MedTech Strategist Article – Great Aspirations: New Mechanical Approaches to Treating Pulmonary Embolism

Just over a year ago, Murali Srivathsa joined Akura Medical as CEO, leaving his position as the head of global marketing for Abbott’s heart failure division. With 25 years of experience in commercial and marketing roles, including multiple exits in the cardiac space, Srivathsa believes that mechanical treatment of venous thromboembolism (VTE), which encompasses both PE and deep vein thrombosis (DVT), is on the cusp of strong growth. “There is a fair amount of competition here and a lot of new players trying to enter the market, which I feel is good because the market has low penetration and there are many patients that need this technology,” he says.

According to the CEO, the first wave of solutions is already here, but additional innovation is required to change the standard of care. He notes that US reimbursement for the procedure is rela-tively good and continued innovation to make the procedure pre-dictable and deliver high performance will drive further adoption.

When Srivathsa started at Akura, the company had fewer than 10 employees. The founding team had put together the business plan, completed a Series A, and demonstrated the effectiveness of the core concept of the technology but hadn’t yet fully defined the feature set of the system, clinical plan, and platform strategy. One of his first executive decisions was to put together a group of physicians that Akura could consult with to help guide day-to-day decisions, and since then, the team has more than tripled in size, including the addition of leadership roles such as a VP of opera-tions, a VP of clinical affairs, and a VP of console development.

From there, Srivathsa says five major questions drove product development: “How can we access clots in more difficult locations? How can we break up a clot and send it outside the body without using larger-bore catheters? How do we eliminate the need to cross the clot (with the catheter)? Can you go in with a single-pass system and complete the case predictably? How do you know when you have removed enough clot to complete the case?”

Akura’s answer to these questions is a platform that uses a completely differentiated approach to deliver an effective solution to address the major challenges in VTE. The bidirectional steerable low-profile (16 Fr) sheath houses a 12 Fr catheter with jets to macerate clots and a funnel to aspirate the pieces by suction generated from a proprietary console. This enables efficient removal of mixed morphology clots without catheter clogging. The sheath’s steerability obviates the need to cross the clot and brings the funnel directly to the proximal face of the clot. The sheath also has continuous pressure sensing to provide real-time data to the physician. Once positioned at the location, clinicians can shoot contrast to confirm the exact boundaries of the clot before they begin jetting and aspiration, during which integrated sensors can provide context to inform users on case progress. The console displays hemodynamic data minimizing guesswork from the procedure. The device’s current bore size is in line with Akura’s approach to both PE and DVT, though Srivathsa says future products are expected to be even smaller.

The main distinction between Akura’s two target markets is the acute nature of PE, compared with DVT. DVT can be “a little more forgiving,” in Srivathsa’s words, allowing for more flexibility and time with treatment. DVT clots are also likely to be older, more chronic than the larger, softer clots often seen in PE, and it is especially important to ensure thorough clot removal in PE due to the risk of further deterioration.

Akura is now conducting biocompatibility testing for its 510(k) submission planned for later this year. April saw the completion of the first five human cases in the Republic of Georgia, to positive reception. The solution’s shallow learning curve allowed doctors with no previous thrombectomy experience to successfully adapt to the methodology, reflecting Akura’s focus on ensuring users are comfortable with the product, even those with lower patient volumes.

Srivathsa credits innovation incubator Shifamed with the swiftness of Akura’s progress thanks to its supportive culture, calling it “the bedrock” of what the company has been able to accomplish. To illustrate this point with an anecdote from his past, Srivathsa recalls how, when working with an Israeli company called Kyma Medical, he was the first US employee. He had to single-handedly sign the lease on an office, assemble furniture, open bank accounts, and ensure compliance with local laws. As CEO, 50% of his time was spent dealing with housekeeping tasks. By stark contrast, Shifamed’s organizational advantages allow people to focus on their companies while giving them a sounding board and the ability to call on other portfolio companies as helpful resources. The close-knit campus enables Srivathsa to walk into a nearby building and ask for help, and vice versa. “Now it’s my turn to return the favor to other portfolio companies,” he says, doing so by offering advice in areas of expertise such as sterilization, dealing with labs, and EMC (electromagnetic compatibility) testing. Shifamed’s portfolio companies also benefit from a combined presence at meetings that wields strength in numbers, as well as a high rate of talent retention, with some three- and four-time Shifamed employees currently in executive roles.

To date, Akura has raised $27 million between its seed round and Series A, led by Cormorant Asset Management with additional participation from The Capital Partnership, PA MedTech VC Fund, Shifamed Angels, and AMED Ventures. With the early FIH data supporting Akura’s claims about the technical capabilities of its device, a Series B is slated for the latter half of 2023 to fund the company through the PE Registry and regulatory approval process. Barring any major delays, Srivathsa is hopeful to begin commercialization with targeted accounts in 2024 to continue to iterate based on early feedback and to fine-tune the DVT product line. With market penetration rates near 20% for DVT and 15% for PE, comprising just 135,000 out of 740,000 patients in the US being treated for these conditions, Akura’s potential reach is massive and growing.

Moving PE Forward
While providers of PE solutions may take distinct technical approaches, their primary goal is unanimous: making procedures as safe as possible for patients. Whether that means increasing the flexibility of a large-bore catheter, developing tools to maximize the effectiveness of smaller-bore applications, improving efficiency of ultrasonic lysis to minimize the dose of lytic agent needed, or exploiting the chemical properties of clots for total thrombus bulk removal, each company in the space aims for the most complete resolution with the least risk of bleeding or vascular damage. Inari continues to flourish, having reported $116.2 million in revenue for the first quarter of this year, an increase of 7.8% over the previous quarter and 33.9% over the same quarter of the previous year. The company also announced at the 2023 American College of Cardiology conference positive results from its FLAME study in high-risk PE.

Based on the growing body of evidence gathered on EKOS, the potential of another combination energy and drug-based platform coming to fruition should not be dismissed. At the same time, multi-capable mechanical solutions are only beginning to diversify. With both categories gaining clinical support, physicians of patients in a range of disease states and morphologies can look forward to selecting the most appropriate treatment for them rather than conceding to a default route.

Posted on May 19, 2023