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PRF Technologies Ltd. reports developments across clinical-stage specialty pharmaceuticals and AI-driven solar analytics. The company focuses on reformulating established therapeutics for post-operative pain management and, through majority-owned LayerBio, is developing OcuRing™-K, a bio-erodible intraocular ring designed to deliver ketorolac for post-cataract pain and inflammation.
PRF news also covers the company’s DeepSolar business unit, which develops AI-driven digital asset management, forecasting, performance monitoring, and technical due diligence tools for utility-scale solar plants. Recurring updates include ocular drug-delivery regulatory milestones, preclinical and clinical safety data, patent activity, SaaS deployments, commercial collaborations, capital actions, and governance changes.
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) has announced positive early safety results from its ongoing Phase 3 bunionectomy study of PRF-110, a proprietary post-surgical pain formulation. The study, which has completed full enrollment with 443 patients across eight U.S. clinical sites, revealed a low incidence of adverse events, averaging just one per subject.
PRF-110 is positioned as a potential non-opioid alternative in the $12 billion post-operative pain market. The company's Chairman and interim CEO, Ehud Geller, expressed optimism about PRF-110's potential to be a game-changer in post-surgical pain management. The formulation leverages the established safety of ropivacaine and GRAS components, supporting its promising safety profile.
PainReform (Nasdaq: PRFX) has provided a business update for Q2 2024, highlighting significant progress in the clinical development of PRF-110, their lead drug candidate for post-operative pain relief. Key achievements include:
1. Full enrollment (443 patients) in the second part of Phase 3 clinical trial for bunionectomy
2. Favorable wound healing data from human clinical trials
3. Promising PK study results showing safe limits
4. New patent filed for a highly scalable manufacturing process
5. Development of new formulations combining PRF-110 with anti-inflammatory agents
Financial results show increased R&D expenses of $11.4 million, primarily due to the Phase 3 trial. The company's net loss increased to $12.8 million. As of June 30, 2024, PainReform had $2.8 million in cash and cash equivalents, with an additional $4 million raised in April 2024 through a public offering.
PainReform (Nasdaq: PRFX) has successfully developed and manufactured new patented formulations of its extended postoperative pain relief therapy, PRF-110. These formulations combine ropivacaine, a local anesthetic, with dexamethasone, an anti-inflammatory agent, to enhance postoperative recovery and pain management.
The company has created specific combination products containing 3.6% or 3.0% ropivacaine and 0.1-0.5% dexamethasone, which have shown promising stability in ongoing studies. This unique formulation addresses the challenge of product stability in ropivacaine-steroid mixtures.
PainReform's approach aims to provide superior pain management by combining the analgesic effects of ropivacaine with the anti-inflammatory properties of dexamethasone, potentially reducing reliance on opioids post-operatively.
PainReform (Nasdaq: PRFX) has announced favorable safety data for its lead product candidate, PRF-110, a post-operative pain management solution. Pharmacokinetic studies in herniorrhaphy and bunionectomy trials revealed maximum blood levels (Cmax) at approximately 10% of the FDA-established safety threshold for local anesthetics. This safety profile suggests PRF-110's potential for use in a broader range of surgical applications, possibly at higher doses.
PRF-110 is a viscous, oil-based solution applied directly to surgical wound beds, providing localized and extended postoperative analgesia. It uses ropivacaine, considered the safest long-acting local anesthetic, which may allow for higher doses and larger volumes compared to other anesthetics. This development could significantly reduce reliance on opioids and improve patient outcomes across various surgical procedures.
PainReform (Nasdaq: PRFX) has announced favorable wound healing data from human clinical trials for its lead product, PRF-110. The trials, involving both hard tissue (bunionectomy) and soft tissue (hernia) surgeries, showed that PRF-110 promoted normal wound healing and prevented scar formation. These results build upon previous preclinical studies that demonstrated PRF-110's compatibility with normal wound healing.
Key points:
- PRF-110 contains 55% lecithin, which forms liposome-like structures potentially enhancing wound healing
- No abnormalities in wound healing or scar formation were observed in patients treated with PRF-110
- The company is on track to report top-line results from the Phase 3 trial in the second half of 2024
These findings support PRF-110's potential to provide effective post-surgical pain relief while promoting normal wound healing, potentially enhancing patient outcomes.
PainReform (Nasdaq: PRFX) has announced a significant advancement in the development of its lead asset, PRF-110. The company's new highly scalable manufacturing process has enabled PRF-110 to achieve full product stability for 18 months at room temperature. This milestone is important for ensuring the drug's safety and efficacy, while also simplifying handling, transportation, and reducing associated costs.
The stability study is ongoing and marks a significant achievement for PainReform. The company recently filed a new patent for this manufacturing process, which is expected to significantly bolster future commercialization efforts. PainReform is on track to report top-line results from its Phase 3 trial in the second half of 2024, which will further inform the regulatory submission process and potential commercialization plans.
PainReform (Nasdaq: PRFX) has filed a patent for a new, highly scalable manufacturing process for PRF-110, its flagship post-operative pain control product. This development follows successful completion and testing of the process, marking a significant step towards potential market launch. The improved process includes:
- Continuous Process Manufacturing for increased productivity
- Single Reactor Manufacturing for reduced costs and contamination risk
- Enhanced Batch Size capabilities while maintaining quality
These improvements are expected to reduce production costs and COGS for PRF-110. The company has completed its bunionectomy Phase 3 trial and believes PRF-110 could set a new standard in non-opioid post-operative pain relief.
PainReform has successfully completed patient enrollment for the second part of its Phase 3 clinical trial for PRF-110, a novel analgesic drug candidate aimed at treating post-operative pain. The double-blind, placebo-controlled study enrolled 428 patients across eight U.S. sites. The trial's primary endpoint is to determine the drug's efficacy in reducing post-operative pain intensity over 72 hours compared to a placebo. Secondary endpoints include comparisons with Naropin and assessments of safety and rescue analgesic use. The company anticipates reporting top-line data in the second half of 2024, a critical step towards regulatory submission and potential commercialization.
PainReform, a clinical-stage specialty pharmaceutical company, announced it received a notification from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share set forth in Listing Rule 5550(a)(2). The company has 180 days, from May 28, 2024, to November 25, 2024, to regain compliance by maintaining a closing bid price of at least $1 for a minimum of ten consecutive business days. Failure to do so may result in delisting, although the company may be eligible for an additional compliance period if it meets other listing standards. The notification does not immediately affect PainReform’s Nasdaq listing or trading under the symbol 'PRFX'.