Viemed Healthcare Announces Date and Time for Conference Call

Viemed Healthcare Announces Date and Time for Conference Call




Viemed Healthcare Announces Date and Time for Conference Call

LAFAYETTE, La., April 23, 2024 (GLOBE NEWSWIRE) — Viemed Healthcare, Inc. (the “Company” or “Viemed”) (NASDAQ:VMD), a national leader in respiratory care and technology-enabled home medical equipment services, announced today that it will host its Quarterly Conference Call on Tuesday, May 7, 2024 at 11:00 a.m. ET.

Interested parties may participate in the call by dialing:

877-407-6176 (US Toll-Free)
+1 201-689-8451 (International)

Financial professionals are invited to call in to register in advance to ask questions. To pre-register as a qualified caller, please e-mail investorinfo@viemed.com by 12:00 p.m. ET Monday, May 6, 2024.

Live Audio Webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=3FnR2caD

Following the live call, a replay will be available in the Investor Relations section of the Company’s website, www.viemed.com.

ABOUT VIEMED HEALTHCARE, INC.

Viemed is a provider of in-home medical equipment and post-acute respiratory healthcare services in the United States. Viemed’s service offerings are focused on effective in-home treatment with clinical practitioners providing therapy and counseling to patients in their homes using cutting-edge technology. Visit our website at www.viemed.com.

For further information, please contact:

Glen Akselrod
Bristol Capital
905-326-1888
glen@bristolir.com

Todd Zehnder
Chief Operating Officer
Viemed Healthcare, Inc.
337-504-3802
investorinfo@viemed.com

Visory Health Secures Women’s Business Enterprise National Council Certification for Third Consecutive Year

Visory Health Secures Women’s Business Enterprise National Council Certification for Third Consecutive Year




Visory Health Secures Women’s Business Enterprise National Council Certification for Third Consecutive Year

The Florida-based, woman-owned business granting accessible, affordable prescriptions to underserved populations joins 18,000 other prestigious female-led companies after rigorous vetting

ESTERO, Fla., April 23, 2024 (GLOBE NEWSWIRE) — Visory Health, a women-led, patient-first health tech prescription platform that is transforming the way women, families and caregivers access affordable healthcare through its online prescription discount card, today announces its national certification as a Women’s Business Enterprise. The certification comes to those who exemplify dedication to creating diversity and supporting the female workforce.

While a company must be at least 51% owned, operated or managed by women to be a certified WBE, Visory Health goes beyond that with an all-female senior executive leadership team. The organization also requires the female owner to have real and substantial control of the capital contributions for the company. Because of the thorough process and strict eligibility requirements, the WBENC Certification is considered the gold standard for women-owned business certification.

“We’ve been female-owned and operated since the very beginning. We’re proud to have the WBE certification as it solidifies Visory Health as a world-class employer supporting women in the workplace,” said Visory Health CEO and Founder Susan Lang. “Healthcare is shifting rapidly with greater numbers of women leaders directly impacting the health of our communities. So it makes sense that inclusion and empowerment for women is essential to our economy in addition to our well-being. This is part of our core values so our team can thrive personally and professionally.”

“It’s powerful to have an entirely female leadership team, all on a mission to disrupt healthcare. In the last few years, we’ve made monumental strides in addressing affordable and accessible medication for women, family caregivers and seniors through our prescription discount cash card. Statistically, women make the majority of healthcare decisions in their homes so showing them an innovative solution to give their families the best healthcare is our priority. Working collaboratively, there are no limits to what our team can accomplish,” said Debbie Sanders, Visory Health’s Co-Founder and COO.

The WBENC standard of certification implemented is a meticulous process including an in-depth review of the business and site inspection. There are over 18,000 WBENC-certified businesses nationwide out of more than 14 million women owned businesses.

About Visory Health
Visory Health is a women-led, patient-first health tech platform transforming the way everyone, especially women, caregivers and underserved individuals have access to healthcare. Visory Health’s model puts customers’ needs and identities at the core of how it operates. They have saved millions of customers money on their prescription medications, creating healthier families and communities. With a network of over 36,000 pharmacy partners nationwide including Kroger, Stop & Shop, Publix, Walmart and more, Visory Health delivers affordable prescription prices all over the country and is free to use. To learn more, visit www.visoryhealth.com.

Media Contact
Erica Torres
Uproar PR for Visory Health
etorres@uproarpr.com

Viemed Healthcare Announces Date and Time for Conference Call

Viemed Healthcare Announces Date and Time for Conference Call




Viemed Healthcare Announces Date and Time for Conference Call

LAFAYETTE, La., April 23, 2024 (GLOBE NEWSWIRE) — Viemed Healthcare, Inc. (the “Company” or “Viemed”) (NASDAQ:VMD), a national leader in respiratory care and technology-enabled home medical equipment services, announced today that it will host its Quarterly Conference Call on Tuesday, May 7, 2024 at 11:00 a.m. ET.

Interested parties may participate in the call by dialing:

877-407-6176 (US Toll-Free)
+1 201-689-8451 (International)

Financial professionals are invited to call in to register in advance to ask questions. To pre-register as a qualified caller, please e-mail investorinfo@viemed.com by 12:00 p.m. ET Monday, May 6, 2024.

Live Audio Webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=3FnR2caD

Following the live call, a replay will be available in the Investor Relations section of the Company’s website, www.viemed.com.

ABOUT VIEMED HEALTHCARE, INC.

Viemed is a provider of in-home medical equipment and post-acute respiratory healthcare services in the United States. Viemed’s service offerings are focused on effective in-home treatment with clinical practitioners providing therapy and counseling to patients in their homes using cutting-edge technology. Visit our website at www.viemed.com.

For further information, please contact:

Glen Akselrod
Bristol Capital
905-326-1888
glen@bristolir.com

Todd Zehnder
Chief Operating Officer
Viemed Healthcare, Inc.
337-504-3802
investorinfo@viemed.com

NeurAxis Announces New Medical Policy Coverage in North Dakota

NeurAxis Announces New Medical Policy Coverage in North Dakota




NeurAxis Announces New Medical Policy Coverage in North Dakota

CARMEL, Ind., April 23, 2024 (GLOBE NEWSWIRE) — NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today announced the publication of medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS), effective 05/06/2024, with a Blue Cross Blue Shield (BCBS) licensee in North Dakota. The BCBS licensee is the largest provider of health care coverage in North Dakota, insuring and/or administering claims for over 310,000 people, effective May 6, 2024.

IB-Stim™ is a non-surgical device that sends gentle electrical impulses into cranial nerve bundles in the ear. Neuraxis’ PENFS technology is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. There are currently no FDA-approved drug therapies for children with abdominal pain-related disorders of the gut-brain interaction. The current medical treatments, which are off-label drugs, can often have serious side effects, and most lack scientific evidence of efficacy.

“We are pleased to announce a new medical coverage policy, expanding our total covered lives for IB-Stim™ to approximately 16.5 million individuals, which speaks to the strength of the clinical data,” said Brian Carrico, President and Chief Executive Officer of NeurAxis. “We remain focused on executing on our commercial strategy, leveraging strong clinical evidence to obtain payer coverage and drive market adoption of our technology. We look forward to receiving additional coverage from payers on a national level.”

About NeurAxis, Inc.
NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive the adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway. For more information, please visit http://neuraxis.com. and https://ibstim.com/important-information/.

Forward-Looking Statements
Certain statements in this press release are 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. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, the conditions in the U.S. and global economy, the trading price and volatility of the Company’s stock, public health issues or other events, the Company’s compliance with applicable laws, the results of the Company’s clinical trials and perceptions thereof, the results of submissions to the FDA, the results of the shareholder vote to enable the issuance of the Preferred Stock, and factors described in the Risk Factors section of NeurAxis’s public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.

Contacts:

Company
NeurAxis, Inc.
info@neuraxis.com

Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com

Mobile-health Network and Online Pharmacy, Lifepack, Sign Partnership Facilitating Cooperation in Singapore and Indonesia

Mobile-health Network and Online Pharmacy, Lifepack, Sign Partnership Facilitating Cooperation in Singapore and Indonesia




Mobile-health Network and Online Pharmacy, Lifepack, Sign Partnership Facilitating Cooperation in Singapore and Indonesia

SINGAPORE, April 23, 2024 (GLOBE NEWSWIRE) — Mobile-health Network Solutions (Nasdaq: MNDR) (“MaNaDr” or the “Company”), a pioneering Asia-Pacific (“APAC”) telehealth provider, has announced a strategic partnership with PT Indopasifik Teknologi Medika Indonesia, better known as Lifepack, an online prescription provider based in Indonesia. The collaboration aims to improve healthcare accessibility in Indonesia by bringing affordable and accessible healthcare to the population.

~2,000 Indonesian physicians to be on-boarded

Under the partnership, approximately 2,000 Indonesian physicians, including general practitioners and specialists, will be on-boarded and trained to provide effective patient teleconsultations through MaNaDr’s platform. Once on the platform, these physicians will initiate an awareness program aimed at encouraging their Indonesian patients to consider the advantages of receiving medical care remotely via teleconsultations on MaNaDr’s platform. These physicians will also gain access to the platform’s AI-enabled face-scan diagnostic tools for remote diagnosis and also have the opportunity to participate in medical symposiums and knowledge-sharing initiatives with their APAC colleagues.

AI-powered Teleconsultations by MaNaDr, with Prescriptions fulfilled by Lifepack

The partnership will permit Indonesian patients, via the use of a MaNaDr mobile app, to access teleconsultations from among these physicians– as well as other preferred general practitioners or specialists on the MaNaDr platform – from the comfort of their homes. The mobile app’s AI-enabled face-scan technology permits patients without measurement equipment to receive remote diagnosis. After a teleconsultation is complete, all medications prescribed by the physician will be automatically routed by the MaNaDr platform to Lifepack, which will fill the prescriptions and arrange delivery to the patient.

Lifepack Prescription Platform

We are excited to partner with Lifepack to bring innovative healthcare solutions to Indonesia,” said Co-CEO of MaNaDr, Dr. Siaw Tung Yeng, PBM, Senior Consultant Family Physician. “This partnership will not only benefit Indonesian physicians and patients but also contribute to the advancement of telemedicine in the region.”

Natali Ardianto, CEO of Lifepack, expressed similar sentiments, stating, “The strategic partnership between MaNaDr and Lifepack aligns with our mission to deliver impactful innovations in healthcare. We look forward to providing Indonesian residents with affordable, quality and 24×7 near-instant access to prescriptions and consultations with this partnership.”

Mr. Ardianto added that Lifepack will follow-up with chronic patients to ensure their medications have been delivered in a timely fashion. 

The program is set to commence in May 2024, with a full-scale rollout expected in Q4 of 2024.

MaNaDr and Lifepack said they believed the partnership represented, “a significant step towards delivering impactful healthcare innovations at reduced cost to Indonesia’s 270 million citizens.”

The parties also said they anticipate that as the program gains acceptance in Indonesia it would likely generate, “significant incremental revenue over the coming years.”

About Mobile-health Network Solutions

Ranked #41 in Financial Times 2024 listing of 500 High-growth Asia-Pacific Companies, we are the first telehealth provider from the Asia-Pacific region to be listed in the US. Through our MaNaDr platform, we offer personalized and reliable medical attention to users worldwide. Our platform allows our community of healthcare providers to have a broader reach to users through virtual clinics without any start-up costs and the ability to connect to a global network of peer-to-peer support groups and partners. Our range of seamless and hassle-free telehealth solutions includes teleconsultation services, prescription fulfillment and other personalized services such as weight management programs and gender-specific care. For more information, please visit https://investors.manadr.com/

About Lifepack

Apotek Lifepack is a modern and reliable pharmacy service that offers a variety of over-the-counter medications, prescription drugs, supplements, and medical equipment at affordable prices. We provide original, BPOM-licensed products and deliver nationwide across Indonesia. Lifepack services are available both online and offline, accessible through our website, social media channels, WhatsApp, and the mobile app.

FORWARD-LOOKING STATEMENTS

Certain statements contained in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing dates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the following: the Company’s ability to execute our strategies, manage growth and maintain our corporate culture; the Company’s future business development, financial conditions and results of operations; expectations regarding demand for and market acceptance of our products and services; changes in technology; economic conditions; the growth of the telehealth solutions industry in Singapore and the other international markets the Company plans to serve; reputation and brand; the impact of competition and pricing; government regulations; fluctuations in general economic and business conditions in Singapore and the international markets the Company plans to serve and assumptions underlying or related to any of the foregoing and other risks contained in reports filed by the Company with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Any forward-looking statements contained in this press release speak only as of the date hereof, and Mobile-health Network Solutions specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

For media inquiries, please contact:

Mobile-health Network Solutions Investor Relations Contact:

2 Venture Drive, #07-06/07 Vision Exchange

Singapore 608526

(+65) 6222 5223

Email: investors@manadr.com

Lifepack Media Contact:

Graha Irama, 10th Floor Room C-D

Jl. HR. Rasuna Said Block X-1 Kav. 1-2,

Kuningan, Daerah Khusus Ibukota Jakarta 12950

E-mail: marketing@itmi.id

Investor Relations Inquiries:

Skyline Corporate Communications Group, LLC

Scott Powell, President

1177 Avenue of the Americas, 5th Floor

New York, New York 10036

Office: (646) 893-5835

Email: info@skylineccg.com

Attachment

CDR-Life to Present Tumor Targeting Capabilities of M-gager® Platform at the TCR-Based Therapies for Solid Tumors Summit

CDR-Life to Present Tumor Targeting Capabilities of M-gager® Platform at the TCR-Based Therapies for Solid Tumors Summit




CDR-Life to Present Tumor Targeting Capabilities of M-gager® Platform at the TCR-Based Therapies for Solid Tumors Summit

ZÜRICH, Switzerland, April 23, 2024 (GLOBE NEWSWIRE) — CDR-Life Inc. today announced a presentation on its proprietary antibody-major histocompatibility complex (MHC) technology for the development of highly specific T-cell engagers (TCE) at the TCR-Based Therapies for Solid Tumors Summit, occurring April 23-25 in Boston, Massachusetts.

The presentation will discuss how antibodies targeting tumor peptides on the MHC enable T-cells access to an untapped reservoir of intracellular tumor antigens and will highlight the M-gager® technology’s ability to leverage the potency, versatility and manufacturability of antibodies to revolutionize cancer immunotherapy.

Presentation Details
Title: Unlocking Tumor Eradication with Antibody-MHC T Cell Engagers
Presenter: Leonardo Borras, Chief Scientific Officer
Date: April 23, 2024

About CDR-Life
CDR-Life is developing powerful T-cell engagers (TCE) to eradicate hard-to-treat solid tumors. Our integrated antibody-based TCE platform unlocks access to a wide range of cancer antigens. We are leveraging this platform to advance a pipeline of potent and selective TCE therapeutics targeting intracellular and surface tumor antigens. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to empower patients’ own immune systems to eliminate tumors.

CONTACT: Contacts

Media:
Holly Hancock
MacDougall Advisors
hhancock@macdougall.bio

ITM, Helmholtz Munich and University Hospital Münster Announce First Patient Dosed in Phase I Investigator-Initiated Glioblastoma Trial

ITM, Helmholtz Munich and University Hospital Münster Announce First Patient Dosed in Phase I Investigator-Initiated Glioblastoma Trial




ITM, Helmholtz Munich and University Hospital Münster Announce First Patient Dosed in Phase I Investigator-Initiated Glioblastoma Trial

A Novel Therapeutic Approach to Treatment using ITM-31

Garching/Munich, Munich and Münster, April 23, 2024 – The Departments of Neurosurgery and Nuclear Medicine at the University Hospital Münster, Helmholtz Munich, and ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the first patient has been dosed in an investigator-initiated trial (IIT) with ITM’s radiopharmaceutical drug candidate, ITM-31 for the potential use in glioblastoma patients. The IIT is sponsored by the University Hospital Münster, conducted in hospitals in Münster, Essen, Cologne, and Würzburg, and supported by Helmholtz Munich and ITM.

After glioblastoma patients receive standard treatment with surgery, radio- and chemotherapy, individual tumor cells often remain undetected in surrounding tissue and grow again leading to relapse. This makes glioblastoma one of the most aggressive, deadliest and hard-to-treat cancers.

“Glioblastoma remains a challenging disease. Eliminating residual tumor cells in the surrounding tissue post-surgery could be crucial to address and prevent relapses. As such, we believe that ITM-31 has the potential to improve current treatment methods in this high-need indication,” said Prof. Walter Stummer, Principal Investigator and Chairman of the Department of Neurosurgery at the University Hospital Münster. Study Coordinator, Prof. Hans-Jürgen Reulen added, “The phase I study will allow us to further analyze the impact that ITM-31 could make in this patient population, and marks a critical step in the clinical development of this promising radiopharmaceutical drug candidate.

ITM-31 is a carbonic anhydrase (CA) XII-specific antibody Fab fragment developed by Helmholtz Munich and coupled with ITM’s medical radioisotope, non-carrier-added Lutetium-177 (n.c.a. 177Lu, EndolucinBeta®).

“The phase I study builds on previous preclinical data that point to radiopharmaceuticals as a potential new method with which to circumvent previous challenges posed by glioblastoma,” commented Prof. Reinhard Zeidler from Helmholtz Munich, who spearheaded the basic research and provided scientific oversight throughout the transition to clinical trials.

“Innovative radiopharmaceuticals have the potential to address gaps in current treatment paradigms, particularly in aggressive cancers with poor prognoses such as glioblastoma,” said Steffen Schuster, CEO of ITM.ITM is proud to support this trial conducted by Prof. Stummer and the University Hospital Münster.”

The dose-escalation study (NCT05533242) is enrolling up to 15 patients and will evaluate the impact of ITM-31 on glioblastoma patients by analyzing the tolerability and safety of ITM-31 while evaluating the best possible patient dose for future studies. Patients presenting either no or stable, high-grade glioma residue following standard therapy (surgery and radiochemotherapy, adjuvant chemotherapy), are eligible for the trial, 6 weeks after completing radiotherapy, at the earliest. Patients will receive their personalized calculated total doses of ITM-31 in three fractions with an interval of 4 weeks between injections.

About ITM Isotope Technologies Munich SE

ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including two phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our nearly two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life.
www.itm-radiopharma.com

Helmholtz Munich

Helmholtz Munich is a leading biomedical research center. Its mission is to discover breakthrough solutions for better health in a rapidly changing world. It is home to interdisciplinary research teams investigating the development of environmentally triggered diseases. With the power of artificial intelligence and bioengineering, the researchers accelerate the translation process to patients in the areas of therapy and prevention with a focus on diabetes, obesity, allergies and chronic lung diseases. Helmholtz Munich has more than 2,500 employees and is headquartered in Neuherberg, north of Munich. It is a member of the Helmholtz Association, the largest scientific organization in Germany with more than 43,000 employees and 18 research centers. Learn more about Helmholtz Munich (Helmholtz Zentrum München, Deutsches Forschungszentrum für Gesundheit und Umwelt GmbH): www.helmholtz-munich.de/en

ITM Contact

Corporate Communications
Kathleen Noonan / Gerrit Siegers    
Phone: +49 89 329 8986 1502        
Email: communications@itm-radiopharma.com

Investor Relations
Ben Orzelek  
Phone: +49 89 329 8986 1009
Email: investors@itm-radiopharma.com

Helmholtz Munich
Media Relations, Verena Coscia
Phone: +49 89 3187- 49342
Email: presse@helmholtz-munich.de

University Hospital Münster
Media Relations, Dr. Thomas Bauer
Phone: +49 251 83 58937
Email: thomas.bauer@ukmuenster.de

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Sequana Medical announces the Annual and Extraordinary General Meetings of Shareholders on 23 May 2024

Sequana Medical announces the Annual and Extraordinary General Meetings of Shareholders on 23 May 2024




Sequana Medical announces the Annual and Extraordinary General Meetings of Shareholders on 23 May 2024

PRESS RELEASE
REGULATED INFORMATION
23 April 2024, 07:00 am CET

Sequana Medical announces the Annual and Extraordinary General Meetings
of Shareholders on 23 May 2024

Publication of Annual Report 2023

Ghent, Belgium – 23 April 2024 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today invites the holders of securities issued by the Company to attend the Annual and Extraordinary General Meetings of Shareholders on Thursday, 23 May 2024. The annual report for the financial year 2023 has been published on Sequana Medical’s website and can be accessed here.

The items on the agendas of the meetings include (among other) the proposed approval of a number of resolutions relating to the financial year ended 31 December 2023, the proposed approval of the revised remuneration policy, the proposed reappointment of the statutory auditor, the application of Article 7:151 of the Belgian Companies and Associations Code, the proposed contribution in kind of certain receivables pursuant to the unsecured and subordinated convertible loan agreement entered into on 7 February 2024 between the Company and Partners in Equity and Rosetta Capital (the “Lenders“) in the principal amount of EUR 3,041,507.59 (the “Convertible Loan Agreement“) and the resulting proposed share capital increase, as well as the renewal of the authorization to the Board of Directors to increase the share capital within the framework of the authorised capital.

The Annual and Extraordinary General Meetings of Shareholders will take place at the Company’s registered offices in Ghent and will start at 09:00 am CET. The full convening notice with the agenda and proposed resolutions can be accessed on the Sequana Medical website: www.sequanamedical.com/investors/shareholder-information.

The Company recommends the holders of its securities to use e-mail for all communications with the Company regarding the Annual and Extraordinary General Meetings of Shareholders. The Company’s e-mail address for such communications is: IR@sequanamedical.com.

Disclosures in accordance with Article 7:97, §4/1 of the Belgian Companies and Associations Code

The following information is provided, in as far as needed and applicable, pursuant to Article 7:97, §4/1 of the Belgian Companies and Associations Code in connection with the proposed contribution in kind to the share capital of the Company of the receivables that are or will be due by the Company under the Convertible Loan Agreement to the Lenders (the “Convertible Receivables“) (the “Transaction“).

Partners in Equity and Rosetta Capital are both shareholders of the Company and are represented on the board of directors of the Company. As a result, Partners in Equity and Rosetta Capital could each be considered as a “related party” in accordance with the International Financial Reporting Standards, as adopted by the European Union (IFRS), as referred to in Article 7:97 of the Belgian Companies and Associations Code. In view hereof, and in accordance with paragraph 2, 1° of Article 7:97 of the Belgian Companies and Associations Code, the board of directors of the Company has applied the procedure of Article 7:97 of the Belgian Companies and Associations Code in connection with the contemplated proposal of the board of directors to the extraordinary general meeting to contribute in kind the Convertible Receivables to the share capital of the Company. Ids van der Weij (a director of the Company representing Partners in Equity) and Kenneth Macleod (a director of the Company representing Rosetta Capital) did not participate in the deliberation and voting by the board of directors of the Company in relation to the approval of the Transaction.

Consequently, a committee of three independent directors of the Company (the “Committee“) issued an advice to the board of directors in which the Committee has assessed the proposal to the extraordinary general meeting to contribute in kind the Convertible Receivables. In its advice to the board of directors, the Committee concluded the following:

The Committee believes that (i) under the then existing circumstances and taking into account the then existing immediate working capital needs of the Company as well as the then available financing options, the provisions of the Convertible Loan Agreement, including the agreed provisions relating to the (mandatory) contribution in kind of Convertible Receivables, were in the interest of the Company, its shareholders and other stakeholders, given that without the Convertible Loan Agreement, the Company may not have been able to meet its short-term financing needs and the going concern of the Company could no longer be guaranteed; (ii) the proposed contribution in kind is in the interest of the Company, its shareholders and creditors, given that via the proposed contribution in kind the Company (x) can meet its obligation to settle the Convertible Receivables without having to use existing or new funds (in cash), which it can use to finance working capital needs and, in particular, the further development of its products and clinical trials, (y) reduce its indebtedness, and (z) improve its net equity position (as the amount of the share capital is strengthened); (iii) while an additional and significant potential dilution will be incurred by the holders of shares and share options of the Company as a result of the Transaction (in particular because of the agreed conversion price representing a high discount compared to the price of the Company’s existing shares as they are currently traded at the date of this advice), the Transaction does not seem to be unreasonable and seems to be commensurate to the risks of investing in the Company and, in particular, the risks and opportunity costs of the Lenders to agree to the Convertible Loan Agreement).

After consideration, the Committee is therefore of the opinion that the expected benefits of the proposed contribution in kind, taking into account the context in which this obligation had arisen, are in balance with the expected risks and disadvantages thereof. Accordingly, the Committee is of the opinion that the Transaction is in the interest of the Company, and in any event is not manifestly unlawful.

In light of this, the Committee provides a favourable and approving advice to the board of directors of the Company.

The board of directors of the Company did not deviate from the Committee’s favourable and approving conclusion. The assessment by the Company’s statutory auditor of the Committee’s advice and the minutes of the meeting of the board of directors of the Company relating to the Transaction, is as follows:

Based on our assessment, nothing has come to our attention that leads us to believe that the financial and accounting information mentioned in the advice of the Ad Hoc Committee of independent directors dated 19 April 2024 and in the minutes of the board meeting dated 19 April 2024, which justify the intended transaction in writing and substantially, are not, in all material respects, fair and sufficient with the information available to us within the scope of our engagement. Our engagement was solely conducted within the framework of Article 7:97 of the Belgian Companies and Associations Code, and therefore our report cannot be used in any other context.

For more information, please contact:

Sequana Medical

Ian Crosbie
Chief Executive Officer
E: IR@sequanamedical.com
T: +44 7973 42 99 17

About Sequana Medical

Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. This causes major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing and restricted mobility. Although diuretics are standard of care, they become ineffective, untolerable or exacerbate the problem in many patients. There are limited effective treatment options, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing “diuretic-resistant” patient population.

alfapump® and DSR® are Sequana Medical’s proprietary platforms that work with the body to treat diuretic-resistant fluid overload, delivering major clinical and quality of life benefits for patients and reducing costs for healthcare systems.

The Company’s Premarket Approval (PMA) application for the alfapump was submitted to the US FDA in December 2023 and accepted for substantive review in January 2024, having reported positive primary and secondary endpoint data from the North American pivotal POSEIDON study in recurrent or refractory ascites due to liver cirrhosis. US market approval of the alfapump is anticipated by the end of Q3 2024.

Results of the Company’s RED DESERT and SAHARA proof-of-concept studies in heart failure support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements. The independent Data Safety Monitoring Board approved the start of the randomized MOJAVE cohort of up to a further 30 patients, which is planned after alfapump US PMA approval.

Sequana Medical is listed on the regulated market of Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Regulatory Disclaimers

The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump system is currently under clinical investigation (POSEIDON Trial) and is being studied in adult patients with refractory or recurrent ascites due to liver cirrhosis. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. There is no link between DSR therapy and ongoing investigations with the alfapump system in Europe, the United States or Canada.

Note: alfapump® and DSR® are registered trademarks.

Forward-looking statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

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AAVantgarde presents positive preclinical data in large animal models from its Stargardt disease program in an oral presentation at the ASGCT 2024 annual meeting

AAVantgarde presents positive preclinical data in large animal models from its Stargardt disease program in an oral presentation at the ASGCT 2024 annual meeting




AAVantgarde presents positive preclinical data in large animal models from its Stargardt disease program in an oral presentation at the ASGCT 2024 annual meeting

MILAN, Italy, April 23, 2024 (GLOBE NEWSWIRE) — AAVantgarde Bio (AAVantgarde), a clinical-stage, Italian-based international biotechnology company with two proprietary Adeno-Associated Viral (AAV) vector platforms for large gene delivery, today announces the publication of an abstract accepted as an oral presentation submitted to The American Society of Gene & Cell Therapy 27th Annual Meeting (ASGCT), to be held May 7-11 in Baltimore.

The data to be presented confirms that AAV intein-mediated retinal gene therapy for Stargardt disease is effective and safe in large animal models (pig and NHP). In pigs, AAVantgarde demonstrate that lipofuscin accumulation in the retinal pigmented epithelium was reduced upon subretinal delivery of AAV-ABCA4 intein vectors. Similarly, in NHP, BaseScope analysis showed nearly total photoreceptor co-expression of mRNAs encoding both ABCA4-intein halves across an extended NHP retinal region.

Prof. Alberto Auricchio, CSO of AAVantgarde stated “We are very excited to be presenting positive Pig and NHP safety and efficacy data from our Stargardt program as an oral presentation, supporting both the efficacy and safety of AAV-ABCA4-intein vectors in relevant large animal models, and providing important insights towards the clinical translation of this platform for gene therapy of STGD1.”

Dr. Natalia Misciattelli, CEO of AAVantgarde added that “This preclinical positive data in large animal models is promising and provides hope for underserved Stargardt patients that don’t have any therapeutic options to prevent them from losing their sight.”

Oral Presentation details:
Presentation Date/Time: Friday May 10, 2024, 4:00pm – 4:15pm
Session title: AAV Vectors – Non-Human Primates and Large Animal Models
Session Room: Ballroom 4
Final abstract number: 297

About AAVantgarde Bio
AAVantgarde Bio is a clinical stage, Italian headquartered, international biotechnology company that has developed two proprietary Adeno-Associated Viral (AAV) vector platforms to address the gene therapy cargo capacity limitations of AAV vectors. The AAVantgarde platforms could be used to deliver large genes to ocular and non-ocular tissues. Co-founded by Professor Alberto Auricchio at TIGEM (Telethon Institute of Genetics and Medicine) in Naples, Italy, and Telethon Foundation, AAVantgarde will initially validate the platform in the clinic in two inherited retinal diseases with clear unmet need. For more information, please visit: www.aavantgarde.com

Contact:
Magda Blanco – Head of Corporate Development AAVantgarde
Phone: +44 (0) 7522 128285
Email:  m.blanco@aavantgarde.com

Sequana Medical announces the Annual and Extraordinary General Meetings of Shareholders on 23 May 2024

Sequana Medical announces the Annual and Extraordinary General Meetings of Shareholders on 23 May 2024




Sequana Medical announces the Annual and Extraordinary General Meetings of Shareholders on 23 May 2024

PRESS RELEASE
REGULATED INFORMATION
23 April 2024, 07:00 am CET

Sequana Medical announces the Annual and Extraordinary General Meetings
of Shareholders on 23 May 2024

Publication of Annual Report 2023

Ghent, Belgium – 23 April 2024 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today invites the holders of securities issued by the Company to attend the Annual and Extraordinary General Meetings of Shareholders on Thursday, 23 May 2024. The annual report for the financial year 2023 has been published on Sequana Medical’s website and can be accessed here.

The items on the agendas of the meetings include (among other) the proposed approval of a number of resolutions relating to the financial year ended 31 December 2023, the proposed approval of the revised remuneration policy, the proposed reappointment of the statutory auditor, the application of Article 7:151 of the Belgian Companies and Associations Code, the proposed contribution in kind of certain receivables pursuant to the unsecured and subordinated convertible loan agreement entered into on 7 February 2024 between the Company and Partners in Equity and Rosetta Capital (the “Lenders“) in the principal amount of EUR 3,041,507.59 (the “Convertible Loan Agreement“) and the resulting proposed share capital increase, as well as the renewal of the authorization to the Board of Directors to increase the share capital within the framework of the authorised capital.

The Annual and Extraordinary General Meetings of Shareholders will take place at the Company’s registered offices in Ghent and will start at 09:00 am CET. The full convening notice with the agenda and proposed resolutions can be accessed on the Sequana Medical website: www.sequanamedical.com/investors/shareholder-information.

The Company recommends the holders of its securities to use e-mail for all communications with the Company regarding the Annual and Extraordinary General Meetings of Shareholders. The Company’s e-mail address for such communications is: IR@sequanamedical.com.

Disclosures in accordance with Article 7:97, §4/1 of the Belgian Companies and Associations Code

The following information is provided, in as far as needed and applicable, pursuant to Article 7:97, §4/1 of the Belgian Companies and Associations Code in connection with the proposed contribution in kind to the share capital of the Company of the receivables that are or will be due by the Company under the Convertible Loan Agreement to the Lenders (the “Convertible Receivables“) (the “Transaction“).

Partners in Equity and Rosetta Capital are both shareholders of the Company and are represented on the board of directors of the Company. As a result, Partners in Equity and Rosetta Capital could each be considered as a “related party” in accordance with the International Financial Reporting Standards, as adopted by the European Union (IFRS), as referred to in Article 7:97 of the Belgian Companies and Associations Code. In view hereof, and in accordance with paragraph 2, 1° of Article 7:97 of the Belgian Companies and Associations Code, the board of directors of the Company has applied the procedure of Article 7:97 of the Belgian Companies and Associations Code in connection with the contemplated proposal of the board of directors to the extraordinary general meeting to contribute in kind the Convertible Receivables to the share capital of the Company. Ids van der Weij (a director of the Company representing Partners in Equity) and Kenneth Macleod (a director of the Company representing Rosetta Capital) did not participate in the deliberation and voting by the board of directors of the Company in relation to the approval of the Transaction.

Consequently, a committee of three independent directors of the Company (the “Committee“) issued an advice to the board of directors in which the Committee has assessed the proposal to the extraordinary general meeting to contribute in kind the Convertible Receivables. In its advice to the board of directors, the Committee concluded the following:

The Committee believes that (i) under the then existing circumstances and taking into account the then existing immediate working capital needs of the Company as well as the then available financing options, the provisions of the Convertible Loan Agreement, including the agreed provisions relating to the (mandatory) contribution in kind of Convertible Receivables, were in the interest of the Company, its shareholders and other stakeholders, given that without the Convertible Loan Agreement, the Company may not have been able to meet its short-term financing needs and the going concern of the Company could no longer be guaranteed; (ii) the proposed contribution in kind is in the interest of the Company, its shareholders and creditors, given that via the proposed contribution in kind the Company (x) can meet its obligation to settle the Convertible Receivables without having to use existing or new funds (in cash), which it can use to finance working capital needs and, in particular, the further development of its products and clinical trials, (y) reduce its indebtedness, and (z) improve its net equity position (as the amount of the share capital is strengthened); (iii) while an additional and significant potential dilution will be incurred by the holders of shares and share options of the Company as a result of the Transaction (in particular because of the agreed conversion price representing a high discount compared to the price of the Company’s existing shares as they are currently traded at the date of this advice), the Transaction does not seem to be unreasonable and seems to be commensurate to the risks of investing in the Company and, in particular, the risks and opportunity costs of the Lenders to agree to the Convertible Loan Agreement).

After consideration, the Committee is therefore of the opinion that the expected benefits of the proposed contribution in kind, taking into account the context in which this obligation had arisen, are in balance with the expected risks and disadvantages thereof. Accordingly, the Committee is of the opinion that the Transaction is in the interest of the Company, and in any event is not manifestly unlawful.

In light of this, the Committee provides a favourable and approving advice to the board of directors of the Company.

The board of directors of the Company did not deviate from the Committee’s favourable and approving conclusion. The assessment by the Company’s statutory auditor of the Committee’s advice and the minutes of the meeting of the board of directors of the Company relating to the Transaction, is as follows:

Based on our assessment, nothing has come to our attention that leads us to believe that the financial and accounting information mentioned in the advice of the Ad Hoc Committee of independent directors dated 19 April 2024 and in the minutes of the board meeting dated 19 April 2024, which justify the intended transaction in writing and substantially, are not, in all material respects, fair and sufficient with the information available to us within the scope of our engagement. Our engagement was solely conducted within the framework of Article 7:97 of the Belgian Companies and Associations Code, and therefore our report cannot be used in any other context.

For more information, please contact:

Sequana Medical

Ian Crosbie
Chief Executive Officer
E: IR@sequanamedical.com
T: +44 7973 42 99 17

About Sequana Medical

Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. This causes major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing and restricted mobility. Although diuretics are standard of care, they become ineffective, untolerable or exacerbate the problem in many patients. There are limited effective treatment options, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing “diuretic-resistant” patient population.

alfapump® and DSR® are Sequana Medical’s proprietary platforms that work with the body to treat diuretic-resistant fluid overload, delivering major clinical and quality of life benefits for patients and reducing costs for healthcare systems.

The Company’s Premarket Approval (PMA) application for the alfapump was submitted to the US FDA in December 2023 and accepted for substantive review in January 2024, having reported positive primary and secondary endpoint data from the North American pivotal POSEIDON study in recurrent or refractory ascites due to liver cirrhosis. US market approval of the alfapump is anticipated by the end of Q3 2024.

Results of the Company’s RED DESERT and SAHARA proof-of-concept studies in heart failure support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements. The independent Data Safety Monitoring Board approved the start of the randomized MOJAVE cohort of up to a further 30 patients, which is planned after alfapump US PMA approval.

Sequana Medical is listed on the regulated market of Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Regulatory Disclaimers

The alfapump® system is currently not approved in the United States or Canada. In the United States and Canada, the alfapump system is currently under clinical investigation (POSEIDON Trial) and is being studied in adult patients with refractory or recurrent ascites due to liver cirrhosis. DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. There is no link between DSR therapy and ongoing investigations with the alfapump system in Europe, the United States or Canada.

Note: alfapump® and DSR® are registered trademarks.

Forward-looking statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

Attachments