PainReform Bunionectomy Study Observations Confirm Optimal Delivery Method for PRF-110 in Bunionectomy Procedures
PainReform (Nasdaq: PRFX) has successfully determined the optimal delivery method for PRF-110 in bunionectomy procedures, marking a significant milestone in advancing post-surgical pain management. Phase III evaluations have demonstrated PRF-110's superior physical properties, ensuring optimal coverage of cut nerve endings and traumatized tissue surfaces.
Key findings include effective wound coverage, competitive advantages over leading products, enhanced viscosity and uniformity, and precision delivery coverage. PRF-110 exhibited superior adhesion and location adherence compared to competitors, maintaining effectiveness even in the presence of physiological fluids. The product's optimal viscosity and uniformity facilitated ease of application and even distribution across the wound bed.
PainReform (Nasdaq: PRFX) ha determinato con successo il metodo di somministrazione ottimale per PRF-110 nelle procedure di bunionectomia, segnando un'importante pietra miliare nell'avanzamento della gestione del dolore post-operatorio. Le valutazioni di Fase III hanno dimostrato le superiori proprietà fisiche di PRF-110, garantendo una copertura ottimale delle terminazioni nervose recise e delle superfici del tessuto traumatizzato.
I risultati chiave includono una copertura efficace della ferita, vantaggi competitivi rispetto ai prodotti leader, viscosità e uniformità migliorate e copertura di somministrazione precisa. PRF-110 ha mostrato una superiore adesione e aderenza alla posizione rispetto ai concorrenti, mantenendo l'efficacia anche in presenza di fluidi fisiologici. La viscosità e l'uniformità ottimali del prodotto hanno facilitato l'applicazione e la distribuzione uniforme del prodotto sul letto della ferita.
PainReform (Nasdaq: PRFX) ha determinado con éxito el método de entrega óptimo para PRF-110 en procedimientos de bunionectomía, marcando un hito importante en el avance de la gestión del dolor postquirúrgico. Las evaluaciones de la Fase III han demostrado las superiores propiedades físicas de PRF-110, asegurando una cobertura óptima de las terminaciones nerviosas seccionadas y de las superficies de tejido traumatizado.
Los hallazgos clave incluyen una cobertura efectiva de la herida, ventajas competitivas sobre los productos líderes, viscosidad y uniformidad mejoradas, y cobertura de entrega precisa. PRF-110 presentó una mejor adherencia y adherencia a la ubicación en comparación con los competidores, manteniendo la eficacia incluso en presencia de fluidos fisiológicos. La viscosidad y uniformidad óptimas del producto facilitaron la aplicación y distribución uniforme a través del lecho de la herida.
PainReform (Nasdaq: PRFX)는 수술 후 통증 관리의 진전을 나타내는 중요한 이정표인 bunionectomy 절차에서 PRF-110의 최적 전달 방법을 성공적으로 결정했습니다. 3상 평가에서는 PRF-110의 우수한 물리적 특성이 입증되어 절단된 신경 끝과 손상된 조직 표면의 최적 커버리지를 보장했습니다.
핵심 결과로는 효과적인 상처 커버리지, 경쟁 우위가 있는 주요 제품들에 대한 향상된 점도 및 균일성, 그리고 정밀한 전달 커버리지가 있습니다. PRF-110은 경쟁자에 비해 우수한 접착성과 위치 고정을 보여주었으며, 생리학적 액체의 존재에서도 효과를 유지했습니다. 제품의 최적 점도와 균일성은 상처 바닥에서의 적용 용이성과 고른 분포를 촉진했습니다.
PainReform (Nasdaq: PRFX) a déterminé avec succès la méthode de livraison optimale pour PRF-110 dans les procédures de bunionectomie, marquant une étape importante dans l'avancement de la gestion de la douleur post-chirurgicale. Les évaluations de la Phase III ont démontré les propriétés physiques supérieures de PRF-110, garantissant une couverture optimale des extrémités nerveuses sectionnées et des surfaces tissulaires traumatisées.
Les résultats clés incluent une couverture efficace de la plaie, des avantages concurrentiels par rapport aux produits leaders, une viscosité et une uniformité améliorées, et une couverture de livraison précise. PRF-110 a montré une meilleure adhérence et une localisation précise par rapport aux concurrents, maintenant son efficacité même en présence de fluides physiologiques. La viscosité et l'uniformité optimales du produit ont facilité l'application et la distribution uniforme sur le lit de la plaie.
PainReform (Nasdaq: PRFX) hat erfolgreich die optimale Liefermethode für PRF-110 bei Bunionektomie-Verfahren bestimmt und damit einen bedeutenden Meilenstein in der Verbesserung des postoperativen Schmerzmanagements gesetzt. Die Phase-III-Bewertungen haben die überlegenen physikalischen Eigenschaften von PRF-110 gezeigt, die eine optimale Abdeckung der durchtrennten Nervenenden und des traumatisierten Gewebeoberflächen gewährleisten.
Zu den wichtigsten Ergebnissen gehören effektive Wundabdeckung, Wettbewerbsvorteile gegenüber führenden Produkten, verbesserte Viskosität und Uniformität sowie präzise Lieferabdeckung. PRF-110 zeigte eine überlegene Haftung und Standorttreue im Vergleich zu Mitbewerbern und blieb auch in Gegenwart von physiologischen Flüssigkeiten wirksam. Die optimale Viskosität und Uniformität des Produkts erleichterten die Anwendung und gleichmäßige Verteilung auf der Wundfläche.
- Successful determination of optimal delivery method for PRF-110 in bunionectomy procedures
- PRF-110 demonstrated superior coverage and stability in surgical wounds
- Effective wound coverage of both nerve endings and surrounding tissue surfaces
- Superior adhesion and location adherence over the wound bed compared to competitors
- Optimal viscosity and uniformity, maintaining effectiveness in presence of physiological fluids
- Precision delivery coverage using a cannula connected to the syringe's Luer lock
- None.
The Phase III study findings for PRF-110 in bunionectomy procedures reveal promising advancements in post-surgical pain management. The product's superior spreadability and adhesion to wound surfaces address key challenges faced by existing treatments. This could potentially lead to more effective pain control and improved patient outcomes.
However, it's important to note that while these physical properties are encouraging, they don't necessarily guarantee clinical efficacy or safety. The next critical step would be to see how these characteristics translate into actual pain reduction and patient comfort in large-scale clinical trials. Additionally, the cost-effectiveness of PRF-110 compared to current standards of care will be a significant factor in its market potential.
PainReform's progress with PRF-110 could potentially strengthen its market position in the post-surgical pain management sector. The product's unique properties may provide a competitive edge over existing solutions, potentially leading to increased market share and revenue growth if approved.
However, investors should remain cautious. The company is still in the clinical stage and FDA approval is not guaranteed. Moreover, the financial implications of these findings are not yet clear. We need to see data on production costs, pricing strategy and potential market size to fully assess the impact on PainReform's financial outlook. The company's ability to secure funding for further development and commercialization will be important for long-term success.
The post-surgical pain management market is highly competitive, with established players and ongoing innovation. PRF-110's unique properties could potentially disrupt this space, addressing unmet needs in wound coverage and drug delivery. If these advantages translate to superior clinical outcomes, PainReform could capture a significant market share.
However, market acceptance will depend on several factors beyond just product efficacy. Pricing strategy, reimbursement policies and the company's ability to effectively market to healthcare providers will be crucial. Additionally, the regulatory landscape and potential changes in healthcare policies could impact market penetration. It's also worth considering how PRF-110 fits into the broader trend towards multimodal pain management strategies in post-surgical care.
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: prfx@crescendo-ir.com
Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com
FAQ
What are the key findings from PainReform's Phase III study for PRF-110 in bunionectomy procedures?
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