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Charge Enterprises to Present at the 2nd Annual Evercore ISI Global Clean Energy and Transition Technologies Summit

Charge Enterprises to Present at the 2nd Annual Evercore ISI Global Clean Energy and Transition Technologies Summit

NEW YORK–(BUSINESS WIRE)–Charge Enterprises, Inc. (Nasdaq: CRGE) (“Charge” or the “Company”), a global business connecting people with communications and electric vehicle (“EV”) charging infrastructure, announced today that Andrew Fox, Founder, Chairman and CEO, will be presenting at the 2nd Annual Evercore ISI Global Clean Energy & Transition Technologies Summit in New York City on June 15th and June 16th, 2023.

Event: 2nd Annual Evercore ISI Global Clean Energy & Transition Technologies Summit

Presentation Date: Friday, June 16, 2023

Presentation Time: 9:25-9:45 a.m. ET

Webcast link:https://wsw.com/webcast/evercore34/crge/2339106

Interested investors should reach out to their Evercore sales contact directly to schedule in-person meetings with Andrew Fox during the conference.

About Charge Enterprises, Inc.

Charge Enterprises, Inc. is an electrical, broadband and EV charging infrastructure company that provides clients with end-to-end project management services. We operate in two segments: Infrastructure, which has a primary focus on EV charging, broadband and wireless, and electrical contracting services; and Telecommunications, which provides connection of voice calls, Short Message Services (SMS) and data to global carriers. Our vision is to be a leader in enabling the next wave of transportation and connectivity. By building, designing, and operating seamless infrastructure for electric vehicles, we aim to create a future where transportation is clean, efficient, and connected and to empower individuals, communities, and businesses to thrive in a more sustainable world. Our plan is to cultivate repeat customers and recurring revenue by deploying a multi-phased strategy, initially where investment in the EV charging revolution is taking place, the nation’s approximately 18,000 franchised auto dealers.

To learn more about Charge, visit Charge Enterprises, Inc.

Notice Regarding Forward-Looking Information

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect current expectations or beliefs regarding future events or Charge’s future performance. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “potential”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved. All forward-looking statements, including those herein, are qualified by this cautionary statement. Although Charge believes that the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements involve risks and uncertainties, and actual results may differ materially from any future results expressed or implied by such forward-looking statements. Such risks and uncertainties include the business plans and strategies of Charge, Charge’s future business development, market acceptance of electric vehicles, the success of Charge’s retail dealership initiative and the size, scope and success of the related initial installation projects, Charge’s ability to generate profits and positive cash flow, changes in government regulations and government incentives, subsidies, or other favorable government policies, rising interest rates and the impact on investments by our customers, and other risks discussed in Charge’s filings with the U.S. Securities and Exchange Commission (“SEC”). Readers are cautioned that the foregoing list of risks and uncertainties is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this press release speak only as of the date of this press release or as of the date or dates specified in such statements. For more information on us, investors are encouraged to review our public filings with the SEC, including the factors described in the section captioned “Risk Factors” of Charge’s Annual Report on Form 10-K filed with the SEC on March 15, 2023, as well as subsequent reports we file from time to time with the SEC which are available on the SEC’s website at www.sec.gov. Charge disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

Investor Relations:

Christine Cannella (954) 298-6518

[email protected]

Christine Petraglia (917) 633-8980

[email protected]

Media:

Kristopher Conesa (305) 975-5934

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Technology Mobile/Wireless EV/Electric Vehicles Automotive Batteries Alternative Energy Energy Environment Other Technology Telecommunications Sustainability Hardware Green Technology Consumer Electronics

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Novocure Pledges $3 Million to Conquer Cancer®, the ASCO Foundation, to Support Cancer Research and Education

Novocure Pledges $3 Million to Conquer Cancer®, the ASCO Foundation, to Support Cancer Research and Education

ROOT, Switzerland–(BUSINESS WIRE)–
Novocure (NASDAQ: NVCR) today announced that it will donate $3 million to Conquer Cancer®, the ASCO Foundation, to advance cancer research and education.

Conquer Cancer is a global community of advocates, patients, doctors, researchers, caregivers, and others dedicated to improving the lives of people affected by cancer. Its mission is to accelerate breakthroughs in lifesaving research and empower people everywhere to conquer cancer.

Since 1984, Conquer Cancer has raised more than $500 million to fund research, education, and quality programs. The nonprofit organization’s grants and awards support clinical and translational cancer research done by gifted physician-scientists at every stage of their careers, from the best and brightest among young investigators to senior researchers providing mentorship opportunities for the next generation of cancer researchers.

Novocure will disburse $1 million annually to Conquer Cancer through 2025. Conquer Cancer will use the funding in support of cancer research and education.

“We are very proud to support Conquer Cancer and ASCO in their vital work accelerating breakthroughs in cancer treatment,” said Pritesh Shah, Chief Growth Officer at Novocure. “We admire and align with their unwavering commitment to improving lives through groundbreaking cancer research and education. This donation reflects our shared aspiration to make transformative progress in cancer care.”

ASCO, the world’s leading professional organization for physicians and oncology professionals caring for people with cancer, will hold its 2023 Annual Meeting in Chicago from June 2 to June 6.

“We are grateful for Novocure’s multi-year support of cancer research and essential educational programs,” said Clifford A. Hudis, MD, FACP, FASCO, Chief Executive Officer of ASCO and Executive Vice Chair of Conquer Cancer. “This contribution will help us achieve new advances and improve the care patients receive around the world.”

About Novocure

Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma. Novocure has ongoing or completed clinical studies investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.

Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 23, 2023, and subsequent flings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion. ASCO® and Conquer Cancer®, the ASCO Foundation, are registered trademarks of the American Society of Clinical Oncology. Used with permission. ASCO and Conquer Cancer are not partners or affiliates of Novocure and do not recommend or endorse any organization, product, or service.

Investors:

Ingrid Goldberg

[email protected]

610-723-7427

Media:

Leigh Labrie

[email protected]

610-723-7428

KEYWORDS: Europe Switzerland United States North America

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical Oncology Health Philanthropy Foundation

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NRG Announces $1.75 Billion Asset Sale, Unlocking Significant Shareholder Value; Announces 2023 Investor Day

NRG Announces $1.75 Billion Asset Sale, Unlocking Significant Shareholder Value; Announces 2023 Investor Day

Leverage Neutral Transaction; Accelerates & Upsizes Share Repurchase Program

HOUSTON–(BUSINESS WIRE)–
NRG Energy, Inc. (NYSE: NRG) today announced that it has entered into a definitive agreement to sell its 44% equity interest in South Texas Project Electric Generating Station (STP) to Constellation Energy for a purchase price of $1.75 billion, subject to customary purchase price adjustments. The purchase price represents an implied valuation multiple of 11.7x EV/EBITDA and 17.5x Free Cash Flow.

“Today’s announcement is the continuation of our strategy to optimize our portfolio while creating significant shareholder value,” said Mauricio Gutierrez, NRG President and Chief Executive Officer. “The work on this transaction over the last several months will release significant capital to be deployed at value—accelerating and upsizing our current share repurchase program while achieving our balance sheet targets.”

The transaction is targeted to close by the end of 2023, subject to regulatory approvals by the United States Nuclear Regulatory Commission, Hart-Scott-Rodino, and the Public Utility Commission of Texas. Upon closing, the sale exceeds the previously disclosed 2023 asset sale target of $500 million. The sale is expected to be leverage neutral with net cash proceeds, after $500 million of deleveraging, to be used primarily for share repurchases.

STP is a 2,645 MW nuclear facility located about 90 miles southwest of Houston in Bay City, Texas. NRG’s current 44% interest represents approximately 1,100 MWs of output.

Barclays Capital Inc. and Morgan Stanley & Co. LLC are serving as NRG’s financial advisors, and McGuireWoods LLP is serving as legal counsel.

Share Repurchase Update

On May 31, 2023, the NRG Board of Directors authorized $650 million in share repurchases to be initiated following the closing of the STP sale. This authorization, when combined with the approximately $350 million remaining under the existing share repurchase program, brings the total amount of share repurchases to be completed to $1 billion.

NRG reiterates its expectation to achieve its investment grade 2.50x to 2.75x corporate net debt to adjusted EBITDA credit metrics by late 2025 or 2026.

NRG to Host 2023 Investor Day

NRG plans to host its 2023 Investor Day on Thursday, June 22, 2023, at 9:00 am Eastern Time. A live webcast of the event, including presentation materials, will be posted on NRG’s website at www.nrg.com under the ‘investors’ section. The event will be archived on the site for those unable to listen in real-time.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are subject to certain risks, uncertainties and assumptions and typically can be identified by the use of words such as “expect,” “estimate,” “should,” “anticipate,” “forecast,” “plan,” “guidance,” “outlook,” “believe” and similar terms. Although NRG believes that the expectations are reasonable, it can give no assurance that these expectations will prove to be correct, and actual results may vary materially.

NRG undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. The foregoing review of factors that could cause NRG’s actual results to differ materially from those contemplated in the forward-looking statements included in this news release should be considered in connection with information regarding risks and uncertainties that may affect NRG’s future results included in NRG’s filings with the SEC at www.sec.gov.

About NRG

NRG Energy is a leading energy and home services company powered by people and our passion for a smarter, cleaner, and more connected future. A Fortune 500 company operating in the United States and Canada, NRG delivers innovative solutions that help people, organizations, and businesses achieve their goals while also advocating for competitive energy markets and customer choice. More information is available at www.nrg.com. Connect with NRG on Facebook and LinkedIn, and follow us on Twitter, @nrgenergy.

Media:

Laura Avant

713.537.5437

[email protected]

Investors:

Brendan Mulhern

609.524.4767

[email protected]

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Other Energy Utilities Oil/Gas Coal Alternative Energy Energy Nuclear

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FARFETCH Announces New Guards Group Management Changes

FARFETCH Announces New Guards Group Management Changes

  • Cristiano Fagnani named CEO of Off-White; remains responsible for the Reebok Business as CEO of NGG++
  • Stephanie Phair appointed Chair of New Guards Group (NGG); retains her role as Group President, FARFETCH
  • NGG co-founders Davide De Giglio and Andrea Grilli step down from their roles nearly four years after FARFETCH’s acquisition of NGG

LONDON & MILAN–(BUSINESS WIRE)–
FARFETCH, the leading global platform for the luxury fashion industry, today announced that Cristiano Fagnani has been named CEO of Off-White and also remains responsible for NGG’s Reebok business as CEO of NGG++.

Stephanie Phair has been appointed Chair of NGG. The company also announced that NGG CEO, Davide De Giglio, along with his co-founder, Executive Director and Off-White CEO, Andrea Grilli, are stepping down from their roles. The existing leadership team for Palm Angels remains unchanged; with Stefano Robino as General Manager and Francesco Ragazzi as Founder and Creative Director. The leadership of the other NGG brands remains unchanged as well.

Founded in 2015 and based in Milan, NGG manages the design, production and distribution for a range of global brands, including Palm Angels, Off-White and Reebok. It was acquired by FARFETCH in 2019.

Mr. Fagnani has over 20 years of industry experience, including as Chief Marketing Officer for NGG where he worked closely with Off-White. Prior to joining NGG more than three years ago, he had a highly successful career at Nike, where he led Energy Marketing, Brand Experience and Product Collaborations.

Stefano Robino has more than two decades of experience in the luxury fashion industry, having held senior roles with brands including Ami, Tom Ford, Zegna and Lanvin, prior to joining NGG more than three years ago. Under Mr. Robino’s leadership, the Palm Angels brand more than doubled its revenues from 2020 to 2022.

Ms. Phair, who has been working closely with the NGG Group, including as a member of the operational boards for the NGG brands, will support the NGG leadership team toward achieving the goals set out for the business and foster the continued successful integration with the FARFETCH Group. She maintains her role as Group President, FARFETCH. A seasoned luxury executive, she founded TheOutnet.com while an executive at Net-a-Porter, and has held roles with Issey Miyake and Vogue. Previously, the multi-lingual Ms. Phair also served on the Board of Directors for Moncler S.p.A., and was the Chair of the British Fashion Council.

José Neves, Founder, CEO and Chair, FARFETCH, said:

“New Guards has performed extremely well since 2019, and has continued to execute on its strategy with the recent launch of Reebok. I would like to thank Davide and Andrea for their dedicated leadership over the past four years, and for building a very strong team of successors to continue driving the strategy and operations of NGG. They leave with my fondest best wishes for their future endeavours. With a very experienced management team in Cristiano, Ib, Stefano and Francesco and the added benefit of Stephanie’s oversight, I am confident in the continued success of NGG.”

Davide De Giglio said:

“As the co-founder of NGG, I take this moment to reflect on the remarkable decade that has transpired since the inception of our platform. This journey, filled with challenges, learnings, and victories, has been nothing short of extraordinary. From an initial idea to a leading light in the fashion world, NGG’s evolution has been one of the most fulfilling experiences of my life. We’ve been a symbol of innovation, creativity, and independence, setting trends and collaborating with phenomenal talent. We are indebted to FARFETCH, who recognized our potential and backed our ambitions. Their acquisition has not just fostered our growth but has also ensured our global presence and influence.

Today, after a beautiful ten-year journey, I step down from my position at NGG. My heart is filled with gratitude for the opportunities I have been given, the extraordinary individuals I had the privilege to work with, and the collective successes we achieved. I leave behind a resilient, dynamic, and robust group that I’m confident will continue to flourish and uphold our shared vision. I look forward with excitement to seeing where the next decade will take NGG.”

Andrea Grilli said:

“Nine years, more than 800 employees, over 70 stores, customers in more than 100 countries and over 170 collaborations and capsule collections. Behind these numbers are endless emotions that can’t really be summed up in a few lines. Contributing to the development of NGG by helping the brands gain global visibility and respect in the luxury industry since day one is a priceless experience because it highlights all the efforts made by the wonderful people who I’ve had the good fortune to work with.

NGG, today more than ever and thanks to the involvement and support of FARFETCH, is in an incredible position. I wish them and the team all the best and will carry this experience with me forever.”

ENDS

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the future operational and financial performance of our New Guards Group business, as well as statements that include the words “expect,” “plan,” “aim,” “enable,” “believe,” or the negative of these terms and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to the important factors discussed under the caption “Risk Factors” in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (“SEC”) for the fiscal year ended December 31, 2022, as such factors may be updated from time to time in our other filings with the SEC, accessible on the SEC’s website at www.sec.gov and on our website at http://farfetchinvestors.com. In addition, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements that we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. In addition, the forward-looking statements made in this release relate only to events or information as of the date on which the statements are made in this release. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.

About FARFETCH

Farfetch Limited is the leading global platform for the luxury fashion industry. Founded in 2007 by José Neves for the love of fashion, and launched in 2008, Farfetch began as an e-commerce marketplace for luxury boutiques around the world. Today, the Farfetch Marketplace connects customers in over 190 countries and territories with items from more than 50 countries and over 1,400 of the world’s best brands, boutiques and department stores, delivering a truly unique shopping experience and access to the most extensive selection of luxury on a global platform. Farfetch’s additional businesses include Browns and Stadium Goods, which offer luxury products to consumers, and New Guards Group, a platform for the development of global fashion brands. Farfetch offers its broad range of consumer-facing channels and enterprise level solutions to the luxury industry under its Luxury New Retail initiative. The Luxury New Retail initiative also encompasses Farfetch Platform Solutions, which services enterprise clients with e-commerce and technology capabilities, and Future Retail, which develops innovations such as our Connected Retail solutions.

For more information, please visit www.farfetchinvestors.com.

Media Contacts:

Susannah Clark

EVP Communications, FARFETCH Limited

[email protected]

+44 7788 405224

Brunswick Group

[email protected]

US: +1 (212) 333 3810

UK: +44 (0) 207 404 5959

Investor Relations Contact:

Alice Ryder

VP Investor Relations, FARFETCH Limited

[email protected]

KEYWORDS: Europe United Kingdom Italy

INDUSTRY KEYWORDS: Fashion Online Retail Retail Luxury Technology Electronic Commerce

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Bausch + Lomb Announces Key Leadership Changes

Bausch + Lomb Announces Key Leadership Changes

VAUGHAN, Ontario–(BUSINESS WIRE)–
Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb” or the “Company”), a leading global eye health company dedicated to helping people see better to live better, announced a reshaping of its executive leadership team, including the elevation of all business unit heads. Luc Bonnefoy, senior vice president (SVP), Surgical; John Ferris, SVP, Consumer; and Yang Yang, SVP, Vision Care; will join the executive management team of the Company reporting directly to Brent Saunders, chairman and CEO. Concurrent with this change, Joseph Gordon, president, Global Consumer, Surgical and Vision Care, will transition to the role of Strategic Advisor to Saunders. Additionally, Louis Yu, Ph.D., executive vice president (EVP) and Chief Quality Officer, has notified Bausch + Lomb of his intent to retire later this summer, and the Company will commence an internal and external search for his replacement.

“I rejoined Bausch + Lomb because I am confident that we can build upon our 170-year legacy of innovative eye health products and bring forward the next generation of solutions to meet the ever-changing eye care needs of patients globally. With these changes to the executive management team, our leaders will be closer to customers and patients, which will set the stage for accelerated growth and propel Bausch + Lomb toward a highly competitive, efficient and effective future,” said Saunders. “The next chapter of Bausch + Lomb is built upon the efforts of the strong business unit leadership we’ve had for the past several years.”

“I’d also like to express my deep gratitude to Joe Gordon and Louis Yu. Under Joe’s leadership, the Company has built a broad and diverse commercial platform across many geographies, and we are fortunate to have his continued expertise in his new role. I also want to thank Louis for the vast contributions he has made throughout his entire career to ensure patients all around the world receive top-quality health care products and solutions,” continued Saunders.

About Bausch + Lomb

Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on Twitter, LinkedIn, Facebook and Instagram.

Forward-looking Statements

This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “will,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties associated with our ability to attract, retain and motivate our executives and other key employees and the plans and objectives of the new executive leadership team. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

© 2023 Bausch + Lomb.

Investor Contacts

Allison Ryan

[email protected]

(877) 354-3705 (toll free)

(908) 927-0735

Media Contacts:

Lainie Keller

(908) 927-1198

[email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Medical Supplies Medical Devices Health Surgery Pharmaceutical Optical

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Xeris Biopharma to Participate at the Jefferies Healthcare Conference

Xeris Biopharma to Participate at the Jefferies Healthcare Conference

CHICAGO–(BUSINESS WIRE)–
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies, today announced that members of its senior management will participate in a fireside chat at the Jefferies Healthcare Conference on Thursday, June 8 at 10:30am Eastern Time.

A live webcast of the event will be available on the ‘Events & Presentations’ section of Xeris’ Investor Relations website at https://xerispharma.com/investor-relations or https://wsw.com/webcast/jeff281/xers/1879020. A replay of the webcast will be available for 60 days.

About Xeris

Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and innovative products across a range of therapies. Xeris has three commercially available products: Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; Keveyis®, a proven therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris has a pipeline of development and partnered programs using its formulation sciences, XeriSol™ and XeriJect™, to support long-term product development and commercial success.

Xeris is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow Xeris on Twitter, LinkedIn or Instagram.

Investor Contact

Allison Wey

Senior Vice President, Investor Relations and Corporate Communications

[email protected]

KEYWORDS: United States North America Illinois

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health Clinical Trials

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All-Electric Fisker Ocean Extreme Achieves EPA Range of 360 Miles, the Longest of Any New Electric SUV Under $200,000 Sold in the United States Today

All-Electric Fisker Ocean Extreme Achieves EPA Range of 360 Miles, the Longest of Any New Electric SUV Under $200,000 Sold in the United States Today

  • Fisker achieves an EPA estimated total range of 360 miles for the all-electric Fisker Ocean Extreme on 20” wheels, exceeding Fisker’s previous estimates

  • EPA values confirm the Fisker Ocean Extreme has the longest range of any new electric SUV under $200,000 sold in the United States today

  • Following European certification of WLTP 707 km / 440 UK mile range, the Fisker Ocean Extreme has the longest range of any electric SUV sold in Europe today

  • Fisker Ocean Extreme receives EPA Certificate of Conformity and California Air Resources Board Executive Order, approving it for sale and delivery in the US

  • CARB Executive Order grants the Fisker Ocean Extreme the maximum 4.0 Zero-Emission Vehicle credits per vehicle sold

  • Customers can configure their Fisker Ocean directly via the Fisker website

LOS ANGELES–(BUSINESS WIRE)–Fisker Inc. (NYSE: FSR) (“Fisker”), driven by a mission to create the world’s most emotional and sustainable electric vehicles, announces that as of May 31, the all-electric Fisker Ocean Extreme has an Environmental Protection Agency (“EPA”) estimated total range of 360 miles1 on standard 20” wheels and tires, exceeding Fisker’s previous estimates.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230601005463/en/

Fisker Inc. driven by a mission to create the world's most emotional and sustainable electric vehicles, announces that as of May 31, the all-electric Fisker Ocean Extreme has an Environmental Protection Agency (“EPA”) estimated total range of 360 miles on standard 20” wheels and tires, exceeding Fisker’s previous estimates. The EPA values confirm that the Fisker Ocean Extreme, including the limited edition Fisker Ocean One, has the longest range of any new electric SUV under $200,000 sold in the United States today. This news follows the Fisker Ocean Extreme’s recent European WLTP certification of 707 km / 440 UK mile range on standard 20” wheels and tires, which is the longest range of any electric SUV sold in Europe today. Image credit: Fisker Inc.

Fisker Inc. driven by a mission to create the world’s most emotional and sustainable electric vehicles, announces that as of May 31, the all-electric Fisker Ocean Extreme has an Environmental Protection Agency (“EPA”) estimated total range of 360 miles on standard 20” wheels and tires, exceeding Fisker’s previous estimates. The EPA values confirm that the Fisker Ocean Extreme, including the limited edition Fisker Ocean One, has the longest range of any new electric SUV under $200,000 sold in the United States today. This news follows the Fisker Ocean Extreme’s recent European WLTP certification of 707 km / 440 UK mile range on standard 20” wheels and tires, which is the longest range of any electric SUV sold in Europe today. Image credit: Fisker Inc.

The EPA values confirm that the Fisker Ocean Extreme, including the limited edition Fisker Ocean One, has the longest range of any new electric SUV under $200,000 sold in the United States today.

This news follows the Fisker Ocean Extreme’s recent European WLTP certification of 707 km / 440 UK mile range on standard 20” wheels and tires2, which is the longest range of any electric SUV sold in Europe today.

The Fisker Ocean Extreme has also received both an EPA Certificate of Conformity and a California Air Resources Board (CARB) Executive Order (EO), approving the Fisker Ocean Extreme for sale and delivery in all 50 US states and the District of Columbia.

“A lot of hard work went into achieving these results, and it feels great to give our customers a better range than we had estimated. Delivering an EPA 360 mile range in the US and WLTP 707 km range in Europe gives our drivers what they want: a fantastic 5-passenger vehicle, and the confidence they’re driving the electric SUV with the longest range available in an affordable new vehicle,” CEO Henrik Fisker said.

“This is a huge milestone for everyone at Fisker,” he continued. “We are looking forward to getting Oceans to customers in the US, and we plan to send out communications today to our first customers.”

The CARB Executive Order grants the Fisker Ocean Extreme the maximum 4.0 Zero-Emission Vehicle credits per vehicle sold. The Fisker Ocean Extreme recently completed all applicable FMVSS testing required for US National Highway Traffic Safety Administration (NHTSA) self-certification and meets New Car Assessment Program (NCAP) standards for a 5-star rating. The Fisker Ocean Extreme has been certified by European authorities for sale in Europe.

The Fisker Ocean Extreme equipped with optional 22” wheels and tires also achieved a WLTP 701 km / 436 UK mile range3, demonstrating that performance wheels and tires have minimal effect on the Fisker Ocean’s range.

The first Fisker Ocean customer took delivery in Denmark on May 5. Deliveries are expected to begin in the United States in June.

As part of Fisker’s mission to create the most sustainable SUV on Earth, the Fisker Ocean Extreme combines its 113kWh Hyper Range battery pack, optimized engineering, and aerodynamic design to produce a powerful, efficient, and responsive SUV with an EPA estimated range to drive from Philadelphia to Boston or Los Angeles to San Jose.

The Fisker Ocean all-electric SUV combines ingenious engineering, innovation, affordability, and sustainability in three versions: Extreme, Ultra, and Sport, with some trims sold out in several launch markets. The Fisker Ocean also recently won the 2023 Red Dot Product Design Award for Best Electric Vehicle.

Shoppers can reserve and configure the Fisker Ocean via the Fisker website.

About Fisker Inc.

California-based Fisker Inc. is revolutionizing the automotive industry by designing and developing individual mobility in alignment with nature. Passionately driven by a vision of a clean future for all, the company is on a mission to create the world’s most sustainable and emotional electric vehicles. To learn more, visit Fiskerinc.com and enjoy exclusive content across Fisker’s social media channels: Facebook, Instagram, Twitter, YouTube, and LinkedIn.

Download the revolutionary new Fisker mobile app from the App Store or Google Play.

Forward-Looking Statements

This press release includes forward-looking statements, which are subject to the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “feel,” “believes,” “expects,” “estimates,” “projects,” “intends,” “should,” “is to be,” or the negative of such terms, or other comparable terminology and include, among other things, the quotation of our CEO, the statements regarding the planned launch timing, pricing, delivery, and estimated range of the Fisker Ocean, the planned timing of the opening of Fisker facilities, the Company’s future performance, and other future events that involve risks and uncertainties. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, which could cause actual results to differ materially from the forward-looking statements contained herein due to many factors, including, but not limited to: Fisker’s limited operating history; Fisker’s ability to enter into additional manufacturing and other contracts with Magna or tier-one suppliers in order to execute on its business plan; the risk that OEM and supply partners do not meet agreed-upon timelines or experience capacity constraints; Fisker may experience significant delays in the design, manufacture, regulatory approval, launch and financing of its vehicles; Fisker’s ability to execute its business model, including market acceptance of its planned products and services; Fisker’s inability to retain key personnel and to hire additional personnel; competition in the electric vehicle market; Fisker’s inability to develop a sales distribution network; and the ability to protect its intellectual property rights; and those factors discussed in Fisker’s Annual Report on Form 10-K, under the heading “Risk Factors”, filed with the Securities and Exchange Commission (the “SEC”), as supplemented by Quarterly Reports on Form 10-Q, and other reports and documents Fisker files from time to time with the SEC. Any forward-looking statements speak only as of the date on which they are made, and Fisker undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release.

1 EPA estimated range. Actual results may vary for many reasons, including driving conditions, wheel size, state of battery charge, and how the vehicle is driven and maintained.

2 This WLTP range number applies to Fisker’s European markets. WLTP measurements conducted on Fisker Ocean Extreme with standard 20” and optional 22” wheels. Actual range will vary with conditions such as external environment, vehicle configuration, wheel size and diameter, and vehicle use.

3 This WLTP range number applies to Fisker’s European markets. WLTP measurements conducted on Fisker Ocean Extreme with standard 20” and optional 22” wheels. Actual range will vary with conditions such as external environment, vehicle configuration, wheel size and diameter, and vehicle use.

European Media:

[email protected]

US Media

[email protected]

Customer service: [email protected]

Fisker Inc. Communications:

Matthew DeBord

Sr Director, Communications Strategy & Storytelling

[email protected]

Franziska Queling

Regional Head of Public Relations Europe

[email protected]

Investor Relations:

Frank Boroch, VP of Investor Relations

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: General Automotive EV/Electric Vehicles Automotive Alternative Vehicles/Fuels

MEDIA:

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Fisker Inc. driven by a mission to create the world’s most emotional and sustainable electric vehicles, announces that as of May 31, the all-electric Fisker Ocean Extreme has an Environmental Protection Agency (“EPA”) estimated total range of 360 miles on standard 20” wheels and tires, exceeding Fisker’s previous estimates. The EPA values confirm that the Fisker Ocean Extreme, including the limited edition Fisker Ocean One, has the longest range of any new electric SUV under $200,000 sold in the United States today. This news follows the Fisker Ocean Extreme’s recent European WLTP certification of 707 km / 440 UK mile range on standard 20” wheels and tires, which is the longest range of any electric SUV sold in Europe today. Image credit: Fisker Inc.
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LYNPARZA® (olaparib)plus abiraterone approved in the US for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer

LYNPARZA® (olaparib)plus abiraterone approved in the US for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer

LYNPARZA combination reduced the risk of disease progression or death by 76% vs. abiraterone alone

First PARP inhibitor approved in combination with a novel hormonal agent underscores clinically meaningful benefit of new treatment approach

WILMINGTON, Del.–(BUSINESS WIRE)–
AstraZeneca and Merck & Co., Inc’s, known as MSD outside the US and Canada, LYNPARZA®(olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

This approval was based on a subgroup analysis of the Phase III PROpel trial which showed that LYNPARZAplus abiraterone demonstrated highly clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR of 0.24, 95% CI, 0.12-0.45) and overall survival (OS) (HR of 0.30, 95% CI, 0.15-0.59) versus abiraterone alone in patients with BRCA mutations.1 Median rPFS and median OS were not reached for patients treated with LYNPARZAplus abiraterone versus a median of 8 months and 23 months, respectively, for those treated with abiraterone alone.

Prostate cancer is the second-most common cancer in men and despite an increase in the number of available therapies for patients with mCRPC, five-year survival remains low.2,3 Approximately 10% of patients with mCRPC have BRCA mutations, which is associated with poor prognosis and outcomes.4,5

Andrew Armstrong, MD, ScM, of the Duke Cancer Institute, Durham, North Carolina, US, and an investigator in the trial, said: “Preventing or delaying radiographic progression or death is an important clinical endpoint in assessing cancer treatment and is very important to patients, their caregivers, and their families. The PROpel results showed the LYNPARZAcombination demonstrated a notable clinically meaningful benefit that should rapidly be considered as the standard of care treatment for patients with BRCA-mutated metastatic castration-resistant prostate cancer.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “There is a critical unmet need for new first-line treatment options for patients with BRCA-mutated metastatic castration-resistant prostate cancer and this approval underscores the importance of BRCA testing at metastatic diagnosis. We look forward to bringing the benefit of this LYNPARZAcombination to patients earlier in their treatment.”

Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, MSD Research Laboratories, said: “It is imperative that we create new ways to treat advanced cancers and help improve patient outcomes by building on the current standard of care. In PROpel, the LYNPARZAcombination improved radiographic progression-free survival and overall survival for the subgroup of patients with BRCA-mutated metastatic castration-resistant prostate cancer. This approval reinforces the importance of routine testing for genetic mutations at metastatic diagnosis to help guide clinical decisions.”

The safety and tolerability profile of LYNPARZA plus abiraterone in PROpel was in line with that observed in prior clinical trials and the known profiles of the individual medicines.

LYNPARZA in combination with abiraterone and prednisone or prednisolone is approved in the European Union (EU) and several other countries for the treatment of adult patients with mCRPC based on the PROpel trial.

LYNPARZA is already approved in the US based on results from the PROfound Phase III trial as monotherapy for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCAm and other HRR gene mutations) who have progressed following prior treatment with enzalutamide or abiraterone; and in the EU, Japan, and China for patients with BRCAm mCRPC who have progressed following prior therapy that included a novel hormonal agent.

Financial considerations

Following this approval for LYNPARZA in the US, AstraZeneca will receive a regulatory milestone payment from Merck & Co, anticipated to be booked as Collaboration Revenue by the Company and confirmed in the second quarter 2023 results.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome. The median duration of therapy in patients who developed MDS/AML was 2 years (range: <6 months to >10 years). All of these patients had previous chemotherapy with platinum agents and/or other DNA-damaging agents, including radiotherapy.

Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤Grade 1). Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities, interrupt LYNPARZA and monitor blood count weekly until recovery.

If the levels have not recovered to Grade 1 or less after 4 weeks, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.

Pneumonitis: Occurred in 0.8% of patients exposed to LYNPARZA monotherapy, and some cases were fatal. If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation. Discontinue LYNPARZA if pneumonitis is confirmed and treat patient appropriately.

Venous Thromboembolism (VTE): Including severe or fatal pulmonary embolism (PE) occurred in patients treated with LYNPARZA. In the combined data of two randomized, placebo-controlled clinical studies (PROfound and PROpel) in patients with metastatic castration-resistant prostate cancer (N=1180), VTE occurred in 8% of patients who received LYNPARZA, including pulmonary embolism in 6%. In the control arms, VTE occurred in 2.5%, including pulmonary embolism in 1.5%. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism, and treat as medically appropriate, which may include long-term anticoagulation as clinically indicated.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm. Verify pregnancy status in females of reproductive potential prior to initiating treatment.

Females

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months following the last dose.

Males

Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months following the last dose of LYNPARZA and to not donate sperm during this time.

ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), urinary tract infection (13%), thrombocytopenia (11%), and stomatitis (11%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for SOLO-1 were: decrease in hemoglobin (87%), increase in mean corpuscular volume (87%), decrease in leukocytes (70%), decrease in lymphocytes (67%), decrease in absolute neutrophil count (51%), decrease in platelets (35%), and increase in serum creatinine (34%).

ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian Cancer in Combination with Bevacizumab

Most common adverse reactions (Grades 1-4) in ≥10% of patients treated with LYNPARZA/bevacizumab and at a ≥5% frequency compared to placebo/bevacizumab in the first-line maintenance setting for PAOLA-1 were: nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia (24%), vomiting (22%), and leukopenia (18%). In addition, the most common adverse reactions (≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were: diarrhea (18%), neutropenia (18%), urinary tract infection (15%), and headache (14%).

In addition, venous thromboembolic events occurred more commonly in patients receiving LYNPARZA/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients for LYNPARZA in combination with bevacizumab in the first-line maintenance setting for PAOLA-1 were: decrease in hemoglobin (79%), decrease in lymphocytes (63%), increase in serum creatinine (61%), decrease in leukocytes (59%), decrease in absolute neutrophil count (35%), and decrease in platelets (35%).

ADVERSE REACTIONS—Maintenance Recurrent Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the maintenance setting for SOLO-2 were: nausea (76%), fatigue (including asthenia) (66%), anemia (44%), vomiting (37%), nasopharyngitis/upper respiratory tract infection (URI)/influenza (36%), diarrhea (33%), arthralgia/myalgia (30%), dysgeusia (27%), headache (26%), decreased appetite (22%), and stomatitis (20%).

Study 19: nausea (71%), fatigue (including asthenia) (63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory tract infection (22%), constipation (22%), headache (21%), decreased appetite (21%), and dyspepsia (20%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the maintenance setting (SOLO-2/Study 19) were: increase in mean corpuscular volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease in absolute neutrophil count (51%/47%), increase in serum creatinine (44%/45%), and decrease in platelets (42%/36%).

ADVERSE REACTIONS—Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: nausea (57%), fatigue (including asthenia) (42%), anemia (24%), vomiting (23%), headache (20%), diarrhea (18%), leukopenia (17%), neutropenia (16%), decreased appetite (13%), dysgeusia (12%), dizziness (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the adjuvant setting for OlympiA were: decrease in lymphocytes (77%), increase in mean corpuscular volume (67%), decrease in hemoglobin (65%), decrease in leukocytes (64%), and decrease in absolute neutrophil count (39%).

ADVERSE REACTIONS—gBRCAm, HER2-Negative Metastatic Breast Cancer

Most common adverse reactions (Grades 1-4) in ≥20% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: nausea (58%), anemia (40%), fatigue (including asthenia) (37%), vomiting (30%), neutropenia (27%), respiratory tract infection (27%), leukopenia (25%), diarrhea (21%), and headache (20%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the metastatic setting for OlympiAD were: decrease in hemoglobin (82%), decrease in lymphocytes (73%), decrease in leukocytes (71%), increase in mean corpuscular volume (71%), decrease in absolute neutrophil count (46%), and decrease in platelets (33%).

ADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic Pancreatic Adenocarcinoma

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: fatigue (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA in the first-line maintenance setting for POLO were: increase in serum creatinine (99%), decrease in hemoglobin (86%), increase in mean corpuscular volume (71%), decrease in lymphocytes (61%), decrease in platelets (56%), decrease in leukocytes (50%), and decrease in absolute neutrophil count (25%).

ADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA for PROfound were: anemia (46%), fatigue (including asthenia) (41%), nausea (41%), decreased appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia (12%), cough (11%), and dyspnea (10%).

Most common laboratory abnormalities (Grades 1-4) in ≥25% of patients who received LYNPARZA for PROfound were: decrease in hemoglobin (98%), decrease in lymphocytes (62%), decrease in leukocytes (53%), and decrease in absolute neutrophil count (34%).

ADVERSE REACTIONS—Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA/abiraterone with a difference of ≥5% compared to placebo for PROpel were: anemia (48%), fatigue (including asthenia) (38%), nausea (30%), diarrhea (19%), decreased appetite (16%), lymphopenia (14%), dizziness (14%), and abdominal pain (13%).

Most common laboratory abnormalities (Grades 1-4) in ≥20% of patients who received LYNPARZA/abiraterone for PROpel were: decrease in hemoglobin (97%), decrease in lymphocytes (70%), decrease in platelets (23%), and decrease in absolute neutrophil count (23%).

DRUG INTERACTIONS

Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment.

CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA.

USE IN SPECIFIC POPULATIONS

Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose.

Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients.

Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child-Pugh classification C).

Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min).

INDICATIONS

LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

First-Line Maintenance BRCAm Advanced Ovarian Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance HRD-Positive Advanced Ovarian Cancer in Combination with Bevacizumab

In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:

  • a deleterious or suspected deleterious BRCA mutation, and/or

  • genomic instability

Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Maintenance Recurrent Ovarian Cancer

For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

Adjuvant Treatment of gBRCAm, HER2-Negative, High-Risk Early Breast Cancer

For the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

gBRCAm, HER2-Negative Metastatic Breast Cancer

For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

First-Line Maintenance gBRCAm Metastatic Pancreatic Cancer

For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

BRCAm Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

In combination with abiraterone and prednisone or prednisolone (abi/pred) for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Please see complete Prescribing Information, including Medication Guide.

Notes

Prostate cancer

Prostate cancer is the second most commonly diagnosed cancer in men and the fifth leading cause of cancer death in men globally, with an incidence of 1.4 million and 375,000 deaths in 2020.2,3 In the US, it is estimated that there will be 288,300 new cases and 34,700 deaths in 2023.6 Overall survival for patients with mCRPC is approximately three years in clinical trial settings, and even shorter in the real-world.7 Approximately half of patients with mCRPC may receive only one line of active treatment, and those that go on to receive further treatment often have diminishing benefit of subsequent therapies.8-13

Metastatic castration-resistant prostate cancer

Metastatic prostate cancer is associated with a significant mortality rate.14 Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone.15

In patients with mCRPC, their prostate cancer grows and spreads to other parts of the body despite the use of androgen-deprivation therapy to block the action of male sex hormones.16 Approximately 10-20% of men with advanced prostate cancer will develop castration-resistant prostate cancer (CRPC) within five years, and at least 84% of these men will have metastases at the time of CRPC diagnosis.17 Of patients with no metastases at CRPC diagnosis, 33% are likely to develop metastases within two years.17

Despite the advances in mCRPC treatment in the past decade with taxane and novel hormonal agent (NHA) treatment, there is high unmet need in this population.16-19

PROpel

PROpel is a randomized, double-blind, multi-center Phase III trial testing the efficacy, safety, and tolerability of LYNPARZAversus placebo when given in combination with abiraterone, as well as prednisone or prednisolone, in men with mCRPC who had not received prior chemotherapy or NHAs in the mCRPC setting.

The primary endpoint is rPFS and secondary endpoints include OS, time to secondary progression or death, and time to first subsequent therapy. In September 2021 at a planned interim analysis, the Independent Data Monitoring Committee concluded that the PROpel trial met the primary endpoint of rPFS.

For more information about the trial please visit ClinicalTrials.gov.

LYNPARZA

LYNPARZA® (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumors harboring a deficiency in HRR, such as those with mutations in BRCA1 and/or BRCA2, or those where deficiency is induced by other agents (such as NHAs).

Inhibition of PARP with LYNPARZA leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death.

LYNPARZA is currently approved in a number of countries across multiple tumor types including maintenance treatment of platinum-sensitive relapsed ovarian cancer and as both monotherapy and in combination with bevacizumab for the 1st-line maintenance treatment of BRCA-mutated (BRCAm) and homologous recombination repair deficient (HRD)-positive advanced ovarian cancer, respectively; for gBRCAm, HER2-negative metastatic breast cancer (in the EU and Japan this includes locally advanced breast cancer); for gBRCAm, HER2-negative high-risk early breast cancer (in Japan this includes all BRCAm HER2-negative high-risk early breast cancer); for gBRCAm metastatic pancreatic cancer; in combination with abiraterone for the treatment of metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated (EU) and as monotherapy in HRR gene-mutated metastatic castration-resistant prostate cancer in patients who have progressed on prior NHA treatment (BRCAm only in the EU and Japan). In China, LYNPARZA is approved for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer, as a 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer as well as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer.

LYNPARZA, which is being jointly developed and commercialized by AstraZeneca and Merck & Co., Inc., known as MSD outside the US and Canada, has been used to treat over 75,000 patients worldwide. LYNPARZA has a broad clinical trial development program, and AstraZeneca and Merck are working together to understand how it may affect multiple PARP-dependent tumors as a monotherapy and in combination across multiple cancer types. LYNPARZA is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

The AstraZeneca and Merck strategic oncology collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialize LYNPARZA, the world’s first PARP inhibitor, and KOSELUGO® (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types.

Working together, the companies will develop LYNPARZA and KOSELUGO and other potential new medicines as monotherapies and as combinations. The companies will also develop LYNPARZA and KOSELUGO in combination with their respective PD-L1 and PD-1 medicines independently.

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

References

  1. Clarke N, et al. Abiraterone and Olaparib for Metastatic Castration-Resistant Prostate Cancer. NEJM Evid. 2022;1(9).

  2. Cancer.Net. Prostate Cancer: Statistics. Available at https://www.cancer.net/cancer-types/prostate-cancer/statistics. Accessed March 2023.

  3. Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019; 10(2):63-89.

  4. de Bono, et al. Central, Prospective Detection of Homologous Recombination Repair Gene Mutations (HRRm) in Tumour Tissue From >4000 Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Screened for the PROfound Study. Presented at: ESMO Congress; September 27-October 1, 2019; Barcelona, Spain. Abstract 847PD

  5. Na R, et al. Germline Mutations in ATM and BRCA1/2 Distinguish Risk for Lethal and Indolent Prostate Cancer and are Associated with Early Age at Death. Eur Urol. 2017;71(5):740-747.

  6. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021; 71(3):209-249.

  7. Cancer.Org. Key Statistics For Prostate Cancer. Available at https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Accessed March 2023.

  8. Ng K, et al. Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Advances and Treatment Strategies in the First-Line Setting. Oncol Ther. 2020;8:209–230.

  9. George DJ, et al. Treatment Patterns and Outcomes in Patients with Metastatic Castration-Resistant Prostate Cancer in a Real-World Clinical Practice Setting in the United States. Clin Genitourin Cancer. 2020;18:284-294.

  10. de Bono J, et al. Antitumour Activity and Safety of Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate Plus Prednisone for ≥24 weeks in Europe. Eur Urol. 2018;74(1):37-45

  11. Hussein M, et al. Prostate-Specific Antigen Progression Predicts Overall Survival in Patients with Metastatic Prostate Cancer: Data from Southwest Oncology Group Trials 9346 (Intergroup Study 0162) and 9916. J Clin Oncol. 2009;27(15):2450.

  12. de Wit, R, et al. Real-World Evidence of Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Cabazitaxel: Comparison with the Randomized Clinical Study CARD. Prostate Cancer Prostatic Dis. 2022;2660.

  13. Ryan C, et al. Abiraterone Acetate Plus Prednisone Versus Placebo Plus Prednisone in Chemotherapy-Naive Men with Metastatic Castration-Resistant Prostate Cancer (COU-AA-302): Final Overall Survival Analysis of a Randomised, Double-Blind, Placebo-Controlled Phase 3 Study. Lancet Oncol. 2015 Feb;16(2):152-60.

  14. Miller K, et al. The Phase 3 COU-AA-302 Study of Abiraterone Acetate Plus Prednisone in Men with Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer: Stratified Analysis Based on Pain, Prostate-Specific Antigen, and Gleason Score. Eur Urol. 2018;74(1):17-23.

  15. Chowdhury S, et al. Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry. Target Oncol. 2020;15(3):301-315.

  16. Cancer.Net. Treatment of Metastatic Castration-Resistant Prostate Cancer. Available at https://www.cancer.net/cancer-types/prostate-cancer/types-treatment. Accessed March 2023.

  17. Kirby M, et al. Characterising the Castration-Resistant Prostate Cancer Population: Systematic Review. Int J of Clin Pract. 2021;65(11):1180-1192.

  18. UroToday. What is Changing in Advanced Prostate Cancer? Available at https://www.urotoday.com/journal/everyday-urology-oncology-insights/articles/122176-what-is-changing-in-advanced-prostate-cancer.html. Accessed March 2023.

  19. Liu J, et al. Second-Line Hormonal Therapy for the Management of Metastatic Castration-Resistant Prostate Cancer: A Real-World Data Study Using a Claims Database. Sci Rep. 2020;10(1):4240.

 US-63536  Last Updated 6/23

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New Jersey Natural Gas Files Annual Rate Adjustments With the New Jersey Board of Public Utilities

New Jersey Natural Gas Files Annual Rate Adjustments With the New Jersey Board of Public Utilities

Filings to Reduce Overall Bills for Residential Heating Customers by 1.7%

WALL, N.J.–(BUSINESS WIRE)–
New Jersey Natural Gas (NJNG), a regulated subsidiary of New Jersey Resources (NYSE: NJR), today filed its annual Basic Gas Supply Service (BGSS) and Conservation Incentive Program (CIP) rates with the New Jersey Board of Public Utilities (BPU). Separately, NJNG also filed to recover costs associated with its energy-efficiency (EE) programs. The overall impact of these filings is a decrease of 1.7% for residential heating customers purchasing their supply from NJNG.

“New Jersey Natural Gas is dedicated to providing safe, reliable natural gas service at a reasonable price,” said Patrick Migliaccio, senior vice president and COO of New Jersey Natural Gas. “Our team works hard to manage supply costs, and we are pleased to pass these savings on to our customers.”

In its filings, NJNG is seeking to reduce its BGSS and Balancing Charge, resulting in a 5.9% reduction to a typical residential heating customer’s bill. The decrease is driven by lower market prices and savings generated by the company’s supply management strategies. This decrease is partially offset by a 3.1% increase related to the CIP due to the warm weather and lower usage experienced this past heating season. In its other filing, NJNG is also seeking a 1% increase to recover costs associated with the annual investment in its energy-efficiency programs. The net effect of these filings is an overall decrease of 1.7%, or $26.20, for the typical residential heating customers using 1000 therms annually.

The BGSS and Balancing Charge recover the cost of natural gas supply used to serve its customers and balance deliveries with customer usage. The BGSS is a pass through to customers. Any change to this rate does not result in a change in profits for the company. The CIP helps normalize year-to-year fluctuation from changing weather and usage patterns on both customers’ bills and NJNG’s financial margins. Weather in NJNG’s service territory this past heating season was 14.2% warmer-than-normal with January through February 2023 being 26.5% warmer-than-normal.

This latest decrease comes on top of the savings NJNG provided customers in March 2023. Due to a decline in wholesale prices at the time, NJNG was able to lower its BGSS rate and provide a one-time bill credit for residential and small commercial customers, resulting in a decrease of approximately 8% on the annual bill for the typical residential heating customer using 1000 therms a year. NJNG continues to monitor market conditions to look for opportunities that benefit its customers.

Pending BPU approval, NJNG’s current proposed rate adjustments would take effect October 1, 2023.

About New Jersey Resources

New Jersey Resources (NYSE: NJR) is a Fortune 1000 company that, through its subsidiaries, provides safe and reliable natural gas and clean energy services, including transportation, distribution, asset management and home services. NJR is composed of five primary businesses:

  • New Jersey Natural Gas, NJR’s principal subsidiary,operates and maintains over 7,700 miles of natural gas transportation and distribution infrastructure to serve over 570,000 customers in New Jersey’s Monmouth, Ocean and parts of Morris, Middlesex, Sussex and Burlington counties.
  • Clean Energy Ventures invests in, owns and operates solar projects with a total capacity of approximately 440 megawatts, providing residential and commercial customers with low-carbon solutions.
  • Energy Services manages a diversified portfolio of natural gas transportation and storage assets and provides physical natural gas services and customized energy solutions to its customers across North America.
  • Storage and Transportation serves customers from local distributors and producers to electric generators and wholesale marketers through its ownership of Leaf River and the Adelphia Gateway Pipeline, as well as our 50% equity ownership in the Steckman Ridge natural gas storage facility.
  • Home Services provides service contracts as well as heating, central air conditioning, water heaters, standby generators, solar and other indoor and outdoor comfort products to residential homes throughout New Jersey.

NJR and its over 1,300 employees are committed to helping customers save energy and money by promoting conservation and encouraging efficiency through Conserve to Preserve® and initiatives such as The SAVEGREEN Project® and The Sunlight Advantage®.

For more information about NJR:

Visit www.njresources.com.

Follow us on Twitter @NJNaturalGas.

“Like” us on facebook.com/NewJerseyNaturalGas.

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Orthofix Announces First Presentation of Seven-Year Outcome Data for the M6-C Artificial Cervical Disc With Other Clinical and Scientific Abstracts at the ISASS Annual Meeting

Orthofix Announces First Presentation of Seven-Year Outcome Data for the M6-C Artificial Cervical Disc With Other Clinical and Scientific Abstracts at the ISASS Annual Meeting

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the presentation of multiple clinical and scientific abstracts during the International Society for the Advancement of Spine Surgery (ISASS) annual meeting in San Francisco June 1-3, 2023.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230601005376/en/

Illustration of the Orthofix M6-C artificial cervical disc. (Graphic: Business Wire)

Illustration of the Orthofix M6-C artificial cervical disc. (Graphic: Business Wire)

“We are pleased to support a wide range of abstracts and clinical data during the annual ISASS meeting, including the first presentation of the seven-year data from the M6-C artificial cervical disc U.S. IDE study,” said Kevin Kenny, President of Global Spine. “ISASS is an important opportunity for attendees to learn from a distinguished surgeon panel that will provide their insights about cervical disc replacement and long-term outcomes of this therapy. Additionally, we are proud to support presentation of data for our Bone Growth Therapy and Biologic solutions.”

At the ISASS annual meeting, Orthofix is presenting a variety of industry abstracts and posters focused on the company’s M6-C™ artificial cervical disc, CervicalStim™ bone growth stimulator and Trinity Elite™ Allograft with viable cells.

Motion Preservation

“M6-C Artificial Cervical Disc: Seven-Year Outcomes for Single-Level Total Disc Replacement with a Novel Viscoelastic Artificial Cervical Disc” – abstract presentation by Dr. Todd Lanman.

This abstract is the first public presentation of specific seven-year clinical results associated with the use of the M6-C artificial cervical disc for the treatment of single-level symptomatic cervical radiculopathy. The presentation will be on Saturday, June 3 at 10:00 a.m. in Salons 10-12 by Dr. Todd Lanman. Highlighted results include:

  • Decreases in disability as measured by NDI and decreases in Neck and Arm Pain Scores that were observed at prior follow-up periods and were retained through seven-years post-op

  • Eleven Secondary Surgical Interventions (SSI) were observed among the M6-C disc cohort (6.9%). This rate is comparable to seven-year SSI rates reported for other commercially available artificial cervical discs

  • Annual follow-up of this cohort will continue through 10-years post-op

“Cervical Disc Arthroplasty Expert Panel: Osteolysis and Periprosthetic Bone Changes in Cervical Disc Replacement” – academic programsession with moderator Dr. Gunnar Andersson and speakers Dr. Josh Jacobs, Dr. Armen Khachatryan, Dr. Todd Lanman, Dr. Steven Kurtz and Dr. Sophia Sangiorgio.

This multidisciplinary panel of clinicians and researchers will discuss the assessment of bone changes around artificial cervical disc implants, leveraging prior research in hip and knee arthroplasty. Panel will be conducted on Friday, June 2 at 1:20 p.m. in Salons 10-12. Topics covered include:

  • Categorization and classification of radiographic observations

  • Clinical management of observed bone changes post-cervical disc replacement

“Proposed Classification System of Radiographic Bony Changes after Cervical Disc Replacement” – poster by Dr. Armen Khachatryan.

Poster will be located in the Exhibit Hall. Content highlights include:

  • Introduction of classification system for post-cervical disc replacement radiographic observations

  • Analysis of system reliability

Bone Growth Therapy

“CervicalStim Bone Growth Therapy: Electrical Stimulation Used as an Adjunct to Cervical Spine Fusion in Patients at Risk for Pseudarthrosis” – podium presentation with Dr. Ilyas Aleem.

This presentation will cover the results of a prospective multicenter study that evaluated the adjunct effect of PEMF in subjects undergoing cervical spinal surgery who presented with risk factors for pseudarthrosis (multilevel fusion, prior failed cervical spine fusion, diabetes, osteoporosis, or nicotine use). Presentation will be conducted on Saturday June 3, at 10:32 a.m. in Salons 13-15. Highlights include:

  • Out of 160 subjects, 144 (90.0%) were graded as fused (all levels) at the 12-month visit

  • Fusion success was 91.7% (n=55/60) for subjects with a single risk factor, 89.0% (n=89/100) for subjects with two or more risk factors, and 90.9% (n=20/22) for subjects with three or more risk factors

  • Significant improvements in NDI, VAS (arm and neck), SF-36, and EQ-5D were observed compared to baseline scores (p<0.001)

“CervicalStim Bone Growth Therapy: Adjunctive Use of Bone Growth Stimulation in Cervical Spine Fusion in Patients at Risk for Pseudarthrosis” – poster by Dr. Ilyas Aleem.

Poster highlights results of a study that evaluated cervical spine fusion rates for subjects with one or more risk factors for pseudarthrosis; subjects that received PEMF treatment were compared to matched subjects that did not receive PEMF treatment. Poster will be located in the Exhibit Hall. Results include:

  • At 12 months post-op, subjects in the PEMF treated group (n=161) had a 90.1% fusion rate, compared to a 65.4% fusion rate for the control group (n=26) (p<0.001)

  • Subjects in the PEMF treated group had a significantly higher number of risk factors for nonunion (1.8 for treated group vs. 1.1 for control, p<0.001), and significantly higher number of surgical levels (2.8 for treated group vs. 2.0 for control, p<0.005)

  • When compared to control subjects that did not use PEMF stimulation, treated subjects had improved fusion outcomes despite being older, having more risk factors for pseudarthrosis, and undergoing more complex surgeries

Biologics

“Trinity Elite Allograft: Radiographic and Clinical Outcomes in Subjects that Underwent Single-Level or Multilevel Anterior, Posterior or Lateral Lumbar Interbody Fusion with a Cellular Bone Allograft” – podium presentation by Dr. Pierce Nunley on behalf of Dr. Todd Lansford.

This study investigates the effectiveness of cellular bone allograft in lumbar spinal fusion by surgical approach (e.g., anterior, lateral, and posterior). Presentation of data will be on Saturday, June 3 at 10:30 a.m. in Salons 13-15. Highlights include:

  • Analysis of 252 subjects treated via anterior, lateral, or posterior approaches reported fusion success by bridging bone assessment, as well as bridging bone and Quantitative Motion Analysis (QMA) assessment, at time of study closure.

  • At 12 months, the overall fusion success rate for bridging bone was 98.5%; fusion success was 98.1%, 100.0%, and 97.9% for anterior, lateral, and posterior approaches, respectively. Fusion success for bridging bone and QMA assessment was 83%, 94.6%, and 93.8% for anterior, lateral, and posterior approaches, respectively.

  • At 24 months, the overall fusion success rate for bridging bone was 98.9%; fusion success was 97.9%, 100.0%, and 98.8% for anterior, lateral, and posterior approaches, respectively. Fusion success for bridging bone and QMA assessment was 85.4%, 96.1%, and 92.9% for anterior, lateral, and posterior approaches, respectively.

  • Significant improvements in quality-of-life, pain, and disability scores were also noted, irrespective of the surgical approach.

“Trinity Elite Allograft: Twenty-Four-Month Interim Results from a Prospective Clinical Trial Evaluating the Performance and Safety of Cellular Bone Allograft in Patients Undergoing Lumbar Spinal Fusion” – podium presentation by Dr. Daniel Park.

This abstract reports on the outcome measures from a prospective, multicenter center clinical study that assessed the efficacy and safety of cellular bone allograft when used as an adjunct to lumbar arthrodesis out to 24-months follow-up. This data will be presented on Friday, June 2 at 11:02 a.m. in Salons 10-12. Highlights include:

  • At the time of interim analysis, 86 subjects reported data necessary to evaluate both fusion and disability through 24-months postoperative

  • Fusion rate, based on bridging bone assessment and QMA, was reported to be 95.3% (N=86)

  • ODI and VAS Leg and VAS Back Pain scores all reported significant improvements from baseline (p<0.001)

To learn more about the full portfolio of Orthofix solutions, please visit us at booth #100 at the ISASS meeting.

About Orthofix

The newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Its products are distributed in approximately 68 countries worldwide.

The Company is headquartered in Lewisville, Texas and has primary offices in Carlsbad, CA, with a focus on spine and biologics product innovation and surgeon education, and Verona, Italy, with an emphasis on product innovation, production, and medical education for orthopedics. The combined company’s global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA, Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Branch, MS, Maidenhead, UK, Munich, Germany, Paris, France and São Paulo, Brazil.

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Illustration of the Orthofix M6-C artificial cervical disc. (Graphic: Business Wire)