Series H warrants exercisable following release of positive outcomes results related to one-year follow-up from the Company’s C-GUARDIANS pivotal trial. Participating warrant holders include Marshall Wace, OrbiMed, Rosalind, Nantahala, Soleus, Velan, and certain InspireMD Board members. Represents first of four milestone-driven warrant tranches pursuant to private placement financing of up to $113.6 million announced in May 2023. TEL AVIV, Israel and WESTIN, Fla., July 01, 2024 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the completion of the full exercise of 12.9 million Series H warrants. The Series H warrants were converted primarily into pre-funded warrants. The gross proceeds to the company from the warrant exercise were $17.9 million, and $16.9 million after fees. The Series H warrants were issued as part of the transformational private placement financing of up to $113.6 million that InspireMD announced in May 2023. The Series H warrants became exercisable following the release of positive results related to one-year follow-up from the Company’s C-GUARDIANS pivotal trial of the CGuard Carotid Stent System. Participating warrant holders include Marshall Wace, OrbiMed, Rosalind, Nantahala, Soleus, Velan, and certain InspireMD Board members. Marvin Slosman, chief executive officer of InspireMD, stated, “We are grateful for the continued support of these highly regarded healthcare investors, who have elected to exercise 100% of the available Series H warrants. This capital strengthens our business and helps fuel our growth, including advancing our CGuard Prime Carotid Stent System through to potential FDA approval and U.S. launch in the first half of next year. CGuard is a highly differentiated stent implant that delivers superior short- and long-term patient outcomes, as reflected in the best-in-class evidence that was reported at both the VIVA 2023 and LINC 2024 conferences. Looking ahead, we are working to catalyze these milestones to continue building momentum toward commercialization, while advancing both our CAS and TCAR programs to address the broadest range of physicians and patient needs of any company within the field of carotid revascularization.” About InspireMD, Inc.InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR. We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com. Forward-looking StatementsThis press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Examples of such statements include, but are not limited to, statements relating to the C-Guardians U.S. IDE clinical trial, including one-year results from such trial presented at LINC 2024, as well as the timing and outcome of any subsequent results, PMA or potential launch, and statements relating to expectations regarding future warrant exercises or expected proceeds therefrom. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Investor Contacts: Craig ShoreChief Financial OfficerInspireMD, Inc.888-776-6804craigs@inspiremd.com Chuck Padala, Managing DirectorLifeSci Advisors646-627-8390chuck@lifesciadvisors.cominvestor-relations@inspiremd.com
Financial
Idorsia’s JERAYGO (aprocitentan) approved in Europe as first and only ERA for the treatment of resistant hypertension
Idorsia receives approval from the European Commission (EC) for JERAYGO™ (aprocitentan) as the first and only endothelin receptor antagonist (ERA) for the treatment of resistant hypertension.JERAYGO is a new oral antihypertensive therapy – the first in almost 40 years – that is working via a new therapeutic pathway. Allschwil, Switzerland – July 1, 2024Idorsia Ltd (SIX: IDIA) announced today that the European Commission (EC) has approved JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products.1 The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure (BP) control.1 Hypertension is one of the leading causes of cardiovascular disease worldwide, impacting an estimated 1.3 billion people globally.2 Approximately 10% of these people have uncontrolled BP, despite receiving at least three antihypertensive medications from different classes, at optimal doses and they are categorized in hypertension guidelines as having resistant hypertension.3,4 Prof. Krzysztof Narkiewicz, MD, PhD, Head of the Department of Hypertension and Diabetology, Medical University of Gdansk, Poland, commented:“JERAYGO is an oral antihypertensive therapy that is tackling a new therapeutic pathway – the endothelin system. JERAYGO has demonstrated clinically meaningful rapid and long-term reduction in blood pressure. What I was particularly impressed with, this effect was shown in patients with resistant hypertension, whose blood pressure remained uncontrolled despite receiving at least three antihypertensive medications as background therapy. In Europe, there are millions of patients with resistant hypertension, and they are at a higher risk of heart attack, heart failure, stroke, end-stage renal disease and death due to their high blood pressure. With JERAYGO, doctors now a have an effective new treatment option to help control blood pressure in these patients.” Alberto Gimona, MD, Head of Global Clinical Development & Medical Affairs, commented:“We are very proud to have gained approval for JERAYGO, the first innovative anti-hypertensive drug in 40 years, acting on the endothelin pathway, which we believe is a key player in patients with resistant hypertension. We have seen a clinically meaningful and consistent blood pressure lowering across blood pressure measurement methodologies and in subgroups of patients with serious comorbidities – for example in patients with chronic kidney disease. We also saw a marked reduction in albuminuria with JERAYGO as evidenced by a decrease in baseline UACR. I’m very pleased that the wealth of data we have generated with JERAYGO is well reflected in the label. We will now work to expand marketing authorization by also applying for JERAYGO approval in the UK, Canada, and Switzerland.” André Muller, Chief Executive Officer of Idorsia commented:“With aprocitentan, we have a largely unencumbered asset approved in the US and Europe. We continue to carefully evaluate all our funding options including potential collaborations for the commercialization of aprocitentan, while preparing to make aprocitentan available in these two key markets.” About the Phase 3 PRECISION study1,5The efficacy of aprocitentan was evaluated in one randomized, double-blind (DB), placebo-controlled Phase 3 multicenter study. Patients with uncontrolled blood pressure (systolic blood pressure [SBP] ≥140 mmHg) despite the use of at least three antihypertensive medicinal products and following exclusion of pseudo-resistant hypertension (e.g., white coat effect, inappropriate blood pressure measurement, secondary causes of hypertension) were considered to have resistant hypertension. The patients were switched to standardized background antihypertensive therapy consisting of an angiotensin receptor blocker (valsartan 160 mg), a calcium channel blocker (amlodipine 5 or 10 mg), and a diuretic (hydrochlorothiazide 25 mg) throughout the study. Patients with concomitant use of beta-blockers continued this treatment throughout the study, in addition to the standardized background antihypertensive therapy and study treatment. A total of 730 patients received either aprocitentan 12.5 mg, aprocitentan 25 mg, or placebo once daily during the initial 4-week DB treatment (part 1). Thereafter, patients received aprocitentan 25 mg once daily during the 32-week single-blind treatment (part 2). At the end of the 32 weeks, patients were re-randomized to receive either aprocitentan 25 mg or placebo, once daily, during the 12-week double-blind withdrawal (DB-WD) treatment (part 3). The primary efficacy endpoint was the change in sitting SBP (SiSBP) from baseline to Week 4 during DB treatment (part 1), measured at trough by unattended automated office blood pressure (uAOBP). The key secondary endpoint was the change in SiSBP measured at trough by uAOBP from DB-WD baseline (Week 36) to Week 40 (part 3). Patients had a mean age of 61.7 years (range 24 to 84 years; 34.1% were ≥ 65 and < 75 years; 9.9% were ≥ 75 years) and 59.5% were male. Patients were White (82.9%), African American (11.2%) or Asian (5.2%). The mean body weight was 97.6 kg (range 46 to 196 kg) and mean BMI was 33.7 kg/m2 (range 18 to 64 kg/m2). Patients had a medical history of type 2 diabetes mellitus (54.1%), ischemic heart disease (30.8%), central nervous system vascular disorders (23.0%), chronic kidney disease stages 3 and 4 (22.2%; 19.3% of patients had eGFR 30–59 mL/min/1.73 m2 and 2.9% had eGFR 15–29 mL/min/1.73 m2), congestive heart failure (19.6%), and sleep apnea syndrome (14.1%). 63.0% of patients had four or more antihypertensive medicinal products. Key PRECISION findings1,5Doses of aprocitentan 12.5 and 25 mg showed a statistically significant reduction vs placebo on SiSBP at Week 4. The treatment effect was consistent for sitting diastolic blood pressure (SiDBP). The persistence of the BP-lowering effect of aprocitentan was shown in DB-WD treatment (part 3). In patients re-randomized to placebo, the mean SiSBP increased, whereas in patients re-randomized to aprocitentan 25 mg the mean effect on SiSBP was stable, resulting in a statistically significant difference. The treatment effect was consistent for SiDBP. The effect was also consistent across SBP and DBP measured by ambulatory BP monitoring (ABPM) and assessed as daytime, night-time, and 24h periods at Week 4 and Week 40. A substantial proportion (i.e., at least 90%) of the BP-lowering effect was observed within the first two weeks of treatment with aprocitentan. The effect of aprocitentan was consistent across subgroups of age (including patients ≥ 75 years), sex, race (including patients with Black or African American origin), BMI, baseline urine albumin-to-creatinine ratio (UACR), baseline eGFR and medical history of diabetes. The most frequently reported adverse reactions with aprocitentan were edema/fluid retention (mostly peripheral edema) (9.1%, 12.5 mg; 18.4%, 25 mg) and hemoglobin decreased (3.7%, 12.5 mg; 1.2%, 25 mg). JERAYGO is contraindicated for use in women who are pregnant, breast-feeding and in women of childbearing potential who are not using reliable contraception, and patients with severe hepatic impairment. For more information on the marketing authorization of JERAYGO in the European Union, please review the Summary of Product Characteristics (SmPC). Notes to the editor About aprocitentanThe team at Idorsia has been working on the research and development of endothelin receptor antagonists for more than 30 years, successfully bringing three other molecules from this class to patients in different indications. Endothelin (ET)-1, via its receptors (ETA and ETB), mediates a variety of effects such as vasoconstriction, fibrosis, cell proliferation, and inflammation and is upregulated in hypertension. Aprocitentan is a dual ERA that inhibits the binding of ET-1 to ETA and ETB receptors and hence the effects mediated by these receptors.1 References JERAYGO™ Summary of Product Characteristics. 2024.NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet 2021; 398:957-80.Noubiap JJ, et al. Global prevalence of resistant hypertension: a meta-analysis of data from 3·2 million patients. Heart 2019; 105: 98–105.Williams B, et al. 2018 ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J 2018; 39: 3021–104.Schlaich MP, et al. A randomized controlled trial of the dual endothelin antagonist aprocitentan for resistant hypertension. The Lancet, 2022; Dec 3;400(10367):1927-1937. About Prof. Krzysztof Narkiewicz, MD, PhDProfessor Krzysztof Narkiewicz is the Head of the Department of Hypertension and Diabetology, Medical University of Gdansk, Gdansk, Poland. His research has been focused on the role of the sympathetic nervous system and metabolic factors in regulation of cardiovascular function in physiological and pathological states, and on prevention and treatment of cardiometabolic diseases including hypertension, diabetes, coronary artery disease, congestive heart failure and obstructive sleep apnea. He has published over 700 full-text publication; ( > 39 000 citations; h-index: 69). He was the President of the Scientific Council of the European Society of Hypertension (2009-2011). He was a member of the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC) preparing the 2007, 2013 and 2018 Guidelines for the Management of Arterial Hypertension. He also contributed to the 2023 ESH hypertension guidelines. Prof. Krzysztof Narkiewicz serves as a consultant to Idorsia. About IdorsiaIdorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a 25-year heritage of drug discovery, a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, and commercial operations in Europe and North America – the ideal constellation for bringing innovative medicines to patients. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 750 highly qualified specialists dedicated to realizing our ambitious targets. For further information, please contactInvestors & MediaAndrew C. WeissSenior Vice President, Head of Investor Relations & Corporate CommunicationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com • media.relations@idorsia.com • www.idorsia.com The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
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Elucid Moves into New Headquarters in Preparation for Commercial Launch
BOSTON–(BUSINESS WIRE)–Elucid, a pioneering medical technology company providing physicians with imaging analysis software based on ground truth histology to support treatment of cardiovascular disease, today announced it has moved its headquarters to 399 Boylston Street in the heart of Boston’s Back Bay neighborhood. The move into the modern space comes […]
VenoStent Completes $20 Million Series A with $4 Million Investment from Norwest Venture Partners
Company Builds on Momentum with New $3.6 Million NIH SBIR Grant to Fund U.S. Clinical Trial of Breakthrough Medical Device Showing Promise in Improving Dialysis Patient Outcomes
HOUSTON, June 27, 2024 /PRNewswire/ — VenoStent, Inc., a clinical-stage medical device company developing a novel therapeutic device for improving dialysis patient outcomes, announced today that it closed an additional $4 million from Norwest Venture Partners to round out its Series A financing at $20 million with Good Growth Capital and IAG Capital Partners co-leading the deal. In addition, the company was awarded a $3.6 million Small Business Innovation Research (SBIR) Phase II Grant by the National Institutes of Health (NIH), which will help fund its multi-center, 200-patient, randomized controlled trial (RCT) in the US.
Norwest General Partner Dr. Zack Scott and Investor Dr. Ehi Akhirome are joining the company as board observers. Dr. Scott and Dr. Akhirome bring deep medtech expertise from previous experience as a surgeon and physician scientist, respectively.
“2024 has been a momentous year for VenoStent so far. In the span of a few months, we initiated our first clinical sites, enrolled the first patients in our large RCT and closed our Series A with Norwest,” said Tim Boire, Ph.D., VenoStent CEO and co-founder. “We also received the NIH grant, which enables us to execute our trial with the highest degree of quality and rigor to make it as scientifically robust and impactful to patients as possible. Each of these are major company milestones that collectively represent many years of intensive and fruitful R&D and collaboration. These recent milestones will propel our company forward to an exciting next phase.”
As a clinical-stage therapeutic medical device company, VenoStent has developed a bioabsorbable perivascular wrap, SelfWrap, that goes around arteriovenous (AV) access sites at the time of AV fistula creation surgery. The bioabsorable wrap is intended to accelerate the usability and increase the durability of the fistula sites for chronic kidney disease (CKD) patients requiring hemodialysis. SelfWrap uses the body’s own healing mechanisms to mimic the arterial environment in veins, which experience a 10x increase in pressure and flow during AV creation and causes the veins to become unusable in dialysis.
In May 2023, SelfWrap was approved by the U.S. Food and Drug Administration to begin its U.S. Investigational Device Exemption (IDE) study, SAVE-FistulaS: The SelfWrap-Assisted ArterioVEnous Fistulas Study. The study is designed to show how SelfWrap can improve clinical outcomes for CKD patients requiring hemodialysis. Based on the compelling results from the company’s first-in-human clinical trial, the FDA granted SelfWrap a Breakthrough Device Designation in May 2022.
“Over half a million people in the U.S. rely on hemodialysis to survive and require an arteriovenous fistula creation surgery in order to receive the treatment. However, the AV fistula procedure has a one-year failure rate of more than 60%, which significantly impacts patients’ survival rates and quality of life,” said Norwest’s Dr. Scott. “VenoStent’s groundbreaking technology for AV fistula formation, SelfWrap, has the potential to significantly improve these odds. We look forward to working with the VenoStent team as it proves the efficacy of this breakthrough technology in order to improve the lives of hundreds of thousands of CKD patients.”
“Norwest’s investment is tremendous validation for VenoStent, and we are thrilled to have both Zack and Ehi joining the company’s board,” said VenoStent COO and Co-Founder, Geoffrey Lucks. “Zack and Ehi have extensive knowledge in our space, and their added value will match the capital and cache of Norwest dollar-for-dollar.”
About VenoStentVenoStent, Inc. (www.venostent.com) is a therapeutic medical device company developing a bioabsorbable wrap, SelfWrap, to transform outcomes in vascular surgery, starting with hemodialysis access. The device is intended to improve the usability and durability of arteriovenous fistulas (AVFs), the artery-vein connections that are surgically created in the arms of CKD patients to enable life-saving dialysis treatments. SelfWrap has been finely tuned through a decade of development to provide optimal mechanical support, improving hemodynamics and outward vein growth, and ultimately leading to improved quality and length of life for end-stage renal disease (ESRD) patients. Headquartered in Houston, Texas, VenoStent is venture backed by Good Growth Capital, IAG Capital Partners and Norwest Venture Partners, amongst others.
About Norwest Venture PartnersNorwest Venture Partners is a global venture and growth equity investment firm managing more than $15.5 billion in capital. Since its inception, Norwest has invested in more than 700 companies and currently partners with more than 230 companies in its venture and growth equity portfolio. The firm invests in early- to late-stage businesses across key sectors with a focus on enterprise, consumer and healthcare. The Norwest team offers a deep network of connections, extensive operating experience, and a wide range of impactful services to help CEOs and founders scale their businesses. Norwest has offices in Menlo Park and San Francisco, Calif.; Mumbai, India; and Tel Aviv, Israel. For more information, please visit www.nvp.com.
SOURCE VenoStent
UltraSight Joins Butterfly Garden to Expand AI Real-Time Guidance Across Point of Care Ultrasound Devices
Leveraging Butterfly Network’s platform, UltraSight seeks to enable patients to access cardiac imaging with real-time AI guidance
TEL AVIV, Israel, June 27, 2024 /PRNewswire/ — Today, UltraSight, a digital health pioneer transforming cardiac imaging through the power of artificial intelligence, announced it has joined Butterfly Garden, an artificial intelligence (AI) Marketplace launched by Butterfly Network, Inc. (“Butterfly”) (NYSE: BFLY), a digital health company transforming care through the power of portable, semiconductor-based ultrasound technology and intuitive software.
UltraSight and Butterfly have partnered to increase patient access to cardiac care by enabling more healthcare professionals to perform cardiac ultrasound. Subject to regulatory approvals and authorizations, UltraSight aims to integrate and deploy its real-time AI guidance software on Butterfly’s imaging platform and build the software for use with Butterfly’s single-probe, whole-body handheld ultrasound system.
Cardiovascular disease (CVD) is the leading global cause of death, accounting for an estimated 18 million deaths yearly. Today patients face significant delays in receiving crucial cardiac testing due to a fragmented market full of system bottlenecks, in addition to a national shortage of expert sonographers.
UltraSight’s mission is to empower any medical professional, including novice users with no prior sonography experience, to confidently conduct echocardiographic examinations and capture diagnostic quality cardiac ultrasound images at the point of care. Achieving compatibility with the most prominent handheld ultrasound device companies in the market, such as Butterfly, facilitates the company’s goal of increasing access to cardiac care and reducing system bottlenecks for patients.
“Joining the Butterfly Garden marks an important moment in our mission to revolutionize cardiac care,” said Davidi Vortman, CEO of UltraSight. “By integrating our real-time AI guidance software with Butterfly’s cutting-edge ultrasound technology, we are poised to transform the landscape of cardiac imaging. This collaboration will empower healthcare professionals, regardless of their experience level, to perform accurate and timely cardiac ultrasound exams at the point of care. Together, we will break down existing barriers in cardiac care, ensuring that more patients receive the critical diagnostics they need, when and where they need it most.”
“We are thrilled to partner with UltraSight to bring their AI guidance software to Butterfly devices in an effort to mitigate the pressing issue of sonographer shortages, among other workforce challenges, impacting medical communities around the world,” said Darius Shahida, chief strategy officer of Butterfly Network. “UltraSight and Butterfly are jointly dedicated to making healthcare more efficient, effective and accessible through high-quality ultrasound that’s easy-to-use and globally available.”
In August 2023, Butterfly Network launched Butterfly Garden, allowing third-party developers access to its proprietary SDK and APIs to build new AI applications that work in conjunction with Butterfly’s imaging platform, bringing with it access to the largest point-of-care ultrasound customer base. UltraSight, with capabilities to provide more medical professionals with the ability to take high-quality diagnostic images of the heart, has the potential to close the gap between novice and skilled Butterfly ultrasound users, and is an ideal match for the program.
When paired with ultrasound devices, and following the appropriate regulatory clearance for each device, UltraSight’s underlying AI neural network can predict the position of the ultrasound probe relative to the heart based on the ultrasound video stream and guide the user on maneuvering the probe to capture diagnostic quality cardiac images.
UltraSight’s partnership with Butterfly follows a series of recent collaborations with other industry leaders such as Mayo Clinic and EchoNous. For more information about UltraSight, visit www.ultrasight.com. For more information about Butterfly, visit www.butterflynetwork.com.
About UltraSight
UltraSight’s mission is to make diagnostic imaging more accessible by empowering medical professionals to successfully acquire timely and accurate cardiac ultrasound images anywhere. UltraSight’s AI-driven software offers real-time guidance, making cardiac ultrasound accessible and efficient, which may lead to quicker diagnoses and improved patient care. In 2022, UltraSight won the Bristol Myers Squibb Improving Cardiovascular Disease Outcomes Challenge as the most “innovative cardiac technology.” Additionally, the company was awarded a patent for its real-time guidance solution for ultrasound devices. UltraSight’s software has FDA 510(k) Clearance, is UKCA and CE Marked, and has Israeli AMAR Clearance to assist medical professionals in performing cardiac ultrasound scans. For more news and information, visit our website or follow UltraSight on LinkedIn and Twitter
About Butterfly Network
Founded by Dr. Jonathan Rothberg in 2011, Butterfly Network is a digital health company with a mission to democratize medical imaging by making high-quality ultrasound affordable, easy-to-use, globally accessible, and intelligently connected, including for the 4.7 billion people around the world lacking access to ultrasound. Butterfly created the world’s first handheld single-probe, whole-body ultrasound system using semiconductor technology, Butterfly iQ. The company has continued to innovate, leveraging the benefits of Moore’s Law, to launch its second-generation Butterfly iQ+ in 2020, and third-generation iQ3 in 2024 – each with increased processing power and performance enhancements. The disruptive technology has been recognized by TIME’s Best Inventions, Fast Company’s World Changing Ideas, CNBC Disruptor 50, and MedTech Breakthrough Awards, among other accolades. With its proprietary Ultrasound-on-Chip™ technology, intelligent software, and educational offerings, Butterfly is paving the way to mass adoption of ultrasound for earlier detection and remote management of health conditions around the world. Butterfly devices are commercially available to trained healthcare practitioners in areas including, but not limited to, parts of Africa, Asia, Australia, Europe, the Middle East, North America and South America; to learn more about available countries, visit: www.butterflynetwork.com/choose-your-country.
SOURCE UltraSight
Medtronic announces departure of Karen Parkhill, Chief Financial Officer
DUBLIN, June 26, 2024 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that Karen Parkhill will resign as executive vice president and chief financial officer to accept the role of chief financial officer for HP Inc.
“On behalf of our employees, our executive committee and our board of directors, I want to thank Karen for her leadership over the last eight years. I am personally grateful to Karen for her support through my transition to CEO, navigating the pandemic and delivering a new operating model for the company. We wish her all the best as she takes on the next chapter of her career,” said Geoff Martha, Medtronic chairman and chief executive officer. “Across the company, we’re building momentum with our innovation-driven growth strategy, and we remain focused and committed to delivering on our short- and longer-term financial objectives.”
“It has been a pleasure to serve Medtronic and our Mission for the last eight years,” said Parkhill. “I am grateful to have had the opportunity to lead the outstanding finance team at Medtronic, and I know they will continue to deliver on our commitments. I remain excited about the plans Medtronic has for the future, and most of all, the huge impact Medtronic technologies will have on the lives of patients around the world.”
The company is evaluating internal and external succession candidates. Parkhill will continue to serve as chief financial officer until her departure on August 2, and Gary Corona, senior vice president, Global Financial Planning and Analysis, will serve as interim chief financial officer upon her departure.
In addition, the company also reaffirmed guidance for its first quarter and full fiscal year 2025, as previously disclosed in its May 23, 2024, earnings press release and webcast.
About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn.
Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including risks related to competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, government regulation, geopolitical conflicts, general economic conditions, and other risks and uncertainties described in the company’s periodic reports on file with the U.S. Securities and Exchange Commission including the most recent Annual Report on Form 10-K of the company. Medtronic does not undertake to update its forward-looking statements, including to reflect future events or circumstances.
Contacts:
Erika Winkels
Ryan Weispfenning
Public Relations
Investor Relations
+1 (763) 526-8478
+1 (763) 505-4626
SOURCE Medtronic plc
Avive Solutions, Inc. Welcomes Mark Peters as New Vice President of Sales
SAN FRANCISCO, June 25, 2024 /PRNewswire/ — Avive Solutions, Inc., a manufacturer of innovative Automated External Defibrillators (AEDs) and software solutions to improve access to AEDs and response to cardiac arrest emergencies, is excited to announce the appointment of Mark Peters as their new Vice President of Sales. A highly-regarded sales leader in the AED, medical device, and public safety industries, Peters brings with him a wealth of experience building and leading high-performing sales teams and an impressive track record of driving commercial and strategic growth.
“I am thrilled to join Avive’s leadership team and bring both my professional experience and personal passion for the proliferation of AEDs to the company at this exciting time in their journey,” said Peters. “For years, there have been millions of AEDs out in the world with very little change in Sudden Cardiac Arrest survival rates. Avive is the only AED company innovating on new ways to change the outlook for Sudden Cardiac Arrest response, now and into the future. It has been incredible to watch the founders take their mission to democratize defibrillation from concept to reality, with the first truly new technological advancement in the AED space in over 20 years.”
After losing a close friend to Sudden Cardiac Arrest (SCA) in 2000, Peters suffered Sudden Cardiac Arrest himself in 2009 and was fortunate to survive, an event that altered the trajectory of his life. Since then, he has devoted his career to increasing the presence of this lifesaving device throughout the nation, beginning with a role as an Account Executive on the sales team at AED manufacturer Cardiac Science. Over the subsequent 8.5 years, Peters ascended the sales ranks quickly, culminating in a role as Senior Director of U.S. Distribution and Strategic Growth, overseeing a high-performing national sales team and the company’s channel expansion strategy. Peters and his team achieved exemplary performance and increased the company’s market share significantly during his tenure, culminating in an acquisition by ZOLL Medical in 2019. Since then, Peters has held a variety of executive sales leadership roles in the public safety field, showcasing his expertise in sales and go to market strategy, market growth, and strategic partnerships in service of making public safety and lifesaving tools and technologies more readily available throughout the nation.
“We are excited to have Mark join our leadership team at Avive, where he not only brings tremendous domain expertise from his time at Cardiac Science, but also a proven track record of building high-performing and customer centric sales teams,” said Sameer Jafri, Avive’s co-founder and CEO. “He is taking the leadership reins of our sales team at the perfect time in our company’s journey, as he will play a key role in continuing to drive and catalyze our rapid commercial ramp in the U.S.”
As Peters takes the helm of the Sales team at Avive Solutions, Inc., he is singularly focused on developing the most knowledgeable and customer-centric, consultative sales team in the industry, while keeping Avive’s mission to increase the presence of lifesaving AEDs and save more lives front and center at all times. “Simply put, Avive is mission-driven and mission-first,” he said. “The proliferation of AEDs over the past couple of decades has unfortunately not correlated to increased SCA survival rates. Now, Avive is fundamentally changing the way the entire AED industry thinks about response and survival. My mission here will be to drive market adoption in key verticals to make more Avive AEDs accessible to everyone, ultimately helping us have a tangible, positive impact on SCA survival rates and saving countless lives.”
About Avive Solutions, Inc.
Avive Solutions is a new kind of AED company, revolutionizing Sudden Cardiac Arrest response with an innovative platform that brings together a 21st-century AED device and a first-of-its-kind software solution. With their award-winning product, the Avive Connect AED, Avive is the first new company to bring an AED to market in the U.S. in over 20 years. Focused on portability, accessibility, and connectivity, the Avive Connect AED is one of the most advanced products in the industry. Additionally, Avive’s software solutions not only make owning and managing AEDs simple, they also deliver a comprehensive cardiac arrest response solution to communities, with the goal of increasing bystander intervention, decreasing time-to-defibrillation, and transmitting valuable data to the people who need it, when they need it. Founded in 2017, Avive is on a mission to empower bystanders, first responders, and 911 telecommunicators to provide lifesaving care as quickly and easily as possible. Learn more at avive.life.
Media Contact:Kyle Noble[email protected] (415) 287-6881
SOURCE Avive Solutions, Inc.
CVRx Announces Appointment of Robert Allen John as Chief Revenue Officer
MINNEAPOLIS, June 25, 2024 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, today announced the appointment of Robert John as Chief Revenue Officer effective June 27. In this role, John will lead the Company’s US sales team with the objective of maximizing the positive impact of Barostim therapy on patients suffering from heart failure and establishing Barostim as standard of care in the United States. “We are thrilled to welcome Robert to the CVRx executive team as we continue to expand the adoption of Barostim therapy,” said Kevin Hykes, President and CEO of CVRx. “Robert is well-known and respected within the heart failure community and has extensive experience building global sales organizations, launching novel heart failure therapies, and delivering results. He will be invaluable as we accelerate our commercial momentum.” John brings over 25 years of sales leadership experience in the medical device industry, with a strong track record of building high-performing sales teams. Most recently, he served as Divisional Vice President and General Manager of Cardiac Rhythm Management EMEA at Abbott, where he led a global business unit spanning over 90 countries. Prior to this role, he was first Senior Vice President, then the Divisional Vice President of the Heart Failure business, responsible for integrating the Thoratec and CardioMEMs businesses and leading the commercial teams for St. Jude, then at Abbott post-acquisition. Prior to the acquisition, John held multiple commercial leadership positions at St. Jude Medical across the Cardiac Rhythm, Electrophysiology, Capital, Structural Heart, Vascular and Heart Failure businesses. Prior to Abbott/St. Jude, John held commercial roles at Medtronic, Guidant and Pfizer. He holds a Bachelor of Science from the University of North Texas and a Master of Arts in Human Resources Management from the University of Alabama, Tuscaloosa. “I am excited to join CVRx at this pivotal time for the company and the patients we serve,” said Robert John. “Throughout my career, I have been passionate about bringing innovative therapies to market that can significantly improve patient outcomes. CVRx’s Barostim therapy is a truly revolutionary technology with the potential to transform the treatment of heart failure. I look forward to working with the talented CVRx team to make this groundbreaking therapy available to more patients and drive the next phase of the company’s growth.” About CVRx, Inc. CVRx is focused on the development and commercialization of the Barostim™ System, the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors activate the body’s baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact: Mark Klausner or Mike VallieICR Westwicke443-213-0501ir@cvrx.com Media Contact: Laura O’NeillFinn Partners402-499-8203laura.oneill@finnpartners.com
HeartFocus Joins Butterfly Garden to Develop Software Enabling Any Healthcare Professional to Conduct Lifesaving Echos on Butterfly’s Imaging Platform
June 24, 2024 07:00 AM Eastern Daylight Time BORDEAUX, France–(BUSINESS WIRE)–HeartFocus, the revolutionary, AI-driven heart exam software by DESKi, a provider of automated, accurate, and data-driven image analysis tools today announced it has joined Butterfly Garden, an artificial intelligence (AI) Marketplace launched by Butterfly Network, Inc., (“Butterfly”) (NYSE: BFLY) a digital health […]
Acasti Announces Year-End 2024 Financial Results, Provides Business Update
Patient Enrollment in Pivotal STRIVE-ON Phase 3 Safety Trial for GTX-104 On-Track for Potential NDA Submission in 1H Calendar 2025Projected Cash Runway into Second Calendar Quarter 2026 PRINCETON, N.J., June 21, 2024 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced financial results and business highlights for the year ended March 31, 2024. “During the past year we continued to execute our focused strategy around our biggest value driver program GTX-104 and its pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405),” said Prashant Kohli, CEO of Acasti. “Since initiating STRIVE-ON and dosing the first patient last October, enrollment has proceeded steadily, and we believe the trial is on track for a potential NDA submission to the FDA in the first half of calendar 2025. With our balance sheet enhanced by the $7.5 million private placement secured in September 2023, and disciplined execution of the strategic realignment plan we announced in May 2023, our cash runway is expected to extend into the second calendar quarter of 2026, well beyond our planned submission of the GTX-104 NDA.” 2024 Corporate Highlights Overview of STRIVE-ON trial, a prospective, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 compared with oral nimodipine, in patients hospitalized for aSAH, presented as a poster at the 2024 International Stroke ConferenceEnrollment of STRIVE-ON trial on track for potential NDA submission to FDA anticipated in the first half of calendar 2025Conducted a meeting of STRIVE-ON trial investigators in April 2024; the in-person/virtual meeting provided an excellent opportunity to energize the principal investigators from all sites, engage in an interactive discussion about the trial inclusion/exclusion criteria, and to review key procedures to ensure quality data collectionIn October 2023 hosted a Key Opinion Leader Event GTX-104: A Potential New Treatment Standard for Rare and Life-Threatening aneurysmal Subarachnoid Hemorrhage (aSAH)Completed $7.5 million private placement equity financing led by ADAR1 Partners, LP in September 2023Presented a pharmacokinetic comparison of GTX-104 with oral nimodipine at the 2023 Neurocritical Care Society annual meeting in August 2023. Fiscal Year 2024 Financial Results The Company reported a net loss of $12.9 million, or $1.35 loss per share, for the year ended March 31, 2024, a decrease of $29.5 million from the net loss of $42.4 million or $5.71 per share for the year ended March 31, 2023. The decrease in net loss was primarily due to asset impairments, net of income tax benefit, totaling $25.3 million during the year ended March 31, 2023 that did not recur during the year ended March 31, 2024, the impact of the Company’s strategic realignment in May 2023 to align the organizational and management cost structure to prioritize resources to GTX-104, and the change in fair value of the Company’s derivative warrant liabilities that was primary attributable to an increase in stock price. Research and development expenses for the year ended March 31, 2024 were $4.7 million, compared to $10.0 million for the year March 31, 2023. The decrease from the prior year period was mainly attributable to the Company’s strategic realignment in May 2023, which resulted in reduced clinical development and salaries and benefits expenses. General and administrative expenses were $6.4 million for the year ended March 31, 2024, a decrease of $1.2 million from $7.6 million for the year ended March 31, 2023. The decrease was primarily a result of decreased salaries and benefits due to a reduction in general and administrative headcount as a result of the restructuring and reorganization of our management structure offset by increased legal, tax, accounting and other professional fees related to the restructuring and private placement. At March 31, 2024 the Company had cash and cash equivalents of $23.0 million, as compared to $27.9 million as of March 31, 2023. The Company believes it has sufficient cash to support operations into the second calendar quarter of 2026. About aneurysmal Subarachnoid Hemorrhage (aSAH) aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm. Approximately 70% of aSAH patients experience death or dependence, and more than 30% die within one month of hemorrhage. Approximately 50,000 patients in the United States are affected by aSAH per year, based on market research. Outside of the United States, annual cases of aSAH are estimated at approximately 60,000 in the European Union, and approximately 150,000 in China. About the Acasti Asset Portfolio GTX-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTX-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTX-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTX-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTX-104 has the potential to better manage hypotension in aSAH patients. GTX-104 has been administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in the United States for GTX-104 is estimated to be about $300 million, based on market research. GTX-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are currently no FDA-approved therapies. GTX-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that, together with other excipients can be sprayed conveniently over the tongue of the A-T patient and is rapidly absorbed. The further development of GTX-102 has been deprioritized in favor of our focus on development of GTX-104. It is also possible that we may out-license or sell our GTX-102 drug candidate. GTX-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to ease the symptoms of patients suffering with postherpetic neuralgia (“PHN”). GTX-101 is administered via a metered-dose of bupivacaine spray and forms a thin bio-adhesive topical film on the surface of the patient’s skin, which enables a touch-free, non-greasy application. It also comes in convenient, portable 30 ml plastic bottles. Unlike oral gabapentin and lidocaine patches, we believe that the biphasic delivery mechanism of GTX-101 has the potential for rapid onset of action and continuous pain relief for up to eight hours. No skin sensitivity was reported in a Phase 1 trial. The further development of GTX-101 has been deprioritized in favor of our focus on development of GTX-104. It is also possible that we may out-license or sell our GTX-101 drug candidate. About Acasti Acasti is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Acasti’s novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Acasti’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Acasti’s lead clinical asset, GTX-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. For more information, please visit: www.acasti.com. Forward-Looking Statements Statements in this press release that are not statements of historical or current fact constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Such forward looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” “estimates”, “potential,” “should,” “may,” “will,” “plans,” “continue”, “targeted” or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the Company’s anticipated cash runway, the timing of the planned NDA submission with the FDA in connection with the Company’s STRIVE-ON trial, GTX-104’s commercial prospects, GTX-104’s potential to bring enhanced treatment options to patients suffering from aSAH, and the anticipated benefits and future development, license or sale of the Company’s other drug candidates are based upon Acasti’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 safety trial for GTX-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTX-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Acasti’s clinical trials as compared to management’s current expectations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and are filed by Acasti from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Acasti undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws. For more information, please contact: Acasti Contact: Prashant KohliChief Executive OfficerTel: 450-686-4555Email:info@acastipharma.comwww.acasti.com Investor Relations: LifeSci AdvisorsMike MoyerManaging DirectorPhone: 617-308-4306Email: mmoyer@lifesciadvisors.com —tables to follow— ACASTI PHARMA INC.Consolidated Balance Sheets March 31, 2024 March 31, 2023 (Expressed in thousands except share data) $ $ Assets Current assets: Cash and cash equivalents 23,005 27,875 Short-term investments — 15 Receivables 722 802 Prepaid expenses 283 598 Total current assets 24,010 29,290 Operating lease right of use asset — 463 Equipment, net 24 104 Intangible assets 41,128 41,128 Goodwill 8,138 8,138 Total assets 73,300 79,123 Liabilities and Shareholders’ equity Current liabilities: Trade and other payables 1,684 3,336 Operating lease liability — 75 Total current liabilities 1,684 3,411 Derivative warrant liabilities 4,359 — Operating lease liability — 410 Deferred tax liability 5,514 7,347 Total liabilities 11,557 11,168 Commitments and contingencies Shareholders’ equity: Class A common shares, no par value per share; unlimited shares authorized; 9,399,404 and 7,435,533 shares issued and outstanding as of March 31, 2024 and 2023,respectively 261,038 258,294 Class B, C, D and E common shares, no par value per share; unlimited shares authorized; none issued and outstanding — — Additional paid-in capital 17,862 13,965 Accumulated other comprehensive loss (6,038) (6,038)Accumulated deficit (211,119) (198,266)Total shareholders’ equity 61,743 67,955 Total liabilities and shareholders’ equity 73,300 79,123 ACASTI PHARMA INC.Consolidated Statements of Operations and Comprehensive Loss Year ended March 31, 2024 Year ended March 31, 2023 (Expressed in thousands, except share and per data) $ $ Operating expenses Research and development expenses, net of government assistance (4,683) (9,972)General and administrative expenses (6,432) (7,614)Sales and marketing (252) (661)Restructuring cost (1,485) — Impairment of intangible assets — (28,682)Impairment of goodwill — (4,826)Impairment of assets held for sale — (400)Loss from operating activities (12,852) (52,155) Foreign exchange loss (16) (72)Change in fair value of derivative warrant liabilities (2,728) 10 Interest income and other expense, net 911 246 Total other income (expense), net (1,833) 184 Loss before income tax benefit (14,685) (51,971) Income tax benefit 1,832 9,542 Net loss and total comprehensive loss (12,853) (42,429) Basic and diluted loss per share (1.35) (5.71) Weighted average number of shares outstanding 9,529,123 7,435,472



