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Past Profile

eBlast
Xcorporeal, Inc. (AMEX: XCR)
May 29th, 2008.

 
 Xcorporeal Inc., (AMEX: XCR)

Dear Reader,

At StockUpTicks we’re unabashed in our affinity for health care related small cap stories. As always, we focus on demand driven industries where the market segment is growing as it is in health care where baby boomers are increasing the class of consumers at an unprecedented rate.

Today, we’re fortunate to have the opportunity to offer for review a public company attempting to dramatically change the lives of kidney (renal) dialysis patients. From our view, this appears to be one of those Better Mousetrap stories we search for, a business model that could become popular based on need and superior technology.

If you know anything of dialysis or have known a dialysis patient, then you’ve probably come to the same conclusion we have- that this is a vast market in need of innovation. Take a look at today’s comprehensive profile and see if you think this emergent company could be the source of that innovation.


Looking to "Clean Up" the Dialysis Space;
Roth Capital Partners 
Initiating Coverage
May 27, 2008


ROTH Capital Partners is a full service investment banking firm dedicated to the small and micro-cap market. The firm is privately owned with current principals being majority owners. The core management team has been consistent for many years. Since the inception of the firm in 1984 ROTH has been a leader and innovator in the small and micro cap markets. ROTH's exclusive focus has been, is, and will continue to offer a full spectrum of investment banking services, including raising capital, research coverage, trading and market making, merger and acquisition advisory services, and investor conferences. 


View Roth Capital Partners' May 2008 Research Report on Xcorporeal Inc. HERE 

 
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    About Xcorporeal
Xcorporeal ("XCR") is focused on the development and commercialization of renal replacement products that will satisfy an unmet need for small, light-weight, portable and easy to use devices. XCR devices remove unwanted chemicals, toxins and excess fluids from the blood, thus replacing many of the essential functions of the damaged kidney. These devices have the potential to achieve superior mass transfer and improve solute clearance despite significant reductions in the weight, size, and fluid and energy consumption of the device. 

Xcorporeal, Inc. is a medical device company developing an innovative extracorporeal platform technology that may be used in devices to replace the function of various human organs. The platform will lead to three initial products; a device for home hemodialysis, a device for hospital Renal Replacement Therapy (RRT), and the Wearable Artificial Kidney (WAK) for continuous ambulatory hemodialysis.

Xcorporeal is developing three devices that are designed to provide intermittent or continuous renal replacement therapy for patients with malfunctioning kidneys. The first product is designed to provide either hemodialysis or hemofiltration to hospitalized patients with acute renal failure. The second device is a truly portable hemodialysis machine that provides home therapy to patients with ESRD. The final device will be the wearable artificial kidney (WAK), an innovation that will revolutionize the delivery of ESRD care. 

These devices could radically improve the quality of life led by dialysis patients. The RRT markets represent multibillion dollar opportunities. For the RRT market, Xcorporeal is developing a portable, multifunctional renal replacement device that will offer cost effective therapy for patients suffering from Acute Renal Failure (ARF) which causes a rapid decline in kidney function. In the U.S., ARF affects more than 200,000 patients annually, with a mortality rate of 50%. 

The platform is being adapted into a wearable artificial kidney that can provide patients with cost effective, continuous (as opposed to intermittent) therapy and allow them to achieve a quality of life closer to that of a healthy individual.

There were approximately 350,000 patients with end stage renal disease (ESRD) in the United States at the end of 2006 and the population is estimated to be growing approximately 6% annually. In the US, kidney disease has become the ninth leading cause of death and one of the most expensive chronic diseases, with treatment costs approaching $30 billion annually

Xcorporeal has developed an innovative extra-corporeal platform that has been adapted to solve health issues related to kidney failure in both the hospital (acute) and home (chronic) settings. 

QUALITY OF LIFE
Any company can make a machine.

But the management, advisors and engineers at XCR are driven by the needs of a growing population that have become restricted in their treatment options and have found the quality of their life constrained and expensive. XCR's unified sense of compassion for those suffering from chronic illness is a powerful tool in bringing their technology platform to market.


What Is Renal Failure ?

Renal failure is the loss of kidney function that leads to the accumulation of excessive water and toxic metabolic waste. It can occur acutely where the potential for some degree of recovery may exist or it may be progressive and permanent, leading to end stage renal disease (ESRD). With the loss of kidney function, the blood pressure rises, and red blood cell production decreases dramatically. 

When this sequence of events occurs, renal replacement therapy is needed in order to replicate the function of the normal kidneys to sustain life. The most common renal replacement therapy in the United States is hemodialysis. XCR is combining our potentially superior filtration technology with the best attributes of currently marketed hemodialysis machines to create a product that will offer a convenient, durable, cost-effective, and portable device for the hospital and home hemodialysis markets. 

The XCR Goal

The ultimate goal at XCR is to develop and commercialize a wearable artificial kidney that will allow patients to undergo dialysis 24 hours a day/7 days per week, thereby mimicking the normal kidney.

This revolutionary device will be cost effective, fully automated, battery operated, 
light weight, easy to use, and waterproof. Continuous and unobtrusive dialysis will
provide patients with tremendous health benefits while not impeding upon their lifestyle
or restricting their diet.

Most importantly, Xcorporeal’s device is expected to notably lower patient morbidity and mortality. This, in turn, will dramatically lower expenditures related to the hospitalization and treatment of ESRD related complications.
 
    The Market

The projected 2008 market opportunities for the US, EU and Asia are $1.5 billion, $1.2 billion and $800 million, respectively. The disposable market is expected to grow at 10% per year while the devices need to be replaced every five years. The prevalence of ARF in the US was 200,000 patients in 2005. In Europe, 124,000 patients developed ARF in 2004

Each of these markets represents a significant opportunity
XCR management believes that its products will enable Xcorporeal
to garner a significant share within each of these markets

The prevalence is increasing at a rate of 10% per year due to an aging population and the increasing severity of illness of hospitalized patients. Most patients with ARF require at least short-term renal replacement therapy.

Currently, intermittent dialysis is the predominant treatment for ARF despite growing research demonstrating the benefits of continuous dialysis over intermittent dialysis in critically ill patients. Continuous renal replacement therapy (CRRT) was developed for these patients since it most closely replicates
the normal functioning kidney. Patients receiving CRRT do not experience the large fluid shifts that are associated with intermittent hemodialysis. However, CRRT is still an emerging therapy and the market is not fully penetrated. 

The Xcorporeal product is a natural fit for the hospital market of renal replacement therapy since it is designed to provide cost-effective, continuous or intermittent therapy.

aaaaaaaa

Staggering costs of ESRD Recent progress in the prevention and treatment of end-stage renal disease (ESRD) in the United States give reason for "cautious
optimism," but skyrocketing costs are a major concern, according to a Special Article in the October Journal of the American Society of Nephrology.

In 2004, the most recent year for which complete data was available, 104,364 Americans (approximately 0.03 percent of the population) started dialysis or received a kidney transplant. This represented nearly a one percent decline in renal replacement therapy, compared with the previous year.

The decline is especially encouraging at a time when type 2 diabetes mellitus, a major risk factor for kidney disease, has reached epidemic proportions. The data suggest that improvements in preventive care may be helping to reduce diabetes-related kidney disease, although several years of new data will be needed to confirm this trend.

Diabetes remains the leading cause of ESRD. Rising rates of diabetic ESRD among younger African-American adults suggest "a looming public health crisis," according to the new report. An apparent increase in kidney disease caused by atherosclerosis (narrowing or "hardening" of the arteries) among older
adults is another area of concern.

The USRDS data show improvement in several indicators of the quality of dialysis care, including evidence that patients are starting renal replacement therapy at a less-severe stage of kidney disease. The increased use of fistulas for dialysis access reduces problems associated with the use of grafts or catheters.
At the same time, there is continued concern about overaggressive use of drugs called erythrocyte-stimulating agents (ESAs) for the treatment of dialysis-related anemia.

While most of these findings are grounds for cautious optimism, the same cannot be said for issues of cost. The cost implications are staggering . The most recent estimates showed that Medicare costs for ESRD reached $20.1 billion, while non-Medicare costs rose to $12.4 billion. Costs for the care of ESRD patients now account for 6.7 percent of total Medicare expenditures.

Products such as Xcorporeal's Wearable Artificial Kidney and portable, home dialysis unit could greatly reduce these costs to Medicare and society as a whole. In this win-win scenario, ESRD patients live longer more productive lives, while government saves a bundle on healthcare costs.


Nearly 1.3 million people worldwide suffer
from chronic kidney failure requiring treatment with dialysis. 

Since organ donors are scarce, very few receive kidney transplants. Conventional dialysis cleanses the blood of only about 17% of the toxic chemicals a healthy kidney removes. Of the 300,000 Americans who depend on dialysis to stay alive, most are crippled by an array of complications caused by the buildup of dangerous poisons in their blood. Sadly enough, only one-third survive more than five years.

Xcorporeal's WAK would allow dialysis patients to have their blood cleansed round the clock instead of being hooked up to machines 12 hours a week. There has been tremendous innovation in dialysis over the past few years. The WAK Xcorporeal is developing could be one of the medical industries’ most important innovations.

Quality of life could be improved by providing a form of dialysis that is much more like what natural kidneys do. The Sad Truth About Dialysis remains that people with chronic kidney failure face a bleak future. Currently, people suffering from chronic kidney failure must undergo half-day hemodialysis sessions, using devices that look like washing machines, three times a week to have toxic chemicals cleared from their blood. The treatment can be physically and
psychologically draining and cause cramps and nausea. Patients must restrict their fluid intake, since their kidneys no longer flush out fluids, and avoid foods containing potassium and phosphorous, because their bodies can't metabolize these chemicals properly.

Patients also take a handfuls of pills to help their bodies absorb certain minerals and to stave off the collateral damage of kidney failure such as heart disease, anemia, high blood pressure, osteoporosis, severe joint pain and loss of mental acuity. Medical research suggests that increasing the frequency and duration of dialysis treatments could greatly reduce this suffering. But dialysis is expensive, and there are not enough machines or nurses to give everyone daily treatments. In some countries, patients dialyze daily. As you might expect, the mortality rate in those countries is higher than in the U.S.

XCR Accomplishments

2006 was a very busy year for Xcorporeal. XCR commenced business operations in 2006 with the acquisition of an exclusive license to our platform technology from National Quality Care, Inc. XCR hired its first employees, Victor Gura, MD who was joined by his team of research scientists. Dr Gura’s passion and vision of the wearable artificial kidney drives the daily operations within our Company. In the fourth quarter of 2006, we completed our initial financing through a private placement netting $27.4 million; thereby providing us with sufficient resources to execute our business plan.

In 2007 XCR built its management team with Winson W Tang, MD, FACP joining as the Chief Operating Officer and Robert Weinstein as the Chief Financial Officer. XCR's Chief Scientific Officer and Chief Medical Officer continues to be Victor Gura, MD. They are now joined by Nina Peled, PhD, who has over 20 years of experience in the medical device industry and is our Senior Vice President of Quality and Regulatory Affairs. She is responsible for shepherding XCR devices through the United States Federal Drug Agency approval process as well as countries in the European Union and Asia. The design and development of our devices is be led by our Senior Vice President Jim Braig. In addition to being outstanding and ethical individuals, members of XCR's  management team have demonstrated the ability to develop and commercialize medical products. XCR will continue to build its management team including an Operations executive with expertise in supply chain procurement and manufacturing in anticipation of the commercial launch of our medical devices in 2009. 

XCR has successfully completed a “proof of concept” studies in human subjects
with an initial prototype of the wearable artificial kidney.

This study was conducted in Europe and demonstrated not only the feasibility of our device but its potential to outperform currently marketed devices. In this study, eight ESRD subjects were treated for up to eight hours. The device successfully removed uremic toxins over a broad range of molecular weights. Subjects remained hemodynamically stable during treatment and there were no adverse effects. Six of the eight subjects ambulated untethered, without impact on device performance, and without detriment to the subjects. The data from this study was received enthusiastically by thought leaders within the renal and cardiac academic community. Dr Gura is preparing a manuscript of this study that will be submitted to peer-review journals for publication.

The XCR engineering team continues to make great progress towards the development of our medical devices. XCR has engaged a product development consultancy in Irvine that enables us to leverage the expertise of a staff of 10 to 15 engineers in the construction of our devices. Dr. Gura and his research team are exploring innovative sorbent technology for our next generation devices. 

The Company continues to add individuals with relevant expertise and strategic vision to its Board of Directors. Kelly J McCrann is a senior healthcare executive with extensive experience in board governance, strategic leadership, profit and loss management, and merger and acquisition transactions. He has extensive contacts within the hemodialysis industry, most recently as the Senior Vice President of DaVita Inc, the United State’s second largest kidney dialysis provider. Dan Goldberger, who has over 25 years of experience in the medical device industry, is assisting our management team in the compilation of intellectual property, business development and executive recruitment.

XCR believes that the successful development and commercialization of our medical devices will result in the creation of tremendous value for patients, physicians and Xcorporeal shareholders.


Renal Replacement Therapy

Hemodialysis is a process by which uremic waste is removed by the passage of blood through a filter. The filter is made of a complex arrangement of semi-permeable hollow fibers which increase the effective surface area for fluid and waste exchange. Blood flows continuously through the hollow fibers while dialysate (waste absorbing fluid) flows in the opposite direction in the dialysate chamber. Due to differences in the concentration of metabolic wastes between the blood and dialysate compartments, molecules smaller than the pores of the membrane diffuse from the blood across the membrane to the dialysate compartment. 

A major disadvantage of currently marketed hemodialysis machines is the large volume of dialysate that is required (30 - 120 liters). The Xcorporeal renal replacement products utilize sorbents to regenerate the dialysate and thus afford a considerable reduction in the amount of dialysate required for each treatment. Waste products in the dialysate are removed by passage through a column of sorbent resulting in the regeneration of fresh dialysate. 

XCR has reduced the size and weight of the device making it portable and eventually wearable. 

Hemodialysis removes uremic toxins through the diffusion of small molecular weight uremic toxins across a semi permeable membrane from the blood into the dialysate compartment. However, diffusion is ineffective at removing middle molecular weight uremic toxins. Therefore, hemofiltration which utilizes convective clearance was developed. With this technique, blood is filtered across a highly permeable membrane and toxins are removed by convection and solvent drag. In order to avoid volume depletion, a highly purified, non-pyrogenic fluid must be re-administered to patients to replace the waste laden ultrafiltrate that is removed. The advantages of this treatment modality include improved cardiovascular stability and enhanced removal of middle molecular weight uremic toxins.


A closer look at the technology platforms

XCR's three devices are:

- Hospital device for continuous renal replacement therapy /intermittent hemodialysis 
- Portable device for home chronic renal replacement therapy
- Wearable Artificial Kidney (WAK) 

The Xcorporeal platform technology is a natural fit for the hospital market of renal replacement therapy since the technology is designed to provide cost-effective, continuous therapy. The projected 2008 market opportunity for the U.S. is approximately $1.1 billion. The disposable market is expected to grow at 10% per year. The devices typically need to be replaced every five years. Xcorporeal intends to commercialize this device during the first half of 2009.

Xcorporeal also plans to commercialize a home hemodialysis machine and the WAK for the End Stage Renal Disease (ESRD) market, which is comprised of patients whose kidneys have ceased to function. Xcorporeal's devices will combine the best attributes of currently marketed home hemodialysis machines to create hemodialysis devices which offer patients convenient, durable and truly portable devices for home use. Xcorporeal believes its machines will provide a cost-effective alternative to current home treatment modalities, due to their ability to offer hemodialysis therapy without the need for large quantities of dialysate fluid or purified water. 
 

The Wearable Artificial Kidney

(WAK)

Patients with chronic kidney failure could be freed from fixed dialysis machines. In a recent pilot study, British researchers said the battery powered device had proved successful when worn for periods of 4 to 8 hours. Over the next several years, Xcorporeal plans to pioneer efforts to allow dialysis patients to dialyze 24 hours a day, seven days a week, just like our own kidneys work. Currently, dialysis patients use a fixed hemodialysis machine in a hospital or clinic for 12 hours a week. 

"The device has the potential to become a
practical means of delivering extended and more frequent dialysis to patients with endstage kidney failure," Andrew Davenport of University College London and colleagues wrote in the
Lancet medical journal.

Further tests are now needed, since their small study involved only eight patients, with an average age of 52 years, who were established on regular hemodialysis before being fitted with the wearable - though rather bulky - device. The rate of blood flow and the speed at which toxic chemicals were removed from the body was considerably slower than in conventional dialysis but this was not seen as a problem, since the device can be worn for long, continuous periods. Two of the patients experienced blood clotting, due to receiving insufficient anticoagulant medication. Additionally, another patient was temporarily disconnected when a needle became dislodged.

THE WAK

Xcorporeal's WAK device consists of a tiny, double-channeled pulsating pump -- one circulates blood, the other water -- a fluid collection bag, a filtration system to cleanse impurities and disposable cartridges to purify the water so that it can be recirculated. The device weighs about 10 pounds, uses about 14 ounces of water and is powered by a 9-volt battery. These components are attached to a belt worn around the waist. Although not derived from the WAK technology, the same attributes (portability, size, weight, fluid and power reduction) will be applied to develop a PAK that will be able to provide Continuous Renal Replacement Therapy (CRRT) and/or acute intermittent hemodialysis to hospitalized patients with acute renal failure. This device will also be modified to provide home hemodialysis to patients with ESRD. Xcorporeal's system can also be configured into a portable ultra filtration device to treat fluid overload in Congestive Heart Failure (CHF) patients. Xcorporeal plans to focus initially on the renal replacement device applications described above, and may  eventually exploit Congestive Heart Failure applications through licensing or strategic arrangements.

Hospital (Acute care) Renal Replacement Device

Acute renal failure (ARF) is defined as a rapid decline in kidney function resulting in the accumulation of excessive water and toxic waste. There are a variety of causes of ARF including ischemia, sepsis, obstruction and nephrotoxins. ARF is often asymptomatic and is diagnosed through laboratory screening of hospitalized patients.  In many cases, patients with ARF suffer from multiple organ failure and are hospitalized in intensive care units (ICU). 

The majority of patients with ARF require at least short-term renal replacement therapy. Currently, intermittent dialysis is the predominant treatment for ARF despite growing research demonstrating the benefits of continuous dialysis over intermittent dialysis in critically ill patients. Continuous renal replacement therapy (CRRT) was developed for these patients since it most closely replicates the normal functioning kidney. In addition, patients receiving CRRT do not experience the large fluid shifts that are associated with intermittent hemodialysis. However, CRRT is still an emerging therapy and the market is not fully penetrated. The Xcorporeal product is a natural fit for the hospital market of renal replacement therapy since it is designed to provide cost-effective, continuous or intermittent therapy.

Xcorporeal believes that home hemodialysis is the next growth opportunity in the ESRD market. Physicians have increasingly recognized the benefits of daily dialysis which includes decreased mortality, decreased hospitalizations, and an improved quality of life. Daily dialysis is defined as six dialysis treatments per week with each session lasting 3 to 4 hours. However, for a variety of reasons, the implementation of daily dialysis can only be practically achieved with home hemodialysis. 

The Company will combine its innovative platform with the best attributes of currently marketed home hemodialysis machines to create a device that will offer patients with ESRD a convenient, durable, cost-effective, and truly portable device for home use. Xcorporeal’s platform is designed to achieve mass transfer and solute clearance over a broad range of molecular weights despite significant reductions in the weight, size, and energy consumption of the device. 

For dialysis clinic operators, the easy-to-use and low-cost design will
increase per patient profits and allow increased patient capacity.


clinical development

There has been one clinical study performed with an initial prototype of the wearable artificial kidney. 

This study was recently completed with Dr. Andrew Davenport at the Royal Free Hospital, London in the United Kingdom, and demonstrated the feasibility of a small, wearable, self-contained hemodiafiltration system. 

Eight ESRD subjects were dialyzed with this device for up to eight hours. The data indicates that the wearable artificial kidney will be capable of performing hemodialysis resulting in significant removal of uremic toxins over a broad range of molecular weights. Subjects remained hemodynamically stable during treatment and there were no reported adverse events. The average plasma clearances for urea, creatinine, and 2-microglobulin were 22.7±5.2, 20.7±4.8 and 11.3±2.3 (ml/min), respectively. Six of the eight subjects ambulated, untethered and without any impact on device performance, and without detriment to the subjects. 

Regulation Strategy

The medical device industry is subject to US federal, state, and local regulations as well as those of foreign countries. Xcorporeal will structure business operations and relationships with customers and suppliers to comply with all applicable regulatory requirements. The statutes and regulations most relevant to Xcorporeal’s business are as follows: 

United States Food and Drug Administration

The Food and Drug Administration (FDA) regulates medical devices under the authority of the Federal Food, Drug and Cosmetic Act (FFDCA) and the regulations stemming from it. These regulations govern, among other things, the following activities related to medical devices: pre-clinical and clinical testing, design, clearance or approval to come to market, manufacture, safety, efficacy, labeling, storage, record keeping, sales and distribution, post-market adverse event reporting, and advertising and promotion. The FFDCA utilizes a categorization system for medical devices which is risk-based and consists of three classes from lowest risk (Class I) to highest risk (Class III). For the most part, Class I devices are exempt from the need for FDA pre-market clearance while class II devices require pre-market clearance through a pre-market notification known as a 510(k) clearance process. Class II devices may also be subject to special controls such as performance standards and FDA guidelines that are not applied to Class I devices. Class III devices involve a more comprehensive FDA review and prior to commercial distribution require a pre-market application known as a Pre-Market Approval (PMA). 

Under the 510(k) clearance path, the FDA reviews the company’s submission and determines whether or not a proposed device is substantially equivalent to a predicate device that the company identifies. If the two devices are comparable in intended use, technological aspects and in safety and effectiveness, the device may be cleared for marketing. The 510(k) submission typically includes risk analysis and bench testing. The FDA may also request additional animal and clinical data depending upon the complexity or novelty of the device. The 510(k) clearance pathway usually takes from 3 to 6 months. After a device receives 510(k) clearance, a modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, may require a new 510(k) clearance or, depending on the nature of the modification, may even require a PMA process. 

In the PMA review process, the company submits detailed data related to the safety and effectiveness of the device. This information includes design, development, manufacture, labeling, advertising, bench testing data, and when applicable animal and human clinical data. PMA applications may require U.S. clinical studies to support the application under an Investigational Device Exemption (IDE) application. The study can not begin until the IDE is reviewed and approved by the FDA and by an Institutional Review Board at the clinical testing site. The FDA also conducts an inspection of the manufacturing facilities of the device and of the clinical sites where the supporting studies are conducted. Generally, towards the end of the review cycle, the FDA will convene an advisory panel meeting to review the data presented in the PMA. The FDA may also approve the PMA with post approval conditions intended to ensure the safety and effectiveness of the device. A typical review time for a new PMA application is 18 to 24 months. Post approval, a new PMA or a PMA supplement is required in the event of a modification to the device, its labeling or its manufacturing process. 

The Company believes that the hospital renal replacement device and the home renal replacement device will fall in the Class II category of devices having similar existing predicate devices already in commercial distribution and therefore requiring 510(k) clearances. The wearable artificial kidney is the only product that may require a PMA approval process. The Company estimates that using the 510(k) clearance process for two of its products would reduce time to market significantly. Therefore, the Company estimates that the hospital renal replacement device may require 18 months to clearance, while the home renal replacement device may require 21 months since small clinical trials (30 to 40 subjects) may be required. Due to the 18 to 24 month review period for a PMA application, the wearable artificial kidney will be available for marketing in the US in 5 years. 

Medical device companies are in addition subject to inspection and marketing surveillance by the FDA to determine compliance with regulatory requirements. 

Foreign Regulation

Regulatory approvals for medical devices are also required in some foreign countries. The regulations, including the requirements for approvals or clearance and the time required for regulatory review, vary from country to country. The primary regulatory body in Europe is that of the European Union, which consists of 25 countries encompassing most of the major countries in Europe. The European Union requires that manufacturers of medical products obtain the right to affix a CE mark to their products before selling them in member countries of the European Economic Area (EEA). The CE mark is an international symbol of adherence to quality assurance standards and to compliance with applicable European medical device directives. While the directives for authorizing a product for sale are not as stringent as the US approval process, the Xcorporeal devices may still need to undergo a review period in the EU. 

Compliance with the Medical Device Directive, as certified by a recognized European Notified Body, permits the manufacturer to affix the CE mark on its products and commercially distribute those products throughout the European Union. The resulting estimated time to the European market is 15 months for the hospital acute care and home renal replacement devices, and 3 years for the wearable artificial kidney.
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    Investment Incentives


A Major Investment Incentive

When a new technology comes along that revolutionizes the medical industry, investors profit. In 1963, Syntex pioneered "the pill" and shareholders were rewarded with a 980% return from January, 1963 to January, 1964. Medtronic (MDT) went public in 1960 and shareholders have been rewarded by 20
stock-spits since 1967. $10,000.00 invested in Amgen in 1990 would be worth $450,000.00 today. As far as medical technology is concerned, one way to make big money in the market is to invest in companies that can revolutionize an industry and save lives. 

THE TRUTH 

Since Xcorporeal began trading on the American Stock Exchange, its shares have declined from $6.00 to current levels.
As Xcorporeal's revolutionary technology unfolds, there could be significant gains in the stock price as XCR accomplishments are made public and investor interest grows.

1. Fresenius, Inc. (NYSE: FMS), the largest dialysis service provider in the world, last month announced the purchase of Renal Solutions for up to $190 million in cash plus the assumption of $10 million of debt. Renal Solutions, has less advanced technology than Xcorporeal and a smaller potential product line.

2.Xcorporeal is nearly debt free and has $13 million in cash and marketable securities.

3. NxStage Medical, Inc., (NASDAQ: NXTM), has a market capitalization of $160 Million, but only has a year or two lead on Xcorporeal. Xcorporeal will have product in approximately 1 year that, in our opinion, will be far superior to those marketed by NxStage Medical.

4. The Xcorporeal units are targeted to be half the size of the NxStage Medical unit, use minimal fluid reagents, and be more cost effective. This allows patient’s increased mobility while saving service providers money.

5. Xcorporeal has a reimbursement code for insurance and government coverage, which covers all forms of payments.

6. NxStage's unit is designed for a smaller person. Since most people on dialysis are overweight, Xcorporeal's unit is designed for both large and small framed people.

7. According to filings with the SEC, a member of Xcorporeal's Board of Directors, Marc G. Cummins, purchased 552,244 shares for $3.8 million in the last quarter of 2007.

8. Cummins was a buyer in December when the stock traded between $4.25 and $6.10.

9. Xcorporeal has a well-seasoned, experienced management team.

10.The recent downturn in the equity markets has created a tremendous buying opportunity and allows us to buy shares of Xcorporeal at a 40% discount to what insiders recently paid.

other publicly traded medical device companies ...

Fresenius, Inc. (NYSE:FMS) Medtronic Inc (NYSE:MDT)
Zimmer Holdings (NYSE:ZMH) St Jude Medical (NYSE:STJ)
Intuitive Surgical (NASDAQ:ISRG) Smith & Newphew PLC (NYSE:SNN)
Varian Medical Systems (NYSE:VAR) NxStage Meducal (NASDAQ:NXTM)

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     Recent News From XRC 

Press Release Source: Xcorporeal, Inc. 
Monday April 7, 8:30 am ET 

Xcorporeal Announces 2007 Operational Highlights

LOS ANGELES--(BUSINESS WIRE)--Xcorporeal, Inc. (AMEX:XCR - News) announced today operational highlights for calendar year 2007. Xcorporeal's common stock began publicly trading on October 15, 2007. Selected highlights included: -- 

Publication of promising results in prestigious medical journal. The Lancet, a leading medical journal, published an article on the Company's Wearable Artificial Kidney (WAK) prototype device in its Journal dated December 15, 2007. The data, from a pilot study conducted by Drs. Andrew Davenport and Victor Gura, at the Royal Free and University College Hospital Medical School, London, UK, showed that the WAK's clearance rate, if sustained and used continuously, could be more effective than conventional three times weekly or daily hemodialysis treatment. Dr. Gura is a director of the Company and its Chief Medical and Scientific Officer. This proof of concept study also provides preliminary indications on the safety features of the WAK and permitted the patient to be ambulatory during treatment. The WAK is a battery-powered, wearable dialysis machine that will allow users to have their blood cleansed round the clock, instead of being tethered to conventional dialysis machines, intermittently, for many hours. MORE



Press Release Source: OTCStockReview.com; Xcorporeal, Inc. 
Wednesday April 2, 7:22 am ET 

Amex Review Issues Report on Xcorporeal, Inc.

ATLANTA, April 2, 2008 (PRIME NEWSWIRE) -- Amex Review announces that it has initiated coverage of Xcorporeal, Inc. (AMEX:XCR - News). Xcorporeal, Inc., headquartered in Los Angeles, CA, is a medical device company developing an innovative extra-corporeal platform technology that may be used in devices to replace the function of various human organs. The platform will lead to three initial products: a device for home hemodialysis; another device for hospital Renal Replacement Therapy (RRT); and the Wearable Artificial Kidney (WAK) for continuous ambulatory hemodialysis. These devices could dramatically improve the quality of life led by dialysis patients. The RRT markets represent multi-billion dollar opportunities. MORE 

IN MEDICAL NEWS

Prestigious Medical Journal Publishes Data On Xcorporeal's Wearable Artificial Kidney

MORE

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     XCR Management

Terren S. Peizer
Executive Chairman

Mr. Peizer was appointed as a Director and Chairman on August 31, 2006. Mr. Peizer is Chairman and CEO of Hythiam, which he founded in 2003. From April 1999 to October 2003, Mr. Peizer served as Chief Executive Officer of Clearant, Inc., which he founded to develop and commercialize a universal pathogen inactivation technology. He served as Chairman of its board of directors from April 1999 to October 2004 and a Director until February 2005. From February 1997 to February 1999, Mr. Peizer served as President and Vice Chairman of Hollis-Eden Pharmaceuticals, Inc. In addition, from June 1999 through May 2003 he was a Director, and from June 1999 through December 2000 he was Chairman of the Board, of supercomputer designer and builder Cray Inc., and remains its largest beneficial stockholder. Mr. Peizer has been the largest beneficial stockholder and held various senior executive positions with several technology and biotech companies. In these capacities he has assisted the companies with assembling management teams, boards
of directors and scientific advisory boards, formulating business and financial strategies, investor and public relations, and capital formation. Mr. Peizer has been a Director, Chairman of the Board and Chief Executive Officer of Hythiam, Inc., a healthcare services management company focused on delivering solutions for those suffering from alcoholism and other substance dependencies, since September 2003. Mr. Peizer has a background in venture capital, investing, mergers and acquisitions, corporate finance, and previously held senior executive positions with the investment banking firms Goldman Sachs, First Boston and Drexel Burnham Lambert. He received his B.S.E. in Finance from The Wharton School of Finance and Commerce.

"We at Xcorporeal are building an exciting new company that will commercialize extra-corporeal medical devices that can replace the function of failing or failed human organs. Our innovative proprietary platform has been adapted to solve health issues related to kidney and heart failure. Xcorporeal’s technology may be superior to that employed in current medical devices and our devices have the potential to redefine and improve therapy for patients with renal or cardiac failure."


Terren S. Peizer
Executive Chairman of the Board 
Xcorporeal, Inc.



Winson W Tang, MD, FACP
Chief Operating Officer

Dr Winson Tang has over 20 years experience in academic medicine, biomedical research and the biopharmaceutical industry. Dr. Tang is a graduate of The Albert Einstein College of Medicine and completed a Residency in Internal Medicine (University of Southern California), Clinical Fellowship in Nephrology (University California San Diego) and Research Fellowship in Immunology (The Scripps Research Institute). Dr. Tang has held drug development positions of increasing responsibility at Amgen, Vertex, Tularik, and Isis Pharmaceuticals. During his biopharmaceutical career, he has successfully filed four Investigational New Drug Applications and Clinical Trial Applications, two Biologic License Applications, in-licensed a preclinical drug candidate that is now marketed (Sensipar®) and commercialized 2 drugs (Infergen® and Aranesp®). Both Sensipar ® and Aranesp® are important therapies for patients with ESRD. He was most recently the Director of Research for the Pacific Capital Group, where he managed the biotech investment portfolio. Dr. Tang is a Diplomate of the American Board of Internal Medicine and a fellow of the American College of Physicians. He has published more than 30 original research articles and book chapters.


Victor Gura, MD
Chief Medical and Scientific Officer
 

Dr. Gura became our Chief Medical and Scientific Officer in December 2006. Dr. Gura has been a member of our board of directors since October 13, 2006. Prior to joining Xcorporeal, Dr. Gura has been the Chief Scientific Officer of National Quality Care, Inc. since 2005. He was formerly its Chairman of the Board, President and Chief Executive Officer. Dr. Gura is a medical doctor who is board certified in internal medicine/nephrology. He is a director and principal shareholder of Medipace Medical Group, Inc., a medical group in Los Angeles, California, since 1980. Dr. Gura has been an attending physician at Cedars-Sinai Medical Center since 1984 and the medical director of Los Angeles Community Dialysis since 1985. Dr. Gura also serves as a Clinical Assistant Professor at UCLA School of Medicine. Dr. Gura graduated from the School of Medicine, Buenos Aires University in 1966, completed his residency in internal medicine and nephrology in Israel, and was a fellow at the nephrology departments at Tel Aviv University Medical School and USC Medical Center.

Robert Weinstein
Chief Financial Officer

Robert Weinstein was appointed Chief Financial Officer in August 2007. Prior to joining us, Mr. Weinstein served as Vice President, Director of Quality Control & Compliance of Citi Private Equity Services (formerly BISYS Private Equity Services), New York, a worldwide private equity fund administrator and accounting service provider. In 2005, Mr. Weinstein was the Founder, Finance & Accounting Consultant for EB Associates, LLC, Irvington, NY, an entrepreneurial service organization. From 2003 to 2004, Mr. Weinstein served as the Chief Financial Officer for Able Laboratories, Inc., Cranbury, NJ. In 2002, he served as Acting Chief Financial Officer for Eurotech, Lid., Fairfax, VA, a distressed, publicly traded early-stage technology transfer and development company. Mr. Weinstein received as M.B.A, Finance & International Business from the University of Chicago, Graduate School of Business and a B.S. in Accounting from the State University of New York at Albany. Mr. Weinstein is a Certified Public Accountant (inactive) in the State of
New York.

Nina Peled
Senior Vice President of Quality Assurance and Regulatory Affairs

Effective January 2, 2007, Nina Peled, Ph.D., became Vice President of Quality Assurance and Regulatory Affairs. From 2005 until joining us, Dr. Peled served as Vice President, Quality and Regulatory Affairs with Hansen Medical, leading the quality and regulatory functions engaged in the development of a complex robotic system that controls and manipulates the placement of catheters in the chambers of the heart. From 2002 to 2004 she served as Executive Vice President, Global Quality, Regulatory and Clinical Affairs with Lumenis, Inc., which developed medical devices based on laser and intense light technologies. From 1998 to 2002, Dr. Peled served as Vice President, Scientific Affairs with Amira Medical. From 1997 to 1998, she served as Vice President, Regulatory Affairs with Cygnus, Inc. which developed a minimally invasive continuous glucose monitor. From 1994 to 1997 she served as Director, Clinical and Regulatory Affairs for I-Stat Corporation. From 1982 to 1994 she held positions of increasing responsibility with Boehringer Mannheim Corporation, including Director, New Technology, Technical Affairs, Research, Marketing and Quality Assurance. Dr. Peled is a member or chair of several committees of National Committee for Clinical Laboratory Standards. She received a B.S. in Physics and Chemistry, an M.S. in Physical Organic Chemistry and a Ph.D. in Physical Chemistry from Hebrew University of Jerusalem, and an MBA from University of Houston.

James Braig
Senior Vice President of Product Development

James R. Braig serves as Senior Vice President, Product Development. He is a senior executive with over 30 years of experience in the medical device industry. Over the past 13 years, he was with OptiScan Biomedical Inc. where he served in a variety of positions including Co-founder President, Chief Technical Officer and Vice President of Engineering. Prior to that, he co-founded Square One Technology, a company founded as a contract manufacturer of medical devices. Some of the devices that were developed during his tenure included a mainstream capnometer (J&J Critikon), cardiac bypass oximeter (Baxter-Bentley), blood warmer (Dupaco), and Tympanic thermometer (Becton Dickenson). Mr. Braig began his career at Ohio medical products, Liston Edwards Inc and Nellcor. Mr. Braig is the inventor and/or coinventor of over 53 US patents. Mr. Braig received his B.S. in Physics and M.S. in Electrical Engineering from the University of Cincinnati.

Russell T Joseph, M.S.
Vice President of Disposables Engineering 

Prior to joining Xcorporeal, Mr. Joseph had been the Director of Research & Development and Engineering for Gish Biomedical, Inc., a developer and manufacturer of cardiopulmonary medical devices, since 2001. Prior to Gish he was Director of Engineering at Sorin Biomedical from 1997 to 1999. From 1983 to 1997 Mr. Joseph held multiple positions with Baxter Healthcare including Director of Systems Integration and Directory of LabLink Product Development. Mr. Joseph also held the position of Assistant Professor at Temple University, ending in 1980. Mr. Joseph received his B.S. in Medical Technology from the University of Massachusetts (North Dartmouth Campus) in 1974, his M.S. in Biochemistry from Temple University in 1977 and his M.S. in Engineering Management from the University of Southern California in 1999.

Barry Fulkerson
Vice President of Hardware Systems

Barry Fulkerson has over 20 years of experience in the dialysis industry. From 1999 until 2006, he served as the Director of Hardware Systems for NxStage Medical, which developed the first true portable home dialysis machine. Mr. Fulkerson led the electronics & software efforts from conception to final product. The NxStage Cycler has helped open the door to better dialysis treatments for thousands of patients. The NxStage Cycler has also changed the CRRT market with its innovative design and ease of use for Clinicians in the ICU/CCU. From 1986 to 1999 Mr. Fulkerson held various positions within the Gambro group developing dialysis, apheresis, and cardiovascular systems. He received a BS in Electrical Engineering at Western Kentucky University.
a
    Financial Highlights For XCR

Sector: Healthcare 
Industry: Medical Appliances & Equipment 
Full Time Employees: 20 

AMEX Ticker Symbol: XCR
Recent Price: $1.96
Shares Outstanding: 14.35 Million
Market Cap: $28.1 Million
52-Week Low: $1.84 - 52-Week High: $9.50

XCR operates as a highly efficient and transparent business. It's corporate committee charters include an Audit Committee Charter, a  Compensation Committee Charter, a Nominating Committee Charter, and the highest standard Code of Ethics. 

For XCR's SEC Filings: Click Herea

    Company Contacts 

Xcorporeal, Inc.

11150 Santa Monica Boulevard, Suite 340, Los Angeles, CA 90025
Phone: 310-424-5668 - Web Site: http://www.xcorporeal.com


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