Category: Uncategorized

NESS ZIONA, Israel, May 08, 2025 (GLOBE NEWSWIRE) — BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that the Company will host a conference call and a live audio webcast on Thursday, May 15, 2025, at 2:00 p.m. ET, to report first quarter 2025 financial results and provide business and program updates.

To participate in the conference call, please dial 1-877-407-0724 (U.S.) or +1 201-389-0898 (International). The live and archived webcast will be available in the Investors section of the Company’s website at www.biomx.com.

About BiomX

BiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT (“BacteriOphage Lead to Treatment”) platform to customize phage compositions against these targets. For more information, please visit www.biomx.com, the content of which does not form a part of this press release.

BiomX, Inc.

Ben Cohen
Head Corporate Communications
[email protected]

MINNEAPOLIS, May 08, 2025 (GLOBE NEWSWIRE) — Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on fluid management solutions for patients with fluid overload, today announced a meaningful step forward for children facing fluid overload with the recent expansion of its Aquadex SmartFlow^® therapy into two additional pediatric centers across the Southeastern United States. The company now has 47 pediatric centers that have adopted Aquadex therapy as part of their fluid management approach.

Even in well-managed care settings, fluid overload can be a turning point in recovery for pediatric patients—who often have a narrow margin for error. When alternative therapies fall short, the patient risks can escalate quickly. More hospitals are now turning to Aquadex to support pediatric life-saving intervention, helping teams act before fluid overload drives complications and, in some cases, mortality.

“Pediatric patients require an added level of precision. The margin for error is narrow, and the clinical stakes are often immediate,” said John Jefferies, MD, MPH, FACC, FHFSA, Chief Medical Officer of Nuwellis. “That is why this expansion matters—it provides care teams with an additional therapeutic option for managing fluid overload in critically ill children.”

Aquadex is a nurse-managed, bedside-compatible therapy that allows for controlled, gentle fluid removal. Designed for use in adults and pediatric patients weighing 20 kg and above, it offers an approach that supports stability without the need for aggressive intervention—especially important in pediatric care.

For Nuwellis, the expansion is not just a number. It is a signal that more clinical teams are rethinking how and when they intervene. Early, precise fluid management is increasingly viewed as a path to better outcomes, and fewer setbacks, for this vulnerable population.

“Every new hospital that brings in Aquadex is one more team empowered to act with confidence and control,” said John Erb, Interim Chief Executive Officer of Nuwellis. “We are immensely proud to support that shift.”

For more information, visit www.nuwellis.com.

About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit www.nuwellis.com or visit us on LinkedIn or X, formerly known as Twitter.

About the Aquadex SmartFlow System The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.

Forward-Looking Statements Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2025 and beyond. 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 risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.

For further information, please contact:

Investor Relations:

Louisa Smith
Gilmartin Group
[email protected]

Media Contact:

Leah McMullen
Director of Communications
[email protected]

ALACHUA, Fla. and TAMPA, Fla., May 08, 2025 (GLOBE NEWSWIRE) — Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced the appointment of Lindsey Hartley, CPA, as Chief Financial Officer, effective May 12, 2025. Ms. Hartley, who currently serves as Vice President, Corporate Controller at Axogen, will succeed Nir Naor, who is departing to pursue other opportunities. Mr. Naor will remain with the Company in an advisory capacity until July 1, 2025, to ensure a smooth transition.

“I want to express my sincere gratitude to Nir for his service to Axogen,” said Michael Dale, President, Chief Executive Officer and Director of Axogen. “Nir joined the company at a time of significant leadership transition to provide leadership and stability to the finance function. Under his leadership, our finance team implemented significant improvements in operating expense and cash flow management and successfully supported development of Axogen’s new strategic plan. His efforts in strengthening our financial foundation and driving operational efficiencies have been instrumental in the company’s improved performance and we wish him continued success in his future endeavors.”

“To succeed Mr. Naor, I am delighted to announce the promotion of Lindsey Hartley to the role of Chief Financial Officer for Axogen,” continued Dale. “Having worked closely with Lindsey since I joined Axogen, I have grown to appreciate her deep understanding of our business, strong financial acumen, and untiring work ethic and commitment to excellence. I am confident her experience and institutional knowledge make her the ideal partner to the Executive Leadership team to help guide Axogen through our next phase of growth as we work to fulfill our business purpose to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care.”

Ms. Hartley brings more than 19 years of financial leadership experience to her new role, with significant expertise in corporate finance, accounting, and financial reporting within the healthcare and medical device sectors. Since joining Axogen in October 2021 as Vice President, Corporate Controller, she has overseen all accounting operations including SEC reporting, treasury management, internal controls, and SOX compliance. During her tenure, she has significantly improved financial reporting processes, reduced month-end close time by 40%, and enhanced cash forecasting capabilities. Prior to Axogen, she served as VP of Finance, Accounting and Human Strategy at VERO Biotech, an emerging biotechnology company focused on innovative nitric oxide delivery systems. Earlier in her career, Ms. Hartley held controller positions at Brookhaven Medical, a medical device manufacturing company specializing in peripheral vascular and regenerative medicine products and held management roles at Bluegreen Vacations and as an audit manager at EY. Ms. Hartley holds a Bachelor of Science in Accounting from the University of South Florida and is a Certified Public Accountant.

“I am honored to step into the CFO role at this pivotal moment for Axogen,” said Lindsey Hartley. “Having worked closely with our talented finance team over the past three years, I’ve witnessed our remarkable progress and tremendous potential. I look forward to focusing on financial discipline and strategic growth initiatives that support our innovative work to restore nerve function and transform patients’ lives.”

About Axogen

Axogen (AXGN) is the leading Company focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves by providing innovative, clinically proven, and economically effective repair solutions for surgeons and health care providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.

Axogen’s product portfolio includes Avance^® Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site; Axoguard Nerve Connector^®, a porcine submucosa ECM coaptation aid for tensionless repair of severed peripheral nerves; Axoguard Nerve Protector^®, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; Axoguard HA+ Nerve Protector™, a porcine submucosa ECM base layer coated with a proprietary hyaluronate-alginate gel, a next-generation technology designed to provide short- and long-term protection for peripheral nerve injuries; Avive+ Soft Tissue Matrix™, a multi-layer amniotic membrane allograft used to protect and separate tissues in the surgical bed during the critical phase of tissue repair; and Axoguard Nerve Cap^®, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

Cautionary Statements Concerning Forward-Looking Statements

This press release contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and predictions of future conditions, events, or results, which are derived from various assumptions and estimates of trends and economic factors in the markets where we operate, as well as our business plans. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “forecasts,” “continue,” “may,” “should,” “will,” “goals,” and similar expressions are intended to identify these forward-looking statements.

In addition to general industry and economic conditions, factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, the risk factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and other risks and uncertainties detailed from time to time in reports filed by the Company with the SEC.

Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those projected. These statements are representative only as of the date they are made, and except as required by applicable law, we assume no obligation to publicly update or revise any forward-looking statements.

Investor Contact:
Axogen, Inc. [email protected]