PainReform Bunionectomy Study Observations Confirm Optimal Delivery Method for PRF-110 in Bunionectomy Procedures
PRF-110 Demonstrates Superior Coverage and Stability in Surgical Wounds
Findings Highlight PRF-110's Competitive Edge
Over Leading Pain Management Products
TEL AVIV, Israel, Aug. 21, 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 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, 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]
