PainReform Ltd. Confirms Sutures Compatibility in Human Clinical Trials for PRF-110
September 11 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 positive findings regarding the
compatibility of sutures in human clinical trials of its lead
product, PRF-110. PRF-110 is designed to provide extended,
non-opiate, post-surgical pain relief.
The Company conducted comprehensive in vitro
studies to assess the impact of PRF-110 on both non-absorbable and
resorbable sutures. Given that suture materials are often in
proximity to the PRF-110 oily solution following surgery, it was
critical to evaluate whether PRF-110 would affect the mechanical
properties of these sutures. The mechanical integrity, including
breaking force and elongation, of PROLENE™ non-absorbable sutures
and Vicryl™ resorbable sutures was tested at the outset (time zero)
and after 14 days, with comparisons made to a control group.
The results indicated that PRF-110 does not
impact the mechanical properties of either PROLENE™ or Vicryl™
sutures. This clearly suggests that the use of PRF-110 in wound
closure procedures adjacent to surgical sutures is compatible with
suture performance under surgical conditions. These findings are
consistent with the phase III clinical results from the
bunionectomy trial.
Ehud Geller, Chairman and interim CEO of
PainReform, commented, "We are pleased to report that PRF-110 has
demonstrated compatibility with common surgical sutures in our
clinical trials. This important milestone underscores the safety
and efficacy of PRF-110 as we continue to advance our lead product
toward commercialization. The ability to deliver extended pain
relief without compromising suture integrity represents a
significant advancement in post-surgical care."
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.
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on assumptions and assessments made in light of management's
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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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