SAN JOSE, Calif., Jan. 7, 2013 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to fuse the sacroiliac (SI) joint announced today that Jeffrey Dunn, President and CEO, will speak at the 31st Annual J.P. Morgan Healthcare Conference in San Francisco, California, on Tuesday, January 8, 2013 at 2:00 p.m. Pacific Time.
Mr. Dunn will present the company's accomplishments during its brief 4-year history highlighting the rapid adoption of the iFuse procedure resulting in impressive revenue growth that has enabled the company to become profitable and achieve positive cash flow. In addition to achieving profitability, the company has also secured a $5 million line of credit with Silicon Valley Bank to provide additional working capital for future expansion in sales and clinical operations in 2013. Mr. Dunn's presentation will cite the clinical success of the iFuse procedure recently published in medical journals showing pain reduction and overall patient satisfaction. Adding to the growing body of iFuse clinical evidence, which includes over a dozen abstracts, the company announced today publication of a 2nd peer-reviewed article titled: "One year successful outcomes for novel sacroiliac joint arthrodesis system" by Donald Sachs, MD of Lakeland, FL. The article is a retrospective analysis of 11 consecutive patients treated with iFuse by a single surgeon. Results showed an average improvement of 6.2 points from baseline (using a 0 – 10 point numerical rating scale) and a 100% patient satisfaction where all patients indicated they would have the same procedure again.1 Last month another paper was published in The Open Orthopedics Journal on 50 consecutive patients with similar results.2
Mr. Dunn commented: "We are honored to be asked to present at this years' J.P. Morgan Healthcare Conference. We started out four years ago with a belief that the SI joint was one of the most under diagnosed and underserved areas in orthopedics and that iFuse was a significant treatment alternative for patients. We have witnessed remarkable growth during a very short time treating over 5,000 patients and achieving a $50 million dollar revenue run rate. Our focus on educating clinicians and patients has been a driving force behind our success and with our continued emphasis on education, we believe many more patients will benefit from our technology in the months and years to come."
The company also announced today the appointment of John Freund, MD to the board of directors. Dr. Freund, founding partner of Skyline Venture Partners, will bring extensive experience to SI-BONE's board and help guide the company through the next phase of growth and development in 2013 and beyond.
SI-BONE, Inc. received original clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System for fracture fixation of long bones and large bone fragments of the pelvis and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010.
Clinical publications have identified the SI joint as a pain generator for up to 22 percent of low back pain patients.3 In addition, DePalma et al, Pain Medicine 2011, identified the SI joint as a pain generator in low back pain in 40 to 61% of post-lumbar fusion patients, so-called "failed back surgery" patients.4 Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse may provide an option.
The iFuse Implant System is a commercially available device in the U.S. and Europe. The iFuse procedure uses a small incision for delivery and implantation of titanium implants. The implants are coated with a porous, titanium plasma spray that acts as an interference surface, designed to help decrease implant motion and provide immediate fixation and long term fusion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional screws used to surgically fix bony structures. The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant.
About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to SI joint disorders. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of certain SI joint pathology. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2013 SI-BONE, Inc. All Rights Reserved.
1 Sachs, D, Capobianco, R. One year successful outcomes for novel sacroiliac joint arthrodesis system. Annals of Surgical Innovation and Research, 2012, 6:13.
2 Rudolf, L. Sacroiliac Joint Arthrodesis – MIS Technique with Titanium Implants: Report of the First 50 Patients and Outcomes. The Open Orthopaedics Journal, 2012, 6, 492-499.
3 Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics 1987;217:266–80.
4 DePalma, M. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine, 2011;12:732-39.
SOURCE SI-BONE, Inc.