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Xcorporeal,
Inc., (AMEX: XCR)
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Dear Reader,
We are proud to bring you today's featured company, Xcorporeal, Inc.
(AMEX: XCR), a company that is committed to dramatically improving
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.
The dialysis marketplace is vast and in need of innovation. Take a look
at today’s comprehensive profile and see if you agree that 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 |
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Xcorporeal (AMEX: XCR) 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. Click
here to view the latest corporate presentation.
Xcorporeal is focused on the commercialization
of renal replacement devices. These devices remove unwanted chemicals,
toxins and excess fluids from the blood, thus replacing many of the essential
functions of the damaged kidney. Unlike other renal replacement devices
currently on the market, the Xcorporeal devices are user friendly, lightweight,
portable and eventually wearable, providing patients with continuous treatments
(as opposed to intermittent) and allowing them to achieve a quality
of life closer to that of a healthy individual.
The Resulting Renal Replacement
Therapy (RRT) Products are:
- Hospital device for continuous renal replacement
therapy /intermittent hemodialysis
- Portable device for home chronic renal replacement
therapy
- Wearable Artificial Kidney (WAK)
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%.
| Dan Goldberger, Chief Executive
Officer of Xcorporeal, recently presented at the Seventh Annual Needham
Biotechnology & Medical Technology Conference in New York City.
View the presentation HERE |
XCR HIGHLIGHTS
- Extra-corporeal medical devices that could replace
the function of failing or failed organs
- Multiple initial products
- Mobile Hospital Hemodialysis device
- Portable Home Hemodialysis device – The “XCR-6”
- Wearable Artificial Kidney
- First U.S. 510(k) filing anticipated Q4, 2008
- Minimal to low risk strategy
- Prototype device tested successfully
- Well defined and straightforward regulatory strategy
- Well delineated reimbursement codes
- Multi-billion dollar, clearly defined markets
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.
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The Market |
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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.
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 of each of these markets.
Nearly 1.3 million people worldwide
suffer
from chronic kidney failure
requiring treatment with dialysis.
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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.
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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.
WAK Summary
- “Disruptive” technology
- Wearable, battery operated light-weight device
- Fully automated, simple to use
- Prototype tested successfully
- Successful human trials published in The Lancet & Kidney
International December 2007
- 24 hrs/7 days therapy with potential to revolutionize care
of ESRD patients
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.
Hospital Hemodialysis Device Market
- US Market Opportunity > $150 million (a)
- Growing at 10% per year
- Aging Population
- Increasing severity of hospitalized patients
- Disposable Market
- 242,000 patient hospitalizations per year estimated 2008
- $200 revenue per day for fluids and disposables for supplier
- Disposable Market = 242,000 x $200 = $49 million
- Device Market
- 2008 Market = $100 million
(a) Per William Blair & Co. LLC estimate
Clinical Trial Results
- Initial clinical study conducted with a prototype device
at The Royal Free Hospital, London
- 8 ESRD subjects dialyzed for mean of 6.4 hrs
- Clearances of creatinine, urea, and beta-2-microglobulin
achieved (chart follows)
- No adverse events reported
- Subjects were able to walk unhindered during dialysis treatment
- Presented at ASN November 5, 2007
Intellectual Property
- Portable Artificial Kidney
- 20 patents in process, company initiated
-Various processes and device components
- Wearable Artificial Kidney
- 9 patents in process, exclusive in-license
-Wearable ultra-filtration device
- Wearable, self-contained, device for continuous excess fluid
management
-Wearable continuous renal replacement therapy device
- Expands on patent above to include renal replacement patients
and battery-operated power source
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Investment Considerations |
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Company Near-Term Milestones
- Hospital Mobile Hemodialysis Device
- Functional Prototype (completed)
Q4, 2007
- Pre-Production Prototype
Q3, 2008
- FDA 510(k) submission Q4,
2008
- Commercialization target
Q3, 2009
- Home Portable Hemodialysis Device
- Functional Prototype (completed)
Q4, 2007
- Pre-Production Prototype
Q3, 2008
- Home Use Clinical trial complete
Q3, 2009
- Home Use FDA 510(k) submission Q3,
2009
- Commercialization target
Q2, 2010
Xcorporeal Highlights
- Extra-corporeal medical devices that
could replace the function of failing or failed organs
- Multiple initial products
- Mobile Hospital Hemodialysis device
- Portable Home Hemodialysis device
- Wearable Artificial Kidney
- First U.S. 510(k) filing anticipated
Q4, 2008
- Minimal to low risk strategy
- Prototype device tested successfully
- Well defined and straightforward regulatory
strategy
- Well delineated reimbursement codes
- Multi-billion dollar, clearly defined
markets
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.
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Recent News From XCR |
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Press
Release Source: Xcorporeal, Inc.
Monday
June 9, 8:30 am ET
Xcorporeal
to Present at Needham Biotechnology & Medical Technology Conference
on Thursday,
June 12th
LOS
ANGELES--(BUSINESS WIRE)--Xcorporeal, Inc. (AMEX:XCR - News) announced today that Dan Goldberger, Chief Executive Officer at Xcorporeal,
will be presenting at the Seventh Annual Needham Biotechnology & Medical
Technology Conference, at the New York Palace Hotel in New York City, on
Thursday, June 12, 2008 at 3:30 p.m. Eastern Time.
The
Company’s presentation will also be webcast live and archived for future
reference, for 30 days, at www.wsw.com/webcast/needham25/xcor/ and also available on the Company’s website at www.xcorporeal.com.
MORE
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 |
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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.
Daniel S. Goldberger
Chief Executive Officer
Daniel S. Goldberger has served as acting Chief Executive
Officer since February 2008. He served as our President and Chief Operating
Officer from October 2006 to August 2007. Mr. Goldberger is the Chief Executive
Officer of Sound Surgical Technologies, a privately held company developing
ultrasonic technologies for aesthetic surgery. He has been the Chief Executive
Officer of Glucon Inc., a privately held glucose monitoring business from
2004 to 2006. From 2001 to 2004, Mr. Goldberger served as President and
as a Director of the Medical Group of OSI Systems, Inc. (NASDAQ: OSIS),
which included the Spacelabs, Dolphin, Osteometer product lines with combined
revenue approaching $250 million. Mr. Goldberger was also the co-founder
of Optiscan Biomedical Corporation, where he served as Director from 1994
to 2001 and also served as its Vice President from 1994 to 1998 and then
as its President from 1998 to 2001. Mr. Goldberger has over 25 years of
management experience with large and small medical device companies, including
Nellcor and Square One Technology. He received his B.S.M.E. from Massachusetts
Institute of Technology and his M.S.M.E. from Stanford University.
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
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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.
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Financial Highlights For XCR |
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Sector: Healthcare
Industry: Medical Appliances & Equipment
Full Time Employees: 20
AMEX Ticker Symbol: XCR
Recent Price: $1.08
Average Vol: 29,306 (3 mo)
Shares Outstanding: 14.35 Million
Market Cap: $15.76 Million
52-Week Low: $0.98 - 52-Week High: $17.78
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
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Company Contacts |
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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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