FDA Approves BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) from Merck Animal Health to Treat and Control Asian Longhorned Tick and Gulf Coast Tick for 12 Months in Dogs




FDA Approves BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) from Merck Animal Health to Treat and Control Asian Longhorned Tick and Gulf Coast Tick for 12 Months in Dogs

Expanded label for once-yearly parasiticide treatment for dogs now includes Haemaphysalis longicornis (Asian longhorned tick) and Amblyomma maculatum (Gulf Coast tick) for 12 months

RAHWAY, N.J.–(BUSINESS WIRE)–Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), today announced the U.S. Food and Drug Administration (FDA) approved an expanded label for BRAVECTO^® QUANTUM (fluralaner for extended-release injectable suspension) in dogs. The updated indication adds treatment and control of Asian longhorned tick (H. longicornis) and Gulf Coast tick (A. maculatum) for 12 months, when administered as a single, veterinarian‑delivered injection.

BRAVECTO QUANTUM was approved in the U.S. on July 10, 2025, and continues to be indicated to kill adult fleas, for the treatment and prevention of flea infestations, and for the treatment and control of Ixodes scapularis, Dermacentor variabilis, and Rhipicephalus sanguineus infestations for 12 months and A. americanum infestations for 8 months in dogs and puppies 6 months of age and older.

“For more than a decade, BRAVECTO has set the benchmark for extended‑duration flea and tick protection, and today’s label expansion reinforces our leadership in parasiticide innovation,” said Meg Conlon, DVM, executive director, U.S. Companion Animal Veterinary Services, Merck Animal Health. “With BRAVECTO QUANTUM, Merck Animal Health continues to deliver the longest‑lasting protection available in a single dose – now covering an even broader range of clinically important tick species. This advancement reflects our unwavering commitment to help veterinarians protect dogs with the most comprehensive, convenient, and science‑driven solutions on the market.”

Key Information:

• What’s new: BRAVECTO QUANTUM is now approved to provide 12 months of treatment and control for two additional tick species – Asian longhorned tick (H. longicornis) and Gulf Coast tick (A. maculatum) – following a single injection administered by a veterinarian. This approval expands the product’s already robust label, reinforcing BRAVECTO’s position as the longest‑lasting flea and tick protection available for dogs in the United States.
• Complete Parasite Protection Profile: BRAVECTO QUANTUM is indicated to kill adult fleas and for treatment and prevention of flea infestations. BRAVECTO QUANTUM also provides 12 months of protection against Asian longhorned ticks, Gulf Coast ticks, black‑legged ticks, American dog ticks, and brown dog ticks, along with 8 months of protection against lone star ticks following a single veterinarian administered‑injection.
• Why this matters: The extended‑release injectable formulation offers veterinarians and pet owners a simple, once‑yearly approach that supports improved compliance and consistent, uninterrupted protection. This label update helps veterinarians address the evolving parasite landscape, as both Asian longhorned and Gulf Coast ticks continue to expand geographically and present risks to canine health.
• Where it’s available: BRAVECTO QUANTUM remains available exclusively through licensed veterinarians, ensuring appropriate in‑clinic administration, guidance, and support.

The expanded indication underscores Merck Animal Health’s continued leadership in delivering innovative, extended‑duration parasite protection solutions. With BRAVECTO QUANTUM, veterinarians have an unmatched, once‑yearly option that now defends dogs against an even broader range of ticks – supporting year‑round protection and helping meet the evolving needs of pets and the people who care for them. For more information, visit us.bravecto.com or follow BRAVECTO on Instagram @bravecto.us.

About BRAVECTO^®

Since its introduction in 2014, BRAVECTO has provided longer-lasting flea and tick protection, with more than 450 million doses distributed in 100 countries over eight years. BRAVECTO is available in a variety of formulations, including products for both dogs and cats.

The flea lifecycle can last as long as 12 weeks, and monthly treatments may leave gaps in protection. Providing pets with continuous flea and tick protection is essential – whether the pet goes outside or not. Contrary to popular belief among pet owners, fleas and ticks are not only active in the spring and summer months and are a year-round risk. Fleas and ticks can easily latch onto dogs and cats and can spread serious diseases. Fleas are the most common external parasite found on pets. BRAVECTO products are available through licensed veterinarians.

About Merck Animal Health

Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is a global animal health business committed to The Science of Healthier Animals™. For more than 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. For more information, visit www.merck-animal-health.com and connect with us on LinkedIn, Facebook, X (formerly Twitter) and Instagram.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

FAQ:

• What changed with today’s approval?
  • The BRAVECTO QUANTUM label now includes treatment and control of H. longicornis (Asian longhorned tick) and A. maculatum (Gulf Coast tick) for 12 months following a single injection administered by a veterinarian, in addition to existing indications (fleas and other listed tick species) and the 8‑month indication for A. americanum (lone star tick).
• Why focus on Asian longhorned and Gulf Coast ticks?
  • These ticks are clinically relevant and expanding in geographic range. Adding them strengthens year‑round, single‑dose tick control options for more dogs across more U.S. regions.
• How is BRAVECTO QUANTUM administered?
  • BRAVECTO QUANTUM is administered via a single subcutaneous injection delivered by a licensed veterinarian.
• Is this the same BRAVECTO formulation that was introduced in 2025?
  • Yes. BRAVECTO QUANTUM remains the once‑yearly fluralaner extended‑release injectable. Today’s update expands the label’s tick species coverage.
• Is BRAVECTO QUANTUM safe?
  • BRAVECTO QUANTUM has undergone extensive safety testing. In fact, safety was demonstrated when dosed at 5 times the recommended dose every 4 months for a total of 6 doses. In a U.S. field study with client owned dogs, 0.9% (2 out of 225 dogs) experienced seizures. This rate is consistent with estimates reported in the general dog population. BRAVECTO QUANTUM (fluralaner) is a member of the isoxazoline class, which has been associated with neurologic adverse reactions, including tremors, ataxia, and seizures. Use with caution in dogs with a history of seizures or neurologic disorders.
• Where can veterinarians find full prescribing information?
  • Please see the Prescribing Information (PI) here and consult Merck Animal Health for training and ordering support.
• Can cats receive BRAVECTO QUANTUM?
  • No. BRAVECTO QUANTUM is approved only for dogs and puppies 6 months of age and older and must be administered by a licensed veterinarian. It is not approved for use in cats. For cats, Merck Animal Health offers BRAVECTO^® Plus, a topical formulation that provides broad‑spectrum, extended‑duration protection against fleas, ticks, and internal parasites.

IMPORTANT SAFETY INFORMATION:

BRAVECTO (fluralaner) Chews for Dogs: The most commonly reported adverse reactions include vomiting, lethargy, diarrhea, anorexia and pruritus. In some cases, adverse events have been reported following use in breeding females. BRAVECTO Chews has not been shown to be effective for 12-weeks’ duration in puppies less than 6 months of age. BRAVECTO Chews is not effective against lone star ticks beyond 8 weeks of dosing. Indicated for dogs 6 months of age and older. BRAVECTO 1-MONTH (fluralaner) Chews: The most commonly reported adverse reactions include itching, diarrhea, vomiting, decreased appetite, elevated ALT, lethargy, and weight loss. Not effective against lone star ticks in puppies less than 6 months of age. Indicated for dogs 8 weeks of age and older. BRAVECTO (fluralaner topical solution) for Dogs: The most commonly reported adverse reactions include vomiting, hair loss, diarrhea, lethargy, decreased appetite, and moist dermatitis/rash. BRAVECTO Topical Solution for Dogs has not been shown to be effective for 12-weeks’ duration in puppies less than 6 months of age. BRAVECTO Topical Solution for Dogs is not effective against lone star ticks beyond 8 weeks of dosing. For topical use only. Avoid oral ingestion. Indicated for dogs 6 months of age and older. BRAVECTO QUANTUM (fluralaner for extended-release injectable suspension) for Dogs: The most commonly reported adverse reactions in a US field study included lethargy, decreased appetite, vomiting, diarrhea, elevated liver enzymes and pruritus. BRAVECTO QUANTUM is not effective against lone star ticks beyond 8 months of dosing. Indicated for dogs 6 months of age and older.

BRAVECTO (fluralaner topical solution) for Cats: The most commonly reported adverse reactions include vomiting, itching, diarrhea, hair loss, decreased appetite, lethargy, and scabs/ulcerated lesions. BRAVECTO Topical Solution for Cats is not effective against American dog ticks beyond 8 weeks of dosing. BRAVECTO Topical Solution for Cats has not been shown to be effective for 12-weeks’ duration in kittens less than 6 months of age. The safety of BRAVECTO Topical Solution for Cats have not been established in breeding, pregnant and lactating cats. For topical use only. Avoid oral ingestion. Indicated for cats 6 months of age and older. BRAVECTO PLUS (fluralaner and moxidectin topical solution) for Cats: The most commonly reported adverse reactions include vomiting, hair loss, itching, diarrhea, lethargy, dry skin, elevated ALT, and hypersalivation. BRAVECTO PLUS has not been shown to be effective for 2 months in kittens less than 6 months of age. Use with caution in cats that are heartworm positive. The effectiveness of BRAVECTO PLUS to prevent heartworm disease after bathing or water immersion has not been evaluated. The safety of BRAVECTO PLUS have not been established in breeding, pregnant and lactating cats. Indicated for cats 6 months of age and older.

All BRAVECTO products contain fluralaner, which is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Neurologic adverse reactions have been reported in cats receiving isoxazoline class drugs, even in cats without a history of neurologic disorders. Use with caution in cats with a history of neurologic disorders.

Contacts

Media Contact:

Laurel Sawicki

(908) 872-9783

laurel.mundth@merck.com

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

peter.dannenbaum@merck.com

Hayley Kasko

(732) 594-4237

hayley.kasko@merck.com

Guardian Pharmacy Services Announces Launch of Underwritten Public Offering of Class A Common Stock




Guardian Pharmacy Services Announces Launch of Underwritten Public Offering of Class A Common Stock

ATLANTA–(BUSINESS WIRE)–Guardian Pharmacy Services, Inc. (“Guardian”) (NYSE: GRDN) today announced the launch of a proposed underwritten public offering (the “Offering”) of 5,000,000 shares of its Class A common stock, consisting of 3,980,000 shares being offered by certain selling stockholders and 1,020,000 newly issued shares being offered by Guardian as part of a non-dilutive “synthetic secondary” transaction, as described below. In addition, the selling stockholders intend to grant the underwriters a 30-day option to purchase up to an additional 750,000 shares of Class A common stock at the public offering price, less the underwriting discount.

The proposed Offering is considered non-dilutive as Guardian intends to use all of the net proceeds it receives in the Offering to repurchase from certain stockholders a number of shares of Class A common stock equal to the number of shares being issued and sold by Guardian in the Offering, at a purchase price per share equal to the public offering price in the Offering, less the underwriting discount (the “Synthetic Secondary”). Accordingly, Guardian will not retain any proceeds from the Offering and, upon completion of the Offering and the Synthetic Secondary, the total number of outstanding shares of Class A common stock will remain the same. The shares to be repurchased by Guardian consist of shares of Class A common stock that were issued upon conversion of shares of Guardian’s Class B common stock that were originally issued in connection with its corporate reorganization in September 2024. Guardian will not receive any proceeds from the offering of shares by the selling stockholders in the Offering.

BofA Securities, Jefferies and Raymond James are acting as joint bookrunners for the proposed Offering. Stephens Inc. and Oppenheimer & Co. are acting as co-managers for the proposed Offering.

A shelf registration statement on Form S-3 relating to the shares being offered in the proposed Offering was filed with the U.S. Securities and Exchange Commission (the “SEC”) on October 14, 2025 and became effective on November 3, 2025. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, and shall not constitute an offer, solicitation, or sale in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

The proposed Offering will be made only by means of a preliminary prospectus supplement and accompanying prospectus. Copies of the preliminary prospectus supplement and the accompanying prospectus related to the proposed Offering can be obtained from: BofA Securities, Attention: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, by email at dg.prospectus_requests@bofa.com; or Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388 or by email at prospectus_department@jefferies.com.

About Guardian Pharmacy Services

Guardian Pharmacy Services is a leading long-term care pharmacy services company that provides an extensive suite of technology-enabled services designed to help residents of long-term health care facilities (“LTCFs”) adhere to their appropriate drug regimen, which in turn helps reduce the cost of care and improve clinical outcomes. As of December 31, 2025, our 61 pharmacies, 54 of which are full-service, served approximately 205,000 residents in approximately 8,400 LTCFs across 38 states.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are all statements other than those of historical fact. Words such as “aims,” “anticipates,” “believes,” “contemplates,” “continues,” “estimates,” “expects,” “intends,” “may,” “plans,” “seeks,” “should,” “will,” “would” and similar expressions are often, but not always, used to identify forward-looking statements. These forward-looking statements include statements regarding the proposed Offering and the Synthetic Secondary, and Guardian’s use of the net proceeds to it from the proposed Offering. These forward-looking statements are based on management’s current expectations and beliefs and are inherently subject to risks and uncertainties, including, among others, uncertainties related to market conditions, and those other risks and uncertainties more fully described under “Risk Factors” in Guardian’s Annual Report on Form 10-K for the year ended December 31, 2025 and the preliminary prospectus relating to the proposed Offering. Except to the extent required by applicable law, Guardian undertakes no obligation to update or revise any information contained in this press release beyond the published date, whether as a result of new information, future events or otherwise.

Contacts

Ashley Stockton

Vice President, Investor Relations

IR@guardianpharmacy.net

GE HealthCare completes Intelerad acquisition – accelerating shift to cloud-first enterprise solutions to deliver precision care




GE HealthCare completes Intelerad acquisition – accelerating shift to cloud-first enterprise solutions to deliver precision care

• Expands GE HealthCare’s enterprise imaging footprint by delivering comprehensive, end‑to‑end solutions across ambulatory, teleradiology, and hospital care settings
• Advances GE HealthCare’s D3 strategy by accelerating the development of disease‑focused smart devices and solutions enabled by digital (cloud and software) and artificial intelligence (AI) capabilities
• Enhances a fully connected, cloud‑first imaging ecosystem with an expanded GE HealthCare portfolio of AI, digital tools, and SaaS offerings designed to improve clinical operations
• Tuck‑in acquisition expected to strengthen the Imaging portfolio, increase recurring revenue mix, and support sustainable top‑line growth and profitability over time

CHICAGO–(BUSINESS WIRE)–GE HealthCare today announced that it has completed the acquisition of Intelerad, a leading medical imaging software provider for the healthcare industry, for a base purchase price of $2.3 billion in cash (subject to customary adjustments). Intelerad’s technology and customer base will extend GE HealthCare’s reach into high-growth specialized clinics and ambulatory care environments, complementing the company’s strength in hospital-based imaging. These combined capabilities will create a more comprehensive, cloud-first and AI-enabled imaging offering, which is expected to help reduce imaging infrastructure costs and enable faster deployment times.

“We are excited to welcome Intelerad to the GE HealthCare team to create an end-to-end, cloud-first and AI-enabled enterprise imaging solution for customers,” said Roland Rott, President and CEO, Imaging, GE HealthCare. “Intelerad’s cloud-enabled software will support GE HealthCare’s imaging technologies and AI capabilities by simplifying complex workflows, and providing patients and customers with more precise, connected care across the continuum.”

“Intelerad enhances our ability to deliver a cloud-first enterprise imaging platform at scale. Together, we are connecting imaging across care settings with interoperable, AI-enabled solutions that simplify operations, improve clinical insight, and help our customers deliver more precise, personalized care,” said Scott Miller, CEO, Solutions for Enterprise Imaging, GE HealthCare.

With the closing of the acquisition, Intelerad will operate as part of GE HealthCare’s Imaging business and continue to serve its enterprise imaging solution customers in the US, Canada, the UK, and Oceania.

“Joining GE HealthCare accelerates our vision for a more intelligent, connected imaging ecosystem. Together, we can harness the cloud and AI to break down longstanding barriers in healthcare, empowering clinicians with faster insights and giving patients a more seamless, precise care experience,” said Jordan Bazinsky, CEO of Intelerad.

GE HealthCare estimates that Intelerad’s revenues in the first full year of ownership will be approximately $270 million, of which approximately 90% is recurring, and Adjusted Earnings before Interest, Taxes, Depreciation and Amortization (EBITDA) margin will be in excess of 30%. Intelerad revenue is growing in the low-double-digit range annually and is expected to accelerate under GE HealthCare ownership. GE HealthCare expects this transaction to be immediately accretive to top line growth and Adjusted Earnings before Interest and Taxes (EBIT) margin¹. Inclusive of the impact of financing costs, GE HealthCare expects the transaction to be slightly dilutive to Adjusted Earnings per Share (EPS)¹ in the short term, and the company plans to offset this with cost efficiencies. GE HealthCare expects a high-single-digit return on invested capital by year five.

GE HealthCare funded this transaction with cash on hand and proceeds from debt financing.

For more information on GE HealthCare’s Intelerad offerings and full portfolio of solutions, please visit https://www.intelerad.com/en/.

Forward-Looking Statements

This release contains forward-looking statements. These forward-looking statements might be identified by words, and variations of words, such as “will,” “expect,” “may,” “would,” “could,” “plan,” “believe,” “anticipate,” “intend,” “estimate,” “potential,” “position,” “forecast,” “target,” “guidance,” “outlook,” and similar expressions. These forward-looking statements may include, but are not limited to, statements about the transaction, the expected results of the transaction, and GE HealthCare Technologies Inc.’s (the “Company’s”) markets, business, products, financial performance, growth opportunities, and strategy. These forward-looking statements involve risks and uncertainties, many of which are beyond the control of the Company. Factors that could cause the Company’s actual results to differ materially from those described in its forward-looking statements include, but are not limited to, the Company may be unable to achieve the anticipated benefits of the transaction; operating costs and business disruptions (including, without limitation, difficulties in maintaining relationships with employees, customers, and suppliers) may be greater than expected; and the Company may assume unexpected risks and liabilities. Other factors that may cause such a difference also include those discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and any updates or amendments it makes in future filings. There may be other factors not presently known to the Company or which it currently considers to be immaterial that could cause the Company’s actual results to differ materially from those projected in any forward-looking statements the Company makes. The Company does not undertake any obligation to update or revise its forward-looking statements except as required by applicable law or regulation.

About GE HealthCare Technologies Inc.

GE HealthCare is a leading global healthcare solutions provider of advanced medical technology, pharmaceutical diagnostics, and AI, cloud and software solutions that help clinicians tackle the world’s most complex diseases. Serving patients and providers for 130 years, GE HealthCare is delivering bold innovations designed for the next era of medicine across its Imaging, Advanced Visualization Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics segments to help clinicians deliver more personalized, precise patient care. We are a $20.6 billion business with approximately 54,000 colleagues working to create a world where healthcare has no limits.

GE HealthCare is proud to be among 2026 Fortune World’s Most Admired Companies™.

Follow us on LinkedIn, Facebook, Instagram, or visit our website for our latest news and perspectives.

¹ Non-GAAP financial measure; see our earnings release dated February 4, 2026, for definition.

Contacts

GE HealthCare Media Contact:
Linh Dinh

Linh.Dinh@gehealthcare.com
M +408 275 5682

GE HealthCare Investor Relations Contact:
Carolynne Borders

Carolynne.Borders@gehealthcare.com
M (631) 662-4317

Nia Therapeutics Receives FDA Breakthrough Device Designation for AI-Guided Brain Implant to Treat Memory Loss




Nia Therapeutics Receives FDA Breakthrough Device Designation for AI-Guided Brain Implant to Treat Memory Loss

The Smart Neurostimulation System is the first neurostimulation device to receive Breakthrough designation for TBI-related memory loss; the implant decodes memory states from neural activity on 60 channels spanning four brain regions and delivers AI-guided personalized stimulation therapy to lateral temporal cortex

BOSTON–(BUSINESS WIRE)–Nia Therapeutics announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Smart Neurostimulation System (SNS) for the treatment of episodic memory loss in adult patients with prior moderate-to-severe traumatic brain injury (TBI) and persistent memory deficits. The SNS is the first device to receive Breakthrough designation for TBI-related memory loss. There is significant unmet need in this indication, with no FDA-cleared or approved therapies to treat memory loss and more than 4.3 million Americans living with TBI-related disability.¹

“The Breakthrough designation validates the approach we’ve spent a decade building—that memory can be improved by listening to the brain and stimulating at precisely the right moment,” said Michael Kahana, PhD, co-founder and CEO of Nia Therapeutics, and the Edmund and Louise Kahn Term Professor at the University of Pennsylvania. “This designation provides a framework to work closely with the FDA as we bring this technology from the laboratory into the clinic.”

A New Approach to Treating Memory Disorders

The SNS is a fully implantable, wireless neuromodulation platform that records neural activity from 60 channels across four brain regions. Using machine-learning classifiers trained on each patient’s own brain signals, the device detects moments of impaired memory encoding in real time and delivers targeted electrical stimulation to the lateral temporal cortex. This closed-loop approach improved recall by 19% in a randomized, sham-controlled study of neurosurgical patients with epilepsy and a history of moderate-to-severe TBI.² Randomly timed stimulation produced no benefit, underscoring the importance of delivering therapy at the right moment.³

“Memory depends on coordinated activity across widespread brain networks—so we built a device that can sense and respond across the entire network. With 60 channels across four brain regions, the SNS offers an order of magnitude improvement over currently approved DBS devices,” said Daniel Rizzuto, PhD, co-founder and CTO of Nia Therapeutics.

Path Forward

The designation provides Nia with prioritized review, increased FDA interaction, and senior management involvement in future submissions. Building on the first in vivo validation of the SNS platform in a large-animal model, published in Brain Stimulation in 2026 (link), this designation will support the company as it advances toward an Investigational Device Exemption (IDE) application this year to support a first-in-human early feasibility study.

“Patients with TBI-related memory loss represent a profoundly underserved population,” said Dr. Ramon Diaz-Arrastia, Presidential Professor of Neurology and Director of the TBI Clinical Research Center at the University of Pennsylvania, and advisor to Nia Therapeutics. “Their disability is invisible but devastating—it affects the ability to work, maintain relationships, and live independently. We are committed to bringing them the first treatment that directly restores the capacity to form new memories.”

About Nia Therapeutics

Nia Therapeutics develops implantable brain-computer interfaces for memory disorders. Founded in 2018, the company’s SNS platform enables closed-loop neuromodulation by detecting brain states linked to impaired memory encoding and delivering targeted stimulation. Visit www.niatx.com.

Sources

1. Center for Disease Control and Prevention. (2015). Report to Congress on traumatic brain injury in the United States: Epidemiology and rehabilitation (cdc:29215). https://stacks.cdc.gov/view/cdc/29215
2. Kahana, M. J., Ezzyat, Y ., Wanda, P. A., Solomon, E. A., Adamovich-Zeitlin, R., Lega, B. C., Jobst, B. C., Gross, R. E., Ding, K., & Diaz-Arrastia, R. R. (2023). Biomarker-guided neuromodulation aids memory in traumatic brain injury. Brain Stimulation, 16(4), 1086–1093. https://doi.org/10.1016/j.brs.2023.07.002
3. Ezzyat, Y ., Kragel, J. E., Solomon, E. A., Lega, B. C., Aronson, J. P., Jobst, B. C., Gross, R. E., Sperling, M. R., Worrell, G. A., Sheth, S. A., Wanda, P. A., Rizzuto, D. S., & Kahana, M. J. (2024). Functional and anatomical connectivity predict brain stimulation’s mnemonic effects. Cerebral Cortex, 34(1), bhad427. https://doi.org/10.1093/cercor/bhad427

Contacts

For media inquiries, contact media@niatx.com.