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Positive Phase 1b/2 Results from Ongoing REC-4881 TUPELO Trial Demonstrate Rapid and Durable Reductions in Polyp Burden in Familial Adenomatous Polyposis (FAP) at 25 Weeks

  • REC–4881 (4 mg QD) achieved rapid clinical activity, with 75% of evaluable patients showing reductions in total polyp burden and a 43% median reduction after 12 weeks of treatment (n=12)
  • After 12 weeks off therapy (week 25 of the study), 82% of evaluable patients (9 of 11) maintained a durable reduction in total polyp burden, with a 53% median reduction observed from baseline
  • Natural history analysis showed that 87% of untreated FAP patients – who resembled the inclusion criteria of TUPELO – had annualized polyp–burden increase, 10% remained stable, and 3% showed modest decrease—underscoring the disease’s progressive trajectory (n=55)
  • 40% of patients (4 out of 10) achieved a ≥1–point improvement in Spigelman stage—a clinically meaningful measure of upper GI disease severity to assess surveillance and clinical management
  • REC–4881 (4 mg QD) has a safety profile consistent with MEK1/2 inhibition, with the majority of treatment–related adverse events being Grade 1 or 2, Grade 3 events occurring in 15.8% of the safety–evaluable patients, and no Grade ≥4 TRAEs reported to date
  • First clinical validation of the Recursion OS, demonstrating how unbiased phenotypic and mechanistic insights—such as MEK1/2 rescue of APC loss–of–function—can translate to novel, differentiated therapeutics for diseases like FAP with no approved therapy and high prevalence of >50,000 patients in US and EU5
  • Next steps: Engage the FDA in the 1H26 to define a potential registration pathway, and in parallel, expand the population from ≥55 to ≥18 years old, and further optimize dosing schedule

SALT LAKE CITY, Dec. 08, 2025 (GLOBE NEWSWIRE) — Recursion (Nasdaq: RXRX), a clinical–stage TechBio company decoding biology to radically improve lives, today announced positive Phase 1b/2 data from the ongoing TUPELO trial of REC–4881, an investigational allosteric MEK1/2 inhibitor for familial adenomatous polyposis (FAP).

Through an unbiased phenotypic screen of thousands of compounds, the earliest version of the Recursion OS identified selective MEK1/2 inhibition as a highly specific mechanism capable of reversing APC loss–of–function signatures. Using high–content cellular phenomics driven by AI, REC–4881 emerged as one of the strongest phenotypic rescue hits, reverting APC–deficient cells toward a healthy state and suppressing ERK/MAPK hyperactivation downstream of APC loss. Guided by this AI–driven insight, Recursion in–licensed REC–4881 from Takeda and redirected REC–4881—originally evaluated clinically in solid tumors—as a mechanistically aligned therapeutic candidate for FAP. REC–4881 is now the first MEK1/2 inhibitor ever studied clinically for this disease.

“The durable polyp burden reduction demonstrated by REC–4881—especially the sustained effect seen at Week 25, 12 weeks after completing therapy—is highly encouraging for the FAP community,” said Jessica Stout, D.O., Assistant Clinical Professor, University of Utah School of Medicine, and Principal Investigator of the TUPELO study. “Given the near–100% lifetime risk of colorectal cancer and the absence of any approved medical therapies, patients today often face a lifetime of intensive surveillance and life–altering surgeries. These Phase 2 results provide a meaningful basis for hope and support the potential for REC–4881 to offer a much–needed non–surgical option for this debilitating, life–long disease.”

“These Phase 2 results mark a meaningful validation of the Recursion OS,” said Chris Gibson, Ph.D., Co–Founder and CEO of Recursion. “An unbiased phenotypic insight from our platform and driven by AI—linking MEK1/2 inhibition to APC loss–of–function biology—has now translated into rapid, substantial, and durable reductions in polyp burden in patients. This is a powerful example of how even the earliest versions of the Recursion OS can uncover therapeutic opportunities in diseases with no approved pharmacotherapy options. And since this discovery, we’ve only added to the breadth, depth, and power of the Recursion OS; we believe this is the first of many potential medicines that will advance as our flywheel of discovery accelerates.”

In the Phase 2 portion of the study, REC–4881 demonstrated rapid and durable reductions in polyp burden, with 43% median reduction in evaluable patients after 12 weeks of treatment. 75% of evaluable patients had a reduction in polyp burden in this same period. Importantly, the effect persisted well beyond the dosing period: 82% of evaluable patients (9 of 11) maintained reductions at Week 25—12 weeks after stopping therapy—with a 53% median decrease from baseline. These results are especially meaningful when considered alongside real–world natural history analyses showing that untreated FAP patients are expected to experience increases when left untreated.

“This program reflects a full validation cycle of the Recursion OS: an unbiased phenotypic signal identifying MEK1/2 inhibition as a rescue mechanism for APC loss–of–function, followed by mechanistic confirmation, clinical translation, and now encouraging human data in a disease with no approved medical therapies,” said Najat Khan, Ph.D., Chief R&D and Commercial Officer and incoming President and CEO. “REC–4881, an allosteric MEK1/2 inhibitor, represents a first precision–medicine approach for the causal biology of FAP. In TUPELO, we are seeing rapid, substantial, and durable reductions in polyp burden — including sustained benefit after patients stop therapy. Equally important, our ClinTech and real–world data capabilities have been instrumental in guiding this program — from refining eligibility to contextualizing a single–arm dataset with a first–of–its–kind natural history study.”

About FAP

FAP is one of the most clinically significant hereditary colorectal cancer syndromes and is caused by inactivating mutations in the APC gene, leading to the growth of hundreds to thousands of gastrointestinal polyps and a near 100% risk of developing colorectal cancer before the age of 40 if left untreated. With no approved pharmacotherapies, excisions followed sequentially by debilitating, life altering surgeries remain the only option to remove polyps and polyp burdened organs, typically involving colectomy in the early 20s. While this procedure removes immediate colon cancer risk, it does not address the underlying disease biology and does not prevent future polyp formation. Patients will continue to develop polyps in the rectum or upper GI tract, with approximately 50% of patients requiring subsequent life–altering surgical procedures to manage the persistent disease. Current treatment approaches lead to substantial long–term loss of quality of life, affecting continence, fertility, and long–term gastrointestinal function in relatively young patients. Approximately 90% of FAP patients go on to develop duodenal adenomas, with 6% eventually undergoing a high–morbidity risk duodenectomy to control polyp growth. FAP affects an estimated >50,000 individuals across the US and EU5 (France, Germany, Italy, Spain, and the UK).

Background on REC–4881 and Recursion’s Platform Insights

REC–4881 was discovered using one of the earliest versions of the Recursion OS (v0.1), through an unbiased, high–content AI–driven phenotypic screening approach in APC–deficient human cell models. Because FAP is driven by loss–of–function mutations in the APC gene, the platform was designed to identify molecules capable of rescuing APC–dependent biology—guided entirely by cellular phenotype, without presupposing any specific mechanism. Using AI/ML to extract and compare over a thousand morphological features that distinguish “diseased” from “healthy” states, the Recursion OS screened numerous investigative compounds and identified REC–4881 as one of the most robust phenotype–rescuing hits. In follow–up assays, REC–4881 consistently reverted APC–deficient cells toward a healthy–state phenotype and demonstrated potent, selective, and concentration–dependent MEK1/2 inhibition that was not seen across hundreds of other oncogenes and tumor suppressor models tested.

Importantly, the Recursion OS highlighted MEK1/2 inhibition as a mechanistic strategy to exploit a therapeutic vulnerability arising from APC loss in FAP—a disease area where MEK1/2 inhibition had not previously been investigated as a therapeutic strategy in a clinical setting. Based on this novel insight, Recursion in–licensed REC–4881 from Takeda, where it had been evaluated in solid tumors, and redirected it as the first MEK1/2 inhibitor advanced clinically for FAP. This program represents the power of a phenotype–first AI–driven discovery model: the platform surfaced a mechanistically aligned therapeutic opportunity solely through scaled high–dimensional exploration.

Today, the Company is using the Recursion OS 2.0 platform—including proprietary ClinTech capabilities of large–scale real–world evidence (RWE) analytics—to further advance the REC–4881 program. This includes a comprehensive natural history collaboration with Amsterdam University Medical Center, home to one of the largest and longest–running FAP registries, as well as analysis of more than 1,000 US FAP patients and 250,000 physician notes processed through Recursion’s custom LLM–based pipeline. Together, these data reinforce the relentlessly progressive nature of FAP, highlight the absence of spontaneous polyp regression, and demonstrate the substantial burden of repeated polyp–removal procedures and major surgeries experienced by real–world patients.

ClinTech insights also helped refine the design of the ongoing TUPELO trial, including expanding age eligibility from ≥55 to ≥18. This expansion was based on a thorough risk–benefit analysis, enabling evaluation of REC–4881 in younger patients who represent a substantial portion of FAP patients. REC–4881 has received Fast Track and Orphan Drug designations from the US FDA, as well as Orphan Drug designation from the European Commission.

Results of the Phase 2 Data for Ongoing REC–4881 Trial

Efficacy and Durability Findings

As of the November 25, 2025 data cutoff in the open–label Phase 2 portion of TUPELO, treatment with REC–4881 (4 mg QD) demonstrated meaningful and durable reductions in polyp burden in patients with FAP.

Week 13 Assessment

  • REC–4881 produced a median 43% reduction in total polyp burden among 12 efficacy–evaluable patients.
  • The majority of evaluable patients responded, with 75% showing reductions in polyp burden after 12 weeks of therapy.
  • 40% of patients (4 out of 10) achieved a ≥1–point improvement in Spigelman stage—a clinically meaningful measure of upper GI disease severity to assess surveillance and clinical management.
  • Other investigational agents currently under evaluation in separate studies generated approximately 17–29% median reduction in polyp burden after 12 months of treatment; no off–treatment durability was reported (Biodexa press release, June 24 2024)

Figure 1: Waterfall plot showing percent change from baseline in total polyp burden at Week 13 for efficacy–evaluable patients receiving REC–4881 (4 mg QD)

Week 25 Assessment

  • After 12 weeks of treatment, patients went off treatment for an additional 12–weeks. Durability of effect was maintained during the off–treatment observation period with 82% of patients responding (>0% reduction; 9 out of 11) at Week 25.
  • 73% achieved durable ≥30% reductions in polyp burden with a 53% median reduction in total polyp burden observed.
  • 40% of patients (4 out of 10) maintained a ≥1–point improvement in Spigelman stage from baseline.

Figure 2: Waterfall plot showing percent change from baseline in total polyp burden at Week 25 for efficacy–evaluable patients receiving REC–4881 (4 mg QD)

Safety Summary

As of the data cutoff, treatment with 4 mg REC–4881 demonstrated a safety profile generally consistent with prior MEK1/2 inhibitors.

  • Across the combined Phase 1b and Phase 2 safety cohorts (n=19), 94.7% of patients reported at least one treatment–related adverse event (TRAE), the majority of which were Grade 1/2 in severity. The most frequent TRAEs (≥10%) included: dermatitis acneiform / rash and blood CPK increase.
  • Grade 3 TRAEs occurred in 15.8% of patients; no Grade ≥4 TRAEs have been reported to date.
  • Treatment modifications were infrequent, with 2 of 19 patients experiencing dose interruption.

Figure 3: Summary of adverse events across Phase 1b and Phase 2 of the TUPELO trial

About the TUPELO Trial Design and Expanded Population
The Phase 1b/2 TUPELO trial is evaluating the safety, tolerability, pharmacokinetics (PK), and efficacy of REC–4881 monotherapy in patients with familial adenomatous polyposis (FAP).

Study Design and Analysis

Efficacy is assessed via upper and lower endoscopy at baseline, Week 13 (on–treatment), and Week 25 (off–treatment).

  • The primary endpoint is percent change from baseline in polyp burden, which is the sum of all polyp diameters in the GI.
  • The Efficacy Evaluable Population includes patients with measurable disease at baseline who received ≥75% of study drug and had at least one post–baseline endoscopic assessment. Disease staging uses the Spigelman system for upper GI polyposis and the InSiGHT classification for the lower GI tract.

Natural History Analyses
To better understand the natural history of FAP and to contextualize the single–arm efficacy of REC–4881, we collaborated with Amsterdam University Medical Center to analyze a registry of ~200 patients with FAP. 55 of these patients met the key inclusion criteria of TUPELO. We also leveraged our clinical development technology (ClinTech) platform to analyze US electronic health records (EHR), including physician notes, of ~1,000 FAP patients to assess disease progression and treatment patterns in the US. Both studies revealed high patient burden and progressive natural history of the disease. Results of the studies suggest that the natural history of FAP is to progress with relentless precancerous polyp progression: 87% of untreated patients in the registry experienced annualized increase in polyp burden. 10% were stable and 3% experienced a modest decrease in polyp burden. Mean increase of 60% and median increase of 28% in annualized polyp burden was observed. At least 75% of patients in the US EHR database had a major invasive surgery along with frequent polypectomies during follow–up.

Next Steps
Recursion plans to expand the population from ≥55 to ≥18 years old and further optimize dosing schedule. In parallel, the Company intends to engage the FDA in 1H26 to define a potential registration pathway.

Forward Looking Statements
This document contains information that includes or is based upon “forward–looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding Recursion’s anticipated engagement with the FDA; the clinical relevance of the TUPELO trial data and obtaining additional confirmatory data; advancing potential transformational therapies for FAP and beyond; subsequent REC–4881 studies, including expanded enrollment and alternate dosing schedule, and their results and advancing Recursion’s REC–4881 program further; the size of the potential FAP patient population; Recursion OS and other technologies potential and advancement of the future of medicine; business and financial plans and performance; and all other statements that are not historical facts. Forward–looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10–K and Quarterly Reports on Form 10–Q. All forward–looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.

About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously generate one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine–learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine. Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Montréal, New York, London, and the Oxford area. Learn more at www.recursion.com, or connect on X and LinkedIn.

Media Contact
[email protected]
Investor Contact
[email protected]

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GLOBENEWSWIRE (Distribution ID 9598312)

Sabin Vaccine Institute’s Investigational Marburg Vaccine Delivered to Ethiopia for Outbreak Response

WASHINGTON, Dec. 04, 2025 (GLOBE NEWSWIRE) — The Sabin Vaccine Institute (Sabin) has sent more than 640 doses of its investigational cAd3–Marburg Vaccine to Ethiopia to support the country’s response to its first–ever outbreak of Marburg virus disease. Marburg is a highly contagious hemorrhagic fever disease and can have a high case fatality rate of up to 88%. There are currently no licensed vaccines or treatments for Marburg.

Soon after Marburg was confirmed as the virus causing a hemorrhagic fever outbreak in Ethiopia’s southern region, the Ethiopia Ministry of Health engaged Sabin and the U.S. government to request access to Sabin’s investigational cAd3–Marburg Vaccine. The U.S. government approved this request. The Biomedical Advanced Research and Development Authority (BARDA), part of U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response (ASPR), funds the development and manufacture of Sabin’s investigational vaccine candidate.

Sabin and the Ethiopia Ministry of Health have entered into a clinical trial agreement under which Sabin is providing BARDA–funded investigational cAd3–Marburg Vaccine doses for a two–cohort Phase 2, rapid response, open–label, randomized trial to assess safety, efficacy, and immunogenicity. Under this approved protocol, Cohort A is limited to high–risk health care and front–line workers or individuals who have had direct contact with infected persons within 21 days, the incubation period for Marburg virus disease. All other health care and front–line workers and contacts will be randomized in Cohort B, some receiving vaccine on Day 1 and others on Day 22 of the trial.

“The Ethiopian Ministry of Health reached out to Sabin early in the outbreak, and we have been working in partnership to support Minister of Health Dr. Mekdes Daba and her team,” says Sabin Chief Executive Officer Amy Finan. “We’ve built on our previous outbreak response experience to quickly assist our Ethiopian colleagues as requested.”

In addition to coordinating directly with the Minister of Health and the Armauer Hansen Research Institute (AHRI), Sabin is also working closely with manufacturing partner ReiThera, clinical research organization IQVIA and the Coalition for Epidemic Preparedness Innovations (CEPI) – the same organizations that came together to support Rwanda’s response to their 2024 outbreak. With authorization from ASPR, Sabin provided cAd3–Marburg Vaccine to the Rwanda Biomedical Center for use in a Phase 2 clinical trial.

Ethiopia’s Ministry of Health has confirmed 13 Marburg infections, including eight deaths, in their most recent update. Another three deaths are suspected but not confirmed. Officials continue to express concern about the outbreak’s proximity to fragile health settings in nearby Kenya and South Sudan.

In addition to Sabin’s single–dose cAd3–Marburg Vaccine being used in a Phase 2 outbreak clinical trial in Rwanda, the vaccine is also in Phase 2 clinical trials in the U.S., Uganda and Kenya. More than 2000 trial participants have received the vaccine and no significant safety concerns have been reported. Results from Phase 1 clinical trials and nonclinical studies indicate that the vaccine is safe and elicits rapid, robust immune responses.

The Sabin cAd3–Marburg Vaccine doses have been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract numbers 75A50119C00055 and 75A50123C00010. 

Once rare, Marburg virus disease outbreaks have surged in Africa in recent years, with incidents reported in 2023 in Tanzania and Equatorial Guinea, in 2024 in Rwanda and in 2025 in Tanzania. Marburg is transmitted from fruit bats to humans, spreading from person to person through contact with infected bodily fluids. 

About the Sabin Vaccine Institute

The Sabin Vaccine Institute is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a non–profit with three decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on X, @SabinVaccine.

About the cAd3 Platform 

In August 2019, Sabin announced exclusive agreements with GSK for Sabin to advance the development of the prophylactic candidate vaccines against the deadly Zaire ebolavirus, Sudan virus, and Marburg virus. The three candidate vaccines were initially developed collaboratively by the U.S. National Institutes of Health and Okairos, which was acquired by GSK in 2013. The candidate vaccines, based on GSK’s proprietary cAd3 (Chimpanzee Adenovirus Type 3) platform, were further developed by GSK, including the Phase 2 development for the Zaire ebolavirus vaccine. Under the agreements between GSK and Sabin, Sabin exclusively licensed the technology for all three candidate vaccines and acquired certain patent rights specific to these vaccines. Sabin is developing the cAd3–Marburg Vaccine and cAd3–Sudan Vaccine, both are in Phase 2 clinical trials in the US and Africa.  

Media Contact: 
Monika Guttman 
Media Relations Specialist 
Sabin Vaccine Institute 
+1 (202) 662–1841 
[email protected] 

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c29e0887–de65–45d0–9d2f–4365a8bc78ea


GLOBENEWSWIRE (Distribution ID 9597202)

Minovia Therapeutics Mitochondrial Augmentation Technology to be Featured in Presentation and Workshop at the 67th ASH Annual Meeting and Exposition

HAIFA, Israel, Nov. 20, 2025 (GLOBE NEWSWIRE) — Minovia Therapeutics Ltd. (“Minovia” or the “Company”), a clinical–stage biotechnology company developing novel therapies to treat mitochondrial diseases and combat age–related decline, announces that data collected by research teams at Memorial Sloan Kettering Cancer Center (MSK) and Shaare Zedek Medical Center (SZMC) featuring the Company’s mitochondrial augmentation technology in myelodysplastic syndrome (MDS) will be presented at the 67th American Society of Hematology’s (ASH) Annual Meeting and Exposition on December 6–9, 2025 in Orlando, FL. The data will be featured in an oral presentation to be held on Saturday, Dec 6, 2PM ET (abs25–9123_abstract), as well as part of a workshop called, “Mitochondria and metabolism – clinical trials,” to be held Friday, Dec 5, 5:10PM ET.

The oral presentation, to be presented by principal investigator Dr. Omar Abdel–Wahab, will outline the MSK team’s progress with Minovia’s mitochondrial augmentation technology in pre–clinical studies using an MDS animal model, as well as the SZMC team’s work studying the lead product, MNV–201, in low risk MDS patients treated in a Phase 1b clinical trial.1 To date, MNV–201 has demonstrated a high safety and tolerability profile in the seven patients receiving treatment, with no anti–mitochondrial antibodies nor drug–related adverse events. One patient experienced transfusion independence with rising hemoglobin levels that have since been sustained for more than 10 months. The same patient also demonstrated improvement in blood–based biomarkers of mitochondrial function.

“The data we continue to see with our lead product, MNV–201, is encouraging, and we are grateful to the MSK nonclinical and SZMC clinical teams for spearheading the research to demonstrate its utility in this indication. We are excited by the possibility suggested by preclinical studies that mitochondrial augmentation of hematopoietic stem and progenitor cells may enable delay in disease progression to Acute Myeloid Leukemia (AML), and by the positive preliminary clinical response. We believe this continues to demonstrate the great potential of mitochondrial augmentation, first highlighted at ASH in a presentation by Dr. Elad Jacoby selected as ‘Best of ASH’ in 2018. We will continue to develop our program to facilitate the introduction of this treatment modality into the MDS context,” said Minovia Co–founder and CEO, Natalie Yivgi–Ohana, Ph.D.

MNV–201 has been granted Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration for MDS, and both Fast Track and Rare Pediatric Disease Designation for Pearson Syndrome.

The Company also announced entry into a definitive business combination agreement (the “Business Combination Agreement”) with Launch One Acquisition Corp. (Nasdaq: LPAA, “Launch One”), a publicly traded special purpose acquisition company. Following the expected closing of the transaction contemplated by this Business Combination Agreement (the “Business Combination”), projected for early 2026, the combined company will operate as Minovia Therapeutics and trade on Nasdaq under a new ticker symbol.

About MDS

MDS is defined by ineffective hematopoiesis resulting in blood cytopenia, and clonal instability with a risk of evolution to AML. Patients with MDS collectively have a high symptom burden and are also at risk of death from complications of cytopenia and AML. The goals of therapy for patients with MDS are to improve cytopenia, reduce disease–associated symptoms and the risk of disease progression and death, thereby improving both quality of life and lifespan. The median age at diagnosis of MDS is ~70 years, but surprisingly some of the Pearson Syndrome patients develop MDS in a much higher prevalence relative to the disease population. About 15% of the MDS patients will present with Sideroblastic Anemia, the most common symptom in Pearson Syndrome. Minovia developed novel blood biomarkers to measure mitochondrial health and has been able to demonstrate for the first time that MDS is presumably an age–related mitochondrial disease. As such, Minovia is currently conducting a Phase Ib study of MNV–201 in low–risk MDS patients. Six out of the nine expected patients in the study have been dosed so far.

About MNV–201

MNV–201 is a first–in–class cell therapy that uses Minovia’s proprietary Mitochondrial Augmentation Technology (MAT) to add healthy, energy–producing mitochondria into a patient’s own stem cells — aiming to restore organ function and improve health. In early–stage clinical studies, MAT has demonstrated a strong safety profile and signs of multi–system benefit in patients with Pearson Syndrome, including improvements in growth, muscle function, hematologic stability, and improved quality of life.

About Minovia Therapeutics

Minovia Therapeutics, chaired by John Cox, is a clinical–state biotechnology company working on treatments to replace dead or defective mitochondria with new healthy mitochondria, helping people with mitochondrial diseases and fighting aging. Minovia’s main treatment, MNV–201, is already being tested for Pearson Syndrome and Myelodysplastic Syndrome. Minovia is also developing ways to help people live longer, healthier lives. Based in Haifa, Israel, where it operates a GMP facility for mitochondrial drug substance and drug product manufacturing for clinical trials related to its therapy, Minovia is planning to expand operations to the U.S. For more information, visit www.minoviatx.com.

About Launch One Acquisition Corp.

Launch One Acquisition Corp. is a company set up to merge with and take public an exciting business in healthcare or technology. Listed on Nasdaq under the ticker LPAA, Launch One is led by experienced leaders who want to support game–changing solutions. For more information, contact Jurgen van de Vyver at [email protected].

Additional Information and Where to Find It

In connection with the Business Combination and the Business Combination Agreement, among Launch One, Minovia and Mito US One Ltd., a newly formed Israeli company limited by shares (“Pubco”), and certain other parties named therein. Launch One and Minovia intend to file relevant materials with the U.S. Securities and Exchange Commission (“SEC”), including a Registration Statement on Form F–4 of Pubco (the “Registration Statement”), which will include a proxy statement/prospectus of Launch One, and will file other documents regarding the proposed Business Combination with the SEC. This communication is not intended to be, and is not, a substitute for the proxy statement/prospectus or any other document that Launch One has filed or may file with the SEC in connection with the proposed Business Combination. The Registration Statement has not been filed or declared effective by the SEC. Following such filing and upon such declaration of effectiveness, the definitive proxy statement/prospectus contained within the Registration Statement and other relevant materials for the proposed Business Combination will be mailed or made available to stockholders of Launch One as of a record date to be established for voting on the proposed Business Combination.

Before making any voting or investment decision, investors and stockholders of Launch One are urged to carefully read, when they become available, the entire Registration Statement, the proxy statement/prospectus, and any other relevant documents filed with the SEC, as well as any amendments or supplements to these documents, and the documents incorporated by reference therein, because they will contain important information about Launch One, Minovia, Pubco and the proposed Business Combination . Launch One’s investors and stockholders and other interested persons will also be able to obtain copies of the Registration Statement, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, other documents filed with the SEC that will be incorporated by reference therein, and all other relevant documents filed with the SEC by Launch One and/or Pubco in connection with the Business Combination, without charge, once available, at the SEC’s website at www.sec.gov, or by directing a request to Launch One or Minovia at the addresses set forth below.

Participants In the Solicitation

Launch One, Minovia, Pubco and their respective directors, executive officers, other members of management and employees may be deemed participants in the solicitation of proxies from Launch One’s stockholders with respect to the Business Combination. Investors and security holders may obtain more detailed information regarding the names, and interests in the Business Combination, of Launch One’s directors and officers in Pubco's and Launch One’s filings with the SEC, including, when filed with the SEC, the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, amendments and supplements thereto, and other documents filed with the SEC. Such information with respect to Minovia’s directors and executive officers will also be included in the proxy statement/prospectus. You may obtain free copies of these documents as described above under the heading “Additional Information and Where to Find It.”

Non–Solicitation

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Launch One, Pubco, or Minovia, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

Forward–Looking Statements

This press release includes certain statements that may be considered forward–looking statements within the meaning of the federal securities laws. Forward–looking statements include, without limitation, statements about future events or Minovia’s, Launch One's, or Pubco's future financial or operating performance. For example, statements regarding the development and regulatory approval of MNV–201, the implications of Fast Track Designation, RPD and PRVs and the timing of future clinical trials or potential applications are forward–looking statements. In some cases, you can identify forward–looking statements by terminology such as “may,” “should,” “could,” “might,” “plan,” “possible,” “project,” “strive,” “budget,” “forecast,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” “potential” or “continue,” or the negatives of these terms or variations of them or similar terminology.

These forward–looking statements regarding future events and the future results of Minovia or Launch One are based on current expectations, estimates, forecasts, and projections about the industry in which Minovia or Launch One operates, as well as the beliefs and assumptions of Minovia’s and Launch One's management. These forward–looking statements are only predictions and are subject to, without limitation, (i) known and unknown risks, including the risks and uncertainties indicated from time to time in the final prospectus of Launch One relating to its initial public offering filed with the SEC, including those under “Risk Factors” therein, and other documents filed or to be filed with the SEC by Launch One or Pubco; (ii) uncertainties; (iii) assumptions; and (v) other factors beyond Minovia’s or Launch One's control that are difficult to predict because they relate to events and depend on circumstances that will occur in the future. They are neither statements of historical fact nor promises or guarantees of future performance. Therefore, Minovia’s actual results may differ materially and adversely from those expressed or implied in any forward–looking statements and Minovia and Launch One therefore caution against relying on any of these forward–looking statements.

These forward–looking statements are based upon estimates and assumptions that, while considered reasonable by Minovia and its management, as the case may be, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Minovia’s or Launch One's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the occurrence of any event, change or other circumstances that could give rise to the termination of the Business Combination Agreement and any subsequent definitive agreements with respect to the Business Combination; (ii) the outcome of any legal proceedings that may be instituted against Launch One, Minovia, Pubco, or others following the announcement of the Business Combination and any definitive agreements with respect thereto; (iii) the inability to complete the Business Combination due to the failure to obtain consents and approvals of the shareholders of Launch One and Minovia, to obtain financing to complete the Business Combination or to satisfy other conditions to closing, or delays in obtaining, adverse conditions contained in, or the inability to obtain necessary regulatory approvals required to complete the transactions contemplated by the Business Combination Agreement; (iv) changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; (v) projections, estimates and forecasts of revenue and other financial and performance metrics, projections of market opportunity and expectations, and the estimated implied enterprise value of Minovia; (vi) Minovia’s ability to scale and grow its business, and the advantages and expected growth of Minovia; (vii) Minovia’s ability to source and retain talent, and the cash position of Minovia following closing of the Business Combination; (viii) the ability to meet stock exchange listing standards in connection with, and following, the consummation of the Business Combination; (ix) the risk that the Business Combination disrupts current plans and operations of Minovia as a result of the announcement and consummation of the Business Combination; (x) the ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, the ability of Minovia to grow and manage growth profitably, maintain key relationships and retain its management and key employees; (xi) costs related to the Business Combination; (xii) changes in applicable laws, regulations, political and economic developments; (xiii) the possibility that Minovia may be adversely affected by other economic, business and/or competitive factors; (xiv) Minovia’s estimates of expenses and profitability; (xv) the failure to realize estimated shareholder redemptions, purchase price and other adjustments; and (xvi) other risks and uncertainties set forth in the filings by Launch One and Minovia with the SEC. There may be additional risks that neither Launch One nor Minovia presently know or that Launch One and Minovia currently believe are immaterial that could also cause actual results to differ from those contained in the forward–looking statements. Any forward–looking statements made by or on behalf of Launch One or Minovia speak only as of the date they are made. Neither Launch One nor Minovia undertakes any obligation to update any forward–looking statements to reflect any changes in their respective expectations with regard thereto or any changes in events, conditions or circumstances on which any such statements are based.

Contact

Minovia Therapeutics Ltd.
Natalie Yivgi Ohana, Co–Founder and CEO
+972–74–7039954
[email protected]

Launch One Acquisition Corp.
Jurgen van de Vyver
[email protected]
+1–510–692–9600

Investor Relations
Dave Gentry, CEO
RedChip Companies
+1–407–644–4256
[email protected]

Investor Relations
Jules Abraham
Managing Director, Communications
CORE IR
1–212–655–0924
[email protected]

___________________________
1 Dr. Abdel–Wahab has financial interests related to Minovia Therapeutics.


GLOBENEWSWIRE (Distribution ID 9579259)

شركة Profound Medical توقع اتفاقية توزيع حصرية لمنتجات TULSA-PRO®وSonalleve® مع شركة Al Faisaliah Medical Systems في المملكة العربية السعودية

الاتفاقية تفتح المجال أمام علاجات Profound التي لا تستلزم أي جراحة أو إشعاع لاستئصال الأنسجة المريضة، لتخترق بذلك أكبر سوق للرعاية الصحية في الشرق الأوسط

تم الحصول بالفعل على جميع الموافقات التنظيمية اللازمة لاستيراد وبيع تقنيتي الاستئصال المتقدمتين من شركة Profound في المملكة العربية السعودية

تورنتو والرياض، المملكة العربية السعودية, Nov. 13, 2025 (GLOBE NEWSWIRE) —

يسر شركة Profound Medical (NASDAQ:PROF; TSX:PRN) (“Profound” أو “الشركة”)، وهي شركة أجهزة طبية في مرحلة تجارية تُطوّر وتُسوّق علاجات بدون جراحات تعمل بالذكاء الاصطناعي (“AI”)، وموجهة بالرنين المغناطيسي، لاستئصال الأنسجة المريضة، أن تُعلن أنها أبرمت اتفاقية توزيع وتوريد حصرية لتقنيتي TULSA–PRO® و Sonalleve®في المملكة العربية السعودية مع شركة Al Faisaliah Medical Systems (“FMS”)، وهي شركة تابعة لإحدى أبرز تكتلات الأعمال في المملكة، مجموعة Al Faisaliah Group (“AFG”).

وتعد Profound الشركة الوحيدة التي تجمع بين قدرات التصوير في الوقت الحقيقي والتصوير الحراري للرنين المغناطيسي (“MR”) مع تصميمات العلاج التي تعتمد على الذكاء الاصطناعي للسماح للأطباء بمعالجة الأنسجة المريضة بدقة ولطف دون أي جراحة أو غلي أو كي الأنسجة المرتبطة أو فقدان الدم أو الألم الشديد/ المُطوَّل أو الحاجة إلى الإقامة في المستشفى لليلة واحدة.

يظل التسويق التجاري لدواء TULSA–PRO، المُصمم خصيصًا لعلاج أمراض البروستاتا (سرطان البروستاتا وتضخم البروستاتا الحميد “BPH” أو أيٍ منهما) في الولايات المتحدة هو الأولوية القصوى لفريق المبيعات المباشرة للشركة. يمثل TULSA Procedure™، الذي يتم إجراؤه باستخدام نظام TULSA–PRO من Profound، تقدمًا كبيرًا في علاج البروستاتا. بدلاً من الجراحة أو الإشعاع، يتم تطبيق إجراء TULSA داخل جناح التصوير بالرنين المغناطيسي لتسخين أنسجة البروستاتا بدقة ولطف “وصولًا لدرجة الحرارة اللازمة للقضاء على الأنسجة المريضة” (55–57 درجة مئوية) باستخدام الموجات فوق الصوتية الاتجاهية، مع حماية الأعصاب المحيطة والبنية التشريحية. من حيث نية العلاج، في حين أن TULSA–PRO يتمتع بالمرونة التي تمكننا من استخدامه في جميع عمليات الاستئصال، بما في ذلك الاستئصال البؤري واستئصال نصف الغدة، فإن غالبية إجراءات TULSA هي إما استئصال الغدة بالكامل أو استئصال الغدة بالكامل تقريبًا. في أواخر عام 2024، أصدرت مراكز الرعاية الطبية والخدمات الطبية (CMS) في الولايات المتحدة القاعدة النهائية لنظام الدفع المستقبلي للمرضى الخارجيين (OPPS) (“القاعدة النهائية”) لرموز الفئة 1 الجديدة CPT® وأوصافها التي تغطي إجراء TULSA، والتي دخلت حيز التنفيذ في 1 يناير 2025. بموجب القاعدة النهائية، تم وضع سداد تكاليف TULSA في تصنيف الدفع الخارجي لمستوى 7 في طب المسالك البولية (APC). حتى الآن، خضع أكثر من 4000 رجل لإجراء TULSA، واعتبارًا من آخر تقرير (أكتوبر 2025)، بلغ عدد أنظمة TULSA–PRO المثبتة لدى Profound 67 نظامًا.

ويحظى المنتج الثاني لشركة Profound، وهو Sonalleve، والذي يُقدّم يتم في المقام الأول كعملية بيع رأسمالية لمرة واحدة، باهتمام تجاري متزايد، وخاصة خارج الولايات المتحدة. يستخدم Sonalleve نفس تقنية التصوير بالرنين المغناطيسي والتصوير الحراري مثل TULSA–PRO، ويجمع ذلك مع الموجات فوق الصوتية المركزة من خارج الجسم لعلاج الأمراض. توجد حاليًا عشرة أجهزة Sonalleve عاملة في أجزاء من أوروبا والصين وجنوب شرق آسيا – حيث تم بالفعل علاج أكثر من 4000 امرأة باستخدام هذه التكنولوجيا لعلاج الانتباذ البطاني الرحمي والأورام الليفية الرحمية، وهي أمراض تصيب الرحم ويمكن أن تسبب آلامًا مزمنة وحيضًا ثقيلًا وطويلًا أو أيًا منهما. وقد أثبت العلاج باستخدام Sonalleve تخفيف الألم والأعراض دون التأثير على احتياطي المبيض، كما تشير تقارير إلى محافظة النساء على خصوبتهن بعد العلاج. ويُستخدم Sonalleve الآن أيضًا في الأبحاث والتجارب السريرية في أوروبا لاستئصال أنسجة سرطان البنكرياس وأمراض الأورام الأخرى. على مدى السنوات الخمس الماضية، قدمت منظمات الأبحاث في أوروبا وكندا ما يقرب من 10 مليون دولار أمريكي لإجراء المزيد من الأبحاث السريرية باستخدام Sonalleve لعلاج أمراض متعددة تهدد الحياة في كثيرٍ من الأحيان.

مع استمرار تزايد اهتمام المستخدمين بتقنيات Profound، تنشر الشركة فريق المبيعات المباشرة الخاص بها في أمريكا الشمالية، في حين تتعاون مع شركاء توزيع استراتيجيين مختارين لدعم إمكانات الأعمال وقاعدة العملاء في أجزاء أخرى من العالم.

وصرح Arun Menawat، الرئيس التنفيذي ورئيس مجلس إدارة شركة Profound، قائلاً: “يشرفنا أن نتعاون مع شركة FMS، إحدى شركات توزيع الأجهزة الطبية الرائدة في المملكة العربية السعودية، لتوزيع كل من TULSA–PRO وSonalleve”. “إن التسويق والتوزيع الناجحين لعلاجاتنا الخالية التي لا تستلزم جراحة لاستئصال الأنسجة المريضة يتطلب فهمًا عميقًا لديناميكيات السوق الإقليمية والاحتياجات المحددة للأطباء والمرضى المحليين. وبفضل سجلها الحافل في تقديم إجراءات الأورام المتقدمة وغيرها من التقنيات الطبية في المملكة، فإننا على ثقة بأن شركة FMS هي الشريك المثالي لنا”.

قال المدير العام لشركة FMS، السيد Abdullah Al Melik: “مع توجه المملكة العربية السعودية نحو التنوع الاقتصادي في إطار رؤية 2030، تلتزم كل من FMS وشركتنا الأم، AFG، بالقيام بدور حاسم في تشكيل مستقبل البلاد. وتعد المجموعة من أهم مُقدمي المعدات والخدمات للمستشفيات القائمة، كما تمتلك وتدير مرافقها الطبية المتخصصة بفعاليةٍ. بفضل شراكتنا مع شركة Profound، نحن متحمسون للغاية لتقديم تقنياتها الفريدة التي لا تستلزم الجراحة أو الإشعاع إلى المستشفيات ومراكز العلاج السعودية التي تهدف إلى أن تكون رائدة عالميًا في نتائج المرضى. نتطلع إلى العمل بشكل وثيق مع فريق Profound.”

نبذة عن شركة Al Faisaliah Medical Systems

تأسست شركة FMS في عام 1973، وكانت في البداية قسم الرعاية الصحية التابع لشركة AFG، حتى تأسيسها كشركة مستقلة في عام 1993. بفضل سابقة أعمالها الضخمة التي تضم العديد من الشركاء والمنتجات، تتمكن الشركة من تقديم حلول متكاملة ومعقدة لمعدات الرعاية الصحية من مصدر واحد لأكبر مقدمي الرعاية الصحية في المنطقة. تعد شركة FMS مزودًا رئيسيًا لحلول الرعاية الصحية المتنوعة، وذلك من خلال انتشار عملياتها في جميع أنحاء المملكة العربية السعودية، حيث توفر أحدث المعدات والحلول لمختلف الاستخدامات مثل الأورام والعمليات والملاحظة والرعاية الحرجة وأمراض القلب والأوعية الدموية وغيرها. لمزيد من المعلومات، يُرجى زيارة www.tibbiyah.com/fms.

نبذة عن Al Faisaliah Group

AFG هي شركة قابضة مملوكة للقطاع الخاص يقع مقرها الرئيسي في الرياض، المملكة العربية السعودية، وتعمل في جميع أنحاء الشرق الأوسط. وقد اشتق اسم الشركة من اسم مؤسسها عبدالله الفيصل الابن الأكبر للملك الراحل فيصل بن عبد العزيز. تأسست المجموعة في عام 1971، وتلعب أدوارًا قياديةً في العديد من الصناعات بما في ذلك منتجات الألبان والإلكترونيات والرعاية الصحية وخدمات الطعام. وتدير AFG أيضًا ذراع رأس المال الاستثماري لشركات (Al Faisaliah Ventures) التي تستثمر في الشركات الرائدة عالميًا وإقليميًا. وتحظى المجموعة بتقدير كبير في مختلف أنحاء المنطقة بفضل قيمها الراسخة وإدارتها المحترفة وشراكاتها الاستراتيجية التي تمتد لعقود من الزمن مع شركات محلية وعالمية رائدة بما في ذلك Sony وDanone وPhilips. لمزيد من المعلومات، يُرجى زيارة www.alfaisaliah.com.

نبذة عن شركة Profound Medical

Profound هي شركة أجهزة طبية في مرحلة تجارية تُطوّر وتُسوّق علاجات بدون جراحات تعمل بالذكاء الاصطناعي (“AI”)، وموجهة بالرنين المغناطيسي، لاستئصال الأنسجة المريضة.

تعمل شركة Profound على تسويق TULSA–PRO® وهي تقنية تجمع بين التصوير بالرنين المغناطيسي في الوقت الفعلي والتخطيط المعزز بالذكاء الاصطناعي والموجات فوق الصوتية عبر مجرى البول التي يتم تشغيلها آليًا والتحكم في درجة الحرارة ذات الحلقة المغلقة. إن إجراء TULSA Procedure™‎، الذي يتم إجراؤه باستخدام نظام TULSA–PRO، لديه القدرة على أن يصبح طريقة علاج رئيسية في جميع أنوع أمراض البروستاتا؛ بدءًا من سرطان البروستاتا منخفض أو متوسط أو عالي الخطورة؛ إلى المرضى الهجينين الذين يعانون من سرطان البروستاتا وفرط تنسج البروستاتا الحميد (“BPH”)؛ إلى الرجال المصابين بتضخم البروستاتا الحميد فقط؛ وأيضًا، إلى المرضى الذين يحتاجون إلى علاج إنقاذي لسرطان البروستاتا الموضعي المتكرر بالإشعاع. يستخدم إجراء TULSA توجيهات التصوير بالرنين المغناطيسي في الوقت الفعلي لضمان الدقة في الحفاظ على القدرة على التحكم في البول والوظيفة الجنسية لدى المرضى، مع قتل أنسجة البروستاتا المستهدفة من خلال تقنية امتصاص الصوت الدقيقة التي تسخنها بلطف حتى تصل إلى 55–57 درجة مئوية. إجراء TULSA هو إجراء جراحي لا يستلزم جراحة أو إشعاع ويتم إجراؤه في جلسة واحدة تستغرق بضع ساعات. يمكن علاج جميع أشكال وأحجام البروستاتا تقريبًا بأمان وفعالية وكفاءة باستخدام إجراء TULSA. لا ينطوي الإجراء على نزيف؛ ولا يتطلب الأمر البقاء في المستشفى؛ ويبلغ معظم مرضى TULSA عن تعافيهم السريع وعودتهم إلى روتينهم الطبيعي. تم وضع علامة CE على منتج TULSA–PRO، وتمت الموافقة عليه من قبل وزارة الصحة الكندية، وتمت الموافقة عليه بموجب 510(k) من قبل Food and Drug Administration (“FDA”).

تقوم شركة  Profoundبتسويق Sonalleve®، وهي منصة علاجية مبتكرة حاصلة على علامة CE لعلاج الأورام الليفية الرحمية، والانتباذ العضلي الليفي، وتخفيف آلام نقائل العظام، والأورام الليفية العضلية، وأورام العظام العظمية. كما تمت الموافقة على Sonalleve من قبل إدارة المنتجات الطبية الوطنية الصينية لعلاج الأورام الليفية الرحمية غير الجراحية، وحصل على موافقة FDA بموجب الإعفاء الإنساني للجهاز لعلاج ورم العظم العظمي. وتجري شركة Profound حالياً المراحل الأولى من استكشاف أسواق علاجية محتملة إضافية لجهاز Sonalleve حيث ثبت أن هذه التقنية لها تطبيقات سريرية، مثل الاستئصال غير الجراحي لسرطانات البطن والحرارة العالية لعلاج السرطان.

البيانات التطلعية

يتضمن هذا البيان الصحفي بيانات تطلعية بشأن شركة Profound وأعمالها والتي قد تشمل، على سبيل المثال لا الحصر، التوقعات المتعلقة بفعالية تقنية Profound في علاج سرطان البروستاتا، وتضخم البروستاتا الحميد، والأورام الليفية الرحمية، وعلاج الألم التلطيفي، وورم العظام العظمي؛ ومدى وتوقيت استكمال Profound لمبيعات نظام TULSA–PRO®‎ من قنوات المبيعات المؤهلة؛ وتوقعات Profound للإيرادات المستقبلية؛ ونجاح إستراتيجية Profound التجارية وأنشطتها فيما يتعلق بـ TULSA–PRO. في كثير من الأحيان، ولكن ليس دائمًا، يمكن التعرف على البيانات التطلعية من خلال استخدام كلمات مثل “يخطط”، “من المتوقع”، “يتوقع”، “مجدول”، “ينوي”، “يتأمل”، “يتوقع”، “يعتقد”، “يقترح” أو الاختلافات (بما في ذلك الاختلافات السلبية) لهذه الكلمات والعبارات، أو تنص على أن بعض الإجراءات أو الأحداث أو النتائج “قد” أو “يمكن” أو “سوف” يتم اتخاذها أو حدوثها أو تحقيقها. وتستند مثل هذه البيانات إلى التوقعات الحالية لإدارة شركة Profound. قد لا تقع الأحداث والظروف التطلعية التي تمت مناقشتها في هذا البيان الصحفي بحلول تواريخ محددة أو قد لا تقع على الإطلاق وقد تختلف ماديًا نتيجة لعوامل الخطر المعروفة وغير المعروفة وعدم اليقين الذي يؤثر على الشركة، بما في ذلك المخاطر المتعلقة بصناعة الأجهزة الطبية، والموافقات التنظيمية، والسداد، والعوامل الاقتصادية، وأسواق الأسهم بوجهٍ عامٍ والمخاطر المرتبطة بالنمو والمنافسة. على الرغم من أن Profound حاولت تحديد العوامل المهمة التي قد تتسبب في اختلاف الإجراءات أو الأحداث أو النتائج الفعلية بشكل مادي عن تلك الموصوفة في البيانات التطلعية، إلا أنه قد تكون هناك عوامل أخرى تتسبب في اختلاف الإجراءات أو الأحداث أو النتائج عن تلك المتوقعة أو المقدرة أو المقصودة. لا يمكن ضمان أي بيان تطلعي. تم وصف العوامل والمخاطر الأخرى التي قد تؤدي إلى اختلاف النتائج الفعلية بشكل مادي عن تلك المنصوص عليها في البيانات التطلعية في التقرير السنوي لشركة Profound على النموذج 10–K والملفات الأخرى المقدمة إلى هيئات تنظيم الأوراق المالية الأمريكية والكندية، والمتاحة على www.sedarplus.ca وwww.sec.gov. باستثناء ما تقتضيه قوانين الأوراق المالية المعمول بها، فإن البيانات التطلعية تتحدث فقط اعتبارًا من تاريخ إصدارها، ولا تتعهد Profound بأي التزام بتحديث أو مراجعة أي بيان تطلعي علنًا، سواء نتيجة لمعلومات جديدة أو أحداث مستقبلية أو غير ذلك، بخلاف ما يقتضيه القانون.

لمزيد من المعلومات، يرجى التواصل مع:

Stephen Kilmer
علاقات المستثمرين
[email protected]
هاتف: 647.872.4849


GLOBENEWSWIRE (Distribution ID 9575020)

Profound Medical Inks Exclusive Distribution Agreement for TULSA-PRO® and Sonalleve® with Al Faisaliah Medical Systems in Saudi Arabia

Agreement creates runway for Profound’s incision–free and radiation–free therapies for the ablation of diseased tissue, to penetrate the largest healthcare market in the Middle East

All required regulatory approvals to import and sell Profound’s two advanced ablative technologies in Saudi Arabia are already in place

TORONTO and RIYADH, Saudi Arabia, Nov. 11, 2025 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial–stage medical device company that develops and markets artificial intelligence (“AI”)–powered, MRI–guided, incision–free therapies for the ablation of diseased tissue, is pleased to announce that it has entered into an exclusive distribution and supply agreement for its TULSA–PRO® and Sonalleve® technologies in Saudi Arabia with Al Faisaliah Medical Systems Co. (“FMS”), a subsidiary of one of the Kingdom’s most prominent business conglomerates, Al Faisaliah Group (“AFG”).

Profound is the only company that combines the real–time imaging and thermography capabilities of magnetic resonance (“MR”) with AI–driven treatment designs to allow physicians to precisely and gently address diseased tissue without any incision, associated tissue boiling or charring, blood loss, severe/prolonged pain, or need for overnight hospital stay.

U.S. commercialization of TULSA–PRO, designed specifically for the treatment of prostate disease (prostate cancer and/or benign prostatic hyperplasia, “BPH”), remains the top priority for the Company’s direct sales team. The TULSA Procedure™, performed using Profound’s TULSA–PRO system, is a significant advancement in prostate care. Instead of surgery or radiation, the TULSA procedure is performed inside an MRI suite to precisely and gently heat prostate tissue to ‘kill temperature’ (55–57°C) with directional ultrasound, while protecting surrounding nerves and anatomy. By intention–to–treat, while TULSA–PRO has the flexibility to be used for all ablations, including focal and hemi–gland, the majority of TULSA Procedures are either whole–gland or near–whole–gland ablations. In late 2024, the U.S. Centers for Medicare & Medicaid Services (CMS) issued its outpatient prospective payment system (OPPS) final rule (“Final Rule”) for the three new CPT® Category 1 codes and their descriptors covering the TULSA procedure, which became effective on January 1, 2025. With the Final Rule, TULSA reimbursement was established at Urology Level 7 Ambulatory Payment Classification (APC). To–date, more than 4,000 men have undergone the TULSA Procedure, and as of last report (October 2025), Profound’s TULSA–PRO installed base stood at 67 systems.

Profound’s second product, Sonalleve, which is offered primarily as a one–time capital sale, is also gaining increasing commercial interest, particularly outside of the United States. Sonalleve uses the same MR imaging and thermographic technology as TULSA–PRO, and combines that with focused ultrasound from outside the body to treat disease. There are currently ten Sonalleve devices operational in parts of Europe, China and Southeast Asia – where over 4,000 women have already been treated with the technology for adenomyosis and uterine fibroids, diseases of the uterus that can cause chronic pain and heavy and/or prolonged menstruations. Treatment with Sonalleve has demonstrated pain and symptom relief without affecting the ovarian reserve, and with reports of women preserving their fertility. Sonalleve is also now being used in research and clinical trials in Europe for the ablation of pancreatic cancer tissue and other oncological disease. Over the last five years, approximately $10 million has been granted by research organizations in Europe and Canada to further conduct clinical research using Sonalleve for multiple, often life–threatening, diseases.

As user interest in Profound’s technologies continues to build, the Company is deploying its own direct sales team in North America, while partnering with select strategic distribution partners to support the business potential and the customer base in other parts of the world.

“We’re honored to partner for the distribution of both TULSA–PRO and Sonalleve with FMS, one of the leading medical device distributors in the Kingdom of Saudi Arabia,” commented Profound’s CEO and Chairman, Arun Menawat. “Successfully marketing and distributing our incision–free therapies for the ablation of diseased tissue requires a deep understanding of regional market dynamics and the specific needs of local clinicians and patients. With its proven track record in introducing advanced oncological procedures and other medical technologies in the Kingdom, we’re confident that FMS is the ideal partner for us.”

FMS’ GM, Mr. Abdullah Al Melik, said, “As Saudi Arabia moves toward economic diversification under Vision 2030, both FMS and our parent company, AFG, are committed to playing a crucial role in shaping the country’s future. The group is a major provider of equipment and services to existing hospitals, and also actively owns and operates its own specialized medical facilities. With our partnership with Profound, we're extremely excited to bring its unique, incision– and radiation–free ablative technologies to Saudi hospitals and treatment centers that aim to be worldwide leaders in patient outcomes. We look forward to working closely with the Profound team.”

About with Al Faisaliah Medical Systems Co.

Founded in 1973, FMS was initially the healthcare division of AFG, until its establishment as an independent company in 1993. Its broad portfolio of partners and products enables it to deliver complex, integrated, single–source healthcare equipment solutions to the largest healthcare providers in the region. With operations across the Kingdom of Saudi Arabia, FMS is a major provider of diversified healthcare solutions, supplying state–of–the–art equipment and solutions for various uses such as oncology, operations, monitoring and critical care, cardiovascular and others. For further information, visit www.tibbiyah.com/fms.

About Al Faisaliah Group

AFG is a privately held holding company headquartered in Riyadh, Saudi Arabia, operating across the wider Middle East. Its name is derived from the name of its founder, Abdullah Al Faisal, eldest son of the late King Faisal. Founded in 1971, the Group holds leading positions in multiple industries including Dairy, Electronics, Healthcare and Food Service. AFG also operates a corporate venture capital arm (Al Faisaliah Ventures) that invests in global and regional disruptive players. The Group is recognized across the region for its strongly–held values, professional management and decades–long strategic partnerships with leading local and global firms including notably Sony, Danone and Philips. For further information, visit www.alfaisaliah.com.

About Profound Medical Corp.

Profound is a commercial–stage medical device company that develops and markets AI–powered, MRI–guided, incision–free therapies for the ablation of diseased tissue.

Profound is commercializing TULSA–PRO®, a technology that combines real–time MRI, AI–enhanced planning, robotically–driven transurethral ultrasound and closed–loop temperature feedback control. The TULSA Procedure™, performed using the TULSA–PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low–, intermediate–, or high–risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio–recurrent localized prostate cancer. The TULSA Procedure employs real–time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55–57°C. The TULSA Procedure is an incision– and radiation–free “one–and–done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with the TULSA Procedure. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA–PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).

Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. Sonalleve has also been approved by the China National Medical Products Administration for the non–invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. Profound is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non–invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Forward–Looking Statements

This release includes forward–looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma; the extent and timing of Profound’s completion of TULSA–PRO® system sales from its qualified sales pipeline; Profound’s expectations for future revenues; and the success of Profound’s commercialization strategy and activities for TULSA–PRO. Often, but not always, forward–looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward–looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward–looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward–looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward–looking statements are described in Profound's Annual Report on Form 10–K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.ca and www.sec.gov. Except as required by applicable securities laws, forward–looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward–looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

For further information, please contact:

Stephen Kilmer
Investor Relations
[email protected]
T: 647.872.4849


GLOBENEWSWIRE (Distribution ID 9573632)

NeOnc Technologies (Nasdaq: NTHI) to Host Investor Conference Call to Present Data Updates from Ongoing NEO100-1 Phase 1/2a Clinical Trial and Compassionate Use Program

CALABASAS, Calif., Nov. 07, 2025 (GLOBE NEWSWIRE) — NeOnc Technologies Holdings, Inc. (NTHI) (“NeOnc” or the “Company”), a clinical–stage biopharmaceutical company developing novel brain–penetrant therapeutics for patients with malignant brain tumors and central nervous system (CNS) disorders, today announced that it will host an investor conference call and webcast on Wednesday, November 12, 2025, at 6:00 a.m. Pacific Time / 9:00 a.m. Eastern Time (prior to market open).

During the call, members of the NTHI management team and independent members of the company’s Scientific Advisory Board (SAB) will present data updates from the Company’s ongoing Phase 1/2a NEO100–1 clinical trial and compassionate use program, evaluating intranasal delivery of NEO100 (high–purity perillyl alcohol) in patients with recurrent high grade malignant glioma.

The discussion will highlight MRI–based radiographic response data, progression–free survival (PFS), and overall survival (OS) trends observed to date, providing important insights into long–term clinical outcomes for patients treated with NEO100.

Featured Participants:

  • Dr. Henry S. Friedman, MD – Deputy Director, Preston Robert Tisch Brain Tumor Center, Duke University; Independent Member, NTHI Scientific Advisory Board
  • Dr. Alexander Miller, MD – Chief Neuro–oncology, Brain Tumor Program, NYU Langone Health; Independent Member, NTHI Scientific Advisory Board
  • NTHI Management Team:
    • Amir Heshmatpour – Chief Executive Officer, Executive Chairman and President
    • Dr. Thomas C. Chen, MD, PhD – Chief Medical Officer and Chief Scientific Officer
    • Dr. Josh Neman, PhD – Chief Clinical Officer
    • Keith Garnett – Chief Financial Officer

Conference Call Details:

  • Date: Wednesday, November 12, 2025
  • Time: 6:00 a.m. PT / 9:00 a.m. ET
  • Webcast: A live webcast can be accessed by visiting https://investors.neonc.com

ABOUT NEONC TECHNOLOGIES HOLDINGS, INC.
NeOnc Technologies Holdings, Inc. is a clinical–stage life sciences company focused on the development and commercialization of central nervous system therapeutics that are designed to address the persistent challenges in overcoming the blood–brain barrier. The company’s NEO™ drug development platform has produced a portfolio of novel drug candidates and delivery methods with patent protections extending to 2038. These proprietary chemotherapy agents have demonstrated positive effects in laboratory tests on various types of cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast–Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions.

For more about NeOnc and its pioneering technology, visit neonc.com.

Important Cautions Regarding Forward–Looking Statements
This press release contains “forward–looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward–looking statements can be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “plan,” “budget,” “forecast,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward–looking information.

Examples of forward–looking statements include, among others, statements regarding whether a definitive agreement will be reached with Quazar. These statements reflect our current expectations based on information available at this time, but future events may differ materially from those anticipated.

The “Risk Factors” section of our most recent Annual Report on Form 10–K filed with the Securities and Exchange Commission, along with other cautionary language in that report or in our subsequent filings, outlines important risks and uncertainties. These may cause our actual results to differ materially from the forward–looking statements herein, including but not limited to the failure to finalize the agreement with Quazar, modifications to its terms, or alternative uses of proceeds.

We assume no obligation to revise or update any forward–looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations.

“NEO100” and NEO “212” are registered trademarks of NeOnc Technologies Holdings, Inc.

Company Contact:
[email protected]

Investor Contact:
James Carbonara
Hayden IR
(646)–755–7412
[email protected]


GLOBENEWSWIRE (Distribution ID 9571142)

PharmaJet® Signs Distribution Agreement with EVA Pharma to Provide Needle-free Injection Systems to Support Routine Polio Immunization in Egypt

GOLDEN, Colo. and CAIRO, Oct. 31, 2025 (GLOBE NEWSWIRE) — PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling needle–free injection technology, today announced that it has signed a Distribution Agreement with ATR, an affiliate to EVA Pharma, the leading pharmaceutical company driving healthcare innovation and access across the Middle East and Africa. The agreement, signed in Frankfurt at the CPHI meeting on October 30, 2025, includes provisions for Tropis distribution, technology transfer, and manufacturing.

The aim of the collaboration is to increase needle–free access within Egypt and regionally while broadening Egypt’s manufacturing capabilities. PharmaJet’s Tropis® intradermal needle–free delivery offers several strategic advantages for Egypt including substantial polio immunization cost savings1, reduced vaccine hesitancy2,3, increased coverage3, and the potential for medical technology regional manufacturing. The signing follows the July 2025 Memo of Understanding (MOU) that was signed between PharmaJet, Egypt’s Unified Procurement Agency (UPA) and EVA Pharma, which outlined plans for how UPA could incorporate Tropis into its portfolio.

The introduction of Tropis into immunization programs supports Egypt’s “1000 Golden Days” initiative which was launched to support the health and development of families during the critical period from conception to a child's second birthday. The collaboration will enable total immunization cost reduction and improved acceptability of polio vaccinations. Longer–term, the Tropis manufacturing and other needle–free product development initiatives may expand the benefits to vaccination against other infectious agents and improved pandemic preparedness.

EVA Pharma is a leading pharmaceutical and medical appliances manufacturing company that has vast experience in manufacturing, registering, marketing, distributing, and promoting pharmaceutical products. “This collaboration puts children first,” said Riad Armanious, CEO of EVA Pharma. “We’re reimagining vaccination through local innovation that improves every child’s experience while empowering healthcare professionals. By localizing manufacturing, we expand access and use existing budgets to reach many more children in Africa sustainably.”

“We are proud to collaborate with ATR and EVA Pharma to localize needle–free manufacturing and delivery,” said Paul LaBarre, Senior Vice President of Business Development for PharmaJet. “This partnership represents a strategic step forward for PharmaJet in the Middle East and Northern Africa region. Working with these innovative teams will accelerate integration of needle–free intradermal vaccine delivery into routine immunization programs in Egypt and beyond.”

Refer to Instructions for Use to ensure safe injections and to review risks.

1 Data on file
2 Soonawala, D et al, Intradermal fractional booster dose of inactivated poliomyelitis vaccine with a jet injector in healthy adults, Vaccine, Volume 31, Issue 36, 12 August 2013, Pages 3688–3694
3 Mohan, D et al, Evaluating the impact of needle–free delivery of inactivated polio vaccine on Nigeria’s routine immunization program: An implementation hybrid trial , Vaccines,16 May 2025, 13(5), p.533

Media Contacts:
Nancy Lillie
[email protected]
1–888–900–4321 Option 3
Marina Faltas
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a68cea50–6f2b–4c9d–80af–cf4a85632192


GLOBENEWSWIRE (Distribution ID 1001136225)

Inteleos Opens Africa Office to Advance Basic Obstetric Point of Care Ultrasound (OPOCUS) Certification Across East Africa

ROCKVILLE, Md. and NAIROBI, Kenya, Oct. 30, 2025 (GLOBE NEWSWIRE) — Inteleos, a global nonprofit healthcare certification organization, expands its commitment to working on the ground in Africa to elevate the standard of global healthcare with the opening of an office with a dedicated, local team in Nairobi, Kenya. Inteleos Africa, opened in October 2025, will focus on improving the quality of and access to Point–of–Care Ultrasound (POCUS) education and certification in East Africa and beyond.

Improving Outcomes Through Certification

Through education and validation of clinical proficiency by certification, the ultimate goal is to improve maternal and fetal health outcomes. In addition, certification stands to expand economic and employment opportunities for frontline clinicians, especially midwives and nurses. Inteleos will continue its prior work in Kenya in collaboration with the Ministry of Health and their new certification requirements to set standards that other nations will follow as a model for improving maternal–fetal outcomes.

“Certification ensures that the pockets and pilots of POCUS training meet the global standard of proficiency while aligning with the local scope of practice. This ensures sustainable proficiency and accessible quality of care,” noted Pamela Ruiz, Chief Business Development Officer at Inteleos. “Our ongoing collaboration with Kenya’s Ministry of Health and stakeholders on the ground shows how local and global leadership can drive meaningful change.”

Global Experience, Local Impact

Inteleos and its related organizations bring a 50–year legacy of working with communities of practice and institutions to ensure equitable access to quality care through sonography and other imaging certification, including POCUS and obstetric POCUS (OPOCUS) certification programs. Inteleos has certified more than 150,000 healthcare practitioners of varying levels in 113 different countries. As a leading provider of certification in Africa, Inteleos has actively worked in Kenya for the last three years and also brings certifications to the country that are ISO certified.

The first Inteleos Africa executive is Steven Opondo, the new Director of Partnerships and Growth. “Kenya is pioneering approaches that will help transform healthcare outcomes regionally,” said Mr. Opondo. “Having an Inteleos Africa team on the ground will accelerate adoption of international standards and benefit patients across Africa.”

Nairobi was chosen as the location for Inteleos’ first Africa office since Kenya is at the forefront of setting standards and policies that will transform patient care. While OPOCUS certifications are accepted across the globe, Kenya is the only nation that requires certification for OPOCUS trainers. The Kenya Ministry of Health has set out the certification requirements as a part of its National Obstetrics Point of Care Ultrasound (O–POCUS) Guidelines, with the goal of improving maternal and fetal health outcomes.

Supporting Growth and Collaboration

Inteleos Africa will participate in two upcoming events: The Kenya Medical Association OPOCUS training and certification event in late October and the African Venture Philanthropy Alliance (AVPA) conference in early November.

For more information on Inteleos Africa, visit Inteleos.org/Africa_office.

About Inteleos

Inteleos™ is a non–profit organization dedicated to ensuring equitable access to quality healthcare globally. It oversees the American Registry for Diagnostic Medical Sonography® (ARDMS®), the Alliance for Physician Certification & Advancement™ (APCA™), and the Point–of–Care Ultrasound Certification Academy™ (PCA), collectively representing 150,000 certified medical professionals worldwide. The Inteleos Foundation manages the organization’s philanthropic initiatives. Learn more at Inteleos.org.


GLOBENEWSWIRE (Distribution ID 9563521)

Curia investiert 4 Mio. US-Dollar in die Optimierung der Herstellung steriler Wirkstoffe

ALBANY, New York, Oct. 27, 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), ein weltweit führendes Forschungs–, Entwicklungs– und Produktionsunternehmen, gab heute den Abschluss einer 4 Millionen US–Dollar schweren Investition zur Modernisierung seiner beiden aseptischen API–Anlagen in Valladolid, Spanien, bekannt. Die Investition entspricht den neuesten Standards des EU–GMP–Anhangs 1 und unterstreicht das langjährige Engagement von Curia für regulatorische Exzellenz und Produktqualität. Anhang 1 enthält allgemeine Leitlinien für die Gestaltung und Kontrolle von Anlagen, Ausrüstung, Systemen und Verfahren, die für die Herstellung aller sterilen Produkte verwendet werden. Dabei werden die Grundsätze des Qualitätsrisikomanagements (QRM) angewendet, um eine Kontamination des Endprodukts mit Mikroorganismen, Partikeln und Endotoxinen zu verhindern.

Die Verbesserungen unterstützen die Modernisierung der Infrastruktur und Technologie in Valladolid. Curia nutzte innovative Tools, um neue Möglichkeiten zu erschließen, die sich aus einem verbesserten Prozessverständnis ergaben. Der Großteil der Investitionen floss in die Modernisierung der Anlagen am Standort. Dazu gehörten die Installation neuer Isolatoren, die Modernisierung der Klimaanlagen, der pharmazeutischen Schalttafeln, der Automatisierung, der Sterilisation vor Ort sowie der allgemeinen Versorgungsanlagen. Der Hauptgrund für diese Modernisierungen war der Übergang zu einem vollständig geschlossenen System. Damit sollten die Prozess– und Produktsicherheit gewährleistet und mikrobiologische Kontaminationen in jeder Phase der Produktion verhindert werden. Ergonomische Verbesserungen waren darüber hinaus für die Erhöhung der Betriebssicherheit von entscheidender Bedeutung. Ebenso wichtig war die Implementierung zusätzlicher automatischer Kontrollen gemäß den strengeren Richtlinien zur Datenintegrität, wie in 21 CFR Part 11 beschrieben.    

„Qualität und Compliance sind wesentliche Bestandteile unserer Geschäftstätigkeit“, sagte Philip Macnabb, CEO von Curia. „Die neuen Anforderungen in Anhang 1 sind mit unserem proaktiven Ansatz zur Qualitätskontrolle vereinbar. Wir sind stets bestrebt, unseren Kunden ein Höchstmaß an Sicherheit in Bezug auf die Einhaltung von Vorschriften sowie unsere Fähigkeit zur Lieferung hochwertiger, steriler Wirkstoffe in großem Maßstab zu bieten. Unsere Kunden verlassen sich auf unsere Zuverlässigkeit, Präzision und Vertrauenswürdigkeit. Mit diesen Verbesserungen in Valladolid können sie darauf vertrauen, dass wir weiterhin vor den Branchentrends investieren werden, um gemeinsam mit ihnen ihre Produkte auf den Markt zu bringen.

Die Aktualisierungen in Valladolid erfolgten auf Basis einer unternehmensweiten Bewertung des globalen Curia–Netzwerks, mit der Verbesserungsmöglichkeiten im Zusammenhang mit den neuen Anforderungen des Anhangs 1 identifiziert wurden. Die Bewertung umfasste Verfahren, Ausrüstung, Versorgungsanlagen, Qualifikationen und Validierungen, um maßgeschneiderte Lösungen für jeden Standort zu entwickeln und Optimierungsmöglichkeiten zu ermitteln.

Seit mehr als 20 Jahren bedient das globale Netzwerk von Curia für die aseptische Verarbeitung von APIs ein breites Spektrum von Kunden weltweit. Dank dieser Investition ist das Unternehmen nun in der Lage, immer komplexere Fertigungsprojekte zu realisieren und gleichzeitig sein Engagement für die Bereitstellung lebensverändernder Medikamente in kompromissloser Qualität und Zuverlässigkeit zu verstärken.

Über Curia
Curia ist ein Auftragsforschungs–, Entwicklungs– und Produktionsunternehmen (CDMO) mit über 30 Jahren Erfahrung, einem integrierten Netzwerk von 20 Standorten weltweit und 3.200 Mitarbeitern, das mit Kunden aus der Biopharmazie zusammenarbeitet, um lebensverändernde Therapien auf den Markt zu bringen. Unser Angebot an niedermolekularen Wirkstoffen, generischen Wirkstoffen, sterilen Arzneimitteln und Biologika deckt den gesamten Prozess von der Entdeckung bis zur Vermarktung ab. Dazu gehören auch integrierte Kompetenzen in den Bereichen Zulassung, Analytik und sterile Abfüllung. Unsere Wissenschafts– und Prozessexperten sowie unsere Einrichtungen, die den behördlichen Vorschriften entsprechen, bieten erstklassige Kompetenz bei der Herstellung von Arzneimittelwirkstoffen und –produkten. Von der Neugier bis zur Heilung – wir unterstützen Sie bei jedem Schritt, um Ihre Forschung zu beschleunigen und das Leben von Patienten zu verbessern. Besuchen Sie uns unter curiaglobal.com.

Kontakt zum Unternehmen:
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9562221)

Curia investit 4 millions de dollars pour renforcer la fabrication stérile de substances actives (API)

ALBANY, New York, 27 oct. 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), l’une des principales organisations de recherche, de développement et de fabrication sous contrat, a annoncé aujourd’hui l’achèvement d’un investissement de 4 millions de dollars destiné à moderniser ses deux unités aseptiques de production de substances actives (API) à Valladolid, en Espagne. Cet investissement s’inscrit dans le cadre des dernières normes de l’annexe 1 des BPF de l’Union européenne (EU GMP Annex 1) et réaffirme l’engagement de longue date de Curia en matière d’excellence réglementaire et de qualité produit. L’annexe 1 fournit des orientations générales concernant la conception et le contrôle des installations, équipements, systèmes et procédures utilisés pour la fabrication de produits stériles. Elle applique les principes de la gestion des risques qualité (QRM) afin de prévenir toute contamination microbienne, particulaire ou endotoxinique des produits finis.

Ces améliorations soutiennent la modernisation des infrastructures et des technologies du site de Valladolid. Curia a eu recours à des outils innovants afin d’exploiter pleinement les opportunités offertes par une meilleure compréhension des procédés. La majeure partie de l’investissement a été consacrée à la modernisation des équipements du site, avec l’installation de nouveaux isolateurs et la mise à niveau des systèmes de ventilation (CVC), des panneaux pharmaceutiques, de l’automatisation, de la stérilisation in situ et des utilités générales. La transition vers un système entièrement fermé a été le principal moteur de ces améliorations, visant à renforcer la sécurité des procédés et des produits et à prévenir toute contamination microbiologique à chaque étape de la production. Par ailleurs, des améliorations ergonomiques pour les opérateurs ont été essentielles pour renforcer la sécurité opérationnelle, accompagnées de la mise en place de contrôles automatiques supplémentaires, conformes aux politiques plus strictes d’intégrité des données, telles que décrites dans le 21 CFR Part 11.

« La qualité et la conformité sont au cœur de notre fonctionnement », a déclaré Philip Macnabb, PDG de Curia. « Les nouvelles exigences de l’annexe 1 s’inscrivent dans notre approche proactive du contrôle qualité. » « Nous nous efforçons en permanence d’offrir à nos clients le plus haut niveau de garantie en matière de conformité, ainsi que notre capacité à fournir des substances actives stériles de haute qualité à grande échelle. » « Nos clients comptent sur nous pour notre fiabilité, notre rigueur et la confiance qu’ils peuvent nous accorder. » « Grâce à ces améliorations sur le site de Valladolid, nos clients peuvent être assurés que nous continuerons à investir en avance sur les tendances du secteur, tout en les accompagnant dans la mise sur le marché de leurs produits. »

Les améliorations apportées au site de Valladolid font suite à une évaluation menée à l’échelle mondiale au sein du réseau de Curia, afin d’identifier les opportunités d’optimisation en lien avec les nouvelles exigences de l’annexe 1. L’évaluation a porté sur les procédures, les équipements, les utilités, les qualifications et les validations, afin de concevoir des solutions adaptées à chaque site et de traiter toutes les opportunités d’optimisation.

Le réseau mondial de fabrication aseptique de substances actives (API) de Curia dessert un large portefeuille de clients à travers le monde depuis plus de 20 ans. Cet investissement permet à l’entreprise de soutenir des projets de fabrication de plus en plus complexes, tout en renforçant son engagement à fournir des médicaments capables de transformer la vie des patients, avec une qualité et une fiabilité sans compromis.

À propos de Curia
Curia est une organisation de recherche, de développement et de fabrication sous contrat (ou CDMO pour Contract Development and Manufacturing Organization) forte de plus de 30 ans d’expérience à son actif. Elle exploite un réseau intégré de plus de 20 sites à travers le monde et emploie quelque 3 200 collaborateurs travaillant en partenariat avec des clients biopharmaceutiques pour mettre sur le marché des traitements qui changent véritablement la vie. Nos offres en matière de petites molécules, d’API génériques et de produits biologiques couvrent le cycle complet de la découverte à la commercialisation, et intègrent des capacités réglementaires, analytiques et de remplissage et finition stériles. Nos experts en sciences et en processus, ainsi que nos installations conformes à la réglementation, offrent une expérience de premier ordre dans la fabrication de substances et de produits pharmaceutiques. De la curiosité au traitement, nous réalisons toutes les étapes permettant d’accélérer vos recherches et d’améliorer la vie des patients. Consultez notre site à l’adresse curiaglobal.com.

Contact de l’entreprise :
Viana Bhagan
Curia
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9562221)