EluPro becomes the only drug-eluting biologic envelope to receive FDA clearance in the $600 million U.S. implantable electronic device protection market EluPro also granted clearance for indications beyond CIEDs, including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence, and sleep apnea SILVER SPRING, Md., June 17, 2024 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today announced that its Antibiotic-Eluting BioEnvelope, EluPro® (referred to as CanGaroo®RM during development), has received clearance from the U.S. Food and Drug Administration (FDA). Specifically designed to prevent post-operative complications for devices such as pacemakers and defibrillators, EluPro incorporates powerful antibiotic therapy combined with advanced tissue engineering to create a BioEnvelope that over time regenerates into a protective pocket of the patient’s own tissue. Infection, migration, and skin erosion are some of the most frequently encountered complications of pacemaker surgery, occurring in up to five to seven percent of cases. These cause significant patient morbidity and mortality, increase the length of hospitalization, and can add more than $50,000 to healthcare costs per event. In development since 2019 and protected by intellectual property extending beyond 2032, EluPro is the only biologic offering in the $600 million U.S. implantable electronic device protection market. The Company also announced that EluPro was granted clearance for indications beyond the cardiac implantable electronic devices (CIEDs), including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence, and sleep apnea. These additional markets, estimated to be $8 billion worldwide, have not previously been served by a drug-eluting biomatrix and present significant additional growth opportunities for EluPro. “When I implant a pacemaker or defibrillator, minimizing the risk of any future complications is crucial,” said Dr. Benjamin D’Souza, Associate Professor of Medicine at the University of Pennsylvania and Section Chief of Cardiac Electrophysiology at Penn Presbyterian Medical Center. “However, the body’s natural immunity can treat the device like a foreign object contributing to inflammation, causing device migration, potentially eroding through the skin, or sometimes causing a serious infection. Those are the specific problems EluPro was designed to solve. It combines the remodeling properties of regenerative medicine through extracellular matrix along with long-acting antibiotic delivery to create a healthy environment for every device implantation.” The EluPro BioEnvelope is constructed from reinforced layers of natural extracellular tissue matrix and designed to create a conforming envelope with optimal stability for implantable electronic devices. The walls of EluPro are embedded with powerful antibiotics rifampin and minocycline, engineered for extended delivery directly into the surgical site long after closure. This unique combination of drug and biomatrix supports the regeneration of a healthy, vascularized pocket from the patient’s own tissue, mitigating a long-term foreign body response. “Post-operative infection, migration and erosion can result in significant morbidity and mortality for patients receiving a pacemaker or defibrillator. That is why we developed the antibiotic-eluting BioEnvelope,” said Dr. Randy Mills, Elutia’s Chief Executive Officer. “While the approval of EluPro is a major value inflection for Elutia, we believe it is just the tip of the iceberg. We have created a platform to protect patients from the foreign body response that can inevitably develop with any long-term implantable device. We intend to rapidly extend our product offering to other indications as we fulfill our mission to humanize medicine so patients can thrive without compromise.” EluPro represents a significant opportunity in the $600 million U.S. implantable electronic device protection market, previously served by a single competitor. With over 600,000 devices implanted in the U.S. annually, EluPro addresses significant complications arising from these procedures. Elutia plans to launch EluPro into the CIED market nationwide in the second half of 2024 and is prioritizing adjacent markets in the neurostimulation and modulation space, where implantable medical devices result in high rates of addressable complications. About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise,” “opportunity” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements regarding EluPro’s potential future success in the CIED protection market or in device protection for other types of implantable devices, like neurostimulators or neuromodulators, and statements regarding market size. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to continue as a going concern; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits; our ability to achieve or sustain profitability; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; the continued and future acceptance of our products by the medical community; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; and our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2023, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com
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Cytokinetics Announces Initiation of Phase 1 Study of Aficamten in Healthy Japanese Participants
SOUTH SAN FRANCISCO, Calif., June 17, 2024 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 study evaluating the pharmacokinetics, safety and tolerability of aficamten in healthy Japanese and Caucasian participants. “We are conducting this Phase 1 bridging study to characterize the pharmacokinetics of aficamten in healthy Japanese adults and to gather evidence that we believe will be required for potential approval in Japan,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “In parallel, we are continuing to execute on our later-stage global clinical development program for aficamten alongside preparing regulatory submissions in the U.S. and Europe which we expect to submit this year.” Phase 1 Clinical Trial Design The primary objective of this Phase 1 double-blind, randomized, placebo-controlled study is to evaluate the pharmacokinetics of aficamten following administration of single ascending doses and multiple doses in 70 healthy Japanese and Caucasian participants. The secondary objective is to evaluate the safety and tolerability of aficamten in healthy Japanese and Caucasian participants. The study will enroll four cohorts including three single-ascending cohorts and one multiple dose cohort. Cohorts 1, 2 and 3 will enroll 10 Japanese participants and 10 Caucasian participants each, randomized on an 8:2 basis to receive single-ascending doses of aficamten (5 mg, 10 mg and 20 mg, respectively) or placebo. Enrollment of Cohort 2 and Cohort 3 will commence upon evaluation of the safety of the preceding Cohort. Following the completion of the single ascending dose cohorts, Cohort 4 will enroll 10 healthy Japanese participants randomized on an 8:2 basis to receive single doses of aficamten (5 mg) or placebo, once daily for 14 days. About Aficamten Aficamten is an investigational selective, small molecule cardiac myosin inhibitor discovered following an extensive chemical optimization program that was conducted with careful attention to therapeutic index and pharmacokinetic properties and as may translate into next-in-class potential in clinical development. Aficamten was designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with hypertrophic cardiomyopathy (HCM). In preclinical models, aficamten reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. The development program for aficamten is assessing its potential as a treatment that improves exercise capacity and relieves symptoms in patients with HCM as well as its potential long-term effects on cardiac structure and function. Aficamten was evaluated in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), a positive pivotal Phase 3 clinical trial in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Aficamten received Breakthrough Therapy Designation for the treatment of symptomatic obstructive HCM from the U.S. Food & Drug Administration (FDA) as well as the National Medical Products Administration (NMPA) in China. Cytokinetics expects to submit a New Drug Application (NDA) to the FDA in Q3 2024 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q4 2024. Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, and CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. About Cytokinetics Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in obstructive hypertrophic cardiomyopathy. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of HFpEF, and CK-136, a cardiac troponin activator for the potential treatment HFrEF and other types of heart failure, such as right ventricular failure resulting from impaired cardiac contractility. Cytokinetics continues its longstanding history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements express or implied relating to the properties or potential benefits of aficamten or any of our other drug candidates, our ability to file a new drug application for aficamten with FDA in third quarter 2024, our ability to file a marketing authorization application for aficamten with EMA in the fourth quarter 2024, our ability to obtain regulatory approval for aficamten for the treatment of obstructive hypertrophic cardiomyopathy or any other indication from FDA or any other regulatory body in the United States or abroad, and the labeling or post-marketing obligations that may be required by FDA or any other regulatory body in the United States or abroad as a condition to regulatory approval. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlines in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757
Spur Therapeutics (Formerly Freeline) Announces New Name and Brand
With a mission to redefine what gene therapy can do, Spur is optimizing every component of its product candidates to develop a new generation of gene therapies Spur is advancing two potentially life-changing gene therapy candidates in clinical trials and a bold research strategy to move gene therapy beyond rare diseases into more prevalent conditions Lead program FLT201 for Gaucher disease poised to enter Phase 3 development in 2025 Acquired SwanBio, adding Phase 1/2 program for adrenomyeloneuropathy to its clinical-stage pipeline and strengthening CNS expertise Founding investor Syncona commits additional $50 million to support development of pipeline LONDON, June 17, 2024 (GLOBE NEWSWIRE) — Spur Therapeutics, formerly Freeline Therapeutics, today announced a new name and brand to reflect its focus on developing a new generation of gene therapies and advancing the practice of genetic medicine. Building on compelling data for its lead program FLT201, a highly differentiated gene therapy candidate for Gaucher disease, Spur is pursuing an ambitious research strategy to unlock the promise of gene therapy for more prevalent chronic conditions, starting with Parkinson’s disease and certain forms of cardiovascular disease. “At Spur Therapeutics, our mission is to redefine what gene therapy can do,” said Michael Parini, Spur’s Chief Executive Officer. “Our new name and new brand reflect our determination to alter the course of a disease with a single dose of genetic medicine and change the course of people’s lives. By optimizing every component of our product candidates to get just the right expression, packaged and delivered to the body in just the right way, we are working to develop a new generation of therapies that spur gene therapy forward to transform the lives of even more patients.” Spur today also announced its acquisition of SwanBio Therapeutics, which adds a potential first-in-class gene therapy program for adrenomyeloneuropathy (AMN), a devastating neurodegenerative disease, to its clinical-stage pipeline, as well as strengthened capabilities in central nervous system (CNS) disorders that can be leveraged across both its AMN and Parkinson’s disease programs. The AMN program, SBT101, is currently in a Phase 1/2 clinical trial, and Spur plans to report an initial safety update from the higher-dose cohort in this trial in the first half of next year. There are no approved treatments for AMN, and SBT101 is the only gene therapy candidate in development for the disease. Syncona Ltd., the founding shareholder in both Freeline and SwanBio and a leading life science investor focused on creating, building and scaling global leaders in life science, has committed an additional $50 million (£40 million) to support development of the expanded pipeline. Syncona Executive Partner and former SwanBio Executive Chair John Tsai has joined Spur’s Board of Directors. “We see great promise across Spur’s broadened pipeline, with a highly differentiated lead clinical program backed by compelling data and a second potentially first-in-class clinical asset,” said Chris Hollowood, CEO of Syncona Investment Management Limited and Chairman of the Board of Directors of Spur. “Building on its work, Spur has an exciting opportunity to become a leading gene therapy company developing one-time treatments for debilitating chronic diseases, potentially setting new standards of care and changing lives.” Spur expects to initiate a Phase 3 trial for FLT201 in 2025 in Gaucher disease. There is no cure for Gaucher disease, and even with current treatments, many patients continue to experience debilitating symptoms. Recently reported data from its Phase 1/2 GALILEO-1 trial highlight FLT201’s potential to set a new standard of care for Gaucher disease. The data show that a single dose of FLT201 resulted in dramatic reductions in the toxic buildup of glucosylsphinogsine (lyso-Gb1), one of the best predictors of clinical response and disease severity in Gaucher disease, in patients who have had persistently high levels despite years of treatment on currently approved therapies. Early signs of clinical improvement in fatigue and bone marrow burden were also observed. FLT201 has demonstrated a favorable safety and tolerability profile. Building on its work in Gaucher disease, Spur’s research program in Parkinson’s disease is focused on a subset of patients with mutations in the GBA1 gene, the same gene implicated in Gaucher disease. The program leverages the same transgene as FLT201. Spur is further optimizing the transgene for expression in the brain and identifying the best capsid and route of administration to deliver its proprietary GBA1-85 transgene to key areas of the brain affected by Parkinson’s disease. Spur expects to select a development candidate later this year to progress into preclinical studies designed to support the program’s advancement into clinical trials. No disease-modifying therapies currently exist for Parkinson’s disease, and this program could be a first step toward a gene therapy for hundreds of thousands of people with GBA1 Parkinson’s worldwide. Additionally, Spur has a research program, leveraging a suite of promising cardioprotective proteins to develop gene therapy candidates for cardiovascular diseases, starting with a severe subset of chronic heart failure. About Spur TherapeuticsSpur Therapeutics is a clinical-stage biotechnology company focused on developing life-changing gene therapies for debilitating chronic conditions. By optimizing every component of its product candidates, Spur aims to unlock the true potential of gene therapy to realize outsized clinical results. Spur is advancing a breakthrough gene therapy candidate for Gaucher disease and a potential first-in-class gene therapy candidate for adrenomyeloneuropathy, as well as a research strategy to move gene therapy into more prevalent diseases, including forms of Parkinson’s, dementia, and cardiovascular disease. Expanding our impact, and advancing the practice of genetic medicine. Toward life-changing therapies, and brighter futures. Toward More™ For more information, visit www.spurtherapeutics.com or connect with Spur on LinkedIn. Media Contact:Naomi Aokinaomi.aoki@spurtherapeutics.com+ 1 617 283 4298 A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0e68ddce-d346-46c3-b5bf-d03686e6d5e9
Avive Solutions Recognized as One of the 2024 Bay Area Best Places to Work
SAN FRANCISCO, June 14, 2024 /PRNewswire/ — Avive Solutions, Inc., a Brisbane, CA-based manufacturer of lifesaving Automated External Defibrillators (AEDs) has been recognized as a Top 3 winner of the 2024 Bay Area Best Places to Work, an awards program presented by the San Francisco Business Times and the Silicon Valley Business Journal.
Select employers from the Bay Area were named winners of the awards at a celebratory event on June 13th, 2024 in San Francisco. These winning organizations were honored for having created exceptional workplaces with collaborative, supportive workplace cultures that their employees value highly.
Award applicants were evaluated and ranked across 5 categories according to the number of Bay Area employees. The rankings find companies in the region whose employees rate them as the highest on such values as fun, collaborative culture, solid compensation, benefits offerings and other amenities, as well as management practices. The rankings were unveiled on June 14th, 2024 in the San Francisco Business Times and the Silicon Valley Business Journal.
“We are honored and thrilled to be named to the 2024 list of Bay Area Best Places to Work,” said Jess Koenig, Head of People at Avive. “With so many fantastic, established companies with amazing culture and perks located in the region to choose from, we are proud to know that our employees value our culture, lifesaving mission, and workplace environment so highly and are excited to come to work every day at Avive.”
Co-founder and CEO Sameer Jafri added, “I’m proud of our team’s commitment to attracting and retaining exceptional talent that connects with our mission to save lives, contributes positively to our culture, and is driven to do what it takes to push our company forward to new heights. We’re building something special here, and the tremendous emphasis we place on building a great culture has, and continues to pay off. It’s humbling to be recognized with this award, and we are committed to Avive continuing to be one of the best places to work in the Bay Area for many years to come.”
About Avive Solutions, Inc.Avive Solutions is a new kind of AED company. We are revolutionizing Sudden Cardiac Arrest response with our innovative platform that brings together a 21st-century AED device and first-of-its-kind software solutions. With our award-winning product, the Avive Connect AED, we are 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, our 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 getting valuable data to the people who need it, when they need it. Founded in 2017, we are on a mission to empower bystanders, first responders, and 911 telecommunicators to provide lifesaving care as quickly and easily as possible. Our versatile platform is designed to meet the needs of all types of industries – schools, gyms, places of worship, any size business and even your home. Join us on our mission to save lives and learn more at avive.life.
About 2024 Bay Area Best Places to Work Best Places to Work is an innovative publication and awards program produced by the San Francisco Business Times and the Silicon Valley Business Journal. The rankings were determined by surveys that went directly to employees who answered a series of questions. The survey was administered online by the employers and through a service provided by Quantum Workplace, our research partner. The rankings are numeric based on Quantum’s scoring process. By ranking companies and sharing best practices we facilitate idea sharing and help other companies learn from the best.
Media Contact:Kyle Noble[email protected](415) 287-6881
SOURCE Avive Solutions, Inc.
Positron Corporation Joins Cardiac PET Industry Coalition (CPIC)
Niagara Falls, NY, June 14, 2024 (GLOBE NEWSWIRE) — Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a leading molecular imaging medical device company offering PET and PET-CT (Positron Emission Tomography/Computed Tomography) imaging systems and clinical services, is pleased to announce its membership in the national alliance “Cardiac PET Industry Coalition” (CPIC), an organization at the forefront of quality of patient care, advocacy and innovation to advance the field of cardiovascular PET imaging. Positron joins forces with the coalitions founding members, Bracco Diagnostics, CDL Nuclear Technologies and Siemens Healthcare who have come together to promote federal policies that advance health outcomes for patients with cardiovascular disease and improve the availability of cardiac PET diagnostics throughout the United States. The CPIC will be a leading advocate for fair and transparent coverage and reimbursement policies that facilitate access to cardiac PET, align practitioners with regard to research opportunities, highlight the clinical and economic benefit of the modality, and provide expanded opportunities to educate healthcare providers and policymakers on the overall value of cardiac PET. CPIC has begun its work by weighing in on 2024 final payment rules, engaging with stakeholders in the cardiac community, and developing a 2024 policy agenda. Adel Abdullah, President of Positron stated, “Positron welcomed the opportunity to join the coalition, and personally, and I am honored to be part of current and future CPIC committees focused on the education, availability and advancement of the PET modality for cardiac studies. We believe Positron’s PET/PET-CT technology and ability to deliver the best value in the industry will play a key role in the adoption and growth of cardiac PET. Positron and our team will support and serve the coalition as best as possible for the future of the industry, concluded Mr. Abdullah.” Cardiac PET Industry Coalition CPIC passionately advocates for and protects the reimbursement of Cardiac PET, ensuring equitable access to innovative and life-saving technologies for healthcare providers and patients. For more information please visit www.cpicoalition.com About Positron Corporation Positron Corporation is a medical technology company that co-develops, manufactures, and sells state-of-the-art PET and PET-CT imaging systems and clinical services to nuclear medicine healthcare providers throughout North America. Positron specializes in the field of cardiac Positron Emission Tomography (PET) imaging, the gold standard in cardiac diagnostics. Positron’s innovative PET/PET-CT technologies, clinical services and practice solutions enables healthcare providers to accurately diagnose coronary artery disease and improve patient outcomes while practicing cost effective medicine. Positron’s Attrius® PET and NeuSight PET-CT imaging systems and distinct market position are substantial advantages unique to Positron that will facilitate the adoption of cardiac PET and the growth of the nuclear imaging market. Positron will soon offer a state-of-the-art PET-CT 4D molecular imaging device in the Affinity PET-CT 4D 64-Slice. Positron’s PET-CT(s) will enable nuclear cardiologists to utilize the full capabilities of molecular imaging and nuclear medicine. Positron’s PET-CT systems will also enable the Company to fully service and meet the demands of the vast oncology imaging segment of nuclear medicine. Positron is committed to expanding the cardiac and oncology PET modality by delivering the best technology and value to imaging specialists and will continue to advance its technology through its co-developer, supplier, and R&D venture with Shenyang Intelligent Neuclear Technology Co. a subsidiary of Neusoft Medical Systems. For more information please visit www.positron.com Forward-Looking Statements This press release contains statements which may constitute “forward-looking statements” within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief or current expectations of Positron Corporation, and members of its management as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results even if new information becomes available in the future. FOR FURTHER INFORMATION, please visit the company’s website at www.positron.com, or contact: investor@positron.com
Mineralys Therapeutics Appoints Biopharmaceutical Executive Alexander M. Gold, M.D. to its Board of Directors
RADNOR, Pa., June 14, 2024 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by dysregulated aldosterone, today announced that Alexander M. Gold, M.D. has been appointed to the Company’s Board of Directors (the Board), effective June 13, 2024. “We are delighted to welcome Alex to our Board of Directors as we advance the late-stage clinical development of lorundrostat for the treatment of hypertension and related cardiorenal metabolic disorders,” stated Jon Congleton, Chief Executive Officer of Mineralys. “As a cardiologist and accomplished biopharmaceutical clinical development executive, Alex brings tremendous experience driving value for biopharmaceutical companies. We believe Alex’s track record of successful pipeline development, regulatory approvals, and joint ventures will make him be a valuable director and resource for the Company’s team.” “I am honored to join the Mineralys Board of Directors,” stated Dr. Gold. “I look forward to working with the Company’s executive team and fellow Board members to advance the treatment of cardiorenal metabolic disorders. There is significant potential with lorundrostat in offering a targeted treatment approach for hypertension and other diseases driven by dysregulated aldosterone.” Dr. Gold is a cardiologist with more than 20 years of experience leading the development, approval, and commercialization of new therapies. He has held executive positions at several biopharmaceutical companies that targeted numerous therapeutic areas, including cardiometabolic, renal, and inflammation. Currently, Dr. Gold is the Chief Medical Officer of a clinical-stage biotech company. Prior to his current role, he held the role of Head Medical Officer at Sanifit-CSL. He originally joined as Chief Medical Officer and President of Sanifit Inc. in 2017, which was then acquired by Vifor Pharma in January 2022 and subsequently by CSL Ltd. in August 2022. Prior to Sanifit, Dr. Gold held the role of Senior Vice President and Head of Clinical Development at Portola Pharmaceuticals. Prior to Portola Pharmaceuticals, Dr. Gold was Head of Clinical Development at Reata Pharmaceuticals. For 11 years he held multiple leadership positions at AstraZeneca, including the Executive Director and Development Leader for BRILINTA, CRESTOR and ONGLYZA. Dr. Gold is currently an Adjunct Professor at Stanford University School of Medicine. Dr. Gold completed his residency in internal medicine and fellowship in cardiology at the Beth Israel Deaconess Medical Center / Harvard Medical School in Boston and conducted translational and clinical research as a fellow in cardiovascular research at the Harvard Clinical Research Institute and was a Scholar in Clinical Science. Dr. Gold received his M.D. from Harvard Medical School and his B.A in Biology from Brandeis University. In addition, the Company announced the resignation of Olivier Litzka, Ph.D. from its Board, effective June 13, 2024. Dr. Litzka stated: “It was an honor for me to serve on the Mineralys Board since the Company’s final private financing round prior to the initial public offering. The Company has shown tremendous progress, which is due to its exceptionally talented and hard working team. As a venture capital investor, I’ve decided to step down in order to make room for new, well-suited board members like Alex Gold to support the Company going forward. I wish Mineralys all the best on its path forward.” “The Board and I would like to express our collective gratitude to Olivier for his contributions and dedication to the Board. We wish him future success as he turns his attention to other venture investments at Andera Partners,” stated Mr. Congleton. About LorundrostatLorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension and CKD. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated approximately a 70% reduction in plasma aldosterone concentration in hypertensive subjects. In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated clinically meaningful blood pressure reduction in individuals with uncontrolled hypertension, in both automated office blood pressure measurement and 24-hour ambulatory blood pressure monitoring. Adverse events observed were a modest increase in serum potassium, decrease in estimated glomerular filtration rate, urinary tract infection and hypertension with one serious adverse event possibly related to study drug being hyponatremia. About Mineralys TherapeuticsMineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for cardiorenal conditions affected by dysregulated aldosterone, including hypertension and CKD. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn and Twitter. Forward Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Investor Relationsinvestorrelations@mineralystx.com Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@elixirhealthpr.com
Venus Medtech VenusP-Valve Completed First Implantation in IDE Pivotal Clinical Study in U.S.
HANGZHOU, China, June 14, 2024 /PRNewswire/ — Venus Medtech (02500. HK), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced today that its in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, VenusP-Valve, has completed its first implantation in the PROTEUS IDE Pivotal Clinical Study at the University of Virginia School of Medicine. This momentous procedure was performed by a multidisciplinary team coordinated by Prof. Scott Lim and Prof. Michael Hainstock of the center.
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This marks a significant advancement in the international progress of VenusP-Valve and represents another milestone following its CE MDR approval in April 2022.
The VenusP-Valve PROTEUS STUDY, abbreviated from Evaluation of the PerfoRmance Of The VEnUsP-Valve System in Patients with Native Right Ventricular Outflow Tract (RVOT) Dysfunction, is a prospective multi-center non-randomized interventional study in patients with RVOT disorders comorbid with moderate or greater pulmonary regurgitation. With a target enrollment of 60 subjects, data from this trial will support VenusP-Valve’s registration with the U.S. FDA and Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
In late 2023, the VenusP-Valve PROTEUS trial received coverage approval from the U.S. Centers for Medicare & Medicaid Services (CMS). With this endorsement, all eligible beneficiaries can be reimbursed for VenusP-Valve treatment in the study.Following its first clinical implantation in 2013, VenusP-Valve has been applied in clinical practice for 11 years. To date, the device has been included in national health insurance programs in Germany, France, etc., and has been approved in more than fifty countries, including China, Germany, France, the United Kingdom, Italy, Spain, Canada, and Australia, with its implantation seeing continuous growth in new hospitals and centers.”We’re honored to be part of the VenusP-Valve PROTEUS trial,” said Prof. Scott Lim after the procedure. “We’ve just completed the first patient enrollment in that trial using the VenusP-Valve. This worked quite well, and it really represents a possibility of better ways of treating patients with significant pulmonary valve disease.” “That went really smoothly in this teenage patient with free pulmonary insufficiency”, commented Prof. Michael Hainstock. “I’m very happy with the valve deployment and position. This (VenusP-Valve) is another option for our patients to treat pulmonary valve disease.””The successful first implantation in the VenusP-Valve PROTEUS study in the U.S. represents an important milestone for Venus Medtech in this crucial market,” said Lim Hou-Sen, General Manager and CEO of Venus Medtech. “The device has already received compassionate use approval from the FDA in a number of cases, underscoring its unique clinical advantages and high regulatory recognition. Moving forward, we will redouble efforts to advance VenusP-Valve’s clinical progress, speeding up its approval process with both the FDA and Japan’s PMDA.”About VenusP-ValveAs the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve is able to meet the needs of 85% of patients in the case of large RVOT.The long-term safety and efficacy of VenusP-Valve has been backed by impressive clinical data. According to three-year follow-up results of the clinical trial in Europe, the product demonstrated 100% procedural success and 0% all-cause mortality and reoperation among 81 patients who underwent TPVR. Right ventricular function improved significantly. Only one patient had severe pulmonary regurgitation.About Venus MedtechVenus Medtech (Hangzhou) Inc. (02500.HK) is committed to structural heart innovation. We are developing and commercializing comprehensive solutions for structural heart disease. Our robust pipeline, encompassing all four heart valves from TAVR, TPVR, TMVR, and TTVR to hypertensive renal denervation (RDN) therapy, underscores our unwavering commitment.For more information, please visit https://www.venusmedtech.com
*Provided for informational and academic purposes only, this content is not intended as professional medical or legal advice. Venus Medtech makes no representations, warranties or guarantees regarding the completeness, accuracy, or timeliness of this content.
*Venus Medtech makes no representations, warranties or guarantees regarding the property or clinical performance of any medical devices mentioned.
*VENUSMEDTECH, the stylized QI logo, VenusP-Valve, etc. are trademarks of Venus Medtech (Hangzhou) Inc.
Copyright 2024. Venus Medtech (Hangzhou) Inc. All Rights Reserved.
Contacts:Jill Liu Public Relations [email protected]Ophelia ChenInvestor Relations[email protected]SOURCE Venus Medtech (Hangzhou) Inc.
New FDA Cleared Balloon Catheter Used for Vessel Occlusion During Patient Resuscitation
Temporary vessel occlusion a growing practice for trauma patients.
SALT LAKE CITY, June 13, 2024 /PRNewswire/ — Emergency Scientific, a Utah-based medical device company specializing in innovative solutions for the emergency medicine industry, has announced the first patient use of its Landmark REBOA Catheter. The Landmark Catheter was developed for resuscitative endovascular occlusion of the aorta (REBOA), a procedure developed by the military to treat hemorrhage from non-compressible fractures of the pelvis and penetrating trauma of the abdomen and has since been adopted by civilian providers.
REBOA is also used for postpartum hemorrhage (PPH), cardiac arrest (CA), abdominal aortic aneurysm (AAA) ruptures, and gastrointestinal (GI) bleeds.
“Landmark was easy to use and easy to deliver with a smooth insertion,” said Scott T. Youngquist, MD, MS, FACEP, FAEMS, FAHA, an emergency medicine physician at the University of Utah who performed the first case. “REBOA can be an important tool to aid in patient resuscitation.” It is estimated that more than 60,000 people die every year in the United States from traumatic hemorrhage, making it the number one cause of death in patients under 45 years old.1,2
“We are pleased to offer another solution for physicians to treat challenging emergency hemorrhage,” said Ryan Murri, Emergency Scientific’s Chief Executive Officer. “With high quality emergency medicine solutions, we hope to be able to save more patients suffering life threatening injuries. We believe nobody should die from the loss of blood who could be saved with the right tools, and we look forward to continuing to serve our healthcare partners with additional novel treatment options.”
The Landmark REBOA Catheter recently received FDA 510(k) clearance and is indicated for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Emergency Scientific is a privately held company engaged in the development, manufacturing, and distribution of novel emergency medicine solutions.
Latif, R.K., Clifford, S.P., Baker, J.A. et al. Traumatic hemorrhage and chain of survival. Scand J Trauma Resusc Emerg Med 31, 25 (2023).
Kauvar, David S. MD; Lefering, Rolf PhD; Wade, Charles E. PhD. Impact of Hemorrhage on Trauma Outcome: An Overview of Epidemiology, Clinical Presentations, and Therapeutic Considerations. The Journal of Trauma: Injury, Infection, and Critical Care 60(6):p S3-S11, June 2006.
SOURCE Emergency Scientific
CARMAT Announces the Start of the Equitization of the First Tranche of Its EIB Loan
June 13, 2024 12:00 PM Eastern Daylight Time PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR): On February 14, 2023, the French financial markets authority (Autorité des marchés financiers) invited companies issuing equity securities or securities giving access to capital on a staggered basis to adopt a standard communication and warning on the […]
Viz.ai Collaborates with Hypertrophic Cardiomyopathy Association to Improve Care for Hypertrophic Cardiomyopathy Patients
SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced a collaboration with the Hypertrophic Cardiomyopathy Association (HCMA), the preeminent organization improving the lives of those with hypertrophic cardiomyopathy (HCM), to support, educate and advance research for HCM. “We’re thrilled to collaborate with the HCMA […]
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