Regulatory

Sirnaomics Announces Completion of IND-Enabling Studies of Safety and Efficacy for STP125G with NHP Models, Targeting ApoC3 for Treatment of Cardiovascular Diseases

Regulatory by Comments are Disabled

HONG KONG, GERMANTOWN, Md. and SUZHOU, China, July 12, 2024 /PRNewswire/ — Sirnaomics Ltd. (the “Company”, Stock Code: 2257.HK, together with its subsidiaries, the “Group” or “Sirnaomics”), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, announced today that the Group has completed IND-enabling studies for STP125G, an siRNA therapeutics targeting Apolipoprotein C3 (ApoC3), based on its proprietary GalAhead™ mxRNA technology. The safety and efficacy results from the non-human primate (NHP) studies strongly support for an IND filing with the U.S. FDA for initiating a Phase I clinical study of STP125G for cardiovascular disease indications.
ApoC3 is a widely known player in triglyceride metabolism, and it has been recently recognized as a polyhedric factor which may regulate several pathways beyond lipid metabolism by influencing cardiovascular, metabolic, and neurological disease risk. High levels of triglycerides (TG) have been shown to be associated with increased risk of cardiovascular diseases. For severe hypertriglyceridemia (sHTG) patients whose TG level is more than 1000 mg/dL, the risk of developing acute pancreatitis is 5 to 10 times to that in the general population. Down-regulation of ApoC3 using siRNA or antisense oligonucleotides has been shown to be effective in lowering TG in sHTG patients.
During an efficacy evaluation of STP125G with non-human primate model (N = 4), we observed a dose-dependent silencing activity among 1 mg/kg, 3 mg/kg and 10 mg/kg doses with a strong safety profile. The maximum target silencing efficacy was achieved at 10 mg/kg dosage around week 4 and was maintained for an additional 9 weeks (the total length of this 13-week study). The safety evaluation of STP125G using non-human primate model (N = 4) demonstrated an excellent safety readout with a single subcutaneous administration at 50 mg/kg, 100 mg/kg or 250 mg/kg. The maximum target silencing efficacies were like the level of 10 mg/kg for all three high dosages.
“STP125G is the second drug candidate based on our GalAhead™ mxRNA technology that has shown excellent safety and potent efficacy results with the NHP models. Its long-lasting silencing activity against ApoC3 may provide better therapeutic benefit to patients suffering cardiovascular conditions, than those of antisense and other siRNA drugs.” Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics, indicated. “Those data readouts further validated STP125G as a novel siRNA therapeutic candidate for treatment of hypertriglyceridemia and other cardiovascular diseases, using our proprietary GalAhead™-based delivery technology”.
– End –
About ApoC3 and STP125G
ApoC3 is an important emerging target linking hypertriglyceridemia with cardiovascular disease (CVD). ApoC3 is a potent modulator of many established CVD risk factors, and is found on chylomicrons, VLDL, LDL, and HDL particles. Many studies show that in humans, apoC3 levels are an independent risk factor for CVD, and its presence on lipoproteins may promote their atherogenicity. Recent findings of the role of ApoC3 has been implicated in HDL metabolism and in the development of atherosclerosis, inflammation, and ER stress in endothelial cells. ApoC3 has been recently considered an important player in insulin resistance mechanisms, lipodystrophy, diabetic dyslipidemia, and postprandial hypertriglyceridemia (PPT). The emerging evidence of the involvement of ApoC3 in the pathogenesis of Alzheimer’s disease open the way to further study if modification of ApoC3 level slows disease progression. Furthermore, ApoC3 is clearly linked to cardiovascular disease (CVD) risk, and progression of coronary artery disease (CAD) as well as the calcification of aortic valve and recent clinical trials has pointed out the inhibition of ApoC3 as a promising approach to manage hypertriglyceridemia and prevent CVD. Several evidences highlight the role of ApoC3 not only in triglyceride metabolism but also in several cardio-metabolic pathways. STP125G is a single-stranded siRNA therapeutics targeting ApoC3 mRNA, based on Sirnaomics proprietary GalAhead™ mxRNA technology.
About Sirnaomics
Sirnaomics is an RNA therapeutics biopharmaceutical company that focuses on the discovery and development of innovative drugs for indications with unmet medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both Asia and the United States. Based on its proprietary delivery technologies, a polypeptide nanoparticle RNAi platform and GalNAc RNAi platform, GalAhead™, Sirnaomics has established an enriched drug candidate pipeline. STP122G, which represents the first drug candidate utilizing the Group’s GalAhead™ mxRNA technology, is currently in Phase I development. STP125G is the second siRNA therapeutics based on Sirnaomics proprietary GalAhead™ mxRNA technology, targeting ApoC3 mRNA for cardiovascular disease treatment. STP237G is the first dual-targeted drug based on a GalAhead™ muRNA technology and is in the late stage of preclinical evaluation. The Group has also had multiple successes with oncology applications through its clinical programs for STP705 and STP707. With the expansion of the Group’s clinical pipeline and establishment of the Group’s manufacturing facility, Sirnaomics focuses on a transition from a biotech company to a biopharma corporation. Learn more at: www.sirnaomics.com.
SOURCE Sirnaomics

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

Peripheral/Endo Regulatory by Comments are Disabled

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

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Microbot Medical Has Received FDA Approval to Proceed with its Pivotal Human Clinical Trial

Peripheral/Endo Regulatory by Comments are Disabled

BRAINTREE, Mass., June 03, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces that it has received the U.S. Food and Drug Administration’s (“FDA”) approval to proceed with its pivotal human clinical trial as part of its Investigational Device Exemption (“IDE”) application for its LIBERTY® Endovascular Robotic Surgical System. The study will be conducted in the U.S., and the Company has already signed a clinical trial service agreement with a leading academic medical center. The Company is also in the process of engaging additional leading centers to participate in the trial. In parallel to commencing the pivotal human clinical trial, the Company is completing its biocompatibility tests as required by its IDE application. “The recent authorization by the FDA to commence our pivotal clinical study, following submission of the results of our extensive pre-clinical studies and tests, reinforces our confidence in our innovative technology,” commented Harel Gadot, CEO, President and Chairman. ”It is also a testament to our commitment to meet meaningful milestones as we continue our path towards potential regulatory clearance and subsequent commercialization in the US and other regions across the globe”. About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body. The Investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com. Safe Harbor Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law. Investor Contact: Michal Efraty+972-(0)52-3044404IR@microbotmedical.com

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Stereotaxis Receives CE Mark Recertification Under EU’s MDR Regulatory Framework

Regulatory Rhythm by Comments are Disabled

ST. LOUIS, May 24, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework. The recertification under MDR covers all Stereotaxis devices currently available in Europe. MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive, which had governed the approval and marketing of medical devices in the EU. The new regulation includes more stringent standards and requirements across quality, clinical and post-market surveillance areas. It is intended to create a robust regulatory framework for improved clinical safety and market access for medical devices. Stereotaxis has now received its updated EU Quality Management System Certificate. This certificate shows that the Stereotaxis Quality System is in accordance with MDR and that Stereotaxis’ products now have a valid CE Mark under MDR. This MDR certification will support regulatory clearances of upcoming innovations. “This final step in the certification of our products and quality systems under MDR is the culmination of several years of diligent work by the Stereotaxis team,” said Matthew Stepanek, Sr. Director of Regulatory Affairs, Quality & Technical Writing. “We appreciate the collaboration with our Notified Body in this entire process.” “This is a reflection of Stereotaxis’ commitment to high-quality devices, systems, and processes to ensure the best possible experience for the patients and physicians that rely on our technology,” said David Fischel, Chairman and CEO. “Congratulations to all those at Stereotaxis who made this possible.” About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 100,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.Stereotaxis.com. This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Company Contacts:                                                        David L. FischelChairman and Chief Executive Officer Kimberly R. Peery                                                        Chief Financial Officer 314-678-6100Investors@Stereotaxis.com

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Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk

Coronary/Structural Heart Regulatory by Comments are Disabled

Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial infarction and stroke.1The Roche Diagnostics Tina-quant® Lp(a) assay measures lipoprotein (a) in a person’s bloodstream, and will be made available on Roche’s installed base of over 90,000 serum work area (SWA) systems worldwide. The test has been developed in collaboration with Amgen. Basel, 22 May 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development. Lp(a) is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease, a major public health issue. “While modern lifestyles are a major driver, as much as 30% of mortality associated with cardiovascular disease occurs in individuals without modifiable risk factors,2” said Matt Sause, CEO of Roche Diagnostics. “Lp(a) is a critical marker for people at risk of cardiovascular disease, but medicine has had limited solutions to adequately address the problem. Through our collaboration with Amgen, Roche is paving the way to make elevated Lp(a) an actionable biomarker.” “Lp(a) testing rates are markedly low, and existing lab tests may not consistently and accurately measure Lp(a) levels,3” said Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen. “By combining Amgen’s deep legacy and expertise in cardiovascular disease with Roche’s diagnostic expertise, we can accelerate access to more standardised testing and equip more patients and healthcare providers with important information to better understand their risk for cardiovascular disease.” Once approved, the new Tina-quant® test is expected to be made available to support the selection of patients who may benefit from an innovative Lp(a)-lowering therapy. About Lp(a)Globally, as many as one in five people have elevated Lp(a),1 where lifestyle interventions such as diet and exercise have no significant impact. While Lp(a) levels can be influenced by non-genetic factors including menopause, kidney and liver disease and hyperthyroidism, they are predominantly ( >90%) determined by genetic variations in the LPA gene.4 Raised Lp(A) is particularly prevalent among women, and people of African descent.5,6 High levels of Lp(a) have been shown to promote the buildup of lipids in artery walls, leading to the development of plaques, and have been associated with an increased risk of cardiovascular (CV) events4. Lp(a) testing is therefore an important tool for clinicians, enabling them to make a more accurate assessment of CV risk, and it is expected to become a part of regular diagnostic testing in the coming years. Professional bodies around the world, including the National Lipid Association, Canadian Cardiovascular Society, European Atherosclerosis Society, European Society of Cardiology, and the Beijing Heart Society have recommended that Lp(a) measurement should be considered at least once in every adult person’s life. As Lp(a) has no single, defined molecular weight, there is a consensus in the scientific community that, ideally, Lp(a) levels should be measured in terms of the number of molecules per litre of blood (nmol/L). This contrasts with widely available tests that measure the molecular weight of Lp(a) in the blood (mg/L). About Tina-quant® Lp(a) RxDx assay The FDA has granted Breakthrough Device Designation to the Tina quant Lp(a) RxDx assay for use in selecting patients with elevated Lp(a) and a history of atherosclerotic disease for treatment with an Lp(a) lowering drug. A lipoprotein (a) test involves a routine blood draw during which a small sample of blood is used for measurement. This test measures the number of Lp(a) molecules per litre in a person’s bloodstream, which paves the way for Lp(a) to serve as an actionable biomarker in future. If approved, it will be available on selected cobas® platforms. Currently, there is no FDA authorised Lp(a) assay measuring Lp(a) in nmol/L available in the US. This assay will be part of Roche’s wider portfolio of tests for cardiovascular diseases. Together, these tests provide healthcare professionals the opportunity to make informed decisions, allowing patients to access new and innovative treatments. About Breakthrough Device DesignationThe Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these medical devices.  About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Tsimikas S and Marcovina S, Ancestry, Lipoprotein(a), and Cardiovascular Risk Thresholds: JACC Review Topic of the Week, J Am Coll Cardiol. 2022 Aug, 80 (9) 934–946 ​​ https://www.jacc.org/doi/full/10.1016/j.jacc.2022.06.019[2] Beaglehole, R., Reddy, S., Leeder, S.R. (2007). Poverty and human development: the global implications of cardiovascular disease. Circulation 116, 1871–1873.[3] Zheng W, Chilazi M, Park J, et al. Assessing the Accuracy of Estimated Lipoprotein(a) Cholesterol and Lipoprotein(a)‐Free Low‐Density Lipoprotein Cholesterol. Journal of the American Heart Association. 2022;11(2). d oi: 10.1161/jaha.121.023136[4] Kronenberg F. et al, Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement, European Heart Journal, Volume 43, Issue 39, 14 October 2022, Pages 3925–3946, https://doi.org/10.1093/eurheartj/ehac361[5] Simony SB, Mortensen MB, Langsted A, Afzal S, Kamstrup PR, Nordestgaard BG. Sex differences of lipoprotein(a) levels and associated risk of morbidity and mortality by age: The Copenhagen General Population Study. Atherosclerosis. 2022 Aug;355:76-82. doi: 10.1016/j.atherosclerosis.2022.06.1023. Epub 2022 Jun 27. PMID: 35803767.[6] Mehta A, Jain V, Saeed A, Saseen JJ, Gulati M, Ballantyne CM, Virani SS. Lipoprotein(a) and ethnicities. Atherosclerosis. 2022 May;349:42-52. doi: 10.1016/j.atherosclerosis.2022.04.005. PMID: 35606075. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25  Simon GoldsboroughPhone: +44 797 32 72 915  Karsten KleinePhone: +41 79 461 86 83  Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262  Yvette PetillonPhone: +41 79 961 92 50 Dr. Rebekka SchnellPhone: +41 79 205 27 03   Roche Investor Relations Investor Relations North America
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4C Medical’s AltaValve System Secures Dual FDA Breakthrough Device Designations, Expediting Patient Access to Advanced Mitral Valve Therapies

Coronary/Structural Heart Regulatory by Comments are Disabled

MINNEAPOLIS, May 8, 2024 /PRNewswire/ — 4C Medical Technologies, Inc. (“4C Medical”), a medical device company dedicated to advancing minimally invasive therapies for structural heart disease, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA)…

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