First Trial to Ever Evaluate Radiofrequency (RF) Ablation in a Transvascular Approach to Reduce Pain Associated with Pancreatic Cancer
Study Design
25
Subjects Involved in the Study*
01
Clinical Site
Objective
Ablate Relevant Nerves and Mitigate Intractable Pain
* Five lead-in subjects used for procedure optimization will not be included in the final data release
Clinical Evidence
Positive Topline Results from First 15 Patients’ 7-Day Data Highlighting Significant Impact on Treatment of Pancreatic Cancer Pain with Maintained Pain Reduction
Clinically meaningful mean of 4.96 or 63% reduction of pain on the VAS pain scale
79% responder rate achieved with zero opioid use and quality of life improvement at 7 days post-procedure
No unexpected complications or procedural-related significant adverse events
Pancreatic Cancer Pain Proof-of-Concept Study: Responders Mean VAS Score Over Time (From First 15 Patients)1
- First 15 subjects includes the five lead-in subjects, which will not be included in the final data release;
- Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1. PMID: 16320034; PMCID: PMC3454549.
Physician and Lead-In Patient Interviews from First-in-Human Trial
ABOUT PAIN ASSOCIATED WITH PANCREATIC CANCER
Pancreatic Cancer Pain Management is Part of a $2.2 Billion Market
The current market capitalization of pancreatic cancer treatment is $2.2 billion*. This first-in-human proof of concept study for pancreatic cancer pain is the first step in obtaining approval to treat pancreatic cancer pain with a first-of-its-kind technology and technique using Autononix’s platform technology, a proprietary microchip and unique antenna sensing array that delivers precise treatments through a simple and safe transvascular procedure.
A Major Unmet Need
Negative Impact On Quality of Life and Survival
- 11th most prevalent cancer worldwide1
- One of the most lethal: 95% mortality1
- >50% of patients have intractable pain2
- 80-90% of patients have unresectable tumors and/or metastatic cancer2
Leads to:
- Poor diet and lower caloric intake
- Poor quantity and quality of sleep
- Inability to work and socialize
- Poor tolerance to chemotherapy
- Pancreatic cancer statistics. WCRF International. (2024, June 26). https://www.wcrf.org/cancer-trends/pancreatic-cancer-statistics/;
- RAWLA, P., SUNKARA, T., GADUPUTI, V.. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World Journal of Oncology, North America, 10, feb. 2019.
Problem – Opportunity
Creativity & Innovation
Pancreatic tumors often cause severe pain that is very difficult to manage.
Lack of Treatment Options
Injections of ethanol are difficult to control and can destroy nerve tissue indiscriminately. Opioids have significant side effects and are often not effective in fully managing the pain.
Durable Pain Relief
We are seeking to create a minimally invasive procedure to deliver a durable and meaningful reduction in the pain of the patient.
Targeted Treatments
Our device is being developed to travel within the vascular system and detect the individual nerve bundles causing pain.