RevnaBio Secures Triple International Laboratory Accreditation to Expand Precision Medicine and Clinical Research Infrastructure in Africa

RevnaBio Secures Triple International Laboratory Accreditation to Expand Precision Medicine and Clinical Research Infrastructure in Africa




RevnaBio Secures Triple International Laboratory Accreditation to Expand Precision Medicine and Clinical Research Infrastructure in Africa

A2LA accreditation across ISO 15189, ISO 20387, and ISO/IEC 17043 strengthens diagnostic quality for patients while enabling global pharmaceutical and research partnerships.




ACCRA, Ghana–(BUSINESS WIRE)–#A2LA–RevnaBio today announced that it has received triple accreditation from the American Association for Laboratory Accreditation (A2LA), validating its laboratory and biobanking operations under three internationally recognized standards: ISO 15189 for medical laboratories, ISO 20387 for biobanking, and ISO/IEC 17043 for proficiency testing providers.

The combined accreditation confirms the strength of RevnaBio’s integrated quality systems across clinical diagnostics, biospecimen management, and laboratory performance monitoring. These capabilities support the delivery of reliable molecular testing for patients while providing a trusted platform for pharmaceutical companies, diagnostics developers, and research organizations conducting biomedical research in Africa.

The milestone represents a significant step toward expanding precision medicine infrastructure in West Africa and strengthening access to internationally accredited diagnostic services.

Improving Diagnostic Quality for Patients

Accurate and reliable diagnostics are essential for effective treatment selection, disease monitoring, and improved clinical outcomes.

Through its ISO 15189–accredited medical laboratory, RevnaBio provides molecular and genomic testing systems that meet internationally recognized standards for quality, accuracy, and traceability. These capabilities help clinicians make better-informed treatment decisions while expanding access to advanced molecular testing that historically required samples to be sent overseas.

By strengthening local diagnostic capacity, RevnaBio contributes to improving healthcare delivery and patient outcomes across Ghana.

Building Research Infrastructure for the Region

RevnaBio’s ISO 20387 biobanking accreditation validates the company’s governance and operational standards for collecting, processing, storing, and managing research-grade biospecimens.

These systems ensure that biological samples are linked to high-quality clinical and molecular data, supporting scientific research aimed at improving understanding of diseases affecting African populations and people of African descent globally.

Strengthening biospecimen infrastructure within Africa allows research involving African populations to be conducted with greater scientific rigor, representation, and ethical oversight.

Advancing Laboratory Quality Across West Africa

RevnaBio’s ISO/IEC 17043 accreditation authorizes the company to design and deliver accredited proficiency testing programs that help laboratories measure and improve their performance.

In regions where locally delivered external quality assessment programs remain limited, this capability enables RevnaBio to support laboratory networks through standardized benchmarking and quality monitoring.

Expanding access to accredited proficiency testing strengthens diagnostic reliability across healthcare systems, ultimately benefiting patients, clinicians, and public health programs throughout the region.

Supporting Global Biomedical Research and Drug Development

The accreditation also strengthens RevnaBio’s ability to collaborate with biopharmaceutical companies, diagnostics developers, and international research institutions seeking high-quality laboratory and biospecimen infrastructure in Africa.

Accredited diagnostics, validated biobanking systems, and reliable laboratory quality monitoring are essential for enabling biomarker discovery, pharmacogenomic research, and clinical studies involving diverse populations.

RevnaBio’s integrated platform helps facilitate research that advances precision medicine while ensuring that African populations are appropriately represented in global biomedical research.

Leadership Perspective

Commenting on the milestone, Dr. Derrick Akpalu, CEO and Co-Founder of RevnaBio, said: “This accreditation reflects our commitment to building laboratory systems that meet the highest international standards while serving the needs of patients and clinicians in Ghana. By strengthening diagnostic quality, biospecimen infrastructure, and laboratory performance monitoring, we aim to support improved healthcare locally while enabling meaningful collaboration with global research partners working to advance precision medicine.”

Ms. Jennifer Dent, a board member of the company, remarked, “I am incredibly proud to see the company achieve this important milestone. Receiving triple accreditation from the American Association for Laboratory Accreditation reflects RevnaBio’s commitment to quality, scientific excellence, and global laboratory best practices. The triple accreditation reflects the team’s commitment to quality, scientific excellence, and global standards. It also strengthens partnerships and supports African scientists and clinicians in leading impactful research.”

About Revna Biosciences (RevnaBio)

Revna Biosciences (RevnaBio) is a precision medicine company with an operational base in Accra, Ghana that provides genomic testing, clinical research services, and biobanking infrastructure across Africa. Founded in 2017 and domiciled in Delaware, RevnaBio partners with hospitals, research institutions, and global pharmaceutical companies to generate high-quality genomic and clinical datasets that reflect Africa’s genetic diversity, an essential foundation for precision-medicine discovery and drug development.

The company operates advanced laboratory and biospecimen infrastructure that supports molecular diagnostics, biomarker research, and clinical research programs across the region. Through these capabilities, RevnaBio enables pharmaceutical partners and academic researchers to conduct high-quality studies and develop therapies informed by African genomic data.

RevnaBio holds triple accreditation from the American Association for Laboratory Accreditation (A2LA) to ISO 15189:2022 (Medical Laboratories), ISO 20387:2018 (Biobanking), and ISO/IEC 17043 (Proficiency Testing Providers). This rare combination of accreditations confirms adherence to internationally recognized standards for diagnostic accuracy, biospecimen governance, and laboratory quality systems.

By building trusted biomedical infrastructure and generating globally relevant genomic data, RevnaBio is helping expand Africa’s role in precision medicine, clinical research, and pharmaceutical innovation.

Contacts

Media Contact
Revna Biosciences

Communications Office

Email: info@revnabio.com
Phone: +233-59-161-2549 / +233-59-900-9977

Website: www.revnabio.com

KERENDIA® (finerenone) Meets Primary Endpoint in Investigational Phase III FIND-CKD Study in Patients with Non-Diabetic Chronic Kidney Disease

KERENDIA® (finerenone) Meets Primary Endpoint in Investigational Phase III FIND-CKD Study in Patients with Non-Diabetic Chronic Kidney Disease




KERENDIA® (finerenone) Meets Primary Endpoint in Investigational Phase III FIND-CKD Study in Patients with Non-Diabetic Chronic Kidney Disease

  • KERENDIA® (finerenone) met its primary endpoint demonstrating a statistically significant improvement vs. placebo in the estimated glomerular filtration rate (eGFR) slope from baseline to Month 32 – a surrogate endpoint for slowing kidney disease progression1
  • FIND-CKD is the fifth consecutive Phase III clinical trial where KERENDIA met its primary endpoint, adding to a clinical trial program of more than 20,000 patients across multiple patient populations with heart and kidney diseases
  • FIND-CKD is the largest Phase III study to date focused on non-diabetic chronic kidney disease (CKD) and now expands KERENDIA’s clinical data in CKD to both diabetic and non-diabetic patients
  • The clinical data from FIND-CKD will be presented at an upcoming scientific conference, and Bayer anticipates submitting the data to the U.S. Food and Drug Administration (FDA) to extend the indication of KERENDIA to this patient population
  • KERENDIA is currently approved by the FDA for use in adults with CKD associated with type 2 diabetes (T2D) and heart failure with left ventricular ejection fraction (HF LVEF) ≥40%2

WHIPPANY, N.J.–(BUSINESS WIRE)–The Phase III study FIND-CKD (NCT05047263) — investigating the efficacy and safety of KERENDIA® (finerenone) versus placebo when added to standard of care in adult patients with non-diabetic chronic kidney disease (CKD) — has met its primary endpoint.1 The results demonstrated a statistically significant improvement versus placebo in the primary efficacy outcome of estimated glomerular filtration rate (eGFR) slope, defined as the mean annual rate of change from baseline to Month 32,1 a validated surrogate endpoint for kidney disease progression.3 The safety profile of KERENDIA in the FIND-CKD study was consistent with its established safety profile.1

The FIND-CKD clinical trial data will be presented at an upcoming scientific conference. Bayer anticipates submitting the data to the U.S. Food and Drug Administration (FDA) to extend the indication of KERENDIA to non-diabetic CKD patients.

“Patients with chronic kidney disease have substantial risk for cardiovascular events and kidney failure, so new treatments are needed to help slow kidney disease progression and improve outcomes,” said Hiddo L. Heerspink, Professor of Clinical Trials and Personalized Medicine, clinical trialist at the Department of Clinical Pharmacy and Pharmacology at the University Medical Center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee. “The FIND-CKD topline results are encouraging because they now provide evidence for finerenone in a non-diabetic chronic kidney disease population, on top of its established evidence in diabetic chronic kidney disease.”

Since 2021, KERENDIA has been approved to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), non-fatal myocardial infarction, sustained eGFR decline, and end-stage kidney disease in adult patients with CKD associated with type 2 diabetes (T2D). In July 2025, KERENDIA also received FDA approval for the treatment of heart failure with left ventricular ejection fraction (HF LVEF) ≥40%.2

Approximately 850 million people worldwide are living with CKD, and those with non-diabetic CKD represent more than half of these cases.4,5,6 In the U.S., more than 35 million people are estimated to have CKD.7 In 2023, CKD accounted for over 1.4 million deaths, ranking as the ninth leading cause of death.8

“The FIND‑CKD findings mark the fifth consecutive Phase III trial in the KERENDIA clinical development program to meet its primary endpoint and represent a major milestone for people living with non-diabetic chronic kidney disease,” said Carolina Aldworth, M.D., MSc, Executive Medical Director at Bayer. “When considered alongside the growing evidence base, this important trial adds to our understanding of KERENDIA across multiple patient populations with heart and kidney diseases.”

KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys.2 FIND-CKD is the largest Phase III study to date focused on non-diabetic CKD and investigated KERENDIA in a population spanning different etiologies of non-diabetic CKD.

About FIND-CKD

The Phase III FIND-CKD9 study investigated finerenone compared to placebo in addition to standard of care in more than 1,500 patients with non-diabetic CKD etiologies, of which etiologies included hypertension and chronic glomerulonephritis (inflammation of the kidneys’ blood filters). Patients were randomized to receive either finerenone 10mg or 20mg, based on serum potassium levels and eGFR, or placebo on top of individually tolerated maximum labeled doses of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). The primary endpoint was the mean annual rate of change in eGFR from baseline to 32 months. The safety endpoints were the occurrence of treatment-emergent adverse events (AEs), treatment-emergent serious AEs, and hyperkalemia AEs.

About KERENDIA’s Clinical Trial Program

KERENDIA’s clinical trial program—called FINEOVATE—currently comprises 10 Phase III studies with dedicated programs in HF (MOONRAKER) and CKD (THUNDERBALL). The MOONRAKER program includes FINEARTS-HF10 as well as the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF,11 CONFIRMATION-HF12 and FINALITY-HF.13 The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD,14 FIGARO-DKD,15 FINE-ONE16 and FIND-CKD17 as well as the ongoing investigational studies, FIONA18 and FIONA-OLE.19

About Chronic Kidney Disease

CKD is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD affects 850 million people worldwide. In the U.S., 1 in 3 adults is at risk for the disease. At advanced stages of CKD, patients may need dialysis or a kidney transplant to stay alive. Healthy kidneys act as the body’s filter, removing waste products from the blood. They also control how much water and electrolytes are in the body, regulating blood pressure. As kidney function goes down, patients may experience a range of symptoms including leg swelling, tiredness in the day, nausea, muscle cramps, joint pain, confusion, trouble focusing and memory problems. Major underlying causes of CKD include diabetes, hypertension and glomerulonephritis such as immunoglobulin A nephropathy, focal segmental glomerulonephritis and membranous nephropathy.

About KERENDIA® (finerenone)2

INDICATIONS:

KERENDIA (finerenone) is indicated to reduce the risk of:

  • sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets)
  • cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

  • Hypersensitivity to any component of this product
  • Concomitant use with strong CYP3A4 inhibitors
  • Patients with adrenal insufficiency

WARNINGS AND PRECAUTIONS:

  • Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia.

    Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium.

  • Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed.

    Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m2 is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function.

MOST COMMON ADVERSE REACTIONS:

  • CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%).
  • HF LVEF ≥40%: From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%).20 Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%).

DRUG INTERACTIONS:

  • Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.
  • Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate.
  • Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers.
  • Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions.

USE IN SPECIFIC POPULATIONS:

  • Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment.
  • Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B).

Please see the Prescribing Information for KERENDIA.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases

Bayer’s legacy in cardiovascular care spans decades of scientific innovation and patient-focused research. As a long-standing leader in cardiology, Bayer has consistently advanced therapies that address the complex interplay between the heart and kidneys—two organs deeply connected in both health and disease. Today, that heritage continues to guide our commitment to developing innovative treatments for patients facing high unmet medical needs. With a growing portfolio of approved therapies and promising compounds in development, Bayer is shaping the future of cardiovascular care through precision medicine, scientific rigor, and a deep sense of purpose.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on X: @BayerPharma

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports, which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

___________________________

1 Data on file.

2 Bayer Pharmaceuticals. Kerendia (finerenone) [package insert]. U.S. Food and Drug Administration. Available at: https://labeling.bayerhealthcare.com/html/products/pi/Kerendia_PI.pdf. Accessed March 4, 2026

3 Research C for DE and. Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure. FDA. Published online August 20, 2020. https://www.fda.gov/drugs/development-resources/table-surrogate-endpoints-were-basis-drug-approval-or-licensure

4 Jager KJ, et al. Kidney Int. 2019;96(5):1048-1050.

5 GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. The Lancet. 2018;392(10159):1789-1858

6 Wanner C, et al. BMC Nephrol. 2025;26:1–11. / Webster AC, Nagler EV, Morton RL, Masson P. Chronic kidney disease. Lancet. 2017;389:1238–52.

7 NIDDK. Kidney disease statistics for the United States. National Institute of Diabetes and Digestive and Kidney Diseases. Published 2023. Accessed March 4, 2026. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease

8 GBD 2023 Chronic Kidney Disease Collaborators. The Lancet. 2025;406(10518):2461-2482.

9 Heerspink HJL, Agarwal R, Bakris GL, et al. Design and baseline characteristics of the Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease (FIND-CKD) randomized trial. Nephrol Dial Transplant. 2025;40(2):308-319. doi:10.1093/ndt/gfae132

10 Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF) Clinical trial registration No. NCT04435626. https://clinicaltrials.gov/study/NCT04435626 Accessed March 4, 2026

11 A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF). Clinical trial registration No. NCT 06008197. https://www.clinicaltrials.gov/study/NCT06008197. Accessed March 4, 2026.

12 A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF) (CONFIRMATION). Clinical trial registration No. NCT06024746. https://www.clinicaltrials.gov/study/NCT06024746. Accessed March 4, 2026.

13 A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF). Clinical trial registration No. NCT06033950. https://www.clinicaltrials.gov/study/NCT06033950. Accessed March 4, 2026.

14 Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD) Clinical trial registration No. NCT02540993. https://clinicaltrials.gov/study/NCT02540993. Accessed March 4, 2026.

15 Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD) Clinical trial registration No. NCT02545049 https://clinicaltrials.gov/study/NCT02545049. Accessed March 4, 2026.

16 A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys’ Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes (FINE-ONE). Clinical trial registration No. NCT05901831. https://www.clinicaltrials.gov/study/NCT05901831. Accessed March 4, 2026.

17 A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease (FIND-CKD). Clinical trial registration No. NCT05047263. https://www.clinicaltrials.gov/study/NCT05047263. Accessed March 4, 2026.

18 A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children with Chronic Kidney Disease and Proteinuria (FIONA). Clinical trial registration No. NCT05196035. https://www.clinicaltrials.gov/study/NCT05196035. Accessed March 4, 2026.

19 A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria (FIONA OLE). Clinical trial registration No. NCT05457283. https://www.clinicaltrials.gov/study/NCT05457283. Accessed March 4, 2026.

20 Data on file.

COR-KER-US-0185-1 3/26

Contacts

Media Contact:
Sarra Herzog

Bayer Media Relations

Sarra.Herzog@bayer.com
+1 862.460.8764

BioVersys Receives Green Light from US FDA for BV100 HABP/VABP Phase 3 Pivotal Trial Start

 

Basel, Switzerland. March 16, 2026, 7am CET

 

 

  • BV100 is a potential best-in-class anti-infective agent in treating hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), caused by carbapenem-resistant Acinetobacter baumannii (CRAB).
  • US FDA confirms that the BV100 global pivotal Phase 3 HABP/VABP trial may proceed, based on the initial IND submission.
  • BV100 global pivotal Phase 3 is on track to read-out by the end of 2027.

 

BioVersys AG (SIX: BIOV), a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (MDR) bacteria, announced today that the US Food and Drug Administration (US FDA) has confirmed that the global Phase 3 pivotal trial to recruit US patients into the RIV-TARGET clinical trial (NCT07326540) can proceed. The Phase 3 trial will recruit patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VABP), due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus Complex (CRABC).

CRABC is a highly-drug resistant Gram-negative pathogen that is recognized as a critical priority by global health authorities. BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex.  BV100 is being developed for MDR hospital infections caused by Acinetobacter baumannii, including carbapenem-resistant Acinetobacter baumannii (CRAB) strains. BV100 has Qualified Infectious Disease Product (QIDP) Designation from the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity.

Dr. Glenn E Dale, Chief Development Officer: “This is a significant step towards our goal of completing the BV100 global Phase 3 trial by the end of 2027. HABP and VABP infections remain a leading cause of infectious disease hospital mortality and represent a substantial burden on healthcare systems. Our teams have already gathered interest from US-based clinical sites to participate in the trial, and this successful IND application will allow us to activate the clinical sites prior to enrolling US patients in the coming months.”

Dr. Marc Gitzinger, Chief Executive Officer of BioVersys: “We are excited about this regulatory development. Enrolling US patients into the trial is an important contribution towards the global nature of the study. This follows closely behind our announcement in December 2025 that we had initiated the BV100 global Phase 3 trial. I am incredibly proud of our team’s multi-pronged efforts in ensuring that this trial can proceed simultaneously in all the key regions of the world. We will bring this much-needed treatment option to patients in dire need.”

Phase 3 trial design

The global Phase 3 trial, is a randomized, active-controlled two-part parallel-group trial to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP suspected or confirmed to be due to CRABC infection (RIV-TARGET). Part A is the pivotal, randomized, comparative portion of the trial, employing a partially blinded design aiming to enroll approximately 300 HABP/VABP patients with suspected or confirmed CRABC infections. Patients will be randomized 1:1 to receive either [1] BV100 combined with low dose polymyxin B or [2] colistin combined with high-dose ampicillin-sulbactam, with both arms allowing meropenem as background in case of polymicrobial infections. The primary efficacy endpoint is defined as 28-day all-cause mortality (ACM) in the CRABC microbiological modified intention-to-treat (CRABC m-MITT) population. Secondary efficacy endpoints will include clinical cure status at the test of cure (ToC) in CRABC m-MITT, ventilator free days, time spent in intensive care unit (ICU) and time in hospital. As part of the study protocol, data safety monitoring boards (DSMB)[1] will be convened at regular intervals to review trial progress.

The Phase 3 trial also includes an open-label, non-randomized, additional single group (Part B) to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP due to CRABC known to be resistant to colistin or polymyxin B prior to study entry and patients where colistin or polymyxin B regimen has failed prior to study entry. Approximately 25 patients are expected to be enrolled in Part B.

This pivotal Phase 3 trial follows the successful completion of a Phase 2 trial in documented Acinetobacter VABP patients. BV100 combined with polymyxin B demonstrated a clear survival benefit, resulting in a 50% relative reduction in 28-day ACM compared with best available therapy (BAT), in VABP patients suffering from confirmed CRAB infections (28-day ACM: 60% for BAT vs 25% for BV100), and was generally safe and well tolerated. The current Phase 3 trial mimics the successful study design of the positive Phase 2 trial and is expected to read-out towards the end of 2027. Subsequent regulatory submissions aimed at commercial approval are planned in 2028, initially for the US, Europe and China.

In parallel to the Phase 3 pivotal trial an open-label Phase 2b differentiation trial (RIV-CARE) will be initiated in H1 2026 comparing BV100 with BAT in multiple geographies. The Phase 2b trial aims to provide real world evidence of clinical practices in settings with very high drug resistance levels. Interim analysis is planned for end of 2026.

About BV100

BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including carbapenem-resistant ABC (CRABC) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.

 

About Acinetobacter baumannii

Acinetobacter baumannii calcoaceticus complex (ABC) are Gram-negative bacteria found in the environment (e.g., in soil and water) and an opportunistic pathogen in humans, typically infecting critically ill and immunocompromised patients, that can result in severe pneumonia and bloodstream infections in addition to affecting other parts of the body. ABC is considered a significant worldwide threat in the healthcare setting given its ability to survive for prolonged periods on surfaces, combined with its ability to develop or acquire resistance to standard of care antibiotics, e.g. carbapenems. Carbapenem-resistance as well as multi-drug resistance (MDR) rates for ABC are among the highest recorded for any bacteria in current times (The Lancet 2022; 399: 629–55). Incidence and resistance rates for ABC are trending upwards and COVID-19 has exacerbated this significantly. BioVersys forecasts the annual number of carbapenem-resistant A. baumannii infections in hospitals to have surpassed one million globally and due to the limited treatment options, such infections come with high (up to 50%) mortality rates.

 

About BioVersys

BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3), and tuberculosis (alpibectir, Phase 2, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland.

BioVersys contact 
Hernan Levett, CFO, Tel. +41 61 633 22 50; Mail: hernan.levett@bioversys.com
For media: media@bioversys.com Website: www.bioversys.com

 

 

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

 


[1] The DSMB review is the periodic evaluation of unblinded or partially unblinded clinical trial data by an independent committee of experts to determine whether the study should continue, be modified, or be stopped based on safety, efficacy, or futility considerations.

Tecan presents 2025 results and provides details on program to reignite profitable growth

Tecan presents 2025 results and provides details on program to reignite profitable growth




Tecan presents 2025 results and provides details on program to reignite profitable growth

Ad hoc announcement pursuant to Article 53 of the SIX Exchange Regulation Listing Rules

Tecan presents 2025 results and provides details on program to reignite profitable growth

Financial results for the full year 2025 – Summary

  • Sales of CHF 882.5 million (2024: CHF 934.3 million), down 1.6% in local currencies for the year, with second-half sales growth of 0.4%
  • Order entry increased by 3.8% in local currencies for the full year and by 8.6% in the second half
  • Adjusted EBITDA of CHF 142.1 million (2024: CHF 164.4 million), adjusted EBITDA margin of 16.1% (2024: 17.6%), impacted by adverse foreign exchange effects and tariffs, partly offset by cost-reduction measures and underlying improvements
  • Net profit impacted by non-cash impairment charges of CHF 139.5 million resulting in a reported net loss of CHF 110.7 million (2024: net profit of CHF 67.7 million)
  • Strong operating cash flow of CHF 138.0 million (2024: CHF 148.5 million),
    cash conversion increased to 118% of reported EBITDA (2024: 100%)
  • Proposal for an unchanged dividend of CHF 3.00 per share

Outlook

  • Outlook for 2026
    • Sales expected to increase in the low single-digit percentage range in local currencies, with the relevant market anticipated to remain broadly flat
    • Adjusted EBITDA margin forecast at 15.5-16.5% of sales, reflecting a -110 basis points headwind from FX and tariffs
    • This margin expectation includes an underlying profitability improvement of 50-150 basis points from the transformation program
  • Medium-term outlook maintained
    • Ambition to achieve sales of CHF 1 billion and a 20% adjusted EBITDA margin by 2028, supported by the ongoing transformation program contributing 200-300 basis points

Männedorf, Switzerland, March 16, 2026 – The Tecan Group (SIX Swiss Exchange: TECN) today announced its audited financial results for 2025, reporting a return to sales growth and strong order entry in the second half of the year. Tecan also initiated its short-term financial outlook for 2026 and reaffirmed its medium-term outlook. Later today, the company will host a Capital Markets Update, providing further details on the key drivers supporting its medium-term growth and profitability ambitions.

Tecan CEO Monica Manotas commented: «Our 2025 performance does not reflect Tecan’s potential. We are acting decisively to change that. Our core is intact, and our balance sheet is strong. Through our transformation program, built on portfolio optimization, commercial excellence, and operational excellence, we are focused on returning to profitable growth now, while positioning our company for what is next and beyond.

While the return to growth in our industry is gradual, the forces shaping its future, AI integration, automation, scientific complexity, economic pressure, are powerful and durable. We expect them to drive significant growth in laboratory automation over the coming decade, and we intend to outgrow the market by leading its AI- and data-driven future.

To achieve that, we have launched “Rewired”, a transformation program to future-proof Tecan and excel at both innovation and execution. Technology leadership and the ability to translate it into profitable growth are decisive, for customers and shareholders alike. We will pursue this with financial discipline, rigorous capital allocation, and the strategic focus needed to realize Tecan’s long-term potential.»

Financial results full-year and second half of 2025

Order entry and sales
Order entry for the Group reached CHF 900.9 million for full-year 2025 (2024: CHF 903.6 million), declining by 0.3% in Swiss francs but growing by 3.8% in local currencies. The book-to-bill ratio was above 1 in both business segments. In the second half, order entry grew by 8.6% in local currencies and by 2.6% in Swiss francs.

Group sales for 2025 decreased by 1.6% in local currencies and 5.5% in Swiss francs, totalling CHF 882.5 million (2024: CHF 934.3 million). In the second half of the year, Tecan returned to moderate sales growth, with sales increasing by 0.4% in local currencies. Sales declined by 5.2% in Swiss francs to CHF 443.0 million (2024: CHF 467.1 million).
These sales results were previously communicated in a trading statement on January 9, 2026.

Profitability and Cash Flow
Adjusted EBITDA1 (operating profit before depreciation and amortization) was CHF 142.1 million, down from CHF 164.4 million in 2024. The adjusted EBITDA margin decreased to 16.1% of sales (2024: 17.6%). Margins were significantly impacted by adverse foreign exchange effects (-130 basis points) and tariffs (-70 basis points), partly offset by underlying improvements (+50 basis points). Excluding the combined 200 basis point headwind from foreign exchange effects and tariffs, the adjusted EBITDA margin was 18.1%, in line with the outlook communicated on March 12, 2025. Reported EBITDA was CHF 117.1 million, compared to CHF 148.0 million in the prior year, corresponding to reported margins of 13.3% and 15.8%, respectively.

Net profit was impacted by non-cash impairment charges of CHF 139.5 million from the strategic restructuring of less profitable or loss-making product lines in the Partnering Business. Tecan will leverage synergies between its design and development capabilities and Paramit’s manufacturing capabilities, discontinuing dedicated design functions acquired in 2021. As a result of the impairment charges, the company reported a net loss of CHF 110.7 million (2024: net profit of CHF 67.7 million). In addition to a lower operating profit, net profit was further weighed down by a reduced financial result, mainly reflecting negative foreign exchange effects and the translation of US dollar-denominated assets into Swiss francs. Reported basic earnings per share were CHF -8.74 (2024: CHF 5.30). Adjusted net profit2 amounted to CHF 87.0 million (2024: CHF 103.1 million), with adjusted earnings per share2 of CHF 6.87 (2024: CHF 8.08).

Cash flow from operating activities was CHF 138.0 million, compared to CHF 148.5 million in 2024. Cash conversion improved to 118% of reported EBITDA (2024: 100%). Thanks to solid cash flow management, Tecan’s net liquidity position (cash and cash equivalents plus short-term time deposits, less bank liabilities, loans, and the outstanding bond) increased to CHF 160.8 million as of December 31, 2025, up from CHF 153.7 million on December 31, 2024.
Through its share buyback program, from August 2025 to December 31, 2025, Tecan purchased own shares with a value of CHF 24.8 million. The program allows for the repurchase of registered shares with a value of up to CHF 120 million.

Information by business segment

Life Sciences Business (end-customer business)
Sales in the Life Sciences Business reached CHF 377.1 million (2024: CHF 397.0 million), representing a decrease of 1.0% in local currencies and 5.0% in Swiss francs. In the second half, sales declined by 3.2% in local currencies. During 2025, demand for instruments in Academia & Government was significantly impacted by budget uncertainty and volatile public funding, particularly in the US and China. Biopharma sales were slightly below the prior year in local currencies, with order entry picking up significantly in the second half. Diagnostic accounts continued to see solid sales and order growth in local currencies throughout the year.
Order entry in the Life Sciences Business increased in the low single-digit percentage range in local currencies for the full year, with an acceleration in the second half. The book-to-bill ratio remained above 1 in 2025.

Reported EBIT in the Life Sciences Business segment (earnings before interest and taxes) was CHF 25.7 million (2024: CHF 39.5 million), with the reported operating profit margin decreasing to 6.7% of sales (2024: 9.8%). The segment absorbed the majority of the negative impact from foreign exchange rates and tariffs. In addition, as part of the portfolio optimization, Tecan decided to exit selected activities at Tecan Genomics, resulting in a CHF 5.3 million asset write-off. Cost control measures partially offset these negative effects. Adjusted EBITDA3 for the segment was CHF 63.4 million (2024: CHF 79.1 million), reflecting an adjusted EBITDA margin of 16.5% of sales (2024: 19.6%).

Partnering Business (OEM business)
The Partnering Business recorded sales of CHF 505.4 million (2024: CHF 537.3 million), representing a decrease of 2.0% in local currencies and 5.9% in Swiss francs. In the second half, sales increased by 3.3% in local currencies.
Overall weak demand for life science instrumentation negatively impacted sales of Cavro OEM components and Paramit CDMO manufacturing services. In contrast, strength in diagnostics drove solid growth in local currencies for in-vitro diagnostics systems in the Synergence product line.
Order entry in the Partnering Business grew at a mid-single-digit rate in local currencies for the full year. As expected, order entry accelerated significantly in the second half, with growth in the low double-digit percentage range. The book-to-bill ratio was also above 1 for this segment in 2025.

Reported EBIT in the Partnering Business amounted to a loss of CHF 103.6 million (2024: profit of CHF 46.6 million), primarily due to the non-cash impairment charge of CHF 139.5 million from the strategic restructuring of less profitable or loss-making product lines. Adjusted EBITDA3 for the segment was CHF 89.7 million (2024: CHF 91.1 million), reflecting an adjusted EBITDA margin of 17.7% of sales (2024: 16.9%). The adjusted EBITDA margin increased, mainly due to a positive product mix and strong cost control, which outweighed the adverse effects of foreign exchange and tariffs.

Proposals to the Annual General Meeting

Based on the solid cash flows for the full year 2025 and as an expression of the confidence in Tecan’s future and of the commitment to shareholder returns, the Board of Directors will propose an unchanged dividend of CHF 3.00 per share at the Annual General Meeting on April 15, 2026. Half of the dividend, i.e., CHF 1.50, will again be paid out from the available capital contribution reserve and is therefore not subject to withholding tax.

In addition to the changes in the Board of Directors announced on December 4, 2025, Guillaume Daniellot will also be proposed as a new independent member of the Board of Directors. Guillaume Daniellot has been serving as CEO of the Straumann Group since January 2020, after previously holding various senior management roles within the company. Earlier in his career, he held positions in hospital product management at Coloplast and B. Braun, and in sales and marketing at Dentsply France. He holds a Bachelor’s degree in physics from the University of Dijon, a Master in marketing from FGE in Tours, and a Master’s in business administration from ESC European School of Management, Paris. Guillaume will complement the Board with his extensive knowledge of the medtech industry and his proven leadership in global healthcare markets.

Outlook

For 2026, Tecan expects end markets to recover gradually. However, a full normalization is not anticipated, and market growth is expected to range from a moderate decline to moderate growth. With anticipated improvements in certain customer segments, but continued uncertainty in others, Tecan is initiating its short-term financial outlook for 2026, expecting sales to increase in the low single-digit percentage range in local currencies.

Foreign exchange rates and the annualized impact from tariffs will continue to weigh on profitability in 2026. Tecan assumes a combined headwind of 110 basis points on the adjusted EBITDA margin from these external factors4. Including these effects, Tecan forecasts an adjusted EBITDA margin – excluding restructuring, acquisition, and integration-related costs – of 15.5% to 16.5% of sales. This forecast also reflects an underlying profitability improvement of 50 to 150 basis points as a result of the ongoing transformation program.

Tecan also reiterates its medium-term outlook, which will be further detailed at today’s Capital Markets Update, including an update on the key drivers supporting this outlook. Tecan expects a continued gradual improvement in end markets, with market growth increasing to a range of 1% to 3% in the years 2027-2028. Tecan’s ambition is to achieve sales of CHF 1 billion⁴ and a 20% adjusted EBITDA margin⁴ by 2028. This will be supported by the ongoing “Rewired” transformation program, which is expected to contribute 200-300 basis points through incremental revenue and efficiencies across operations, commercial, G&A, and R&D.

From 2029 onwards, Tecan assumes a return to normal market conditions, with market growth in the previous range of 3% to 5%. In this environment, Tecan expects to return to average organic growth rates in the mid- to high-single-digit percentage range in local currencies, while continuously improving profitability.

Annual Report and Webcast

The full 2025 Annual Report and the 2025 Sustainability Report were also published today and can be accessed on the company’s website www.tecan.com under Investor Relations.

Tecan will hold an analyst and media conference to discuss the 2025 annual results today at 14:00 (CET) in Zurich. The event will also feature a Capital Markets Update, including an update on the key drivers supporting the company’s medium-term outlook. The presentation will be relayed by live audio webcast, which interested parties can access at www.tecan.com. A link to the webcast will be provided immediately prior to the event. A replay of the webcast will be available after the presentation on www.tecan.com for a period of 12 months.

The dial-in numbers for the conference call are as follows (Access Code: 127505):
Switzerland: +41 22 518 90 26

UK: +44 20 3936 2999
United States: +1 646 233 4753
Participants should, if possible, dial in 15 minutes before the start of the event.

Key upcoming dates

  • The Annual General Meeting of Tecan’s shareholders will take place on April 15, 2026
  • A Q1 2026 Qualitative Update will be published on May 12, 2026
  • The 2026 Interim Report will be published on August 11, 2026
  • A Q3 2026 Qualitative Update will be published on November 5, 2026

1 The adjusted operating profit before depreciation and amortization excludes restructuring costs as well as acquisition- and integration-related costs (+CHF 25.0 million)

2 The calculation of adjusted net profit and adjusted earnings per share excludes restructuring costs, acquisition- and integration-related costs (CHF 25.0 million), accumulated amortization of acquired intangible assets (CHF 23.3 million), and one-off, non-cash impairment charges of CHF 139.5 million. They were calculated using the reported Group tax rate of 9.9%.

3 The adjusted operating profit before depreciation and amortization for the Life Sciences Business segment excludes restructuring costs as well as acquisition- and integration-related costs (+CHF 8.1 million). The adjusted operating profit before depreciation and amortization for the Partnering Business segment excludes restructuring costs as well as acquisition- and integration-related costs (+CHF 14.4 million).

4 Assumes tariff rates in effect as of December 31, 2025. Any changes to tariff rates may impact the outlook. Profitability expectations for 2026 and for the medium-term sales and adjusted EBITDA margin outlook are based on an average exchange rate forecast of one euro equaling CHF 0.92 and one US dollar equaling CHF 0.80.

About Tecan
Tecan (www.tecan.com) improves people’s lives and health by empowering customers to scale healthcare innovation globally from life science to the clinic. Tecan is a pioneer and global leader in laboratory automation. As an original equipment manufacturer (OEM), Tecan is also a leader in developing and manufacturing OEM instruments, components and medical devices that are then distributed by partner companies. Founded in Switzerland in 1980, the company has 3,000 employees, with manufacturing, research and development sites in Europe, North America and Asia, and maintains a sales and service network in over 70 countries. In 2025, Tecan generated sales of CHF 883 million (USD 1,063 million; EUR 939 million). Registered shares of Tecan Group are traded on the SIX Swiss Exchange (TECN; ISIN CH0012100191).

For further information:

Tecan Group
Martin Brändle
Senior Vice President, Corporate Communications & IR
Tel. +41 (0) 44 922 84 30
Fax +41 (0) 44 922 88 89
investor@tecan.com
www.tecan.com

Attachment

InnoCare Announces First Healthy Volunteer Dosed in Clinical Trial of Novel VAV1 Degrader ICP-538 in China

InnoCare Announces First Healthy Volunteer Dosed in Clinical Trial of Novel VAV1 Degrader ICP-538 in China




InnoCare Announces First Healthy Volunteer Dosed in Clinical Trial of Novel VAV1 Degrader ICP-538 in China

BEIJING, March 15, 2026 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first healthy volunteer has been dosed in a clinical trial of ICP-538, a VAV1-directed molecular glue degrader (MGD), in China. This is the first VAV1 degrader approved to enter clinical trials in China and the second globally.

ICP-538 is a novel, potent, highly selective, orally administered molecular glue degrader targeting VAV1, a key protein downstream of T-cell and B-cell receptors. ICP-538 induces rapid and efficient degradation of VAV1 protein in a dose-dependent manner by selectively mediating the formation of a ternary complex between the CRBN E3 ubiquitin ligase and the VAV1 protein. ICP-538 will be developed for the treatment of autoimmune diseases, such as inflammatory bowel disease, systemic lupus erythematosus, and multiple sclerosis. Currently, there are no approved VAV1-targeted therapies globally.

Degradation of VAV1 can effectively inhibit T-cell proliferation, differentiation, activation, and cytokine release, as well as B-cell activation and cytokine release, thereby exerting anti-inflammatory and immunomodulatory effects and alleviating autoimmune and inflammatory pathological processes. Preclinical studies have shown that ICP-538 induces deep degradation of VAV1, leading to a significant reduction in cytokines associated with immune-mediated diseases, with no detectable effects on other proteins.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, “We are committed to developing innovative drugs in the field of autoimmune diseases. As a novel therapy, the VAV1 molecular glue degrader offers three major advantages: high target selectivity, mediation of multiple mechanisms of action, and high efficacy. We are pleased to see that we have rapidly advanced clinical development, and we believe that ICP-538 will become a better treatment option for patients with autoimmune diseases.”

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-Looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

Contact
 
Media Investors
Chunhua Lu  
86-10-66609879 86-10-66609999
chunhua.lu@innocarepharma.com ir@innocarepharma.com

Pittsburgh Aesthetics Rebrands as Avere Beauty, Expanding Med Spa Services in Mars, Pennsylvania and Surrounding Areas

Pittsburgh Aesthetics Rebrands as Avere Beauty, Expanding Med Spa Services in Mars, Pennsylvania and Surrounding Areas




Pittsburgh Aesthetics Rebrands as Avere Beauty, Expanding Med Spa Services in Mars, Pennsylvania and Surrounding Areas

Transition brings enhanced patient experience and Botox, lip filler, and other med spa treatments

Avere Beauty Logo

Avere Beauty Logo

PITTSBURGH, March 15, 2026 (GLOBE NEWSWIRE) —  Pittsburgh Aesthetics, a physician-led medical aesthetics practice in Mars, Pennsylvania, announced today that it will officially operate under the Avere Beauty brand beginning March 16, 2026. The rebrand unifies the practice under a single identity, offering a consistent, high-quality patient experience while expanding access to advanced med spa services across the Pittsburgh region.

The transition reflects Avere Beauty’s commitment to patient-centered care, ensuring that individuals seeking aesthetic treatments continue to receive the same personalized attention while benefiting from a broader range of services and locations.

What Patients Can Expect:

  • Same care team & location: The Mars office will continue to operate at 179 Scharberry Ln, providing the same experience and care patients know and trust.
  • Expanded med spa services: Patients can continue to access a full suite of services, including Botox, lip filler, biostimulators, PDO threads, facials, Hydrafacials, laser treatments, and weight loss programs. Laser tattoo removal and weight loss services will be available Mid-April
  • Brand updates: Over the coming weeks, patients will notice updated signage, digital platforms, and communications reflecting the Avere Beauty brand.
  • Scheduling continuity: Current appointments will proceed as planned, with new booking details shared via email, text, and the website.
  • Expanded access across locations: In addition to Mars, Avere Beauty operates in Lawrenceville (3453 Butler Street, Pittsburgh, PA 15201), Export/Murrysville (5100 Old William Penn Hwy, Export, PA 15632), and Blawnox (307 Freeport Road, Pittsburgh, PA 15238). These locations offer increased appointment availability and access to the practice’s full med spa offerings.

Avere Beauty Foyer

Avere Beauty Foyer

Founder’s Vision

Alyssa Luciano, RN, an ICU nurse with over fifteen years of experience, founded Avere Beauty to create a med spa that blends professional expertise with a welcoming and educational environment. “Our mission is to provide aesthetic treatments that empower patients and enhance confidence,” said Luciano. Her approach emphasizes natural aesthetics, transparency, and individualized care. The Mars location now offers advanced treatments, including Botox lip filler, Sculptra, and multiple lasers – helping patients achieve natural-looking results tailored to their goals.

Driving Growth

Frank Udavcak, Chief Operations Officer, leads Avere Beauty’s expansion and marketing strategy. With a background in content creation, pharmaceutical branding, and storytelling, Udavcak has guided the practice’s growth and helped bring its physician-led services to more communities in the Pittsburgh area.

This rebrand and expansion aim to strengthen the patient experience, offering more appointment availability and new med spa services.

For more information or to book an appointment, visit Avere Beauty online.

About Avere Beauty

Avere Beauty is a med spa based in Pittsburgh, Pennsylvania, dedicated to providing personalized aesthetic treatments in a comfortable, educational environment. Founded by Alyssa Luciano, RN, the practice offers a full range of services including Botox, lip filler, facials, Hydrafacials, laser treatments, PDO threads, and weight loss programs. With multiple locations across the Pittsburgh region, Avere Beauty combines professional expertise with a patient-centered approach to deliver natural-looking, high-quality results.

Media Contact:
Sophie Brinkman
Avere Beauty
sophie@averebeauty.com
https://www.averebeauty.com/

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b128c7a3-6481-4b96-8f9f-2efb6540cf54

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/89ffce74-3bea-4619-8603-628af8b99de4

Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate

Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate




Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate

MELBOURNE, Australia and INDIANAPOLIS, March 16, 2026 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces the resubmission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-Px, (Pixclara®1, Floretyrosine F 18 or 18F-FET), an investigational PET2 imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

Telix has resubmitted the NDA with the additional data requested by the FDA. The Company believes, based on the Type A meeting and ongoing consultation with the FDA, that the additional data and statistical analysis, along with the primary data set provided in the original submission, appropriately addresses the Complete Response Letter3.

Given the potential to address significant unmet medical need, TLX101-Px has been granted Orphan Drug4 and Fast Track5 designations by the FDA. PET imaging with 18F-FET is already included in international clinical practice guidelines for the imaging of gliomas6, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.

Dr. David N. Cade, Telix Group Chief Medical Officer, said, “We appreciate the FDA’s recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. Our resubmission is supported by an extensive and compelling data set – particularly so for an orphan indication. We are grateful to our global clinical collaborators, who share our commitment to ensuring patients in the U.S. can benefit from this important patient management tool.”

Maggie Haynes, Executive Director, Head for the Cure Foundation, added: “Our community is encouraged by the FDA’s ongoing engagement and guidance to the sponsor and support for the Expanded Access Program for TLX101-Px. We are hopeful of an expedited review, so this important and proven imaging option can become available to those who urgently need it.”

About TLX101-Px

TLX101-Px is a PET imaging agent, which has been granted fast track and orphan drug designations by the FDA as an imaging agent for the characterization of recurrent or progressive glioma from treatment related changes. TLX101-Px targets membrane transport proteins known as LAT1 and LAT27. This enables TLX101-Px to be potentially utilized as a companion diagnostic agent to TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in the pivotal IPAX-BrIGHT study8

About gliomas in the U.S.

Gliomas are very diffusely infiltrative tumors that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) neoplasm that originates from glial cells, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors9. In the U.S., there are six cases of gliomas diagnosed per 100,000 people every year10. GBM is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.11. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients12, with an expected survival duration of 12-15 months from diagnosis13

About Telix Pharmaceuticals Limited

Telix is a global biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies, with the goal to address significant unmet medical needs in oncology and rare diseases. With international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan, Telix is headquartered in Melbourne, Australia. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA14. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.

Telix Investor Relations (Global)

Ms. Kyahn Williamson
SVP Investor Relations and Corporate Communications
kyahn.williamson@telixpharma.com

Telix Investor Relations (U.S.)  

Ms. Annie Kasparian  
Director Investor Relations and Corporate Communications  
annie.kasparian@telixpharma.com 

Telix Investor Relations (Australia)

Ms. Charlene Jaw
Associate Director Investor Relations
charlene.jaw@telixpharma.com

Media Contact

Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com

This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

Legal Notices

Cautionary Statement Regarding Forward-Looking Statements. 

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, including the planned NDA resubmission for TLX101-Px and the planned BLA resubmission for TLX250-Px, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties.

©2026 Telix Pharmaceuticals Limited. All rights reserved.

1 Brand name subject to final regulatory approval.
2 Positron emission tomography.
3 Telix ASX disclosure April 28, 2025.
4 Telix ASX disclosure October 6, 2020.
5 Telix ASX disclosure April 16, 2024. Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. More: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
6 Galldiks et al. Lancet Oncol. 2025 (Joint guidelines from the European Association of Nuclear Medicine (EANM), European Association of Neuro-Oncology (EANO), Society of Nuclear Medicine and Molecular Imaging (SNMMI), Response Assessment in Neuro-Oncology (RANO), The European Society for Pediatric Oncology and The Response Assessment in Pediatric Neuro-Oncology for the characterization of recurrence in glioma patients); National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V1.2025.
7 L-type amino acid transporters 1 and 2.
8 ClinicalTrials.gov ID: NCT07100730.
9 Goodenberger et al. Cancer Genet. 2012.
10 Mesfin et al. StatPearls. 2024.
11 Ostrom 2022, CBTRUS (Central Brain Tumor Registry of the United States) Statistical Report.
12 Park et al. Journal of Clinical Oncology. 2010.
13 Ostrom et al. Neuro Oncol. 2018.
14 Telix ASX disclosure March 21, 2025.

Samsung Bioepis and Epis NexLab Sign Research Collaboration and License Agreement with G2GBIO to Develop Novel Assets Including Long-acting Semaglutide

Samsung Bioepis and Epis NexLab Sign Research Collaboration and License Agreement with G2GBIO to Develop Novel Assets Including Long-acting Semaglutide




Samsung Bioepis and Epis NexLab Sign Research Collaboration and License Agreement with G2GBIO to Develop Novel Assets Including Long-acting Semaglutide

  • Samsung Bioepis to receive exclusive license to develop and commercialize two novel assets including long-acting semaglutide using G2GBIO’s proprietary microsphere technology
  • Epis NexLab, a sister company to Samsung Bioepis under Samsung Epis Holdings, also signs the agreement to collaborate in the development of the long-acting microsphere drug delivery platform

INCHEON, Korea–(BUSINESS WIRE)–#Biosimilar–Samsung Bioepis Co., Ltd. and Epis NexLab Co., Ltd., a sister company to Samsung Bioepis under Samsung Epis Holdings (KRX: 0126Z0), today announced a research collaboration and license agreement with G2GBIO, a company specializing in the development of sustained-release formulations, to develop novel assets based on G2GBIO’s proprietary microsphere technology.


Under the agreement, Samsung Bioepis will be given a full license right for the novel long-acting semaglutide asset, and an option to license another asset from G2GBIO. In addition, Samsung Bioepis will be given the first negotiation rights for the three other novel assets to be determined. Epis NexLab will be responsible for the co-development of the long-acting microsphere drug delivery platform using G2GBIO’s proprietary technology. The details of the financial terms remain confidential.

“This agreement represents an important step in expanding our drug delivery capabilities and pipeline,” said Kyung-Ah Kim, President and Chief Executive Officer, at Samsung Bioepis. “By leveraging G2GBIO’s proprietary microsphere technology and collaborating with Epis NexLab, we look forward to the development of innovative therapies and deliver meaningful treatment options to patients.”

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

Contacts

Media Contact
Yoon Kim, yoon1.kim@samsung.com
Anna Nayun Kim, nayun86.kim@samsung.com

Be Well OC Launches “Red Tape” Campaign Calling for Full Access to Behavioral Health Campuses

Be Well OC Launches “Red Tape” Campaign Calling for Full Access to Behavioral Health Campuses




Be Well OC Launches “Red Tape” Campaign Calling for Full Access to Behavioral Health Campuses

Orange and Irvine beds sit empty while community looks to County to deliver on its word

IRVINE, Calif., March 15, 2026 (GLOBE NEWSWIRE) — Two state-of-the-art behavioral health campuses in Orange County are ready to serve all residents, regardless of insurance type. One remains closed. The other is operating under restrictions that limit who can access care.

This week, Be Well Orange County (Be Well OC) launched its “Red Tape” campaign, a movement calling on the County of Orange to open the Irvine Campus and provide access to all residents, regardless of insurance type at both campuses in Irvine and Orange.

To remove the red tape limiting access to care, Be Well OC launched a Change.org petition for the community to sign, asking the County to deliver on its promises.

“Seven years ago, Orange County said access to behavioral health care was fragmented and out of reach. Be Well OC together with public, private, faith-based, academic, healthcare organizations, and others, took steps to solve that problem, building world-class facilities ready to serve everyone. But today the problem continues, red tape is keeping access limited and in the case of the new Irvine campus, the doors are closed. We need your help to open them,” said Phillip Franks, CEO, Be Well OC.

At the Be Well OC Orange Campus, access to the residential treatment programs is limited to County-approved referrals through their behavioral health programs. Since one must come through the County system, which serves roughly 1/3 of the County population, 2/3 of Orange County residents with employer-sponsored, private insurance or MediCare are unable to access services at the campus. In addition, the County-approved referral list for residential programs at the Orange Campus does not include any Orange County hospitals, despite having invested millions in both campuses

“Two-thirds of the Orange County taxpayers who funded these facilities are denied access based on their insurance type. This is the opposite of the Be Well OC vision the community rallied behind – including the County Board of Supervisors. Why are they going back on their promises?” said Dr. Richard Afable, Chairman of the Board, Be Well OC.

Zero Orange County General Fund (local discretionary tax dollars) were used to build the Be Well campuses:

  • Orange Campus — $40M project
    • Hospitals — $12M
    • CalOptima Health — $11.4M
    • California Mental Health Services Act (MHSA) and California Senate Bill 82 funding — $16.6M
  • Irvine Campus — $114M project
    • State of California funding — $50M
    • Federal funding — $4M
    • American Rescue Plan Act (ARPA) funds — $20M
    • Mental Health Services Act (MHSA) funding — $20M
    • CalOptima Health — $15M
    • Hospitals — $5M

In addition to the limited access to the Orange Campus, the Sobering Center was closed by the Orange County Health Care Agency, without explanation in 2024, and remains closed to date.

“The County continues to try to sow distrust in Be Well through their public comments and legal filings, with the ultimate goal of gaining ownership of millions in real estate assets,” continued Franks. “We won’t be distracted. We look forward to our day in court and remain focused on making the campuses accessible to all.”

According to a recent online survey conducted by independent research firm, Mackenzie, among 403 Orange County, Ca. residents from Jan. 8-13, 2026: (Results are statistically valid at a 95% confidence level with a margin of error of approximately +/-4.9%):

  • 65% of residents either personally sought behavioral health care, or knew someone who did, in the past year.
  • 28% of those who sought help, or knew someone who did in the past year, were unable to access the care they needed.
  • Overall, 66% say expanded behavioral health services are extremely or very urgent.

The Irvine Campus is ready to start serving the community. The County has yet to approve the sublease agreement, though it has been submitted to the County for approval on multiple occasions, preventing Be Well OC from entering into leases with County contracted providers, thus causing delays in opening the campus.

“In my work as a rabbi, a therapist, and a chaplain, I have sat with people at their most vulnerable – in pain, and in desperate need of support. I have watched mental health challenges tear through families and communities without warning and without discrimination, and I have seen firsthand what happens when people cannot access care. The opening of the Irvine Campus to all, and the full accessibility of the Orange Campus are not policy discussions; they are moral imperatives,” said Rabbi Richard Steinberg, congregational rabbi in Irvine and Be Well OC Founding Board Member.

Visit Change.org/CutTheRedTapeOC to sign the petition today and express support for opening the Irvine Campus and expanding access to care for all Orange County residents.

ABOUT BE WELL OC
Be Well OC is a transformative initiative bringing together public, private, academic and faith-based organizations to create a coordinated system of behavioral health care and support for all Orange County residents regardless of ability to pay. The Be Well OC behavioral health system, which includes mental health crisis stabilization and substance use services, features two state-of-the-art mental health and wellness facilities in Orange and Irvine, a mobile response program, and a navigation center for individuals and families. Be Well OC’s movement spans across all of Orange County and a range of needs, from prevention and early intervention to crisis aversion, crisis management, acute care and recovery. For more information visit bewelloc.org.

MEDIA CONTACT
Karena Bibbins
karena@ideahall.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/76f5638e-553d-4fcf-a250-63ed1d5df1e6

First Ever Real-World Evidence of Eversense 365 Presented at ATTD Demonstrates Sustained Performance and Positive Impact Throughout One-Year of Wear

First Ever Real-World Evidence of Eversense 365 Presented at ATTD Demonstrates Sustained Performance and Positive Impact Throughout One-Year of Wear




First Ever Real-World Evidence of Eversense 365 Presented at ATTD Demonstrates Sustained Performance and Positive Impact Throughout One-Year of Wear

New data shows positive real-world impact of the world’s first and only one-year CGM, with a full year of strong patient adherence, glucometrics and hypoglycemic outcomes

Eversense 365 delivered comparable adherence and outcomes between the first and second six-month period, indicating high accuracy and performance from a single sensor across an entire year

GERMANTOWN, Md., March 14, 2026 (GLOBE NEWSWIRE) — Senseonics, a medical technology company focused on the development, manufacturing and commercialization of long-term, implantable Continuous Glucose Monitoring (CGM) Systems for people with diabetes, today announces new data from a real-world evidence study which demonstrates the sustained performance and positive impact of Eversense 365 across the full one-year period. These findings were presented during an oral presentation entitled ‘Real-World Evaluation Of The Implantable One Year Eversense 365 CGM System’ at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), taking place on March 11-14 in Barcelona, Spain.

“The promise of a year-long CGM has now been demonstrated in the real world,” said Francine Kaufman, M.D., Chief Medical Officer at Senseonics. “Since Eversense 365 was launched in the US, we have consistently heard positive feedback about the system and its impact from both patients and their healthcare providers. Today, we have presented real-world evidence that further validates our belief in this technology and what we are hearing from the diabetes community. The data demonstrate that Eversense 365 can perform exceptionally well and consistently across its entire lifespan, with strong adherence supporting a full year of positive glycemic outcomes with just one sensor.”

Strong adherence and positive outcomes
The study evaluated the first 5,059 real-world Eversense 365 CGM sensors to be used by patients in the US, all with open-loop insulin regimens. The analysis revealed strong patient adherence, glucometrics and hypoglycemic outcomes, demonstrating how Eversense 365 can support effective management of diabetes over a full one-year period with just one implantable CGM sensor.

Patients using Eversense 365 had an average transmitter wear time of 93.8%, with comparable results for the first and second six-month periods, indicating a year of consistent and meaningful system use. This resulted in a mean Glucose Management Indicator (GMI) of 7.14% and a mean Time in Range (TIR) of 66%, demonstrating effective glycemic control. GMI is an established metric that provides an estimated A1C using only CGM data, with a lower value indicating better management and reduced health risks. GMI is often used alongside TIR to provide a more complete picture of glycemic control.

Furthermore, over 75% of users of the implanted, year-long CGM system achieved hypoglycemic targets, reinforcing that Eversense 365 is the most accurate CGM in low glucose ranges1,2,3, where errors can have the greatest impact on patient safety and treatment decisions. The real-world analysis also showed that glucometrics and hypoglycemic outcomes were comparable for both the first six months and second six months of wear

Specific age group benefits
Additionally, analysis by age revealed that Eversense 365 supported positive glucometrics and outcomes across all age groups. However, glycemic outcomes were seen to improve with increasing age, with the >65 year-old population achieving a mean GMI of 6.99% and a mean TIR of over 70%, with over 85% achieving hypoglycemic targets. The trend was also observed with adherence, with over 95% average wear time in those 65 years and older. This suggests that, whilst all age groups can benefit from Eversense 365, there may be particular benefits and positive outcomes in older populations.

Furthermore, the analysis suggested that Eversense 365 could bring specific benefits to young adults (aged 18-25), who typically have poorer glycemic control. Encouragingly, this age group had a mean GMI of 7.3% with a mean wear time over 90%, which again demonstrates strong adherence.

Encouraging early analysis of AID combination
Two weeks after the commercial launch of the twiist™ Automated Insulin Delivery (AID) system with Eversense 365, real-world data was also analyzed from the first ~120 people who had used the combined system for more than seven days. The glucose outcomes were extremely encouraging with a mean GMI of 6.79%, mean TIR of 77% and time in hypoglycemia of 2.7%, all meeting the international consensus targets. twiist is the first AID system to be compatible with Eversense 365 and, whilst still in the early stages, the initial data analysis suggests that this powerful combination is already having a positive clinical impact. Senseonics plans to present a longer-term real-world analysis later this year.

Brian Hansen, Chief Commercial Officer at Senseonics, added: “We are proud to present these data at ATTD, which is always a fantastic opportunity to connect with the diabetes ecosystem and discuss the latest developments in technology and care. The meeting is particularly timely for us this year following the recent CE mark approval and upcoming launch of Eversense 365 in select European markets. We are gaining momentum commercially in the US and look forward to bringing the benefits of this unique, implantable CGM to new patients and geographies.”

Eversense 365 is the world’s first and only one year CGM, which was approved by the United States Food and Drug Administration in September of 2024 and launched across the country in October of the same year. In January 2026, Eversense 365 received European CE Mark approval and Senseonics expects to launch Eversense 365 in Germany, Italy, Spain and Sweden in the coming months.

As the only implantable CGM available, Eversense 365 offers patients a truly differentiated CGM experience, providing one year of exceptionally accurate monitoring with minimal interruptions. Eversense 365’s unique approach allows people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs, so that patients can focus on managing their diabetes and not their CGM.

1 Senseonics. (2026) Eversense 365 Continuous Glucose Monitoring System User Guide. LBL-7702-01-001
2 Abbott. (2024) Freestyle Libre 3 PLUS User Guide ART49385-001
3 Dexcom (2025) G7 15 Day User Guide AW00078-10 MT-00078-10


About Eversense

Eversense 365 is developed by Senseonics and, as the only implantable CGM available, offers patients a truly differentiated CGM experience, providing One Year of exceptionally accurate monitoring with minimal interruptions. It benefits endocrinologists and care teams by offering their patients confidence in decision making, long-term peace of mind and enhanced quality of life with just one CGM. The unique approach also allows people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs, so that patients can focus on managing their diabetes and not their CGM.

The Eversense® Continuous Glucose Monitoring (CGM) Systems are indicated for continually measuring glucose levels for up to 365 days for Eversense® 365 and 180 days for Eversense® E3 in persons with diabetes age 18 and older. The systems are indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration primarily one time per week after day 14 for Eversense® 365 and one time per day after day 21 for Eversense® E3, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense CGM Systems are prescription devices; patients should talk to their health care provider to learn more. For important safety information, see https://www.eversensediabetes.com/safety-info/.

About Senseonics
Senseonics Holdings, Inc. (“Senseonics”) is a medical technology company focused on the development, manufacturing and commercialization of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics’ CGM system Eversense® 365 and Eversense® E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user’s smartphone.

Senseonics Media Contact

Tim Stamper
FTI Consulting
Tim.Stamper@senseonics.com / Eversense365@FTIConsulting.com

Senseonics Investor Contact

Jeremy Feffer
LifeSci Advisors
investors@senseonics.com