PainReform Ltd. enters into a Strategic Investment Agreement to Expand its Non-Opiate Pain Management Pipeline into Opthamology with LayerBio
PainReform (Nasdaq: PRFX) has announced a strategic investment agreement with LayerBio Inc., acquiring a majority equity stake and board position for up to $3 million in milestone-based investments. The deal expands PainReform's non-opiate pain management pipeline into ophthalmology.
LayerBio's lead product, ܸ龱Բ�-, is a sustained-release intraocular ring delivering anti-inflammatory and analgesic agents post-cataract surgery, targeting a market of 3 million annual U.S. procedures. The initial investment of $600,000 will support a planned Phase II clinical trial, with remaining funds disbursed based on development milestones.
The transaction, expected to close by July 2025, will maintain LayerBio's current management under CEO Dr. Ken Mandell, a Harvard-trained ophthalmologist and biotechnology entrepreneur with extensive experience in drug delivery innovations.
PainReform (Nasdaq: PRFX) ha annunciato un accordo di investimento strategico con LayerBio Inc., acquisendo una quota di maggioranza e una posizione nel consiglio di amministrazione con investimenti basati su milestone fino a 3 milioni di dollari. L'accordo amplia il portafoglio di gestione del dolore non oppioide di PainReform nel campo dell'oftalmologia.
Il prodotto principale di LayerBio, ܸ龱Բ�-, è un anello intraoculare a rilascio prolungato che somministra agenti antinfiammatori e analgesici dopo un intervento di cataratta, rivolgendosi a un mercato di 3 milioni di procedure annue negli Stati Uniti. L'investimento iniziale di 600.000 dollari sosterrà una prevista sperimentazione clinica di Fase II, mentre i fondi rimanenti saranno erogati in base al raggiungimento di specifici obiettivi di sviluppo.
La transazione, che si prevede sarà completata entro luglio 2025, manterrà l'attuale management di LayerBio sotto la guida del CEO Dr. Ken Mandell, oftalmologo formato ad Harvard e imprenditore biotecnologico con vasta esperienza nelle innovazioni per la somministrazione di farmaci.
PainReform (Nasdaq: PRFX) ha anunciado un acuerdo de inversión estratégica con LayerBio Inc., adquiriendo una participación mayoritaria y un puesto en la junta directiva con inversiones basadas en hitos por hasta 3 millones de dólares. El acuerdo amplía la cartera de manejo del dolor no opiáceo de PainReform hacia la oftalmología.
El producto principal de LayerBio, ܸ龱Բ�-, es un anillo intraocular de liberación sostenida que administra agentes antiinflamatorios y analgésicos después de una cirugía de cataratas, dirigido a un mercado de 3 millones de procedimientos anuales en EE. UU.. La inversión inicial de 600,000 dólares apoyará un ensayo clínico de Fase II planificado, con los fondos restantes distribuidos según los hitos de desarrollo alcanzados.
La transacción, que se espera cerrar para julio de 2025, mantendrá la gestión actual de LayerBio bajo la dirección del CEO Dr. Ken Mandell, oftalmólogo formado en Harvard y emprendedor biotecnológico con amplia experiencia en innovaciones de administración de fármacos.
PainReform (나스�: PRFX)� LayerBio Inc.와 전략� 투자 계약� 체결하여 최대 300� 달러� 마일스톤 기반 투자� 다수 지분과 이사� 자리� 확보했습니다. 이번 계약으로 PainReform� 비마약성 통증 관� 파이프라인이 안과 분야� 확장됩니�.
LayerBio� 주력 제품� ܸ龱Բ�-� 백내� 수술 � 항염� � 진통제를 지속적으로 방출하 안구 � 링으�, 연간 미국 � 300� 건의 수술 시장� 목표� 합니�. 초기 투자� 60� 달러� 예정� 2� 임상시험� 지원하�, 나머지 자금은 개발 마일스톤� 따라 지급됩니다.
이번 거래� 2025� 7월까지 완료� 예정이며, 하버� 출신� 안과 전문의이� 바이오테� 기업가� CEO Ken Mandell 박사가 이끄� 기존 LayerBio 경영진은 그대� 유지됩니�.
PainReform (Nasdaq : PRFX) a annoncé un accord d'investissement stratégique avec LayerBio Inc., acquérant une participation majoritaire et un siège au conseil d'administration pour un investissement basé sur des étapes pouvant atteindre 3 millions de dollars. Cet accord étend le portefeuille de gestion de la douleur non opioïde de PainReform à l'ophtalmologie.
Le produit phare de LayerBio, ܸ龱Բ�-, est un anneau intraoculaire à libération prolongée délivrant des agents anti-inflammatoires et analgésiques après une chirurgie de la cataracte, ciblant un marché de 3 millions d'interventions annuelles aux États-Unis. L'investissement initial de 600 000 dollars soutiendra un essai clinique de phase II planifié, les fonds restants étant versés en fonction des étapes de développement atteintes.
La transaction, dont la clôture est prévue d'ici juillet 2025, maintiendra la direction actuelle de LayerBio sous la conduite du PDG Dr Ken Mandell, ophtalmologiste formé à Harvard et entrepreneur en biotechnologie, riche d'une vaste expérience en innovations de délivrance de médicaments.
PainReform (Nasdaq: PRFX) hat eine strategische Investitionsvereinbarung mit LayerBio Inc. bekannt gegeben und erwirbt eine Mehrheitsbeteiligung sowie einen Sitz im Vorstand mit Meilenstein-basierten Investitionen von bis zu 3 Millionen US-Dollar. Der Deal erweitert PainReforms Pipeline für nicht-opioide Schmerzbehandlung in den Bereich der Ophthalmologie.
Das Hauptprodukt von LayerBio, ܸ龱Բ�-, ist ein intraokularer Ring mit verlängerter Wirkstofffreisetzung, der nach einer Kataraktoperation entzündungshemmende und schmerzlindernde Mittel abgibt. Zielmarkt sind 3 Millionen jährliche Eingriffe in den USA. Die Anfangsinvestition von 600.000 US-Dollar unterstützt eine geplante Phase-II-Studie, die restlichen Mittel werden basierend auf Entwicklungsmeilensteinen ausgezahlt.
Die Transaktion, die voraussichtlich bis Juli 2025 abgeschlossen wird, erhält das derzeitige Management von LayerBio unter der Leitung von CEO Dr. Ken Mandell, einem Harvard-ausgebildeten Augenarzt und Biotechnologie-Unternehmer mit umfangreicher Erfahrung in Arzneimittelabgabetechnologien.
- Strategic expansion into ophthalmology market with 3 million annual U.S. cataract surgeries potential
- Majority equity stake and board control in LayerBio for $3 million milestone-based investment
- Addition of experienced leadership with Dr. Ken Mandell, a proven innovator with over 15 U.S. patents
- OcuRing-K offers potential solution to replace problematic post-surgical eye drops
- Additional $2.4 million investment dependent on milestone achievements
- Phase II clinical trials still pending for OcuRing-K, indicating significant development work ahead
Insights
PainReform's strategic investment in LayerBio expands its non-opiate pipeline into the lucrative ophthalmology market with milestone-based funding structure.
PainReform's
LayerBio's OcuRing-K platform addresses a substantial market opportunity with approximately 3 million annual cataract surgeries in the US alone. The technology's "dropless" approach targets critical limitations in current post-surgical eye treatments: poor absorption, compliance issues, and ocular complications. This differentiated approach could drive meaningful adoption if clinically successful.
The retention of LayerBio's management team, particularly Dr. Ken Mandell, brings considerable expertise and intellectual property credentials to this venture. His background in ophthalmic drug delivery (including commercially successful products) and extensive regulatory experience (contributing to numerous IND applications) significantly derisks the development pathway for OcuRing-K's upcoming Phase II trial.
This transaction effectively expands PainReform's addressable market and creates potential for technology platform synergies while maintaining focus on their core mission of non-opiate pain management solutions. The strategic timing allows PainReform to advance its existing lead candidate (PRF-110) while simultaneously establishing a foothold in ophthalmology through a separate but complementary technology platform.
This Investment will add a differentiated ophthalmic platform, targeting an estimated 3 million annual U.S. cataract surgeries with long-acting, “dropless� pain and inflammation treatment
TEL AVIV, Israel, July 10, 2025 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX), today announced, through its pharmaceutical division, the signing of a strategic investment agreement with LayerBio Inc., a privately held Boston biotechnology company developing proprietary, long-acting, non-opiate treatments for ophthalmic surgery.
This agreement marks PainReform’s plan to strategically expand into ophthalmology through the addition of a new drug delivery platform to its specialty pharma, non-opiate pain management pipeline. While the Company continues to advance its lead candidate, PRF-110, for the treatment of post-operative pain in general surgery, this strategic investment introduces a distinct and complementary technology targeting the high-volume cataract surgery market.
LayerBio’s lead product candidate, ܸ龱Բ�-, is a patent-protected, sustained-release intraocular ring designed to deliver anti-inflammatory and analgesic agents following cataract procedures. This “dropless� therapy has the potential to replace traditional post-surgical eye drops, which are often associated with poor absorption, low patient compliance, and ocular surface complications. With approximately 3 million cataract surgeries performed annually in the United States, OcuRing-K has the potential to address a significant clinical and commercial opportunity.
Under the terms of the agreement, PainReform will receive a majority equity stake in LayerBio as well as a majority position on LayerBio’s board in consideration for an investment based on the successful achievement of milestones of an aggregate amount of
The transaction is expected to close by the end of July 2025, subject to customary closing conditions.
“This agreement reflects our plans to broaden PainReform’s non-opiate pain management pipeline through innovative technologies in high-need surgical markets,� said Dr. Ehud Geller, Chairman and interim CEO of PainReform. “We believe LayerBio’s OcuRing-K platform is an ideal fit with our mission, enabling us to participate in the ophthalmology space with a differentiated, clinically promising product.�
Dr. Ken Mandell will continue to lead LayerBio as Chief Executive Officer, guiding its operations and product development efforts. A Harvard-trained ophthalmologist and biotechnology entrepreneur, Dr. Mandell is the founder of LayerBio and a recognized leader in sustained-release drug delivery. He is a co-inventor of TYRVAYA® (approved for dry eye disease) and Aldeyra’s reproxalap eye drop for ocular inflammation and holds over 15 U.S. patents. Over the course of his career, he has contributed to more than a dozen Investigational New Drug (IND) applications and overseen multiple Phase 1�3 clinical trials. Prior to founding LayerBio, Dr. Mandell served as Chief Medical Officer at Aramis Biosciences, Intergalactic Therapeutics, Neurotech Pharmaceuticals, and Noveome Biotherapeutics. He currently serves as a board member and advisor to several ophthalmic and drug delivery companies, including NexEos Bio, Invirsa, and Proteris Biotech.
Dr. Geller continued, “We are looking forward to working with Dr. Ken Mandell and believe that his expertise and vision will be invaluable as he continues to lead LayerBio’s operations and drive the next phase of innovation together.�
PainReform remains committed to expanding its pharmaceutical business through targeted investments and partnerships that support its mission of delivering long-acting, non-opiate therapies to improve surgical recovery and reduce opioid dependence.
About PainReform
PainReform Ltd. (Nasdaq: PRFX) is a company focused on the reformulation of established therapeutics, and a developer of AI-driven energy optimization technologies through its DeepSolar platform. The Company’s pharmaceutical programs leverage a proprietary extended-release drug-delivery system intended to provide prolonged post-surgical pain relief while minimizing the need for repeated dosing and reducing reliance on opioids. Through DeepSolar, PainReform also delivers advanced software solutions that enable both consumers and enterprises to monitor, forecast, and optimize energy consumption—particularly in solar-integrated environments. This dual business model reflects PainReform’s strategic commitment to applying precision technology across high-impact sectors including healthcare and sustainable energy. For more information, please visit .
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements about PainReform’s expectations, beliefs and intentions including with respect to the anticipated benefits to PainReform of its planned strategic investment in LayerBio, the anticipated market opportunity, the timing and completion of the strategic investment, and the planned use of proceeds by LayerBio. .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 and the commercialization of the DeepSolar solution; 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; our ability to maintain our listing on the Nasdaq Capital Market; and statements as to the impact of the political and security situation in Israel on our business, including due to the current war in Israel. 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
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Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
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