Imagin Medical Acquires Ablation Tech From TROD Medical

Imagin Medical Inc. has purchased the enCAGE Coil Precision Ablation System for prostate cancer from TROD Medical NV, and has opened a new $7.25 million convertible note to support both the transaction and the product’s development.

Prostate ablation is a procedure used to treat prostate cancer. During a prostate ablation procedure, energy (such as heat, cold, lasers, or chemicals) is used to kill the cancer cells. The energy may also destroy some of the surrounding normal prostate tissue.
The enCAGE Coil device is a disposable focal therapy precision ablation device for prostate cancer that delivers bipolar radiofrequency energy through a distinctive “coil” electrode during a minimally invasive office-based procedure. The system allows the surgeon to pre-set precise ablation margins to target only the cancerous tissue, addressing the limitations of other forms of thermal ablation technologies for prostate cancer that risk damaging adjacent structures e.g., the erectile nerves that control urinary and sexual function.
 
The device has U.S. Food and Drug Administration (FDA) 510(k) approval and has been used in 51 patients, including 20 patients who participated in a Phase II Trial, with results published lalst spring in The Journal of Urology. Dr. Clement Orczyk, lead of Prostate Cancer Focal Therapy Program, UCL Hospitals in London, England, an Investigator for the trial and first author of the publication, said the technology “is the most versatile and promising of the many I’ve evaluated for performing focal therapy of prostate cancer with accuracy and safety”.
 
Imagin will be refining the device based on this experience for commercialization.
 
By acquiring the enCAGE Coil, Imagin is strengthening its position as a urologic oncology company and expanding its portfolio of products to address prostate cancer. With close to 250,000 new cases diagnosed each year, prostate cancer is the most prevalent cancer among men after skin cancer and the second leading cause of cancer deaths among men. The enCAGE Coil device joins Imagin’s lead product, the i/Blue Imaging System for bladder cancer, building out a best-in-class pipeline for the diagnosis and treatment of urologic cancers.
 
“As a urologist who has cared for patients with cancer over a 25-year career as a professor and urological oncologic surgeon, I have a deep knowledge of the field and of the needs of patients with prostate and bladder cancer,” said Dr. Kevin Slawin, board chairman of Imagin. “Our growing focus on bringing best-in-class technologies to patients in an outpatient setting is the culmination of my thoughts over my career in the field of urologic oncology on how to best care for these patients.”
 
The aggregate cost to acquire the enCAGE Coil is $2.5 million, which will be paid over time as certain developmental milestones are met. The initial payment, on closing, is $350,000 and $150,000 of Imagin shares (based on a 10 day average price as of the date of closing). The first milestone payment ($500,000) will be made upon receipt of FDA 510(k) approval to the next trial phase or modification. The second milestone payment ($1 million) will be made upon receipt of FDA de novo approval and the third milestone payment ($250,000) will be made upon achieving sales of 1,000 BPH (Benign Prostate Hyperplasia) cases following 510(k) approval. The fourth and final milestone payment ($250,000) will be made upon achieving sales of 500 BPH (Benign Prostate Hyperplasia) cases following de novo approval.
 
“We are excited to add the enCAGE Coil to Imagin’s portfolio as we build our pipeline of products,” said Jim Hutchens, president and CEO of Imagin. “This additional funding will support on-going product development and the company’s progress in bringing our products through the FDA approval process.”
 
The company’s lead product, the i/Blue Imaging System, uses technology that improves the utility of blue light imaging for visualizing bladder cancer. The i/Blue System contains a patented dual-view camera head that uses sophisticated optical filters to split the image into white light and blue light channels to display simultaneous, side-by-side white and blue light images on the monitor in real time without the need to toggle between the two images. The i/Blue System is designed to work with most endoscopes on the market, providing a more practical, cost-effective device that will make blue light cystoscopy more accessible to hospitals and patients.
 
The enCAGE Coil is a disposable focal therapy precision ablation device for prostate cancer that delivers bipolar radiofrequency energy through a distinctive coil electrode during minimally invasive office-based surgery. The system allows precise pre-set targeting of the cancer, avoiding total removal of the prostate and damage to the adjacent erectile nerves. The enCAGE coil addresses the limitations of other forms of prostate cancer treatment, including surgery, radiation and current focal therapy technologies, that lack the ability to precisely target only the cancer cells, risking damage to the remainder of the prostate and surrounding erectile nerves that can cause impaired urinary and sexual function.
 
Focal therapy of prostate cancer is a minimally invasive method to destroy more limited prostate cancers, in situ in the prostate, leaving the remainder of the prostate gland and surrounding important structures like the erectile nerves intact, reducing the risk of impaired urinary and sexual function as compared to other “whole-gland” directed therapies like surgery or radiation therapy. Using mpMRI fused with real-time ultrasound to target the tumor improves the precision of the technique. Current focal ablation modalities for prostate cancer are primarily thermal therapies, either freezing (cryotherapy) or heating (HIFU, single electrode RF, laser, water, steam, electricity). All suffer from the same challenges as the lesion grows from the center outward. The margin of cancer cell “kill” is indeterminate and difficult to precisely determine using thermocouples or imaging. Ablation therefore often extends beyond the area necessary to control the cancer in order to ensure complete cancer ablation. Important structures, often immediately adjacent to tumors, are therefore hard to preserve e.g. erectile nerves. enCAGE Coil is a bipolar radio frequency-based probe (bRF) enabling precision ablation, limited only to the edge of the outer coil. Thus the ablation margin is pre-set via treatment planning and placement of the “coil” electrodes, yielding 100% ablation within the ablation zone in conjunction with 100% tissue preservation beginning just outside the ablation zone. This allows complete ablation of tumor tissue with preservation of adjacent erectile nerves.
 
Imagin Medical develops proprietary technologies to better visualize and treat urologic cancers, including bladder and prostate cancer through minimally invasive surgery that can be performed in the urologist’s office. Imagin’s proprietary technologies are poised to expand patient access improve outcomes and quality of life.