TheraScope SYSTEM TECHNOLOGY

Dr. Franzino, Chief of Surgery, Day Kimball Hospital Testing TheraScope Technology

MITI has developed proprietary technology which combines digital imaging with therapeutic intervention, harnessing the optical spectrum to “heal with light waves.”  MITI’s Photo Microbial Therapy has conclusively demonstrated this technology’s ability to destroy bacterial organisms such as staphylococcus with lightwaves. 

On behalf of MITI, Ethide Laboratories have conducted tests which demonstrate that our lightwave therapy can destroy entire colonies of bacteria such as Staphylococcus, H. pylori, E. coli, Pseudomonas aeruginosa and Aspergilla within seconds.[1]  Furthermore, work reported by Robert Ganz, M.D. has confirmed the negative impact of ultraviolet light on H. pylori.[2]  This new capability could provide the patient with better healthcare and greater safety. and surgeons with additional revenue.

The technology may be used to supplement, or even replace traditional drug therapy.  Specifically, a surgeon would sweep the bacteria-killing endoscope over a surgical field, including trocar ports, before closing, thus either eradicating or greatly diminishing the potential for bacterial infection.   Tables 1 & 2 show the killing effect of MITI’s lightwave technology on these pathogens.

                       Tables 1 & 2: Lab Results of Pathogen Kill with Lightwaves

In addition to endoscopic photo microbial therapy, our TheraScope technology will include laser ablation and coagulation, photo fluorescence technology, and infrared imaging.  These methodologies were discussed in a recent paper presented to the Society of American Gastro-intestinal Endoscopic Surgeons by John Bala and Ronald Franzino, M.D. 

TheraScope,™ represents a complete departure from the past.   The core of this unique system is a newly designed endoscope with extended wavelength light cables, specialized pulsed light source, computer-based digital camera and control system, and video monitors with multiple displays.  MITI’s therapeutic instruments will look identical to current endoscopes.  However, that is where the similarity ends. TheraScopes will be designed with a much different illumination capability than current endoscopes.  LightGuides will be constructed of a special fiber optic with high ultraviolet transmission capability that will efficiently transmit ultraviolet and infrared energy at light intensities that can destroy pathogens.   Conventional endoscopes cannot transmit ultraviolet light.

MITI’s rigid TheraScope will integrate our patented imaging technology with a specialized fiber optic LightGuide that will replace the conventional fiber optic illuminators now used in all current endoscopes.    This new LightGuide will efficiently transmit the optical wavelengths necessary for intervention, while, simultaneously, providing sufficient energy to gather high quality images.   Although similar in appearance to conventional endoscopes in operation and image quality, TheraScope’s primary objective will be to direct lightwave therapy to a localized area inside the body in order to destroy infectious bacteria.   These pathogen-fighting endoscopes will require pre-market animal and human studies before they can be sold for surgical use on human patients.   Although over-exposure to sunlight has been linked to skin cancer, the levels of ultraviolet generated by MITI’s pulsed light source is significantly less than that of sunlight, and less than that generated by the FDA-approved “Woods Lights” which is used in conventional open surgery.   

TheraScope will use standard light cables camera systems or light sources to achieve therapeutic intervention.  Because TheraScope is a dynamic system which time-shares (multiplexes) the pathway into the body with wavelengths which conventional endoscopes cannot pass, the instrument must be connected to the VITI 1410 and the PX 1020 Pulsed light source for therapeutic applications. Only the complete MITI multispectral light source system is capable of this performance.

TheraScope will function over the entire optical spectrum from 190 to 1100nm. In addition, the VITI 1410 operates in a dynamic mode by time sharing the light guide pathway into the body.  The technology also requires the use of MITI’s PX 1020 Pulsed Light Source to provide the lightwave energy for performing photo microbial  (also called anti-bacterial therapy), photo fluorescence, photo dynamic, and biofilm therapies.   Laser therapy is also integrated into the TheraScope technology. 

TheraScope products will combine imaging with therapeutic intervention in closed procedures to locate the source of infection and attack it with lightwaves.   The PX 1020 light source is programmed to selectively control the light wave output.  Short light pulses permit time-sharing of both imaging and therapy.  The short duration of the light pulse enables lasers of different optical wavelengths to be used without interfering with imaging or with each other.  This capability occurs in the “Dark Space,” the time from one imaging pulse to the next, is shown in the diagram below.

                                     Multiplexed Therapeutic LightGuide

TheraScope OPPORTUNITIES

                       GASTROINTESTINAL ENDOSCOPE

MITI gastrointestinal endoscopes will be flexible devices 600-800cm in length and 6mm in diameter that will carry therapeutic light waves generated by MITI’s multispectral pulsed light source directly to the site of bacterial infections. These endoscopes will be designed to transit through the esophagus into the stomach to visually locate areas of infection.  They will be “joystick–guided,” and illuminated with ultraviolet lightwaves.  A specially-designed lens will disperse these lightwaves over the broadest area possible to target and destroy H. pylori.  The beam of light will contain sufficient energy density to destroy the infection but not enough energy to damage healthy stomach tissue.

Infected areas will be imaged in tandem with delivery of therapeutic light waves.  A U.S. patent application for this technology is pending.  We expect to seek FDA approval in May, 2008.

                                 COLONOSCOPE

MITI plans to develop a product similar in size to the gastrointestinal therapeutic endoscope for use in the colon area. The colonoscope’s optics will be designed to optimize the circumferential image, and to maintain the same dispersive therapeutic and visible imaging light. This instrument will be able to direct a laser beam to destroy polyps, E. coli infections or other gastrointestinal pathogens. We expect to seek FDA approval in July, 2008.

                 OB/GYN OFFICE-BASED ENDOSCOPE

The OB/GYN office-based endoscope will be a 3mm endoscope with a disposable illuminator, laser channel and therapeutic intervention capability. This endoscope will utilize a clear plastic “balloon” capable of good light transmission to expand the cervix with as little pain as possible. The endoscope would be used, primarily, for ablation of benign uterine conditions—predominantly fibroids and polyps. We expect to seek FDA approval in February, 2008

            THERAPEUTIC ENDOSCOPE FOR BIOFILMS

BioFilms are bacteria-harboring, glue-like slimes that adhere to implanted medical devices or damaged tissue; encase themselves in a hydrated matrix of polysaccharide and protein; and form a slimy, protective film layer that is extremely resistant to antibiotics. This resistance is of particular concern to patients with various types of implants, i.e. cochlear implants, arterial stents, intravascular devices, hip and joint replacements, and urinary catheters, as well as organ transplants. 

MITI plans to design a dedicated therapeutic endoscope that will use ultraviolet wavelengths to kill microbes in biofilms. We expect to seek approvals to conduct clinical testing FDA in November, 2008.