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| iFuse Implant System--Courtesy of SI-Bone |
A few weeks ago, minimally invasive surgical startup SI-Bone announced that it had nabbed an expanded indication for its iFuse Implant System from the FDA. Now, the company has gained million credit facility from Oxford Finance and Silicon Valley Bank worth $39.2 million to help market iFuse.
The new indication is expanded to attribute to the implant improvement in pain, patient function and quality of life after a year. Specifically, the indication statement now includes the following: "Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function and quality of life at 12 months post-implantation."
The iFuse System is for sacroiliac fusion for joint dysfunction due to sacroiliac joint disruption and degenerative sacroiliitis, including those conditions resulting during pregnancy and postpartum. It's intended to off a minimally invasive option to ease the lower back pain associated with these indications.
"Oxford is pleased to provide SI-Bone a growth capital credit facility to support the company's continued expansion," Christopher Herr, senior managing director at Oxford Finance, said in a statement. "We believe there is a substantial market for SI-Bone's innovative iFuse Implant System."
The latest FDA expansion is part of long regulatory process that started in 2008 with an initial FDA clearance for the system; in 2010 it got a CE mark for it. In 2011, the FDA clearance was expanded. More recently, its surgical category gained a reimbursement code earlier this year. iFuse uses titanium implants coated with a porous, titanium plasma spray to decrease implant motion, provide immediate fixation and long-term fusion.
In March, SI-Bone disclosed 6-month U.S. data for iFuse. The 148-patient study found that joint pain as measured by visual analog scale fell to 29.8 from 82.3 at baseline, nearly a 53-point decrease. The trial has a control group that did not receive nonsurgical management such as medication, physical therapy, steroid injections and joint radiofrequency ablation. These patients reported a pain level of 70.4 at 6 months, down from 82.2 at baseline.
This debt financing isn't SI-Bone's first time to the well this year; in May it raised $21 million from new investor Redline Capital Management and existing investors OrbiMed Advisors, Novo A/S, Skyline Ventures and Montreux Equity Partners. SI-Bone also brought on a new CFO with public company experience earlier this year, suggesting that perhaps an IPO is on the table.
"SI-Bone is driving important medical advancements through its iFuse Implant System for the treatment of certain conditions that can cause lower back pain," said Shawn Parry, VP of life science at Silicon Valley Bank. "It is our objective to provide the SI-Bone team with the right financing, connections and global services that they need to move their business forward quickly."
- here is the announcement