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Peijia Medical Reports Audited 2023 Financial Results and Resumes Trading

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HONG KONG, June 17, 2024 /PRNewswire/ — Peijia Medical (HKG:9996), a leading Chinese domestic player in the high-growth transcatheter valve therapeutic and neurointerventional procedural medical device markets, announced the publication of its audited financial results for the year ended December 31, 2023 (“the period”) on June 16, 2024. Additionally, the Company announced that it would resume trading on the Hong Kong Stock Exchange on June 17, 2024.
“We are pleased to be reporting an exceptional year for Peijia and are eager for our investors to have access to the public markets once again,” said Dr. Yi Zhang, Chairman and CEO of Peijia Medical. “The preliminary, unaudited results published on March 28, 2024 remain unchanged following the audit, reiterating revenue growth of 75.9% and significant increases to our operational efficiencies. Our success was driven by market share gains, product portfolio expansion and key strategic partnerships. I’m very proud of our team and all that we were able to accomplish in 2023 and look forward to leveraging that momentum for the remainder of 2024.”
On March 28, 2024, Peijia announced a delay in the filing of the Company’s 2023 Annual Report as a result of the auditor’s work on certain financial assets, specifically related to the valuation of a prior HK$80million investment by the Company. On April 2, 2024, trading in Peijia shares was suspended pending publication of audited results. According to the Company’s announcement on June 16, 2024, the audit of the 2023 Annual Results have been completed in accordance with International Standards on Auditing issued by the International Auditing and Assurance Standards Board and the Company’s auditor, PricewaterhouseCoopers, have expressed unqualified opinion in the independent auditor’s report.
Trading resumed on June 17, 2024.
Financial Highlights
During the period, the Company recorded an operating revenue of RMB441.1 million, representing an increase of 75.9% year-over-year. The increase in revenue was mainly attributable to:
(i)  the terminal implantation volume of the Company’s TAVR products was 2,484 units, which is more than double the implantation volume in 2022. This has allowed the Company to achieve an over 20% share of the Chinese TAVR market;
(ii)  first-and second-generation TAVR products were utilized in approximately 200 new hospitals, bringing total penetration to nearly 500 hospitals;
(iii)  sales volume of coil products increased significantly as a result of the implementation of VBPs in the provinces where the Company had won bids, especially the 21-province alliance VBP led by Jilin province;
(iv)  sales volume of our existing and newly approved ischemic and vascular access products increased significantly as a result of the professional marketing activities and the quick penetration of neurointerventional procedures following the construction of stroke centers.
During the period, the Company recorded a gross profit of RMB325.4 million, representing an increase of 84.7% over the prior year, driven by continuous cost improvement measures throughout the business. 2023 gross profit margin of 73.8% increased by 350 basis points over the prior year. Expense ratios for selling and distribution, administrative costs, and research and development improved year over year by 22.7%, 17.1% and 82.2%, respectively. 
Financial and Business Results by Segment:
Transcatheter Valve Therapeutic (“TVT”) Business:
During the period, the TVT Business recorded revenue of RMB185.6 million, representing an increase of 72.9% year-over-year. Gross profit increased 86.0% to RMB159.0 million year-over-year. The segment’s gross profit margin was 85.7%, representing an increase of 6.0% year-over-year, driven by supply chain optimization and yield rate improvement. TVT selling and distribution expenses, administrative expenses and research and development expenses ratios decreased by 32.5%, 25.9% and 169.5%, respectively. The segment loss narrowed by 13.5% year-over-year.
With the recovery of procedure volume in the market and the increase in unit production of the sales team, implantation volume of the Company’s TAVR products have increased significantly, leading to further gains in market share. During the period, the Company’s first-and second-generation TAVR products were utilized in approximately 200 new hospitals, bringing total penetration to nearly 500 hospitals. During the year, the terminal implantation volume of the Company’s TAVR products was 2,484 units, which is more than double the implantation volume in 2022. This has allowed us to achieve an over 20% share of the Chinese transfemoral TAVR market.
During the period, the Company made significant progress in the research and development of pipeline products.
In aortic valve product line, the Company expedited the registration clinical trials for TaurusTrio the in-licensed JenaValve Trilogy Transcatheter Heart Valve (“THV”) System designed for pure aortic regurgitation (AR), and TaurusNXT, the Company’s internally developed third-generation durability-enhanced TAVR product. As of June 16, 2024, patient enrollment has been completed for both trials and patient follow-up is ongoing. Specially, in July 2023, the Company launched the multi-center registration clinical trial for TaurusTrio, enrolling a total of 116 AR patients in six months and finished ahead of enrollment schedule targets. In addition, the Company has successfully completed the technology transfer from JenaValve and established local manufacturing facilities at its new headquarters in Suzhou to produce the product independently.
In the mitral and tricuspid valve product lines, the Company has been steadily advancing the research and development progress of each product. The registration clinical trial for GeminiOne, the Company’s internally developed Transcatheter Edge-to-Edge Repair device, was progressing as planned with patient enrollment completed in May 2024. In addition, in October 2023, the early clinical findings of GeminiOne and the novel TTVR product MonarQ were presented at the 2023 Transcatheter Cardiovasvular Therapeutics (“TCT”) conference with preparations now being made to conduct early feasibility studies in the United States.
Operationally, in December 2023, TVT production facilities were relocated to new headquarters, increasing the current manufacturing capacity by three times.
Neurointerventional (“NI”) Business:
During the period, the NI Business recorded revenue of RMB255.6 million, representing a better-than-expected year-over-year increase of 78.1%. Gross profit for the segment increased 83.4% year-over-year to RMB166.4. Gross profit margin improved to 65.1% for the full year, an increase of 190 basis points over 2022. Hemorrhagic, ischemic and vascular access products accounted for 32.0%, 33.6% and 34.1% of the segment revenue, a much more balanced product sales mix over 2022 with 39.4%, 27.6% and 32.9%, respectively. With the increasing sales of ischemic products, the segment’s gross profit margin increased to 67.1%, an increase of 3.5% over the prior year. These gains were driven by coil products winning bids and quick market penetration of new and existing ischemic products.
Selling and distribution expenses, administrative expenses and research and development expenses ratios improved year-over-year by 14.2%, 9.9% and 15.7%, respectively. Also, due to the increase in revenue and gross profit, and the Company’s long-term efforts in cost reduction and efficiency improvement, the segment loss significantly narrowed by 98.8% year-over-year, with the expectation of reaching profitability in 2024.
About the Company
Peijia Medical (09996.HK) was established in 2012 and is headquartered in Suzhou, China. Peijia Medical focuses on the high-growth interventional procedural medical device market in China and aims to become a world-renowned medical device platform that provides comprehensive treatment solutions for structural heart and neurovascular diseases. The Company now has two generations of TAVR systems and sixteen neurointerventional devices commercialized in China and various innovative product candidates at different stage of development. For more information about Peijia visit peijiamedical.com/about. 
SOURCE Peijia Medical

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Centers for Medicare & Medicaid Services (CMS) Issues ICD-10-PCS Codes for Humacyte’s Human Acellular Vessel™ (HAV™)

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– Four unique ICD-10-PCS codes, effective October 1, 2024, for replacement of arteries in the upper and lower extremities using Humacyte’s HAV – – BLA submission under Priority Review by FDA for the treatment of vascular trauma, supported by Phase 2/3 clinical trial results and real-world use treating wartime trauma injuries in Ukraine – DURHAM, N.C., June 17, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, Human Acellular Vessels (HAVs) at commercial scale, today announced the issuance of four new ICD-10-PCS codes by the U.S. Centers for Medicare & Medicaid Services (CMS) ICD-10 Coordination and Maintenance (C&M) Committee. These codes, effective for hospital discharges beginning October 1, 2024, cover procedures for replacing arteries in the upper or lower extremities using Humacyte’s HAV. Humacyte also announced that, based on guidance from the Food and Drug Administration (FDA), the common (non-brand) name for the HAV will be the “acellular tissue engineered vessel” (ATEV). The CMS ICD-10 C&M Committee issues ICD-10-PCS codes to facilitate accurate classification and tracking of procedures. The ICD-10-PCS is a classification for procedures performed during inpatient hospital admissions1. The codes are widely used by hospitals and insurers to support data collection, payment, and monitoring. Obtaining these codes marks a significant milestone as Humacyte advances toward submission of a New Technology Add-on Payment (NTAP) application to CMS planned for later in 2024. Obtaining an ICD-10-PCS code is necessary to file an NTAP application. The newly issued codes are: X2R50WA: Replacement of Right Upper Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10 X2R60WA: Replacement of Left Upper Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10 X2R70WA: Replacement of Right Lower Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10 X2R80WA: Replacement of Left Lower Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10 The ATEV is designed for urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. ATEVs, which are bioengineered human tissues, are under investigation as universally implantable vascular replacements that resist infection and do not require immune suppression. The ATEV is intended to be readily available – “off-the-shelf” – with the potential to save valuable time for surgeons, thereby improving patient outcomes and reducing complications. Humacyte has extensive experience with the ATEV, accumulating over 1,200 patient-years of worldwide use in clinical trials for vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease. The company’s manufacturing facilities are capable of producing ATEVs at commercial scale to meet the potential needs of thousands of patients. The Prescription Drug User Fee Act (PDUFA) date for the FDA’s regulatory decision on Humacyte’s Biologics License Application (BLA), is August 10, 2024. This is based on a Priority Review which was granted by the FDA. The BLA submission was supported by positive results from the V005 Phase 2/3 clinical trial, and real-world evidence from the treatment of wartime injuries in Ukraine. In these studies, Humacyte’s ATEV demonstrated higher patency (blood flow) rates and lower amputation and infection rates as compared to historic synthetic graft benchmarks. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. 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. 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 also has received an RMAT designation. 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; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; our ability to successfully complete, preclinical and clinical trials for our ATEVs; the anticipated benefits of our ATEVs 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; the timing or likelihood of regulatory filings, acceptances and approvals, including the BLA for our V005 clinical trial and the NTAP application to CMS; timing, scope, and rate of reimbursement for our ATEVs; and our estimated available market opportunity. 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 ________________________1 Centers for Medicare & Medicaid Services. (2024). ICD-10-PCS Official Guidelines for Coding and Reporting 2025. Retrieved from https://www.cms.gov/files/document/2025-official-icd-10-pcs-coding-guidelines.pdf

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Spur Therapeutics (Formerly Freeline) Announces New Name and Brand

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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

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Avive Solutions Recognized as One of the 2024 Bay Area Best Places to Work

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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.

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Mineralys Therapeutics Appoints Biopharmaceutical Executive Alexander M. Gold, M.D. to its Board of Directors

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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

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CARMAT Announces the Start of the Equitization of the First Tranche of Its EIB Loan

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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 […]

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Simpson Interventions Announces Appointment of Dr. Joseph Knight as CEO

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June 12, 2024 10:00 AM Eastern Daylight Time CAMPBELL, Calif.–(BUSINESS WIRE)–Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced the appointment of Dr. Joseph Knight to the role of Chief Executive Officer, effective May 1st, 2024. He replaces Simpson Interventions’ Founder and previous CEO, […]

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Positron Corporation Enters Agreement to Acquire FDA 510(k) for NeuSight PET-CT

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Niagara Falls, NY, June 12, 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 support services, is pleased to announce it has entered an agreement to acquire the FDA 510(k) for the NeuSight PET-CT from its cooperative partner Neusoft Medical Systems’ subsidiary, Shenyang Intelligent Neuclear Medical Technology Co.   A 510(k) is a premarket submission made to the FDA (U.S. Food and Drug Administration) to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. Positron’s ownership of the existing 510(k) and FDA clearance will enable the marketing and sale of the NeuSight PET-CT 64 slice imaging system. This 510(k) also will facilitate future FDA clearances, including for the Company’s Affinity PET-CT 4D 64 slice system. This agreement allows Positron to immediately market and sell the NeuSight PET-CT, with plans to introduce Positron’s Affinity PET-CT 4D pending acceptance of an amended 510(k) submission.   Adel Abdullah, President of Positron stated, “Gaining the 510(k) is a significant milestone in Positron’s mission to offer outstanding PET-CT technology and solutions to healthcare practices and hospitals serving both the cardiac and oncology segments of molecular imaging. Our PET imaging product line will now feature PET-CT which will expand access for physicians and practitioners seeking to utilize the full capabilities of the PET modality in nuclear cardiology and oncology.  PET-CT imaging remains at the forefront of oncology studies and has become vital to the future of nuclear cardiology. With the addition of PET-CT, Positron has a range of core products that blend cutting edge technology with strong economics, appealing to most nuclear imaging specialist and practices.” Mr. Abdullah further added, “We appreciate the full support of Neusoft Medical Systems whose unwavering support and expertise in imaging technologies and extensive R&D continues to enhance our current and future capabilities. I am confident in Positron’s important role in advancing the PET modality and our commitment to delivering the best value in the industry.” 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.    About Neusoft Medical Systems Co., Ltd. Neusoft Medical Systems is a leading global clinical diagnosis and treatment solution provider, headquartered in China. Neusoft Medical Systems is constantly innovating its portfolio of medical imaging diagnosis and clinical solutions in CT, MRI, DSA, XR, PET/CT, RT, US and IVD. Neusoft Medical Systems also is developing MDaaS (Medical Devices & Data as a Service), a strategic product line built using the Internet, big data, artificial intelligence, combined with other technologies improving medical institutions’ ability to diagnose and treat patients, achieving operational excellence. Innovation is always the driving force of Neusoft Medical Systems. Neusoft Medical Systems is collaborating with global scientists and medical institutions dedicated to advancing the technology of medical imaging solutions. Together with 45,000 installations in more than 110 countries, Neusoft Medical Systems provides advanced, high-quality medical imaging solutions to patients around the world. Neusoft Medical Systems is dedicated to being an excellent value innovator of global healthcare services. Through innovation and excellent operations, Neusoft Medical Systems is advancing healthcare products across a wide range of medical solutions and services to enhance global healthcare for all. 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. Words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and similar expressions are forward-looking statements and involve risks, uncertainties and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. 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

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University Hospitals Transforms Patient Care with Aidoc’s AI-Enabled Solutions Across Its Entire Health System

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Aidoc aiOS™ integration across 13 hospitals focuses on enhancing clinical outcomes and streamlining workflow with access to 17 FDA-cleared AI algorithmsCLEVELAND, June 12, 2024 /PRNewswire/ — University Hospitals (UH) has announced a major advancement in its AI strategy with the deployment of Aidoc’s comprehensive AI platform (aiOS™) across 13 of its hospitals and dozens of its outpatient locations. This initiative marks a significant leap forward in leveraging cutting-edge technology for superior patient outcomes.

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Image of University Hospitals Medical Center Campus in Cleveland, Oh. (PRNewsfoto/Aidoc)

University Hospitals Logo (PRNewsfoto/Aidoc)

Driven by a commitment to provide the highest standard of care, UH sought a standardized, hyper-accurate AI platform that could be seamlessly integrated across its network of academic hospitals and outpatient locations. Having utilized AI in various small-scale applications, UH chose to expand its capabilities with Aidoc to empower care teams with the information they need to address some of today’s most pressing medical issues.

Patients at UH will benefit from faster diagnosis and treatment of acute conditions such as pulmonary embolism, aortic dissection, vertebral compression fracture and pneumothorax. When a patient arrives at a UH facility and undergoes a CT scan for an injury or pain, Aidoc’s AI analyzes the scan using its comprehensive algorithms. The technology identifies both expected and unexpected findings, helps physicians prioritize urgent cases and ensures all flagged conditions are reviewed by the care team. Aidoc’s AI facilitates communication between the care team to enhance collaboration and speed up treatment.
Key Benefits of Aidoc for University Hospitals
Seamless integration across the entire health network
Immediate access to critical patient information
Expedited care and improved patient outcomes
Access to all 17 FDA-cleared AI algorithms for triage, quantification and care coordination
“Today’s care delivery is incredibly complex with numerous moving parts,” shared Dr. Donna Plecha, Chair of Radiology at University Hospitals.” Aidoc’s AI technology assists our radiologists in evaluating various patient images, allowing our clinicians to access precise, actionable data quickly. The AI technology enables our care teams to be more accurate and efficient leading to even more exceptional care for our patients.”The agreement leverages Aidoc’s proprietary aiOS™, a groundbreaking platform that addresses common AI implementation challenges such as integrating with existing IT systems, ensuring EHR compatibility, and managing data and reporting. This comprehensive approach ensures that UH can provide leading-edge care while maintaining operational efficiency and clinical excellence.”We are thrilled to collaborate with University Hospitals to drive healthcare innovation through our AI solutions,” said Elad Walach, CEO, Aidoc. “University Hospitals’ visionary approach to healthcare and dedication to integrating technology sets a new standard for patient care. UH is not only enhancing care coordination and streamlining workflows but also ensuring every patient receives the precise, timely and exceptional care they deserve. UH’s commitment to medical ingenuity and excellence is truly transformative.”By integrating Aidoc’s AI platform, University Hospitals ensures seamless deployment and minimal technical challenges, allowing for a collaborative approach to continuous monitoring and governance. This partnership not only enhances patient safety and care but also enables UH to maintain high standards in AI performance and reliability. Through this collaborative effort, UH can focus more on patient care, ensuring every patient receives the best possible treatment with the aid of AI technology.About University Hospitals Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 21 hospitals (including five joint ventures), more than 50 health centers and outpatient facilities, and over 200 physician offices in 16 counties throughout northern Ohio. The system’s flagship quaternary care, academic medical center, University Hospitals Cleveland Medical Center, is affiliated with Case Western Reserve University School of Medicine, Northeast Ohio Medical University, Oxford University, the Technion Israel Institute of Technology and National Taiwan University College of Medicine. The main campus also includes the UH Rainbow Babies & Children’s Hospital, ranked among the top children’s hospitals in the nation; UH MacDonald Women’s Hospital, Ohio’s only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, with more than 3,000 active clinical trials and research studies underway. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including “America’s Best Hospitals” from U.S. News & World Report. UH is also home to 19 Clinical Care Delivery and Research Institutes. UH is one of the largest employers in Northeast Ohio with more than 30,000 employees. Follow UH on LinkedIn, Facebook and Twitter. For more information, visit UHhospitals.org.About AidocAidoc is a pioneering force in clinical AI. We focus on aiding and empowering healthcare teams to optimize patient treatment, which results in improved economic value and clinical outcomes. Our clinically proven AI solutions eliminate silos, increase efficiencies, and improve outcomes by delivering critical information when and where care teams need it leading to immediate collective action. Built on Aidoc’s proprietary aiOS™, we analyze and aggregate medical data to enable care teams to operationalize the unexpected and work seamlessly with a continued focus on the patient. Used in more than 1,000 medical centers worldwide, Aidoc has the most FDA clearances (17) in clinical AI and its AI-based solutions cover 75 percent of patient populations, enabling physicians to make informed decisions based on real-time data. Aidoc AI is always on, running in the background to change the foreground. Visit Aidoc.com to see how we are connecting all points of care with always on AI.Photo – https://mma.prnewswire.com/media/2436134/Aidoc_UH.jpgLogo – https://mma.prnewswire.com/media/2015772/4756850/Aidoc_Always_On_AI_Logo.jpgLogo – https://mma.prnewswire.com/media/2436135/University_Hospitals_Logo.jpgSOURCE Aidoc

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Kardium Announces $104M in New Financing for Innovative Atrial Fibrillation Treatment

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VANCOUVER, British Columbia–(BUSINESS WIRE)–Kardium Inc., developer of the Globe® Mapping and Ablation System for the treatment of atrial fibrillation, has raised US $104 million in a new financing round. The round is led by existing investor Fidelity Management & Research Company, together with follow-on participation by funds and accounts advised by T. Rowe […]

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