Veranex Unveils MedTech's First Innovation CRO (iCRO)--Redefining R&D in a Capital‑Tight Market
RALEIGH, N.C. — Veranex, a global provider of product development and contract research services, today introduced the industry's first Innovation CRO (iCRO) —an integrated development and research platform engineered to move medical devices and in-vitro diagnostics (IVDs) from concept to commercial success faster, with tighter budget control and a built-in path to payer adoption.
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Introducing the world's first Innovation CRO (iCRO)—delivering safer, smarter, faster MedTech development in today's challenging capital markets. From concept to commercialization, we're redefining how medical device innovation gets done.
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Speed & Capital Efficiency – Integrated teams and workflows can cut 3–6 months per development phase and reduce budget variance 18 percent versus transactional (traditional) outsourcing. Flexible partnership tiers— Full Stack, Stage Select, and Strategic Augment —let sponsors deploy only the iCRO services they need while retaining velocity.
Evidence Integration from Day One – Product design research, human factors engineering, and reimbursement strategists collaborate upfront in the iCRO model to identify data packages that resonate with regulators, investors, and payers—reducing the likelihood of late-stage pivots commonly encountered today.
Device & IVD Specific Depth – Over 1,000 device & IVD programs and 2,500 clinical trials completed by a team of 800+ experts across North America, Europe, and APAC. Veranex brings deep expertise in cardiovascular, neurovascular, ophthalmology, in-vitro diagnostics and more.
Regulatory & Market Access Alignment – 96 percent approval rate and proven market access pathways in 30+ countries, guided by in-house health economics analysts and payer panels.
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'Speed and capital efficiency are no longer competitive advantages—they are survival mandates,' said Patrick Donnelly, Chief Executive Officer, Veranex. 'Our Innovation CRO answers that mandate with excellence and rigor, integrating every critical discipline—design, engineering, preclinical, clinical, regulatory, quality, manufacturing, market access—into one accountable team that delivers validated evidence at every step.'
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Meeting Today's Market Demands
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The iCRO model addresses evolving industry challenges where venture investment and access to cheap capital in MedTech have dropped significantly from recent highs. Constrained teams face industry consolidation and internal capability gaps, while evolving EU MDR/IVDR and FDA requirements extend market clearance timelines. At the same time, artificial intelligence features are racing into next-generation devices, raising both regulatory scrutiny and evidence demands. In this complex landscape, today's innovators need more than traditional vendors. They need strategic partners who can deliver integrated solutions with speed and certainty.
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'Whether you're a seed-stage innovator or a global strategic, our iCRO partnerships enable clients to focus scarce capital on innovation while we derisk execution across multiple geographies,' said Ryan Roberts, Chief Commercial Officer, Veranex. 'We provide access to cross-functional expertise precisely where and when it's needed, accelerating progress toward critical milestones.'
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About Veranex
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Veranex
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Media Contact
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John W. Colby III
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These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit (Founder's Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. Article content Forward-Looking Statements Article content This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding future operating results and prospects, commercialization activities, momentum and market data, discussions and meetings with the U.S. FDA, including with respect to the previously reported RTF letter received by the Company and potential implications thereof, potential next steps, decisions and timelines related to the Company's regulatory submissions and strategy, participation by urology practices in ImmunityBio's rBCG EAP, the expectation that the rBCG EAP will enable ImmunityBio to reliably bring an alternative source of BCG to patients in the U.S., the expectation that the EAP for lymphopenia will enable patients to have access to ANKTIVA for the indication described, the RMAT designation as previously reported and potential results therefrom and regulatory submissions and clinical development plan and trial in connection therewith, the belief that ALC levels and NLR levels obtained from a CBC are predictors of clinical benefit and outcomes relating to overall survival, clinical trial and expanded access program enrollment, timing, data and potential results to be drawn therefrom, anticipated components of ImmunityBio's CancerBioShield™ platform, anticipated review timeline for the Company's NCCN guidelines submission in NMIBC papillary only and potential implications therefrom, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents for the prevention or reversal of lymphopenia, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents across multiple tumor types and indications and for potential applications beyond oncology, potential Article content regulatory pathways and the regulatory review process and timing thereof, the application of the Company's science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that have the potential to change the paradigm in cancer care, and ImmunityBio's approved product and investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as 'anticipates,' 'believes,' 'continues,' 'goal,' 'could,' 'estimates,' 'scheduled,' 'expects,' 'intends,' 'may,' 'plans,' 'potential,' 'predicts,' 'indicate,' 'projects,' 'is,' 'seeks,' 'should,' 'will,' 'strategy,' and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio's management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio's statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding the FDA regulatory submission, filing and review process and the timing thereof, as well as that associated with regulatory agencies outside of the U.S. such as the European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) and other regulatory agencies, (ii) risks and uncertainties regarding commercial launch execution, success and timing, (iii) whether the RMAT designation will lead to an accelerated review or approval, of which there can be no assurance, (iv) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation programs described herein, (v) whether clinical trials will result in registrational pathways, (vi) whether clinical trial data will be accepted by regulatory agencies, (vii) whether the NCCN will review and/or approve the Company's submission described herein on the anticipated timeline or at all, (viii) risks and uncertainties regarding market access initiatives and timing, (ix) whether the FDA will permit the resubmission of the NMIBC papillary sBLA and the requirements thereof, (x) whether the FDA will ultimately approve the sBLA, or other submissions in a timely matter, or at all, of which there can be no assurance, (xi) risks and uncertainties regarding changes in personnel at the FDA and limited resources at the FDA and potential delays associated therewith, (xii) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (xiii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (xiv) potential delays in product availability and regulatory approvals, (xv) the risks and uncertainties associated with third-party collaborations and agreements, including that with Serum Institute of India, (xvi) ImmunityBio's ability to retain and hire key personnel, (xvii) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xviii) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xix) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xx) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xxi) ImmunityBio's ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio's business are described under the heading 'Risk Factors' in the Company's Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and the Company's Form 10-Q filed with the SEC on May 12, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at ImmunityBio cautions you not to place undue reliance on any forward looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. Article content Article content Article content Article content Article content Contacts Article content Investors Article content Article content Hemanth Ramaprakash, PhD, MBA Article content Article content ImmunityBio, Inc. Article content Article content +1 858-746-9289 Article content Article content Article content Media Article content Article content Sarah Singleton Article content Article content ImmunityBio, Inc. Article content Article content Article content
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