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20 Years after Landmark FDA Approval, SynCardia Remains World’s Only Commercially Approved Total Artificial Heart

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Few total artificial hearts make it to human clinical trials, and only the SynCardia Total Artificial Heart has met the rigorous requirements for commercial approval.

TUCSON, Ariz., July 25, 2024 /PRNewswire/ — Nearly twenty years ago, the SynCardia Total Artificial Heart became the first total artificial heart to receive commercial approval from the U.S. Food & Drug Administration (FDA). Since then, a number of experimental total artificial hearts have come and gone, but unlike the SynCardia Total Artificial Heart, none have been able to achieve commercial approval nor widespread clinical use.

“Completely implantable heart replacement therapy is the zenith in the world of artificial organs,” said Patrick Schnegelsberg, CEO of SynCardia. “The Total Artificial Heart we have developed is the first and remains the only commercially available device. Our vision is to build on our experience and proven technology to make our dream of fully implantable technology a reality.”

The SynCardia Total Artificial Heart received FDA approval on Oct. 15, 2004, following a 10-year pivotal clinical study. According to the study results, which were published in the New England Journal of Medicine on Aug. 26, 2004, of the 81 patients who received the SynCardia Total Artificial Heart, 79% were bridged to a heart transplant. In comparison, only 46% of the control patients who did not receive the device survived to transplantation.

Overall, the one-year survival rate post-transplant among the clinical study patients who received the SynCardia Total Artificial Heart was 70% compared with only 31% of patients who did not receive the device prior to receiving a heart transplant. One-year and five-year survival rates after transplantation among patients who received the SynCardia Total Artificial Heart were 86% and 64%, respectively.

More recent studies in the US and in Europe have confirmed these results in real world populations.

Today, there have been more than 2,000 implants of the SynCardia Total Artificial Heart at more than 130 hospitals across 25 countries.

Over the years, several experimental total artificial hearts have made headlines but have yet to achieve commercial success and have remained in clinical trials.

About SynCardia
The SynCardia Total Artificial Heart is the first and only commercially available FDA and Health Canada approved total artificial heart. It is available in two sizes, to accommodate a wide variety of patients providing cardiac output flows up to 9 lpm.

The SynCardia Total Artificial Heart has been implanted in over 2,000 patients across 20 countries and has provided 293,997 days of life to patients with heart failure.  Powered by the Freedom Portable Driver™, the SynCardia Total Artificial Heart has allowed many patients to live at home while waiting for a donor heart including a patient currently at home with his family who has been supported by the SynCardia Total Artificial Heart since 2017. To learn more, visit www.syncardia.com and follow us on Facebook, X, and LinkedIn.

Media Contact:
Vivian Highton
vhighton@syncardia.com
520-955-3634

View original content:https://www.prnewswire.com/news-releases/20-years-after-landmark-fda-approval-syncardia-remains-worlds-only-commercially-approved-total-artificial-heart-302206912.html

SOURCE SynCardia Systems, LLC

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Datavault AI expands deployment, strengthens market position on Available neocloud infrastructure

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Datavault’s deployment onto SanQtum is expanding: in addition to NYC and Philadelphia, the company is also live with edge AI on a third hub in Washington, DC, and will be live in three more cities by the end of the year.

TYSONS CORNER, Va. and PHILADELPHIA, Sept. 8, 2026 /PRNewswire-PRWeb/ — In a pair of announcements in early January 2026, Datavault AI announced nationwide deployment of the company’s DataValue, DataScore, and Information Data Exchange (IDE) solutions onto Available’s SanQtum neocloud platform, along with initial edge AI hubs in New York City and Philadelphia in collaboration with Available and IBM.

Eight months later, Datavault’s deployment onto SanQtum is expanding: in addition to NYC and Philadelphia, the company is also live with edge AI on a third hub in Washington, DC, and will be live in three more cities — San Francisco, Chicago, and Raleigh (NC) — totaling six by the end of the year.

Complementing these “super node” hubs, ~200 Available Infrastructure micro edge sites located at cell towers across 30 US cities are operating or under construction, with edge clusters in 70 cities to be added to Available’s neocloud in the coming months. This represents phase 1 of Available’s US neocloud infrastructure buildout, which the company unveiled as Project Qestrel in March.

Market forecasts show very strong demand for neocloud offerings. Synergy Research Group reports $9B (US) in Q4 2025, up 223% year-over-year, exceeding $25B (US) total in 2025 and a 58% CAGR approaching $400B by 2031. The World Economic Forum projects the neocloud market at $250B by 2030.

Companies that can differentiate within this neocloud market segment — such as with sovereign architecture, ultra-low-latency for real-time AI inference, and superior cybersecurity — are well-positioned to excel. The entire SanQtum platform is purpose-built to such specs: sovereign, resilient, edge-first, zero trust, and Q Day ready. These are all attributes that in turn strengthen Datavault’s value proposition for its customers.

The next step in Datavault’s deployment onto the Project Qestrel fleet of Available’s SanQtum neocloud is manufacturing $QEST coins to monetize the value of the associated compute, including moving into compelling new markets such as sovereign edge AI inference. Available is proud to provide the foundation for Datavault CEO Nate Bradley and his team to embark on a game-changing endeavor with their solutions around digital twins, tokenization of real-world assets (RWA), and more.

About Available Infrastructure

Based in Northern Virginia along the Washington, DC, beltway, Available Infrastructure offers SanQtum: a secure, sovereign environment for running mission critical applications, deploying AI inference, and storing sensitive data. SanQtum is offered as an integrated, managed service that conveniently bundles three crucial components: a cybersecure zero trust network overlay, high-performance neocloud compute at urban and frontier micro edge sites, and AI inference governance and orchestration. Available Infrastructure is an IBM Platinum Partner.

For more information, visit www.availableinfrastructure.com.

About DataVault AI

About Datavault AI Datavault AI Inc. (Nasdaq: DVLT) is an Artificial Intelligence Platform (“AIP”) company focused on transforming data and real-world assets into intelligent, secure and monetizable digital assets. The Company’s integrated platform combines artificial intelligence, an AI-driven inference layer, data valuation, tokenization, cybersecurity, high-performance computing and exchange technologies to support the lifecycle of data and digital assets—from identification and valuation through tokenization, commercialization and monetization.

Datavault AI operates through two synergistic divisions: Data Science and Acoustic Science. The Data Science division includes the Company’s patented Data Vault®, DataValue®, and DataScore® technologies, together with its cybersecurity, tokenization and exchange capabilities. The Acoustic Science division includes WiSA®, ADIO® and related spatial audio and data-over-sound technologies, as well as the Company’s events and experiential media businesses, including CompuSystems, Inc., operated under the Event Citadel brand, and API Media Innovations Inc.

Together, these capabilities form an integrated AI platform designed to connect data, intelligence, value and markets, enabling enterprises, institutions and asset owners to identify, protect, value and monetize data and real-world assets.

The Company is headquartered in Philadelphia, PA. For more information, visit www.dvlt.ai. Investor information is available at ir.datavaultsite.com. Technology news and insights are published at dvlt.ai/insights.

Media Contact

Inflection Point Agency, Available Infrastructure, 1 (719) 357-8344, nikki@inflectionpointagency.com, https://availableinfrastructure.com/

View original content:https://www.prweb.com/releases/datavault-ai-expands-deployment-strengthens-market-position-on-available-neocloud-infrastructure-302872536.html

SOURCE Available Infrastructure

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Harbor Compliance Accelerates Growth Strategy, Earns 8th Inc. 5000 Recognition

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New CEO, Strengthened Board, and Growth Investment from Bregal Sagemount Fuel the Company’s Next Phase of Expansion

LANCASTER, Pa., Sept. 8, 2026 /PRNewswire/ — Harbor Compliance, a leading provider of compliance, licensing, and registered agent services, is executing an ambitious growth strategy backed by new leadership, a strengthened board, and a committed capital partner. That momentum is reflected in the company’s eighth appearance on the Inc. 5000 list of America’s fastest-growing private companies, with three-year revenue growth of 55 percent.

In February 2026, Harbor Compliance secured a majority growth investment from Bregal Sagemount, a growth-focused private capital firm, and appointed Chad Nuss as Chief Executive Officer. Industry veteran John Weber, former CEO of CT Corporation, joined the company’s board of directors alongside partners from Bregal Sagemount, bringing decades of regulatory and compliance leadership to guide the company’s next phase. The investment is fueling continued expansion of Harbor Compliance’s regulatory data, software, and managed services — the same combination that has driven the company’s growth since it was founded in 2012 and that today serves more than 40,000 customers nationwide.

“This recognition reflects the alignment we have across our leadership team, board, and investors around a single strategy: making compliance simple for the customers we serve,” said Chad Nuss, CEO of Harbor Compliance. “Sustaining growth over eight years means making our customers’ lives easier no matter how fast requirements change. That’s why we listen to the needs in the market, continue to expand our compliance services, and deliver additional capabilities through technology. Organizations can see and address their full compliance picture in one place rather than piecing it together state by state. This complete regulatory compliance is the peace of mind organizations are asking for.”

“Harbor Compliance has the rare combination of a differentiated product, a large and growing market, and a leadership team that knows how to execute,” said John Weber, board member and former CEO of CT Corporation. “That combination is why the board and our investment partners are confident in the company’s path forward.”

Through a unique combination of proprietary data, advanced software, and expert support, Harbor Compliance helps businesses and nonprofits manage the registration rules, licensing categories, renewal calendars, and reporting obligations that vary by jurisdiction and change with little warning. From a single interface, users can track renewal dates, assign tasks to colleagues, store records, and access registered agent documents. The software is available as a service and also serves as the foundation of the company’s managed services.

About Harbor Compliance

Harbor Compliance helps organizations simplify regulatory compliance. Through Harbor Everywhere, Harbor Compliance delivers its purpose-built entity, licensing, tax registration, and registered agent data directly inside the operational systems organizations already use to run their business. Trusted by more than 40,000 organizations nationwide, Harbor Compliance combines purpose-built technology with expert support to help organizations stay compliant and confidently grow across jurisdictions.

Media Contact:
Brock Klinger, Director of Sales & Marketing
717.431.9022
bklinger@harborcompliance.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/harbor-compliance-accelerates-growth-strategy-earns-8th-inc-5000-recognition-302872599.html

SOURCE Harbor Compliance

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Panasonic Automotive Systems Group secures SBTi validation for greenhouse gas emissions reduction targets

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YOKOHAMA, Japan, Sept. 8, 2026 /PRNewswire/ — Panasonic Automotive Systems Co., Ltd. (Headquarters: Yokohama, Kanagawa, Japan; President: Masashi Nagayasu) and its group companies (collectively, the “Group”) today announced that they have received validation from the Science Based Targets initiative (SBTi)* for the Group’s greenhouse gas (GHG) emissions reduction targets as science-based targets aligned with efforts to limit global warming to 1.5°C.

Science Based Targets (SBTs) are corporate greenhouse gas emissions reduction targets aligned with the Paris Agreement’s goal of limiting global warming to 1.5°C above pre-industrial levels. The targets validated for the Group are shown in the table below.

Category

Target

Near-Term

Scope 1 and 2

Reduce GHG emissions by 63.0% by FY2035 from an FY2024 base year

Scope 2

Increase the annual sourcing of renewable electricity to 100% by FY2030 and maintain through FY2035

Scope 3

Reduce Scope 3 Category 1 and Category 11 emissions by 37.5% by FY2035 from an FY2024 base year

Long-Term

Scope 1 and 2

Reduce GHG emissions by 90.0% by FY2050 from an FY2024 base year

Scope 3

Reduce Scope 3 Category 1 and Category 11 GHG emissions by 90.0% by FY2050 from an FY2024 base year

Net-Zero

Scope 1, 2, and 3

Achieve net-zero GHG emissions across the value chain by FY2050

The Group regards climate change as one of its key management issues and has been working to promote ongoing energy conservation initiatives and expand the use of renewable energy. Since 2023, the Group has maintained net-zero CO2 emissions at its major sites worldwide.
To achieve the newly validated SBTs, the Group will continue to advance energy conservation initiatives and expand the adoption and use of renewable energy, while also expanding low-carbon products and services and strengthening collaboration with suppliers. Through these efforts, the Group will promote reductions in GHG emissions across the entire value chain and contribute to the realization of a sustainable mobility society.

* Science Based Targets initiative (SBTi): Jointly operated by CDP, United Nations Global Compact (UNGC), World Resources Institute (WRI), and World Wide Fund for Nature (WWF), the SBTi encourages companies to set science-based greenhouse gas (GHG) emissions reduction targets to support achievement of the goals of the Paris Agreement.

About Panasonic Automotive Systems Co., Ltd.
Headquartered in Japan, Panasonic Automotive Systems Co., Ltd., (PAS) is a global company with subsidiaries in eight other countries and, as a Tier 1 company, it provides advanced proprietary technologies such as infotainment systems to automakers in Japan and overseas, helping to create comfortable, safe, and secure automobiles. PAS is committed to meeting the expectations of its customers around the world with technologies that stand by people in pursuit of its corporate vision of becoming the “Joy in Motion” design company.
We are changing our company name and brand to Mobitera Inc., effective April 1, 2027. To learn more about our company, please visit https://automotive.panasonic.com/en

View original content to download multimedia:https://www.prnewswire.com/news-releases/panasonic-automotive-systems-group-secures-sbti-validation-for-greenhouse-gas-emissions-reduction-targets-302872654.html

SOURCE Panasonic Corporation of North America

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