At Norwest, we are always looking to partner with healthcare companies that are transforming the lives of overlooked or underserved patient populations. We are delighted to announce the latest of these investments in our medical device portfolio: Nectero Medical, which is developing a revolutionary approach to treat patients with abdominal aortic aneurysms (AAAs).
A Potentially Deadly Condition
An AAA is a thinning, weakening, and ballooning of the walls of the aorta (the main artery in the abdomen) which is caused by smoking, high blood pressure, atherosclerosis, and genetics. In the U.S. about 1.2 million people live with AAAs and are forced to face the risk of the aneurysm rupturing as it continues to grow over time. If an aneurysm ruptures it often leads to the patient’s immediate death and is, in fact, the leading cause of death for patients with large aneurysms.
The risk of an aneurysm rupturing is directly related to the size of the aneurysm, and while there are existing surgical treatments for AAAs, those procedures carry significant risks and are reserved for patients whose AAAs reach a size threshold where the risk of rupture outweighs the risks of the procedures.
However, the vast majority of diagnosed AAA cases are in patients that don’t meet the threshold for surgical repair — so-called, small to medium-sized AAAs (3.5 cm – 5.0 cm). Today, there are no approved therapies for these patients, and, as a result, they undergo routine surveillance with periodic ultrasound or CT scans waiting for their aneurysms to reach the size threshold for surgical repair. While there is a lower risk of rupture for smaller aneurysms, patients with small to medium-sized AAAs, currently have to live in constant fear of the “ticking time bomb” in their abdomen.
Current Treatment Options Are Limited
For large aneurysms, there are only two proven treatments: endovascular stents (EVAR) and open surgical repair (OSR). However, patients with AAAs typically have multiple other illnesses such as hypertension, diabetes, heart failure, and peripheral vascular disease, making them poor candidates for surgery. Because AAA patients are in such poor health, both EVAR and OSR have significant morbidity and mortality risks (1-2 percent procedure-related mortality for EVAR and 3-5 percent for OSR). As a result, EVAR and OSR are reserved for patients once the AAA reaches a certain size threshold (5.5 cm for males and 5.0 cm for females).
For patients with small to medium sized AAAs, their aneurysms continue to grow over time. So these patients are actively monitored for growth via ultrasound or CT scans every 6 to 24 months waiting for their aneurysms to reach the size threshold for surgical repair. Today, most of these patients will eventually require a repair. In fact, as many as 60 percent of patients get a repair procedure within three years of their diagnosis.
We spoke to countless patients and physicians looking for a solution that may eliminate the need for risky procedures for many patients — and deliver peace of mind.
We spoke to countless patients and physicians looking for a solution that will eliminate the need for risky procedures — and deliver peace of mind.
Nectero Medical: Pioneering a Revolutionary Approach
Nectero is on a mission to fundamentally change the standard of care for patients with small to medium sized aneurysms and help them avoid a risky surgical repair. Since its founding in 2017, Nectero has attracted a world-class team of operators and scientific advisors committed to this goal.
The company’s endovascular aneurysm stabilization treatment (EAST) is an outpatient procedure that lasts less than one hour. The treatment delivers a stabilizing agent, pentagalloyl glucose (PGG), to the wall of the aorta via a minimally invasive balloon catheter. The stabilizing agent works by cross-linking the weakening proteins in the wall of the aorta, thereby strengthening the aortic wall and slowing, and potentially preventing, further growth of the aneurysm.
Nectero has completed a first in-human (FIH) trial, which showed very promising results. At 12 months, patients had an average reduction in growth of around 70 percent compared to historical growth rates. This reduction is relevant because by lowering growth by just 50 percent it would extend the time to reach the surgical repair threshold by more than 10 years. Considering the average age of AAA diagnosis is 71, if the EAST procedure is eventually approved, it would allow a significant number of patients to live with their AAA without the need for undergoing a risky surgical repair.
Because of these encouraging early clinical results, in 2023, the FDA awarded Fast Track and Breakthrough Therapy designations to Nectero’s EAST System and approved the design of their Phase II/III clinical trial for FDA approval.
Norwest is delighted to lead an oversubscribed Series D financing, raising $94 million to support the company’s clinical trial through FDA approval and early commercialization.
A Highly Promising Opportunity to Address Unmet Needs
Nectero reflects many of the core principles we look for at Norwest in our healthcare investments.
First and foremost, Nectero offers a groundbreaking solution for a patient population with a significant unmet need. The company’s EAST procedure is a novel, minimally invasive therapy that addresses the core, underlying pathophysiology of AAA formation and that has demonstrated a compelling early efficacy signal, as demonstrated in its first-in-human trial.
Nectero’s EAST procedure has the potential to be the first effective AAA treatment for roughly one million patients with no safe alternatives.
Second, Nectero’s EAST procedure has the potential to be the first effective treatment for roughly one million unaddressed patients. There are about 20 times as many patients with small to medium sized AAAs as there are with large aneurysms. And that number increases about five percent per year. We estimate the total addressable market in the U.S. at around $8 billion.
We are also impressed by Nectero’s accomplished management team, led by Jack Springer, former global head of Cordis Endovascular (Johnson & Johnson’s cardiovascular medical device business) and former U.S. president of Invatec, a peripheral vascular medical device company which was acquired by Medtronic in 2010 for $675 million.
Finally, several major players in the cardiovascular field are co-investors in this round, including Boston Scientific, BioStar Capital, and Aphelion Capital.
Most promising of all is the potential to improve and extend the lives of hundreds of thousands of patients, while lowering costs for the healthcare system.
