The customers of MT’s contrast agent are the patients with suspected prostate cancer after PSA screening. However, its application can be extended to other solid cancer types, including breast cancer, and etc. Clinical decisions of using the contrast agent in the patients with prostate cancer will be made by the clinicians, including oncologists, urologists, and radiologists. Currently, prostate biopsy, the gold-standard diagnostic method of prostate cancer, after PSA screening only presents 24% accuracy. In addition, most of the diagnosed cases do not lead to a prostate cancer related death, so it is important to find the most severe cases and avoid over-treating the rest. MRI is increasingly considered by the urological community as a useful diagnostic modality with the potential to help diagnosis and treatments. MT’s targeted MRI contrast agent has the potential to provide non-invasive and accurate differential diagnosis of high-risk prostate cancer and spare millions of patients from unnecessary painful biopsies.

 

This seems to be a stable, attractively sized market that is growing due to favorable demographics driving demand. Many of the main products have been on the market for decades, and the pace of innovation seems slow. The potential hurdles to gain the acceptance from the market and customer are the following: 

 

1) The use of MRI prior to biopsies seems performance-limited because of lack of tumor specific contrast agent, but is still finding increasing use. MT’s contrast agent is designed to address this unmet clinical need. The advantages of MRI with MT’s contrast agent over current diagnostic modalities are non-invasiveness and accuracy, which are appealing to both patients and clinicians. Once the efficacy of our targeted contrast agent is demonstrated in clinical trials, MT will work closely with clinicians to demonstrate on the strengths, value, and clinical benefit of this technology during marketing. 

 

2) The other hurdle is whether this will be reimbursed by Medicare and private insurers. Once MT can demonstrate the value of this technology towards improving diagnostics, patient outcomes, and reducing healthcare cost in later stages of clinical development, we will work closely with Medicare and private insurers in the US for reimbursement. Current clinical diagnostic methods produced very high false positive diagnoses, resulting in high cost in healthcare of prostate cancer patients. MT’s technology has the potential to substantially reduce false positives, and to eliminate many unnecessary diagnostic procedures and treatments and associated costs. Consequently, it will also eliminate the following costs associated with side effects and complications derived from the unnecessary invasive procedures and significantly reduce the overall healthcare cost. This will benefit the patients, care providers, and insurers. At the same time, MT will actively explore the marketing potential in Asia and Europe. 

 

3) Safety concerns associated with some of the gadolinium-based contrast agents (GBCAs) could be another hurdle. The U.S. Food and Drug Administration (FDA) have issued a black box warning concerning the risk of nephrogenic systemic fibrosis (NSF) from all GBCAs in patients with acute or chronic severe renal insufficiency. The FDA is also investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for MRI. So far, these concerns are primarily associated with the linear GBCAs. MT’s agent is designed based on highly stable macrocyclic agents with good safety profiles. No safety issues have been reported with these macrocyclic GBCAs. Therefore, MT’s contrast agent should have the same safety as the clinically used macrocyclic GBCAs and should address the potential safety concerns.