Brightseed’s 2025 Consumer Research Finds 45% of U.S. Adults Are Now “Bioactivists” – the Largest and Fastest-Growing Health Segment — Up from 27% in 2022




Brightseed’s 2025 Consumer Research Finds 45% of U.S. Adults Are Now “Bioactivists” – the Largest and Fastest-Growing Health Segment — Up from 27% in 2022

Latest research shows that this mainstream segment is 20% more likely to keep up with the latest health trends and 25% more willing to pay more for foods, beverages, and supplements containing bioactives compared to other segments

SAN FRANCISCO–(BUSINESS WIRE)–Brightseed, the bioactives leader unlocking nature with AI to elevate human health and developer of the Forager® AI platform, today announced findings from its second installment of Bioactivist consumer research. The updated findings revealed that 45% of U.S. adults now identify as Bioactivists – proactive, health-conscious consumers who see health as a foundation rather than a fix, and who are increasingly seeking products with proven health benefits. This is a sharp rise from 27% in Brightseed’s 2022 survey, making Bioactivists the fastest growing and largest health-focused consumer segment in the U.S. Access Brightseed’s infographic detailing the survey findings here.

KEY FINDINGS

• Bioactivists now represent 45% of U.S. adults
• High purchasing power & loyalty: Bioactivists skew toward higher incomes and are more likely to be repeat buyers when their health needs are met.
• Proactive health focus:
  • 87% use supplements; 43% use them consistently.
  • 68% regularly check nutrition labels.
  • +20% more likely to follow the latest health trends vs. other consumers.
  • +16% more likely to seek products with added nutrients.
• Bioactive-driven purchasing:
  • +25% more willing to pay more for foods, beverages, and supplements containing bioactives.
  • +14% more likely to try a new product because it contains bioactives.
  • +12% more interested in increasing bioactive intake.
• Health mindset: Bioactivists view health as a foundation, not a fix, and are motivated by long-term goals like avoiding future illness, living longer, and maintaining a healthy lifestyle.
• Market opportunity: More than 60% of consumers want brands to improve product healthfulness, communicate bioactive content, and back claims with science.

Bioactivists outpace other consumers in their commitment to health, with 87% incorporating supplements into their routines, 68% regularly checking nutrition labels, and strong interest in products with bioactives – naturally occurring compounds in plants and other sources that positively impact human health.

These consumers not only represent a large share of the U.S. population, they also hold significant purchasing power, skew toward higher incomes, and are brand-loyal when their health needs are met.

“The Bioactivist is no longer a niche wellness enthusiast – they’re your neighbor, your coworker, and a powerful driver of market trends,” said David Blackwood, SVP, Commercial at Brightseed. “For food, beverage, and health companies, this is a prime opportunity to engage a large, motivated, and high-spend audience that is actively seeking products with proven functional benefits.”

The research also found growing consumer expectations for transparency and science in health products. More than 60% of consumers agree that their favorite brands should improve product healthfulness, communicate bioactive content, and back claims with science.

Brightseed’s proprietary AI platform, Forager – an advanced discovery and development engine for small molecules and bioactives – is uniquely positioned to meet this demand.

“Bioactives are nature’s health drivers, and Forager allows us to discover and unlock them at an unprecedented scale, providing our partners market disrupting innovation and development tools,” said Sofia Elizondo, Co-Founder and President of Brightseed. “This research confirms that consumers are ready – and eager – for products that harness bioactives to support human health.”

The 2025 Brightseed Health & Nutrition Survey was conducted online in April 2025 among a nationally representative sample of 1,200 U.S. adults, ages 18 and older.

About Brightseed

Brightseed®, the bioactives leader unlocking nature with AI to elevate human health, is a World Economic Global Innovator. Brightseed’s proprietary AI, Forager®, accelerates bioactive discovery, biological validation, and ingredient formulation from years to months, rapidly revealing new connections between nature and humanity. Brightseed produces clinically-proven bioactives for dietary supplements, food & beverage CPG, specialty nutrition, and medical foods to power proactive health worldwide. Learn more at brightseedbio.com.

Contacts

Media Contact
Nicki Briggs, MS, RDN

Communications, Brightseed

press@brightseedbio.com

Chrislaina Anderson Awarded 2025 Adam Ferrari Health Science Scholarship




Chrislaina Anderson Awarded 2025 Adam Ferrari Health Science Scholarship

Chrislaina Anderson is proudly announced as the winner of the 2025 Adam Ferrari Health Science Scholarship, a $20K award honoring future healthcare leaders dedicated to compassionate care.

IRVINE, Calif.–(BUSINESS WIRE)–The Ferrari Foundation has named Chrislaina Anderson as the recipient of the 2025 Adam Ferrari Health Science Scholarship. This $20,000 award, established by Phoenix Energy CEO Adam Ferrari, recognizes exceptional health science students dedicated to enhancing care for individuals with physical disabilities.

Anderson was chosen from a competitive pool of applicants nationwide and impressed the selection committee with her academic excellence and dedication to service. Throughout the process, she demonstrated a clear vision for integrating bioengineering, medicine, and compassion to restore mobility, dignity, and independence for patients.

“Winning this scholarship is more than financial aid—it shows that people believe in me and my dreams,” Anderson shared. “When I found out I was selected, I was ecstatic. I immediately started yelling for my family to let them know the good news. This scholarship allows me to pursue a B.S. in Bioengineering at UC Berkeley, where I will have amazing opportunities to research medical devices and other healthcare-related technologies. It reassures me that I am ready for this big leap to make an impact within the medical community. I would like to thank everyone who made this possible.”

Anderson’s passion for healthcare is deeply personal. Growing up with a father and an aunt living with neuropathy, she witnessed firsthand how physical disability can affect not only mobility but also pride and independence. These experiences inspired her to pursue bioengineering as a way to design solutions that improve the quality of life for individuals with physical disabilities.

Anderson co-founded Hands Across Horizons, a nonprofit that provides educational resources to underserved students and trafficking survivors, and created Hands on Music, a free program for Title I children, including those with fine motor challenges. She has served as a class president, drum major, and tutor in over 20 college-level subjects—all while graduating as valedictorian with 129 college credits and earning an Associate’s Degree in Mathematics and Sciences at just 15 years old.

“Chrislaina’s academic accomplishments are extraordinary, but it is her empathy and commitment to designing healthcare solutions that truly stand out,” said Adam Ferrari, founder of the Ferrari Foundation. “Her mission to merge engineering with direct patient care reflects the core values that inspired this scholarship and carries forward the values shaped by my father’s experience.”

Now in its fifth year, the Adam Ferrari Health Science Scholarship continues to empower future healthcare leaders who combine academic excellence with a commitment to compassionate, patient-centered care. The award is presented annually to a student whose achievements and aspirations align with the Ferrari Foundation’s mission to advance accessibility, innovation, and high-quality care for individuals with physical disabilities.

For more information about the Adam Ferrari Health Science Scholarship, visit www.adamferrarischolarship.com.

Contacts

Caroline Scroggins

The Ferrari Foundation

949-526-8611

info@theferrarifoundation.org
https://www.theferrarifoundation.org/

Lumaegis Secures $200,000 in Pre-Seed Funding to Accelerate FDA De Novo Certification—Propelling Its Breakthrough Sterilization Technology Toward Market Readiness




Lumaegis Secures $200,000 in Pre-Seed Funding to Accelerate FDA De Novo Certification—Propelling Its Breakthrough Sterilization Technology Toward Market Readiness

AUSTIN, Texas–(BUSINESS WIRE)–Lumaegis, Inc., an emerging leader in medical device innovation, was recently honored as one of the 2024 RadLaunch Challenge Winners by the International Ultraviolet Association, recognizing its groundbreaking contributions to solid-state lighting-based sterilization technologies.

Lumaegis has also successfully closed a $200,000 pre-seed funding round, led by one of their global strategic partners. Lumaegis will use these funds to build the next set of production units and conduct FDA, UL/CE, and longevity testing.

At the heart of Lumaegis’ innovation is the RadBox, a patent-protected sterilization device designed as a fast, energy-efficient alternative to traditional sterilizers. The RadBox has received FDA De Novo classification, a designation reserved for breakthrough technologies with no existing, approved predicate device. This status highlights the RadBox’s significant advantages and its potential to improve patient outcomes, all the while saving the practitioners tens of thousands of dollars per year.

The company is set to begin FDA-required testing later this year. The RadBox utilizes dual-modality approach i.e., combination of germicidal and thermal radiation emitted by Light Emitting Diodes to achieve sterility. With key patent already granted and additional applications nearing completion, Lumaegis is preparing for commercial launch upon FDA De Novo approval.

“We anticipate our first sales in 2026,” said CEO John S. Morreale. “Production will begin that year, and we already have customers lined up. Many dental professionals who collaborated with us during the RadBox design phase will be among our first users, providing essential clinical feedback. Additionally, we’ve secured our first major customer — a global industry partner and investor in the disinfection and sterilization space — representing over 2,000 units in initial sales.”

Lumaegis is poised to redefine sterilization standards across dental and medical practices, offering a transformative solution that combines speed, efficiency, and safety, all the while reducing practitioners’ costs and improving their productivity.

About:

Lumaegis is headquartered in Austin, TX and is a member of University of Texas’ Austin Technology Incubator. Its mission is to support global health security and to reduce the environmental impact of sterilization processes globally. The founders are seasoned serial entrepreneurs with a proven track record of leveraging technology to address sustainability challenges.

Contacts

John S. Morreale

sterilize@lumaegis.com

LeafWorks Launches Industry-First DNA Quantification Test for Mushroom Blends and Beyond




LeafWorks Launches Industry-First DNA Quantification Test for Mushroom Blends and Beyond

New Test Delivers DNA Quantification, Filling a Critical Gap in Botanical and Functional Mushroom Testing

SEBASTOPOL, Calif.–(BUSINESS WIRE)–LeafWorks, a pioneering botanical genomics and testing company for natural products, today announced the immediate availability of DNA-based Quantification Testing for botanicals, starting with a focus on mushroom blends, a purpose-built assay that measures the composition of multi-species functional mushroom products.

Functional mushroom blends are gaining popularity, driving one of the fastest-growing categories in the natural products industry. Booming consumer demand has heightened the call for transparency, expanding pressure on manufacturers to confirm ingredient integrity amid complex supply chains.

LeafWorks’ Ingredient Quantification Testing provides quality control and quality assurance teams, sourcing managers and formulators the ability to validate ingredient composition with confidence—meeting 21 CFR 111 requirements, protecting against costly recalls and strengthening consumer trust.

Verifying mushroom blends can be a major challenge in processed materials—especially when using microscopy or when working with species of overlapping and/or variable metabolic profiles. LeafWorks’ DNA-based approach fills gaps with quantification that stands up to scientific and regulatory scrutiny.

“We’ve been hearing for years that brands struggle to verify what’s in their mushroom blends,” said Eleanor Kuntz, Ph.D., CEO of LeafWorks. “Now, with this new DNA-based quantification option, we’re giving them a tool that cuts through the noise. No guesswork. No ambiguity.”

To serve a wide range of industry needs, LeafWorks’ Ingredient Quantification Testing supports:

• Accuracy: This test uses validated, species-specific markers.
• QA/QC and product integrity checks: Confirm ingredient makeup against specifications.
• Regulatory compliance: Meet 21 CFR 111 label verification requirements with third-party validated results.
• Supplier validation and purchasing confidence: Audit claims in global supply chains with scientific precision.
• Product development and R&D: Monitor blend consistency, guide formulation improvements and ensure purity.
• Mycelium products: Quantify percent mushroom versus percent substrate with accuracy.
• Affordable, rapid tests built to AOAC International standards

What sets LeafWorks apart is its reliance on species-specific DNA regions rather than universal barcodes, which are prone to false positives and negatives, and its use of qPCR to perform highly sensitive quantification. And—critically for mycelium products—this test can distinguish percent substrate versus percent mushroom, delivering a clear picture of product composition.

This rigorous design ensures accuracy even in complex blends, where mushrooms may share overlapping chemistry profiles or appear visually similar.

“This is a major step forward for the industry,” said Nick Batora, Managing Director and Head of R&D at LeafWorks. “Chemistry can show you that certain metabolites are present in a blend, but it can’t always tell you which species they came from. Many plants and mushrooms share overlapping chemistries, and metabolite profiles can shift depending on things like tissue type, growing conditions or environment. With qPCR, we can go straight to the DNA and identify the source species with quantitative accuracy—whether it’s mushrooms or substrates like oats or grain.”

By filling a critical gap in the quantitative verification of blends, LeafWorks is giving sourcing managers, QA/QC professionals, and product developers actionable data to support compliance, protect brand reputation, and strengthen consumer trust.

“Variation in ingredient amounts can cause major risks for companies trying to meet their label claims in complex blend formulations,” said Kerin Law, Ph.D., LeafWorks’ Chief Scientific Officer. “Our Ingredient Quantification Test solves that immediately.”

The LeafWorks® Ingredient Quantification Test, starting in mushroom blends, is available immediately. For more information or to inquire about testing, visit leafworks.com or contact info@leafworks.com.

About LeafWorks

LeafWorks Inc. is a botanical genomics company conducting cutting-edge research and developing commercial DNA testing services for natural products. Co-founded by CEO Eleanor Kuntz, Ph.D., and CSO Kerin Law, Ph.D., the company combines scientific rigor with uncompromising ethics, specializing in DNA identification—from species ID down to trait detection—to protect and empower business operators. The company provides the necessary testing and services that help cultivators preserve their genetic IP, improve efficiency and ultimately evolve their operations. Learn more about LeafWorks Inc. at leafworks.com and connect on Facebook, Instagram, X and LinkedIn.

Contacts

Media Contact

Kerin Law

info@leafworks.com

Genentech and Roche Break Ground on State-of-the-Art Manufacturing Facility in Holly Springs, North Carolina




Genentech and Roche Break Ground on State-of-the-Art Manufacturing Facility in Holly Springs, North Carolina

– The $700 million project is part of Genentech and Roche’s $50 billion investment in U.S. manufacturing, infrastructure and R&D –

– The facility will create more than 1,900 jobs and support the production of next-generation metabolic medicines, including treatments for obesity –

– U.S. Rep. Deborah Ross, Gov. Josh Stein and other local leaders attended the groundbreaking event –

HOLLY SPRINGS, N.C.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today broke ground on its newest U.S. manufacturing site in Holly Springs, North Carolina. This significant development marks the establishment of Genentech’s first manufacturing facility on the East Coast. The 700,000-square-foot facility is strategically designed to support production of the company’s future portfolio of metabolic medicines, including next-generation treatments for obesity. The event was attended by federal, state and local officials, including U.S. Rep. Deborah Ross, North Carolina Gov. Josh Stein, State Sec. of Commerce Lee Lilley, State Sens. Sydney Batch and Lisa Grafstein, State Rep. Erin Paré, Wake County Commissioner Cheryl Stallings and Holly Springs Mayor Sean Mayefskie.

The project will add more than 400 local manufacturing jobs when the site is operational and more than 1,500 construction jobs during the development phase. Genentech’s initial investment in North Carolina is estimated at more than $700 million, part of a larger $50 billion commitment to President Trump’s initiatives to invest in U.S. manufacturing, infrastructure and R&D.

The company selected Holly Springs, a growing hub for biopharmaceutical innovation, for its highly skilled local workforce, strong academic institutions and proximity to other leading life science companies in the Raleigh-Durham area.

The new facility is expected to be completed and operational by 2029, incorporating modern biomanufacturing technologies, as well as advanced automation and digital capabilities. The future facility will increase production capacity for the company’s manufacturing network, while enhancing supply chain resilience through a high-volume, high-efficiency yet sustainable design. The 100-acre lot includes space for future expansion.

Genentech CEO Ashley Magargee:

“We are proud to break ground on our new manufacturing site in Holly Springs, North Carolina, with its world-class biotech talent, top research institutions and a robust infrastructure that will enable our growth for years to come. With this step, we are taking action to deliver more life-changing medicines to patients faster, contribute to the local economy, and bolster manufacturing and innovation in the U.S.,” Magargee said.

“We are supportive of President Trump’s goal to bring more pharmaceutical manufacturing to the United States and appreciate the work that Commerce Secretary Lutnick and the Department of Commerce’s U.S. Investment Accelerator are doing to remove regulatory barriers that cause delays in establishing manufacturing sites in the U.S. We also thank the North Carolina, Wake County and Holly Springs officials for their partnership. Their warm welcome and leadership in the life sciences bodes well for great things to come for our company, your communities, and, ultimately, for patients.”

U.S. Rep. Deborah Ross, 2nd North Carolina Congressional District:

“This groundbreaking is a milestone for our community and for North Carolina’s growing role in the biotech economy. Investments like this one mean good-paying jobs for our residents, expanded opportunities for workers with a range of skills and education, and continued growth for the Research Triangle’s innovation ecosystem. I look forward to working with Genentech to ensure this facility helps our region to thrive for decades to come.”

North Carolina Gov. Josh Stein:

“North Carolina has earned its reputation as the best state for business, and Genentech’s decision to put down roots in Holly Springs is further proof of our leadership in the biotech sector. From our top-tier research universities to our world-class workforce, North Carolina has exactly what companies need to succeed. I am pleased to welcome Genentech to Holly Springs as they expand their operations to the East Coast.”

Holly Springs Mayor Sean Mayefskie:

“The groundbreaking of Genentech’s new facility marks a defining step forward for Holly Springs. Not only does it strengthen Holly Springs’ role as a cornerstone in North Carolina’s life sciences manufacturing ecosystem, but we expect to see a powerful boost to our local economy, particularly for small businesses. We are thrilled for Genentech to be part of our community!”

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: Shirley Dang, (650) 467-6800

Media Contact: Dean Mastrojohn, (650) 467-6800

Advocacy Contact: Danielle Haney, (240) 805-4810

Investor Contacts: Loren Kalm, (650) 225-3217

Apimeds Pharmaceuticals US, Inc. Partners with University of Alabama to Advance Biotech Business Development via ai² Future Labs




Apimeds Pharmaceuticals US, Inc. Partners with University of Alabama to Advance Biotech Business Development via ai² Future Labs

MATAWAN, N.J.–(BUSINESS WIRE)–Apimeds Pharmaceuticals US, Inc. (NYSE American: APUS) (“Apimeds”) today announced the launch of its ai² Future Labs program in partnership with The University of Alabama Culverhouse College of Business’s STEM Path to the MBA program. The initiative aims to identify important assets critical to improving human health and to cultivate the next generation of pharmaceutical industry business leaders.

Future Labs is part of Apimeds’ ai² innovation platform, connecting university students with real-world biopharmaceutical strategy and business development projects. Through this partnership, student teams will work closely with Apimeds mentors to identify and evaluate opportunities to advance development projects previously abandoned by industry.

“We’re excited to welcome The University of Alabama and their STEM Path to the MBA students to the Future Labs program,” said Erik Emerson, CEO of Apimeds. “UA will be the first of a select group of academic institutions we partner with to identify opportunities to improve patient care by reexamining promising projects. Drug development is complex, expensive, and time-consuming, which means many therapies with true potential never reach patients. Future Labs is designed to function as a discovery engine for products and future leaders – we look forward to working with University of Alabama and the students – Roll Tide – until you encounter #goducks.”

Students will gain hands-on experience in market analysis, FDA regulations, clinical development requirements, competitive positioning, intellectual property considerations, and commercialization planning—skills that extend far beyond the classroom. Top-performing teams at each participating institution will be eligible for paid internships or consulting opportunities with Apimeds, providing a direct pathway into the industry.

“We see this program as a way to uncover development opportunities while also giving students a practical look at the business side of biopharma,” said Brian Peters, SVP of the ai² Division at Apimeds Pharmaceuticals.

Rob Morgan, Ph.D., Director of the STEM Path and CREATE Path to the MBA programs at The University of Alabama, added: “Our students will gain unique experience contributing to the success of a biopharma company. This program provides a one-of-a-kind opportunity to bring the business of biotechnology to a new generation of leaders.”

The partnership underscores Apimeds’ commitment to fostering innovation, building industry–academic alliances, and developing the next generation of biotech leaders.

About Apimeds Pharmaceuticals

Apimeds Pharmaceuticals (NYSE American: APUS) is a clinical-stage biopharmaceutical company focused on developing non-opioid, biologic-based therapies for pain management. The company’s lead product candidate, Apitox, is in late-stage clinical development for osteoarthritis of the knee. For more information visit www.apimedsus.com. Information on the Apimeds’ website does not constitute a part of and is not incorporated by reference into this press release.

About Culverhouse College of Business and the STEM Path to the MBA Program

Established in 1919 by Lee Bidgood and currently led by Dean Kay Palan, the Culverhouse College of Business at The University of Alabama is a top-ranked leader in business education, offering bachelor’s, master’s, and doctoral degrees and has been accredited by AACSB since 1929.

Culverhouse launched the STEM Path to the MBA program in 2011, providing students from technical and scientific disciplines with unique exposure to business education throughout their undergraduate studies, culminating in the earning of an MBA with one additional year of study.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “anticipate”, “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Apimeds undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Apimeds will be realized or, even if substantially realized, that they will have the expected consequences to or effects on the company or its business or operations. Readers are cautioned that certain important factors may affect Apimeds’ actual results and could cause such results to differ materially from any forward-looking statements that may be made in this press release. Factors that may affect Apimeds’ results include, but are not limited to, the ability of Apimeds to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to Apimeds’ ability to advance its product candidate and successfully complete clinical trials; risks relating to its ability to hire and retain qualified personnel; and the additional risk factors described in Apimeds’ filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on April 15, 2025 (as amended on May 2, 2025).

Contacts

Media:
Brian Peters

Apimeds Pharmaceuticals

919-602-6557

jCyte Announces Publication of Phase I/IIa Safety Study of Retinal Progenitor Cells in Retinitis Pigmentosa in Frontiers in Cellular Neuroscience




jCyte Announces Publication of Phase I/IIa Safety Study of Retinal Progenitor Cells in Retinitis Pigmentosa in Frontiers in Cellular Neuroscience

IRVINE, Calif.–(BUSINESS WIRE)–jCyte, a clinical-stage biotechnology company developing transformative cell therapies for retinal diseases, today announced the publication “Retinal Progenitor Cells (jCell) for Retinitis Pigmentosa” containing results from its Phase I/IIa clinical trial evaluating the safety and tolerability of intravitreal injection of retinal progenitor cells (RPCs) in adults with non-syndromic retinitis pigmentosa (RP).

The prospective, multicenter, open-label, single-arm study enrolled 28 adults with RP across two vision cohorts. Participants received a single intravitreal injection of allogeneic RPCs at escalating dose levels (0.5, 1.0, 2.0, or 3.0 million cells). The primary objective was safety, with exploratory efficacy endpoints including best-corrected visual acuity (BCVA) and patient-reported outcomes.

Key findings include:

• Intravitreal RPC injection was well tolerated at all dose levels. The majority of adverse events were mild to moderate and transient in nature. Importantly, there were no signs of graft rejection.
• While designed as a safety study, exploratory efficacy data suggested potential vision benefits. At Month 12, mean BCVA changes (treated vs. untreated eyes) were:
  • 0.5M dose: +1.4 letters
  • 1.0M dose: +1.0 letters
  • 2.0M dose: +4.8 letters
  • 3.0M dose: +9.0 letters
• Patients also reported improvements in light sensitivity, object recognition, color discrimination, and reading ability.

“These encouraging results demonstrate that a single intravitreal injection of RPCs was safe and well tolerated, with exploratory signals suggesting a potential dose-related treatment effect,” said Henry Klassen MD, PhD and Co-Founder of jCyte. “While these findings must be interpreted with caution, they provide important rationale for advancing into later-stage controlled studies.”

The RPC technology has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, underscoring its potential to address a serious unmet medical need. Ongoing and planned future trials will further evaluate the therapy’s efficacy and durability in a larger RP population.

The activities described were made possible by grant funding from the California Institute of Regenerative Medicine (CIRM).

About Retinitis Pigmentosa

Retinitis pigmentosa (RP) is a group of rare inherited retinal diseases that cause progressive vision loss due to degeneration of photoreceptor cells. There are currently no broadly available disease-modifying therapies for RP, and patients face inevitable decline in visual function.

About the Gavin Herbert Eye Institute

The Gavin Herbert Eye Institute is dedicated to advancing the understanding and treatment of eye diseases through innovative research and clinical care.

About the California Institute for Regenerative Medicine (CIRM)

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies.

With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality.

About jCyte

jCyte, Inc. is a clinical-stage biotech company focused on developing its first-in-class allogeneic cell therapy, jCell, for retinitis pigmentosa (RP) and other retinal degenerative disorders. The treatment has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation and is administered as a minimally invasive intravitreal injection. Currently there are no FDA approved therapies for over 99% of RP patients. The company is pioneering a new era of regenerative therapies to address the significant unmet medical needs of patients suffering from a broad set of retinal degenerative diseases and is currently recruiting for its JC02-88 trial. For more information, visit www.jcyte.com.

Contacts

jCyte, Inc.

Victor Chao

Vice President Commercial Strategy and Operations

Media@jcyte.com

C2N Diagnostics Expands the PrecivityAD2™ Alzheimer’s Disease Blood Test Intended Use to Patients 50 Years and Older




C2N Diagnostics Expands the PrecivityAD2™ Alzheimer’s Disease Blood Test Intended Use to Patients 50 Years and Older

Lower Age Limit Addresses Increasing Calls from Clinicians Seeking Access to the PrecivityAD2™ Test for Patients With Earlier Onset of Cognitive Symptoms;

Test Provides Potential to Inform Earlier Intervention

ST. LOUIS–(BUSINESS WIRE)–#Alzheimers–Clinicians worried about early-onset Alzheimer’s disease in patients with cognitive concerns between the ages of 50 and 55 years can now prescribe the PrecivityAD2™ blood test to aid in the diagnosis of the neurological disorder for that expanded population. The test helps healthcare professionals in the detection of amyloid plaques in the brain, a pathological hallmark of Alzheimer’s disease, and helps inform medical management and treatment decisions.

C2N Diagnostics introduced the PrecivityAD2 blood tests two years ago for patients 60 years and older. C2N has now completed additional validation to lower the age limit to 50 and older (meaning those born in 1975 and before).

Alzheimer’s Disease International reports that 75% all dementia cases go undiagnosed across the globe, with the figure rising to 90% in developing countries. C2N believes the expansion of the age range for the PrecivityAD2 test can play a role in reducing these high numbers.

The Journal of the American Medical Association (JAMA) published a large clinical study examining the ability of the PrecivityAD2™ blood test to improve the diagnostic accuracy of Alzheimer’s disease in primary care settings, where most patients with cognitive concerns turn to for initial answers about their memory loss. The study found similar robustness for the PrecivityAD2 test in patients who saw memory care specialists. The PrecivityAD2 test delivered a highly statistically significant accuracy of over 90% at a pre-defined, single binary cutoff compared to cerebrospinal fluid (CSF) analysis or amyloid PET analysis.

The article, “Blood Biomarkers to Detect Alzheimer’s Disease in Primary Care and Secondary Care,” also states that these results involving over 1,200 patients were substantiated despite a relatively high rate of medical comorbidities such as cardiovascular disease, high cholesterol, chronic kidney disease, and diabetes among prospectively enrolled patients in both primary and secondary care. The paper further demonstrated the test’s effectiveness for those between the ages of 50 and 55. Further insights about Precivity’s clinical validity and performance are available on its website.

C2N CEO Dr. Joel Braunstein says, “We’ve been working diligently to meet the need for easy, accessible, and affordable blood tests for those patients and families who want answers in their early 50s, and we’re proud we’ve reached this milestone. We recognize that patients with mild cognitive impairment due to Alzheimer’s disease are very eager to access the new disease-modifying therapies, and scientists have stated these therapies are most successful when they start early. C2N believes it’s uniquely positioned, more than ever, to support the medical community in confirming Alzheimer’s disease pathology with its PrecivityAD2 test.”

Dr. Braunstein also says that C2N technology was used in the clinical trials of some of the latest therapies now available to patients with early Alzheimer’s disease.

In addition, the revised PrecivityAD2 intended use to allow for testing in patients 50 and older has been incorporated into the MHRA Medical Device Certification in the United Kingdom, which C2N announced earlier this year.

Precivity Test Availability and Quality Standards

The Precivity tests are available in 49 states in the U.S., excluding New York (where certification is pending), as well as the District of Columbia and Puerto Rico. C2N also recently signed additional global partners to broaden access in Asia, Latin America, Europe and the Middle East.

C2N’s Precivity tests for patient care are performed under the ISO 13485:2016 standard and in the company’s CAP accredited, CLIA certified laboratory.

About C2N Diagnostics, LLC

C2N is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C2N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health.

C2N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health.

C2N assays have been used in over 150 Alzheimer’s disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer’s disease. C2N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer’s Association, and other non-profits and consortiums in addition to research and distribution partnerships with leading labs around the world including Grupo Fleury, Healius, Mediford, Unilabs, and Mayo Clinic Laboratories. Over 50,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review.

The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, BrightFocus Foundation, and Alzheimer’s Association. For more information visit www.c2n.com.

Contacts

COMPANY CONTACT:

Joni Henderson

info@C2N.com

MEDIA CONTACT:

Adam Shapiro

Adam.Shapiro@ASPR.bz
202-427-3603

US Narcolepsy Drugs Market Outlook and Company Analysis Report 2025-2033 Featuring Jazz Pharma, Ligand Pharma, Novartis, Takeda Pharma, Teva, Hikma, Harmony Biosciences, Roche – ResearchAndMarkets.com




US Narcolepsy Drugs Market Outlook and Company Analysis Report 2025-2033 Featuring Jazz Pharma, Ligand Pharma, Novartis, Takeda Pharma, Teva, Hikma, Harmony Biosciences, Roche – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “United States Narcolepsy Drugs Market to Reach US$ 2,233.56 Million by 2033 – 7.88% CAGR Driven by Novel Therapies and Better Diagnosis” report has been added to ResearchAndMarkets.com’s offering.

The United States Narcolepsy Drugs Market is expected to reach US$ 2.23 billion by 2033 from US$ 1.12 billion in 2024, with a CAGR of 7.88% from 2025 to 2033. The market is expanding mainly due to the growing prevalence of sleep disorders, improved knowledge and diagnosis of narcolepsy, continuous improvements in medication development, and a supportive regulatory environment.

United States Narcolepsy Drugs Market Overview

The market for narcolepsy medications in the US is expanding steadily due to rising awareness, better diagnostic rates, and continuous developments in treatments for sleep disorders. Between 135,000 and 200,000 Americans suffer from narcolepsy, a chronic neurological disorder that affects the brain’s ability to control sleep-wake cycles.

A growing need for efficient symptom management is driving the market, and drugs like pitolisant, sodium oxybate, armodafinil, and modafinil are essential. In order to improve treatment compliance and efficacy, the U.S. Food and Drug Administration (FDA) keeps approving new formulations and extended-release medications. Clinical trial enrollment and public awareness of the illness have also improved as a result of greater research funding and patient activism.

In many areas, the prevalence of sleep disorders, including narcolepsy, is generally rising. For example, a Narcolepsy Network article states that approximately one in every 2,000 Americans suffers from narcolepsy. This amounts to about 200,000 Americans and approximately 3 million people worldwide.

A growing number of sleep problems are caused by lifestyle variables such as increasing stress, inconsistent sleep habits, and the rise in late-night technology use. The need for narcolepsy treatments is growing as more people look for solutions to their sleep problems. In the upcoming years, these factors are anticipated to drive the expansion of the narcolepsy medication market.

Leading pharmaceutical firms leading the way in product research and commercialization include Harmony Biosciences, Avadel Pharmaceuticals, and Jazz Pharmaceuticals. Particularly for the treatment of cataplexy and excessive daytime sleepiness, Jazz’s Xyrem and Xywav continue to lead the market.

However, the introduction of novel therapies and generic competition are changing the market dynamics. By providing more convenient dosing and fewer side effects, the introduction of once-nightly sodium oxybate and orexin receptor agonists has the potential to completely change therapy paradigms.

High medication costs and restricted access to specialists continue to be major obstacles in spite of these developments. However, with robust regulatory support and an increasing emphasis on enhancing the quality of life for narcolepsy patients, the U.S. narcolepsy medication market is well-positioned for further innovation.

Key Factors Driving the United States Narcolepsy Drugs Market Growth

Enhanced Awareness and Diagnosis

• Early detection and precise diagnosis of narcolepsy have been greatly aided by the past ten years’ increase in clinical and public awareness of the disorder.
• Broader media coverage and educational campaigns spearheaded by patient advocacy organizations like the Narcolepsy Network have contributed to a decrease in stigma and a greater awareness of the symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy.
• The time between symptom onset and diagnosis has decreased as a result of improved training for clinicians to identify the signs. Patient outcomes and quality of life are enhanced by earlier diagnosis, which enables more prompt management.
• More people are seeking medical attention as a result of this increased knowledge, which is fueling the need for efficient treatment choices in the US.

Developments in Diagnostic Tools

• The precision of narcolepsy diagnosis has increased due to technological developments in sleep medicine.
• Nowadays, sleep clinics all across the United States have access to tools like polysomnography (PSG) and the Multiple Sleep Latency Test (MSLT), which allow clinicians to quantify sleep patterns, REM onset, and sleep latency – all important markers of narcolepsy – objectively.
• These tests are assisting medical professionals in differentiating narcolepsy from other sleep disorders such as insomnia or sleep apnea, in conjunction with enhanced clinical guidelines and diagnostic criteria.
• As a result, more patients are getting the right care, and misdiagnosis rates have dropped.
• In addition to expediting the patient journey, improved diagnostic capabilities are driving market expansion by increasing the number of diagnosed patients in need of medication.

Launch of Novel Therapies

• The launch of novel therapies that cater to unmet clinical needs is drastically altering the market for narcolepsy medications in the United States.
• These days, novel medicines like once-nightly sodium oxybate and non-scheduled drugs like pitolisant are replacing or supplementing traditional stimulants and older formulations like twice-nightly sodium oxybate.
• These new medications provide better long-term adherence, fewer side effects, and more convenient dosage.
• Furthermore, there is promise for even more individualized treatment in the near future thanks to the development of orexin receptor agonists and other targeted medicines.
• In addition to improving patients’ quality of life, these developments set pharmaceutical products apart in a crowded market, promoting both clinical uptake and financial success.

Challenges in the United States Narcolepsy Drugs Market

Regulatory and Reimbursement Obstacles

• Although the FDA in the United States has taken action to encourage the development of orphan medications, such as those for uncommon ailments like narcolepsy, market access is still extremely difficult because of reimbursement obstacles.
• The cost of many narcolepsy treatments is considerable, including those based on sodium oxybate and more recent medications like pitolisant.
• Before granting coverage, insurance companies frequently demand a lot of paperwork, prior permission, or step therapy procedures, which delays patients’ access to treatment.
• Both doctors and patients may become frustrated by these administrative obstacles, which may cause them to stop receiving therapy or avoid it entirely.
• Disparities in access are also brought about by variations in reimbursement practices between government programs and private insurers.
• Navigating reimbursement is a significant barrier to providing the best possible care, which is especially important in a market where prompt and ongoing therapy is necessary for symptom management and quality of life maintenance.

Stigma and Ignorance

• Despite advancements in public health education, the general public and even medical professionals continue to have a poor understanding of narcolepsy.
• Hallucinations, cataplexy, and excessive daytime sleepiness are some symptoms that are frequently confused with sadness, laziness, or other mental health conditions.
• Patients experience severe emotional distress and social humiliation as a result of this misperception.
• Furthermore, many primary care doctors are not familiar with the full clinical presentation of narcolepsy due to its rarity and complexity, which can result in incorrect diagnoses or delayed referrals to sleep specialists.
• Patients may experience significant effects on their education, careers, and interpersonal connections over the several years it takes on average to receive a diagnosis.
• This ignorance impacts research funding and policy attention in addition to impeding early detection and treatment.
• To improve outcomes for people with narcolepsy in the United States, it is imperative to address stigma and enhance clinical education.

Company Analysis: Overviews, Key Persons, Recent Developments, SWOT Analysis, Revenue Analysis

• Jazz Pharmaceuticals
• Ligand Pharmaceuticals
• Novartis AG
• Takeda Pharmaceutical
• Teva Pharmaceutical
• Hikma Pharmaceuticals Plc
• Harmony Biosciences Holdings
• Roche Holding AG
• Johnson & Johnson

Key Attributes:

Key Topics Covered:

1. Introduction

2. Research & Methodology

2.1 Data Source

2.1.1 Primary Sources

2.1.2 Secondary Sources

2.2 Research Approach

2.2.1 Top-Down Approach

2.2.2 Bottom-Up Approach

2.3 Forecast Projection Methodology

3. Executive Summary

4. Market Dynamics

4.1 Growth Drivers

4.2 Challenges

5. United States Narcolepsy Drugs Market

5.1 Historical Market Trends

5.2 Market Forecast

6. Market Share Analysis

6.1 By Disease Type

6.2 By Therapeutic Type

6.3 By End Users

6.4 By States

7. Disease Type

7.1 Daytime Extreme Sleepiness

7.2 Cataplexia

7.3 Other Disease Type

8. Therapeutic Type

8.1 Central Nervous Systems Stimulants

8.2 Tricyclic Antidepressants

8.3 Sodium Oxybate

8.4 Selective Serotonin Reuptake Inhibitor

8.5 Others

9. End Users

9.1 Diagnostics Centers

9.2 Hospitals

9.3 Others

10. Top 10 States

10.1 California

10.2 Texas

10.3 New York

10.4 Florida

10.5 Illinois

10.6 Pennsylvania

10.7 Ohio

10.8 Georgia

10.9 Washington

10.10 New Jersey

10.11 Rest of United States

11. Value Chain Analysis

12. Porter’s Five Forces Analysis

12.1 Bargaining Power of Buyers

12.2 Bargaining Power of Suppliers

12.3 Degree of Competition

12.4 Threat of New Entrants

12.5 Threat of Substitutes

13. SWOT Analysis

13.1 Strength

13.2 Weakness

13.3 Opportunity

13.4 Threats

14. Pricing Benchmark Analysis

14.1 Jazz Pharmaceuticals

14.2 Ligand Pharmaceuticals

14.3 Novartis AG

14.4 Takeda Pharmaceutical

14.5 Teva Pharmaceutical

14.6 Hikma Pharmaceuticals Plc

14.7 Harmony Biosciences Holdings

14.8 Roche Holding AG

14.9 Johnson & Johnson

15. Key Players Analysis

For more information about this report visit https://www.researchandmarkets.com/r/phpu4s

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Varian Completes Enrollment and Treatment in FAST-02 Clinical Trial of Flash Therapy in Treating Thoracic Bone Metastases




Varian Completes Enrollment and Treatment in FAST-02 Clinical Trial of Flash Therapy in Treating Thoracic Bone Metastases

• Flash ultra-high dose rate therapy enabled by Varian proton and planning technologies
• Collaboration between Varian and leading institutions drives progress toward next-generation cancer treatments
• Flash delivers treatment over 100 times faster than conventional radiation therapy

PALO ALTO, Calif.–(BUSINESS WIRE)–#varian–Varian, a Siemens Healthineers company, has announced the successful completion of enrollment and treatment in its FAST-02 (Flash Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax) clinical trial. The FAST-02 study targets painful bone metastases in the thoracic region and represents a significant step toward bringing this investigational radiotherapy treatment into clinical practice.

The trial was conducted at Cincinnati Children’s Hospital/UC Health Proton Therapy Center and enrolled 10 participants. It focused on evaluating treatment-related side effects and the efficacy of treatment, which was assessed using trial participants’ reported pain relief. FAST-02 builds upon findings from Varian’s FAST-01 trial, which evaluated clinical workflow feasibility of Flash therapy and treatment-related side effects for participants with bone metastases in the extremities. The trial is led by Principal Investigator John Perentesis, M.D., Professor and Director, Cancer and Blood Disease Institute, Cincinnati Children’s Hospital, and lead Co-Investigator Emily Daugherty, M.D., Associate Professor of Radiation Oncology, University of Cincinnati Cancer Center.

Flash therapy delivers treatment at ultra-high dose rates in typically less than one second – over 100 times faster than conventional radiation therapy—and has demonstrated potential in preclinical studies to reduce damage to surrounding healthy tissues while maintaining effective tumor control.

“Completing treatments for FAST-02 is a pivotal and progressive step in our effort to establish the safety and effectiveness of Flash radiotherapy,” said John Perentesis, M.D., Professor and Director, Cancer and Blood Disease Institute, Cincinnati Children’s Hospital Medical Center (CCHMC). “This trial helps lay the groundwork needed to move Flash into more advanced clinical settings—an innovation that could redefine radiation oncology and meaningfully improve patient outcomes.”

As part of the FAST-02 trial, Varian’s ProBeam proton therapy system was modified to enable ultra-high dose rate delivery for Flash treatments. In parallel, the Eclipse treatment planning system was enhanced to support planning for Flash therapy. Varian is advancing Flash therapy as an integrated system, encompassing planning, quality assurance, and treatment delivery technologies.

“The integration of treatment and planning represents a major technological achievement,” said Anthony Mascia, executive director and director of medical physics of the CCHMC Proton Therapy Center. “From a physics standpoint, we’re pushing the boundaries of both planning and delivering ultra-high dose rates, and we’re doing it safely.”

OSF HealthCare, a multi-site healthcare system with locations across Illinois and Michigan, collaborated in the trial and referred participants for enrollment.

James McGee, MD, founding director of the OSF Cancer Institute, stated: “We’re proud to have supported the FAST-02 trial. It is rewarding to contribute to research that further advances Flash therapy.”

Added Deepak “Dee” Khuntia, MD, senior vice president and chief medical officer at Varian: “This is an exciting time for radiation oncology; completing enrollment in FAST-02 underscores our commitment to develop the evidence needed to advance technologies that have the potential to transform the future of cancer care. We are proud to collaborate with institutions that share our vision for patient-centered innovation.”

Now that participant treatment is complete, data analysis of the results will inform future clinical studies and further evaluation of the potential of Flash therapy across broader treatment applications.

For information about the FAST-02 clinical trial, go to: Study Details | FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax | ClinicalTrials.gov

© 2025 VARIAN MEDICAL SYSTEMS, INC. All trademarks are the property of their respective owners.

CAUTION: The Flash-enabled ProBeam system is an investigational device and is limited by United States law for investigational use.

QR700027418

About Varian

At Varian, a Siemens Healthineers company, we envision a world without fear of cancer. For more than 75 years, Varian has developed, built, and delivered innovative technologies and solutions that help care providers around the globe treat millions of patients each year. Today, as a Siemens Healthineers company, we support every step of the cancer care journey – from screening to survivorship. From advanced imaging and radiation therapy to comprehensive software and services, to interventional radiology, we are harnessing the power of our perspective while also pursuing clinical research to create a more efficient, and more personalized care pathway. Because, for cancer patients everywhere, their fight is our fight. For more information, visit http://www.varian.com.

Contacts

Varian Press Contact

Kristin Corey

Varian Corporate Communications

Kristin.Corey@varian.com