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OrthoSpace Announces Publication of InSpace Data

InSpace was demonstrated to improve shoulder function and reduce pain.

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OrthoSpace Enrolls the First Canadian Subjects in the InSpace™ Pivotal Study

Enrollment has opened at Ottawa Hospital in Ontario.

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OrthoSpace Announces Publication of InSpace Data

OrthoSpace announced the publication of long-term follow-up data for patients enrolled in an open-label, single-arm, prospective study evaluating the use of the InSpace System for the treatment of massive rotator cuff tears (RCTs).

The study, published in the Archives of Orthopaedic and Trauma Surgery, reported that a cohort of 20 patients with irreparable, full-thickness RCTs showed improvements in shoulder function and subjective pain scores starting at six weeks of follow-up, with these gains maintained at up to five years.


Posted April 06, 2017

OrthoSpace Enrolls the First Canadian Subjects in the InSpace™ Pivotal Study

OrthoSpace Ltd. (“OrthoSpace” or “the Company”) today announced that Ottawa Hospital in Ottawa, Ontario has begun enrolling patients in the ongoing pivotal study of the InSpace™ System for the treatment of massive rotator cuff tears (MRCTs). Peter Lapner, MD, FRCSC, principal investigator at Ottawa Hospital, is the first to enroll subjects in Canada.

“Our team is thrilled that we are the first center in Canada to start accruing to the InSpace study, which represents a novel, minimally-invasive treatment for patients with massive rotator cuff tears,” Dr. Lapner commented. “As a hospital dedicated to supporting innovative therapies and improving patient care, we’re looking forward to the continued enrollment of Canadian patients in this study.”

OrthoSpace expects to activate the second Canadian site at Fowler Kennedy Sport Medicine Clinic under direction of Robert Litchfield, MD, FRCSC and the third Canadian site at St. Joseph’s Health Care in London, Ontario, where George Athwal, MD, FRCSC will act as Principal Investigator. Dr. Athwal stated, “Thousands of patients with massive rotator cuff tears live with debilitating pain. With limited treatments available, we are excited to begin the InSpace study at St. Joseph’s, the results of which could open up new surgical options to address this unmet clinical need.”

“We are proud to be initiating enrollment at three of the leading orthopedics hospitals in Canada and to be collaborating with Dr. Lapner, Dr. Athwal and Dr. Litchfield,” said Itay Barnea, Chief Executive Officer of OrthoSpace. “This planned expansion for the InSpace study will contribute to more robust data as well as expand surgeon knowledge and experience with the device.”

The InSpace System is currently being evaluated in a prospective, single-blinded, multi-center, randomized, controlled study that will enroll up to 184 patients in North America. It is designed to assess the safety and effectiveness of the InSpace device, a biodegradable balloon spacer implanted arthroscopically in the sub-acromial space and intended to relieve pain and improve function in patients with MRCTs. Eligible patients are at least 40 years of age, have imaging-confirmed, full-thickness MRCTs and have documented failure of conservative therapy, in addition to meeting other criteria. Enrolled subjects are randomized to undergo arthroscopic implantation of the InSpace System or arthroscopic partial repair of MRCTs.

The InSpace System is CE Marked in Europe and Israel and investigational in the U.S. and Canada. Details for the clinical study, including participating institutions and complete eligibility requirements, are available at ClinicalTrials.gov under identifier NCT02493660.


Posted May 08, 2017
OrthoSpace Announces the Publication of Positive InSpace™ Study

Shoulder pain, function were significantly improved at up to three years of follow-up.

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Results Published from New InSpace Studies

InSpace reduces pain and improves function in patients with rotator cuff tears.

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OrthoSpace Announces the Publication of Positive InSpace™ Study

OrthoSpace Ltd. (“OrthoSpace” or “the Company”) today announced the publication of positive data on the use of the InSpace™ subacromial spacer for the treatment of massive rotator cuff tears. The case series of 39 shoulders (37 patients) was published in Arthroscopy and demonstrated improved function and reduced pain in patients treated with the InSpace System.

“Patients who fail conservative therapy for massive rotator cuff repair have historically had few options for further treatment of this debilitating, painful condition,” said Julien Deranlot, M.D., principal investigator of the study and an orthopedic surgeon at Clinique Drouot in Paris, France. “The InSpace provides a safe and reliable surgical alternative that can improve shoulder pain and function, allowing patients to have a better quality of life post-operatively.”

The InSpace System consists of a biodegradable balloon spacer deployed in the subacromial space between the acromion and the humeral head, allowing smooth gliding and frictionless movement between the two bones and emulating the function of the original bursa. It is usually placed arthroscopically in a procedure that requires only 10 minutes to perform.

This study assessed clinical, functional and radiographic outcomes for all patients with symptomatic massive irreparable rotator cuff tears who were treated with the InSpace at the Clinique Drouot between January 2011 and December 2014. Patients included in this study had a minimum of one year and up to three years of follow-up at the time of analysis.

The investigators reported the following results:

  • Range of motion was significantly increased for all patients in anterior elevation, abduction and external rotation.
  • The mean Constant score, which measures pain, activity level and function, improved from 40 (±14.6) (45 [±15.2] when adjusted for age and gender) at baseline to 59 (±13.7) at one year, and up to 64 (±13.6) (adjusted = 76 [±17.1]) (P < 0.0001) at last follow-up. Notably, there was a significant improvement between the one-year follow-up and three-year follow-up regarding the adjusted Constant score (P=0.02).
  • At last follow-up, adjusted Constant score was excellent (greater than 100 points) for three shoulders (9%), good (86-99 points) for eight (23%), fair (65-85 points) for sixteen (45%), and poor (fewer than 65 points) for eight shoulders (23%).
  • Among the radiographic outcomes, when assessing for Hamada score (a measure of osteoarthritis), four shoulders progressed by one radiographic stage (15%), and two shoulders progressed by three stages (4%). 32 shoulders had no progression during follow-up.

“We continue to be encouraged by the compelling clinical improvements we see in patients treated with the InSpace System, which are in line with the strong results demonstrated in previous studies,” OrthoSpace CEO Itay Barnea commented. “The system offers a safe, minimally invasive option that can be effectively used to relieve pain and improve shoulder function for patients, especially in elderly patients with chronic pain and disability, poor tissue quality or other health issues, who may not have alternative treatment options.”

The InSpace System is CE Marked in Europe and Israel and is investigational in the U.S. and Canada, where it is currently being evaluated in a prospective, single-blinded, multi-center, randomized, controlled study that will enroll up to 184 patients.


Posted June 30, 2017

Results Published from New InSpace Studies

OrthoSpace Ltd. (“OrthoSpace” or “the Company”) today announced that results from two studies evaluating the use of the InSpace™ biodegradable balloon spacer to treat massive, irreparable rotator cuff tears have been published in the journals Musculoskeletal Surgery and Acta Bio Medica. Massive, irreparable rotator cuff tears (RCTs) are associated with severe pain and disability, and patients with RCTs of this magnitude have historically had few treatment options.

The two publications reported the following results, respectively:

  • In an independent, prospective, single-arm study, 44 patients (46 shoulders) with massive, irreparable RCTs were treated with the InSpace System. At one year of follow-up, patients reported a mean reduction in pain scores of 3.5 points (on a scale of 0 to 10), with 74% of patients achieving a difference of 2 points, which was considered the threshold for minimal clinical importance. Shoulder function, as measured by the Oxford shoulder score (OSS) and Constant–Murley shoulder score, improved significantly in this treatment cohort, and the authors noted that 80% of patients reported that they were satisfied with their outcome. Notably, this study also included a subset of 11 patients (24%) who were concurrently treated with a partial repair of the rotator cuff. The authors found no differences in outcomes of these patients in regard to pain or function compared to the patients who received InSpace alone. (Piekaar et al, 2017)
  • In an independent, retrospective study of 30 patients with irreparable rotator cuff tears treated with the InSpace System, authors Ricci et al reported statistically significant increases in Constant Scores in a cohort of patients evaluated at 6 months (from 39.89 to 62.33 points) and in a separate cohort evaluated at 12 months (from 41.66 to 65.38 points) after surgery. Range of Movement and Activity of Daily Living measures significantly improved with the reduction of VAS and pain scores at 12 months. The authors reported a further increase in functional performance with the reduction of pain at 24 months post-operatively. Additionally, the authors analyzed X-ray and MR imaging to observe that all patients had a pre-operative acromiohumeral distance less than 6 mm and lesion grades of 3 to 4 according to the Goutallier classification, while, post-operatively, each case was observed to have an acromiohumeral distance of greater than 7 mm at all imaging timepoints. MRI also confirmed the complete degradation of the spacer in each patient by 24 months. (Ricci et al, 2017)

“We are pleased to see the publication of these positive results from Drs. Piekaar and Ricci and colleagues, which demonstrate the compelling benefit of InSpace to patients with massive rotator cuff tears,” said Itay Barnea, CEO of OrthoSpace. “We note in particular the promising outcomes from the addition of InSpace to partial repair of the tendon, which helps to demonstrate the versality of the InSpace System. These results add to the growing body of evidence favoring the use of InSpace as a novel, minimally invasive treatment for patients who have failed conservative therapy or otherwise have few options to treat painful, irreparable RCTs.”

The InSpace System is deployed in the subacromial space between the acromion and the humeral head, allowing smooth gliding and frictionless movement between the two bones and emulating the function of the original bursa. It is usually placed arthroscopically in a procedure that requires only 10 minutes to perform, and the balloon is believed to fully degrade within 12 to 24 months.

The InSpace System is CE Marked in Europe and Israel and is investigational in the U.S. and Canada, where it is currently being evaluated in a prospective, single-blinded, multi-center, randomized, controlled study that will enroll up to 184 patients.


Posted December 12, 2017