Former senior executive at JenaValve Technology Inc
- Major trends and developments in the heart valve replacement space, focusing on AR (aortic regurgitation) and AS (aortic stenosis)
- Core value proposition and differentiation of JenaValve’s Trilogy device
- Conclusion of ALIGN-AR clinical trial and preparation for US commercial product launch
- Long-term growth strategy and untapped market opportunities
What major trends and developments have you been following in the structural heart market specifically relating to AS [aortic stenosis] or AR [aortic regurgitation], which may better inform our discussion on JenaValve?
How would you quantify JenaValve’s TAM opportunity? How much of that opportunity lies in the AR indication vs other indications such as AS?
What’s your assessment of JenaValve’s core Trilogy product offering and unique approach in AR? How is the company differentiated from devices such as Edwards Lifesciences’ Sapien 3 or Medtronic’s CoreValve? I appreciate that JenaValve is operating primarily in regurgitation and not stenosis, but perhaps we could use those more well-known devices as a reference point.
JenaValve raised USD 100m in a lucrative Series C financing round in September 2022 from several private investors. How might the company deploy this capital infusion to develop products or enhance its commercial prospects?
Could you dive a little deeper on the ALIGN-AR trial? Are there any particular milestones or benchmarks we should be monitoring to gauge the progress of this pivotal trial?
Assuming all goes well in the trial, JenaValve will likely proceed to obtain a pre-market approval from the FDA. How should we think about a commercialisation timeline post hypothetically positive ALIGN trial results? What’s a realistic timeline, perhaps based on similar product regulatory processes?
What go-to-market strategy might JenaValve employ to optimally commercialise Trilogy?
You described surgeons as fairly cautious regarding what they think they can accomplish compared to actual device capabilities, but how cautious are they when switching devices? Trilogy aims to treat regurgitation and stenosis in one device. Does that factor into switching costs at all, or would surgeons be happy or content with using Sapien 3 for stenosis and Trilogy for AR, for example?
What commercial investment will it take to build out a qualified sales force to scale and maximise uptake for Trilogy? You alluded to a one-third metric of its recent funding round, but what are your thoughts around the company’s overall commercial runway, assuming the device becomes surgeons’ preferred option, as you suggested?
Why do you think Edwards, Medtronic or even Abbott haven’t been focusing on AR? Is it not a large enough slice of the pie compared to AS, MR [mitral regurgitation] and tricuspid repair?
Could you discuss the penetration potential in asymptomatic AS and AR respectively? What are the keys to identifying these patients to drive adoption in some of these untapped end markets?
It seems there’s a fairly substantial asymptomatic population for TAVR [trans aortic valve replacement]. What’s your sense on the AR asymptomatic population percentage and how that stacks up against AS?
Where do you see JenaValve expanding its portfolio offerings once it has a fully commercialised and operational platform? Could you juxtapose the relative opportunities in mitral repair, TR [tricuspid regurgitation], heart failure, etc?
How do you assess JenaValve’s ability to be competitive outside of AR? The company clearly has a first-mover advantage in AR, but AS, MR and TR are dominated by Abbott, Medtronic and Edwards. How much ability does it have to carve out market share at the expense of these incumbents?
What are your thoughts on the current limitations of catheter and/or guidewire technology? Has JenaValve expressed interest in partnering with smaller upstarts, such as Pi-Cardia to develop a novel lower-profile transfemoral catheter for AS. How would you assess the unmet need for a more innovative catheter and/or guidewire?
Do you think an incumbent such as a Medtronic or Edwards would think about purchasing JenaValve to protect their market positions? How would you gauge JenaValve’s interest in selling to a competitor or a large medtech player?
What are your thoughts on JenaValve’s international positioning and how the company’s penetration prospects stack up in regions such as Europe? Are there any materially different commercialisation considerations when operating outside the US?
What strategic balance might JenaValve strike between R&D and innovation vs commercialisation over the longer term and why?
Do you think JenaValve could ever develop a suitable platform for heart failure? I appreciate this opportunity might be many years away, but how is the company thinking about heart failure as an avenue to potentially unlock that next growth iteration in structural heart?
What are your thoughts on JenaValve’s executive leadership team, including the recently appointed CFO Kari Moore? What expertise does she bring to the table and how might this affect the company’s strategic outlook?
Is there anything you’d like to highlight as especially important to consider when looking at JenaValve?
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