Products
FAQs
Q: Which of your products are approved by the FDA?
A: Our WavSTAT Optical Biopsy System is approved as an adjuctive tool to aid the clinician in the determining whether observed tissue in the colon is normal, pre-cancerous or cancerous. Our LUMA System is approved for use as an adjuctive tool to aid the clinician in determining whether observed tissue in the cervix is normal, pre-cancerous or cancerous.
Q: What future FDA approvals will you seek?
A: We are conducting a trial to detect pre-cancers of the esophagus, sometimes associated with what is known as Barrett's esophagus.
Q: Are there other approvals from the FDA that you are considering?
A: Lung cancer is a significant cancer killer. We are looking into this now. Our WavSTAT System technology can be evaluated in any part of the body that we can reach with an optical fiber.
Q: What approvals are required to sell your product in the rest of the world?
A: We are approved to sell in any country that permits the CE mark. This includes Europe (EU), Africa, South America and many places in Asia.
Q: How does the LUMA Cervical Scanning System work?
A: A 337nm safe blue laser scans the surface of the tissue much like a TV (cathode ray tube) does. The laser reflection and video are all combined through sophisticated software algorithms to give the LUMA System scan a color overlay of the suspicious tissue.
Q: How many patents do you own or have the rights to?
A: We currently hold, or have pending, 60 issued patents related to our products. We believe this represents the strongest patent portfolio in the field today.
Q: What are the biggest hurdles that you face?
A: Time. So many projects occur serially that to complete any one of them requires that others are completed beforehand. This must be done carefully and properly.
Q: Do you have any issues with the FDA? For instance, what was the most critical item on your last inspection's List of Observations?
A: There are no issues that we know of. Our last FDA inspection did not result in any observations.
Q: I notice that you have about 60 patents related to your technology. How strong are the patents?
A: You never know the strength of your patents until they are tested in court. To date, the Company has not been challenged on any of its claims.