PainReform Files Patent Covering Highly Scalable Manufacturing Process for PRF-110 Following Successful Completion and Testing
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 (Nasdaq: PRFX) ha presentato una domanda di brevetto per un nuovo processo di produzione altamente scalabile per PRF-110, il suo prodotto di punta per il controllo del dolore post-operatorio. Questo sviluppo segue il completamento e il collaudo di successo del processo, segnando un passo significativo verso il potenziale lancio sul mercato. Il processo migliorato include:
- Produzione a Processo Continuo per aumentare la produttività
- Produzione in Unico Reattore per ridurre costi e rischi di contaminazione
- Aumentate Dimensioni dei Lotti mantenendo la qualità
Questi miglioramenti dovrebbero contribuire a ridurre i costi di produzione e i COGS per PRF-110. L'azienda ha completato il suo studio di Fase 3 sulla bunionectomia e crede che PRF-110 possa stabilire un nuovo standard nel sollievo dal dolore post-operatorio non oppioide.
PainReform (Nasdaq: PRFX) ha presentado una patente para un nuevo proceso de fabricación altamente escalable para PRF-110, su producto insignia para el control del dolor postoperatorio. Este desarrollo sigue la finalización y prueba exitosa del proceso, marcando un paso significativo hacia un posible lanzamiento al mercado. El proceso mejorado incluye:
- Fabricación en Proceso Continuo para aumentar la productividad
- Fabricación en Reactor Único para reducir costos y el riesgo de contaminación
- Capacidades Mejoradas de Tamaño de Lote manteniendo la calidad
Se espera que estas mejoras reduzcan los costos de producción y COGS para PRF-110. La empresa ha completado su ensayo de Fase 3 para bunionectomía y cree que PRF-110 podría establecer un nuevo estándar en el alivio del dolor postoperatorio no opioide.
PainReform (Nasdaq: PRFX)는 PRF-110, 자사의 주력 제품인 수술 후 통증 조절 제품을 위한 새로운 고도로 확장 가능한 제조 공정에 대한 특허를 출원했습니다. 이 발전은 공정의 성공적인 완료 및 테스트에 이어지며, 잠재적인 시장 출시를 위한 중요한 단계를 나타냅니다. 개선된 프로세스에는 다음이 포함됩니다:
- 연속 공정 제조로 생산성 증가
- 단일 반응기 제조로 비용 및 오염 위험 감소
- 품질을 유지하면서 향상된 배치 크기 역량
이러한 개선 사항은 PRF-110의 생산 비용 및 COGS를 줄이는 데 기여할 것으로 예상됩니다. 회사는 족저수술 3단계 임상을 완료했으며, PRF-110이 비오피오이드 수술 후 통증 완화의 새로운 기준을 세울 수 있다고 믿고 있습니다.
PainReform (Nasdaq: PRFX) a déposé un brevet pour un nouveau processus de fabrication hautement évolutif pour le PRF-110, son produit phare pour le contrôle de la douleur post-opératoire. Ce développement fait suite à l'achèvement réussi et au test du processus, marquant une étape significative vers un lancement potentiel sur le marché. Le processus amélioré comprend :
- Fabrication en Processus Continu pour augmenter la productivité
- Fabrication en Réacteur Unique pour réduire les coûts et le risque de contamination
- Capacités Améliorées de Taille de Lot tout en maintenant la qualité
Ces améliorations devraient réduire les coûts de production et le COGS pour le PRF-110. L'entreprise a terminé son essai clinique de Phase 3 sur la bunionectomie et estime que le PRF-110 pourrait établir un nouveau standard en matière de soulagement de la douleur post-opératoire non opioïde.
PainReform (Nasdaq: PRFX) hat ein Patent für einen neuartigen, hochgradig skalierbaren Herstellungsprozess für PRF-110, sein flagship Produkt zur Kontrolle postoperativer Schmerzen, eingereicht. Diese Entwicklung folgt auf den erfolgreichen Abschluss und die Testung des Verfahrens, was einen bedeutenden Schritt in Richtung eines möglichen Markteintritts darstellt. Der verbesserte Prozess umfasst:
- Kontinuierliche Prozessproduktion zur Steigerung der Produktivität
- Ein-Reaktor-Produktion zur Kostensenkung und Verringerung des Kontaminationsrisikos
- Verbesserte Chargengrößen bei gleichbleibender Qualität
Diese Verbesserungen werden voraussichtlich die Produktionskosten und die COGS für PRF-110 senken. Das Unternehmen hat seine Phase-3-Studie zur Hallux-Valgus-Operation abgeschlossen und ist der Meinung, dass PRF-110 einen neuen Standard für nicht-opioide postoperative Schmerzbehandlung setzen könnte.
- Filed patent for new, highly scalable manufacturing process for PRF-110
- Successful completion and testing of the new manufacturing process
- Continuous Process Manufacturing implemented for increased productivity
- Single Reactor Manufacturing introduced to reduce costs and contamination risk
- Enhanced Batch Size capabilities while maintaining product quality
- Expected reduction in production costs and Cost of Goods Sold (COGS)
- Completed bunionectomy Phase 3 trial for PRF-110
- None.
TEL AVIV, Israel, July 24, 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 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, LLC
Tel: 212-671-1021
Email: prfx@crescendo-ir.com
Dr. Ehud Geller
Chairman and acting Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com
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