Osprey Medical announces additional findings from AVERT clinical trial

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Posted: 2015-12-18 in Press Releases

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Osprey Medical announces additional findings from the physician steering committee analysis of the AVERT clinical trial

 

Minnesota, United States and Melbourne, Australia – December 18, 2015 – Osprey Medical Inc. (ASX: OSP) has today announced additional findings from the steering committee analysis of the AVERT randomized controlled trial.

 

The physician steering committee for the AVERT clinical trial met on November 17, 2015 to review and analyze data from the 578 patient clinical trial. Investigation of the primary data and steering committee directed sub-group analysis revealed further findings. These findings provide additional information about the clinical trial but do not affect the current FDA cleared claims of dye savings, reflux reduction and image quality achieved on October 15, 2015.

 

  Dye savings analysis

In the AVERT clinical trial, patient data was analyzed according to the type of procedure (diagnostic vs. PCI/stenting) and separately on the number of lesions treated. Below is a table summarizing steering committee analysis of the dye savings co-primary endpoint:

 

Group

Dye savings

Overall (as reported on October 19, 2015)

15%

Dye Savings by procedure type

Diagnostic

8%

PCI

23%

Dye Savings by number of lesions treated

PCI – 1 lesions treated

15%

PCI – 2 lesions treated

31%

PCI – 3 or more lesions treated

46%

 

 

The steering committee observed that the AVERT trial’s overall dye savings endpoint (15%) was skewed downward due to the high number of diagnostic procedures in the trial. The analysis indicates that in more complex multi- lesion, high dye volume cases, the AVERT system offers increased levels of dye savings for patients (31% - 46%).

 

  CIN reduction analysis

The steering committee reviewed the full set of primary data to further investigate the Contrast Induced Nephropathy (CIN) co-primary endpoint. The steering committee noted that the FDA directed criteria for CIN measurement (Serum Creatinine increase of > 0.3mg/dl) captured subtle changes in kidney function. Based on the FDA directed criteria, Osprey was not able to show a reduction of CIN events in the patient population.

 

The FDA directed criteria for CIN measurement, often called AKIN criteria, is a more recent methodology that captures subtle changes in kidney function.  The “standard criteria” for CIN (Serum Creatinine increase of > 0.5mg/dl or > 25%) is the classic measurement which captures significant changes in kidney function. The “standard criteria” is the typical measurement used by hospitals and physicians when evaluating CIN.

 

Pleasingly, the steering committee noted that the patient population who suffered more significant changes in kidney function, as measured by the “standard criteria”, revealed an 8.4% reduction in CIN events in the AVERT treated patients as compared to the control group.
 

These findings, while not statistically significant, demonstrate a key trend for CIN reduction in patients with significant kidney function changes. The steering committee reasoned that this trend may reflect a masking of the technology’s true CIN benefit due to small trial size.


Full study findings are planned for submission to The Society for Cardiovascular Angiography and Interventions meeting to be held May 4-7 in Orlando, Florida. Professor Roxana Mehran, the Principal Investigator (PI) of the AVERT study, commented: “The AVERT clinical trial is an important study that clearly demonstrates the AVERT  system reduces dye in angiography procedures. I am thankful to all the dedicated investigators who participated in this trial and to the company for collecting Tier One clinical evidence of the safety and efficacy of its AVERT System. I look forward to presenting the full analysis from the trial in the first half of CY 2016”.


About Osprey

Osprey Medical's core technologies originated from research conducted by Dr David Kaye at Melbourne’s Baker IDI Heart and Diabetes Institute. Osprey is focused on improving patients’ quality of life by protecting those with chronic kidney disease from contrast (dye) related Acute Kidney Injury. The Company’s AVERT™ Plus and DyeVert™, are designed to reduce the amount of dye (contrast) injected during commonly performed heart and peripheral procedures. 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 AVERT™ System 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.

 

 

Contact details:

 

Media

Investors

Company

Gavin Lower

Rebecca Wilson

Doug Schoenberg

Buchan Consulting

Buchan Consulting

VP of Marketing

T: (613) 8866 1215

M: (61) 417 382 391

T: (952) 955 8230

glower@buchanwe.com.au

rwilson@buchanwe.co.au

dschoenberg@ospreymed.com