Georgia Bio Sign-on to State Medical Technology Alliance HHS & CMS Letter

Georiga Bio sign-on to the State Medical Technology Alliance (SMTA) letter to U.S. Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid. Please see the language below.


The Honorable Alex M. Azar II
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

The Honorable Seema Verma
Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244


Dear Secretary Azar and Administrator Verma:

As members of the State Medical Technology Alliance (SMTA), we are state and regional life sciences associations representing biotechnology, medical device companies, universities, research institutions, and venture capital firms across the country, all dedicated to developing and delivering life-enhancing and life-saving products, we write to express our strong support for your leadership in the U.S. Department of Health and Human Services’ (HHS) efforts to provide coverage for transformative medical devices that are approved as breakthrough devices by the FDA.

The COVID-19 pandemic highlighted the need for our nation’s health care system to better align care for patients.  We commend HHS for taking swift action to create appropriate waivers and incentives across different health care stakeholders to better address this devastating disease.  Providing patients with access to breakthrough devices would further this push to align care for patients by promoting innovation and providing patients with the latest in life-changing medical technology.

The medical technology industry is an important and thriving sector in the U.S. economy, creating jobs in all 50 states and representing a sizable portion of the nation’s Gross Domestic Product.  The industry is responsible for about 1.9 million jobs in the U.S. and an economic output of approximately $381 billion annually.

Access to state-of-the art medical technology and diagnostics can help to improve care and patient outcomes, and CMS has acknowledged the value of breakthrough products by including a Breakthrough Product Pathway for new technology add-on payments (NTAP) in the Final Rule on the FY 2020 Inpatient Prospective Payment System. 

We commend HHS and CMS for these efforts and urge you to take the next step by providing coverage for all medical devices that are approved and cleared as FDA-designated breakthrough in all settings.  Providing this needed certainty will help ensure the next round of truly life-changing innovation can get to the patients who need them as quickly as possible.

As members of the SMTA, we look forward to working with the Administration to finalize this critical effort.



Sincerely,


Arizona BioIndustry Association (AZBio)

Biocom: Life Science Association of California

BioFlorida

BioForward Wisconsin

BioOhio

Bioscience Association of West Virginia (BioWV)

BioUtah

California Life Sciences Association (CLSA)

Colorado BioScience Association (CBSA)

Florida Medical Manufacturers Consortium (FMMC)

Georgia Bio

Healthcare Institute of New Jersey (HINJ)   

Illinois Biotechnology Innovation Organization (iBIO)

Indiana Health Industry Forum (IHIF)

Indiana Medical Device Manufacturers Council (IMDMC)

Iowa Biotechnology Association (IowaBio)

Kentucky Life Sciences Council

Life Sciences Pennsylvania

Life Science Tennessee

Life Science Washington

Massachusetts Medical Device Industry Council (MassMEDIC)

Medical Alley Association

MedTech Association New York

Michigan Biosciences Industry Association (MichBio)

Mississippi Biotechnology Association

Missouri Biotechnology Association (MOBIO)

NCBIO

SCBIO

Southeast Life Sciences

Texas Healthcare & Bioscience Institute (THBI)

April 17, 2026
April 17, 2026 - Nutrivert Inc., a developer of non-antibiotic replacements for antibiotic growth promoters in livestock, today announced it has completed the first close, raising $2.375 million, of its Series A-2 funding round of $6 million. The round was led by global animal health investor Arrow Ventures with participation from other investors. The funding will be used to further develop Nutrivert’s manufacturing, human food safety and target animal safety and efficacy packages for the company’s lead product Nutrivert LDPP. Nutrivert LDPP is a proprietary, novel, orally available, lipidated synthetic enantiomeric desmuramyl analog of muramyl dipeptide, the smallest conserved immunoactive component of bacterial peptidoglycan. LDPP has no antibacterial effect but has consistently promoted growth and improved feed efficiency in pig studies. LDPP binds to the mammalian NOD2 receptor and is the only NOD2 ligand reported to inhibit the inflammatory signal NF-κB. In pilot studies, LDPP rescued 70kg pigs from an otherwise lethal dose of porcine reproductive and respiratory syndrome virus (PRRSV) and abrogated influenza disease symptoms in piglets. The Company intends to develop LDPP for all major livestock species worldwide. Patents have been granted in most major markets. The global antibiotic growth promoter market is worth an estimated $5.8 billion. Approximately 73% of all antibiotics are fed to livestock. The market is believed to be the world’s largest drug market by volume, with ~100,000 tons of active pharmaceutical ingredient administered annually. FDA’s latest data, for 2024, show a 13% rise in U.S. livestock antibiotic use since 2017. The Food and Agriculture Organization reports that livestock antibiotics are mostly given to speed animal growth. Regulators and non-governmental organizations have called for reduction of antibiotic use in livestock, citing concerns that the global, intensive use of antibiotics, often at subtherapeutic doses, selects for antimicrobial resistance: bacteria that are “immune” to antibiotics and that therefore pose a threat to public health. Spillovers of antibiotic-resistant bacteria from livestock to humans have been documented. “Nutrivert LDPP has consistently improved feed efficiency in pigs without antibiotics,” said Bernhard Kaltenboeck, CSO. “We are excited to have the support of Arrow Ventures and our other investors in bringing a new tool that will help producers reduce production costs and reduce selection pressure for antimicrobial resistance.” About Nutrivert LDPP: LDPP is an investigational compound currently undergoing clinical evaluation. It has not been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or any other global regulatory authority for any indication. The safety and efficacy of LDPP have not been established. Any mention of potential use is based on preliminary data and does not guarantee future regulatory clearance or commercial availability.
April 16, 2026
[Seattle, WA] April 15, 2026 – Apprenti, the leading national intermediary for Registered Apprenticeship (RA), is proud to announce the formal approval and filing of the National Biomanufacturing Technician Standards with the U.S. Department of Labor (USDOL). Crafted under the strategic guidance of the Apprenti Life Science Advisory Board—which includes leaders from Pfizer, Merck, Thermo Fisher, and Biogen—these standards were developed in close partnership with the Life Sciences Workforce Collaborative (LSWC) and InnovATEBIO as part of a high-impact NIIMBL project. This approval represents a foundational shift for the industry, moving away from a fragmented, state-by-state approach to a scalable, consistent model for developing biomanufacturing professionals at sites across all 50 states. The national standards provide a “plug-and-play” framework that ensures a technician trained in Massachusetts or North Carolina meets the same rigorous, industry-vetted benchmarks as one in Ohio or Missouri. The foundational development of these national standards was informed by existing Life Science RA programs from organizations across the country, including: MassBioEd, Oregon Life Sciences, National Center for Therapeutics Manufacturing (NCTM), BioSTL, Wistar Institute, North Carolina Life Sciences Apprenticeship Consortium (NCLSAC) and others. A National Engine for Talent: The filing of these standards is a cornerstone of NIIMBL’s efforts to strengthen domestic biomanufacturing capabilities and develop the workforce of the future. Beyond the standards themselves, the project is delivering a suite of resources and tools—including a comprehensive Employer Toolkit and specialized screening rubrics—that state-based organizations and employers can leverage to implement RA programming for their most in-demand roles. “These national standards set the stage for a sustainable, skills-first pipeline that mirrors the rigor of the industry’s most complex manufacturing processes,” said Daniel Weagle, Director of Life Science Business Development at Apprenti. “By providing a unified approach, we are empowering national employers to scale their workforce development efforts strategically and accessibly.” The Value Proposition of Registered Apprenticeship For Life Science employers, the Registered Apprenticeship model offers a compelling business case rooted in cost-effectiveness and long-term stability: High Retention: RA programs boast exceptional retention rates—historically as high as 89% to 90%—as apprentices are trained within a company’s specific culture and protocols from day one. Cost Efficiency: Research indicates that for every dollar spent on apprenticeship, employers see an average return of $1.47 in increased productivity and reduced recruitment costs. Inclusive Innovation: The model expands access to untapped talent pools, including non-degreed individuals and career-switchers, ensuring the biomanufacturing workforce reflects the demographics of the communities it serves. As the global biopharmaceutical market is projected to exceed $570 billion by 2032 , this partnership between Apprenti, NIIMBL, and industry leaders ensures that the U.S. workforce is not just prepared for the future of manufacturing, but is actively driving it. This project was developed with an award from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and financial assistance from the U.S. Department of Commerce, National Institute of Standards and Technology (70NANB21H086). About Apprenti: Apprenti is a 501(c)(3) nonprofit organization and a U.S. Department of Labor recognized Intermediary. Apprenti designs and delivers scalable Registered Apprenticeship (RA) programs in high-demand industries. By adapting the proven apprenticeship model, Apprenti helps employers meet workforce needs while training the next generation of skilled professionals. Apprenti’s programs are industry-recognized, federally approved, and supports employers across the country. Since launching in 2015, Apprenti has partnered with employers, government agencies, and education providers to create new apprenticeship pathways. About NIIMBL The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of industry standards, and educate a world-leading workforce. Media Contact: Dan Maiese, Communications Manager, dmaiese@niimbl.org , 302-831-3824 About the Life Sciences Workforce Collaborative (LSWC) The Life Sciences Workforce Collaborative (LSWC) is a national nonprofit coalition of state, regional and national life science associations and institutes who are working together to build a competitive, and future-ready life sciences workforce. Originally founded in 2012 as the Coalition of State Bioscience Institutes (CSBI), LSWC connects industry, academia, and government partners through data-driven insights, best practice sharing, and collaborative programs. Learn more at www.LifeSciencesWorkforce.org About InnovATEBIO InnovATEBIO is a National Center for Biotechnology Education, working to advance the education of highly skilled technicians for the nation’s biotechnology workforce. Toward this goal, InnovATEBIO provides leadership in biotechnology technician education, including support for development and sharing of best practices and emerging technologies in biotechnology workforce development. Read LSWC's full announcement here.
April 4, 2026
April 2, 2026- WASHINGTON, D.C. – John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO) , released the following statement on Section 232 Pharmaceutical Proclamation. “A thriving American biotechnology ecosystem is essential to growing the U.S. economy, strengthening national security, and improving the health and well‑being of everyday Americans. While we appreciate the Administration’s recognition of the need for tariff exemptions for certain critical biotech products, the reality is that any tariffs on America’s medicines will raise costs, impede domestic manufacturing, and delay the development of new treatments - all while doing nothing to enhance our national security. “U.S. biotech companies have been eager to expand investments here at home, but tariffs, along with an uncertain policy environment and efforts to force “most‑favored nation” schemes, work directly against that goal. The risks are especially acute for small and mid‑size biotech companies, which develop more than half of all FDA‑approved medicines yet often lack the capital to build dedicated manufacturing facilities as they weather an industry defined by high costs, long development timelines, and significant risk. “The fact is: tariffs divert scarce resources away from research and development, weaken American biotech against China’s rising industry, and ultimately, harm health and economic wellbeing of Americans. “We stand ready to work with the Administration on a long‑term strategy that encourages biotechnology investment, reduces the time, cost, and uncertainty of developing new medicines, expands U.S. biomanufacturing capacity, and ensures American innovation is fairly valued overseas. Tariffs and MFN are not the answer." Source - https://www.bio.org/press-release/bio-statement-section-232-pharmaceutical-proclamation
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