Author: Ken Dropiewski

Humacyte Acellular Tissue Engineered Vessel (ATEV™) Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation for Patients with Advanced Peripheral Artery Disease (PAD)

Peripheral/Endo Regulatory by Comments are Disabled

– Third RMAT designation by FDA for ATEV – – RMAT will expedite development of ATEV in PAD – DURHAM, N.C., July 01, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, has been granted the U.S. Food and Drug Administration’s (FDA’s) Regenerative Medicine Advanced Therapy (RMAT) designation for patients with advanced peripheral artery disease (PAD). This RMAT designation is granted at the same time as FDA cleared a new Investigational New Drug (IND) application for the PAD indication for Humacyte’s investigational Acellular Tissue Engineered Vessel (ATEV), formerly referred to as the “HAV”. The RMAT designation is designed to provide pathways for expedited development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions. The designation allows for close interactions with the FDA and potentially an expedited/priority review of a Biologics License Application (BLA). This is the third RMAT designation granted by the FDA for Humacyte’s ATEV, in addition to previous RMAT designations for vascular trauma repair and arteriovenous (AV) access in hemodialysis. “We are very pleased to receive our third RMAT designation from the Food and Drug Administration,” said Dr. Cindy Cao, Chief Regulatory Officer at Humacyte. “The RMAT designation we previously received in our lead indication of vascular trauma was very helpful in enhancing our communication with the FDA review team during the filing and review of our BLA. We are excited that this additional designation has been granted in advanced PAD, as we expect that it will further strengthen our communication with the FDA and expedite the development of our ATEV in this important indication.” Humacyte’s ATEV is designed to be a universally implantable vascular conduit for use in vascular replacement and repair. Importantly, the ATEV has been observed to have a low rate of infection in clinical trials and is designed to be available off-the-shelf and ready whenever surgeons need it, potentially saving valuable time and improving patient outcomes. PAD is a cardiovascular disease of blood vessels, affecting the arteries in the legs most commonly. As many as 40% of patients requiring a bypass to the arteries of the lower leg do not have autologous vein available for revascularization, which is the standard of care for such patients. The ATEV has been evaluated in two Phase 2 studies in PAD, with patients followed for as long as six years. In addition, The Mayo Clinic, Rochester, MN, is conducting a study in approximately 30 patients with chronic limb-threatening ischemia, the end stage of PAD, under an investigator IND cleared by the FDA. All patients treated with the ATEV for PAD to date have not had autologous vein available for revascularization, and hence the ATEV may represent an important therapeutic alternative for such patients. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. As announced previously, based on guidance from the FDA, the common (non-brand) name “Acellular Tissue Engineered Vessel” (ATEV) replaces the term ‘Human Acellular Vessel” (HAV) previously used for the engineered vessel product candidate. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of ATEVs, are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application is currently under review by the FDA and was granted Priority Review with a PDUFA date of August 10, 2024. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s RMAT designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, the expected PDUFA date for our ATEV in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials, including our BVP program; the anticipated characteristics and performance of our ATEVs and the BVP; our ability to successfully complete, preclinical and clinical trials for our ATEVs and the BVP; the anticipated benefits of the BVP relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

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Boston Scientific Announces Conference Call Discussing Second Quarter 2024 Results

Financial by Comments are Disabled

MARLBOROUGH, Mass., July 1, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) will webcast its conference call discussing financial results and business highlights for the second quarter ended June 30, 2024, on Wednesday, July 24, 2024, at 8:00 a.m. ET. The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the second quarter on July 24 prior to the conference call.
A live webcast and replay of the webcast will be accessible at htts://investors.bostonscientific.com. The replay will be available approximately one hour following the completion of the event.
About Boston ScientificBoston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.  
CONTACTS:Chanel HastingsMedia Relations+1 (508) 382-0288[email protected]
Jon MonsonInvestor Relations+1 (508) 683-5450[email protected] 
SOURCE Boston Scientific Corporation

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InspireMD Announces Full Exercise of Series H Warrant Tranche for Gross Proceeds of $17.9 Million

Financial by Comments are Disabled

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

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Idorsia’s JERAYGO (aprocitentan) approved in Europe as first and only ERA for the treatment of resistant hypertension

Financial by Comments are Disabled

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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Merck Receives Positive EU CHMP Opinion for WINREVAIR™ (sotatercept) in Pulmonary Arterial Hypertension (PAH)

Coronary/Structural Heart by 0 comments

If approved by the European Commission, WINREVAIR will be the first activin signaling inhibitor therapy for PAH in Europe, offering a new treatment option for certain adults with this rare, progressive disease Milestone highlights Merck’s focus on global filings to expand access to WINREVAIR and commitment to patients living with […]

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Acasti Announces Achievement of 50% Enrollment in Pivotal Phase 3 STRIVE-ON Safety Trial

Neuro by Comments are Disabled

PRINCETON, N.J., June 27, 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 that the Company’s pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405) has exceeded the 50% enrollment milestone. The STRIVE-ON trial, a prospective, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 compared with oral nimodipine in 100 patients hospitalized for aSAH, initiated patient enrollment in October of 2023. The primary endpoint is safety and will be measured as comparative adverse events, including hypotension, between the two groups. “Since dosing the first patient in STRIVE-ON last October, we have continued to build momentum by activating high volume neurocritical care hospitals across the country with unrelenting focus on executing patient enrollment and investigator engagement,” said Prashant Kohli, CEO of Acasti. “Achievement of our 50% enrollment milestone reflects laser sharp focus from both our participating clinical trial sites and the Acasti team. Investigators continue to be enthusiastic about the potential of GTX-104 as an IV alternative to oral nimodipine for the treatment of aSAH. Based on a comprehensive review of enrollment factors, we currently anticipate randomizing all 100 patients in late 2024 to early 2025, while staying on track for a potential NDA submission to the FDA in the first half of calendar 2025.” “Patients with aSAH require intensive management and present with a variety of complications that make consistent administration of oral nimodipine difficult especially in patients with severe neurological deficits with dysphasia or requiring mechanical ventilation,” said Dr. Abhishek Ray, Associate Professor of Neurological Surgery at University Hospitals Cleveland, Case Western Reserve University School of Medicine. “GTX-104 shows great promise as an IV alternative to the current standard of care, and we look forward to assessing the data obtained from this trial.” 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 GTX-104 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. 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 enrollment and NDA submission schedule for the STRIVE-ON trial, GTX-104’s commercial prospects, and GTX-104’s potential to bring enhanced treatment options to patients suffering from aSAH 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.com www.acasti.com  Investor Relations: LifeSci AdvisorsMike MoyerManaging DirectorPhone: 617-308-4306Email:  mmoyer@lifesciadvisors.com  

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St. Joseph’s Hospital’s ‘Tampa 2’ AFib Procedure Contributes to Tampa Bay Legacy of Success

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The Tampa 2 procedure was created to be easy to replicate while achieving equal or better outcomes compared to the Cox-Maze IV, a widely used surgical intervention for AFib introduced in 2002. AFib is a cardiac condition noted by an irregular, frequently rapid heart rhythm and is typically treated with prescription, catheter-based and/or surgical interventions. 
“We created the Tampa 2 procedure after years of collaboration between cardiology and cardiac surgery in conjunction with surgical pioneer Dr. James Cox (originator of the Cox-Maze IV procedure). This state-of-the-art technique has the potential to redefine surgical management of atrial fibrillation,” said Dr. Sherman.
Like its predecessor, the Tampa 2 creates scar tissue to block abnormal electrical signals that cause AFib but adds two lines of ablation (the method to create scar tissue) and has a different approach made possible by new tools and technology. The Tampa 2 achieved its namesake because of the two additional lines of ablation, developed by two Tampa physicians, all while tipping their hat to the success the Tampa Bay Buccaneers had with their Tampa 2 defense. More than 50 successful Tampa 2 procedures have been performed at St. Joseph’s Hospital, including the treatment of Brittany Williams, a patient of Dr. Sherman. Now the benefits of the Tampa 2 procedure extend beyond the walls of St. Joseph’s Hospital as Dr. Sherman and Dr. Makati host lectures across the country to train physicians on all aspects of AFib treatment. In addition, the two physicians presented their procedure and clinical findings at the 2024 International Society for Minimally Invasive Cardiothoracic Surgery annual meeting in Athens, Greece (see abstract here).”We are very proud that this novel procedure was developed here at BayCare and St. Joseph’s Hospital,” said Dr. Makati. “We are excited to continually offer new, lifesaving procedures to our community and beyond. This is only possible by the innovative spirit and collaborative efforts of our colleagues here in Tampa and around the world.” For more information about the Heart Institute at St. Joseph’s Hospital: https://baycare.org/locations/hospitals/st-josephs-hospital/services/heart-and-vascular About St. Joseph’s HospitalSt. Joseph’s Hospital, part of the BayCare Health System, is known for advanced medical technology and compassionate care. Its Centers of Excellence include the Heart and Vascular Institute, Cancer Institute, Stroke and Neuroscience Program, Robotic Surgery Program and Emergency/Trauma Department, which provides more emergency care than any other hospital in Tampa Bay. More than 70 specialties are represented among the medical team, including internal medicine, cardiovascular surgery and neurosurgery. The hospital was founded in 1934 by the Franciscan Sisters of Allegany. The 615-bed hospital is located at 3001 West Dr. Martin Luther King Jr. Boulevard in Tampa, Florida. For more information: BayCare.org/SJH.About BayCareBayCare is a leading not-for-profit health care system that connects individuals and families to a wide range of services at 16 hospitals and hundreds of other convenient locations throughout the Tampa Bay and central Florida regions. The system is West Central Florida’s largest provider of behavioral health and pediatric services and its provider group, BayCare Medical Group, is one of the largest in the region. BayCare’s diverse network of ambulatory services includes laboratories, imaging, surgical centers, BayCare Urgent Care locations, wellness centers and one of Florida’s largest home care agencies, BayCare HomeCare. BayCare’s mission is to improve the health of all it serves through community-owned, health care services that set the standard for high-quality, compassionate care. For more information visit BayCare.org.SOURCE BayCare Health System

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Elucid Moves into New Headquarters in Preparation for Commercial Launch

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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 […]

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UltraSight Joins Butterfly Garden to Expand AI Real-Time Guidance Across Point of Care Ultrasound Devices

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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

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VenoStent Completes $20 Million Series A with $4 Million Investment from Norwest Venture Partners

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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

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