PainReform Files Patent Covering Highly Scalable Manufacturing Process for PRF-110 Following Successful Completion and Testing
July 24 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 it has filed a patent covering its
new and highly scalable manufacturing process for PRF-110, its
flagship product designed to revolutionize post-operative pain
control. The patent filing follows successful completion and
testing of the new process. This milestone not only marks a
critical step forward in preparation for future potential market
launch of PRF-110, allowing a smooth step-wise increase of batch
manufacturing, but also underscores the Company's commitment to
enhancing manufacturing efficiency and reducing costs.
The key improvements introduced in the
manufacturing process include:
- Continuous Process Manufacturing: Streamlining
production to ensure constant and efficient output, thereby
significantly reducing downtime and increasing overall
productivity.
- Single Reactor Manufacturing: Simplifying the
manufacturing process by using a single reactor, which not only
reduces equipment and maintenance costs but also minimizes the risk
of exposure to contamination.
- Enhanced Batch Size: Incorporating additional
steps that facilitate larger batch sizes while maintaining the
stringent product quality attributes.
These innovative manufacturing techniques are
now being protected by a patent application filed by PainReform,
highlighting the Company's dedication to intellectual property
support. The introduction of these manufacturing improvements is
expected to have a positive impact on the production cost of
PRF-110, leading to a reduction in the cost of goods sold
(COGS).
"We are immensely proud of our team's
achievements in enhancing the manufacturing process for PRF-110,"
said Ehud Geller, Chairman and interim Chief Executive Officer of
PainReform. "These advancements are a testament to our commitment
to innovation, quality, and affordability in pain management. As we
have completed our bunionectomy Phase 3 trial, we believe that
PRF-110 has the potential to set a new standard in post-operative
care, offering patients a safer and more effective option for
non-opioid pain relief."
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 acting Chief
Executive OfficerPainReform Ltd.Tel: +972-54-4236711Email:
egeller@medicavp.com
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