PainReform Bunionectomy Study Observations Confirm Optimal Delivery Method for PRF-110 in Bunionectomy Procedures
August 21 2024 - 8:30AM
PainReform Ltd. (Nasdaq: PRFX) ("
PainReform" or
the "
Company"), a clinical-stage specialty
pharmaceutical company focused on the reformulation of established
therapeutics, today announced the successful determination of the
optimal delivery method for PRF-110 in bunionectomy procedures.
This achievement marks a significant milestone aimed at advancing
PRF-110 as a leading post-surgical pain management solution.
Building on previously reported in-vitro studies
that demonstrated the superior spreadability of PRF-110, PainReform
has now completed comprehensive Phase III evaluations, focusing on
the practical application of the product in surgical wounds. The
findings underscore PRF-110's exceptional physical properties,
which ensure optimal coverage of cut nerve endings and traumatized
tissue surfaces, contributing to effective post-surgical pain
control.
Key Findings from the Phase III
Study:
-
Effective Wound Coverage: PRF-110 was observed to provide thorough
coverage of both nerve endings and surrounding tissue surfaces.
This is crucial for maximizing pain relief, as full coverage
ensures that the product remains in place throughout wound closure
and delivers the intended dose directly to the target area.
-
Competitive Advantages: Unlike a leading competitor’s aqueous
liposomal suspension, which requires multiple injections with
difficulty in achieving full instillation (coverage of the whole
wound bed), PRF-110 demonstrated superior adhesion and location
adherence over the wound bed. Additionally, PRF-110 resolved
another competitor's product issue, being too viscous and becoming
increasingly difficult to manage when interacting with
physiological fluids.
-
Enhanced Viscosity and Uniformity: PRF-110 exhibited optimal
viscosity and uniformity, maintaining its effectiveness even in the
presence of physiological fluids. These attributes facilitated ease
of application and ensured that the product could be evenly
distributed across the wound bed.
-
Precision Delivery Coverage: To ensure comprehensive coverage
within the wound geometry, PRF-110 was administered using a cannula
connected to the syringe’s Luer lock. This method enabled precise
delivery to all parts of the wound, further enhancing the product's
therapeutic impact.
Ehud Geller, Chairman and interim Chief
Executive Officer of PainReform, stated, "The results from our
Phase III evaluations underscore the unique advantages of PRF-110
in post-surgical pain management. We are particularly pleased with
the product's ability to effectively cover the wound area and
remain in place, which directly addresses the shortcomings of
existing treatments. These findings further validate our commitment
to delivering innovative solutions that improve patient outcomes
and set a new standard in the field."
About PainReform
PainReform is a clinical-stage specialty
pharmaceutical company focused on the reformulation of established
therapeutics. PRF-110, the Company's lead product is based on the
local anesthetic ropivacaine, targeting the postoperative pain
relief market. PRF-110 is an oil-based, viscous, clear solution
that is deposited directly into the surgical wound bed prior to
closure to provide localized and extended postoperative analgesia.
The Company's proprietary extended-release drug-delivery system is
designed to provide an extended period of post-surgical pain relief
without the need for repeated dose administration while reducing
the potential need for the use of opiates. For more information,
please visit www.painreform.com.
Notice Regarding Forward-Looking
Statements
This press release contains forward-looking
statements about our expectations, beliefs and intentions including
with respect to objectives, plans and strategies and expected
timing of results. Forward-looking statements can be identified by
the use of forward-looking words such as "believe", "expect",
"intend", "plan", "may", "should", "could", "might", "seek",
"target", "will", "project", "forecast", "continue" or "anticipate"
or their negatives or variations of these words or other comparable
words or by the fact that these statements do not relate strictly
to historical matters. These forward-looking statements are based
on assumptions and assessments made in light of management's
experience and perception of historical trends, current conditions,
expected future developments and other factors believed to be
appropriate. Forward-looking statements in this press release are
made as of the date of this press release, and we undertake no duty
to update or revise any such statements, whether as a result of new
information, future events or otherwise. Forward-looking statements
are not guarantees of future performance and are subject to risks
and uncertainties, many of which are outside of our control. Many
factors could cause our actual activities or results to differ
materially from the activities and results anticipated in forward-
looking statements, including, but not limited to, the following:
our ability to continue as a going concern, our history of
significant losses, our need to raise additional capital and our
ability to obtain additional capital on acceptable terms, or at
all; our dependence on the success of our initial product
candidate, PRF-110; the outcomes of preclinical studies, clinical
trials and other research regarding PRF-110 and future product
candidates; our limited experience managing clinical trials; our
ability to retain key personnel and recruit additional employees;
our reliance on third parties for the conduct of clinical trials,
product manufacturing and development; the impact of competition
and new technologies; our ability to comply with regulatory
requirements relating to the development and marketing of our
product candidates; our ability to establish and maintain strategic
partnerships and other corporate collaborations; the implementation
of our business model and strategic plans for our business and
product candidates; the scope of protection we are able to
establish and maintain for intellectual property rights and our
ability to operate our business without infringing the intellectual
property rights of others; the overall global economic environment;
our ability to develop an active trading market for our ordinary
shares and whether the market price of our ordinary shares is
volatile; and statements as to the impact of the political and
security situation in Israel on our business, including due to the
current war between Israel and Hamas. More detailed information
about the risks and uncertainties affecting us is contained under
the heading "Risk Factors" included in the Company's most recent
Annual Report on Form 20-F and in other filings that we have made
and may make with the Securities and Exchange Commission in the
future.
Contact:Crescendo
Communications, LLCTel: 212-671-1021Email:
prfx@crescendo-ir.com
Dr. Ehud GellerChairman and interim Chief
Executive OfficerPainReform Ltd.Tel: +972-54-4236711Email:
egeller@medicavp.com
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