Anteris Technologies (ASX: AVR)
AVR)

The ever-growing demand for improved outcomes in patients with Aortic Stenosis (AS) has shifted the eligibility criteria and broadened transcatheter aortic valve replacement’s (TAVR) capabilities to include younger, intermediate to low-risk, and asymptomatic patients. This much-needed shift demands greater valve durability to last longer lifetime expectancies. However, current technologies are failing within the patient’s lifetime, making the need for a sustainable solution critical.

Established to address this need is Anteris Technologies, a leading MedTech company focused solely on structural heart disease.

Founded in 2006, Anteris Technologies has a legacy surgical tissue matrix that produced a patented process to make the tissue, which is resistant to calcification in cardiac and vascular applications. Identifying the emerging need in the valve space, the company soon pivoted its focus to develop a transcatheter aortic heart valve designed to work better and last longer.

“Our goal is to restore normal heart function and provide patients with a lifetime solution,” says Wayne Paterson, the CEO of Anteris Technologies. “Our organizational culture is defined by an all-encompassing drive to deliver clinically superior structural heart solutions that help physicians create life-changing outcomes for patients.”

With its extensive experience in the structural heart disease space, Anteris Technologies is firmly positioned to deliver a range of clinically superior cardiovascular therapies. The company’s proprietary ADAPT^™ anti calcification process reduces cytotoxicity of bovine pericardium by removing lipids, all cells and cell remnants, nucleic acids (DNA and RNA), and α-galactosyl (α-Gal) epitopes. In addition, it helps maintain tissue strength and elasticity, followed by steps to detoxify the tissue with non glutaraldehyde sterilization and storage.

Anteris Technologies’ novel ADAPT^™ method reduces antigenicity, immunologic reactions, and inflammatory processes—all precursors to tissue calcification. It is ADAPT’s resistance to calcification, which many physicians consider the “holy grail” of tissue engineering, that provides the foundation necessary for delivering true lifetime management for younger, more active patients.

DurAVR^™ is designed to offer better outcomes from day 1 with improved hemodynamics for today’s younger patients. In essence, the company’s tissue science and anatomical valve molding are designed to meet the needs of patients and physicians, which are to have a valve for life, a valve that will last longer and work better.

Anteris Technologies is also recognized for its ComASUR^™ TF Delivery System. It uniquely enables physicians to align the valve accurately and predictably with the native commissures, something no other system on the market can provide today.

ADAPT-treated tissue has been shown to resist calcification in pediatric cardiac repair clinical studies for ten years in over twenty thousand patients. A total of thirteen patients have successfully been treated with the DurAVR^™ THV platform as part of the ongoing first-in-human DurAVR™ THV study conducted at the Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia.

ADAPT^™ has been applied to create the DurAVR^™ valve, a 3D-shaped valve with a single piece of bovine pericardial tissue designed to mimic native human form and function. It shows better coaptation and can reduce leaflet stress to restore hemodynamic function over the patient’s life. The single-piece aortic valve is designed to be more human-like to restore normal valve function. The design intends to provide greater calcification resistance and less mechanical stress than current valves. Anteris Technologies’ Chief Medical Officer, Chris Meduri, oversaw the study, including the initial five aortic stenosis patients implanted with DurAVR™ THV last November at the clinic.

Data from the latest cohort will be reviewed at the 30- day follow-up, which is the key inflection point for indicating ongoing valve performance. All patients enrolled in the study have done exceptionally well. The whole team, including the treating physicians, is excited by the results, and the company continues to progress its clinical program.

DurAVR^™ system’s world-class medical advisory has resulted in a physician-led design to provide true lifetime management of today’s aortic stenosis, TAVR patients. Physicians believe this has three crucial clinical implications. It reduces valve frames and stent heights.

As DurAVR^™ is designed in diastole, it opens wider to the edge of the stent with less pressure and remains open longer. This results in no compromise in geometric and effective orifice areas, dramatically improving hemodynamics. It achieves a longer coaptation length and height of the leaflets, which distributes stresses evenly across the valve— resulting in near-perfect laminar flow.

“We strive to provide functional cures to some of the biggest challenges facing patients and doctors worldwide. Solving critical issues with currently available heart valves used to treat aortic stenosis is where we are single-mindedly focused. But that’s only the beginning,” notes Paterson. “We are firmly positioned to deliver a range of clinically superior cardiovascular therapies that enable doctors to provide life-changing outcomes for patients well into the future.”