Co-founded by John Slump, Eric Sauter, and Dr. Steven Mickelsen, Atraverse Medical is on a mission to improve patient outcomes with its radiofrequency guidewire.
The inception of Atraverse Medical is a story of three seasoned entrepreneurs reuniting to pioneer a next-generation transseptal access device. John Slump, Eric Sauter, and Dr. Mickelsen met over a decade ago while working on a previous startup, FARAPULSE™ which was acquired by Boston Scientific in 2021. "We’ve already gone through one of these things and come out the other end as friends, wanting to do it again," says John Slump, reflecting on their prior experience. The timing of it all worked in their favor too. "We had a perfect storm with both Dr. Mickelsen and Eric Sauter leaving their prior endeavors and having an idea for a best-in-class left-heart access device," Slump explains. The three looked at the success of FARAPULSE™, combined with their camaraderie, and laid the groundwork for their next venture.
The inspiration for Atraverse Medical came from observing the shifting market dynamics in Electrophysiology and Structural Heart procedures, some of the fastest-growing medical device segments. These procedures rely on safe, efficient, and precise access to the left side of the heart. The foundation of Atraverse was to deliver the next generation of innovation in the category to improve patient safety and outcomes in these critical procedures.
The traditional methods of left-heart access can be complex, time-consuming, and carry risks of complications such as mislocation of the crossing site or damage to cardiac tissues. Left-heart access is crucial for nearly two million procedures each year. “There are approximately 1.5 to 2 million procedures each year that require accessing the left side of the heart from the right side to deliver therapies such as atrial fibrillation ablation or left atrial appendage occlusion,” Slump adds.
The traditional method used today involves the use of the Brockenbrough needle, a rigid, three-foot-long hypodermic needle developed in the late 1950s. This mechanical tool has remained the primary method for over six decades despite its limitations. Slump goes on to explain how this is quickly beginning to change saying, “So [the Brockenbrough needle] is the current standard of care, but there's an emergent and rapid increase in the use of RF or radiofrequency, energized devices for safer and more controlled and faster and more predictable left-heart access. And so I'd say the standard of care is mechanical tools but quickly changing to RF.”
One of the main issues with the Brockenbrough needle is its rigidity and invasiveness, leading to complications during procedures. "Heart procedures involving the Brockenbrough needle are complex and fraught with risks due to the tool's inherent design limitations," explains Slump. These risks associated with the Brockenbrough needle can result in longer procedure times, increased patient discomfort, and a higher likelihood of complications. Additionally, the precision required to navigate the needle through the heart's septum often results in variable outcomes, heavily dependent on the operator's skill level. This variability can lead to suboptimal results, leading to additional interventions and increasing healthcare costs.
Atraverse Medical aims to disrupt this landscape with its FDA 510(k) cleared HOTWIRE™ system, an innovative RF (radiofrequency) energized guidewire device. The primary difference lies in the technology's ability to utilize RF energy for a more controlled and precise crossing of the heart's septum, significantly reducing the risk of complications. "Our device uses RF energy, which provides a safer and more controlled approach compared to mechanical needles," explains Slump. This enhanced control translates to shorter procedure times, reduced potential for patient injury, and the ability to improve therapy outcomes.
Moreover, the HOTWIRE™ system is designed with universal sheath compatibility in mind. "We designed the HOTWIRE™ system to work with any existing sheath, simplifying the process for physicians and reducing the need for additional tools," Slump notes. This allows the device to be seamlessly integrated into existing procedural workflows without the need for specialized equipment. The device is also designed to be user-friendly, reducing the dependency on the operator's skill level and ensuring more consistent and reliable results.
Since being founded in 2022, Atraverse Medical has achieved remarkable progress thus far. In May 2024, the company received FDA 510(k) clearance for its HOTWIRE™ radiofrequency (RF) guidewire and also closed a $12.5 million oversubscribed Seed round. The company reached these two major milestones in less than two years since its inception. "This is the fastest I’ve ever seen a medical device company get from formation to FDA clearance," Slump emphasizes, attributing this rapid progress to the relentless efforts of Co-founder and Chief Operating Officer Eric Sauter. "Eric has been instrumental, working around the clock and driving the team forward."
Looking ahead, the company is now gearing up for its initial clinical cases. "We’re planning our initial clinical cases with some of the top key opinion-leading physicians in the country starting in the late July timeframe," says Slump. This phase will mark the start of their limited market release, focusing on a select group of physicians, which will continue into early next year.
In parallel, Atraverse Medical is developing a proprietary generator to work in concert with their RF guidewire. "Our second product, the proprietary generator device, is in development and on track to be FDA-cleared by Q2 of 2025," Slump explains. “This will then enable us to move forward with our full market release.”
In addition, the company is also expanding its team to support its commercialization efforts. "We just hired a VP of Sales and are starting to hire field sales and clinical specialists to help support our limited market release this year," Slump shares. By the end of the year, Atraverse plans to grow from 10 to 15 employees, with further expansion expected in 2025.
According to LSI’s Global Surgical Procedure Volumes database, in 2023 LSI estimated that there were ~800,000 valve replacements, ~500,000 congenital heart defect repair procedures, and ~1.3M ablation procedures performed worldwide. This is in addition to the nearly ~6.4 million standalone diagnostic cardiac catheterizations (i.e., coronary angiograms) procedures that were performed in 2023.
Looking exclusively at therapeutic procedures, many of the fastest-growing procedures require left-heart access, from valve replacement to cardiac ablation. New technologies, such as transcatheter valve repair and replacement devices for the mitral and tricuspid valves, are driving the growth of these procedures.
According to data from LSI’s Market Analysis and Projections (MAP) database, the cardiac ablation devices market is one of the fastest growing device markets, in no small part due to technological improvements that are making this procedure more accessible, effective, and durable for patients with atrial fibrillation. LSI projects that this market will increase at a CAGR of 9.7%, from an estimated $6 billion in 2023 to nearly $10 billion by 2028. Not to be outdone, new transcatheter solutions for aortic, mitral, and tricuspid valve disease will result in the market increasing at a 9.8% CAGR during the same forecast period.
These disruptive markets are primed to benefit from the advantages offered by new technologies, like the HOTWIRE system, that improve procedural outcomes.
John Slump has been selected to present at LSI Europe ‘24 this September 16th-20th in front of hundreds of global medical technology companies, and will be speaking on a panel on "Raising Capital from Family Offices." Join us in welcoming John to the event in Sintra, Portugal where he will share the latest updates on Atraverse Medical’s technology and development.
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