8-K: Anteris Technologies Reports Positive One-Year Patient Outcomes for DurAVR THV

Anteris Technologies announces favorable one-year patient outcomes for its DurAVR Transcatheter Heart Valve (THV), demonstrating sustained hemodynamic performance and zero prosthesis-patient mismatch (PPM) in small annuli patients.

Summary

• Anteris Technologies announced one-year results for patients treated with its DurAVR Transcatheter Heart Valve (THV) System.
• The data was presented at Sydney Valves on March 21, 2025.
• The DurAVR THV demonstrated a favorable hemodynamic profile sustained to one-year, with an Effective Orifice Area (EOA) of 2.1 + 0.2 cm2, a Mean Pressure Gradient (MPG) of 8.6 + 2.6 mmHg and Doppler Velocity Index (DVI) of 0.58.
• Clinical safety outcomes at one-year showed no valve or cardiovascular related mortality and no prosthesis-patient mismatch (PPM) reported in small annuli patients (aortic annulus area 395.80 + 37.26mm2).
• Current commercial devices have demonstrated PPM rates between 11.2% to 35.3%.
• Sixty-five patients have completed the primary endpoint measure at 30 days.
• The company plans to include the one-year data in its Investigational Device Exemption (IDE) submission to the U.S. FDA to seek approval for a pivotal study.

Sentiment

Score: 9

Explanation: The announcement presents highly positive one-year clinical outcomes for the DurAVR THV, particularly the zero PPM rate, which is a significant advancement in the field. This suggests a strong potential for the device and the company.

Positives

• The DurAVR THV demonstrated a favorable hemodynamic profile sustained to one-year.
• There were no valve or cardiovascular related mortalities reported at one year.
• The device achieved zero prosthesis-patient mismatch (PPM) in small annuli patients, a significant improvement over current commercial devices with PPM rates between 11.2% and 35.3%.

Risks

• The announcement contains forward-looking statements subject to risks and uncertainties described in Anteris' Annual Report on Form 10-K.

Future Outlook

The company plans to include the one-year data in its Investigational Device Exemption (IDE) submission to the U.S. FDA to seek approval to conduct the DurAVR THV randomized, global pivotal study.

Management Comments

• Anteris Chief Medical Officer, Chris Meduri, M.D., commented: 'The one-year data for DurAVR THV continues to validate its groundbreaking hemodynamic performance, demonstrating sustained excellent effective orifice area (EOA) and low mean gradients. Most notably, this is the only transcatheter valve to show zero prosthesis-patient mismatch (PPM) in small annuli patientsan achievement that sets a new standard in TAVR. PPM is a well-established predictor of valve failure and disease progression, and eliminating it has profound implications for long-term patient outcomes. These results reinforce the transformative potential of DurAVR as we move toward pivotal trials.'

Industry Context

This announcement highlights Anteris' efforts to improve TAVR technology, particularly in addressing prosthesis-patient mismatch (PPM), a known issue in the field. The DurAVR THV's zero PPM in small annuli patients could position it as a leading solution in this segment.

Comparison to Industry Standards

• Current commercial TAVR devices have demonstrated PPM rates between 11.2% to 35.3%, as referenced by Herrmann HC, Mehran R, Blackman DJ, et al. in the SMART Trial published in the New England Journal of Medicine.
• The DurAVR THV's zero PPM in small annuli patients is a significant improvement compared to these industry benchmarks.
• The results also compare favorably to studies by Ferrara J, Theron A, Porto A, et al., which highlight the challenges of PPM in small aortic annuli and the differences between self-expandable and balloon-expandable TAVR valves.

Stakeholder Impact

• Positive results could lead to improved patient outcomes and increased adoption of the DurAVR THV.
• Successful pivotal trials and FDA approval could significantly increase shareholder value.
• The company's employees may benefit from the company's success.

Next Steps

• The company plans to include the one-year data in its Investigational Device Exemption (IDE) submission to the U.S. FDA.
• The company will seek approval to conduct the DurAVR THV randomized, global pivotal study.

Key Dates

Keywords

DurAVR THV, Transcatheter Heart Valve, TAVR, Aortic Stenosis, Hemodynamic Performance, Prosthesis-Patient Mismatch, Anteris Technologies