Targeting LargeUnmet Medical Need

Abdominal aortic aneurysms (AAAs) occur in nearly

of the population1

In the US


deaths per year are attributed to AAA ruptures2

An additional


deaths annually result from attempted AAA repair2

  1. Prevalence and Trends of the Abdominal Aortic Aneurysms Epidemic in General Population – A Meta-Analysis, PLoS One, 2013; Li, et al. 8(12): e81260
  2. The impact of gender on presentation, therapy, and mortality of abdominal aortic aneurysm in the United States, 2001–2004. McPhee JT, Hill JS, Eslami MH. J Vasc Surg. 2007;45:891–9

No Proven Options for Small- to Mid-Sized AAAs

Small to Mid-Sized AAA

3.5cm-5.0cm (males)

3.5cm-4.5cm (females)


1.1 million patients

Treatment Options:

  • Watch & wait
  • Modify risk factors


  • Little to no efficacy
  • No reduction in AAA growth
  • No advantage of early OSR/EVAR

Large AAA

>5.0cm (males)

>4.5cm (females)


60 thousand patients

Open Surgical Repair (OSR)


  • 4 hour procedure
  • 4+ days hospital stay
  • 8% peri-operative mortality rate
  • 2%-18% re-intervention rate
  • For young, healthy patients only

Endovascular Repair (EVAR)


  • Initial survival benefit declines to 1% in 6 years
  • 30% re-intervention rate
  • 10%-20% rate of endoleaks
  • Only 60% of patients have required anatomy to anchor graft
  • Risk of endograft migration
  • Renewed FDA scrutiny
  • Longer mandated follow-up

Nectero EAST® System

The Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) system is a minimally invasive technology currently undergoing clinical trials. If successful, it may offer patients with smaller AAAs a first approved therapeutic option beyond surveillance.

  • Comprised of a dual-balloon delivery catheter and a stabilizer mixture containing pentagalloyl glucose (PGG)
  • Delivers drug locally into the aneurysmal wall
  • PGG binds to elastin and collagen to potentially strengthen the aortic vessel wall and reduce the risk of further degradation
  • Procedure takes <1 hour to complete
  • No permanent implant is left behind
  • Future interventions are not precluded

Pre-clinical Data

Enzymatic degradation of elastin and collagen results in weakening of the aortic wall and gradual growth and expansion of AAA. Localized treatment that prevents the enzymatic degradation from occurring has the potential to slow or stop an aneurysm from growing and rupturing.

In variety of animal studies, PGG has demonstrated the potential to:

  • Strengthen weakened tissue
  • Sterically hinder enzymatic degradation
  • Inhibit growth of aneurysms
  • Reduce burst risk

Pentagalloyl Glucose (PGG)

Clinical Data

In July 2023 the US Food and Drug Administration (FDA) granted Investigational New Drug (IND) clearance for the company to initiate a prospective, multi-center, randomized clinical trial to evaluate the safety and efficacy of the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System in patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5 – 5.0cm. Learn more

Learn more

Breakthrough Designation

In October 2023, Nectero EAST® System was granted Breakthrough Therapy designation to treat patients with infrarenal AAAs, maximum diameter 3.5 – 5.0cm.

  • Designation intended to expedite the development and review of drugs or combination products to treat a serious condition, and for which preliminary clinical evidence indicates that the drug or combination product may provide a substantial improvement on clinically significant endpoint(s) over available therapy
  • Intensive FDA guidance on an efficient drug development program, including FDA’s organizational commitment to involve senior managers
  • More frequent meetings with the FDA to ensure appropriate data collection in support of drug approval

Expanded Access

Nectero Medical encourages participation in the stAAAble trial as the best way for patients to access investigational products prior to regulatory approval. When it is not possible for a patient to participate in a clinical trial and all other available medical options have been exhausted, physicians may seek expanded access to an investigational product. Expanded Access Policy

Expanded Access Policy

FIH/Phase I Study

  • A global, prospective, multi-center study of the Nectero EAST® System to treat small to mid-sized AAAs was performed outside the U.S.
  • Primary endpoints were technical success and safety (major adverse events at 30 days)
  • Secondary endpoint was growth stabilization, defined as freedom from aneurysm sac enlargement (diameter increase >5 mm per year or volume increase of > 10% per year)
  • Safety and preliminary efficacy results on the initial 20 patients (19 male) were recently published in the Journal of Vascular Surgery with the following results:
    • 100% procedural success
    • 30-day primary safety data indicated the procedure was safe
    • Efficacy data on the initial 11 patients were promising and supported proceeding with further studies

Learn more

Key Publications



To top