Pluristem Therapeutics Inc. (Nasdaq:PSTI)
(TASE:PSTI), a leading regenerative medicine company
developing a platform of novel biological products, today announced
results from a market access comprehensive research study conducted
by Marwood Group, a healthcare advisory firm, for the critical limb
ischemia (CLI) market in the U.S. The report included data from
published literature as well as direct interviews regarding
Pluristem’s PLX-PAD regenerative cell therapy with dozens of
physicians, who are key opinion leaders (KOL) in CLI, and with
payers covering millions of lives. Pluristem believes that the
in-depth report reflects a favorable market for PLX-PAD, which is
currently in a global Phase III study with clinical sites in the
U.S., Europe, and Israel. According to the report, CLI is a
significant unmet need indication, and constitutes a significant
burden on the U.S. healthcare system. The report suggests that the
addressable market for PLX-PAD for Rutherford 5 CLI patients that
are unsuitable for revascularization is expected to reach $2
billion by 2023. In addition, the physicians interviewed as part of
the study suggest that they would use the PLX product in cases
where multiple medical interventions are needed per year. Based on
the report, and assuming such an approach, this could support an
annual addressable market in the U.S. of $6 billion.
The incidence of CLI in the U.S. is rising,
driven by an aging population and the increase in the prevalence of
diabetes, both underlying drivers for CLI. Currently, there are
between 2 and 3 million CLI patients in the U.S., with 500,000 to
600,000 new cases per year. Of these, 30% to 35% are classified as
Rutherford 5, the target population in Pluristem’s ongoing Phase
III study. Approximately half of Rutherford 5 and Rutherford 6 CLI
patients have diabetes, and this patient population has a 50%
higher probability of amputation than patients without diabetes due
to the rapid progression of the disease.
About 35% of CLI patients today are unsuitable
for revascularization surgery, according to KOLs and market
researches in this field, and face high rates of death and
amputation, which carries high medical and personal costs. The
average cost for major amputation in the U.S. is estimated at
$47,000, with ongoing annual costs for amputees estimated at
$75,000 and estimated lifetime cost of $500,000-$800,000. The
current cost of potential amputation, and of treating CLI, is well
recognized by payers and many of them see amputation as a cost
benchmark for a new treatment like PLX-PAD.
As disclosed in the report, vascular surgeons
who typically treat CLI expressed interest in using PLX-PAD, which
is provided as an outpatient setting, thus potentially reducing the
need for hospitalization. Both KOLs and payers confirmed that
amputation free survival (AFS), Pluristem’s primary efficacy
endpoint for its Phase III study, is an endpoint that should drive
adoption. Pluristem’s Phase III study population includes
Rutherford 5 patients who are considered unsuitable for
revascularization surgery. In addition to treating these patients,
more than three-quarters of vascular surgeons expressed an unmet
need and willingness to use PLX-PAD for patients with non-healing
wounds and who already receive two revascularizations, or more,
annually.
“Based on this thorough market report, it is
clear to us that CLI patients, and especially those unsuitable for
revascularization that are suffering from a very poor quality of
life and carry a heavy burden on the health care system, require
better medical solutions. We believe that this market report
highlights payers’ and physicians’ interest in PLX-PAD as an
alternative method of care for CLI patients,” said Yaky Yanay,
Pluristem President and CEO. “We also believe that this market
report validates our understandings regarding the potential
substantial market for our PLX-PAD product in the U.S., and the
importance of implementing novel regenerative medicine in CLI to
control increased healthcare spending. Pluristem is committed to
finding a solution for CLI and believes that our Phase III study
will show promise in preventing amputation and help improve the
lives of millions of CLI patients.”
About Pluristem
TherapeuticsPluristem Therapeutics Inc. is a leading
regenerative medicine company developing novel placenta-based cell
therapy product candidates. The Company has reported robust
clinical trial data in multiple indications for its patented PLX
cell product candidates and is currently conducting late stage
clinical trials in several indications. PLX cell product candidates
are believed to release a range of therapeutic proteins in response
to inflammation, ischemia, muscle trauma, hematological disorders
and radiation damage. The cells are grown using the Company's
proprietary three-dimensional expansion technology and can be
administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; a
Company-owned and operated GMP-certified manufacturing and research
facility; strategic relationships with major research institutions;
and a seasoned management team.
About Marwood
GroupMarwood Group is a healthcare focused strategic
advisory and financial services firm headquartered in New York City
with offices in Washington, D.C. and London. Marwood Group’s
consulting practice, Marwood Group Advisory, is a leading
healthcare-focused strategic advisory firm that provides due
diligence, market access, and life cycle management consulting
services for life sciences companies and investors. Marwood
operates at the intersection of healthcare policy analysis, market
diligence and strategic consulting; Marwood’s senior team includes
former healthcare and life sciences operators, investment bankers,
and veterans of top-tier strategy consulting firms as well as
former senior-level government officials and policy makers. To
inquire about Marwood’s work in the life sciences sector, please
contact Nayan Ghosh at nghosh@marwoodgroup.com.
Safe Harbor Statement
This press release contains express or implied
forward-looking statements within the Private Securities Litigation
Reform Act of 1995 and other U.S. Federal securities laws. For
example, Pluristem is using forward-looking statements when it
discusses the potential size of the U.S. market for patients
suffering from CLI, the potential benefits and use of PLX-PAD in
the treatment of CLI over the current standard of care in the
context of preventing amputations and in place of
revascularization, the belief that the market report highlights
payers’ and doctors’ interest in PLX-PAD as an alternative method
of care for CLI patients, the belief that the market report
validates its understanding regarding the potential market for its
PLX-PAD product in the U.S. and the importance of implementing
novel regenerative medicine in CLI to control increased healthcare
spending, and the belief that its Phase III study will show promise
in preventing amputation and help improve the lives of millions of
CLI patients. These forward-looking statements and their
implications are based on the current expectations of the
management of Pluristem only, and are subject to a number of
factors and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to
differ materially from those described in the forward-looking
statements: changes in technology and market requirements;
Pluristem may encounter delays or obstacles in launching and/or
successfully completing its clinical trials; Pluristem’s products
may not be approved by regulatory agencies, Pluristem’s technology
may not be validated as it progresses further and its methods may
not be accepted by the scientific community; Pluristem may be
unable to retain or attract key employees whose knowledge is
essential to the development of its products; unforeseen scientific
difficulties may develop with Pluristem’s process; Pluristem’s
products may wind up being more expensive than it anticipates;
results in the laboratory may not translate to equally good results
in real clinical settings; results of preclinical studies may not
correlate with the results of human clinical trials; Pluristem’s
patents may not be sufficient; Pluristem’s products may harm
recipients; changes in legislation may adversely impact Pluristem;
inability to timely develop and introduce new technologies,
products and applications; loss of market share and pressure on
pricing resulting from competition, which could cause the actual
results or performance of Pluristem to differ materially from those
contemplated in such forward-looking statements. Except as
otherwise required by law, Pluristem undertakes no obligation to
publicly release any revisions to these forward-looking statements
to reflect events or circumstances after the date hereof or to
reflect the occurrence of unanticipated events. For a more detailed
description of the risks and uncertainties affecting Pluristem,
reference is made to Pluristem's reports filed from time to time
with the Securities and Exchange Commission.
Reference herein to any specific commercial
products, process, or service by trade name, trademark,
manufacturer, or otherwise, does not necessarily constitute or
imply its endorsement, recommendation, or favoring by Marwood Group
Advisory, LLC (“Marwood”).
Marwood undertakes no obligation to provide the
recipient of the information herein with any additional or
supplemental information or any update to or correction of the
information contained herein.
Neither Marwood nor its affiliates, nor their
respective employees, officers, directors, managers or partners,
shall be liable to any other entity or individual for any loss of
profits, revenues, trades, data or for any direct, indirect,
special, punitive, consequential or incidental loss or damage of
any nature arising from any cause whatsoever, even if Marwood has
been advised of the possibility of such damage. Marwood and its
affiliates, and their respective employees, officers, directors,
managers or partners, shall have no liability in tort, contract or
otherwise to any third party. The information herein is proprietary
to Marwood. Any duplication or use of such material is not
permitted without Marwood's written consent.
Contact: |
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Dana Rubin |
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Ayala Michael |
Director of Investor Relations |
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Marketing Communications Manager |
972-74-7107194 |
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972-74-7107135 |
danar@pluristem.com |
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ayalam@pluristem.com |
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