San Jose, Calif.-based SI-Bone has big plans for its newly raised $33 million, saying it’ll use the new funds to add additional resources and chase regulatory approvals overseas for its iFuse bone fixation system.
Financing came from new investors Orbimed and Novo A/S, as well as from existing funders Skyline Ventures and Montreux Equity Partners, SI-Bone reported.
The company is making big moves outside the U.S, seeking regulatory approvals in a dozen countries in Asia, the Middle East and South America. SI-Bone is further planning new commercial efforts in Australia, New Zealand and Hong Kong, according to a press release.
Those big steps will be supported by a bigger U.S. workforce, as the company is looking to boost its resources in R&D, medical affairs, regulatory, compliance and reimbursement. Finally, the new funds will help support the company’s trio of ongoing clinical trials, 2 of which are in the U.S. and the 3rd in Europe.
"This is an incredibly exciting time for our company as we anticipate significant growth in the coming years," president & CEO Jeffrey Dunn said in prepared remarks. "The strong clinical evidence supporting MIS SI joint fusion, the AMA’s decision in March to establish a Category 1 CPT code for the procedure, along with the increasing adoption and demand for iFuse by surgeons in the U.S. and around the world further validates our belief that minimally invasive fusion of the SI joint is being recognized as the standard surgical treatment option."
SI-Bone last month touted a reimbursement win for its iFuse spinal fusion device, saying that a Medicare administrator reversed its non-coverage policy on the company’s flagship device. That decision opened coverage for the iFuse sacroiliac procedure to patients on a case-by-case basis in North Carolina, South Carolina, Virginia and West Virginia.
The iFuse device has had FDA clearance since 2008 and has been available in Europe since 2010. Palmetto GBA is the 1st of the 8 regional Medicare contractors to lift the ban on iFuse coverage.