INVESTOR REMINDER: Berger Montague Notifies Marqeta (NASDAQ: MQ) Investors of a Class Action Lawsuit and Deadline

PHILADELPHIA, Jan. 13, 2025 (GLOBE NEWSWIRE) — Nationally recognized law firm Berger Montague PC informs investors that a lawsuit was filed against MARQETA, INC. (“Marqeta” or the “Company”) (NASDAQ: MQ) on behalf of purchasers of MARQETA securities between May 7, 2024 and November 4,2024, inclusive (the “Class Period”).

Investors that suffered losses from MARQETA (NASDAQ: MQ) investments can follow the link below for more information regarding the lawsuit:



CLICK HERE


to learn your rights.

Investors who purchased or acquired MARQETA securities during the Class Period may, no later than

FEBRUARY 7, 2025

, seek to be appointed as a lead plaintiff representative of the class.

Headquartered in Oakland, CA, Marqeta operates a cloud-based platform which enables businesses to issue and manage their own payment cards.

On November 4, 2024, the Company issued a press release entitled “Marqeta Reports Third Quarter 2024 Financial Results.” In addition to reporting its third quarter results, Marqeta announced lower fourth quarter guidance which reflected “several changes that became apparent over the last few months with regards to the heightened scrutiny of the banking environment and specific customer program changes.”

On this news, the price of Marqeta stock fell $2.53 per share – more than 42% – from a close of $5.95 per share on November 4, 2024 to close at $3.42 per share on November 5, 2024.


For additional information or to learn how to participate in this litigation,




CLICK HERE




or please contact Berger Montague: Andrew Abramowitz at




[email protected]




or (215) 875-3015, or Peter Hamner at




[email protected]


.

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the Court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.


Berger Montague
, with offices in Philadelphia, Minneapolis, Delaware, Washington, D.C., San Diego, San Francisco and Chicago, has been a pioneer in securities class action litigation since its founding in 1970. Berger Montague has represented individual and institutional investors for over five decades and serves as lead counsel in courts throughout the United States.

Contacts:

Andrew Abramowitz, Senior Counsel
Berger Montague
(215) 875-3015
[email protected]  

Peter Hamner
Berger Montague PC
[email protected]



SciSparc: AutoMax Enters the Direct Import Market with a $13 Million First Shipment of JAC Electric Vehicles

TEL AVIV, Israel, Jan. 13, 2025 (GLOBE NEWSWIRE) — SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), announced that AutoMax Motors Ltd., (“AutoMax”), a leading automotive importer and distributor in Israel with which the Company has entered into an agreement and plan of merger, received its first shipment of vehicles manufactured by Anhui Jianghuai Automobile Group Co., Ltd. (“JAC Motors”), a globally recognized Chinese automotive company. This marks a significant milestone in AutoMax’s direct import and distribution operations, launched under agreements signed earlier this year with JAC Motors.

The shipment follows regulatory approvals for direct importation and positions AutoMax to begin marketing and sales activities for JAC Motors vehicles across Israel. 

JAC Motors has a strong focus on electric vehicles (“EVs”), making it a pioneer in sustainable transportation. The company has developed an impressive range of EVs, including passenger cars and commercial vehicles, supported by advanced R&D and cutting-edge battery technologies.  AutoMax sees JAC’s innovative EV lineup as an opportunity to meet the rising demand for electric vehicles in Israel, aligning with its strategy to bring sustainable transportation solutions to the local market.

SciSparc has provided financial support to AutoMax, which SciSparc believes helped provide AutoMax with resources to facilitate the transaction with JAC Motors.  Further, as part of its growth strategy, AutoMax entered into a merger agreement with the Company in April 2024, that if completed would pave the way for SciSparc’s expansion into the automotive sector.  The merger is subject to closing conditions, including the approval of the shareholders of each of the Company and AutoMax.

About SciSparc Ltd. (Nasdaq: SPRC):

SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol: SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer’s disease and agitation; and SCI-210 for the treatment of autism and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seeds’ oil-based products on the Amazon.com Marketplace.

Additional Information and Where You Can Find It

In connection with the proposed transaction between the Company and AutoMax, the Company has filed a preliminary registration statement, which includes a preliminary proxy statement/prospectus, with the Securities and Exchange Commission (the “SEC”). This press release is not a substitute for the registration statement, the proxy statement/prospectus or any other documents that the Company may file with the SEC or send to its shareholders in connection with the proposed transactions. Before making any voting decision, investors and securityholders are urged to read the final registration statement or the proxy statement/prospectus, as applicable, and all other relevant documents filed or furnished or that will be filed with or furnished to the SEC in connection with the proposed transaction as they become available because they will contain important information about the proposed transaction and related matters.

You may obtain free copies of the proxy statement/prospectus and all other documents filed or that will be filed with the SEC regarding the proposed transaction at the website maintained by the SEC at www.sec.gov. Once filed, the final proxy statement/prospectus will be available free of charge on the Company’s website at https://investor.scisparc.com/, by contacting the Company’s Investor Relations at [email protected] or by phone at +972-3-6167055.

Participants in Solicitation

The Company, AutoMax and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the holders of the Company’s Ordinary Shares in connection with the proposed transaction. Information about the Company’s directors and executive officers is set forth in the Company’s annual report on Form 20-F, for the year ended December 31, 2023, filed with the SEC on April 1, 2024. Other information regarding the interests of such individuals, as well as information regarding AutoMax’s directors and executive officers and other persons who may be deemed participants in the proposed transaction, will be set forth in the final proxy statement/prospectus, which will be filed with the SEC. You may obtain free copies of these documents as described in the preceding paragraph.

Non-Solicitation

This press release will not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor will there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses AutoMax’s growth strategy, that the merger potentially might pave the way for SciSparc’s expansion into the automotive sector, and AutoMax’s strategy to bring sustainable transportation solutions to the local market.  Since such statements deal with future events and are based on SciSparc’s current expectations, they are subject to various risks and uncertainties related to the Company’s ability to complete the merger on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of the closing conditions related to the Merger Agreement and risks and uncertainties related to the failure to timely, or at all, obtain shareholder approval for the transaction, and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in SciSparc’s Annual Report on Form 20-F filed with the SEC on April 1, 2024, and in subsequent filings with the SEC. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Investor Contact:
[email protected]
Tel: +972-3-6167055



Global Atlantic Announces New Registered Index-Linked Annuity

Global Atlantic Announces New Registered Index-Linked Annuity

ForeStructured Growth II innovates RILA market with growth and exclusive yield opportunities, provides an element of built-in loss protection

NEW YORK–(BUSINESS WIRE)–Global Atlantic Financial Group (Global Atlantic), a leading insurance provider meeting the retirement and life insurance needs of individuals and institutions, today announced the launch of ForeStructured Growth II, an innovative registered index-linked annuity (“RILA”) designed to help balance growth potential with an element of downside protection.

This next-generation RILA solution offers more than 50 index-linked strategies providing a variety of buffer and floor protection features along with the opportunity to grow assets with the index crediting strategy 1. Some of these strategies include unique Dual Directional features that can generate positive crediting at the end of the Strategy Term, even in some negative markets. The product addresses a critical need identified in Global Atlantic’s 2024 Retirement Outlook Survey, where nearly 70% of investors expressed interest in protection against investment loss.

“Americans are clearly concerned about the combined effects of economic uncertainty and market volatility on their retirement savings. ForeStructured Growth II evolves the RILA landscape giving new protection strategies while also introducing the potential for growth,” said David Lacusky, Head of Annuity Sales at Global Atlantic. “The combination of buffer and floor protection, along with the ability to customize allocations, allows financial professionals to fine-tune solutions for each client’s growth objectives and risk tolerance.”

ForeStructured Growth II also offers two innovative crediting strategies:

  • Dual Directional Trigger and Cap with Buffer Strategy
  • Dual Directional Yield with Buffer Strategy 2

The Dual Directional Trigger and Cap with Buffer Strategy combines features of Dual Directional Trigger Strategies with an index cap to enhance interest crediting potential. The Dual Directional Yield with Buffer Strategy is exclusive to Global Atlantic and offers an opportunity to earn Performance Credits quarterly throughout a six-year Strategy Term. These new crediting strategies give financial professionals a powerful solution to offer their clients seeking growth potential and income.

To learn more visit: ForeStructured Growth II

1 A Strategy Interim Value is applied if amounts are withdrawn or otherwise removed from an Indexed Strategy before the end of a Strategy Term, which may result in significant loss.

2 An Index Credit will also be applied at the end of the Strategy Term, but it will be either negative or equal to zero (never positive).

About Global Atlantic

Global Atlantic Financial Group is a leading insurance company meeting the retirement and life insurance needs of individuals and institutions. With a strong financial foundation and risk and investment management expertise, the company delivers tailored solutions to create more secure financial futures. The company’s performance has been driven by its culture and core values focused on integrity, teamwork, and the importance of building long-term client relationships. Global Atlantic is a wholly owned subsidiary of KKR, a leading global investment firm. Through its relationship, the company leverages KKR’s investment capabilities, scale and access to capital markets to enhance the value it offers clients. KKR’s parent company is KKR & Co. Inc. (NYSE: KKR).

This material is intended to provide educational information regarding either the features and mechanics of the product or for general reference/education and is intended for use with the general public. It should not be considered, and does not constitute, personalized investment advice. The issuing insurance company is not an investment adviser nor registered as such with the SEC or any state securities regulatory authority. It’s not acting in any fiduciary capacity with respect to any contract and/or investment.

This material is authorized for distribution only when accompanied or preceded by a prospectus and an applicable product brochure for the annuities being offered. The prospectus contains features, benefits, risks, fees, and other information regarding the registered index‐linked annuity contract, which should be considered carefully before investing. You should read the prospectus carefully before investing money.

Registered Indexed‐linked annuity products are complex insurance and investment vehicles. There is risk of loss of principal. Early withdrawals may be subject to withdrawal charges and a market value adjustment. Please refer to the prospectus for other important information including any risks about the product.

Guarantees provided are subject to the financial strength of the issuing insurance company; not guaranteed by any bank or the FDIC.

ForeStructured Growth II registered index‐linked annuity is issued by Forethought Life Insurance Company, 10 West Market Street, Suite 2300, Indianapolis, Indiana. ForeStructured Growth II is available with Contract A24RILA‐SPDA‐02 and rider forms FA4131‐01, RA24‐ROP‐01, RA24‐PLOCK‐01, RA24‐MVA‐02, ICC14‐FL‐FIATI, ICC14‐ FL‐FIANC, RA24‐FSR‐01, RA24IS‐PTPCB‐02, RA24IS‐PTPCF‐02, RA24IS‐PTPCAF‐02, RA24IS‐PTPPB‐02, RA24IS‐PTPTPB‐02, RA24IS‐PTPTRB‐01, RA24‐PCA‐01, RA24IS‐DD‐ PTPCB‐01, RA24IS‐DD‐PTPTRB‐01, RA24IS‐DD‐PTPTRACB‐01, RA24IS‐DD‐YB‐01. ForeStructured Growth II is underwritten and distributed by Global Atlantic Distributors, LLC.

Products, features, and marketing materials are subject to state and firm variations and availability. Read the Contract for complete details.

Global Atlantic Financial Group (Global Atlantic) is the marketing name for The Global Atlantic Financial Group LLC and its subsidiaries, including Forethought Life Insurance Company and Accordia Life and Annuity Company. Each subsidiary is responsible for its own financial and contractual obligations. These subsidiaries are not authorized to do business in New York.

ICR Inc.

[email protected]

(203) 682-8268

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Professional Services Business Other Professional Services Insurance Finance Banking

MEDIA:

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ReShape Lifesciences® Provides Update on Merger Agreement With Vyome Therapeutics and Asset Purchase Agreement With Biorad Medisys

Transactions Continue to Progress and Remain on Track

IRVINE, Calif. and CAMBRIDGE, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) — ReShape Lifesciences Inc. (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health-solutions company, and Vyome Therapeutics, Inc. (“Vyome”), a private clinical-stage company targeting immuno-inflammatory and rare diseases, today provided an update on the definitive merger agreement under which ReShape and Vyome will combine in an all-stock transaction. The combined company will focus on advancing the development of Vyome’s immuno-inflammatory assets and on identifying additional opportunities between the world-class Indian innovation corridor and the U.S. market. ReShape also provided an update on the asset purchase agreement with Biorad Medisys.

On July 9, 2024, ReShape Lifesciences Inc. entered into a definitive merger agreement with Vyome, under which ReShape and Vyome will combine in an all-stock transaction. At the closing of the merger, ReShape will be renamed Vyome Holdings, Inc. and expects to trade under the Nasdaq ticker symbol “HIND,” representing the company’s alignment with the U.S.-India relationship. The board of directors of the combined company will be comprised of six directors designated by Vyome and one director designated by ReShape, and executive management of the combined company will consist of Vyome’s executive officers.

Simultaneously with the execution of the merger agreement, ReShape entered into an asset purchase agreement with Biorad, which is party to a previously disclosed exclusive license agreement with ReShape for ReShape’s Obalon® Gastric Balloon System. Pursuant to the asset purchase agreement, ReShape will sell substantially all of its assets to Biorad (or an affiliate thereof), including ReShape’s Lap-Band® System, Obalon® Gastric Balloon System and the Diabetes Bloc-Stim Neuromodulation™ (DBSN™) System (but excluding cash), and Biorad will assume substantially all of ReShape’s liabilities. The cash purchase price under the asset purchase agreement will count toward ReShape’s net cash for purposes of determining the post-merger ownership allocation between ReShape and Vyome stockholders under the merger agreement.

On October 1, 2024, ReShape filed a Form S-4 registration statement with the U.S. Securities and Exchange Commission (SEC), for the merger with Vyome and on December 6, 2024 ReShape filed an amendment to that Form S-4 registration statement.

On December 20, 2024, ReShape filed a Form S-1 registration statement for the previously announced Equity Line of Credit (ELOC) with Ascent Partners Fund LLC.

“As previously reported, in July, we coordinated a merger agreement with Vyome and a concurrent asset purchase agreement with Biorad, successfully maximizing value for our stockholders. Since entering into the agreement, both the ReShape and Vyome teams have worked diligently to answer comments from the SEC on the S-4. We are currently in the process of responding to comments from the SEC,” stated Paul F. Hickey, President and Chief Executive Officer of ReShape Lifesciences®. “Once the S-4 filing is declared effective, we will set the record date for the subsequent shareholder meeting. It is important to note that our board unanimously recommended merging with Vyome and concurrently selling assets to Biorad. We believe this merger will unlock significant value for our shareholders in the newly combined entity. Additionally, we are working to finalize the S-1 resale registration statement for the ELOC, which is intended to provide capital for our general operations and also expenses related to the closing of the merger and asset purchase agreements. I am truly excited about the value we are delivering to our stockholders and the growth potential resulting from these transactions.”

“We believe this transaction will allow us to unlock the full potential of Vyome’s pipeline as a publicly listed company following the merger with ReShape, as we continue to address the unmet needs of patients suffering from immune-inflammatory diseases and building a broader platform that leverages our comparative advantage in the U.S.-India innovation corridor,” added Krishna K. Gupta, current director of Vyome and to be appointed Chairman of the combined company. “Our vision for Vyome is to build a world-class company leveraging the best of talent and capital between the U.S. and India to develop new therapies for unmet chronic immune-inflammatory conditions in a highly-cost efficient manner. We also have a broader vision of augmenting our portfolio along the three pillars of biopharma, medical devices, and healthcare artificial intelligence. It is important to note that we have no debt and a clean capital structure, positioning Vyome for success in the public markets.”

About Vyome

Vyome Therapeutics is building a healthcare platform spanning the US-India innovation corridor. Vyome’s immediate focus is leveraging its clinical-stage assets to transform the lives of patients with immune-inflammatory conditions. By applying groundbreaking science and its unique positioning across the US-India innovation corridor, Vyome seeks to deliver lasting value to shareholders in a hyper cost-efficient manner while upholding global standards of quality and safety. Based in Cambridge, MA, the company has announced its intent to be listed on the Nasdaq exchange under the ticker ‘HIND’ pursuant to a reverse merger with ReShape Lifesciences Inc. (Nasdaq: RSLS) in early 2025. To learn more, please visit www.vyometx.com.

About Biorad Medisys

Biorad Medisys Pvt. Ltd.® is a rapidly growing med-tech company dedicated to redefining healthcare standards with precision-engineered medical devices backed by rigorous scientific research. It operates three business units – Indovasive, Orthovasive and Neurovasive. Indovasive offers consumables and equipment in Urology and Gastroenterology. The Orthovasive segment sells a complete range of Knee and Hip implants for both Primary and Revision surgeries. It has recently forayed into Neurovascular BU for selling a wide portfolio of products in peripheral vascular, neurovascular and rehabilitation segments. It has two manufacturing facilities in India and is currently exporting to 50+ countries. To realize its global expansion strategy, it recently acquired a Swiss based company, Marflow, which specializes in commercialization of products in Urology & Gastroenterology.

About ReShape Lifesciences®

ReShape Lifesciences® is America’s premier weight loss and metabolic health-solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. The FDA-approved Lap-Band® System provides minimally invasive, long-term treatment of obesity and is an alternative to more invasive surgical stapling procedures such as the gastric bypass or sleeve gastrectomy. The investigational Diabetes Bloc-Stim Neuromodulation™ (DBSN™) system utilizes a proprietary vagus nerve block and stimulation technology platform for the treatment of type 2 diabetes and metabolic disorders. The Obalon® balloon technology is a non-surgical, swallowable, gas-filled intra-gastric balloon that is designed to provide long-lasting weight loss. For more information, please visit www.reshapelifesciences.com.

Additional Information

In connection with the proposed Merger and Asset Sale, ReShape has filed with the Securities and Exchange Commission (the “SEC”) and plans to mail or otherwise provide to its stockholders a joint proxy statement/prospectus and other relevant documents. Before making a voting decision, ReShape’s stockholders are urged to read the joint proxy statement/prospectus and any other documents filed by ReShape with the SEC in connection with the proposed Merger and Asset Sale or incorporated by reference therein carefully and in their entirety when they become available because they will contain important information about ReShape, Vyome and the proposed transactions. Investors and stockholders may obtain a free copy of these materials (when they are available) and other documents filed by ReShape with the SEC at the SEC’s website at www.sec.gov, at ReShape’s website at www.reshapelifesciences.com, or by sending a written request to ReShape at 18 Technology Drive, Suite 110, Irvine, California 92618, Attention: Corporate Secretary.

Participants in the Solicitation

This document does not constitute a solicitation of proxy, an offer to purchase or a solicitation of an offer to sell any securities of ReShape and its directors, executive officers and certain other members of management and employees may be deemed to be participants in soliciting proxies from its stockholders in connection with the proposed Merger and Asset Sale. Information regarding the persons who may, under the rules of the SEC, be considered to be participants in the solicitation of ReShape’s stockholders in connection with the proposed Merger and Asset Sale will be set forth in joint proxy statement/prospectus if and when it is filed with the SEC by ReShape and Vyome. Security holders may obtain information regarding the names, affiliations and interests of ReShape’s directors and officers in ReShape’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the SEC on April 1, 2024. To the extent the holdings of ReShape securities by ReShape’s directors and executive officers have changed since the amounts set forth in ReShape’s proxy statement for its most recent annual meeting of stockholders, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. Additional information regarding these individuals and any direct or indirect interests they may have in the proposed Merger and Asset Sale has been set forth in the joint proxy statement/prospectus filed with the SEC in connection with the proposed Merger and Asset Sale, at ReShape’s website at www.reshapelifesciences.com.

Forward-Looking Statements

Certain statements contained in this filing may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Merger and Asset Sale and the ability to consummate the Merger and Asset Sale. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and ReShape undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: (1) ReShape may be unable to obtain stockholder approval as required for the proposed Merger and Asset Sale; (2) conditions to the closing of the Merger or Asset Sale may not be satisfied; (3) the Merger and Asset Sale may involve unexpected costs, liabilities or delays; (4) ReShape’s business may suffer as a result of uncertainty surrounding the Merger and Asset Sale; (5) the outcome of any legal proceedings related to the Merger or Asset Sale; (6) ReShape may be adversely affected by other economic, business, and/or competitive factors; (7) the occurrence of any event, change or other circumstances that could give rise to the termination of the Merger Agreement or Asset Purchase Agreement; (8) the effect of the announcement of the Merger and Asset Purchase Agreement on the ability of ReShape to retain key personnel and maintain relationships with customers, suppliers and others with whom ReShape does business, or on ReShape’s operating results and business generally; and (9) other risks to consummation of the Merger and Asset Sale, including the risk that the Merger and Asset Sale will not be consummated within the expected time period or at all. Additional factors that may affect the future results of ReShape are set forth in its filings with the SEC, including ReShape’s most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC’s website at www.sec.gov, specifically under the heading “Risk Factors.” The risks and uncertainties described above and in ReShape’s most recent Annual Report on Form 10-K are not exclusive and further information concerning ReShape and its business, including factors that potentially could materially affect its business, financial condition or operating results, may emerge from time to time. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements. Readers should also carefully review the risk factors described in other documents that ReShape files from time to time with the SEC. The forward-looking statements in these materials speak only as of the date of these materials. Except as required by law, ReShape assumes no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

CONTACTS:

ReShape Lifesciences Contact:                                        
Paul F. Hickey
President and Chief Executive Officer
949-276-7223
[email protected]        

Investor Relations Contact:

Rx Communications Group

Michael Miller
(917)-633-6086
[email protected]



Global Water Resources Taps Water Industry Veteran, Robert J. Kuta, for EVP of Engineering and Environmental Resources

Seasoned Executive Brings 35 Years of Experience at Industry-Leading Water Peers as Company Prepares for Growth and Infrastructure Expansion in 2025 and Beyond

PHOENIX, Jan. 13, 2025 (GLOBE NEWSWIRE) — Global Water Resources, Inc. (NASDAQ: GWRS), a pure-play water resource management company, has appointed Robert J. Kuta to the new position of executive vice president of engineering and environmental resources.

The strategic hire supports the company’s ongoing efforts to further enhance its water and wastewater services for customers in Arizona’s booming economy and prepare for growth and regional expansion. The new position provides numerous benefits with the combination of engineering and environmental resources, including helping to ensure Global Water Resources maintains its exceptional compliance record as the company continues to acquire troubled utilities and manage new regulatory standards.

Kuta brings to Global Water Resources more than 35 years of experience in the water industry, from operations, project delivery and strategic planning to developing and delivering innovative business performance models and regulatory strategies. He also has considerable executive experience within the southwest U.S. regulated utility space.

Kuta has led large and diverse water industry organizations in both domestic and international business settings. This has included managing large and complex water and wastewater design-build-operate projects around the world which have involved food processing, mining, oil & gas, energy production and other high-growth industries.

“We welcome Rob’s extensive experience and exceptional record of achievement as we prepare to implement what could be our largest capital improvement program in the years to come,” stated Global Water Resources CEO, Ron Fleming. “We have great confidence in Rob’s ability to use his diverse skill set to enhance our organizational performance.

“In coordination with our exceptional existing team, Rob will develop and execute on infrastructure and environmental programs designed to benefit our growing regional communities while maintaining compliance as our top mandate. We look forward to Rob’s contributions as we apply our unique approach to Total Water Management in solving today’s infrastructure renewal and environmental challenges.”

Kuta previously served as vice president of engineering and chief water quality and environmental affairs compliance officer at California Water Service Company (Cal Water), the country’s third largest investor-owned water utility. At Cal Water, he oversaw capital expenditures of $1.4 billion under a three-year development and infrastructure expansion program.

“I respect Global Water’s approach to the water utility sector and what they have been able to achieve in its relatively short history,” said Kuta. “Global Water has a tremendous opportunity to make an even greater difference in providing reliable water resource management to Arizona communities. This mission has become increasingly vital as the region continues to experience unprecedented growth. I look forward to leading our engineering, construction, and environmental resources departments, including our new industrial division, with a focus on creating successful outcomes for all stakeholders.”

Prior to Cal Water, Kuta served as senior vice president of Operations Management Service – Water, Environment & Nuclear at the engineering firm, CH2M HILL (subsequently acquired by Jacobs). At CH2M, he led 1,400 skilled associates in delivering $250 million in annual service contract work that included site-based operations, maintenance and consulting services for public and private sector clients. He also helped lead infrastructure improvement programs and project management services valued at over $2 billion, including alternative delivery water/wastewater projects and U.S. military utility privatization programs.

Before CH2M HILL, Kuta served in several roles of increasing responsibility at American Water Works, including president of its Arizona American Water Company subsidiary. He also served as regional vice president of Service Delivery at Western Region Company, another subsidiary of American Water, where he managed a rolling 5-year gross capital budget of over $1 billion while maintaining close alignment with the region’s rate recovery plan.

He currently serves on the board for the Design-Build Institute of America’s Western Pacific Region, which provides ‘design-build done right’ education and professional certification opportunities that advance industry best practices.

Kuta previously served as a member of the board of directors of the Bay Area Water Supply and Conservation Agency, which represents the interests of 24 cities and water districts and two private utilities in Alameda, Santa Clara and San Mateo counties.

He is also an active member of several other industry groups, including American Water Works Association, National Association of Water Companies, National Council for Public-Private Partnerships, Water Environment Federation, Water for People, Living Water, and WateReuse Association.

He earned his Bachelor of Science degree in Biology from Central Michigan University and MBA from University of Phoenix. He completed graduate studies in Hydrology/Civil Engineering at Arizona State University and earned an Advanced Certificate for Executives in Management, Innovation, and Technology from MIT.

About Global Water Resources

Global Water Resources, Inc. is a leading water resource management company that owns and operates 32 systems which provide water, wastewater, and recycled water services. The company’s service areas are located primarily in growth corridors around metropolitan Phoenix. Global Water recycles over 1 billion gallons of water annually with 17.4 billion gallons recycled since 2004.

The company has been recognized for its highly effective implementation of Total Water Management (TWM). TWM is an integrated approach to managing the entire water cycle that involves owning and operating water, wastewater and recycled water utilities within the same geographic area in order to maximize the beneficial use of recycled water. It enables smart water management programs such as remote metering infrastructure and other advanced technologies, rate designs, and incentives that result in real conservation. TWM helps protect water supplies in water-scarce areas experiencing population growth.

Global Water has received numerous industry awards, including national recognition as a ‘Utility of the Future Today’ for its superior water reuse practices by a national consortium of water and conservation organizations led by the Water Environment Federation (WEF). The company also received Cityworks’ Excellence in Departmental Practice Award for demonstrating leadership and creativity in applying public asset management strategies to daily operations and long-term planning.

To learn more, visit www.gwresources.com.

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release include certain forward-looking statements which reflect the company’s expectations regarding future events. The forward-looking statements involve a number of assumptions, risks, uncertainties, and other factors that could cause actual results to differ materially from those contained in the forward-looking statements. These forward-looking statements include, but are not limited to, statements about our strategies; expectations about future business plans, prospective performance, growth, and opportunities; future financial performance; technologies; plans and expectations for capital expenditures and regulatory compliance; and other statements that are not historical facts, as well as statements identified by words such as “expects”, “anticipates”, “intends”, “plans”, “believes”, “seeks”, “estimates”, or the negative of these terms, or other words of similar meaning. These statements are based on our current beliefs or expectations and are inherently subject to a number of risks, uncertainties, and assumptions, most of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from these expectations due to changes in political, economic, business, market, regulatory, and other factors. Factors that may also affect future results are disclosed under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our filings with the Securities and Exchange Commission (the “SEC”), which are available at the SEC’s website at www.sec.gov. This includes, but is not limited to, our most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings with the SEC. Accordingly, investors are cautioned not to place undue reliance on any forward-looking statements, which reflect management’s views as of the date hereof. We undertake no obligation to publicly update any forward-looking statement, except as required by law, whether as a result of new information, future developments or otherwise.

Company Contact:

Michael Liebman
CFO and SVP
Tel (480) 999-5104
Email Contact

Investor Relations Contact:

Ron Both or Grant Stude
CMA
Tel (949) 432-7566
Email contact

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b8a50220-88d9-40ec-8e31-2212059dbc82



FlexShopper Announces Preliminary Results of Unit Subscription Rights Offering

Approximately $12 Million in Units Sold in Initial Stage of Offering

BOCA RATON, Fla., Jan. 13, 2025 (GLOBE NEWSWIRE) — FlexShopper, Inc. (Nasdaq: FPAY), a prominent national online lease-to-own retailer and payment solutions provider, today announced the preliminary results of its previously disclosed unit rights offering (the “Rights Offering”), which expired at 5:00 pm ET on January 10, 2025 (the “Expiration Date”). The Company also announced that the holder of the Company’s subordinated debt has elected to convert 25%, or $2.5 million of the outstanding principal balance in the Rights Offering. The units sold at $1.70 were at a 15% discount to the 3-day volume weighted average price and included a share and 3 additional rights to purchase shares at discounts to the trading price.

Preliminary Proceeds

According to Continental Stock Transfer & Trust Company (the “Subscription Agent”), as of the Expiration Date, approximately 5,547,993 subscription rights (the “Subscription Rights”) have been exercised to purchase approximately 21% of the Company’s common stock.   Through the initial portion of the Subscription Rights offering, FlexShopper raised $9.4 million in gross proceeds.   There are an additional 21 million rights that can be exercised over the next 90 days at 30-day intervals for additional shares.

“I want to thank all of my fellow shareholders who subscribed to our subscription rights for their continuing support, confidence, and above all, trust in FlexShopper,” said Russ Heiser, CEO of FlexShopper. “The Rights Offering is an efficient, shareholder friendly, and accretive way to raise capital. At the end of the 2024 third quarter, our stock closed at $1.03 per share, representing a market cap of $22.1 million, compared to FlexShopper’s closing stock price at January 10, 2025 of $1.90 per share, representing a market cap over $54 million.   We believe this appreciation reflects the accretive nature of the Rights Offering’s use of proceeds, as well as the growing strength of our financial and operating results.”

Mr. Heiser continued: “Shareholders that participated in the Subscription Rights now have access to additional opportunities to increase their FlexShopper investment through the upcoming Series A, B, and C rights that expire over the next 30, 60, and 90 days, respectively. The same level of participation in the Series A, B, and C rights would raise a total of approximately $48 million, which we estimate would save approximately $8.5 million in annual dividend and interest expense.”

The Company intends to use the proceeds from the Rights Offering to repurchase over 90% of its Series 2 Convertible Preferred Stock, and by repaying a portion of its credit facility and other outstanding debt facilities. Any remaining proceeds will be used for general corporate purposes, including potential acquisitions of other companies. The shares subscribed for in the Subscription Rights are expected to be issued to participating stockholders on or about January 15, 2025.

Subordinated Debt Conversion

NRNS Capital Holdings LLC (“NRNS”), the manager of which is the Chairman of FlexShopper’s Board of Directors, has elected to convert $2.5 million of the $10.75 million debt principal outstanding as of September 30, 2024 in the Rights Offering. At September 30, 2024, amounts outstanding under the NRNS Note bear interest at a rate of 19.21%. With the partial conversion of the NRNS subordinated debt the proforma outstanding balance is $8.25 million. FlexShopper estimates it will save approximately $0.5 million in annual interest expense as a result of the conversion.

Mr. Heiser concluded, “I’m excited by the direction FlexShopper is headed, as we increase our market share and execute against our growth oriented strategic plan. Equitizing our balance sheet is a powerful opportunity to expand earnings for our equity shareholders. I look forward to providing additional updates on our success in the coming months.”

FlexShopper encourages holders of the Series A, B, and C Rights to contact their broker or financial advisor’s Corporate Actions Department to participate in these subsequent rights. Rights offering information can be found at https://www.sec.gov and https://investors.flexshopper.com.

The offering was made pursuant to the Corporation’s registration statement on Form S-1 (File No. 333-282857), which was declared effective by the U.S. Securities and Exchange Commission on November 29, 2024. The prospectus relating to and describing the terms of the rights offering has been filed with the SEC on December 2, 2024, and is available on the SEC’s website at

www.sec.gov

. This announcement shall not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state.

About FlexShopper, Inc.:

FlexShopper, Inc. (Nasdaq: FPAY) is a leading national financial technology company that provides payment options to consumers. FlexShopper provides a variety of flexible funding options for underserved consumers through its online direct to consumer marketplace at flexshopper.com and in partnership with partner merchants both online as well as at brick and mortar locations. FlexShopper’s solutions are designed to meet the needs of a wide range of consumer segments via lease-to-own and lending products.

Forward-Looking Statements

All statements in this release that are not based on historical fact are “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, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate,” or other comparable terms. Examples of forward-looking statements include, among others, statements we make regarding expectations of lease originations, the expansion of our lease-to-own program; expectations concerning our partnerships with retail partners; investments in, and the success of, our underwriting technology and risk analytics platform; our ability to collect payments due from customers; expected future operating results and expectations concerning our business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, among others, the following: our ability to obtain adequate financing to fund our business operations in the future; the failure to successfully manage and grow our FlexShopper.com e-commerce platform; our ability to maintain compliance with financial covenants under our credit agreement; our dependence on the success of our third-party retail partners and our continued relationships with them; our compliance with various federal, state and local laws and regulations, including those related to consumer protection; the failure to protect the integrity and security of customer and employee information; and the other risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q. The forward-looking statements made in this release speak only as of the date of this release, and FlexShopper assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.

Company Contact:

FlexShopper, Inc.
Investor Relations
[email protected]

Investor and Media Contact

Andrew Berger
Managing Director
SM Berger & Company, Inc.
Tel (216) 464-6400
[email protected]



Giftify, Inc. Powers CVS Gift Card Exchange


White Label Partnership Enters its 2



nd



Year

SCHAUMBURG, IL, Jan. 13, 2025 (GLOBE NEWSWIRE) — Giftify, Inc. (NASDAQ: GIFT) (the “Company”), the owner and operator of leading digital platforms, CardCash.com and Restaurant.com, with a focus on incentives and rewards in retail, dining & entertainment experiences, is pleased to announce its white label partnership with CVS, powering their CVS Gift Card Exchange is now entering its 2nd year.

The platform that enables CVS to accept unwanted gift cards for store e-credit is accessible here:
https://cvs.cardcash.com.

Ketan Thakker, Chief Executive Officer of Giftify, Inc., commented, “We are pleased to enter our second year working together with CVS in enabling their gift card exchange program. More and more retailers are aligning with our vision in that when they’re well-chosen, gift cards are probably the best, most versatile gifts anyone could receive. But if you’ve been given a gift card to a store or restaurant that you don’t enjoy, it can feel like a burden weighing down your wallet. The option to trade in your unwanted gift cards online is a win-win for all.”

About Giftify, Inc.

Giftify, Inc. is a pioneer in the incentive and rewards industry with a focus on retail, dining & entertainment experiences, as the owner and operator of leading digital platforms, CardCash.com and Restaurant.com. CardCash.com is a leading secondary gift card exchange platform, allowing consumers and retailers to realize value by buying and selling gift cards at various scales. Its Restaurant.com is the nation’s largest restaurant-focused digital deals brand. Restaurant.com and our Corporate Incentives division connect digital consumers, businesses and communities offering thousands of dining, retail and entertainment deals options nationwide at over 184,000 restaurants and retailers. Restaurant.com prides itself on offering the best deal, every meal. Our gift cards and restaurant certificates allow customers to save at thousands of restaurants across the country with just a few clicks.

For more information, visit: www.giftifyinc.com and www.cardcash.com and https://www.restaurant.com.

Forward-Looking Statements

Press Releases may include forward-looking statements. In particular, the words “believe,” “may,” “could,” “should,” “expect,” “anticipate,” “estimate,” “project,” “propose,” “plan,” “intend,” and similar conditional words and expressions are intended to identify forward-looking statements. Any statements made in this news release about an action, event or development, are forward-looking statements. Such statements are based upon assumptions that in the future may prove not to have been accurate and are subject to significant risks and uncertainties. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of the company. Accordingly, you should not place undue reliance on these forward-looking statements. Although the company believes that the expectations reflected in the forward-looking statements are reasonable, it can give no assurance that its forward-looking statements will prove to be correct. Investors are cautioned that any forward-looking statements are not guarantees of future performance and actual results or developments may differ materially from those projected. The forward-looking statements in this press release are made as of the date hereof. The company takes no obligation to update or correct its own forward-looking statements, except as required by law or those prepared by third parties that are not paid by the company. Statements in this press release that are not historical fact may be deemed forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Although Giftify, Inc. believes the expectations reflected in any forward-looking statements are based on reasonable assumptions, Giftify, Inc. is unable to give any assurance that its expectations will be attained. Factors that could cause actual results to differ materially from expectations include the company’s ability identify a suitable business model for the corporation.

Investors Contacts:


[email protected]



Lifeward CEO Issues Year-End 2024 Open Letter to Shareholders and Provides 2025 Commercial and Operational Priorities

With recent financing and current capital, the Company believes it has sufficient cash to pursue its goals

MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, Jan. 13, 2025 (GLOBE NEWSWIRE) — Lifeward Ltd. (Nasdaq: LFWD) (“Lifeward” or the “Company”), today issued an open letter from Larry Jasinski, Chief Executive Officer, to shareholders highlighting the Company’s significant achievements in 2024 and outlining the key objectives for 2025. The full letter is published below.

Dear Shareholders and other Stakeholders,

From our founding in 2001, the Company has collectively poured its collaborative efforts into achieving our mission:


To relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities. We are committed to delivering groundbreaking solutions that empower individuals to do what they love.

What we do for patients is utterly life-changing, and they routinely tell us this.  I invite you to remind yourselves of these stories from the voices of our customers in our testimonials section. You’ll see in these testimonials why we are so committed to our mission and our imperative for success.

In this spirit, 2024 was a transformational year in our history. In January, after years of effort, we succeeded in achieving an industry-establishing milestone with the enactment of a defined Exoskeleton category as an orthotic brace that was classified for lump sum payment with the Centers for Medicare & Medicaid Services (“CMS”). Key results include:

  • In April, we achieved a defined payment to provide ReWalk systems to Medicare beneficiaries.
  • Over the course of the year, we delivered over 70 new ReWalk systems, more than twice our prior year total.
  • By year-end, we established a pipeline of approximately 100 qualified users for future ReWalk submissions.
  • During 2024, Lifeward was actively engaged with the ITEM coalition with CMS policy efforts and legislation to expand support for VA policy.
  • In June, we successfully launched the NEO and NEO+ additions to the AlterG product line which we believe will allow greater penetration to a broader range of clinics.
  • During 2024, Lifeward accomplished successful operational consolidation of AlterG, including closure of our Fremont facility, which we expect will reduce our overhead and operating costs.
  • Despite initial headwinds in the U.S. capital equipment market earlier in 2024, the AlterG product offering recovered in Q4 with over 140 units placed, up about 90% sequentially.
  • We added Mike Swinford and Robert Marshall to our Board of Directors, which provides depth within our industry and in financial operations as we achieve the next level of commercial operations.

Highlights of Commercial and Operational Priorities for 2025:


  • Commercial focus with Exoskeletons.
       We are maximizing execution of our current leads, driving new leads through digital marketing, building relationships and a referral base with key centers, streamlining the patient experience from screening to delivery, and expanding physician education for patient selection.

  • AlterG penetration.
    Our new NEO and NEO+ offerings are growth drivers. We are expanding to national chains and with more international distributors.

  • Technology development.
    We seek to complete FDA and CE clearance in the first half of 2025 for ReWalk 7. This next generation exoskeleton with cloud connectivity enables data collection and better service to our customers, multiple walking speeds, a crutch-based control for safer and more intuitive use, and significantly improved batteries for extended use.

  • Financial.
    Our financial priorities are driving efficient, sustainable growth, increasing our margins and reducing our expenses.

The actions completed in 2024 and our commercial strategies for 2025 are the drivers towards profitability. On our year-end earnings call, we look forward to sharing our final 2024 financial results and our outlook for 2025. The preliminary results for 2024 met our revised revenue guidance. In early January 2025, the Company successfully raised $5 million in additional capital to support investment in driving Exoskeleton and AlterG continued awareness and adoption, and to supplement the Company’s liquidity position as a bridge to positive free cash flows. Our goal remains to reach non-GAAP operating profitability at some point during the second half of 2026. To provide more in-depth information and interaction, the company will hold an investor event in New York City on February 20. Details on the session location and time will be provided subsequently.

On behalf of Lifeward and our Board of Directors, I want to wish everyone a happy, healthy, and safe new year. We look forward to further successes and communications with you in 2025.

Regards,

Larry Jasinski
Lifeward CEO

About Lifeward

Lifeward designs, develops, and commercializes life-changing solutions that span the continuum of care in physical rehabilitation and recovery, delivering proven functional and health benefits in clinical settings as well as in the home and community. Our mission at Lifeward is to relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities. We are committed to delivering groundbreaking solutions that empower individuals to do what they love. The Lifeward portfolio features innovative products including the ReWalk Exoskeleton, the AlterG Anti-Gravity System, the MyoCycle FES System, and the ReStore Exo-Suit.

Founded in 2001, Lifeward has operations in the United States, Israel, and Germany. For more information on the Lifeward product portfolio, please visit GoLifeward.com.

Lifeward®, ReWalk®, ReStore® and Alter G® are registered trademarks of Lifeward Ltd. and/or its affiliates.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. Such forward-looking statements may include projections regarding Lifeward’s future performance and future regulatory interactions and other statements that are not statements of historical fact and, in some cases, may be identified by words like “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “should,” “would,” “seek” and similar terms or phrases. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of Lifeward’s control. Important factors that could cause the Company’s actual results to differ materially from those indicated in the forward-looking statements are more fully discussed in the Company’s periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described under the heading “Risk Factors” in the Company’s annual report on Form 10-K and 10-K/A for the year ended December 31, 2023 filed with the SEC and other documents subsequently filed with or furnished to the SEC. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause the Company’s actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for the Company to predict all of them. Except as required by law, Lifeward undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Lifeward Media Relations:

Kathleen O’Donnell
VP Marketing & New Business Development
Lifeward Ltd.
E: [email protected]

Lifeward Investor Contact:
Mike Lawless
Chief Financial Officer
Lifeward Ltd.
E: [email protected]



iRhythm Technologies Shares Preliminary Fourth Quarter 2024 Highlights and Business Update at the 43rd Annual J.P. Morgan Healthcare Conference

SAN FRANCISCO, Jan. 13, 2025 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ:IRTC) a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, today announced preliminary fourth quarter operational highlights and a business update at the 43rd Annual J.P. Morgan Healthcare Conference.

Recent Operational Highlights and Financial Outlook

  • Anticipate full year 2024 revenue slightly above high end of previously stated guidance range of $587.5 million provided in October 2024
  • Record quarter of new account openings for both Zio monitor and Zio AT during the fourth quarter 2024 as well as strong volume contributions from large national accounts
  • Launched first four health care systems on Epic Aura during the fourth quarter 2024 with broad commercial roll out for Epic health systems across the U.S. beginning in 2025
  • Initiated Zio monitor shipments for home enrollment patients during the fourth quarter 2024
  • Five studies presented at the American Heart Association highlight Zio Monitor’s high patient satisfaction, engagement and compliance with the patient MyZio app and digital tools, health economic impact of early arrhythmia detection in type 2 diabetes and respiratory disease, and AI insights on sleep and activity patterns1
  • Expect revenue for the full year 2025 of approximately $675 million to $685 million

“This past year was a period of significant growth and transformation for iRhythm,” said Quentin Blackford, iRhythm’s President and CEO. “In our core U.S. business, we achieved a record number of Zio registrations from across different channels – serving over 2 million patients, advancing Zio utilization earlier in the patient care pathway, and growing our market penetration within ambulatory cardiac monitoring. Notably, we secured FDA clearance for two 510(k) submissions related to our Zio AT device, further advancing our technology for the benefit of patients, physicians, and healthcare systems who rely on our Zio AT services. To enable future growth on a global scale, we also expanded into four European countries, earned Japanese regulatory approval, signed a strategic technology licensing agreement with BioIntelliSense, and launched the initial phase of manufacturing automation for Zio monitor. Lastly, we implemented several sustainable operational efficiencies throughout the business, driving profitability expansion and positioning us to continue to grow efficiently into the future.”

“With this strong foundation of execution in 2024, we are well positioned to continue transforming iRhythm through a commitment to excellence, innovation, and value creation,” Blackford continued. “In 2025, our top priority will be on ensuring that our quality systems are best-in-class. Commercially, we plan to expand further into primary care channels through our land-and-expand strategy and by continuing to drive momentum within risk-bearing entities as Zio becomes a key tool in population health management. Internationally, we are also excited to drive further penetration within international markets where we are earlier in the commercial adoption curve. With our recent achievements and the opportunities ahead, we remain focused on delivering sustainable value for patients, clinicians, healthcare systems, and shareholders,” concluded Mr. Blackford.

Webcast and Conference Presentation Information

At the upcoming 43rd Annual J.P. Morgan Healthcare Conference, iRhythm’s management is scheduled to present on Monday, January 13, 2025, at 7:30 p.m. Eastern Time/4:30 p.m. Pacific Time. Interested parties may access a live and archived webcast of the presentation on the “Events & Presentations” section of the company’s investor website at investors.irhythmtech.com.

About iRhythm Technologies, Inc.

iRhythm is a leading digital health care company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats2 into clinically actionable information. Through a relentless focus on patient care, iRhythm’s vision is to deliver better data, better insights, and better health for all. To learn more about iRhythm, including its portfolio of Zio products and services, please visit irhythmtech.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. An investor can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’, ‘estimate’, ‘expect’, ‘intend’, ‘will’, ‘project’, ‘plan’, ‘believe’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future actions or operating or financial performance. In particular, these statements include statements regarding financial guidance, market opportunity, ability to penetrate the market, anticipated productivity and quality improvements and expectations for growth. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include risks described in the section entitled “Risk Factors” and elsewhere in our filings made with the Securities and Exchange Commission, including those in iRhythm’s most recent filings on Form 10-K, Form 10-Q and other SEC filings, all of which are available on iRhythm’s website. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. iRhythm disclaims any obligation to update these forward-looking statements.

Investor Contact

Stephanie Zhadkevich
[email protected]

Media Contact

Kassandra Perry
[email protected]

  1. The accelerometer data and the sleep and activity classification algorithm presented at AHA in November 2024 are intended exclusively for research purposes and are not available for any commercial use.
  2. Based on the US and UK data using Zio ECG monitors. Data on file. iRhythm Technologies, 2025.



FDA Approves Feasibility Study with SeaStar Medical’s Selective Cytopheretic Device in Adults with Cardiorenal Syndrome

Study to be conducted under $3.6 million NIH grant 

DENVER, Jan. 13, 2025 (GLOBE NEWSWIRE) —

SeaStar Medical Holding Corporation
(Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to evaluate the safety and initial efficacy of SeaStar Medical’s Selective Cytopheretic Device (SCD-ADULT) in reducing inflammation in adult patients with acute heart failure with worsening renal function due to cardiorenal syndrome or severe right ventricular failure awaiting a left ventricular assist device (LVAD) implantation.

This feasibility study is expected to enroll 20 patients at up to five clinical sites and will be funded by a previously announced $3.6 million National Institutes of Health (NIH) grant awarded to Innovative BioTherapies (IBT), which is led by SCD inventor H. David Humes, MD, Professor, Division of Nephrology, Internal Medicine, University of Michigan and SeaStar Medical Scientific Advisor. Dr. Humes will serve as lead investigator for the study and SeaStar Medical will act as clinical research organization (CRO). The FDA’s Center for Biologics Evaluation and Research (CBER) granted Breakthrough Device Designation for the SCD in cardiorenal syndrome with LVAD in September 2023.

“Oftentimes patients with cardiorenal syndrome and worsening renal or cardiac function are ineligible for lifesaving LVAD implantation due to the severity of their condition,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “This study is designed to determine whether employing the SCD-ADULT to reduce hyperinflammation in these extremely ill patients can sufficiently improve their condition to bridge to LVAD implantation. Findings from this study could inform a future pivotal study in this population.”

“We estimate the total addressable U.S. market for the SCD-ADULT in cardiorenal syndrome at more than $1 billion annually, making this a significant commercial opportunity for our company,” said Eric Schlorff, SeaStar Medical CEO. “As acting CRO for this study, we will receive a portion of the NIH grant while gaining valuable experience that may serve us well in future studies.”

About Hyperinflammation

Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic or damaging to vital organs, and result in multi-organ failure and even death. This is known as the cytokine storm.

Selective Cytopheretic Device

The Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT) and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CRRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future renal replacement therapy (RRT), including dialysis.

In addition to cardiorenal syndrome with LVAD, the SCD has been awarded FDA Breakthrough Device Designation in the following indications:

  • Adult Acute Kidney Injury
  • Hepatorenal Syndrome
  • Chronic Dialysis

About Innovative BioTherapies (IBT)

IBT is a privately held biotechnology company founded to facilitate the commercialization of technology developed in Dr. H. David Humes’ academic laboratory. IBT’s research and development program is primarily supported by federal grants and contracts that focus on developing cell therapy devices utilizing human progenitor cells, biomimetic materials and micro-electromechanical systems (MEMs) technology. More information is available at http://www.innbio.com/.

About SeaStar Medical

SeaStar Medical is a commercial-stage medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical’s novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The Company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses. For more information visit www.seastarmedical.com or visit us on LinkedIn or X.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, the ability of the SCD-ADULT to treat patients with cardiorenal syndrome or severe right ventricular failure awaiting a LVAD implantation; the expected patient enrollments and clinical sites for the feasibility study and other diseases; the expected benefits of the feasibility study and the total addressable market for the SCD-ADULT in cardiorenal syndrome. Words such as “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside SeaStar Medical’s control and are difficult to predict. Factors that may cause actual future events to differ materially from the expected results include, but are not limited to: (i) the risk that SeaStar Medical may not be able to obtain regulatory approval of its SCD product candidates; (ii) the risk that SeaStar Medical may not be able to raise sufficient capital to fund its operations, including current or future clinical trials; (iii) the risk that SeaStar Medical and its current and future collaborators are unable to successfully develop and commercialize its products or services, or experience significant delays in doing so, including failure to achieve approval of its products by applicable federal and state regulators, (iv) the risk that SeaStar Medical may never achieve or sustain profitability; (v) the risk that SeaStar Medical may not be able to access funding under existing agreements; (vi) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations, (vii) the risk of product liability or regulatory lawsuits or proceedings relating to SeaStar Medical’s products and services, (viii) the risk that SeaStar Medical is unable to secure or protect its intellectual property, and (ix) other risks and uncertainties indicated from time to time in SeaStar Medical’s Annual Report on Form 10-K, including those under the “Risk Factors” section therein and in SeaStar Medical’s other filings with the SEC. The foregoing list of factors is not exhaustive. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and SeaStar Medical assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact:

Alliance Advisors IR
Jody Cain
(310) 691-7100
[email protected]

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