AVERT Trial Results Presented at SCAI

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Posted: 2016-05-09 in Press Releases

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AVERT Trial Results Presented at SCAI

 

Key Highlights

 

·             Kidney damage reduction – Post-trial subgroup analysis revealed a 49.5% reduction in Contrast-Induced Acute Kidney Injury (CI-AKI) in a key                   patient group treated with AVERT™ System

·             Dye reduction – A statistically significant reduction of dye delivered to patients was shown in the primary analysis as well as in the pre-specified                   subgroup analysis and post-trial subgroup analysis

·             Uncompromised image quality – Adequate image quality reported in > 99.3% of cases

 

Melbourne, Australia and Minnesota, United States – May 9, 2016 – Osprey Medical Inc. (ASX: OSP) is pleased to announce the results of the AVERT Clinical Trial as presented at the Society for Cardiovascular Angiography and Interventions (SCAI) annual meeting in Orlando, Florida on May 4, 2016. The results from the 578 patient trial were presented to one of the world’s largest gatherings of heart specialty physicians and professionals, as the first scientific presentation of the meeting.

The presentation highlighted the significance of post-trial analysis directed by the Physician Steering Committee on the CI-AKI co-primary endpoint of the trial.

Post-trial analysis, presented by Program Chair and AVERT Clinical Trial Principal Investigator, Dr Roxana Mehran, showed a significant reduction of CI-AKI in patients with pre-existing stage 3 kidney disease. Using the “standard criteria” for detection of CI-AKI (Serum Creatinine increase of > 0.5mg/dl or > 25%), a per-protocol analysis of 470 patients revealed:

 

Study groups Mean reduction in CI-AKI
All Patients (N=470) 20.5%
Diagnostic (N=268) 28.5%
PCI/Stenting (N=202) 13.6%
Patients with pre-existing stage 3 kidney disease (N=264) 49.5% *

* Denotes significant finding

Text Box: Dr Mehran commented; “While the overall study did not show a reduction in CI-AKI, post-trial sub-group analysis showed a 49.5% reduction of CI-AKI in patients with pre-existing stage 3 kidney disease. This is an important finding, as numerous other medical devices and/or drug therapies have not been successful in demonstrating a significant reduction in CI-AKI through a randomized controlled trial. This finding highlights the importance of dye minimization with AVERT in patients with poor kidney function and the direct correlation between dye saving and CI-AKI reduction.”

 

Stage 3 kidney disease refers to patients who have lost half or more of normal kidney function. This patient group represents Osprey’s primary market focus and it is extremely encouraging to see such a strong response in this group from the use of AVERT.

Osprey CEO Mike McCormick said; “We are pleased with the findings of the AVERT trial as presented by Dr Mehran. The reduction in CI-AKI in a sub-population is encouraging and feedback from key opinion leading physicians at the conference suggests these findings are important when considering care options for patients with compromised kidneys.”

 

Trial results have already led to the AVERT System and its second generation DyeVert™ System receiving US Food and Drug Administration (FDA) clearance for dye savings, image quality and reflux reduction claims.

 

Increased dye savings in more complex procedures

Post-trial analysis also showed that AVERT facilitated dye reduction in PCI/Stenting procedures showing that as procedure complexity increased so did the amount of dye savings:

 

 

Artery blockages treated (stenting)

Mean reduction in Dye

1

15%

2

31%

>3

46%

 

 

The analysis also showed that dye reduction did not affect image quality; physicians reported adequate image quality in >99.3% of procedures.

 

DyeVert featured at SCAI conference

The DyeVert System was also featured at a Satellite Program during the SCAI conference on May 5, discussing contrast reduction methods in an effort to address CI-AKI. Dr Anand Prasad, University of Texas Medical Center San Antonio, presented results from over 40 patients treated with the DyeVert system. Dr Prasad noted that DyeVert demonstrates dye savings of 49% with uncompromised image quality. He presented that the fully disposable, hands free DyeVert System is easy to use and saves more dye than the first generation AVERT system.

Mike McCormick again commented; “We are committed to showing the benefits our devices have on patient health through tier one medical evidence that demonstrates the safety, efficacy, and cost saving capabilities of our technologies. The immediate reaction to the trial results at the SCAI meeting was very positive which was especially pleasing given that the conference was attended by the world’s leading cardiovascular physicians and experts. We look forward to using these results to assist our commercialization efforts of the DyeVert and AVERT Systems throughout the US.”

 

About Osprey

Osprey Medical is focused on protecting patients from the harmful effects of X-ray dye (contrast) used during commonly performed angiographic imaging procedures. The Company’s core technologies originated from research conducted by Dr. David Kaye at Melbourne’s Baker IDI Heart and Diabetes Institute. Its proprietary dye reduction and monitoring technologies are designed to help physicians minimize dye usage.  The Company’s DyeVert™ System is a next-generation product that reduces contrast while maintaining image quality in a self-adjusting easy-to-use design. Osprey Medical’s Board and Management are comprised of experienced and successful personnel with established track records covering medical device development, regulatory approvals, sales and marketing, and mergers-acquisitions. Osprey Medical’s advisory board comprises world- recognised experts in heart and kidney diseases.

 

Forward-Looking Statements

This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to commercialize our products including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products including our ability to obtain reimbursement for our products; our expectations with respect to our clinical trials, including enrolment in or completion of our clinical trials and our associated regulatory submissions and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position. Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. Osprey does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Osprey may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements.

 

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