AOTH – BSS Life Sciences

An endoscope is the medical device used – by direct insertion – to visualize suspicious masses in the hollow organs of the body such as the gastrointestinal tract, esophagus, lungs, urinary tract and uterus.

In 1805, Philip Bozzini used a rudimentary, light-guiding tube he created (a Lichtleiter – light guiding instrument) to view the urinary tract, pharynx, and rectum.

In 1853, Antoine Jean Desormeaux developed an instrument to view urinary structures. Desormeaux called his instrument an “endoscope.”

In the 1960’s fiber optics allowed a major reduction in the size of the endoscope and helped clarify the doctor’s view. Use of endoscopes in the practice of medicine exploded.

The endoscopy procedure is used to confirm a diagnosis when other tools, such as an MRI, X-ray, or CT scan are considered inappropriate or unclear.

Endoscopies are commonly performed in the diagnosis of cancer; for taking samples of tissue, called biopsies, to find out whether it is cancerous as well as for complete excision (the cutting out) of suspicious lesions.

There are many different types of endoscopes and depending on the site in the body, and the type of procedure, endoscopy may be performed by a doctor or a surgeon, and the patient may be fully conscious or under general anesthetic.

Endoscopes are also used in laparoscopic surgery in which a small incision is made, usually in the navel, through which a viewing tube is inserted. This allows the doctor to examine the abdominal and pelvic organs on a video monitor connected to the tube.

Laparoscopes are also utilized in surgery to visualize various organs and tissues within the body during surgical removal and to avoid damage to adjacent organ and vascular systems and other critical structures. Laparoscopy is less invasive than regular open abdominal surgery.

Because of the endoscope biopsies of the intestines or lungs can be done without the need for major surgery.

White Light

Visible light, or what we call “white light” has been utilized in endoscopes for decades to guide the physician and surgeon so they can “see” the cancer in the organ of interest and subsequently for biopsy and in the removal of suspicious masses.

However, white light has visualization limitations for all cancer types because white light cannot pass through tissue or blood and cannot illuminate tumors beneath the skin surface.

In addition, white light is not effective in visualizing the borders of the tumor to determine where it starts and ends (the margins) especially after the initial removal of the main mass.

If the surgeon does not remove all the cancerous growth and a few cancerous cells remain, or does not remove all cancerous cells at the margins, the tumor can grow back and spread or metastasize to other parts of the body.

Another major problem with endoscopes that utilize only white light is that malignant and premalignant tumors that are flat, or very small, may look similar to normal tissues. As a result a physician may not be able to identify some aggressive cancers. In order to be safe, physicians may have to collect random and repeat biopsies as the only possible way to ensure that cancer is not missed in high risk patients.

Blue Light

Because of the limitations with using white light for visualizing cancers, various companies have begun to explore usage of blue light in conjunction with imaging agents or chemical dyes. These recent advances and successes with blue light and chemical tumor targeting agents have improved the ability to visualize cancers and margins.

However, these chemical agents can cause various adverse effects including anaphylaxis shock and hypersensitivity reactions with repeated usage at the high doses currently required for visualization. It is for this reason that the FDA has limited use to just once for any patient.

Doctors and surgeons cannot repetitively examine a patient with these chemical imaging agents. This is as critical problem for patients with multiple tumors and those with recurrent tumors.

Red Light

Red light requires specialized laser light sources, ultrasensitive cameras and a unique optical design. Currently no commercial instruments are available using red light.

The Unmet Need

What is acutely needed in this particular imaging space is an ultrasensitive endoscope system that uses white light while simultaneously using other wavelengths of light to visualize all tumors, and one that requires only a fraction of the chemical imaging agent so as to reduce the toxicity allowing multiple usage in patents.

Future endoscopes should also have more advanced cancer detection technologies so that ultimately no chemical imaging agents would be necessary, and these future tools should provide ultrasensitive and advanced imaging capabilities.

BSS Life Sciences

BSS Life Sciences is a biotechnology company founded to commercialize an ultrasensitive, next generation imaging technology for extremely accurate visualization of cancers.

BSS’s next generation imaging technology was invented and developed by Dr. Stavros Demos. Dr. Demos worked with UC Davis Cancer Center physicians and the U.C. Davis NSF Center for Biophotonics Science and Technology for more than eight years creating this technology and demonstrating its proof of principle.

The resulting instrument provides physicians a tool to complement white light endoscopy by adding fluorescence imaging for more accurate and complete detection and treatment of cancer and various other conditions.

BSS company inventors have designed, created and tested two different systems that utilize simultaneous recording and display of images using white light and either blue light or red light. One system (blue light) uses targeted imaging dyes that require only a fraction of the current chemical contrast agents and the other system (red light), uses no contrast agents directly visualizing the intrinsic fluorescing tissue biomolecules.

BSS’s technology is based on ultrasensitive detection and imaging instrumentation that can be seamlessly adapted to any type of endoscopic or other type of imaging device commercially available.

The two working prototype systems that have been created provide simultaneous white light and red light, or white light and blue light for detection of tissue structures of interest that can be visually isolated from the surrounding tissue. These systems acquire and display simultaneously conventional white light images and images that arise from either blue light or red light, which alleviates the problem of having to switch back and forth between different light sources for the physician or surgeon to view the tumors.

The company’s first two commercial applications of this technology are advanced endoscope systems for the ultrasensitive detection and effective removal of bladder cancers.

Preliminary testing was performed in vivo in 21 patients undergoing transurethral resection of bladder tumors at the UC Davis Medical Center, a well-respected cancer facility, with excellent results.

BSS Life Sciences has entered into a partnership with the UC Davis Cancer center, to continue testing commercial prototypes for FDA application on human patients.

In addition to clinical testing at UC Davis, BSS Life Sciences has arranged additional testing by certified staff at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center and the UCLA Jonsson Comprehensive Cancer Center.

Competitive Advantages

Although there are many companies that manufacture endoscopy devices, no company to date has developed an ultrasensitive blue light endoscopy system that will use less than 1 percent of the toxic chemical currently (such as Cysview) used per test.

In addition BSS Life Sciences has developed an ultrasensitive red light endoscopy system that requires no chemical imaging agents.  It is expected that this system can also be used in two medical settings for both diagnosis and tumor removal (resection). Because there is no need for chemical imaging agents, this system can be used in a physician’s office or clinic for cystoscopy (diagnosis), and in the operating room (O.R.) or ambulatory surgical center for tumor removal or resection.

BSS has been issued patents covering these imaging systems that are estimated to be at least 1000 times more sensitive in tumor detection than any other devices currently in the marketplace. BSS’s devices will provide improved detection of non-muscle invasive bladder cancer superior to what is currently in the market place.

These devices will lead the marketplace in illumination of cancerous cells and provide an improved surgical outcome as a result of an improved detection and resection, which will lead to more adequate patient management and follow-up.

A key feature of BSS’s technology is based on improving the imaging aspect of endoscopy and it’s a technology that can be adapted to any kind of existing endoscope. The instrumentation involved does not come into contact with the patient, thus significantly reducing regulatory requirements and associated expenditures. Furthermore, the interface of the imaging instrumentation with the endoscope is via a flexible and lightweight adaptor that is very easy for the operator to handle. Also, the white light and fluorescence images are recorded and displayed simultaneously providing an effective real time navigation tool that can be farther enhanced using processing (such as overlapping and pseudo-coloring) of the two principal images. 

Market

The global endoscopy equipment market was estimated at $28.2 billion in 2013 and is expected to reach $37.9 billion by 2018, growing at a Compounded Average Growth Rate (CAGR) of 6.1% from 2013 to 2018. The other factors that are driving the growth of the global endoscopy equipment market include favorable reimbursement in select regions, our aging population, and the increasing prevalence of diseases that require endoscopy procedures.

Letter of Intent

Expedition Mining Inc. TSX.V – EXU has signed a letter of intent (LOI) with BSS Life Sciences Inc. that would see Expedition acquire all of the outstanding securities of BSS in an all-share transaction to be completed by way of a share exchange agreement. Concurrent with the completion of the transaction, the LOI contemplates that Expedition complete a private placement of a minimum of $1-million.

Conclusion

Current endoscopy instruments have a well-documented problem associated with the limited ability to distinguish cancer from normal tissue.

BSS’s advanced ultrasensitive imaging technology is based upon improved optical designs and components, and advanced light sensors. The results are:

• Increased sensitivity and specificity for the detection of cancers and even premalignant lesions.
• A potential decrease in cancer recurrence due to the ability to completely remove tumor tissues along with the cancerous cells in the margins.
• A significant commercial advantage to BSS’s imaging technology because of its adaptability to all endoscopes that are currently on the market.
• Easy adoption of BSS’s two ultrasensitive imaging designs for use in multiple other applications where endoscopy imaging is currently utilized.

For all these reasons Expedition Mining, BSS Life Sciences, and their significantly improved endoscope technology, needs to be on your radar screen.

Is advanced endoscopy on your screen?

If not, it should be.