$33 Million for SI-BONE

SI-BONE, Inc. recently received a major infusion of funding with which to grow and expand…$33 million in capital will go a long way. Those disbursing the funds included Orbimed and Novo A/S, as well as current investors Skyline Ventures and Montreux Equity Partners.

Proceeds from the investment will be used to fund expansion of the U.S. sales organization and add additional resources in R&D, medical affairs, regulatory, compliance and reimbursement.

Regarding use of funds for growth of the U.S. sales organization, Jeffrey Dunn, president and CEO of SI-BONE told OTW, “We plan to double the size of our direct U.S. sales force this calendar year to address growing surgeon demand and interest in SI joint [sacroiliac joint] diagnosis and treatment with iFuse. Due to that level of sales force growth, we will also increase our supporting infrastructure primarily within our medical affairs, marketing and reimbursement organizations to better handle the demand for new surgeon training, case coverage and field support.”

The company is also pursuing regulatory approvals for iFuse in Asia, the Middle East, Canada and South America and initiating commercialization in Australia, New Zealand and Hong Kong.

On this topic, Dunn told OTW, “We have already begun the process of obtaining regulatory approval in over a dozen countries outside of the U.S and Europe. The decision on what countries to target was based on a combination of demand from specific countries for minimally invasive SI joint fusion plus the size of each market as well as accessibility of health care delivery in each market. We will commercialize in new countries based on where regulatory approvals are first obtained. The iFuse Implant System was recently approved in Australia, New Zealand, Israel, and Hong Kong with more approvals to follow this year and next.”

Dunn added, “Over the past year or so, there have been a dozen papers published on the safety and effectiveness of the iFuse Implant System. The positive results of these studies have resulted in the assignment of a Category I CPT code for minimally invasive SI joint fusion. In addition, results from these studies have generated an accelerated interest among surgeons and other health care professionals to identify and treat patients suffering from chronic SI joint mediated pain due to degenerative sacroiliitis and sacroiliac joint disruptions. More and more, medical device growth and adoption is contingent on great clinical evidence.”

“By early next year we expect to publish the first prospective randomized controlled study in this area. Additional publications are expected sooner, such as the first analysis of five-year data on iFuse. This high quality evidence will influence payers in the United States and the rest of the world to establish coverage. Given the strength and consistency of our data, reimbursement coverage is increasing both in the U.S. and abroad. For all of these reasons, we felt it was the right time to take on additional investment capital to meet the growing patient and surgeon demand.”