our market

the clinical need

There is a significant need in the medical market for real-time, high-resolution imaging of tissue microstructures that is not being addressed by existing imaging technologies. The unmet need is for information about the internal structure of biological tissues, which is essential for diagnosis of disease, for planning and monitoring treatment, and for follow-up. Visualizing tissue structure, in real-time at the site of care, offers the opportunity to reduce patient anxiety and risk, shorten treatment time, and reduce the cost of healthcare through earlier diagnosis and treatment, focused treatment, and avoidance of additional procedures. This need must be satisfied in a wide variety of medical specialties and clinical practice settings at a cost effective price.

Diseases in their early stages generally are associated with microscopic structural alterations to tissue that previously could only be identified by biopsy and histology. A decision to biopsy tissue is usually preceded by a diagnostic test that indicates an abnormality, but does not identify the location of that abnormality. For internal organs, a series of biopsy sites is typically chosen using white light (such as endoscopy, cystoscopy, colposcopy, laryngoscopy or other imaging modalities). Established imaging technologies also lack the necessary spatial resolution and tissue contrast to identify early changes, and can be cost-prohibitive. Therefore, a clinician must rely on indirect subtle superficial manifestations of pathological processes in order to identify a suspicious site for biopsy. That dependence on surface manifestations can lead to a high rate of false-negative biopsy results and to late diagnosis.

In contrast to the shortcomings of conventional approaches, OCT can be used to create images that reveal the stratified structure of tissue and alterations to that structure. Visualization of the microstructure alterations have been demonstrated in both ex vivo and in vivo OCT patient investigational studies of normal and abnormal human tissues. By visualizing tissue microstructure, OCT imaging provides physicians and surgeons a valuable tool to assist in the diagnosis, treatment, and surveillance of disease.

Today, in the absence of a commercialized in vivo method to visualize tissue structure alteration, clinicians must do a biopsy and an ex vivo histopathological review using a conventional microscope. Imalux OCT products can be used to visualize structural disruptions in vivo at the point of care. Clinicians across a wide spectrum of medical specialties can use the Imalux Niris Imaging System throughout the entire cycle of care – before, during, and after treatment - often in lieu of more invasive procedures.

OCT has potential applications in many areas, but the main focus of many of our clinical studies has been in Urology. The technology may have usefulness in the diagnosis and treatment of ureteral cancer, bladder cancer, testicular cancer, prostate cancer, urethral cancer, penile cancer, kidney cancer, painful bladder syndromes (interstitial cystitis), and infertility. Current investigations are underway, using the Niris Imaging System, to determine the efficacy of OCT in recognizing these diseases.

market trends

Market growth is driven by an aging U.S. population, a better understanding of early indicators for diseases, and a more vigilant payer/consumer approach to screening for and treating life threatening diseases, such as cancers, at an earlier stage of development.

There are several market trends that accentuate the need for real-time, point-of-care imaging of tissue structure. These include:

• population shift –

(1) The “Baby Boomers” population bubble is advancing in age and approaching the time they will require more medical attention that will result in large medical expenditures.

(2) Life expectancy in the U.S. continues to rise dramatically.

The consequences of both these trends will be enormous. More affluent and more educated about their medical options, Baby Boomer consumers will demand advanced diagnostic tools. At the same time, longer life expectancies will drive the need for more efficient, less expensive health care.

• decentralized care – the need for single episode care is emerging to help control healthcare costs – “see and treat.” Devices/services that enable single episode care will find rapid market adoption.

• reimbursement – clinicians struggle to maintain/increase revenue and at the same time provide the highest possible standard of care. As Imalux is in a clinical phase, reimbursement is not currently an issue, but long-term acceptance of this technology will increase the likelihood that the AMA will assign CPT codes and routinely pay for OCT procedures.