| |
 |
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
|
|
<<<Spacer>>>
 |
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.
a
 |
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)
a
 |
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
a
 |
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
*** The Bull is Running. ***
There
may never be a better time to feature YOUR company
to
over 1 MILLION investors.
To learn
more about our programs email us directly at info@stockupticks.com
Market Pathways
17595 Harvard Ave., Suite
C519 Irvine, CA 92614
949-231-2769
Stockupticks
Safe Harbor Statement: Statements contained in this document,
including those pertaining to estimates and related plans, potential mergers
and acquisitions, estimates, growth, establishing new markets, expansion
into new markets and related plans other than statements of historical
fact, are forward-looking statements subject to a number of uncertainties
that could cause actual results to differ materially from statements made.
StockUpTicks.com is a property of Market Pathways Financial Relations Incorporated
(MP). MP provides no assurance as to the subject company's plans
or ability to effect any planned and/or proposed actions. MP has no first-hand
knowledge of management and therefore cannot comment on its capabilities,
intent, resources, nor experience and makes no attempt to do so. Statistical
information, dollar amounts, and market size data was provided by the subject
company and related sources believed by MP to be reliable, but MP provides
no assurance, and none is given, as to the accuracy and completeness of
this information.
Disclaimer: StockUpTicks.com is a property of Market Pathways Financial Relations Incorporated
(MP). The information, opinions and analysis contained herein are
based on sources believed to be reliable but no representation, expressed
or implied, is made as to its accuracy, completeness or correctness. Past
performance is no guarantee of future results. This report is a paid advertisement
and is for information purposes only and should not be used as the basis
for any investment decision. MP has been paid
ten thousand dollars by Atlanta Capital for preparation and distribution
of this report and other advertising services over a thrity day period. This
constitutes a conflict of interest as to MP’s ability to remain objective
in its communication regarding the subject company. Write or call
MP for detailed disclosure as required by Rule 17b of the Securities Act
of 1933/1934. MP is not an investment advisor and this report is
not investment advice. This information is neither a solicitation to buy
nor an offer to sell securities but is a paid advertisement. Information
contained herein contains forward-looking statements and is subject to
significant risks and uncertainties, which will affect the results.
The opinions contained herein reflect our current judgment and are subject
to change without notice. MP and/or its affiliates, associates and employees
from time to time may have either a long or short position in securities
mentioned. Information contained herein may not be reproduced in
whole or in part without the express written consent of Market Pathways
Financial Relations Incorporated.
|
|