INSPIRE is a prospective decentralized study evaluating post-operative health outcomes in patients who undergo a procedure using implants manufactured by SI-BONE.

开始日期2024-12-15

申办/合作机构

SI-BONE, Inc.

NCT05640908

/ Enrolling by invitationN/A

Pelvic Fixation and Fusion During Multilevel Spinal Surgery

PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.

开始日期2023-06-05

申办/合作机构

SI-BONE, Inc.

NCT05870488

/ Active, not recruiting临床4期

iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction

iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction (STACI) is a prospective, multicenter, study of SIJ fusion using the iFuse TORQ implant system.

开始日期2023-05-23

申办/合作机构

SI-BONE, Inc.

100 项与 SI-BONE, Inc. 相关的临床结果

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0 项与 SI-BONE, Inc. 相关的专利（医药）

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项与 SI-BONE, Inc. 相关的文献（医药）

2025-12-01·International Journal of Spine Surgery

Differential Diagnosis of Posterior Buttock Pain: A Conceptual Review Based on Topographic Localization of Pain, Is It Really the Sacroiliac Joint?

Article

作者: Polly, David W ; Reckling, W Carlton

Diagnosis and management of musculoskeletal pain in the lower back, buttock, and hip can be complex due to the multilayered muscular anatomy in this region. Each structure or functional group (ie, hip abductors) may present as a local pain syndrome. Pain may arise from osseous, intra-articular, ligamentous, musculotendinous, myofascial, neural, or vascular sources. Diagnosis is challenging due to overlapping innervation and referred pain patterns, particularly sclerotomal referral from osseous and ligamentous structures. Effective treatment requires accurate diagnosis. A regionalized approach categorizing pain syndromes into 6 anatomic zones-above the iliac crest, the iliac crest, the lateral hip, the gluteal region, sciatic nerve related, and the ischial tuberosity-may improve diagnostic clarity and guide treatment. A regionalized, 6-zone framework for posterior buttock pain may enhance diagnostic accuracy and guide individualized management.

2025-08-01·INJURY-INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED

Randomized trial of surgery vs. non-surgical management for pelvic fragility fractures

Article

作者: Soles, Gillian ; Black, John David ; Shannon, Steven F ; Michels, Ryan ; Reid, Kristoff ; Dirschl, Douglas ; Hadeed, Michael ; Westrick, Edward ; Cher, Daniel ; Capobianco, Robyn ; Yoon, Richard S

OBJECTIVES:

Non-surgical management (NSM) of posterior pelvic fragility fractures (PFF) can lead to prolonged disability, morbidity, and death. Surgical management (SM) also has risks but has been reported to rapidly restore mobility. This study sought to compare improvement in mobility between NSM and SM in a prospective cohort of patients with PFF.

METHODS:

Design: Prospective, randomized controlled trial of SM vs NSM SETTING: Academic and community trauma centers PATIENT SELECTION CRITERIA: PFF patients without significant cognitive impairment who are bedbound OUTCOME MEASURES AND COMPARISONS: The primary endpoint was time to regain two points on a modified functional mobility scale (MFMS). Secondary endpoints included PROMIS physical function and pain interference, Oswestry Disability Index (ODI), and numeric rating scale (NRS) pain score. A 12-month CT scan was performed in the SM group only.

RESULTS:

Enrollment was challenging despite modifying the study to include an observational cohort. 28 subjects were enrolled (age 78±9.8); 16 underwent SM and 12 received NSM. The primary endpoint occurred at a median of 10 days in the SM group and 16 days in the NSM group (p = .1). 100 % of SM and 83 % of NSM subjects achieved the primary endpoint by 6 weeks. Five subjects who received SM could be considered NSM failures; including these failed subjects in the NSM group widened the difference in primary endpoint success rates (100 % in SM vs. 48 % in NSM, p < 0001). Some trends in secondary outcome measures favored SM, but they did not reach statistical significance. There were no device- or procedure-related serious adverse events.

CONCLUSION:

Despite enrollment challenges, consistent trends were observed to suggest that SM may be superior to NSM in patients with painful PFF. Key challenges in enrollment in geriatric fracture trials comparing NSM to SM were identified. It is conceivable that studies such as this may represent the most robust investigations possible in comparing SM to NSM in PFF.

LEVEL OF EVIDENCE:

II.

2024-05-01·The spine journal : official journal of the North American Spine Society

Effects of BMI on SI joint fusion outcomes: examining the evidence to improve insurance guidelines

Article

作者: Polly, David W ; Cher, Daniel ; Dat, Kari Odland

BACKGROUND CONTEXT:

Obesity is increasing. Previous studies have demonstrated an association between obesity and adverse events after lumbar fusion. There is limited evidence on the effect of obesity on minimally invasive SI joint fusion (SIJF) outcomes.

PURPOSE:

The purpose of this study was to investigate the impact of obesity on patient-reported outcomes in patients undergoing SIJF surgery using triangular titanium implants (TTI).

STUDY DESIGN:

Retrospective cohort study based on four prospective clinical trials (INSITE [NCT01681004], SIFI [NCT01640353], iMIA [NCT01741025], and SALLY [NCT03122899]).

PATIENT SAMPLE:

Adult patients ≥18 years of age who underwent minimally invasive surgery (MIS) sacroiliac joint (SIJ) fusion between 2012 and 2021.

OUTCOME MEASURES:

Visual analog scale (VAS Pain), Oswestry Disability Index (ODI).

METHODS:

Participants were classified using the National Institutes of Health body mass index (BMI). Patients with a BMI of 30 to 39 with no significant comorbidity are considered obese, patients with a BMI of 35 to 39 with a significant comorbidity or a BMI of 40 or greater are considered morbidly obese. All subjects underwent either minimally invasive SIJ fusion with TTI or nonsurgical management (INSITE and iMIA studies only). All subjects completed SIJ pain scale scores (measured with a 100-point VAS) and disability scores (measured with ODI) at baseline and at scheduled visits to 24 months. Repeated measures analysis of variance was used to examine the impact of BMI category on score changes.

RESULTS:

In the SIJF group, mean SIJ pain improved at 24 months by 53.3 points (p<.0001). Over the 24-month follow-up period, BMI category did not impact mean improvement in SIJ pain scale score (repeated measures analysis of variance (ANOVA) p=.44). In the SIJF group, mean ODI at 24 months improved by 25.8 points (p<.0001). BMI category did not impact mean improvement in ODI (ANOVA p=.60). In the nonsurgical management (NSM) group, mean improvements in SIJ pain scale and ODI were clinically small (8.7 and 5.2 points, respectively) and not affected by BMI category (ANOVA p=.49 and .40).

CONCLUSION:

This study demonstrates similar benefits and risks of minimally invasive SIJ fusion with TTI across all BMI categories. This analysis suggests that obese patients benefit from minimally invasive SIJ fusion and should not be denied this procedure based solely on elevated BMI.

项与 SI-BONE, Inc. 相关的新闻（医药）

2025-11-24

·PRNewswire

Galvanize Therapeutics Appoints Laura Francis to its Board of Directors

REDWOOD CITY, Calif., Nov. 24, 2025 /PRNewswire/ -- Galvanize ("Galvanize") Therapeutics, Inc., a commercial-stage medical technology company pioneering pulsed electric field (PEF) therapies for oncology and chronic lung disease, today announced the appointment of Laura Francis to its Board of Directors. An experienced medical technology executive, Francis is Chief Executive Officer and a Board of Directors member of SI-BONE, Inc., a medical device company solving musculoskeletal disorders of the sacropelvic anatomy. She previously served as Chief Financial Officer and Chief Operating Officer. Prior to joining SI-BONE, Ms. Francis held other executive and leadership roles with public and private life science companies, including Auxogyn, now part of Progyny, Promega Corporation, and Bruker Corporation, where she currently serves as a board member. Previously, she was an Engagement Manager with McKinsey & Company and Audit Manager with Coopers & Lybrand, now PricewaterhouseCoopers. Francis also served as a board member of Shockwave Medical, Inc., where Galvanize Chairman and CEO Doug Godshall previously served as President and CEO. Ms. Francis earned a B.B.A. in Accounting and Finance from the University of Wisconsin and an M.B.A. from Stanford University. "Laura's deep expertise in leading innovative, high-growth, medtech companies rooted in strong financial governance makes her an outstanding addition to our board," Godshall said. "Her involvement comes at an important time for Galvanize. We are scaling our commercial organization and advancing our technical and clinical portfolios as we endeavor to make our therapies more readily available for the millions of patients who are underserved by today's approaches. I feel fortunate to have this opportunity to work with Laura again." About Galvanize Therapeutics Galvanize™ aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of diseases, including solid tumors, and chronic bronchitis symptoms. The company is based in Redwood City, CA, and is developing and commercializing its revolutionary Aliya® PEF energy platform in the United States. For more information, please visit . SOURCE Galvanize Therapeutics, Inc. 21% more press release views with Request a Demo

高管变更

2025-05-09

·PRNewswire

Osteotec Signs Exclusive Distribution Agreement with icotec ag to advance Spine Tumour Therapy in Great Britain

NEWBURY, England, May 9, 2025 /PRNewswire/ -- Osteotec, the market leading manufacturer and distributor of specialised medical devices, is pleased to announce an exclusive distribution agreement with icotec, the world leader of non-metallic spinal implants optimized for spine tumour therapy. This collaboration, effective from May 8, marks a key milestone in Osteotec's strategic growth, further expanding its spine product portfolio to provide physicians in Great Britain with advanced solutions that support improved patient outcomes. Headquartered in Altstätten, Switzerland, icotec develops and manufactures innovative, radiolucent implants derived from BlackArmor® Carbon/PEEK material for the operative treatment of tumour diseases of the spine and other indications. icotec's BlackArmor® Carbon/PEEK material provides value in radiotherapy, enabling artifact-free CT/MRI images for accurate delineation of critical structures and accelerated dose planning, helping physicians improve diagnostic accuracy and deliver more effective treatment options for patients suffering with primary and metastatic spinal tumours. "This partnership with icotec represents a significant step forward in our commitment to supporting physicians with innovative spinal solutions," said Dean Stockwell, Osteotec Sales and Marketing Director. "icotec's innovative approach to the treatment of spinal oncology aligns with our mission to improve surgical outcomes and patient care. By adding icotec's BlackArmor® implants to our growing spine portfolio, we are broadening the range of advanced tools available to physicians, enabling them to address the unique challenges associated with treating spinal tumours and other indications." The agreement solidifies Osteotec's role as a supplier of spinal solutions in Great Britain, building on its established presence and expertise in supporting both NHS and private healthcare providers. "We are excited to partner with Osteotec, a company renowned for its deep-rooted connections within the spine community and its dedication to improving patient care," said Kurt Zoller, Chief Marketing Officer at icotec. "Through this collaboration, we aim to make our BlackArmor® Carbon/PEEK implants more accessible to physicians across Great Britain, empowering them to deliver enhanced treatment options for patients with complex spinal conditions." About Osteotec Osteotec is a manufacturer and distributor of medical devices headquartered in Newbury, UK, with offices in Dublin and Malmö. Established in 1993, Osteotec has been supplying into the NHS and private healthcare sectors for the past 31 years. Osteotec manufactures and distributes the Osteotec Silicone Finger, ChiroKlip and the Concentric Bone Graft System and is a distributor for world-leading orthopaedic partners including Highridge Medical, SI-BONE, TriMed, Enovis and Cerapedics. Media Contact: Harriet Bawden Marketing Manager [email protected] | 020 3011 5574 For more information, visit – About icotec icotec is the leading company for the treatment of spinal tumours and other indications with a new generation of high-tech implants. With its BlackArmor® Carbon/PEEK implants, icotec combines cutting-edge technologies and industry expertise to deliver innovative and reliable solutions for spine surgeons and their patients and is dedicated to advancing the field of spinal implantation. With a track record of clinical success and a commitment to continuous innovation, icotec is poised to shape the future of spinal surgery. The comprehensive product portfolio has received FDA and CE clearance and is supported by numerous Key Opinion Leaders and spine surgery centres worldwide. Media Contact: John Clough Vice President of Product Management and New Indications [email protected] For more information, visit Logo - SOURCE Osteotec WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出

2025-03-17

·PRNewswire

Theradaptive Welcomes Jeffrey W. Dunn to its Board of Directors

FREDERICK, Md., March 17, 2025 /PRNewswire/ -- Theradaptive, a privately held, clinical-stage biologics company developing targeted protein therapeutics is pleased to announce the appointment of Jeffrey W. Dunn to its Board of Directors. Mr. Dunn brings over three decades of leadership experience in the medical device, biotechnology, and technology sectors. Currently serving as Chairman of the Board at SI-BONE, Inc., a leading musculoskeletal medical device company he co-founded in 2008, he guided the company through its highly successful IPO leading to a market capitalization of $1B+ when he moved from Chief Executive Officer to Executive Chairman in April 2021. Mr. Dunn has led and successfully exited six companies throughout his career. His extensive leadership experience includes founding and leading companies such as SI-BONE, INBONE Technologies, and Accelgraphis, as well as serving as CEO of Active Decisions, Velogic, and EnterpriseLink Technology Corp., among others. In addition to SI-BONE, he currently serves on the board of directors of Mainstay Medical. Throughout his career, Mr. Dunn has also demonstrated exceptional expertise in building shareholder value, fundraising, and mergers and acquisitions. He has successfully raised hundreds of millions of dollars to support business growth and led multiple high-profile M&A transactions. These include the sale of INBONE Technologies to Wright Medical Technology in 2008 and other strategic exits such as the sale of Active Decisions to Knova Software, Velogic to Keynote Systems, EnterpriseLink to Merant, and AccelGraphics to Evans & Sutherland Computer Corporation. Theradaptive CEO Luis Alvarez stated: "We are thrilled to welcome Jeff to our Board of Directors. His deep industry knowledge, proven track record in fundraising and M&A, and strategic vision will be invaluable as we accelerate to commercial launch. Jeff immediately recognized Theradaptive's rare value proposition that offers the multi billion-dollar annual revenue potential of biopharma with the low capital requirements of medtech." Mr. Dunn expressed his enthusiasm for joining Theradaptive: "Theradaptive's pioneering work in regenerative medicine and targeted therapeutics aligns perfectly with my passion for advancing healthcare innovation that also addresses shortcomings in the healthcare system. Theradaptive has the potential to capture the entire $4B bone graft market by making existing offerings obsolete while also lowering costs for the healthcare system. This is a rare opportunity to improve patient access to the most advanced treatments while returning value to investors. I look forward to contributing to the company's mission to transform this segment of healthcare." Founded in 2017 and headquartered in Frederick, Maryland, Theradaptive is at the forefront of developing novel protein engineering technologies that enable precise drug delivery for multi-indication tissue regeneration and highly targeted therapeutic delivery. The addition of Mr. Dunn to its Board underscores Theradaptive's commitment to strengthening its leadership team as it continues to expand its impact in the biotechnology space. About Theradaptive Theradaptive is a privately held, clinical-stage biologics company developing protein therapeutics for spine, orthopedics, dental, and soft tissue repair and targeted therapeutics in diverse areas such as immuno-oncology. The Company is leveraging its therapeutic delivery platform to deliver recombinant biologics to targeted areas in the body with high precision and persistence to address unmet medical needs. For more information on Theradaptive and its clinical development program, visit and follow the company on LinkedIn. OsteoAdapt ™ SP is an Investigational Device. Limited by US Federal law to investigational use. Contacts: Serena Santiago [email protected] Investors: David Stewart [email protected] SOURCE Theradaptive WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

高管变更IPO

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