FDA clears PRF Technologies (PRFX) IND for OcuRing-K Phase II eye trial
Filing Impact
Filing Sentiment
Form Type
6-K
Rhea-AI Filing Summary
PRF Technologies Ltd. reported that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for OcuRing™-K, allowing the company to begin a Phase II clinical trial in patients undergoing cataract surgery.
OcuRing™-K is a patent-protected, bio-erodible intraocular ring designed to deliver ketorolac through a single application during surgery, aiming to provide sustained local drug release and reduce reliance on post-operative eye drops for pain and inflammation. PRF expects to start a multi-center Phase II trial in the United States, with patient enrollment planned for the second half of 2026, and views the broader LayerBio ocular platform as a potential source of additional ophthalmic drug-delivery products.
Positive
- None.
Negative
- None.
Insights
FDA IND clearance lets PRF advance OcuRing™-K into U.S. Phase II testing.
The clearance of the Investigational New Drug application for OcuRing™-K moves PRF Technologies’ drop-less ocular drug-delivery platform into Phase II clinical development in cataract surgery patients. This is a standard but important regulatory step that permits mid-stage efficacy and safety evaluation in the United States.
The product uses a bio-erodible intraocular ring to deliver ketorolac via a single intraoperative placement, targeting more consistent pain and inflammation control versus multi-week eye-drop regimens. The company plans to start a multi-center Phase II trial with enrollment expected in the second half of 2026, focusing on pain reduction, inflammation control and safety outcomes.
Because no clinical data or commercial timelines are provided, the long-term impact remains tied to future trial results and regulatory interactions. PRF also notes that its majority-owned LayerBio ocular platform could support additional ophthalmic candidates, suggesting a broader pipeline beyond OcuRing™-K, but without quantified milestones here.
Key Figures
Regulatory milestone: FDA IND clearance
Trial phase: Phase II
Enrollment timing: Second half of 2026
+1 more
4 metrics
Regulatory milestone
FDA IND clearance
Enables U.S. Phase II trial for OcuRing™-K
Trial phase
Phase II
Next-stage clinical development in cataract surgery
Enrollment timing
Second half of 2026
Expected start of patient enrollment for Phase II
Subsidiary ownership
Majority-owned LayerBio, Inc.
Ocular platform subsidiary for OcuRing™-K
Key Terms
Investigational New Drug, sustained-release, intraocular ring, nonsteroidal anti-inflammatory drug (NSAID), +1 more
5 terms
Investigational New Drug regulatory
"FDA has cleared the Company’s Investigational New Drug (“IND”) application"
An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.
sustained-release medical
"a drop-less, sustained-release therapy designed to address pain"
Sustained-release describes a drug formulation designed to release its active ingredient slowly over an extended period instead of all at once, like a time-release capsule that dissolves gradually. For investors, it matters because sustained-release products can improve patient convenience and adherence, extend a drug’s market life, reduce dosing frequency, and create competitive advantages that may affect sales, pricing power, and regulatory considerations.
intraocular ring medical
"bio-erodible intraocular ring designed to deliver ketorolac"
An intraocular ring is a small, implantable medical device placed inside the eye to change its shape or support internal structures, commonly used to correct vision problems or stabilize the lens. For investors, it matters because successful devices require clinical proof and regulatory approval, can create recurring revenue through procedures and follow-up care, and carry risks from adoption rates, competition, and potential safety concerns—think of it as a precision upgrade to a camera lens that needs certification before mass use.
nonsteroidal anti-inflammatory drug (NSAID) medical
"including other NSAID, steroid, antibiotic, and anti-VEGF opportunities"
forward-looking statements regulatory
"This press release contains forward-looking statements about PRF’s expectations"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of April 2026
Commission File Number: 001-39481
PRF Technologies Ltd.
(Translation of registrant’s name into English)
65 Yigal Alon St., Tel Aviv 6744316
Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
The first seven paragraphs of the press release attached hereto as Exhibit 99.1 are incorporated by reference into the Company’s Registration Statements on Form S-8 (Registration No. 333-257968 and 333-265902) and the Company’s Registration
Statements on Form F-3 (Registration No. 333-282264, 333-254982,
333-276485, 333-277594, 333-283655 and 333-286941), to be a part thereof from the
date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
On April 28, 2026, PRF Technologies Ltd. issued a press release entitled “PRF Technologies Announces FDA Clearance of IND Application for OcuRing™-K Phase II Clinical Trial”. A copy of the press
release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Exhibit Index
|
Exhibit No.
|
Description
|
|
|
|
|
|
|
99.1
|
Press Release dated April 28, 2026.
|
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
Date: April 28, 2026
|
PRF TECHNOLOGIES LTD.
|
|
|
|
|
|
|
|
By:
|
/s/ Ehud Geller
|
|
|
|
Ehud Geller
Executive Chairman of the Board
|
Exhibit 99.1
PRF Technologies Announces FDA Clearance of IND Application for
OcuRing™-K Phase II Clinical Trial
Milestone supports advancement of PRF’s drop-less ocular drug-delivery platform into next-stage
U.S. clinical development for post-cataract pain and inflammation
Tel Aviv – April 28, 2026 — PRF Technologies Ltd. (Nasdaq: PRFX) (“PRF” or the “Company”), a clinical-stage specialty pharmaceutical company focused on
reformulating established therapeutics for post-operative pain management, together with its majority-owned subsidiary LayerBio, Inc., today announced that the U.S. Food and Drug Administration has cleared
the Company’s Investigational New Drug (“IND”) application for OcuRing™-K, enabling the initiation of a Phase II clinical trial in patients undergoing cataract surgery.
The IND clearance marks an important regulatory milestone for PRF and advances the Company’s strategy to develop OcuRing™-K as a drop-less, sustained-release therapy designed to address pain and
inflammation following cataract surgery.
OcuRing™-K is a patent-protected, bio-erodible intraocular ring designed to deliver ketorolac through a single intraoperative application. The platform is intended to provide sustained, localized
drug release at the surgical site, potentially eliminating the need for complex post-surgical eye-drop regimens that can burden patients and contribute to inconsistent compliance.
Ehud Geller, Executive Chairman of PRF Technologies, commented, “FDA clearance of the IND for OcuRing™-K is a meaningful milestone for PRF and an important step in advancing our ophthalmic
drug-delivery strategy. We believe OcuRing™-K has the potential to address a clear unmet need in cataract surgery by offering a drop-less, inside-the-eye, sustained-release approach designed to improve treatment consistency and simplify
post-operative care. This IND clearance reflects the progress of the program to date and allows us to move into Phase II clinical development in the United States.”
Following IND clearance and completion of trial-startup activities, PRF plans to initiate a multi-center Phase II clinical trial in the United States, with patient enrollment expected to begin in
the second half of 2026. The study is expected to evaluate endpoints related to pain reduction, inflammation control, and overall safety.
Cataract surgery is one of the most commonly performed surgical procedures worldwide, yet post-operative recovery often still depends on weeks of topical steroid and NSAID eye drops. PRF believes
OcuRing™-K’s sustained-release, intraoperative approach may offer a differentiated alternative by improving drug-delivery consistency, reducing dosing burden, and supporting better patient adherence. PRF has previously highlighted that the broader
LayerBio ocular platform may also support additional ophthalmic applications over time, including other NSAID, steroid, antibiotic, and anti-VEGF opportunities.
Through its majority ownership of LayerBio, Inc., PRF believes it is building a differentiated ophthalmic platform with the potential to expand across multiple product candidates and indications,
while creating an additional long-term value driver within its broader healthcare portfolio.
About PRF Technologies
PRF Technologies (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, PRF 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 PRF’s
strategic commitment to applying precision technology across high-impact sectors including healthcare and sustainable energy. For more information, please visit www.prf-tech.com.
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements about PRF’s expectations, beliefs and intentions including with respect to statements related to the development plan for
OcuRing-K and the timing of enrollment in a Phase II clinical trial. F. 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 OcuRing™-K, LayerBio Inc.’s lead product candidate, and the commercialization of the DeepSolar solution; the outcomes of preclinical studies,
clinical trials and other research regarding PRF-110, OcuRing™-K 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.
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
PRF Technologies Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com
FAQ
What did PRF Technologies (PRFX) announce regarding OcuRing™-K?
PRF Technologies announced that the FDA cleared its IND application for OcuRing™-K, allowing initiation of a Phase II trial in cataract surgery patients. This moves the company’s drop-less, sustained-release ocular drug-delivery platform into the next stage of U.S. clinical development for post-operative pain and inflammation.
What is OcuRing™-K and how is it intended to work for PRFX?
OcuRing™-K is a patent-protected, bio-erodible intraocular ring that delivers ketorolac through a single intraoperative application. It is designed to provide sustained drug release at the surgical site, potentially reducing dependence on weeks of topical eye drops after cataract surgery for pain and inflammation control.
When does PRF Technologies (PRFX) expect to begin the OcuRing™-K Phase II trial?
PRF Technologies plans to initiate a multi-center Phase II clinical trial in the United States after completing trial-startup activities, with patient enrollment expected to begin in the second half of 2026. The study will assess pain reduction, inflammation control, and overall safety in cataract surgery patients.
What endpoints will the PRFX OcuRing™-K Phase II trial evaluate?
The planned Phase II clinical trial for OcuRing™-K is expected to evaluate endpoints related to pain reduction, control of inflammation, and overall safety in patients undergoing cataract surgery. These measures will help determine whether the drop-less, sustained-release approach performs as intended in clinical use.
How does LayerBio relate to PRF Technologies (PRFX) and OcuRing™-K?
LayerBio, Inc. is PRF Technologies’ majority-owned subsidiary and the originator of the ocular drug-delivery platform that includes OcuRing™-K. PRF believes this platform may support additional ophthalmic products, such as other NSAID, steroid, antibiotic, and anti-VEGF applications over time.
What other businesses does PRF Technologies (PRFX) operate besides ocular drug delivery?
Beyond pharmaceutical programs like OcuRing™-K, PRF Technologies also develops AI-driven energy optimization software through its DeepSolar platform. DeepSolar provides tools to monitor, forecast, and optimize energy consumption, particularly in solar-integrated environments, reflecting PRF’s dual focus on healthcare and sustainable energy technologies.