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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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Twenty Years After an Attic Startup, TydeCo Brings “HR & Finance Walk Into a Bar” Home

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After becoming a hit in Cape Town and Johannesburg, the event makes its US debut in Maryland with Sage on September 24

FREDERICK, Md., Sept. 8, 2026 /PRNewswire/ — In 2006, two college students started a bookkeeping practice from the attic of a rented house in Maryland. They had $1,500 in the bank and no clients, so they placed an advertisement on Craigslist. One of them was Matt Lescault, now CEO of TydeCo.

That practice became Lescault & Walderman, moved to a fully virtual model in 2010 and expanded from outsourced accounting into software implementation, integration and data.

Twenty years later, the company is TydeCo, operating in four countries with teams across 10 time zones.

This September, TydeCo will bring an idea shaped through that global growth back to the state where the business began. “HR & Finance Walk Into a Bar” makes its US debut September 24 after successful events in Cape Town and Johannesburg, with Sage joining TydeCo for the afternoon.

The complimentary event takes place from 2 p.m. to 5 p.m. at Charley’s Chesapeake Chophouse, Rio Lakefront in Gaithersburg. Designed for finance, HR and payroll leaders, owners and senior decision makers, it combines business conversations with four courses, paired drinks and live magic woven into one continuous story.

The concept was influenced in part by what happens when people leave the structure of the working day. Although TydeCo has operated virtually since 2010, Director of Marketing, Becky Clawson and Lescault occasionally meet at Charley’s when a conversation needs more room than a scheduled video call allows.

“When you sit down at your desk, you are automatically thinking about emails and everything that needs to be checked off,” Clawson said. “When you step outside that environment and talk face to face, your mindset opens. The best conversations and brainstorms happen when you are no longer in that preprogrammed thought process.”

The name “HR & Finance Walk Into a Bar” borrows from one of comedy’s most recognizable setups. And TydeCo put HR and finance at the center because the two functions make decisions about the same organization while often working with different information and separate systems.

“When the right people are part of the conversation, the outcome is better because everyone hears it firsthand and creates the answer together,” Clawson said.

That idea carries through the format. Speakers from finance, HR and payroll share real business experiences, while food, drinks and live magic develop alongside the conversation.

“This is not a business card exchange. This is not a 30-second elevator pitch. This is an experience,” Clawson said.

TydeCo first introduced the format in Cape Town before taking it to Johannesburg. The response established it as one of the company’s signature events and led to the decision to bring it to the US.

“We used South Africa as the test bed and asked whether the concept had legs. Resoundingly, it did,” Clawson said. “What stayed with me was the curiosity. People were willing to step outside the box and consider a business problem in a completely different way.”

During one South African event, guests entered different calculations into their phones. Each followed a different sequence, but when everyone pressed equal, every screen displayed the same number.

“That same number represents the core mission and vision we show up for every single day,” Clawson said. “We may come at the problem differently, but ultimately we are working toward the same outcome.”

The event’s move from South Africa to the US mirrors TydeCo’s own growth. In 2022, Lescault & Walderman acquired a majority stake in AWCape, a South African Sage Platinum Partner, and a minority stake in Applico, a Sage training specialist. The businesses began collaborating across US and African projects before coming together under the TydeCo name, chosen in reference to the tides connecting the continents.

Today, the teams work together across finance, HR and operational technology, supported by TydeCo’s Better Together value.

That value will be reflected in Maryland through TydeCo’s relationship with Sage and integrating them into to the same story rather than appearing as separate sponsor. Representatives from Sage will be attending.

Sage has been part of TydeCo’s evolution from an accounting practice into a global business systems partner. Sage Intacct will bring the financial management and enterprise resource planning perspective to the conversation, alongside human capital management technology.

The Maryland event will explore reporting clarity, accountability and connected data through contributions from Sage and TydeCo.

For TydeCo, however, the real measure of the event comes after the final performance.

“Where the real magic happens is seeing teams move from a conversation with their HR or finance counterpart into actually implementing new technology, new processes and more efficient ways to work together,” Clawson said.

“HR & Finance Walk Into a Bar” takes place from 2 p.m. to 5 p.m. on September 24, 2026, at Charley’s Chesapeake Chophouse, Rio Lakefront, Gaithersburg. Attendance is complimentary and limited.

Registration is available at tydeco.com/event/maryland-event-september. A Boston edition will follow in October.

About TydeCo

TydeCo is a global business transformation partner helping organizations connect finance, people and operational systems. Its services include software implementation and support, integration and automation, data and analytics, and outsourced bookkeeping, controller and CFO services. TydeCo operates in four countries, with teams working across 10 time zones.

tydeco.com

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SOURCE TydeCo

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Regpack Introduces Program Insights, Built Around the People Programs Serve

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SAN DIEGO, Sept. 8, 2026 /PRNewswire/ — Regpack, an online registration and payment platform, today announced Program Insights, an intuitive real-time dashboard that shows directors what is happening with their enrollment and their families while a season is still in motion.

For program directors and staff, registration is not a data point. It’s a kid who signed up, a family who came back, a seat that got filled. Program Insights is built around that. Directors can watch enrollment percentages fill in, class by class, as sign-ups arrive, see which sessions are close to full and which still have room, and see which families from last season have returned and which haven’t.

Additionally, it shows where people stop partway through signing up. If a class loses most of its interest at a particular step, that step becomes visible, and a director can change the form, the wording, or the price and see whether the next group makes it through. The rough spots stop being a mystery.

Every view comes with a short AI summary read of what it means and next steps, so directors and staff aren’t left interpreting a chart between pickup and payroll.

“Nobody starts a program because they love spreadsheets. They do it for the kids in the room, the attendees they bring in,” said Asaf Darash, founder of Regpack. “Directors already know their families better than any dashboard will. What they have asked us for is a faster way to see who is missing, who is coming back, and where a program needs attention, so the time goes to the students instead of the reporting.”

Program Insights is available now to Regpack customers on tiered packages

https://www.regpacks.com/features/registration-reporting/program-insights-dashboard

About Regpack

Regpack is an online registration and payment platform built for the people who run programs. Camps, after-school and enrichment programs, schools, nonprofits, and event organizers use it to handle sign-ups, collect payments, and manage participant information in one place.

Media Contact

Mandi Rogers, Marketing Director, Regpack – mandi@regpacks.com 

View original content to download multimedia:https://www.prnewswire.com/news-releases/regpack-introduces-program-insights-built-around-the-people-programs-serve-302872880.html

SOURCE Regpack

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Consumer Watchdog Alert Calls Out PG&E’s Bailout And PG&E CEO’s Misrepresentation

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SACRAMENTO, Calif., Sept. 8, 2026 /PRNewswire/ — A new Consumer Alert video published by Consumer Watchdog exposes the “bailout blackmail” that PG&E is engaging in to force the legislature to approve a bailout for the company in a special session. The company is cutting back on $2 billion in infrastructure that ratepayers have already paid for unless it gets a bailout, which the legislature has refused to do in its regular session.

The short video features an interview with former California Public Utilities Commission (PUC) President Loretta Lynch alleging that PG&E CEO Patti Poppe lied in a video. Poppe said that PG&E could not provide new services because it would cost it too much in borrowing costs. Lynch pointed out PG&E had already been paid for the new equipment in approved rate hikes with a 10% markup and the cost of taxes on the equipment.

Consumer Watchdog has petitioned the PUC to issue an order to show cause.

Watch the video.

“It’s bailout blackmail,” said former President of the California Public Utilities Commission Loretta Lynch in the Consumer Alert video. “The utility wanted, regardless of whether its negligence caused damage, to not be held liable for that damage, and thankfully the legislature said no. PG&E is trying to browbeat California policy makers into giving PG&E a get out of jail free card for its own liability.”

The Consumer Alert takes issue with this video statement published by PG&E CEO Patti Poppe: “PG&E collects money from customers through rates every year. We use nearly all of that to operate and maintain the existing gas and electric equipment. But that is not enough to build new equipment to keep people safe and energy reliable. That’s why we must raise billions of dollars more every year.”

Lynch responds in the Consumer Alert: “That’s bull. Ratepayers already pay for every single penny PG&E spends. Ratepayers pay $19 billion. In addition, ratepayers pay 10% on every single piece of equipment or power plant or physical infrastructure that they build, own, or maintain. We also pay the taxes on that 10%. So ratepayers end up paying 15 cents out of every dollar we pay for PG&E’s profit and to pay PG&E taxes on their own profit.”

Pope has said that if the legislature approves liability relief in bailout legislation she will spend the $2 billion she is withholding. Consumer Watchdog’s petition to the PUC asks for the Commission to require PG&E to answer why it is withholding the use of dollars ratepayers are already paying for and force a refund or to have those dollars spent.

“PG&E is just choosing to hold us hostage in order to get legal changes that will exempt itself from liability for its own negligence,” said Lynch. “So we need to just say no to PG&E. PG&E enjoys monopoly status because it has entered into a legal duty to serve all customers and to keep us safe. PG&E has plenty of money to do that. And if they don’t, let’s audit their books and see where they’re stashing the cash.”

View original content to download multimedia:https://www.prnewswire.com/news-releases/consumer-watchdog-alert-calls-out-pges-bailout-and-pge-ceos-misrepresentation-302872882.html

SOURCE Consumer Watchdog

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