GlobeNewswire

SI-BONE, Inc. Announces Journal of Bone and Joint Surgery (JBJS) Publishes 2-Year Results from iMIA, a European Multicenter Randomized Controlled Trial (RCT) of SI Joint Fusion with  iFuse Implant System® vs Conservative Care

Del

This is the 67th peer-reviewed iFuse publication and shows rapid and sustained improvements in pain, patient function and quality of life, consistent with INSITE, a U.S. RCT published in August, 2016

SANTA CLARA, Calif., March 06, 2019 (GLOBE NEWSWIRE) -- SI-BONE, Inc. (Nasdaq: SIBN), a medical device company that pioneered minimally invasive surgery of the sacroiliac (SI) joint with the iFuse Implant System® (iFuse), announced publication of 2-year results from iMIA (iFuse Implant System Minimally Invasive Arthrodesis; ClinicalTrials.gov ID NCT01741025), a multicenter European RCT in the Journal of Bone and Joint Surgery (JBJS).

iMIA is a Level 1 RCT, conducted at nine hospitals in four countries in Europe, that assessed the safety and effectiveness of SI joint fusion (SIJF), also referred to as SI joint arthrodesis in the manuscript, with the triangular iFuse Implants compared to conservative management (CM) in patients with chronic SI joint dysfunction.  The JBJS publication, titled Randomized Trial of Sacroiliac Joint Arthrodesis Compared with Conservative Management for Chronic Low Back Pain Attributed to the Sacroiliac Joint,1 showed that minimally invasive SIJF with iFuse Implants was safe and more effective than CM in relieving pain, reducing disability, and improving patient function and quality of life at two years.

“What I find remarkable is the consistency of the results between the 2-year iMIA and 2-year INSITE RCTs,” said David Polly, Jr., MD, Professor, Department of Orthopedic Surgery at the University of Minnesota.  “The studies, which were well designed and well executed, were conducted at a combined 28 different centers on two different continents, yet the results are almost identical, which only further validates the effectiveness of the use of the iFuse triangular titanium implants for the treatment of patients with chronic SI joint dysfunction who no longer respond to conservative treatment.”

The iMIA 2-year results were published in JBJS, which has an impact factor of 4.84, the highest among orthopedic journals, and is a highly valued source of information for orthopedic surgeons and researchers.  As such, this publication, which is the 67th  peer-reviewed iFuse publication, is a significant indication of the broad acceptance of SI joint surgery as an important topic of study in orthopedics. 

“The publication of this Level 1 study in a prestigious orthopedic journal such as JBJS is an important milestone signaling recognition of the sacroiliac joint, like all other joints in the human body, as a pain generator and acknowledgement of the high quality of evidence that supports iFuse as an effective minimally invasive procedure for patients with SI joint pain”, said Daniel Cher, MD, Vice President of Clinical Affairs at SI-BONE, Inc.

As shown in Figures 1 and 2 below, 2-year results from iMIA were remarkably consistent with 2-year results from INSITE (Investigation of Sacroiliac Fusion Treatment – NCT01681004), the RCT conducted at 19 institutions in the U.S. and published in August, 2016 in the International Journal of Spine Surgery.2 

In the iMIA study, 103 subjects were randomly assigned to CM (n=51) or SIJF (n=52) between June 6, 2013 and May 15, 2015.  At 2 years, mean low back pain (as measured on the Visual Analog Scale, or VAS) improved by 45 points in the SIJF group and 11 points in the CM group (mean difference between groups 34 points, p<0.0001).  Mean ODI improved by 26 points in the SIJF group and 8 points in the CM group (mean difference 18 points, p<0.0001).  Parallel improvements were seen in leg pain and several quality of life measures.  Moreover, objective improvements were observed in SI joint function, including active straight leg raise test and a number of positive physical examination signs for SI joint pain. In the SIJF group, the prevalence of opioid use decreased from 56% at baseline to 33% at 2 years (p<0.01), while no significant change was observed in the CM group (47.1% and 45.7%). Subjects in the CM group who derived minimal benefit after 6 months of CM showed improvements in all measures similar to those originally assigned to SIJF after crossing over to surgery. One case of postoperative nerve impingement occurred in the SIJF group.  The full article can be found at the following link: https://journals.lww.com/jbjsjournal/Fulltext/2019/03060/Randomized_Trial_of_Sacroiliac_Joint_Arthrodesis.4.aspx 

About SI-BONE

SI-BONE is a medical device company that pioneered the iFuse Implant System, a minimally invasive surgical system for fusion of the sacroiliac joint to treat sacroiliac joint dysfunction.  The SI joint is the last major joint with a clinically proven surgical treatment.  The iFuse Implant, commercially available since 2009, is the only SI joint fusion device supported by multiple prospective clinical studies showing improved pain, patient function and quality of life resulting from treatment.  There are more than 65 peer-reviewed publications supporting the safety, durable effectiveness, and biomechanical and economic benefits unique to the iFuse Implant (www.si-bone.com/results).  This body of evidence has enabled multiple government and private insurance payors to establish coverage of the SI joint fusion procedure exclusively when performed with the iFuse Implant System.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit. 

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2019 SI-BONE, Inc. All Rights Reserved. 10309.030719

  1. Dengler J, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Gaetani P,  Cher D, Van Eeckhoven E, Annertz M, Sturesson B. Randomized Trial of Sacroiliac Joint Arthrodesis Compared with Conservative Management for Chronic Low Back Pain Attributed to the Sacroiliac Joint. J Bone Joint Surg. 2019;101(5):400-411. doi: 10.2106/JBJS.18.00022
  2. Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10:Article 28. doi: 10.14444/3028

Contact:
For SI-BONE, Inc.:
Joe Powers
Vice President of Marketing
669-206-2521 
jpowers@si-bone.com 

Photos accompanying this announcement are available at

http://www.globenewswire.com/NewsRoom/AttachmentNg/6d116c9c-0bf2-452c-a154-672ac3b2df8f

http://www.globenewswire.com/NewsRoom/AttachmentNg/742f9332-30ef-4f2a-a04f-7eae432dbe0b

Om GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Følg saker fra GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra GlobeNewswire

Tenaris to Acquire IPSCO Tubulars from TMK22.3.2019 13:58:00 CETPressemelding

LUXEMBOURG, March 22, 2019 (GLOBE NEWSWIRE) -- Tenaris S.A. (NYSE, Buenos Aires and Mexico: TS and MTA Italy: TEN) announced today that it has entered into a definitive agreement to acquire from PAO TMK, a Russian company and manufacturer of steel pipe, 100% of the shares of its wholly owned U.S. subsidiary IPSCO Tubulars, Inc., for US$1,209 million, on a cash-free, debt-free basis, which includes US$270 million of working capital. The transaction is subject to regulatory approvals, including approval by the U.S. antitrust authorities, and other customary conditions. IPSCO Tubulars is a U.S. domestic producer of seamless and welded OCTG and line pipe products, with an annual production capacity of 450,000 metric tons of steel bars, 400,000 metric tons of seamless pipe and 1,000,000 metric tons of welded pipe, and production facilities spread throughout the country. The acquisition would enhance Tenaris’s position and local manufacturing presence in the U.S. market, extending its produc

Oxford Immunotec Announces Chief Financial Officer Transition21.3.2019 21:01:00 CETPressemelding

OXFORD, United Kingdom and MARLBOROUGH, Mass., March 21, 2019 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD) (the "Company"), a global, high-growth diagnostics company, today announced that Richard Altieri, the Company’s Chief Financial Officer (CFO), will retire on April 30, 2019. The Company has appointed Matthew McLaughlin, currently Chief Financial Officer, GE Healthcare – U.S. and Canada, as his successor. Mr. McLaughlin will join Oxford Immunotec as CFO on April 8, 2019. Today’s announcement concludes an extensive search process conducted by the Company. As part of the planned succession, Mr. Altieri, who has led Oxford Immunotec’s global finance organization as CFO since 2012, will remain an active member of the Company’s management team until his retirement date. “During his seven year tenure, Rick successfully managed multiple financing rounds, including the Company's IPO, the acquisition and financial integration of three companies and, most recently, the dives

Blackhawks, Flyers, Sabres and Lightning Headline the 2019 NHL Global Series21.3.2019 15:34:00 CETPressemelding

Chicago Blackhawks and Philadelphia Flyers to Open Regular Season in Prague, Czech Republic on Oct. 4 Buffalo Sabres and Tampa Bay Lightning to Face Off in a Pair of Games in Stockholm, Sweden on Nov. 8 and Nov. 9 2019 NHL Global Series Challenge to feature Blackhawks vs. Eisbären Berlin on Sept. 29 in Berlin, Germany and Flyers vs. Lausanne HC on Sept. 30 in Lausanne, Switzerland Tickets to Games in Berlin, Prague and Stockholm Available for Purchase on Wednesday, March 27; Tickets to Game in Lausanne Available for Purchase on Wednesday, April 10 NEW YORK/TORONTO, March 21, 2019 (GLOBE NEWSWIRE) -- The National Hockey League (NHL) and the National Hockey League Players’ Association (NHLPA), in conjunction with Live Nation Sweden, today announced that the Buffalo Sabres, Chicago Blackhawks, Philadelphia Flyers and Tampa Bay Lightning will participate in the 2019 NHL Global Series. The Chicago Blackhawks and Philadelphia Flyers will play their 2019-20 season-opening game against each ot

Farmako: World's Largest Import Contract for Pharmaceutical Cannabis21.3.2019 15:10:00 CETPressemelding

German Farmako secures 50 tonnes of flowers and oils from Polish company Pharmacann Polska FRANKFURT, March 21, 2019 (GLOBE NEWSWIRE) -- Farmako will import 50 tonnes of pharmaceutical cannabis from Pharmacann Polska into the European market over the next four years. This provides the basis for a reliable supply of pharmaceutical cannabis for millions of patients in the European healthcare system. The company expects a total revenue of several hundred million Euros from the agreed exclusive partnership. Founded in September 2018, Farmako now has grown to 40 employees and is distributing high-quality pharmaceutical cannabis to German pharmacies since March 2019. This is the biggest Cannabis contract to date, and the first big contract without participation of a Canadian LP. Farmako has signed an exclusive and binding agreement to import and distribute 50 tons of pharmaceutical cannabis over four years. Farmako and Pharmacann Polska enter strategic partnership to develop custom tailored

NexOptic Appoints Rich Geruson, Former Lexmark CEO, to Board of Directors21.3.2019 14:00:00 CETPressemelding

VANCOUVER, British Columbia, March 21, 2019 (GLOBE NEWSWIRE) -- NexOptic Technology Corp. ("NexOptic" or the "Company") (TSX VENTURE: NXO) (OTCQX: NXOPF) (FRANKFURT: E3O1) is pleased to announce that Richard J. (Rich) Geruson has joined its Board of Directors, effective immediately. Mr. Geruson’s experience spans CEO roles at Lexmark International, Phoenix Technologies and VoiceSignal Technologies, and Senior Vice President and executive positions at Nokia, IBM, Toshiba, and McKinsey & Co. As CEO of Lexmark International, a multibillion-dollar imaging technology and solutions company with 10,000 employees, he grew printer sales faster than at any time in the preceding 10 years while simultaneously executing extensive process reengineering, transforming the business from negative EBITDA and high debt to positive multi-hundred-million-dollar EBITDA and a healthy debt profile. While CEO of Phoenix Technologies, he achieved consistently high profit year-over-year for six years straight in