PainReform Ltd. Confirms Sutures Compatibility in Human Clinical Trials for PRF-110
TEL AVIV, Israel, Sept. 11, 2024 (GLOBE NEWSWIRE) -- 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.
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, LLC
Tel: 212-671-1021
Email: [email protected]
Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: [email protected]
