New device can help people with diabetes detect warning signs of a dangerous complication before it becomes a medical emergency

For Immediate Release: August 25, 2026

The U.S. Food and Drug Administration authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes. The Libre Duo 10 Day is the first wearable device in the U.S. that continuously monitors ketone levels, and the first in the world to continuously monitor both ketones and blood sugar (glucose) together in a single device.

“Today’s authorization is a breakthrough for the safety of children and adults living with diabetes,” said Michelle Tarver, M.D., Ph.D., Director of the FDA’s Center for Devices and Radiological Health. “Knowing that ketone levels are rising, and having that information in real time, around the clock, can be the difference between early intervention and a life-threatening emergency.”

According to the Centers for Disease Control and Prevention, an estimated 40.1 million Americans are living with diabetes, a condition that requires careful monitoring of blood sugar levels. For the estimated 2.1 million Americans with type 1 diabetes, blood sugar is only part of the picture. When the body produces too much ketone, which is made by the body when it is using fat instead of glucose for energy, it can lead to diabetic ketoacidosis, or DKA — a serious complication that can develop quickly and become life-threatening if left untreated.

Early detection of rising ketone levels is critical. Until now, people who needed to monitor ketones had to do so separately, using tests that could only provide a single measurement at one point in time which could not tell users if ketones were rising or falling. The Libre Duo 10 Day addresses that gap by continuously measuring both ketone and glucose levels in the fluid just beneath the skin, every minute, day and night. Readings are sent wirelessly to a compatible smartphone, where users can see their current ketone and glucose levels and whether they are trending up or down. The device can send automatic alerts if ketone levels reach a concerning threshold, which may help patients and caregivers recognize rising ketones before DKA becomes a medical emergency. Ketone information should always be interpreted in the context of glucose readings and symptoms.

The FDA’s authorization is based on a comprehensive review of clinical and performance data submitted by the device sponsor. The clinical program included data from six clinical studies that together enrolled more than 600 participants aged 2 years and older to evaluate the accuracy of the device’s ketone and glucose monitoring functionality across a range of ketone and glucose levels. The results demonstrated that the device accurately tracked clinically meaningful differences in ketone levels across its 10-day wear period, including identifying elevated ketone levels before the onset of diabetic ketoacidosis.

This authorization is also aligned with the FDA’s Home as a Health Care Hub Initiative, which focuses on advancing the development of innovative, patient-centered devices that fit more seamlessly into people’s daily lives at home.

Prior to authorization, the FDA granted Breakthrough Device designation for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System. A breakthrough designation is meant to expedite the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The FDA granted marketing authorization to Abbott Diabetes Care for the Libre Duo 10 Day through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing special controls that define requirements including those related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

GENGLYCOS is the first gene therapy approval, and fifth FDA approval overall, for the company

Approval provides a long-awaited first-ever option to reduce the burden of care associated with GSDIa

Ultragenyx received a Priority Review Voucher upon approval

NOVATO, Calif., August 2026 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for GENGLYCOS™ (pariglasgene brecaparvovec-opnr), also known as DTX401, in adult and pediatric patients eight years and older with glycogen storage disease type Ia (GSDIa).

“The approval of GENGLYCOS fulfills our commitment to provide the first therapy that directly targets the root cause of GSDIa. The reduced reliance on cornstarch, experienced by patients in our clinical studies, demonstrates this gene therapy’s ability to establish the normal breakdown of glycogen to produce glucose during fasting or episodes of metabolic stress. This ability to regulate glucose has alleviated the disease burden and has the potential to mitigate the risk of severe or life-threatening hypoglycemia for these patients,” said Eric Crombez, M.D., chief medical officer at Ultragenyx. “As our first gene therapy approval, GENGLYCOS represents an important achievement for our company and the realization of the promise of a powerful new tool to deliver transformative medicines for people living with rare diseases.”

GSDIa is an ultra-rare genetic metabolic disorder caused by a deficiency of the enzyme needed to release glucose from the liver to the bloodstream. The deficiency reduces the liver’s ability to control glucose levels and is associated with potentially life-threatening hypoglycemia episodes and other serious complications, requiring rigorous nutritional management that involves a burdensome, around-the-clock regimen of raw cornstarch intake as an oral glucose replacement therapy. Glucose control with cornstarch is crude with large swings in glucose, and patients instead end up spending a large fraction of their day significantly hyperglycemic to avoid hypoglycemic episodes. GSDIa affects 1,500-2,500 patients in the U.S. and 6,000-8,000 worldwide within commercially accessible geographies.

“Day-to-day management of GSDIa requires a relentless regimen of raw cornstarch and strict dietary management that can be extraordinarily demanding for patients and families. Even with meticulous adherence to this regimen, patients must be perfect. Any missed cornstarch puts patients at risk of severe hypoglycemia, seizures, and even death,” said David Weinstein, M.D., MMSc, one of the world’s leading GSDIa experts. “The approval of GENGLYCOS represents a major step forward for the GSDIa community and reflects almost 30 years of work and scientific progress aimed at improving safety and the quality of life of people living with this disease.”

“For families affected by GSDIa, every day revolves around strict schedules, overnight vigilance, and the constant worry that a missed meal or dose of cornstarch could trigger life-threatening hypoglycemia,” said David and Wendy Feldman, co-founders and current Board members at The Children’s Fund for Glycogen Storage Disease Research. “This approval is an incredibly meaningful milestone for a community that has spent decades hoping, advocating, and helping advance the research for new treatment options that could ease the burdens of this disease.” 

Clinical Program and Post-Marketing Study Requirements Supporting Accelerated Approval of GENGLYCOS

The approval of GENGLYCOS is based on positive data from the 48-week randomized, double-blind, placebo-controlled Phase 3 GlucoGene study which treated 46 participants aged eight years and older with DTX401 (1.0 x 10^13 GC/kg dose) or placebo, showing a reduction in the cornstarch requirements in the treated group (p<0.001). There were 44 participants in the modified intention-to-treat (mITT) population providing efficacy data within the Week 48 analysis period following treatment with DTX401 (n=20) or placebo (n=24). At Week 48, eligible participants crossed over and received the alternate treatment. After crossover, participants continued to be followed, with analyses conducted at Week 96 and Week 144.

As part of accelerated approval, Ultragenyx has agreed to provide two years of safety and efficacy clinical data from open-label commercial treatment of 50 patients and 20 control patients through enhancement of its existing GSDIa Disease Monitoring Program (DMP). The control group will consist of patients who sought commercial treatment but cannot be treated with GENGLYCOS due to the presence of anti-AAV8 antibodies. The study will provide more data to support the reduction in cornstarch clinical burden, fasting tolerance, and other measures in a post-marketing setting where patients can know their immediate glucose levels, and their cornstarch and diet can be managed more promptly by their physician. The DMP will also evaluate previously treated clinical trial participants as well as these new commercial patients for a total of 10 years.  

Enabling Access for Eligible Patients

Ultragenyx will provide support to help enrolled patients and caregivers navigate access to treatment through its UltraCare^® program, which now includes specially trained UltraCare^® Gene Therapy Guides to help understand insurance coverage, assist in obtaining treatment support, and answer questions about the treatment process. Dedicated in-house UltraCare Gene Therapy Guides are available Monday through Friday from 9 a.m. to 8 p.m. Eastern Time at 888-756-8657. More information is available at www.ultracaresupport.com. 

GENGLYCOS will be available through a national network of Qualified Treatment Centers (QTCs) with specialized expertise and training to safely administer gene therapy.

GENGLYCOS is manufactured entirely at Ultragenyx’s Gene Therapy Manufacturing Facility (GTMF) in Bedford, Mass., strengthening the Company’s ability to scale production of high-quality gene therapy products and deliver them to patients as efficiently as possible. 

More information will be available at www.genglycos.com.

This approval reflects the work of a remarkable team spanning many years and organizations. Ultragenyx is deeply grateful to the patients, families, and clinical investigators who made our clinical studies possible; Dr. David Weinstein, whose scientific and clinical leadership laid critical groundwork across early research and clinical trials; Dr. Janice Chou for her early work at NIH, and the team from Dimension Therapeutics. Their collective commitment and perseverance have transformed a scientific vision into a new therapeutic option for patients.

Investor Conference Call and Webcast Information

Ultragenyx will host a conference call today at 6:00 p.m. Eastern Time / 3:00 p.m. Pacific Time to discuss the approval of GENGLYCOS. The live and replayed webcast of the call will be available through the company’s website at https://ir.ultragenyx.com/events-presentations. 

INDICATION

GENGLYCOS (pariglasgene brecaparvovec-opnr) is indicated to reduce daily cornstarch intake as an adjunct to nutritional management in adult and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa).

This indication is approved under accelerated approval based on reduction in daily cornstarch intake. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GENGLYCOS is contraindicated in patients with known severe hepatic fibrosis or cirrhosis.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Infusion Reactions (IRs)

• Hypersensitivity reactions including anaphylaxis and IRs have occurred with GENGLYCOS treatment. Severe reactions have been reported. Monitor for signs and symptoms of hypersensitivity and IRs, including urticaria, flushing, hypotension, bronchospasm, dyspnea, chest tightness, nausea, vomiting, headache, abdominal pain, lightheadedness, flu-like symptoms, shivering, rash, and hypertension.
• Premedicate with acetaminophen and non-sedating antihistamines and administer GENGLYCOS according to recommended infusion rates. Monitor patients during and after completion of GENGLYCOS infusion as clinically indicated. If anaphylaxis or severe IR occurs, pause GENGLYCOS infusion immediately and initiate medical treatment as clinically indicated, monitoring as needed. For mild to moderate IRs, consider slowing or temporarily interrupting the infusion, and administer symptomatic treatment as clinically indicated. The infusion may be restarted at half the prior rate upon resolution of symptoms.
• Medical support measures, including cardiopulmonary resuscitation equipment and medications for the treatment of anaphylaxis (e.g., epinephrine, antihistamines, corticosteroids), should be available during GENGLYCOS administration.

Hepatotoxicity

• Immune-mediated hepatotoxicity, with elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels, has occurred with GENGLYCOS. Avoid use in patients with preexisting hepatic impairment or acute hepatic viral infection.
• Prior to GENGLYCOS infusion, evaluate liver-related medical history and assess liver function by clinical examination and laboratory testing. Advise patients to immediately report signs and symptoms of hepatotoxicity, including fatigue, jaundice, dark urine, nausea, vomiting, and right upper quadrant pain. Administer corticosteroids to all patients after GENGLYCOS infusion in order to mitigate hepatic reactions. Elevated transaminases may require adjustment of the corticosteroid treatment regimen, including increased dose or prolongation of the corticosteroid taper.
• Monitor transaminase levels for the first 6 months after GENGLYCOS administration. Continue to monitor transaminases in all patients who develop transaminase elevations, until transaminases return to baseline or as clinically indicated.

Adrenal Insufficiency

• Adrenal insufficiency, including serious events, has been reported in patients receiving GENGLYCOS during corticosteroid use and tapering.
• Signs and symptoms of adrenal insufficiency include fatigue, weakness, anorexia, nausea, vomiting, hypotension, hyponatremia, and hypoglycemia. Adrenal crisis may present as severe hypotension, acute abdominal pain, or loss of consciousness.
• Monitor patients for signs and symptoms of adrenal insufficiency and adrenal crisis after GENGLYCOS administration during and after corticosteroid therapy and tapering. Taper corticosteroid therapy gradually. Do not abruptly discontinue corticosteroid therapy.

AAV Vector Integration and Risk of Tumorigenicity

• There is a theoretical risk of tumorigenicity due to integration of AAV vector DNA into the genome.
• GENGLYCOS is composed of a recombinant, non-replicating AAV8 vector whose DNA persists largely in episomal form. Random integration of recombinant AAV-vector DNA into human DNA has been reported with AAV gene therapies. The clinical relevance of individual integration events is unknown, but it is acknowledged that individual integration events could potentially contribute to a risk of tumorigenicity. If a tumor develops in a patient receiving GENGLYCOS, health care providers should contact and report the tumor to Ultragenyx Pharmaceutical Inc. at 1-888-756-8657.

Adverse Reactions

• Seven serious adverse events were observed in the Primary Efficacy Analysis Period (PEAP) of Study 1 (Weeks 1-48), including anaphylaxis/infusion reaction (2), adrenal insufficiency (2), high lactate level (2) and hypoglycemia (1).
• The most common adverse reactions during the PEAP of Study 1 (occurring in ≥10% of patients) with higher frequency in GENGLYCOS compared to placebo were ALT/AST Enzyme elevated (71%), Nausea (38%), Headache (24%), Hypertriglyceridemia (29%), Adrenal Insufficiency (24%), Constipation (19%), Hyperglycemia (14%), Acne/Dermatitis Acneiform (19%), Cushingoid Features (14%), and Anaphylaxis (10%).

DRUG INTERACTIONS

Vaccinations

• Vaccine schedules may need to be adjusted for immunosuppressive therapy, and vaccines should be avoided 1 month prior to GENGLYCOS administration.

USE IN SPECIFIC POPULATIONS

Pregnancy

• GENGLYCOS should not be used during pregnancy. There are no data on the use of GENGLYCOS in pregnant women. It is unknown whether GENGLYCOS can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.

Contraception

• Women of childbearing potential should use effective contraception for at least 12 months after administration of GENGLYCOS.
• For 6 months after administration of GENGLYCOS, men must not donate semen, and men of reproductive potential and their female partners must prevent or postpone pregnancy using an effective form of contraception.

ADDITIONAL PATIENT COUNSELING INFORMATION

Vector Shedding

• Inform patients/caregivers that vector distribution in blood and vector shedding in urine, stool, and saliva can occur after GENGLYCOS infusion. Advise patients/caregivers on proper hygiene when handling patient body waste. These precautions should be followed for 3 months after GENGLYCOS infusion.

Report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Ultragenyx Pharmaceutical Inc. at 1-888-756-8657. 

Please see the full Prescribing Information for GENGLYCOS.

About Glycogen Storage Disease Type Ia (GSDIa)
GSDIa is an ultra-rare, serious, and life-threatening disease due to an inborn error of carbohydrate metabolism caused by pathogenic variants of the G6PC gene, which encodes G6Pase, an enzyme that is critical for the release of glucose from glycogen and other metabolic sources. Deficiency of G6Pase activity results in severe hypoglycemia during periods of fasting between meals and during the night along with excess hepatic glycogen storage, metabolic derangements, and other disease-related complications. Cornstarch is critical in the management of GSDIa throughout the day and night in providing an exogenous source of glucose to help avoid sudden and severe drops in plasma glucose levels; however, current management strategies carry a significant burden to patients and families. GSDIa affects 1,500-2,500 patients in the U.S. and 6,000-8,000 worldwide within commercially accessible geographies.

About Ultragenyx
Ultragenyx is a biopharmaceutical company committed to bringing novel therapies to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved medicines and treatment candidates aimed at addressing diseases with high unmet medical need and clear biology, for which there are typically no approved therapies treating the underlying disease.

The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.

For more information on Ultragenyx, please visit the company’s website at: www.ultragenyx.com.

Forward-Looking Statements and Use of Digital Media
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the commercial launch, availability and market acceptance of GENGLYCOS; Ultragenyx’s ability to manufacture GENGLYCOS at its gene therapy manufacturing facility, scale production and supply GENGLYCOS to Qualified Treatment Centers; patient access to GENGLYCOS, including insurance coverage and reimbursement; the safety, efficacy, durability and potential benefits of GENGLYCOS; estimates of the number of patients with GSDIa and the potential commercial opportunity for GENGLYCOS; the design, enrollment, timing, conduct and results of the post-marketing Disease Monitoring Program and other post-marketing requirements; and Ultragenyx’s ability to satisfy FDA requirements and maintain accelerated approval for GENGLYCOS, are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks and uncertainties related to the commercial launch and market acceptance of GENGLYCOS; the ability to identify eligible patients and establish and support a network of Qualified Treatment Centers; uncertainty related to insurance coverage and reimbursement; risks related to serious or undesirable side effects, including risks associated with AAV gene therapy; manufacturing risks, including Ultragenyx’s limited experience operating its own manufacturing facility and the ability to manufacture and supply GENGLYCOS in sufficient quantities and in compliance with regulatory requirements; Ultragenyx’s ability to complete the post-marketing Disease Monitoring Program and other post-marketing requirements within required timeframes and to confirm clinical benefit; the risk that the FDA may modify the approved indication or impose additional requirements, or may withdraw accelerated approval if clinical benefit is not confirmed or post-marketing requirements are not satisfied; smaller than anticipated market opportunities; competition from other therapies or products; product liability; regulatory scrutiny; and other matters that could affect the availability or commercial potential of Ultragenyx’s products and product candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements.

For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Ultragenyx in general, see Ultragenyx’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2026, and its subsequent periodic reports filed with the SEC.

In addition to its SEC filings, press releases and public conference calls, Ultragenyx uses its investor relations website and social media outlets to publish important information about the company, including information that may be deemed material to investors, and to comply with its disclosure obligations under Regulation FD. Financial and other information about Ultragenyx is routinely posted and is accessible on Ultragenyx’s Investor Relations website (https://ir.ultragenyx.com/) and LinkedIn website (https://www.linkedin.com/company/ultragenyx-pharmaceutical-inc-/).

Ultragenyx Contacts

Investors
Joshua Higa
ir@ultragenyx.com

Media
Jess Rowlands
media@ultragenyx.com

In 2019, Joey Thames attended an SCbio event as a representative of Clemson University. He didn’t know at the time, but a conversation that evening would eventually lead him to his next career.

At that event, Thames met Corporate Manager Sheila Dela Cruz and President Dave Shalaby of Poly-Med, who also serves as SCbio’s Fiduciary and Operations Board Secretary, where he had the opportunity to talk with them about his research, interests and experience. He was already familiar with Poly-Med through the company’s Chief Technology Officer, Scott Taylor, but the conversation gave him a chance to learn more about the company and share what he could bring to the team.

Two years later, Thames received a phone call from Poly-Med about an open position.

Today, he serves as the company’s recruiting manager.

His story is one example of what nearly 14 years of SCbio membership has meant to Poly-Med: connections that continue long after an event ends.

More Than a Membership: Investing in People, Partnerships and Relationships

Based in Anderson, Poly-Med is an industry leader in bioresorbable medical technology. The company develops biomaterials and implantable devices designed to support the body as it heals and then safely dissolve once they are no longer needed.

Poly-Med brings the entire process under one roof, including raw polymer synthesis and fiber extrusion to finished implantable device manufacturing. Their in-house expertise allows the company to turn complex ideas into medical technologies that improve patient care.

But Poly-Med’s impact on South Carolina’s life sciences extends beyond the products it develops.

Since its founding in 1993, the company has invested in people, partnerships and relationships that help drive innovation. Its long-standing membership with SCbio has been one part of that effort, giving Poly-Med opportunities to connect with industry leaders, engage with students, support workforce development, participate in policy conversations and stay informed about the issues shaping South Carolina’s life sciences industry.

Simply put, SCbio membership has given Poly-Med a way to stay connected to people and ideas driving the state’s life sciences ecosystem.

Building Connections that Can Change a Company’s Future

In any industry, relationships matter. In life sciences, they can change the company’s future.

Poly-Med has seen that firsthand through its participation in SCbio events, including Academia + Industry: Bridging the Gap, regional programs such as Breakfast and Bio, the Workforce Roundtable Luncheon and at the Life + Science Annual Conference.

“SCbio conferences are much more than opportunities to hear from leaders across the life sciences industry,” said Thames. “They foster meaningful collaboration, the exchange of ideas and lasting professional relationships.”

Those relationships have become particularly valuable as Poly-Med works to build its talent pipeline.

Over the past year, the company participated in three Academia + Industry events, connecting with more than 100 college students and learning about their interests, skills and career goals.

Some of those conversations have continued well beyond the event.

Turning Conversations into Careers

Kylie King is one example of an SCbio student member who has a career success story with Poly-Med.

Thames first met King, a Clemson University biomedical engineering Ph.D. student, at SCbio’s Life + Science Conference. They crossed paths again at an Upstate Academia + Industry: Bridging the Gap event, where Thames saw the ambition and curiosity that Poly-Med looks for in its employees.

Later, he came across King’s profile on LinkedIn and remembered their conversations.

Today, King is a full-time member of the Poly-Med team.

Another Poly-Med hire came through the SCbio Foundation Internship Grant.

Haley Pepper joined Poly-Med as an intern after receiving support from the SCbio Foundation.

“When we met Haley Pepper, we found someone who was engaging and curious,” Thames said.

After Pepper connected with SCbio President and CEO James Chappell, Ph.D., and Executive Vice President and COO Erin Ford, they referred her to Poly-Med for an internship opportunity.

These connections illustrate one of the most valuable parts of SCbio’s role in the industry: bringing the right people together.

Staying Connected to the Industry

Talent is only one part of Poly-Med’s engagement with SCbio.

The company also uses its membership to stay connected to the issues affecting its business and to better understand where South Carolina’s life sciences industry is headed.

Poly-Med representatives have participated in SCbio’s legislative events and conversations with policymakers. The company has also participated in the BIO Fly-In in Washington, D.C., a roundtable discussion with the office of Sen. Tim Scott and the Life Sciences Legislative Breakfast.

This involvement gives Poly-Med a broader view of the opportunities and challenges facing the industry.

“Being a part of SCbio for almost 14 years has provided us with a birds-eye view of the life sciences ecosystem of experts and technologies operating all over the state of South Carolina,” Thames said.

That perspective has helped Poly-Med stay informed on policy and workforce issues while also giving the company opportunities to share its own experiences and ideas.

Growing With South Carolina’s Life Sciences Industry

Poly-Med’s continued growth in South Carolina reflects many of the strengths that make the state attractive to life sciences companies: a growing talent pipeline, strong research partners and a cost-effective operational environment.

The company expanded to Powdersville in 2019 and again to Liberty in 2022, while continuing to develop biomaterial platforms and engineering capabilities designed to improve patient care.

SCbio has helped Poly-Med stay connected to the people and opportunities surrounding that growth.

Over the past year, Poly-Med has reached more than 775 people through SCbio events and received more than 69,000 brand impressions through SCbio communications.

But those numbers tell only part of the story.

The more meaningful measure is what happens after the event ends, like a researcher meeting a future colleague, a student meeting an employer and a company connecting with a policymaker.

That is what has kept Poly-Med engaged with SCbio for nearly 14 years.

“Membership with SCbio has truly allowed us to engage directly with industry partners and share experiences and ideas that allow member companies a leg up in the highly competitive life sciences industry,” Thames said.

As Poly-Med continues to develop new biomaterial platforms and the engineering expertise to support them, the company plans to keep investing in the people and partnerships that have helped shape its growth.

About Poly-Med, Inc.

Poly-Med’s mission is to design, develop, and manufacture custom components and implantable medical devices using next-generation absorbable biomaterials, propelling customers’ specialty product visions into tangible, highly competitive and unique product offerings.

SCbio, and other healthcare and life sciences leaders, joined the United Nations Foundation to highlight South Carolina’s distinct contributions to global health during the Foundation’s Global Health Celebration on Wednesday in Columbia.

Throughout August, the Foundation will showcase the vital importance of U.S. leadership in global health programs, sharing how these global investments drive local innovation and foster economic vitality within specific states and districts.

The event began with a dedication to Senator Lindsey Graham, who served South Carolina in Congress from 2002 until his passing in July 2026.

Representative Joe Wilson was recognized for his steadfast support for global polio eradication and Gavi, the Vaccine Alliance, the largest purchaser of U.S.-produced vaccines, which helps vaccinate over 50% of children worldwide.

James Chappell, Ph.D., President and CEO of SCbio, thanked Rep. Wilson for his service and explained the importance of his support of healthcare initiatives and programs. “That type of work and support is so important for the life sciences industry I represent in South Carolina. We know that before a treatment reaches those patients, someone has to do the research. Someone has to discover it. 
Someone has to commercialize it. Someone has to manufacture. What I’m most excited about is that someone, more and more, is right here in South Carolina.”

Deputy Secretary of the S.C. Department of Commerce Ashely Teasdel emphasized the large role the South Carolina life sciences industry serves in the intersection of healthcare and global health, where innovation translates into new treatments and medical technologies for patients.

“We’re seeing a thriving and growing sector of the life sciences across the state,” said Teasdel. “What that translates to is our commitment to our mission every single day, which is to create economic opportunities and choices for our South Carolinians.”

Jody Chastain, president and CEO of The Ritedose Corporation, a leading Blow-Fill-Seal CDMO for generic pharmaceuticals, shared how patients in 13 countries are being impacted by products manufactured at the Richland County facility.

“When I think about the globalization effort on the eradication of disease through vaccines and biologics, Ritedose is here in Columbia, South Carolina. And we should have an immense impact on the world.”

The United Nations Foundation has built novel innovations and partnerships to support the United Nations and help solve global problems at scale for over 25 years. As an independent charitable organization, the Foundation was created to work closely with the United Nations to address humanity’s greatest challenges and drive global progress.

About SCbio

SCbio is the definitive, unifying leader in South Carolina’s life sciences sector, fostering authentic collaboration and innovation across academia, startups, government and established enterprises. As a member-driven economic development organization, SCbio represents an industry that generates $20.1 billion in annual economic impact and supports 63,000 jobs across South Carolina. Our members are unified by a mission to positively impact humanity through science across the ecosystem of advanced and specialty manufacturing; digital health and the data frontier; and cutting-edge health specializations. For additional information about SCbio and the life sciences industry, or to become a member, visit SCbio.org.

CHARLESTON, S.C., August 2026 – MUSC Health has once again achieved best-in-class national and statewide rankings for excellence in patient care at its hospitals, cancer care, obstetrics and gynecology, neurology and neurosurgery among others.

MUSC Health University Medical Center in Charleston secured the No. 1 hospital ranking in South Carolina from U.S. News & World Report, marking its 12th straight year at the top. Home to the only National Cancer Institute-designated cancer center in the state, it was also ranked No. 1 in South Carolina for cancer care. The annual rankings assess 4,400 hospitals nationwide, placing MUSC among the top 13% in the United States.

MUSC Health’s Obstetrics and Gynecology program ranked No. 10 nationwide, an increase from No. 16 last year.

Neurology and Neurosurgery is recognized as a “high-performing” specialty ranked among the top 100 in the country. In the U.S. News & World Report rankings, a “high-performing” procedures and conditions designation indicates that a hospital’s performance in these specific areas is significantly better than the national average. This recognizes the hospital’s expertise and commitment to high-quality care for these procedures and conditions.

Twenty-four MUSC Health procedures and conditions received “high-performing” designations in the 2026-2027 U.S. News & World Report rankings, represented in the following MUSC Health system divisions:

MUSC Health-Charleston Division (University Medical Center): Aortic Valve Surgery; Back Surgery (Spinal Fusion); Colon Cancer Surgery; Ear, Nose and Throat Surgery; Gynecological Cancer Surgery; Heart Arrhythmia; Heart Attack; Hip Replacement; Knee Replacement; Leukemia, Lymphoma and Myeloma; Lung Cancer Surgery; Pacemaker Implantation; Prostate Cancer Surgery; and Stroke.

MUSC Health-Midlands Division (Columbia Medical Center Downtown and Northeast): Abdominal Aortic Aneurism Repair; Chronic Obstructive Pulmonary Disease; Ear Nose and Throat Surgery; Heart Arrhythmia; Heart Bypass Surgery; Pacemaker Implantation; and Transcatheter Aortic Valve Replacement (TAVR).

MUSC Health-Pee Dee Division (Florence Medical Center): Heart Failure; Pacemaker Implantation; and Stroke.

“This recognition belongs to our dedicated teams across the state who continually strive to improve the lives of those we serve,” said Patrick J. Cawley, M.D., CEO of MUSC Health and executive vice president for Health Affairs, University. “As South Carolina’s only public statewide health system, we remain committed to delivering world-class care close to home. Being recognized as the state’s top cancer hospital while advancing our future comprehensive cancer hospital reflects our continued investment in transforming cancer care for generations of South Carolinians.”

U.S. News & World Report unveiled its 37th edition of the Best Hospitals rankings online. These rankings are designed to help patients with life-threatening or rare conditions identify hospitals that excel in treating the most difficult cases. Best Hospitals 2026-2027 also includes consumer-friendly data to enable patients to make informed decisions about their care.

U.S. News & World Report Best Hospitals methodology evaluated each hospital’s performance using a variety of measures, such as survival rates, complication rates, patient experience and level of nursing care. It also factors in data from the Centers for Medicare and Medicaid Services, American Hospital Association, professional organizations and medical specialists.

Changes to the methodology for 2026-2027

RTI International, the nonprofit research institute that supports the collection and analysis of the U.S. News & World Report Best Hospitals data, annually refines its methodology based on feedback from hospital leaders, physicians, nurses and patients. This year, RTI further increased the emphasis on patient outcomes and patient experience.
MUSC Health carefully reviews these updates to understand how they affect its rankings and to ensure its focus remains on delivering the highest-quality patient care. As the methodology continues to prioritize clinical outcomes and the patient experience, MUSC Health remains committed to providing exceptional, evidence-based care that leads to the best possible outcomes for the patients and the communities it serves.

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About MUSC

Founded in 1824 in Charleston, MUSC is the state’s only comprehensive academic health system, with a mission to preserve and optimize human life in South Carolina through education, research and patient care. Each year, MUSC educates nearly 3,500 students in six colleges and trains more than 1,175 residents and fellows across its health system. MUSC leads the state in research funding from the National Institutes of Health, including National Institute of General Medical Sciences COBRE awards. For information on our academic programs, visit musc.edu.

As the health care system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest-quality and safest patient care while educating and training generations of outstanding health care providers and leaders to serve the people of South Carolina and beyond. In 2026, for the 12th consecutive year, U.S. News & World Report named MUSC Health University Medical Center in Charleston the No. 1 hospital in South Carolina. To learn more about clinical patient services, visit muschealth.org.

MUSC has a total enterprise annual operating budget of $10.1 billion. The more than 37,130 MUSC members include world-class faculty, physicians, specialty providers, scientists, contract employees, affiliates and care team members who deliver groundbreaking education, research and patient care.

New Cartago facility will expand CathX Medical’s manufacturing footprint and create local jobs, advancing its integrated development-to-production model

ORANGEBURG, S.C., August 2026 — Zeus, the global leader in advanced polymer solutions and a provider of contract manufacturing for catheter sub-assemblies, today announced that its CathX Medical business has signed a lease for a new catheter manufacturing facility in the La Lima Free Zone in Cartago, Costa Rica. The investment expands CathX Medical’s manufacturing capacity to support customer programs as they grow, while continuing development and early production at its existing U.S. operations.

“This investment reflects how we think about supporting our customers over the long term,” said Paddy O’Brien, Chief Executive Officer of Zeus. “As their programs move from development to commercial scale, they need a partner with the capacity and consistency to grow alongside them. Costa Rica strengthens our ability to do that, extending the same quality system and manufacturing discipline our customers rely on today into the volumes they will need tomorrow.”

The Costa Rica facility complements CathX Medical’s sites in San Jose, California, and Arden Hills, Minnesota, and advances the company’s three-site model: new products are developed and built in low volumes in the U.S., and Costa Rica supports commercial-scale manufacturing as those programs mature, all under the same quality management system, equipment, and tooling. The site will initially focus on catheter sub-assembly operations, with the same processes and quality standards customers rely on today.

“Everyone in this business knows where programs stall, and it’s almost never the science, it’s the handoff from development into full-scale production,” said Matt Bradbury, Vice President, Catheter Solutions, CathX Medical. “That’s the gap we designed the CathX model to close, and Costa Rica is the piece that completes it, giving a program one continuous path from prototype to commercial volume under a single team and quality system. For our customers, that can be the difference between a device that makes it to market and one that stalls on the way.”

Costa Rica is a globally recognized hub for medical device manufacturing, with a highly skilled workforce, strong infrastructure, and a well-established free trade zone system. The La Lima location positions CathX Medical alongside many of its customers, supporting faster scale-up and greater supply chain resilience. CathX Medical leases the facility with long-term renewal rights and the option to expand within the park as the business grows.

The facility is now in its build-out and hiring phase, with operational readiness expected in Q2 2027 following equipment installation, validation, and workforce onboarding. CathX Medical expects to hire 100 team members in Costa Rica over the next 12 to 18 months, including positions in engineering, technical, and manufacturing operations. The company is particularly seeking candidates with knowledge and experience in extrusion, braiding, and complex catheter assembly processes.

“Our customers are looking for manufacturing partners they can count on as their programs scale globally,” said Jim O’Connell, Chief Commercial Officer at Zeus. “This investment gives them added capacity and greater supply chain resilience, along with the confidence that Zeus can support their programs wherever they are headed.”

The new site adds capacity and does not change CathX Medical’s approach to development or its existing customer relationships. Costa Rica adds capacity to support customers as their programs grow. The facility will meet all applicable regulatory and quality requirements, including ISO 13485 certification and FDA registration, prior to production.

QUICK FACTS

• Zeus, through its CathX Medical business, has signed a lease for a new catheter manufacturing facility in the La Lima Free Zone in Cartago, Costa Rica.
• The site advances CathX Medical’s three-site model: development and low-volume production continue in San Jose, CA, and Arden Hills, MN, while Costa Rica adds commercial-scale manufacturing as programs mature.
• The facility will initially focus on catheter sub-assembly, using the same quality management system, equipment, and tooling as CathX Medical’s U.S. operations.
• Operational readiness is expected in Q2 2027, following build-out, equipment installation, validation, and hiring.
• The site will meet ISO 13485 and FDA registration requirements prior to production.
• CathX Medical expects to hire approximately 100 team members in Costa Rica over the next 12 to 18 months, across engineering, technical, and manufacturing roles.

ABOUT ZEUS

Zeus, headquartered in Orangeburg, South Carolina, is a global leader in advanced polymer solutions that help accelerate innovation across medical, aerospace, energy, automotive, fiber optics, and other demanding markets. Since 1966, Zeus has helped customers solve complex engineering and manufacturing challenges with advanced materials expertise and precision manufacturing. Through its CathX Medical business, Zeus also provides catheter design support and manufacturing services that help customers bring new technologies to market faster. Zeus operates a network of manufacturing facilities across the United States and Ireland. For more information, visit www.zeusinc.com.