Merz Aesthetics® Introduces New BELOTERO® Syringe Offering Greater Precision, Comfort and Ease of Use




Merz Aesthetics® Introduces New BELOTERO® Syringe Offering Greater Precision, Comfort and Ease of Use

Redesigned syringe seamlessly blends innovation and functionality, setting a new standard for precision and ease in the injection experience.

RALEIGH, N.C.–(BUSINESS WIRE)–Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced today the launch of a new syringe for its category-leading hyaluronic acid (HA) brand BELOTERO^®. The new syringe is ergonomically engineered to elevate the treatment experience, offering greater precision, comfort, and ease of use. The new syringe will launch first in Europe and then will expand to markets worldwide.

“As the first region to introduce this innovation ahead of our global expansion, I’m proud to share this exciting milestone in BELOTERO^®’s history as a trusted leader in hyaluronic acid treatments,” said Gonzalo Mibelli, President EMEA region.

What is BELOTERO^®?

BELOTERO^® is the first and only biomimetic hyaluronic acid (HA) treatment with a Cohesive Polydensified Matrix (CPM)^® gel, designed to mimic characteristics and behavior of the skin and deep layers. The brand features a full portfolio with tailored solutions to enhance facial features, improve skin quality, and reduce signs of aging, with natural-looking, long-lasting results. BELOTERO^® recently marked 20 successful years in the aesthetics market, with over 18 million syringes sold worldwide, a true testament to its legacy.³

Smart Design. Precise Control.

“From a design perspective, the new BELOTERO^® syringe delivers both aesthetics and functionality, particularly with its excellent haptics and ergonomic finger-grip,” said Dr. Tatjana Pavicic, a board-certified dermatologist in Munich, Germany. “The anti-slip, signature color-coded silicone surfaces enhance user experience, providing easy identification, practitioner comfort, and stability during procedures.”

With a patent-protected design developed exclusively for BELOTERO^®, the new premium syringe, with the same trusted formula, stands out in the global marketplace with several key improvements, such as:

• Ergonomic Design: The redesigned syringe offers a more comfortable grip, making handling easier during procedures.⁴
• Precision at Every Angle: Engineered for consistent syringe performance, the syringe adapts to various angles, providing greater control and stability.
• Improved Safety Design: An integrated Luer Lock system keeps the needle securely attached, supporting safer administration.

Clinically Validated and Recognized by Experts.

“We are thrilled that our new BELOTERO^® syringe has already been recognized by a panel of expert users for providing the volume control, adaptability and consistent handling we know our customers and patients are looking for,” said Alexis Stern, Global Chief Marketing Officer at Merz Aesthetics. “In fact, 93% of users rated the new BELOTERO^® syringe as easy and intuitive.”⁴

The new BELOTERO^® syringe will launch starting with BELOTERO^® Balance Lidocaine, BELOTERO^® Soft Lidocaine, and BELOTERO^® Intense Lidocaine in Austria, Belgium, Netherlands, Luxembourg, Germany, Italy, Switzerland, Spain, Portugal, the United Kingdom, Ireland, and Malta, followed by a phased global rollout. All BELOTERO^® products with the current syringe remain safe and effective to use as indicated.

About Merz Aesthetics

Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients, and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.

Important BELOTERO^® Soft Lidocaine, BELOTERO^® Balance Lidocaine, and BELOTERO^® Intense Lidocaine Hyaluronic Acid Treatment Considerations (Regions to update based on local safety language)

BELOTERO^® Soft Lidocaine is an injectable biodegradable implant intended for filling of perioral fine lines. BELOTERO^® Soft Lidocaine is a device without an intended medical purpose. BELOTERO^® Soft Lidocaine is indicated for injection into the superficial to mid-dermis for treatment of perioral fine lines.

BELOTERO^® Balance Lidocaine is an injectable biodegradable implant intended for filling of facial wrinkles and folds as well as for lip enhancement. BELOTERO^® Balance Lidocaine is a device without an intended medical purpose. BELOTERO^® Balance Lidocaine is indicated for injection into the superficial to mid-dermis for treatment of naso-labial folds, marionette lines, perioral lines and oral commissures. BELOTERO^® Balance Lidocaine is indicated for submucosal or subcutaneous injection for lip enhancement.

BELOTERO^® Intense Lidocaine is an injectable biodegradable implant intended for filling of deep facial wrinkles and folds as well as to restore and enhance soft tissue volume. BELOTERO^® Intense Lidocaine is a device without an intended medical purpose. BELOTERO^® Intense Lidocaine is indicated for injection into the deep dermis for treatment of nasolabial folds and marionette lines. BELOTERO^® Intense Lidocaine is indicated for submucosal or subcutaneous injection for lip enhancement.

References

1. Patent Note: WO 2005/085329 “Biocompatible crosslinked gel.”
2. Casabona G, et al. 2025, AMWC Congress, The Cohesive Polydensified Matrix Hyaluronic Acid (CPM-HA) Gels Demonstrate Biomimetic Tissue Plane Adaptation: An Integrative Analysis of Physiochemical Properties.
3. Data on File. (CE approval).
4. Data on file. 2021 Emergo Design Change Validation Report.

Contacts

Media Contact
Merz Aesthetics

Global Corporate Communications

6501 Six Forks Road, Raleigh NC 27615

919-302-3296

media@merz.com

Positive Phase III Data for Genentech’s Gazyva Show Significant Reduction in Disease Activity for Systemic Lupus Erythematosus




Positive Phase III Data for Genentech’s Gazyva Show Significant Reduction in Disease Activity for Systemic Lupus Erythematosus

– Phase III ALLEGORY study met primary and all key secondary endpoints with Gazyva, an anti-CD20 monoclonal antibody designed for enhanced B cell depletion –

– Gazyva has the potential to be a transformative new standard of care for up to 3.4 million people affected by systemic lupus erythematosus (SLE) worldwide –

– If approved, Gazyva would be the first anti-CD20 therapy for SLE to directly target B cells, a key driver of inflammation and disease activity –

– These positive results follow the recent U.S. FDA approval and positive EU CHMP opinion for Gazyva in lupus nephritis, alongside positive Phase III data from the INShore study in idiopathic nephrotic syndrome –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today statistically significant and clinically meaningful results from the Phase III ALLEGORY study of Gazyva^® (obinutuzumab) in adults with systemic lupus erythematosus (SLE) on standard therapy. The study met its primary endpoint showing a higher percentage of people achieved a minimum four-point improvement in SLE Responder Index 4 (SRI-4) at one year (52 weeks) with Gazyva versus standard therapy. SRI is a tool that assesses changes in disease severity, symptoms and physical condition to indicate whether treatment is effective at controlling disease activity. All key secondary endpoints were also met. No new safety signals were identified, and safety was in line with the well-characterized profile of Gazyva.

“Systemic lupus erythematosus is a lifelong condition that can cause irreversible damage to the major organs in the body, leading to life-threatening complications. These pivotal results are unprecedented in demonstrating that by effectively controlling disease activity, Gazyva may delay or prevent further organ damage in people with SLE,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We look forward to sharing the data with global health authorities, with the goal of making this potentially transformative new standard of care available as quickly as possible.”

All key secondary endpoints were met, with results showing statistically significant and clinically meaningful benefits with Gazyva versus standard therapy including British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) response at week 52, sustained corticosteroid control from week 40 to 52, sustained SRI-4 from week 40 to 52, a six-point improvement in SLE disease activity score (SRI-6) at 52 weeks, and time to first flare over 52 weeks as defined by the British Isles Lupus Assessment Group (BILAG) index.

SLE affects over three million people worldwide, mostly women diagnosed between the ages of 15 and 45, with women of color disproportionately impacted. Frequent flares of disease activity inflame and damage multiple organs. Around half of the patients will progress to lupus nephritis, a potentially life-threatening kidney complication, within five years of diagnosis. Achieving better disease control can reduce flares, limit further damage to the organs and lower the risk of developing lupus nephritis.

Data will be presented at an upcoming medical meeting and shared with health authorities as soon as possible, including the U.S. Food and Drug Administration and the European Medicines Agency. If approved, Gazyva would be the first anti-CD20 therapy for SLE to directly target B cells, an underlying cause of disease.

ALLEGORY is the third positive Phase III study for Gazyva in immune-mediated diseases, in addition to REGENCY in lupus nephritis and INShore in idiopathic nephrotic syndrome. This growing evidence suggests that Gazyva, designed to attack and destroy targeted B cells, both directly and together with the body’s immune system, may help address disease activity across a spectrum of autoimmune or immune-related diseases.

In addition to SLE, Gazyva is being investigated in children and adolescents with lupus nephritis, as well as adults with membranous nephropathy, as part of our ambition to be leaders in immune-mediated rheumatology and nephrology diseases.

About Gazyva

Gazyva^® (obinutuzumab) is a humanized monoclonal antibody designed with a Type II anti-CD20 region, for direct B cell death and a glycoengineered Fc region, for higher binding affinity and increased antibody-dependent cellular cytotoxicity (ADCC). CD20 is a protein found on certain types of B cells. Gazyva is approved for adults with lupus nephritis in the U.S. who are receiving standard therapy. In October 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval in the European Union, with a final decision expected from the European Commission in the near future. Gazyva is also approved in 100 countries for various types of hematological cancers.

About the ALLEGORY Study

ALLEGORY [NCT04963296] is a Phase III, randomized, double-blind, placebo-controlled, multicenter study, investigating the efficacy and safety of Gazyva^® (obinutuzumab) compared with standard therapy in adults with systemic lupus erythematosus (SLE) on standard therapy. The study enrolled approximately 300 people, who were randomized 1:1 to receive Gazyva or placebo for up to one year (52 weeks), followed by an open-label period with Gazyva for up to 104 weeks. The primary endpoint is the percentage of people who achieve SLE Responder Index four at week 52.

About Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a potentially life-threatening autoimmune disease that affects more than three million people worldwide, and rising. Due to the non-specific symptoms, it can take two to six years for an accurate diagnosis. During this time, disease severity and organ damage, due to repeated flares of disease activity, typically worsens and quality of life declines.

Around half of people with SLE will develop lupus nephritis within five years of a lupus diagnosis. In lupus nephritis, the disease activity primarily affects the kidneys and there is a risk of end-stage kidney disease, where dialysis and transplant are the only treatment options.

There is a need for additional targeted therapies that can effectively control disease activity and potentially delay or prevent the onset of lupus nephritis.

GAZYVA Indications

GAZYVA^® (obinutuzumab) is a prescription medicine used:

• With the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment
• With the chemotherapy drug, bendamustine, followed by GAZYVA alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment
• With chemotherapy, followed by GAZYVA alone in those who responded, to treat stage II bulky, III, or IV FL in adults who have not had previous FL treatment
• for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy

Important Safety Information

The most important safety information patients should know about GAZYVA

Patients must tell their doctor right away about any side effect they experience. GAZYVA can cause side effects that can become serious or life-threatening, including:

• Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If the patient has a history of hepatitis B infection, GAZYVA could cause it to return. Patients should not receive GAZYVA if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to screen them for hepatitis B before, and monitor the patient for hepatitis during and after, their treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes
• Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. The patient’s weakened immune system could put them at risk. The patient’s doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems

Who should not receive GAZYVA:

Patients should NOT receive GAZYVA if they have had an allergic reaction (e.g., anaphylaxis or serum sickness) to GAZYVA. Patients must tell their healthcare provider if they have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past.

Additional possible serious side effects of GAZYVA:

Patients must tell their doctor right away about any side effect they experience. GAZYVA can cause side effects that may become severe or life-threatening, including:

• Infusion-Related Reactions: These side effects may occur during or within 24 hours of any GAZYVA infusion. Some infusion-related reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion-related reactions. If the patient has a reaction, the infusion is either slowed or stopped until their symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion-related reaction is life-threatening, the infusion of GAZYVA will be permanently stopped. The patient’s healthcare team will take steps to help lessen any side effects the patient may have to the infusion process. The patient may be given medicines to take before each GAZYVA treatment. Symptoms of infusion-related reactions may include: fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort
• Hypersensitivity Reactions Including Serum Sickness: Some patients receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, the patient’s doctor will stop the infusion and permanently discontinue GAZYVA
• Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in patients receiving GAZYVA. GAZYVA works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart and may lead to kidney failure requiring the need for dialysis treatment. The patient’s doctor may prescribe medication to help prevent TLS. The patient’s doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness. TLS is not identified as a risk in LN
• Serious, Including Fatal, Infections: While the patient is taking GAZYVA, they may develop infections. Some of these infections may be fatal and severe, so the patient should be sure to talk to their doctor if they think they have an infection. Patients administered GAZYVA in combination with chemotherapy, followed by GAZYVA alone are at a high risk of infections during and after treatment. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients taking GAZYVA plus standard therapy may be at higher risk for fatal or severe infections compared to patients taking standard therapy plus placebo. Patients with an active infection should not be treated with GAZYVA. Patients taking GAZYVA plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking GAZYVA plus CHOP or CVP. If the patient develops a serious infection, your doctor will immediately discontinue GAZYVA and begin treatment for the infection.
• Low White Blood Cell Count: When the patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking GAZYVA, their doctor will do blood work to check their white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If the patient’s white blood cell count is low, their doctor may prescribe medication to help prevent infections
• Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA may reduce the number of platelets the patient has in their blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While the patient is taking GAZYVA, their doctor will do blood work to check their platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. If the patient’s platelet count gets too low, their treatment may be delayed or reduced

• Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA. DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by the patient’s doctor as it can lead to uncontrollable bleeding

The most common side effects of GAZYVA in CLL were infusion-related reactions and low white blood cell counts.

The most common side effects seen with GAZYVA in a study that included relapsed or refractory NHL, including FL patients were infusion-related reactions, fatigue, low white blood cell counts, cough, upper respiratory tract infection, and joint or muscle pain.

The most common side effects seen with GAZYVA in a study that included previously untreated FL patients were infusion-related reactions, low white blood cell count, upper respiratory tract infections, cough, constipation and diarrhea.

The most common side effects of GAZYVA in LN were upper respiratory tract infection, COVID-19, urinary tract infection, bronchitis, pneumonia, infusion infusion-related reactions, and neutropenia.

Before receiving GAZYVA, patients should talk to their doctor about:

• Immunizations: Before receiving GAZYVA therapy, the patient should tell their healthcare provider if they have recently received or are scheduled to receive a vaccine. Patients who are treated with GAZYVA should not receive live vaccines
• Pregnancy: The patient should tell their doctor if they are pregnant, think that they might be pregnant, plan to become pregnant, or are breastfeeding. GAZYVA may harm their unborn baby. The patient should speak to their doctor about using GAZYVA while they are pregnant. The patient should talk to their doctor or their child’s doctor about the safety and timing of live virus vaccinations to their infant if they received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after your GAZYVA treatment
• Breastfeeding: Because of the potential risk of serious side reactions in breastfed children, patients should not breastfeed while taking GAZYVA and for 6 months after your last dose

Patients should tell their doctor about any side effects.

These are not all of the possible side effects of GAZYVA. For more information, patients should ask their doctor or pharmacist.

GAZYVA is available by prescription only.

Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please visit https://www.GAZYVA.com for the GAZYVA full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.

About Genentech in Immunology

Genentech is committed to harnessing pioneering science and innovation to address critical unmet needs for patients with immune-mediated inflammatory diseases. Our pipeline includes over a dozen clinical programs in immunology aiming to transform care for people living with lupus, MASH, ulcerative colitis, Crohn’s disease, immunoglobulin A nephropathy, idiopathic nephrotic syndrome, atopic dermatitis, and rheumatoid arthritis. We are investing end-to-end in immunology from discovery and R&D to commercialization across a variety of modalities including monoclonal antibodies, bispecifics, and CAR-T cell therapies to help solve some of the most difficult challenges in immunology today.

About Genentech

Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact:

Kendall Tich, (650) 467-6800

Advocacy Contact:

Meg Harrison, (617) 694-7060

Investor Contacts:

Loren Kalm, (650) 225-3217

Bruno Eschli, +41 61 687 5284

Newly Established Samsung Epis Holdings to Drive Growth for Samsung Bioepis and a New Subsidiary




Newly Established Samsung Epis Holdings to Drive Growth for Samsung Bioepis and a New Subsidiary

• Samsung Epis Holdings to be listed on Korea Exchange (KRX) on November 24, 2025
• Samsung Epis Holdings to focus on exploring next-generation growth drivers and optimizing business strategies for its subsidiaries ‒Samsung Bioepis and a new company under Samsung Epis Holdings
• Samsung Bioepis will continue to operate its biosimilar business as a 100% owned subsidiary of Samsung Epis Holdings while the new subsidiary company under Samsung Epis Holdings will focus on developing next-generation biotechnology platforms

INCHEON, Korea–(BUSINESS WIRE)–#SamsungBioepis–Samsung Epis Holdings Co., Ltd. today announced its establishment as a new investment holding company, following the spin-off of Samsung Bioepis Co., Ltd. from Samsung Biologics (KRX: 207940.KS). Samsung Epis Holdings will be listed on Korea Exchange (KRX) on November 24, 2025, after establishment of a new subsidiary company on November 14, 2025. Samsung Bioepis will continue to operate its biosimilar business as a 100% owned subsidiary of Samsung Epis Holdings.

Kyung-Ah Kim will serve as the President and Chief Executive Officer (CEO) of Samsung Epis Holdings, in addition to her current role as the President and CEO of Samsung Bioepis. “The new investment holding company will focus on discovering and securing investment opportunities in biotechnology for the company and its subsidiaries’ long-term growth, with scientific innovation remaining the source of our value creation. In the meantime, Samsung Bioepis will remain committed to ensuring the continued development, manufacturing, and distribution of quality-assured biosimilar medicines to patients around the world,” said Kyung-Ah Kim, President and CEO of Samsung Epis Holdings. “By establishing an independent decision-making structure, we see the potential for further growth and investment. Progress is being made to secure next-generation therapeutic technology on the back of the capabilities accumulated through our biosimilar business. With the spin-off, we expect to have more opportunities to explore next-generation growth drivers.”

Samsung Epis Holdings Co., Ltd.

As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings will optimize business strategies for its subsidiaries and maximize corporate and shareholder value through proactive R&D and investment. Samsung Epis Holdings will implement and deploy a focused growth strategy designed to ensure efficient and effective resources while reinforcing the business strategies and platforms for the two subsidiaries.

The New Subsidiary Company

The new subsidiary company under Samsung Epis Holdings will develop next-generation biotechnology platforms targeting various modalities to identify future growth engines beyond the biosimilar business and drive innovation. The new subsidiary will focus on transforming highly scalable core technologies into platforms and discovering diverse new drug candidates, including joint development with global pharmaceutical companies.

For more information about Samsung Epis Holdings and its new subsidiary, please visit: https://www.samsungepisholdings.com/en/

Samsung Bioepis Co., Ltd.

Samsung Bioepis will continue to focus on its core business, including research and development, manufacturing, supply distribution, and commercialization of biologic medicines. Since its foundation in 2012, Samsung Bioepis has developed the industry’s most rapidly advancing biosimilar medicines portfolio, with 11 biosimilars approved and available around the world. In 2024, the company achieved record-breaking sales of KRW 1.5377 trillion and operating profit of KRW 435.4 billion. Samsung Bioepis will focus on strengthening its development capabilities, with a goal of securing 20+ biosimilars in the long-term. Samsung Bioepis has already opened up access to biologic medicines across immunology, oncology, ophthalmology, hematology, and nephrology, and the company is expanding into other therapeutic areas to address unmet needs of patients. For more information about Samsung Bioepis, please visit: www.samsungbioepis.com and follow Samsung Bioepis on social media – LinkedIn, X.

Contacts

MEDIA CONTACT
Anna Nayun Kim, nayun86.kim@samsung.com
Yoon Kim, yoon1.kim@samsung.com

Where to Get TMS Therapy in Colorado Springs Starts with Serenity Mental Health Centers




Where to Get TMS Therapy in Colorado Springs Starts with Serenity Mental Health Centers

Serenity clinics offer accessible TMS treatment for mental health.

COLORADO SPRINGS, Colo.–(BUSINESS WIRE)–Serenity Mental Health Centers, a leader in innovative psychiatric care and one of the fastest-growing mental health providers in the nation, is setting the standard for TMS therapy in Colorado Springs.

Serenity’s board-certified psychiatrists and psychiatric mental health nurse practitioners provide full-spectrum mental health services tailored to each patient’s needs. Treatments include psychiatric evaluations, medication management, transcranial magnetic stimulation (TMS) therapy, and ketamine treatment for conditions such as depression, anxiety, PTSD, OCD, and more. These evidence-based approaches are designed for patients seeking both traditional support and non-medication treatment options.

“When people are looking for where to get TMS therapy in Colorado Springs, they need more than directions; they need hope,” said Tricia Pease, COO and co-founder. “Serenity’s call center staff is ready and available to help patients get the care they need, and fast.”

Serenity’s outpatient model includes flexible scheduling and same-day appointments, breaking down barriers that often prevent patients from receiving timely care. Serenity is committed to providing patient-first psychiatry and to becoming the go-to destination for TMS therapy in Colorado Springs.

With an 84% response rate and 78% remission rate for TMS patients, Serenity is considered one of the best TMS therapy clinics in Colorado Springs for those seeking alternatives to medication.

To book an appointment, visit https://serenitymentalhealthcenters.com/colorado-springs/ or call 719-414-2331.

About Serenity Mental Health Centers

Serenity Mental Health Centers is a leading provider of comprehensive mental health services, dedicated to transforming the lives of patients through compassionate, innovative, and evidence-based care. With 35 locations across the country, Serenity offers a wide range of treatments tailored to address various mental health conditions, including depression, anxiety, OCD and PTSD. Our highly skilled team of psychiatrists, nurse practitioners and mental health specialists combine innovative therapies like Transcranial Magnetic Stimulation (TMS) and ketamine infusion with personalized care to help patients achieve lasting wellness. Serenity is committed to expanding access to quality mental health care and fostering hope and recovery for individuals and families in the communities we serve. For more information, go to serenitymentalhealthcenters.com.

Contacts

For more information, contact:
Jillian DiMarco

jdimarco@serenityhealthcare.com

Serenity Mental Health Centers Expands Access in Colorado Springs with FDA-cleared Accelerated Deep TMS Protocol




Serenity Mental Health Centers Expands Access in Colorado Springs with FDA-cleared Accelerated Deep TMS Protocol

Patients nationwide can access faster, convenient TMS treatment.

COLORADO SPRINGS, Colo.–(BUSINESS WIRE)–Serenity Mental Health Centers, a leader in innovative psychiatric care and one of the fastest-growing mental health providers in the nation, today announced that its patients now have immediate access to the FDA-cleared accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol from BrainsWay for the treatment of Major Depressive Disorder (MDD), including cases with comorbid anxiety.

“Because Serenity already uses BrainsWay machines in its clinics, patients can now benefit immediately from this faster, convenient, and non-invasive treatment option,” said Tricia Pease, COO and co-founder of Serenity Mental Health Centers. “We are committed to being the best TMS clinic in Colorado Springs.”

Serenity’s board-certified psychiatrists and psychiatric mental health nurse practitioners provide full-spectrum mental health services tailored to each patient’s needs. Treatments include psychiatric evaluations, medication management, TMS, and ketamine treatment for conditions such as depression, anxiety, PTSD, OCD, and more. These evidence-based approaches are designed for patients seeking both traditional support and non-medication treatment options.

Serenity’s outpatient model includes flexible scheduling and same-day appointments, breaking down barriers that often prevent patients from receiving timely care. Serenity is committed to providing patient-first psychiatry and to becoming the go-to destination for TMS therapy in Colorado Springs.

With an 84% response rate and 78% remission rate for TMS patients, Serenity is considered one of the best TMS clinics in Colorado Springs for those seeking alternatives to medication.

To book an appointment, visit https://serenitymentalhealthcenters.com/colorado-springs/ or call 719-414-2331.

About Serenity Mental Health Centers

Serenity Mental Health Centers is a leading provider of comprehensive mental health services, dedicated to transforming the lives of patients through compassionate, innovative, and evidence-based care. With 35 locations across the country, Serenity offers a wide range of treatments tailored to address various mental health conditions, including depression, anxiety, OCD and PTSD. Our highly skilled team of psychiatrists, nurse practitioners and mental health specialists combine innovative therapies like Transcranial Magnetic Stimulation (TMS) and ketamine infusion with personalized care to help patients achieve lasting wellness. Serenity is committed to expanding access to quality mental health care and fostering hope and recovery for individuals and families in the communities we serve. For more information, go to serenitymentalhealthcenters.com.

Contacts

For more information, contact:
Jillian DiMarco

jdimarco@serenityhealthcare.com

Pfizer Receives Early Clearance from U.S. Federal Trade Commission for Metsera Acquisition




Pfizer Receives Early Clearance from U.S. Federal Trade Commission for Metsera Acquisition

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced the U.S. Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), with respect to Pfizer’s pending acquisition of Metsera (NASDAQ: MTSR).

The termination of the waiting period under the HSR Act satisfies the regulatory review requirements under the previously announced proposed acquisition of Metsera, which was set to expire on November 7.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice

The information contained in this release is as of October 31, 2025. This release contains forward-looking information about, among other topics, Pfizer’s proposed acquisition of Metsera that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, risks and uncertainties related to the impact of Novo Nordisk’s proposal on the proposed acquisition; risks related to the satisfaction or waiver of the conditions to closing the proposed acquisition (including the failure to obtain the requisite vote by Metsera stockholders) in the anticipated timeframe or at all, including the possibility that the proposed acquisition does not close; the possibility that competing offers may be made or accepted; the risk that the merger agreement may be terminated; risks related to the ability to realize the anticipated benefits of the proposed acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships, including Metsera’s ability to attract and retain highly qualified management and other clinical and scientific personals; negative effects of this announcement or the consummation of the proposed acquisition on the market price of Pfizer’s or Metsera’s common stock and/or operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition or Metsera’s business; other business effects and uncertainties, including the effects of industry, market, business, economic, political or regulatory conditions; future exchange and interest rates; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws, regulations or policy; changes in tax and other laws, regulations, rates and policies; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer’s business and prospects, adverse developments in Pfizer’s markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment, tariffs and other trade policies or economies generally; future business combinations or disposals; uncertainties regarding the commercial success of Metsera’s pipeline products or Pfizer’s commercialized and/or pipeline products; risks associated with Metsera conducting clinical trials and preclinical studies outside of the United States; Metsera’s reliance on third parties to conduct clinical trials and preclinical studies and for the manufacture and shipping of its product candidates; the risk that Metsera’s product candidates are associated with side effects, adverse events or other properties or safety risks; risks associated with Metsera’s license and collaboration agreements and future strategic alliances; Metsera’s ability to obtain, maintain, defend and enforce patent or other intellectual property protection for current or future product candidates or technology; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications may be filed in any jurisdictions for Pfizer’s or Metsera’s pipeline products for any potential indications; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such products will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of such products; uncertainties regarding the impact of COVID-19; and competitive developments.

You should carefully consider the foregoing factors and the other risks and uncertainties that affect Pfizer’s business described in the “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results” sections of Pfizer’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed from time to time with the U.S. Securities and Exchange Commission, all of which are available at www.sec.gov. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Pfizer assumes no obligation to, and does not intend to, update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law. Pfizer does not give any assurance that it will achieve its expectations.

Contacts

Media Contact: PfizerMediaRelations@Pfizer.com
Investor Contact: IR@Pfizer.com

Immunis Publishes Research Showing Body Fat Loss and Reversal of Liver Steatosis and Fibrosis, While Increasing Lean Muscle Mass, in Aged Models




Immunis Publishes Research Showing Body Fat Loss and Reversal of Liver Steatosis and Fibrosis, While Increasing Lean Muscle Mass, in Aged Models

IRVINE, Calif.–(BUSINESS WIRE)–#biologics—Immunis, Inc., a clinical-stage biotech developing innovative stem cell-derived biologics for age- and disease-related immune dysregulation, announces the publication of its peer-reviewed research in collaboration with Dr. Micah Drummond from the University of Utah. The study published in Obesity is titled, “Stem Cell Secretome Treatment Reduces Adiposity and Improves Glucose Handling During Obesity and Weight Loss in Mice.”

The National Center for Health Statistics reports that the percentage of Americans aged 65+ with obesity has doubled to 40% for both men and women. While pharmacotherapies like GLP-1 receptor agonists have demonstrated global commercial success for its ability to achieve rapid weight loss, 25-40% of the total weight lost from these drugs is attributed to a decrease in lean muscle, not fat. There is a critical need for pharmaceuticals that can promote fat loss without compromising muscle.

Immunis’ publication discusses the effects of its investigational therapeutic, IMM01-STEM, in aged mouse models of obesity. The key findings are as follows:

• IMM01-STEM significantly enhanced weight loss in obese mice by reducing the percentage of whole-body fat while increasing lean mass.

• IMM01-STEM significantly reversed liver steatosis and fibrosis in aged mice on a high fat diet, to levels similar to that of healthy controls.

• IMM01-STEM provided major metabolic benefits during weight loss, including better glucose tolerance and lower fasting insulin levels, with treated mice achieving metabolic profiles similar to healthy controls.

• IMM01-STEM preserves muscle mass and enhances muscle quality by increasing muscle fiber size, increasing blood capillary density, and reducing fibrosis.

These data provide a promising basis for additional investigations of IMM01-STEM in supporting metabolic and tissue health during obesity and weight loss in humans. This research complements the findings from Immunis’ two additional published preclinical studies in GeroScience and Aging Cell, which show a reversal of deficits in aged skeletal muscle resulting in leaner, higher quality tissue with lower fat and fibrosis, thicker myofibers, greater overall strength, improved whole-body metabolism, reduced adiposity, and better balance and coordination.

“Publishing in a leading scientific journal like Obesity reaffirms the importance of our team’s research efforts. IMM01-STEM could possibly transform human healthspan by promoting a healthier form of weight loss. We are fortunate to explore the potential benefits of our multi-active drug when the interest in healthspan therapies is at an all-time high,” says Dr. Hans Keirstead, Immunis’ Chairman and publication author.

About Immunis, Inc.

Immunis is a clinical-stage biotechnology company developing multi-active stem cell-derived biologics for the various manifestations of age-related diseases and immune dysregulation. The investigational product line leverages Immunis’ leading-edge capabilities in stem cell secretome technology to deliver a product of all natural, all human immune modulators in their natural physiological concentrations.

For additional information about Immunis’ programs, please visit our Pipeline.

Cautionary Note Regarding Forward-Looking Statements

This communication contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as applicable. Forward-looking statements include, but are not limited to, statements regarding our plans, beliefs, expectations and assumptions, as well as other statements that are not necessarily historical facts. You are cautioned that these forward-looking statements are only predictions and involve risks and uncertainties. Further, any forward-looking statement speaks only of the date as of which it is made, and we do not intend to update or revise any forward-looking statements. This communication also contains market data related to our business and industry, which includes projections that are based on several assumptions we believe are reasonable and most significant to the projections as of the date of this communication. If any of our assumptions prove to be incorrect, our actual results may significantly differ from our projections based on these assumptions. This communication is neither an offer to sell nor a solicitation of an offer to buy any of the securities described herein.

Contacts

contact@immunisbiomedical.com

Appointment of Yves Decadt as Member of Poxel’s Board of Directors




Appointment of Yves Decadt as Member of Poxel’s Board of Directors

LYON, France–(BUSINESS WIRE)–Regulatory News:

POXEL SA (Euronext : POXEL – FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today announces the appointment of Yves Decadt as a member of its Board of Directors.

Following the governance changes implemented on July 31, this appointment further strengthens Poxel’s strategic and commercial organization. It will be submitted for shareholder approval at the Company’s next Annual General Meeting.

Yves Decadt brings over 25 years of international experience in the pharmaceutical industry. He spent nearly 20 years at Johnson & Johnson within the Global Business Development department, where he was responsible for licensing and deal negotiations, particularly across Asia. He has also held several senior executive positions in leading biopharma and medtech companies. Yves will bring to Poxel a unique combination of scientific and strategic expertise, as well as access to an extensive global network. Since August 2025, Yves has been working with Poxel’s teams under a consultancy agreement, supporting ongoing partnership discussions and conducting an in-depth assessment of the commercial development potential of Poxel’s main assets.

Yves Decadt holds degrees in Bio-Engineering and Industrial Business Administration from University of Ghent (Vlerick School), as well as in Pharmacology and Pharmaceutical Medicine from the Université Libre de Bruxelles. He also holds a Board Director Certification from Duke University.

In order to comply with gender balance requirements applicable to Poxel’s Board of Directors, which currently comprises fewer than eight members, it was agreed that the implementation of Yves Decadt’s appointment would entail the prior resignation of Nicolas Trouche from his position as Director. This ensures compliance with the minimum gender representation required by law.

Nicolas Trouche, Chief Executive Officer of Poxel, stated: “We are delighted to propose the appointment of Yves Decadt to Poxel’s Board of Directors. His expertise and proven track record in developing strategic partnerships will be invaluable in strengthening and accelerating value creation for Poxel and its stakeholders, while continuing to enhance the value of our product portfolio.”

About Poxel SA

Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG^® (Imeglimin), Poxel’s first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.

For more information, please visit: www.poxelpharma.com

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release.

Contacts

Investor relations / Media
NewCap

Aurélie Manavarere, Théo Martin / Arthur Rouillé

investors@poxelpharma.com
+33 1 44 71 94 94

IVI RMA Research Study Wins Best Paper Prize Award at ASRM 2025 with Juno Genetics




IVI RMA Research Study Wins Best Paper Prize Award at ASRM 2025 with Juno Genetics

Company Receives Three Additional Honors for Research into PGT Testing, Progesterone Surges During IVF, and Nutrition Interventions During IVF

MADRID & BASKING RIDGE, N.J.–(BUSINESS WIRE)–IVI RMA, the world’s leading reproductive medicine group, announced that joint research with Juno Genetics that utilized data from the Foundation for Embryonic Competence and RMA New Jersey won the Best Paper Prize at the American Society for Reproductive Medicine (ASRM) 2025 Annual Scientific Congress & Expo, held in San Antonio, Texas, October 25-29.

The research looked at the reproductive potential of segmental aneuploid embryos (embryos in which pieces of chromosomes are missing or gained) to learn more about how many of these embryos can result in a live birth, helping inform doctors and patients as they navigate results of preimplantation testing for aneuploidy (PGT-A).

Three other IVI RMA studies also won recognition at ASRM, with the company winning the top two paper prizes, the second-place poster prize, and the Nutrition Special Interest Group (SIG) prize. This prize-winning research explored the need for more industry standardization in preimplantation genetic testing of embryos, the impact of progesterone surges during ovarian stimulation for IVF outcomes, and the impact of nutrition interventions on IVF outcomes. Three out of four studies were led by fellows and clinicians from Jefferson-RMA Fellowship, a leading fellowship affiliated with IVI RMA, that trains the next generation of reproductive endocrinologists.

“This recognition from our industry peers is a testament to the cutting-edge research we do in concert with partners like Juno, the pre-eminent center for embryo genetic diagnostics, at our global network of research centers. In these spaces, we study the most important questions in reproductive medicine with the scale and efficacy few can rival,” said Dr. Juan A. García-Velasco, Global Chief Scientific Officer at IVI RMA Global. “This award strengthens our commitment to research the science that will make assisted reproductive care more effective and accessible for individuals and families worldwide.”

With five international research centers, over 500 clinical researchers, and 240+ peer-reviewed publications in 2024 alone, IVI RMA research consistently leads innovation in reproductive medicine science with the goal of improving patient care. More than 100 IVI RMA fertility experts from five countries had 65 papers selected to present at this year’s congress.

“Juno Genetics is the worldwide leader in evidence-based PGT embryo testing, utilizing the clinically validated PGTseq platform, and we are proud to present outcome data that helps clinicians and patients make informed decisions,” said Chaim Jalas, CEO & Director of Technology Development at Juno Genetics.

The winning paper, “Investigating the Reproductive Potential of Non-Mosaic Segmental Aneuploidy: A Double-Blinded, Multicenter Non-Selection Study Of 176 Single Frozen Embryo Transfers” was presented by author and attending physician Stephanie Willson, MD, IVI RMA Global Research Alliance, and Jefferson-RMA Fellowship Graduate, 2025. Other authors include Amber Kaplun MS, IVI RMA America; David Ferrando, Yiping Zhan PHD, Xin Tao PHD; Emily Mounts MS, Antonio Capalbo PHD; Chaim Jalas of Juno Genetics; and Richard T Scott MD, of the Foundation for Embryonic Competence.

Other Award-Winning Research

The three other IVI RMA winning submissions were authored by professionals from IVI RMA’s Global Research Alliance and other IVI RMA brands including Boston IVF and Reproductive Medicine Associates (RMA) in Basking Ridge, NJ, with outside partners and the Jefferson-RMA Fellowship program:

Prize Paper – Second Place

“PGT-A Provider Strategies Influence Embryo Selection And Live Birth Rates: A Multicenter Study Of 40,308 Blastocyst Biopsy Results And 8,491 Euploid Embryo Transfers”
Presenting Author: Denny Sakkas, PhD, Boston IVF and principal investigator Mina Popovic, PHD Impact: Clinics need to weigh the trade-offs between embryo availability and success rates when choosing a PGT-A provider, aligning strategies with patient needs and outcome goals.

Prize Poster – Second Place

“Is Premature Progesterone Surge During Ovarian Stimulation For In Vitro Fertilization (IVF) Associated with Impaired Embryologic Outcomes: A Propensity Score–Matched Analysis”
Presenting Author: Devika Sachdev, MD, IVI RMA Global Research Alliance, Fellow, Jefferson-RMA Fellowship Program, 2024-2027

Other Authors: Christine Whitehead MS, IVI RMA Global Research Alliance; Erkan Kalafat MD, Lea George MD, IVI RMA Global Research Alliance; Marie Werner MD, IVI RMA Global Research Alliance; Juan Garcia-Velasco MD PHD, IVI RMA Global Research Alliance; Emre Seli MD, IVI RMA Global Research Alliance

Impact: Premature progesterone surge is associated with a decrease in oocyte maturation and blastulation rates, but not enough to be clinically meaningful.

Nutrition Prize Paper – Winner

“The Impact Of Nutrition Intervention On Reproductive Outcomes Of Women Undergoing In Vitro Fertilization (IVF): A Retrospective Matched Cohort Study Of 3,919 IVF Cycles”
Presenting Author: Andres Reig, MD, RMA Basking Ridge, attending physician, Jefferson-RMA Fellowship graduate, 2024

Other Author: Marisa Sweeney, MS RDN CSSD RYT, Be Well Integrative Health Services

Impact: Nutrition counseling was significantly associated with improved IVF outcomes, supporting incorporation into fertility treatment plans.

Earlier in the conference, it was also announced that Boston IVF Chief Scientific Officer Denny Sakkas, PHD was awarded the 2025 ASRM Distinguished Researcher Award, one of the most prestigious awards in reproductive medicine, for his groundbreaking research into sperm DNA damage, fertilization, early embryo development, and male infertility.

“These recognitions from ASRM highlight the innovation and teamwork that define IVI RMA’s research across North America and around the world,” said Dr. Denny Sakkas, Chief Scientific Officer at Boston IVF. “Achievements like these are never the result of one individual – they are the outcome of a shared vision and the dedication of hundreds of experts working together to give patients the greatest chance to build their families.”

“We are incredibly proud to see our fellow and clinicians’ research recognized among the best at this year’s ASRM,” said Dr. Marie Werner, Program Director, Jefferson-RMA Fellowship in Reproductive Endocrinology & Infertility. “Our fellow Dr. Devika Sachdev and attending Drs. Stephanie Willson and Andres Reig each exemplify our shared commitment to advancing evidence-based reproductive medicine and improving patient outcomes.”

More information is available at: https://www.ivi-rmainnovation.com/

About IVI RMA Global

IVI RMA Global is the global leader in reproductive medicine, committed to delivering personalized, high-quality fertility care backed by science. With more than 5,000 employees across 200+ fertility clinics in 15 countries, the company empowers individuals and couples to build the families they dream of—safely, effectively, and with unwavering support at every step. Learn more at https://www.ivirma.com/

About Juno Genetics

Juno Genetics is the worldwide leader in evidence-based PGT embryo testing, providing evidence-based PGT and genetic testing to IVF clinics and patients. Learn more at https://www.junogenetics.com/

Contacts

Media Contact
Sneha Satish

Ssatish@stantonprm.com
646-502-3556

20/20 Onsite Tops 20+ CNS Trials, Driving Quality Ocular Endpoint Protection at Scale




20/20 Onsite Tops 20+ CNS Trials, Driving Quality Ocular Endpoint Protection at Scale

BOSTON–(BUSINESS WIRE)–#ClinicalTrials–20/20 Onsite today announced it has supported 23 central nervous system (CNS)/neurology studies to date (including epilepsy, MDD, and bipolar disorder), including 10 studies in the last 10 months, with additional trials launching in the coming quarters. The milestone underscores growing sponsor demand for quality ocular endpoint protection delivered at the point of need, all backed by secure data workflows that streamline submissions and protect timelines.

Across its portfolio, 20/20 Onsite has achieved a 95+ patient Net Promoter Score (NPS), 100% screening timelines met, and 85,000+ ophthalmic assessments conducted across 48 states. In verified studies, the company has maintained ~91% patient retention versus an industry Phase 3 average near 70%, helping sponsors reduce re-visits, protect endpoints, and keep programs on schedule.

“CNS and neurology trials can live or die by the consistency and integrity of their ocular endpoints,” said Ivan Quiroz, VP, Clinic Operations, 20/20 Onsite. “Sponsors trust us because we bring certified teams, validated equipment, and a patient-first workflow directly to the point of need—sites, homes, or community locations—so they get high-quality data without adding burden to patients or sites. Our job is to get it done, and get it done right, every time.”

Purpose-Built to Protect Ocular Endpoints in Neuro Trials

20/20 Onsite’s model pairs field-based ophthalmic experts with validated imaging and exam equipment deployed via mobile vision clinics, mobile vision pods, and mobile clinic suites. This point-of-need approach reduces travel, improves consistency across timepoints, and increases access for underrepresented populations. These are key advantages for neurology programs where protocol adherence and patient experience directly influence data quality.

Outcomes Sponsors Can Measure

• 23 CNS/Neuro studies supported (10 in the last 10 months); additional programs in startup
• 95+ NPS from patients, reflecting high satisfaction and reduced burden
• 100% screening timelines met, enabling on-schedule enrollment and visits
• 85,000+ ophthalmic assessments completed across 48 states
• ~91% patient retention vs ~70% Phase 3 industry average, helping protect endpoints and reduce costly re-visits

“Every neuro sponsor we serve asks the same questions: Will our endpoints be protected, will our patients stay engaged, and will we hit our dates?” added Quiroz. “Our answer is operational: certified people, standardized workflows, validated equipment, and a delivery model that meets patients where they are. That’s how we keep trials moving.”

With more neurology studies in early trial phases, 20/20 Onsite continues to expand capacity and geographic coverage to help sponsors scale consistently — from single-site studies to multi-region programs — without sacrificing quality or speed.

About 20/20 Onsite

20/20 Onsite is a clinical trial solutions company specializing in quality ocular endpoint protection through its nationwide point-of-need fleet. By bringing advanced ophthalmic assessments directly to clinical trial participants—whether at sites, homes, or community locations—20/20 Onsite makes it easier for sponsors, CROs, and sites to collect critical data, reduce patient burden, and improve trial outcomes.

20/20 Onsite has supported over 40 clinical trials, served more than 85,000 patients, achieved 100% of screening timelines, and consistently delivered patient Net Promoter Scores (NPS) above 95.

To learn more about how 20/20 Onsite delivers quality ocular endpoint protection at scale, visit www.2020onsite.com.

Contacts

Josh Anderson

Senior Director of Marketing

janderson@2020onsite.com