This proposed supplement expands the commercialization and market assessment activities for the original Phase I grant through the Innovation-CORPs Program at NIH. The expected primary benefit from I-Corps is having dedicated time and mentored direction towards relevant interviews in the endoscopic space; this is expected to provide invaluable information about the needs, in-depth technical knowledge, the market players, and acquisition process for endoscopic accessories and minimally invasive surgery in healthcare facilities. Though AMI has experience in the space with respect to feeding tubes, a significant focus for the company has been to get involved more in the gastrointestinal surgical space. The I-Corps program would help jumpstart the limited exposure so far achieved. Additionally, it is expected that updates from other companies in the program will provide a different perspective on both interview logistics and approach to commercialization. AMI has always been an agile company when evaluating commercial markets and strategies, and welcomes the opportunity to modify/refine the commercialization strategy to improve the successful launch of the Flexible Pancreatic Ablation (FPA) system. It is recognized that needs, technologies, and regulations are dynamic, and as AMI has in the past changed its approach to commercialization ? such as emerging markets in TubeClear or modifying hardware designs to better adapt to new FDA regulations ? it is prepared to do so in this program. Original Project abstract: This Phase I SBIR develops and tests feasibility of the FPA system to endoscopically treat pancreatic tumors. The FPA deploys through an endoscope and into heterogeneous pancreatic tissue with a vibrating head consisting of an array of fine, flexible tines that expand into a predetermined shape. The vibration and geometry of the tines improve tissue penetration and trajectory accuracy to enable complete tumor ablation without destroying healthy tissue. Public Health Problem: Pancreatic cancer is a deadly disease with poor prognosis and short survival. Although it accounts for 3% of new cancer cases overall each year ? an occurrence nearly 80% less than breast cancer ? the estimated number of deaths in 2016 surpassed that of breast cancer, making it the third most deadly cancer (41,780 estimated deaths) in the U.S. This is due in part to its typically late stage diagnosis, which limits eligibility for the preferred treatment of surgical resection to only 20% of patients. Resection is preferred because other percutaneous methods such as laparoscopy using radiofrequency ablation (RFA) have shown similar risks but lower efficacy due to anatomical obstructions and surgical route. Endoscopic techniques are advancing, but are so far limited in scope or capabilities. RFA needles generate set ellipsoidal ablation zones which may not match the shape of tumors. Unlike other organs, damaged pancreatic tissue cannot regenerate; therefore, healthy tissue must be preserved if possible. The pancreatic tissue heterogeneity can also complicate procedures with lengthy, thin, flexible ablation probes ? soft structures can compress and relax, resulting in uncertainty in insertion depth, and harder structures can resist piercing and redirect the probe path. An advanced endoscopic accessory is needed that can fully ablate pancreatic tumors while minimizing patient complications and destruction of healthy tissue ? and provide an effective treatment choice for the 80% of patients with limited options for survival. Phase I Hypothesis. Feasibility of improved endoscopic therapy of pancreatic cancer is demonstrated by deployment of tines and production of spherical ablation zones using the FPA tool in vitro and in vivo.
Specific Aims :
Aim 1 ? Develop FPA handheld prototype and demonstrate improved FPA effector expansion with vibration. Acceptance Criteria: FPA maintains desired effector expansion and reduction-of-force with vibration in all endoscopic phantom insertions.
Aim 2 ? Show efficacy of tissue ablation in vitro and insertion testing in heterogeneous models. Acceptance Criteria: Validate thermal models and demonstrate improved lesion shape to needle ablation in vitro. Demonstrate effective deployment in heterogeneous tissues.
Aim 3 ? Endoscopic demonstration of ablation zone in pancreas using FPA in preliminary preclinical study. Acceptance Criteria: In vivo (N=3) ablation volume is within 20% of simulations. No adverse effects from ablation procedure during 7-day survival.
Relevance ? Pancreatic cancer is one of the most deadly forms of cancer in the United States. Due to its late diagnosis, only 20% of patients diagnosed with the disease are eligible for surgical resection, which is considered the preferred method of treatment. Radiofrequency ablation is a common cancer treatment modality for patients ineligible for open surgery. There is a lack of ablation probes which may be used to generate spherical heating zones which closely match the geometry of typical tumors. This project develops the Flexible Pancreatic Ablation System, a device that deploys through the working channel of standard endoscopes to access pancreatic tissue and deploy a flexible probe to fully ablate tumors, without sacrificing healthy tissue. The supplement proposed here expands the commercialization and market assessment efforts to take the technology to market.
