Efferent Labs Applauds FDA's Shift Away from Animal Testing
'Our CytoComm® platform provides the dynamic cell-based insight and continuous real-time wireless feedback that traditional animal models simply cannot deliver.'— Bill Rader, CEO Efferent Labs
MOUNT PLEASANT, SC, UNITED STATES, April 17, 2025 / EINPresswire.com / -- Efferent Labs, Inc., a preclinical-stage biodevice company specializing in in vivo cellular data collection, celebrates the U.S. Food and Drug Administration's ( FDA ) groundbreaking move toward reducing reliance on mandatory animal testing for monoclonal antibody therapies and other drug classes. The long-awaited regulatory transformation serves to streamline development and improve patient outcomes and safety, while ultimately lowering costs.
The FDA's plan outlines a strategic shift toward New Approach Methodologies (NAMs) and positions Efferent Labs' revolutionary CytoComm® biosensor platform to support the transition with a human-relevant, wireless, real-time alternative that aligns directly with the FDA's roadmap.
'This is the moment we've been building toward,' said Bill Rader, CEO of Efferent Labs. 'Our CytoComm® platform provides the dynamic cell-based insight and continuous real-time wireless feedback that traditional animal models simply cannot deliver. With today's FDA announcement, Efferent Labs moves from visionary to essential.'
The FDA's pivot to AI-based toxicity and efficacy modeling relies on one critical factor: biologically meaningful, statistically reliable and clinically relevant inputs. However, many preclinical systems fall short of this standard.
The CytoComm® platform addresses these limitations by capturing continuous molecular activity from engineered cell lines in vivo. This enables clean, longitudinal data that supports earlier decision-making, reduces animal use, and improves predictive accuracy—all while laying the foundation for AI modeling that regulators can trust.
CytoComm® directly addresses the FDA's key aims under its new framework:
Reduces animal use by replacing live models with embedded, human-relevant cellular sensors
Accelerates development timelines via continuous real-time monitoring
Improves predictive accuracy by capturing complex pharmacodynamic data
Seamlessly integrates with AI workflows, supported by HookeCA™—Efferent's cloud-based analytics interface, which enables real-time data visualization and regulatory-aligned formatting
As the first implantable cellular biosensor of its kind, CytoComm® provides continuous, high-fidelity molecular data without relying on terminal endpoints or high-stress procedures. This enables researchers to capture detailed pharmacodynamic responses using smaller cohorts, fewer animals, and statistically robust outputs.
'We are proud to be part of the solution,' said Rader. 'The science is ready. The technology is here. And with this regulatory shift, the path is now clear. CytoComm® isn't just the future—it's the answer.'
For more information or partnership inquiries, visit http://www.efferentlabs.com
About Efferent Labs
Efferent Labs is pioneering the future of preclinical drug testing with its real-time cellular biosensor platform, CytoComm® Designed to replace static animal-based endpoints, CytoComm® delivers dynamic, high-fidelity cell-based insights—saving time, reducing costs, and elevating both human safety and ethical standards.
Kerry Welch
TRIO
+1 8084290548
email us here
Visit us on social media:
Legal Disclaimer:
EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
22 minutes ago
- Business Wire
Ingram Micro Issues Statement Regarding Cybersecurity Incident
IRVINE, Calif.--(BUSINESS WIRE)--Ingram Micro Holding Corporation (NYSE: INGM) ('Ingram Micro' or the 'Company') today issued the following statement with respect to an ongoing system outage: Ingram Micro recently identified ransomware on certain of its internal systems. Promptly after learning of the issue, the Company took steps to secure the relevant environment, including proactively taking certain systems offline and implementing other mitigation measures. The Company also launched an investigation with the assistance of leading cybersecurity experts and notified law enforcement. Ingram Micro is working diligently to restore the affected systems so that it can process and ship orders, and the Company apologizes for any disruption this issue is causing its customers, vendor partners, and others. About Ingram Micro Ingram Micro (NYSE: INGM) is a leading technology company for the global information technology ecosystem. With the ability to reach nearly 90% of the global population, we play a vital role in the worldwide IT sales channel, bringing products and services from technology manufacturers and cloud providers to a highly diversified base of business-to-business technology experts. Through Ingram Micro Xvantage™, our AI-powered digital platform, we offer what we believe to be the industry's first comprehensive business-to-consumer-like experience, integrating hardware and cloud subscriptions, personalized recommendations, instant pricing, order tracking, and billing automation. We also provide a broad range of technology services, including financing, specialized marketing, and lifecycle management, as well as technical pre- and post-sales professional support. Learn more at Forward-Looking Statements This release contains 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements because they contain words such as 'believes,' 'expects,' 'may,' 'will,' 'should,' 'seeks,' 'intends,' 'plans,' 'estimates,' or 'anticipates,' or similar expressions which concern our strategy, plans, projections, or intentions. By their nature, forward-looking statements: speak only as of the date they are made; are not statements of historical fact or guarantees of future performance; and are subject to risks, uncertainties, assumptions or changes in circumstances that are difficult to predict or quantify. Our expectations, beliefs, and projections are expressed in good faith, and we believe there is a reasonable basis for them. However, there can be no assurance that management's expectations, beliefs, and projections will result or be achieved, and actual results may vary materially from what is expressed in or indicated by the forward-looking statements. Certain important factors that could cause actual results to differ, possibly materially, from our expectations, beliefs, and projections reflected in such forward-looking statements can be found in the 'Risk Factors' and 'Cautionary Note Regarding Forward-Looking Statements' sections included in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by any applicable securities laws. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made.
Business Wire
an hour ago
- Business Wire
Texas Flood Victims Offered 30 Days Free Storage at 37 U-Haul Centers
AUSTIN, Texas--(BUSINESS WIRE)--U-Haul ® has expanded an existing disaster relief offering in metro San Antonio to include its Company centers across metro Austin, where Central Texas flood victims needing a dry and secure place to stow belongings can receive 30 days of free self-storage and U-Box ® services. U-Haul has added 21 centers in metro Austin to its 16 centers in the San Antonio area that are now offering a month of free storage services to Texas flood victims in need of assistance during the recovery process. Share The Guadalupe River's catastrophic flooding has tragically resulted in the loss of life. Intense rains also produced property damage for many residents. Access to dry and secure self-storage units and portable storage containers can assist communities during the clean-up and recovery process after natural disasters. By adding 21 centers in metro Austin to 16 stores in the San Antonio area, there are 37 U-Haul-owned and -operated facilities now participating in the goodwill offer. The U-Haul disaster relief program applies to new self-storage and U-Box rentals and is based on availability at participating facilities. The U-Box portable container offer is for on-site storage at Company centers. People seeking more information on the 30 days free storage offer or needing to arrange services can contact their nearest regional office or stop by a U-Haul self-storage facility in the cities below: U-Haul Co. of North Austin (13 stores) Store locations: Austin, Cedar Park, Copperas Cove, Killeen, Pflugerville, Round Rock, Temple (512) 865-4154 U-Haul Co. of South Austin (8 stores) Store locations: Austin (512) 331-7705 U-Haul Co. of San Antonio East (7 stores) Store locations: New Braunfels, San Antonio (210) 731-2805 U-Haul Co. of San Antonio West (9 stores) Store locations: San Antonio (210) 569-0962 In addition to its 30 days free self-storage disaster relief program, U-Haul is proud to be at the forefront of aiding communities in times of need as an official American Red Cross Disaster Responder. About U-HAUL Celebrating our 80th anniversary in 2025, U-Haul is the No. 1 choice of do-it-yourself movers with more than 24,000 rental locations across all 50 states and 10 Canadian provinces. The U-Haul app makes it easy for customers to use U-Haul Truck Share 24/7 to access trucks anytime through the self-dispatch and -return options on their smartphones with our patented Live Verify technology. Our customers' patronage has enabled the U-Haul fleet to grow to 193,900 trucks, 138,200 trailers and 40,300 towing devices. U-Haul is the third largest self-storage operator in North America and offers 1,060,000 rentable storage units and 92.0 million square feet of self-storage space at owned and managed facilities. U-Haul is the top retailer of propane in the U.S. and the largest installer of permanent trailer hitches in the automotive aftermarket industry. Get the U-Haul app from the App Store or Google Play.
Yahoo
2 hours ago
- Yahoo
ACHV: Achieve's Busy Day
By John Vandermosten, CFA NASDAQ:ACHV READ THE FULL ACHV RESEARCH REPORT Achieve Life Sciences, Inc. (NASDAQ:ACHV) posted a flurry of press releases last week announcing the submission of its new drug application (NDA), a partnership with Omnicom for cytisinicline commercialization, a proposed public offering and the pricing of the offering. The capital raise was closed on June 30th. This is the culmination of more than a decade of work developing cytisinicline for smoking cessation. Now that the development phase of cytisinicline for smoking cessation is coming to a close, we look towards the regulatory and commercialization phases. We expect to see the FDA formally accept the NDA by late August and Achieve's management team to turn its attention towards the sales effort. Assuming normal turnaround times, we expect the FDA to set a target action date sometime in 2Q:26. NDA Submission Achieve announced its NDA submission of cytisinicline for smoking cessation in a June 26th press release. The company conducted two Phase III studies, an open label safety study and other studies that evaluated over 2,000 participants with the results demonstrating the safety, efficacy and tolerability of cytisinicline. We expect to see acceptance of the NDA within 60 days and further expect additional safety data from the ongoing ORCA-OL trial to be shared with the agency near year end. Commercialization Partnership Now that the new drug application has been submitted, Achieve is further advancing its commercialization efforts. During its earnings calls, the company has outlined its commercialization strategy and is now partnering with Omnicom Group to execute the plan. Omnicom Group provides brand and advertising services to thousands of clients globally and is one of the world's largest advertising and marketing services companies. Achieve will work with Omnicom subsidiary Credera, which is focused on digital transformation services. Credera combines consulting, artificial intelligence (AI) and technology expertise to build consumer technology platforms, integrate marketing technology systems and provide strategic consulting services. It will help Achieve to precisely target and engage healthcare professionals and patients through optimization of channel performance and acceleration of meaningful engagement. The team executing the initiative will include Goodby, Silverstein & Partners, DDB Health, and Ketchum Health which are health care-focused subsidiaries of the Omnicom marketing group. The various subsidiaries will provide expertise in consumer brand development, medical education and strategic public relations and communications, applying industry insights to support cytisinicline launch. In the Achieve partnership, Ketchum Health brings public relations and communications expertise, while Credera handles technology, Goodby Silverstein provides creative advertising, and DDB Health focuses on healthcare marketing. The partnership will use generative AI, predictive analytics and social listening to enhance targeting and personalization. Using a comprehensive approach, it will also employ healthcare applications, pharmacies and data providers to expand the reach and depth of insights. Omnicom has worked as media agency, digital and brand experience for other pharmaceutical and biotechnology clients including established firms such as AbbVie, AstraZeneca, Novartis and Moderna among others. Achieve will be the first small company that Omnicom has supported in commercializing a newly approved drug. Therefore, Omnicom will take on a broader strategic role than in its past partnerships. The Omnicom team will help communicate the optimal message to the provider and patient and monitor its effectiveness in real time. This will allow for rapid course corrections and focus on high value activities. Achieve has identified several target groups for its marketing efforts that are stratified by age, social media use and other demographic data. It was able to identify these groups based on subject experiences in the company's many clinical trials. We anticipate that the structure of Achieve's internal marketing team will be heavily tilted toward supporting the digital campaign with contract representatives available for in-person physician meetings when appropriate. Public Offering On June 30th, 2025 Achieve closed its $45 million capital raise. 15 million shares were issued at $3.00, each of which included an attached warrant exercisable at $3.00 per share. An additional 1,766,666 warrants were issued upon the partial exercise by the underwriters of their option to purchase additional shares, bringing total issued warrants to approximately 16.8 million. Net proceeds from the capital raise are estimated to be $41.3 million as disclosed in the June 27th Form 8-K filing. ORCA-OL Safety Trial Achieve began 2025 by announcing that 300 participants had completed six months of treatment in the Ongoing Research of Cytisinicline for Addiction Program, Open Label (ORCA-OL) trial. The Data Safety Monitoring Committee (DSMC) identified no safety concerns as of this milestone allowing registrational filing with the FDA. As of May 2025, a third DSMC safety review was completed which also found no unexpected treatment-related adverse events. As of the first quarter reporting date, more than 100 subjects had completed one year of cytisinicline treatment. Furthermore, about 75% of the 479 (~360) individuals remained on treatment in the trial. We think that it is a material real-world positive that so many participants would remain on a smoking cessation product for that long a period suggesting that cytisinicline is well tolerated. This is particularly notable given the high discontinuation rates for Chantix and the associated unpleasant side effects such as nausea, headache, abnormal dreams and constipation.[1] Achieve expects to complete the one-year safety data package in the next few months and will submit this to the FDA by the 120-day safety review milestone. This should be around year-end 2025. Achieve expects that it will far exceed the 100-patient minimum required for one year of safety observations and could see as many as 300 patients with one year of exposure. Since one of the secondary endpoints is efficacy, this study should be able to show a wealth of data that can help providers use cytisinicline more effectively especially in chronic areas of disease such as Chronic Obstructive Pulmonary Disease (COPD) and cardiology. Milestones Development of cytisinicline product label for smoking cessation – 1H:25 Completion of six months of ORCA-OL safety data for 300 subjects – January 2025 Attendance at Oppenheimer Healthcare Life Sciences Conference, Virtual – February 2025 Attendance at Barclays Healthcare Conference, Miami – March 2025 Selection of 3rd party logistics partner – 2Q:25 NDA Submission – 2Q:25 FDA data submission from patients with twelve months of exposure to cytisinicline – 4Q:25 Launch of Phase III vaping trial – 1H:26 FDA target action date for cytisinicline NDA – 1H:26 Launch of cytisinicline – 3Q:26 SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer . ________________________ [1] Minian, N., et al. Identifying determinants of varenicline adherence using the Theoretical Domains framework: a rapid review. BMC Public Health. March 2024.
