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IH Interests

News and reflections on topics that inspire us.

Results Published from New InSpace Studies

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

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Stryker to Acquire Entellus

The $662 million deal expands SYK's ENT presence.

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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

Stryker to Acquire Entellus

On Thursday, December 7th Stryker Corp (SYK) announced that they would acquire Entellus Medical (ENTL) for $662 million. Stryker is paying a significant premium of roughly 50 percent to where Entellus closed on Wednesday and approximately a 7.1x estimated 2017 revenues. According to Stryker, the deal will be dilutive to 2018 adjusted net earnings by approximately 4 cents per share.

Entellus markets a balloon sinus dilation system called XprESS for the treatment of chronic and recurrent sinusitis. The procedure can be performed in the office as well as in a hospital setting. They also market the MiniFESS line of surgical instruments for use in general sinus surgeries. In July, Entellus announced an acquisition of their own – a $25 million deal to buy Spirox, which makes an absorbable nasal implant that can be implanted using MIS techniques to treat nasal airway obstruction.

The acquisition highlights Stryker’s increasing strategic focus on the ENT market, which we at InnovaHealth Partners estimate is a $16 billion market growing around 5 percent per annum.


Posted December 07, 2017
Device Company CEOs on Innovation and M&A

Our new video series focuses on medical device technology and trends.

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Regentis Enrolls First Patients in IDE Cartilage Trial

The study will compare GelrinC to microfracture.

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Device Company CEOs on Innovation and M&A

We’re excited to launch the InnovaHealth Partners video series with interviews from thought-leading medical device CEOs on innovation, improving patient outcomes, meeting hospital expectations for value and what strategic acquirers are looking for in the companies they target. What’s most important in medical device innovation? How do medical device companies differentiate from their peers? How do innovative companies address the cost constraints of hospitals? We sat down with Stavros Vizirgianakis, President and CEO of Misonix, Paul Nichols, President and CEO of Bio2 Technologies and Philip Sawyer, President and CEO of Invuity to learn more.


 

Many thanks to Stavros G. Vizirgianakis, Paul Nichols and Philip Sawyer for their time and insight.


Posted December 04, 2017

Regentis Enrolls First Patients in IDE Cartilage Trial

Regentis announced that the first three cases have been performed in their IDE study for GelrinC, a novel hydrogel that is applied after standard microfracture for the treatment of focal knee cartilage defects. The liquid formulation becomes solid after exposure to UV light, conforming to the size and shape of the lesion. The company says the implant acts as a scaffold for the growth of new cartilage and that it completely degrades within 6-12 months.

The first three patients were treated at two U.S. sites (Peninsula Orthopaedic Clinic in Salisbury, Maryland and Mansfield Orthopaedics at Copley Hospital in Morrisville, Vermont) and one Danish site (Aarhus University Hospital in Aarhus). The study’s ClinicalTrials.gov page reports that 181 subjects will be enrolled overall. Safety and efficacy endpoints for patients who receive the GelrinC treatment will be compared to a historical microfracture control arm. The company says this study design will enable faster enrollment and thus faster approval.

GelrinC has CE mark approval and is sold in Europe; in the U.S., the ongoing clinical trial will support a PMA in the U.S.


Posted December 01, 2017
Amgen Invests in Fortuna Fix

It's the company's first investment in the regenerative medicine space.

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Mazor Releases Impressive Early Data from Spine Study

Robotic guidance was linked to lower complication and revision rates.

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Amgen Invests in Fortuna Fix

Amgen is participating in a $25 million Series B round for Fortuna Fix, a regenerative medicine company based in Canada that is developing an autologous neural stem cell treatment for the replacement of lost neuronal tissue. The treatment is clinical-stage and uses direct reprogramming of somatic cells into neural precursor cells, which can be further optimized for specific indications. The technology uses no fetal or embryonic cells (i.e., pluripotent cells, which have been associated with safety issues, including development of tetromas) and no animal, viral or bacterial components. Further, the cells, called drNPCs, are believed to be safe to deliver without immunosuppression.

Funds will be used to conduct Phase I/IIa clinical trials in Parkinson’s Disease and Spinal Cord Injury, as well as to expand Fortuna’s automated robotic manufacturing capabilities. FierceBiotech reports that when the cell therapy will be ready for human testing and the exact patient populations where the treatment will be evaluated have not been determined, but the company is in discussions with clinical advisors and the FDA to further those decisions.


Posted November 14, 2017

Mazor Releases Impressive Early Data from Spine Study

Mazor released early results from their ongoing MIS reFRESH study, which is comparing robot-guided thoracic, lumbar or lumbosacral spinal fusions to freehand or fluoro-guided techniques based on endpoints like intraoperative X-ray exposure, surgical complications and need for revision. Among the 379 patients analyzed in this cohort (of a planned total enrollment of 2000), investigators found lower rates of complications and revisions among the patients who had robot-guided procedures. Specifically, the risk of adverse events or complications was 5.3 times higher in the fluoro-guided group (92 subjects at the time of analysis) compared to the robot-guided arm (287 subjects). Further, relative risk for revision surgery was 7.1 times higher in the fluoro-guided group. Both results were statistically significant.

If these results are maintained over the larger study cohort, they will represent compelling evidence for the benefit of robot-assisted techniques in orthopedic and spine surgery.

The company has a strategic partnership with Medtronic for the worldwide distribution of the Mazor X system that has been in place since 2016, though Mazor has said they plan to keep their technology open and compatible with any devicemaker’s implants. Medtronic recently invested an additional $40 million in the company, which was accelerated based on “the early achievement of certain sales and marketing milestones by both companies, as well as higher than expected global market acceptance and demand for the Mazor X system.” Medtronic has now invested a total of $72 million in Mazor.


Posted November 08, 2017