NEW YORK STATE SCIENCE & TECHNOLOGY LAW CENTER AT SYRACUSE UNIVERSITY COLLEGE OF LAW

Research Project for:

Infotonics Inc.

March 31, 2006

The Optical Biopsy Pill

Research Associates
Til Dallavalle
Mike Gussow
Tom Hoehner
Dana Miller
Daniel Tune

Senior Research Associate
Jason Plotkin
Mark Vallone

Director
Professor Theodore Hagelin

Associate Directors
Professor Richard Newman

Professor Jeong Oh
Professor Mark Weldon

© Syracuse University New Technology Law Center

 

Introduction

 The purpose of this report is to provide research and analysis to Infotonics Technology Center (Infotonics) pertaining to a technical overview of optical biopsy pill technology and its effectiveness in diagnosing cancerous and pre-cancerous conditions in the upper digestive tract.  This report begins with a detailed history and background of available optical biopsy pill products, discusses the organizations currently performing research in this area, and analyzes the status of the market for optical biopsy pills.  Next, the report considers several platforms that optical biopsy pills utilize, including, optical imaging, video and chemical bases.  The report evaluates the emerging photonics platform being pioneered by Dr. Robert Alfano and the City University of New York.  Analyzing Dr. Alfano’s patent portfolio in terms of the integral technical characteristics of the photonics platform, this report reviews the underlying science employed by this cancer-detecting technique.  The various methods include: native fluorescent spectroscopy, Raman spectroscopy, spectral wing emission, and the Kubelka-Munk function.  Components necessary to the implementation of optical biopsy pill technology are discussed. 

The report then provides a prospective analysis that addresses issues necessary to the further development and commercialization of optical biopsy pill technologies.  In so doing, the analysis focuses on specifics concerning the mechanics of implementing the optical biopsy pill, as well as examines the perspective from a gastroenterologist in the medical profession.  

 While traditional methods of research were used to analyze this technology, much of the information pertaining to optical biopsy pills, foundational science and subsequent technological fields is more current than most traditional methods can provide.  Much of the research contained in this report is derived from Wikipedia and other internet websites that are not independently verifiable.  In compiling this report, deliberate attempts were made to minimize these risks by finding secondary sources to support the information.     

 

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1 Background of Optical Biopsy Pills

For many years, doctors and others in the study of medical science have grappled with developing less invasive ways of spotting abnormalities within the human body.  In fact, according to the National Museum of Health and Medicine in Washington, D.C., the concept of endoscopy1 (which is derived from the Greek words for “looking inside”) has been around since crude devices were first used in ancient Rome almost two thousand years ago.2  Despite many changes in design since then, the modern concept of endoscopy did not appear until the early 1900s, when doctors first began to look inside the human body by using what amounted to little more than a lighted telescope.3

The main problem with this type of equipment was that these devices were completely rigid.4  No major developments occurred until the 1930s, when “semi-flexible endoscopes called gastroscopes were developed to view inside of the stomach.”5  A major breakthrough in endoscope flexibility arrived in 1957, when an endoscope made with fiber-optic technology was invented by South African-born physician Basil Hirschowitz at the University of Michigan.6  Starting in the 1960s, the use of fiber optic endoscopes became widespread and modifications on the same premise continue to this day.7 

Over time, concerns about the limitations of what could be seen through endoscopy as well as additional fears of damaging the gastrointestinal tract have led the scientific community to consider the development of viable alternatives.8  For years, movies ranging from Fastastic Voyage to Innerspace speculated as to the possibility of using a miniaturized device that could explore inner workings of the human body.9  However by 2001, what was once purely the domain of science fiction became a reality when an Israeli startup company named Given Imaging developed the “the first pill-sized endoscopic capsule with a camera.”10  In recent years, competitors such as Olympus and SmartPill Corp. have emerged to challenge Given and develop enhanced products of their own.11 

This section will provide an overview of organizations that are performing research on optical biopsy-related technology as well as a brief analysis of the existing market for such technology.  In order to demonstrate the benefits of pill-based optical biopsy technology, this section will also discuss a few non-pill products that utilize optical biopsy-related technology.  Finally, this section will also explore the companies that have emerged so far as major players in developing the pill-based optical biopsy technology and descriptions of the pills themselves. 

 

1.1 Organizations Performing Research

As there is a great demand for developing less invasive ways of detecting abnormalities in the human body, it is understandable that there are many diverse research institutions focusing their efforts on optical biopsy-related research.12  The search for modern alternatives to traditional endoscopy has been a global one.13 For example, the Japanese administrative research institution RIKEN has made strides in the area of Raman spectroscopy.14  In addition to Asia, there is a great deal of progress in North American research as well.15  For example, in Canada, the British Columbia Cancer Research Centre has moved forward in its use of optical biopsy-related technology for detection of tissue and organ rejection, while in the United States, the efforts of various universities and national laboratories have made many valuable contributions.16  Amongst these many diverse approaches to optical biopsy-related research, a few interesting examples can be seen in the efforts of three research entities: the Los Alamos National Laboratory in New Mexico, the Massachusetts Institute of Technology and Mediscience Technology Corporation of New Jersey. 

1 National Museum of Health and Medicine, available at http://nmhm.washingtondc.museum/exhibits/gijourney/index.html (last visited Mar. 3, 2006); Wikipedia, available at http://en.wikipedia.org/wiki/Endoscopy (last visited Mar. 3, 2006).
2 National Museum of Health and Medicine, available at http://nmhm.washingtondc.museum/exhibits/gijourney/index.html (last visited Mar. 3, 2006); Wikipedia, available at http://en.wikipedia.org/wiki/Endoscopy (last visited Mar. 3, 2006).
3 Imaginis Medical Procedures, available at http://imaginis.com/endoscopy/#history (last visited Mar. 3, 2006).
4 Id.  
5 Id.
6 Id.
7 Id.
8 Andrew Romano, A ‘Fantastic Voyage’ Into Your GI Tract, Newsweek (Feb. 20, 2006).
9 Steve Ditlea, Fantastic Voyage, New York Daily News (Jul. 26, 2005).
10 Andrew Romano, A ‘Fantastic Voyage’ Into Your GI Tract, Newsweek (Feb. 20, 2006); Wikipedia, available at http://en.wikipedia.org/wiki/Endoscopy (last visited Mar. 3, 2006).
11 Semiconductor Evening News, available at http://www.perfectdisplay.com/id532.html (last visited Mar. 4, 2006).
12 Andrew Romano, A ‘Fantastic Voyage’ Into Your GI Tract, Newsweek (Feb. 20, 2006); 
eMediaWire, available at http://www.emediawire.com/releases/2004/12/prweb184861.htm (last visited Mar. 17, 2006).
13 Vancouver Enterprise Forum, available at http://www.vef.org/web/EventDetails.asp?ProductID=79 (last visited Mar. 17, 2006); eMediaWire, available at http://www.emediawire.com/releases/2004/12/prweb184861.htm (last visited Mar. 17, 2006).
14 RIKEN Optical Biopsy Development Research Unit, available at  http://www.riken.go.jp/engn/index.html . (last visited Mar. 17, 2006).
15 RIKEN Optical Biopsy Development Research Unit, available at http://www.riken.go.jp/engn/index.html; Vancouver Enterprise Forum, available at http://www.vef.org/web/EventDetails.asp?ProductID=79 (last visited Mar. 17, 2006); eMediaWire, available at http://www.emediawire.com/releases/2004/12/prweb184861.htm (last visited Mar. 17, 2006).

 

Los Alamos National Laboratory

 The Los Alamos National Laboratory (Los Alamos), located in northern New Mexico, is an integral part of the United States Department of Energy's laboratory and technological research centers.17  In fact, according to its website it is “one of the largest multidisciplinary science institutions in the world.”18  Los Alamos’ efforts are overseen by the University of California and is the “largest institution in Northern New Mexico with more than 8,300 University of California employees plus approximately 3,000 contractor personnel.”19  Befitting its size, Los Alamos’ budget is also quite large, with an annual budget of approximately $2.2 billion.20  While research related to national security has always been an important role for Los Alamos, Los Alamos has branched out over the years to include 47 separate technical areas.21 

 

16 RIKEN Optical Biopsy Development Research Unit, available at http://www.riken.go.jp/engn/index.html; Vancouver Enterprise Forum, available at http://www.vef.org/web/EventDetails.asp?ProductID=79 (last visited Mar. 17, 2006); eMediaWire, available at http://www.emediawire.com/releases/2004/12/prweb184861.htm (last visited Mar. 17, 2006).
17 US Department of Energy, available at http://www.doe.gov/organization/labs-techcenters.htm (last visited Mar. 17, 2006); Los Alamos’ origins can be traced back to America’s involvement in World War II, when in 1943 the Los Alamos Laboratory was established to support Project Y, a top secret plan to develop and construct an atomic bomb. Los Alamos Laboratory History, available at http://www.lanl.gov/history/overview.shtml (last visited Mar. 17, 2006).
18 Los Alamos Laboratory Organization, available at http://www.lanl.gov/organization (last visited Mar. 17, 2006); Under the guidance of scientists such as J. Robert Oppenheimer and military strategists such as General Leslie R. Groves, the Los Alamos lab was able to develop the first atomic bomb, which was successfully detonated at the Alamogordo bombing range on July 16, 1945. Los Alamos Laboratory History, available at http://www.lanl.gov/history/overview.shtml (last visited Mar. 17, 2006); Nuclear weapons development and testing continued at Los Alamos until 1992, when treaties such as SALT and START led to a halt in nuclear testing and an increase in monitoring the safety of the existing nuclear stockpile in the United States. Los Alamos Laboratory, H Bomb On, available at http://www.lanl.gov/history/hbombon/index.shtml (last visited Mar. 17, 2006).
19 Los Alamos Laboratory Organization, available at http://www.lanl.gov/organization (last visited Mar. 17, 2006).
20 Id.
21 Id.

 

One promising area is biotechnology, where research on optical biopsy technology has been going on since the 1990s.22  For example, in 1994, Los Alamos researcher Judith Mourant was the winner of an R&D 100 Award for her work in developing an Optical Biopsy System (OBS), which consisted of a “noninvasive fiber-optic and spectroscopy system” used to help diagnose cancer.23  According to those who have worked on OBS, the system works through the use of a:

real-time probe based on white-light interaction with tissue, which can be used either through an endoscope or a biopsy needle.  The system consists of small

optical fibers that shine tiny bursts of light onto tissue and then collect the scattered light traveling through the tissue. A computer then analyzes the scattered light.  OBS technology works because cancerous tissue scatters and absorbs light differently than normal tissue. A computer uses artificial intelligence and pattern recognition codes to analyze the scattered light spectra and discern the spectra of normal tissue from diseased tissue.24

The use of OBS with breast cancer patients has proved particularly helpful, since the consistency of breast tissue can vary greatly between individuals.25  As a result of the tissue differences, properly diagnosing abnormalities in breast tissue due to cancerous growth can be extremely challenging.26  OBS’ results when compared to standard pathology seems to be quite promising, as clinical studies undertaken by partners of Los Alamos in the United Kingdom have shown that data generated by OBS concurs with the standard pathology more than 80 percent of the time.27  The quality of OBS is typically measured on the sensitivity of OBS’ aptitude in finding cancer as well as its ability to be precise enough to be able to tell whether the tissue it is analyzing is either cancerous or healthy.28  In addition to detecting cancerous tissue, there are also hopes that by understanding how different types of tissue impact the scattering of light, OBS can actually serve to predict whether cancerous tissue will ultimately appear in a patient.29  This is based on the premise that since light scatters differently depending on the properties of the tissue it is illuminating, there is a high likelihood that if a tissue began to change shape, the scattering of light would change as well.30  

22 LANL News and Public Affairs, Los Alamos researcher wins award from Biophysical Society, (Feb. 2, 1999).
23 Id.
24 US Department of Energy News, Optical Biopsy Studied as Breast Cancer Treatment Aid, Eureka Alert, available at http://www.eurekalert.org/features/doe/2001-06/danl-obs061302.php, (Jun. 16, 2002).
25 Id.
26 Id.
27 Id.
28 Id.
29 US Department of Energy News, Optical Biopsy Studied as Breast Cancer Treatment Aid, Eureka Alert, available at http://www.eurekalert.org/features/doe/2001-06/danl-obs061302.php, (Jun. 16, 2002).

 

The development of OBS appears to be a significant development in the fight against cancer.  In fact, the technology has matured to the point Los Alamos has been able to license the technology for clinical applications.31  

Massachusetts Institute of Technology

 Another major contributor to optical biopsy-related research is the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts.32  MIT’s major involvement in optical biopsy-related technology is in its development of a laser-based technology known as optical coherence tomography (OCT).33  OCT is a non-invasive procedure that can identify nascent signs of cancer or heart disease.34  OCT uses infrared light to magnify body tissues and allow physicians to look at individual cells in the tissue without damaging it.35  OCT uses fiber optics and infrared light waves which, when reflected against human tissue from various angles, are able to display an image of the tissue.36  The infrared light is reflected against the tissue by either endoscopy or catheter, which can be used nearly anywhere in a patient’s body.37 The primary benefit of OCT is its resolution is vastly superior to traditional methods.38  OCT resolution has been found to be at least 10 times clearer than MRIs and ultrasound.39

30 Id.

31 LANL News and Public Affairs, Los Alamos researcher wins award from Biophysical Society, (Feb. 2, 1999).

32 Founded by charter in 1861 largely due to the efforts of its first president William Barton Rogers, MIT did not open for classes until 1865, due to the Civil War.  While MIT grew steadily over the years, its reputation grew significantly in the years leading to and following World War II.  This was largely due to the United States government’s utilizing MIT's researching capabilities by providing funding to MIT to support various national security projects.  MIT consists today of five schools and one college, which together consist of 34 academic departments, divisions, and degree-granting programs.  Among numerous other accolades, MIT has also produced an amazing total of 61 Nobel Prize winners.  Wikipedia, available at http://en.wikipedia.org/wiki/Massachusetts_Institute_of_Technology (last visited Mar. 18, 2005).

33 Massachusetts General Hospital, Optical Technique Allows Non-Surgical Biopsies, available at http://www.massgeneral.org/pubaffairs/releases/june_97_nonsurgical_biopsies.htm (Jun. 27, 1997); Laser Medicine and Medical Imaging Group, available at   http://www.rle.mit.edu/rleonline/research/LaserMedicineandMedicalImagingGroup.html (last visited Mar. 18, 2006).

34 Massachusetts General Hospital, Optical Technique Allows Non-Surgical Biopsies, available at http://www.massgeneral.org/pubaffairs/releases/june_97_nonsurgical_biopsies.htm (Jun. 27, 1997).

35 Id.

36 Id.

37 Id.

 

 Development of OCT began back in 1991, when OCT was developed as a partnership between MIT and the New England Eye Center.40  At that time, OCT was used to provide images of the retina in order to produce a more accurate diagnosis for diseases such as glaucoma and macular edema.41  In 1994, OCT technology made additional progress when OCT imaging was improved so it could be used for optical biopsies in nontransparent tissue.42  This development was significant, as most body tissue consists of nontransparent tissue.43  By allowing nontransparent tissue to be viewed via OCT, the door was now opened to advancements in many types of clinical applications.44  For example, OCT could supplant traditional invasive biopsy where typical means were too risky for patients.45  It could also be used as a means of early diagnosis of cancer, as traditional biopsies may not be able to detect cancers as quickly as OCT.46  Lastly, OCT could be used as a way to assist surgery by allowing surgeons to be more accurate when working on minute details such as nerve tissue or small glands.47

 Today OCT technology serves as a key part of current medical technology, but is also an important part of the future of medical science.48 Since its original development in the 1990s, OCT is used commercially in several countries as a means of detecting eye disease.49 Over the last couple of years, however, OCT technology is being looked at as a way of identifying unstable arterial plaques that could float off into the bloodstream and cause clots.50  MIT research groups under Robert Huber and James Fujimoto explain the process as:

38 Id.
39 Massachusetts General Hospital, Optical Technique Allows Non-Surgical Biopsies, available at http://www.massgeneral.org/pubaffairs/releases/june_97_nonsurgical_biopsies.htm (Jun. 27, 1997).
40 Id.
41 Id.
42 Id.
43 Id.
44 Massachusetts General Hospital, Optical Technique Allows Non-Surgical Biopsies, available at http://www.massgeneral.org/pubaffairs/releases/june_97_nonsurgical_biopsies.htm (Jun. 27, 1997).
45 Id.
46 Id.
47 Id.
48 Neil Savage, Optical Biopsy, Technology Review, available at http://www.technologyreview.com/BioTech/wtr_16450,306,p1.html (Mar./Apr. 2006).
49 Id.

 

using a laser whose light frequency can be tuned extremely rapidly to enhance imaging speed. To allow faster tuning, the researchers built a laser with a coil of optical fiber several kilometers long. The round-trip time of the light in the coil precisely matches the time between frequency adjustments, so the beams provide a ready supply of photons for each adjustment, eliminating the delays normally required to build up enough photons at a new frequency. The technology can scan three centimeters of artery in just 2.5 seconds, at a high enough resolution to diagnose plaques and distinguish cancerous cells from normal ones.51

The experimental OCT technology Huber and Fujimoto discussed looks to become a reality within a few short years, as a spinoff company of MIT known as LightLabs Imaging is currently working on a prototype with a goal of entering clinical trials sometime before 2008.52

Mediscience Technology Corporation

 A third major contributor to optical biopsy-related research is the Mediscience Technology Corporation of Cherry Hill, New Jersey (Mediscience).53  Mediscience is a partner of Infotonics, and as a result merits additional attention.54  Mediscience began its modern existence in 1971, when Cardiac Techniques, Inc. purchased Mediscience Technology Corp. and changed its name to Mediscience.55  Mediscience’s next significant move came in 1988, when it sought to expand its area of expertise by acquiring Laser Diagnostics Instruments (LDI).56  Mediscience’s interest in LDI stemmed largely from LDI’s ownership of a patent application from Dr. Robert Alfano that was titled “Method and Apparatus for Detecting Cancerous Tissue Using Visible Luminescence.”57  Ultimately, the application became a granted patent (the "516 patent") in 1990.58  After the LDI purchase, Mediscience then formed a “long-term research relationship” with both the City University of New York as well as Dr. Alfano.59

50 Id.

51 Id.

52 Id.

53 Mediscience Company History, available at http://www.medisciencetech.com/CompanyHistory.aspx (last visited Mar. 18, 2006).

54 Id.

55 Mediscience Technology Corp., Registration Statement Under the Securities Act of 1933 (Form SB-2), (Dec. 21, 2004).

56 Mediscience Company History, available at http://www.medisciencetech.com/CompanyHistory.aspx (last visited Mar. 18, 2006).

 

Mediscience made additional strides towards its goal of finding new technologies to detect cancer, as the research relationship resulted in “over 30 patents in the areas of tissue spectroscopy and optical imaging with applications in cancer detection.”60  

 In recent years, Mediscience has made further inroads into its goal of developing products that are capable of spotting cancer early through its research on Stokes Shift Emission Spectroscopy, its work on a CD-Ratiometer instrument, and as recently as 2004, its agreement with Infotonics to jointly develop a "compact phototonic explorer" or “pill camera” for both medical and non-medical applications.61

Mediscience’s major area of research in optical biopsy-related technology is in its research relating to the utilization of native tissue fluorescence spectroscopy for in vivo cancer detection.62  The potential for using spectroscopy in this manner was discovered by Dr. Alfano in the early 1980s.63  Using fluorescence spectroscopy allows for the possibility of diagnosing human tissue without having to excise the tissue from the patient.  According to Mediscience, the methodologies they have developed through their research provide “the foundations for optical biopsy by developing technology based on UV-visible fluorescence, excitation, Raman, time-resolved, diffuse reflectance, and most recently, Stokes shift spectroscopies.”64  The ultimate goal of optical biopsy is determine whether “a tissue is malignant, dysplastic [pre-cancer] or benign; in addition to whether it is invasive cancer.”65  Mediscience has indicated that the use of fluorescence leaves a different “signature” depending on whether it is used on normal or cancerous tissue.  That signature, in turn, can be converted into an “[algorithm that can] distinguish malignant tissue from normal tissue.

57 Mediscience Technology Corp., Registration Statement Under the Securities Act of 1933 (Form SB-2), (Dec. 21, 2004); Mediscience Company History, available at http://www.medisciencetech.com/CompanyHistory.aspx (last visited Mar. 18, 2006).

58 Mediscience Technology Corp., Registration Statement Under the Securities Act of 1933 (Form SB-2), (Dec. 21, 2004).

59 Mediscience Company History, available at http://www.medisciencetech.com/CompanyHistory.aspx (last visited Mar. 18, 2006).

60 Id.

61 Id.

62 Mediscience Technology Corp., Registration Statement Under the Securities Act of 1933 (Form SB-2), (Dec. 21, 2004).

63 Id.

64 Id.

65 Id.

 

Mediscience believes its work in optical biopsy carries several benefits over alternative approaches.67  It feels that its methods are less invasive than traditional surgical biopsies, as no tissue is excised from the body.  In addition, results are instantaneous rather than having a significant time delay, it is more sensitive to change, and possibly more accurate than other methods. 

1.2 Market

The market for optical biopsy-related products is intertwined with the impact of cancer on society and the benefits incurred through early detection via various medical devices.  This section will address cancer’s grim impact on our health care system as well as briefly describe the market of endoscopy and camera pill-related products.

 

 

Impact of Cancer

 

The word “cancer” induces an intense fear in most people.  The statistics are particularly alarming.  The National Institute of Health reports that cancer is responsible for one out of every four deaths in the United States; only heart disease takes more lives.68  In fact, 556,902 people in the United States died of the disease in 2003.69  The financial costs of cancer are also unsettling, as it has been reported that in 2005, the “direct medical costs of cancer care totaled $74 billion, while lost productivity and other effects added an additional $136 billion.”70  As it relates to optical biopsy pills, of particular concern is the impact of esophageal and stomach cancer.  

66 Id.

67Mediscience Technology Corp., Registration Statement Under the Securities Act of 1933 (Form SB-2), (Dec. 21, 2004).

68 Thomas H. Maugh II, A First: Cancer Deaths Decline, San Jose Mercury News (Feb. 9, 2006).

69 Id.

70 Id.

 

According to the American Cancer Society (ACS), this year the number of new esophageal cancer cases in the United States will reach around 14,550 people.71  In addition, it is estimated that the number of deaths this year from esophageal cancer will reach 13,770.72  Because esophageal cancer is usually diagnosed at a late stage, most people with esophageal cancer eventually die of this disease.  Esophageal cancer is also particularly dangerous to males, particularly males of African-American descent.73  For example, the ACS’ statistics claim that esophageal cancer strikes men three to four times more than it does women and approximately 50% more to African Americans than Caucasians.74  However, the rate of esophageal cancer in white men has been increasing at a 2% rate per year.75 Also disturbing is the survival rate for esophageal cancer.76  Unfortunately, there are currently no methods or tests for screening people for esophageal cancer.  As a result, people are generally diagnosed too late and the vast majority of people die from the disease.77  However, since the 1960s there have been signs of improvement, as current studies show that “16% of white patients and 9% of African American patients survive at least 5 years after diagnosis.”78  This improvement is due particularly to technological improvements that better allow doctors to identify high-risk patients, in particular those with Barrett’s esophagus and similar abnormalities found in the esophagus.79

As for stomach cancer, the numbers are also disturbing.  The ACS reports that in the United States in 2006, approximately 22,280 new cases of stomach cancer will be diagnosed.80 Of that number, approximately half (11,430 people) will die.81  Stomach cancer appears to be a greater risk for older people as 66% of people diagnosed with stomach cancer are over 65 years old.82  As for early detection, while stomach cancer can be screened and caught early, diagnosis is made difficult due to stomach cancer’s tendency to share symptoms with a variety of other illnesses and conditions.83  On a more positive note, the incidence of stomach cancer has decreased considerably in the United States and is no longer one of the leading causes of cancer deaths in this country.84  While there are many theories for this, many believe this could be due to improved methods of food storage and decreased use of salted and smoked foods.85

71Detailed Guide: Esophagus Cancer, available at http://www.cancer.org/docroot/cri/content/
cri_2_4_1x_what_are_the_key_statistics_for_esophagus_cancer_12.asp (last viewed on Mar. 30, 2006).

72 Id.
73 Id.
74 Id.
75 Id.
76Detailed Guide: Esophagus Cancer, available at http://www.cancer.org/docroot/cri/content/cri_2_4_1x_what_are_the_key_statistics_for_esophagus_cancer_12.asp (last viewed on Mar. 30, 2006).

77 Id.
''> 78 Id.
''> 79 Id.

80Overview: Stomach Cancer, available at: http://www.cancer.org/docroot/CRI/content/
CRI_2_2_3X_How_is_stomach_cancer_found_40.asp?rnav=cri (last viewed on Mar. 30, 2006). 

 

However, there is hope for those afflicted with cancer.  The 2003 cancer statistics show a slight drop in the number of cancer deaths, a statistical first since the government started keeping such statistics back in 1930.86  The downturn is due largely to a combination of fewer people taking up smoking, although early detection and improved medical technology is also important.87  In addition, in large part to early screening, today more people are surviving cancer than ever before.88  In fact, according to the National Cancer Institute there is an estimated “10.1 million living Americans who have had cancer.”89  

Besides saving lives, early screening and detection of cancer can also save a great deal of money.90  The CDC reports that health economists are in general agreement that it is cost effective to save a life if illness is detected early enough, thus saving money that otherwise would have gone towards intense treatment or surgery.91  In fact, the CDC estimates that screening for some types of cancer can save anywhere between 25-75% per patient for each year of life saved.92  These savings could truly make a difference in the long term.

81Overview: Stomach Cancer, available at: http://www.cancer.org/docroot/CRI/content/CRI_2_2_3X_How_is_stomach_cancer_found_40.asp?rnav=cri
(last viewed on Mar. 30, 2006). 

82 Id. 

83 Id.

84 Id.

85 Id.

86 Thomas H. Maugh II, A First: Cancer Deaths Decline, San Jose Mercury News (Feb. 9, 2006).

87 Id., see also  Center for Disease Control and Prevention available at  http://www.cdc.gov/nccdphp/publications/factsheets/Prevention/cancer.htm (last viewed on Mar. 22, 2006).

88 Thomas H. Maugh II, A First: Cancer Deaths Decline, San Jose Mercury News (Feb. 9, 2006).

89 Id.  

90 Center for Disease Control and Prevention available at  http://www.cdc.gov/nccdphp/publications/factsheets/Prevention/cancer.htm (last viewed on Mar. 22, 2006).

91 Id.

 

Endoscopy/Camera Pill Market

While the cost of cancer is startling, the cost of the United States health care industry is simply massive.  In 2004, a whopping 16% ($1.9 billion) of the GDP of the United States was spent on health care, a figure that no other country comes close to achieving.93  Within that market is the endoscope manufacturing market, which is currently dominated by Olympus Optical LTD.94According to statistics from fiscal year 2005, Olympus has a seventy percent share of the world’s gastrointestinal endoscope market, with sales amounting to $1.34 billion.95  The potential for profits has led to competition in the relatively new arena of capsule endoscopy, or “camera pills”.96  According to the Millennium Research Group, camera pills are estimated to create over $180 million in revenues in the United States by 2009. 97  This is a marked increase from recent years, when camera pills generated around $40 million in 2004.98  This growth is expected largely due to the relative ease of swallowing a pill as opposed to the traditional method of endoscopy, which involves some form of anesthesia and the use of a flexible tube which contained a light and a camera to access the upper GI tract and report data to the doctor.99  The issue is best summed up by Given Imaging CEO Gavriel Meron, who stated “We responded to a very basic need…people don’t want to be scoped”.100  In sum, the market for capsule endoscopy, while still not far removed from its infancy, promises to be a highly competitive market in the years ahead.

 

92 Id.

93 The Economist, Desperate Measures, available at http://www.economist.com/world/displaystory.cfm?story_id=5436968 (Jan. 26, 2006).

94 Staff, Ruling the Endoscopy Market, Red Herring, (Feb. 20, 2006).

95 Id.

96 Id.

97 Id.

98 Id.

99 Staff, Ruling the Endoscopy Market, Red Herring, (Feb. 20, 2006).

100 Id.

 

                   1.3 Companies Involved and Their Respective Products

 

One of the most recent developments in the evolution of optical biopsy-related technology is the shift from endoscopy-based medical imaging to medical imaging achieved through a form of “camera pill.”  The use of a camera pill can provide several advantages over traditional endoscopy.101  A pill can cause less anxiety in patients than the use of tubes.102  In addition, it can be more accurate, can explore more areas than traditional endoscopy, and can be easier to use.103

This section will focus on three of the companies that are at the forefront of developing and enhancing pill camera technology: Given Imaging of Yokneam, Israel, Olympus Optical LTD of Tokyo, Japan, and SmartPill Corp of Buffalo, NY.  This section will explore the backgrounds of these three companies as well as discuss their pill camera products.

1.3.1 Given Imaging

 

Given Imaging (Given) was founded in 1998 by Gavriel D. Meron, who is still both the President and the CEO of the company.104  Established under Israeli law as a start-up company, Given stated that its primary goal was to create “patient-friendly” imaging equipment for use in gastrointestinal diagnosis.105  Its headquarters are in a 25,000 square foot facility in Yokneam, Israel, which is a fast growing high-tech “industrial park” located between Tel Aviv and Haifa in the northern part of Israel.106  Given also has a North American headquarters in Atlanta, as well as a European headquarters in Hamburg, Germany.107  Given’s main product since 2001 is its “Given Diagnostic System” which consists of three major components.108  The first component is the PillCam™ Capsule Endoscope, which is described by Given as a non-reuseable capsule that is capable of transmitting color images.109  The second component is the Given DataRecorder, which is a recording device that receives signals from the PillCam through various sensors and is worn by the patient on his or her belt.110  The DataRecorder gives patients the ability to move around freely during the examination of their gastrointestinal tract. The third and final component is the RAPID™ Workstation, which uses Given Imaging's RAPID (Reporting and Processing of Images and Data) Application Software.111  The purpose of RAPID is to process collected data and translate it into a video image of the small intestine.112  The RAPID Workstation allows doctors to look at, alter, save, or e-mail the video, as well as save snapshots of the video or small video clips.113  According to Given, the Given Diagnostic system is marketed in the United States as well as sixty other countries.114

 

 

 

Figure 1.3.1a: The Given Diagnostic System

 

While Given Imaging is a young company, it is also a rapidly growing company.  In 2005, Given generated $86.8 million in sales, a 33.5% increase over the previous year.115  Given also experienced an impressive 117% income growth over its 2004 growth.116  In addition to financial growth , Given is also growing its employee base, having hired 21.6% more employees over the previous year.117Currently, Given’s has a total of 282 employees.118
 

101 N.N.Sachitanand, Painless GI, available at http://www.deccanherald.com/deccanherald/oct42005/snt152272005103.asp (Oct. 4, 2005).
102 Id.
103 Id.
104 Given Imaging: About Us available at http://www.givenimaging.com/Cultures/en-US/Given/English/About/CorporateOverview/default.htm (last viewed on Mar. 22, 2006).
105 Id.
106 Id.; Photonics, available at http://www.photonics.com/todaysheadlines/article.asp?id=822 (Jul. 6, 2000).
107 Given Imaging: About Us available at http://www.givenimaging.com/Cultures/en-US/Given/English/About/CorporateOverview/default.htm (last viewed on Mar. 22, 2006).

108 Id.

109 Id.

110 Id.

111 Id.

112 Given Imaging: About Us available at http://www.givenimaging.com/Cultures/en-US/Given/English/About/CorporateOverview/default.htm (last viewed on Mar. 22, 2006).

113 Id.

114 Id.

 

PillCam

As mentioned earlier, the PillCam is at the heart of Given’s product line.  PillCam is the earliest entrant into the “camera pill” market, having been introduced in 2001.119  The PillCam, which costs approximately $450 per pill, enters the body orally and can be taken with water the same way an ordinary pill is taken.120  In order for images to be visible, the patient is asked to fast for ten hours before taking the pill.121  Unlike a traditional pill, however, the camera inside the PillCam is capable of taking up “50,000 pictures as it moves through the gastrointestinal tract and the small bowel.”122  As it takes pictures throughout the body, the PillCam transmits the images it takes to the Given DataRecorder, then transfers the image to the RAPID™ Workstation computer screen so physicians can study the image.123  As opposed to traditional endoscopy, which could only see up to two meters of the GI tract from either end, PillCam allows the entire tract to be visible.124  The PillCam is not self-propelled; it moves via the natural contractions of the gastrointestinal tract and typically takes approximately eight hours before the disposable capsule is egested.125 

 In order to get a lead on its competitors, Given has taken the approach of producing variations on its PillCam product.  In 2004, for example, Given teamed up with Johnson & Johnson and produced an esophageal capsule that focused on problems related to chronic heartburn.126  In the next few years, Given also plans on creating a PillCam capable of viewing the entire digestive tract, as well as one that is designed for the colon and one that is tailored to work in the stomach.127

115 Staff, Given Imaging, Hoover's Basic Company Records, (Feb. 15, 2006).

116 Id.

117 Id.

118 Id.

119 Andrew Romano, A ‘Fantastic Voyage’ Into Your GI Tract, Newsweek (Feb. 20, 2006).

120 Id., see also Rohan Wade, “Vital body journey for hi-tech 'pill'”, Hobart Mercury (Australia) (Jul. 29, 2005).

121 Andrew Romano, A ‘Fantastic Voyage’ Into Your GI Tract, Newsweek (Feb. 20, 2006); Rohan Wade, “Vital body journey for hi-tech 'pill'”, Hobart Mercury (Australia) (Jul. 29, 2005).

122 Rohan Wade, “Vital Body Journey for Hi-Tech ‘Pill', Hobart Mercury (Australia) (Jul. 29, 2005).

123 Id.

124 Id.

125 Leslie Goldman, Swallow and Say Cheese; Camera in Pill Form Goes Down Easily to Check Esophagus, Chicago Tribune (Aug. 28, 2005).

 

 

 

 

Figure 1.3.1b: PillCam by Given Imaging

                        1.3.2 Olympus Optical LTD

 

In sharp contrast to the recent establishment and subsequent growth of Given Imaging, Olympus Optical LTD (Olympus) has a long history, having been originally established in 1919.128  While Olympus is the number one producer of medical endoscopy equipment in the world, when combined with its other products Olympus produces $7.5 billion dollars in sales and employs 30,339 employees worldwide.129

 

 

EndoCapsule 

 

 Olympus’ entry into the camera pill market is the EndoCapsule, which has been available in Europe since October and is being sold at a cost of $730.130  Unlike Given’s PillCam, the EndoCapsule has not been approved by the FDA.131  It is expected, however, that the EndoCapsule will be introduced to the United States in May of 2006.132  Little is known about how the product is faring, as only 700 people have actually taken the pill.133 

126 Andrew Romano, A ‘Fantastic Voyage’ Into Your GI Tract, Newsweek (Feb. 20, 2006).

127 Id.

128 Olympus History, available at http://www.olympus.co.jp/en/corc/history/chron/index.cfm?ote=1 (last viewed on Mar. 24, 2006).

129 Staff, Olympus Corporation, Hoover's Basic Company Records, (Jan. 4, 2006); Staff, Ruling the Endoscopy Market, Red Herring, (Feb. 20, 2006).

130 Andrew Romano, A ‘Fantastic Voyage’ Into Your GI Tract, Newsweek (Feb. 20, 2006).

131 Id.
132 Id.

133 Id.

 According to Olympus, the primary benefit of its EndoCapsule is that as the leading producer of endoscopes in the world, it is best capable of translating its successful endoscope technology into a capsule endoscope.134  For example, features such as automatic brightness control and high-resolution CCD imaging technology       have been adapted to the EndoCapsule from prior Olympus endoscope technology.135  Besides its experience in endoscopy, Olympus is also touting what it views to be as technical benefits.136  Olympus states that the EndoCapsule provides the world’s first real-time observation capability, which it believes will provide a more useful and consistent examination.137  Real time capability is achieved through what Olympus has termed a “Real Time Viewer,” which is a handheld display that reflects real time images produced by the EndoCapsule while inside the patient.138  The EndoCapsule transmits via a “built-in capsule antenna,” which is capable of transmitting to the data recorder at a rate of two images per second.139  The images that are recorded are capable of being obtained for up to eight hours.140  The EndoCapsule also provides a means for medical practitioners to determine if the pill is working properly before the pill is swallowed, whereas in older versions it apparently could not be determined that a pill was “a dud” until after it was swallowed.141  In addition to real time capability, Olympus feels that the EndoCapsule is also enhanced by its small size [11mm in diameter, 26mm length] and a relatively wide depth of field at 0-22mm.142  Until EndoCapsule is widely released, however, it is difficult to predict its prospects for success.  

 

134 News Release: Olympus Launches High-resolution Capsule Endoscope in Europe,available at http://www.olympus.co.jp/en/news/2005b/nr051013capsle.cfm, (last viewed Mar. 29, 2006).

135 Id.

136 Id.

137 Id.

138 Id.

139 News Release: Olympus Launches High-resolution Capsule Endoscope in Europe,available at http://www.olympus.co.jp/en/news/2005b/nr051013capsle.cfm, (last viewed Mar. 29, 2006).

140 Id.

141 Id.

142 Id.

 

 

Figure 1.3.2: EndoCapsule by Olympus

 

 

 

                        1.3.3 SmartPill Corporation