies, said Bendes, who declined to discuss how the company would spend the remaining $13.8 million. The company raised $1.2 million last year.
Woven is also looking at potential new markets, Odess said.
“Right after we launched in New Zealand and Australia, we got a lot of interest from other countries in Asia, such as Hong Kong and Singapore,” she said.
