Peripheral/Endo

Microbot Medical Enrolled the First Patient in its Pivotal Human Clinical Trial

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The first clinical case was performed at Brigham and Women’s Hospital The clinical trial is expected to support the future submission to the FDA for the commercialization of the LIBERTY® Endovascular Robotic Surgical System BRAINTREE, Mass., July 08, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT) today announced the completion of the first procedure in a patient utilizing its LIBERTY® Endovascular Robotic Surgical System. The procedure took place at Brigham and Women’s Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, as part of the Company’s pivotal human clinical trial. The clinical trial at BWH is led by Dr. Dmitry Rabkin, MD, PhD, Assistant Chief, Division of Angiography & Interventional Radiology, who also performed this first human case. The trial is part of the Investigational Device Exemption (“IDE”) for LIBERTY®, and the Company expects its results will support the future submission to the FDA and subsequent commercialization. “Enrolling the first patient in our pivotal human clinical trial is a significant milestone for the Company, and an important step on our journey to bring LIBERTY® to U.S. physicians,” commented Juan Diaz-Cartelle, MD, Chief Medical Officer of Microbot Medical. “We are very pleased with the rapid pace of site activation, and I’m looking forward to enrolling additional patients in the near future.” About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a clinical- stage 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 IR@microbotmedical.com

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Microbot Medical Partners with Baptist Hospital of Miami to Participate in its Pivotal Human Clinical Trial

Peripheral/Endo by Comments are Disabled

BRAINTREE, Mass., July 03, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announces it has received Institutional Review Board approval and signed a Clinical Trial Agreement with Baptist Hospital of Miami, which includes Miami Cardiac & Vascular Institute and Miami Cancer Institute.   This is the second announced site that will participate in the clinical trial for Microbot’s LIBERTY as part of its Investigational Device Exemption (“IDE”).   The Company had recently announced Brigham and Women’s Hospital as another participating site. The principal investigator at Baptist Hospital of Miami will be Ripal Gandhi, MD, FSVM. “I am very excited to participate in the trial. I believe this technology has the potential to change how we perform endovascular procedures,” said Dr. Gandhi. “We believe the interest in the LIBERTY technology is overwhelming, as evident by the fast pace of enrolling and activating leading sites into the pivotal trial since we announced the IDE. We are excited for our partnership with Baptist Hospital of Miami, which is one of the leading hospitals in the United States,” commented Harel Gadot, CEO, President and Chairman of Microbot Medical. About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a clinical- stage 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 IR@microbotmedical.com

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CorMedix Inc. Announces Outpatient Availability of DefenCath

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BERKELEY HEIGHTS, N.J., July 03, 2024 (GLOBE NEWSWIRE) — CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that it has commenced commercialization of DefenCath® (taurolidine and heparin) to outpatient dialysis centers and vascular access clinics where patients receive outpatient dialysis and catheter placement services. The outpatient launch coincides with the effective date of July 1st for outpatient reimbursement of DefenCath as directed by the Center for Medicare & Medicaid Services (CMS). CorMedix received NDA approval of DefenCath under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, and began commercialization of the product in the inpatient setting on April 15, 2024. This week CorMedix began shipping orders for DefenCath to dialysis operators under previously announced commercial agreements, and anticipates additional customer agreements and orders in the upcoming weeks. “I am very excited to have now commenced outpatient distribution of DefenCath, an important milestone for CorMedix and for patients, who will now have access to the first and only FDA approved antimicrobial catheter lock solution,” says CorMedix CEO, Joseph Todisco. “I am impressed with how efficiently our customers are rolling out the launch of DefenCath thus far, and I am looking forward to expanding access in the upcoming months as we solidify additional customer contracts.” DefenCath® (taurolidine and heparin)IMPORTANT SAFETY INFORMATION These highlights do not include all the information needed to use DefenCath safely and effectively. See full prescribing information for DefenCath. LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients. DefenCath is contraindicated and has warnings and precautions in patients with: Known heparin-induced thrombocytopenia (HIT).Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products. If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures. To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. Please see the full Prescribing Information. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath®, which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and began outpatient commercialization on July 1st following the effectiveness of outpatient reimbursement from CMS. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact:Dan FerryManaging DirectorLifeSci Advisorsdaniel@lifesciadvisors.com (617) 430-7576

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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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Rep. Hillary Scholten and the National Blood Clot Alliance Award Corewell Health Butterworth Hospital as a VTE Center of Excellence

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GRAND RAPIDS, Mich., June 26, 2024 /PRNewswire/ — On June 24, 2024, Rep. Hillary Scholten (MI-03) joined members of the National Blood Clot Alliance “NBCA” (www.stoptheclot.org) to present NBCA’s inaugural Venous Thromboembolism (VTE) Center of Excellence (COE) award to Corewell Health Grand Rapids Hospitals – Butterworth Hospital. This award recognizes the hospital’s outstanding commitment to providing the highest standard of care, patient education, and follow-up treatment for VTE patients.

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Rep. Hillary Scholten (MI-03) (center) presents the inaugural NBCA VTE Center of Excellence Award to the Corewell Health team. Pictured from left to right: Glen VanOtteren, Erin VanDyke, PA-C, MPAS, Michael Knox, MD, and Trevor Cummings, MD, FACEP.

Rep. Scholten stated, “Our friends, families, neighbors, and the wider community can trust the commitment to excellence demonstrated by Corewell’s clinicians.  These incredible providers ensure that all patients, not just some, will receive the highest standard of care when being diagnosed and treated for VTE.  I was delighted to submit a FY25 appropriations request to fund a nationwide public awareness campaign and to train healthcare providers to recognize the symptoms of blood clots. West Michigan is leading the way in addressing this public health crisis, setting a model for both the Great Lakes State and our nation.”

Dr. Michael Knox, MD, FACR, and Co-Director of the Corewell PERT Program, accepted the award on behalf of Corewell. He stated, “I am honored to accept this award on behalf of my team and thank NBCA for this distinction. We appreciate Rep. Scholten’s acknowledgement of the important work we are doing. Tackling this public health crisis will take all of us working together — hospitals, clinicians, patients, and Members of Congress.”
Justin Crockett, NBCA Board Member and Chair of the NBCA VTE COE Committee, added, “Development of this VTE COE designation has been a long journey. We are very proud to present this award and to start reducing the incidence and mortality of VTE, which claims the lives of 100,000 people each year from all age groups and walks of life. We are especially grateful for Congresswoman Scholten’s support and in recognizing the toll VTE takes on both the citizens of Michigan and the entire nation. We also thank her for supporting NBCA’s $5 million federal appropriations request directing funding to the Centers for Disease Control and Prevention’s (CDC) Division of Blood Disorders and Genomics for a national VTE education, awareness, and prevention program for both the public and clinicians.”VTE (venous blood clots) claims the lives of 100,000 Americans each year while impacting another 900,000 individuals. It is the third leading cause of cardiovascular death and the second cause of sudden unexpected death. It kills more people each year than HIV/AIDS, breast cancer and motor vehicle accidents combined. Nearly half of all VTE cases occur in a hospital or post-hospital setting, yet, according to the CDC, 70% of these cases are preventable.  It is estimated that the annual cost to the US healthcare system is $10 billion per annum.About the National Blood Clot Alliance The National Blood Clot Alliance, established in 2003, is the nation’s leading nonprofit, patient advocacy organization dedicated to advancing the prevention, early diagnosis, and successful treatment of life-threatening blood clots, such as deep vein thrombosis (DVT) and pulmonary embolism (PE), DVT +PE=VTE. Each year NBCA provides blood clot information, resources, and support to more than 3 million people. For more information about NBCA please contact [email protected] or visit www.stoptheclot.org.About Corewell Health™People are at the heart of everything we do, and the inspiration for our legacy of outstanding outcomes, innovation, strong community partnerships, philanthropy and transparency. Corewell Health is a not-for-profit health system that provides health care and coverage with an exceptional team of 65,000+ dedicated people—including more than 12,000 physicians and advanced practice providers and more than 15,500 nurses providing care and services in 21 hospitals, 300+ outpatient locations and several post-acute facilities—and Priority Health, a provider-sponsored health plan serving more than 1.3 million members. Through experience and collaboration, we are reimagining a better, more equitable model of health and wellness. For more information, visit www.corewellhealth.org.About Rep. Hillary Scholten:Congresswoman Hillary J. Scholten is honored to serve the people of Michigan’s Third Congressional District, a diverse district that is anchored by the urban centers of Grand Rapids, Muskegon, and Grand Haven, and includes suburbs, farmland, and miles of beautiful Lake Michigan shoreline.Congresswoman Scholten is a fourth-generation West Michigander.  For more information visit www.hillaryscholten.com.SOURCE National Blood Clot Alliance

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Milestone Phase II Clinical Study Demonstrates Niagen®, Patented Nicotinamide Riboside (NR), Improves Functional Mobility for Individuals with Peripheral Artery Disease (PAD)

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June 24, 2024 08:32 AM Eastern Daylight Time LOS ANGELES–(BUSINESS WIRE)–ChromaDex Corp. (NASDAQ:CDXC), the global authority on nicotinamide adenine dinucleotide (NAD+) research, shares results from a milestone phase II clinical study showcasing the promising effects of nicotinamide riboside (NR) supplementation […]

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Microbot Medical Partners with Brigham and Women’s Hospital for Its Pivotal Human Clinical Trial

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Following FDA Approval to Commence the Clinical Trial, an Official Site Initiation Has Taken Place as Preparation for Patient Enrollment Advances Multiple Robotic Systems Already Received by the Site to Allow Inventory Readiness in Support of Trial BRAINTREE, Mass., June 20, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT) announced its agreement with Brigham and Women’s Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, to serve as one of the sites to perform the pivotal human clinical trial for its LIBERTY® Endovascular Robotic Surgical System, as part of its Investigational Device Exemption (“IDE”) application. This development, previously announced on June 17, 2024, follows the U.S. Food and Drug Administration’s approval to commence Microbot’s pivotal human clinical trial. The Company has completed the Site Initiation Visit, during which BWH clinical staff was trained on the clinical study protocols and the use of the LIBERTY® Endovascular Robotic Surgical System. In addition, the first shipment of LIBERTY investigational systems arrived at BWH this week in support of the clinical trial. Dr. Dmitry Rabkin, MD, PhD (Assistant Chief, Division of Angiography & Interventional Radiology), will lead the study for the site as principal investigator at BWH. “We are pleased to work with Dr. Rabkin and the team at Brigham and Women’s Hospital on this clinical study,” commented Harel Gadot, CEO, President and Chairman of Microbot Medical. “We believe their commitment to research and the advancement of science make them an ideal clinical study site.” The Company is in the process of engaging additional leading centers to participate in the clinical trial. About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a clinical stage 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 EfratyIR@microbotmedical.com

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Micro Medical Solutions Achieves Milestone with 200th Enrollment in HEAL Registry

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Clinical investigators complete record enrollment in real-world Registry, HEAL (An All-comers Registry of the MicroStent PeripHeral Vascular StEnt in subjects with PeripherAl ArteriaL Disease)
WILMINGTON, Mass., June 18, 2024 /PRNewswire/ — Micro Medical Solutions — Micro Medical Solutions, a leader in providing innovative medical device solutions, is excited to announce that it has achieved a major milestone with the enrollment of its 200th patient in the HEAL Registry. This unique registry is focused on gathering real world evidence using its MicroStent technology for treatment of patients with Chronic Limb-Threatening Ischemia (CLTI) and Critical Limb Ischemia (CLI).
CLTI and CLI are debilitating conditions that affect the blood vessels in the legs and feet. Those afflicted with this disease often suffer from severe pain, numbness, and open non-healing wounds. Without intervention, these conditions can lead to amputation, loss of mobility, and death. Micro Medical Solutions is committed to providing a potential solution for this medically complex and underserved patient population.
The HEAL Registry, enrolling patients at ten sites in EU countries, including Italy, Germany, Belgium, Austria and the Netherlands, is crucial clinical research in evaluating the use of MMS’ MicroStent to treat real world patients afflicted with CLI/CLTI. HEAL’s research endpoints provide real world evidence of the effectiveness and safety of treatment with the Micro Stent. With enrollment of 200 patients, the registry has reached a significant clinical and research milestone. The registry is also collecting specific data outcomes in below-the-ankle treatment, specific to wound healing. This data will be reported alongside MMS’ US IDE study data to the FDA in its premarket approval application (PMA).
“We are proud to have created the largest real-world cohort of patients and data collection for an implanted stent below the knee in the HEAL Registry,” said Greg Sullivan, CEO of Micro Medical Solutions. “This milestone is a testament to our commitment to providing innovative solutions for those suffering from CLI/CLTI. We are optimistic about the encouraging data that has emerged from the registry and look forward to utilizing this information to continue providing effective treatment options.”
Micro Medical Solutions completed enrollment in its STAND IDE study, a Randomized Controlled Trial, in the US in December of 2023. MMS expects to share this data in early 2025. STAND reflects controlled patient selection with required follow up visits, HEAL reflects general CLI/CLTI patient population treated in everyday practice while including required follow-up. The combination of RCT and RWE data will provide physicians with the opportunity and confidence to make treatment decisions using evidence-based medicine.
MMS is dedicated to making a positive impact on the lives of those affected by this limb threatening disease and is committed to using real world data to support its mission to support physicians in their management of these patients.
Thank you to the physicians and patients for their continued support as we strive towards providing effective and innovative solutions for those in need.
About Micro Medical Solutions
For more about Micro Medical Solutions, visit www.micromedicalsolutions.net. 
SOURCE Micro Medical Solutions

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Cordis Announces Positive 24-Month Results from Superficial Femoral Artery Study, Confirming Sustained Benefits of SELUTION SLR™ (sustained limus release) Drug-Eluting Balloon in Complex Patients

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MIAMI LAKES, Fla., June 18, 2024 /PRNewswire/ — Cordis, a global leader in the development and manufacturing of interventional cardiovascular and endovascular technology, today announces positive 24-month results from the SELUTION SFA Japan Trial. The prospective, multi-center, single arm trial is designed to assess the safety and efficacy of SELUTION SLR™ Drug-Eluting Balloon (DEB) for the endovascular therapy of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the popliteal artery (PA). The findings were presented at the Japan Endovascular Treatment Conference (JET) 2024.

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“The SELUTION SLR™ DEB outcomes demonstrate patient benefits that are sustained out to 24 months and can match proven paclitaxel DCB performance in a complex patient population,” said Dr. Osamu Iida, Osaka Police Hospital Cardiovascular Division, Osaka, Japan. “These are promising results that build confidence in Limus drug-eluting balloons being a safe and effective option for SFA treatment while avoiding any paclitaxel related concerns.”

The long-term follow-up of SELUTION SLR™ DEB confirmed efficient sirolimus drug transfer and retention with safety and efficacy sustained through 24 months in a complex population that included 60.3% diabetics, mean lesion length of 127 mm, 17.2% total occlusions, and 47.8% involvement of the popliteal.
At 24 months, SELUTION SLR™ DEB delivered primary patency of 83.0% and CD-TLR of 95.4% achieving best in class efficacy results without compromise.
The SELUTION SFA Japan trial results demonstrate consistency of the SELUTION SLR™ DEB in being a safe and effective treatment option for femoropopliteal disease.

“The SELUTION SFA Japan trial continues to build confidence in the SELUTION SLR™ DEB technology. The SELUTION SLR™ DEB delivers some of the highest patency rates amongst SFA paclitaxel DCB studies and differentiates from other Limus-based devices. The ability to achieve durable clinical results in a challenging patient population provides clinicians a solution that will offer value to real world patients,” said George Adams, M.D. and Chief Medical Officer at Cordis. “We are excited for the evolution of patient care and to be leading that journey by expanding access to SELUTION SLR™ DEB.”Cordis is committed to generating coronary and peripheral clinical evidence that changes the standard of care. The SELUTION SFA Japan trial is one of the first of several large trials in the SELUTION SLR™ DEB clinical trial portfolio. Long term results validate previous clinical experience and builds confidence and excitement for data to come from four major randomized controlled trials and one real world registry data sets currently underway across coronary, superficial femoral artery and below the knee arteries.About SELUTION SLR ™ DEBSELUTION SLR™ DEB uses MicroReservoirs which contain a mixture of biodegradable polymer intermixed with the anti-restenotic drug sirolimus, applied as a coating on the surface of an angioplasty balloon. These MicroReservoirs are designed to provide controlled and sustained release of the drug. The proprietary CELL ADHERENT TECHNOLOGY (CAT)™ enables the MicroReservoirs to be coated onto balloons and efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon.SELUTION SLR™ Drug-Eluting Balloon coronary, SFA, and BTK platforms are commercially available in Europe, the Middle East, and several markets across Asia and Latin America and most other countries where the CE mark is recognized.SELUTION SLR™ Drug-Eluting Balloon is investigational in the United States and not approved for sale or distribution.About CordisCordis is a global leader in the development and manufacturing of interventional cardiovascular and endovascular technologies. For over 60 years, we have remained committed to improving patients’ lives through innovation, enhanced clinical outcomes, education, and service. Our mission is to relentlessly pursue our dedication to transform cardiovascular care.For more information about Cordis, please visit www.cordis.com and follow Cordis on LinkedIn.Media Contact:Chris BinghamVice President, Global Market & Strategy[email protected]SOURCE Cordis

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ISTH 2024 Unveils Late-Breakthrough Abstracts to be Presented in Bangkok, Thailand Showcasing Groundbreaking Science and Research

Peripheral/Endo by Comments are Disabled

International scientific meeting convenes in Bangkok, Thailand, for the first time highlighting the important work of the Asian-Pacific scientific and clinical community
BANGKOK, June 17, 2024 /PRNewswire/ — Today, the International Society on Thrombosis and Haemostasis (ISTH) announces that all ISTH 2024 Congress (June 22-26, 2024) abstracts are available online, including late-breakthrough abstracts, to give a detailed glimpse into the posters, presentations and plenaries that will be presented at the Congress in Bangkok, Thailand.
At the ISTH 2024 Congress, thousands of the world’s leading experts on thrombosis, hemostasis and vascular biology will convene in Bangkok, Thailand, to present the most recent advances, exchange the latest science and discuss the newest clinical applications designed to improve patient care. This marks the Congress’s return to the Asia-Pacific region for the first time since it was held in Kyoto, Japan, in 2011, and its debut in Bangkok.
Through an extensive lineup of educational sessions, poster and oral communications, state-of-the-art lectures, medical industry exhibits and professional networking opportunities, the Congress promotes the latest scientific discourse and advancement in the field.
The following late-breakthrough abstracts will be highlighted during the ISTH 2024 Congress:

Evaluation of recombinant human prourokinase in the treatment of acute pulmonary embolism (ERUPTE): A randomized, single-blinded, multicenter, phase 2 trial, Zhi-Cheng Jing, Guangdong Provincial People’s Hospital, China
Efficacy and safety of Mim8 prophylaxis in adults and adolescents with hemophilia A with or without inhibitors: Phase 3, open-label, randomized, controlled FRONTIER2 study, Maria Elisa Mancuso, IRCCS Humanitas Research Hospital, Italy
EMA601, a novel humanised fab inhibits platelet Glycoprotein VI with unprecedented potency and protects mice from arterial thrombosis and ischemic stroke, Stefano Navarro, University of Würzburg, Germany

To see a full list of the late-breakthrough abstracts that will be presented throughout the Congress, continue reading below.
Sunday, June 23, 2024

Safety, tolerability, and efficacy of mezagitamab (TAK-079) in chronic or persistent primary immune thrombocytopenia: Interim results from a phase 2, randomized, double-blind, placebo-controlled study by David Kuter, Massachusetts General Hospital, United States – Late Breakthrough Session 1.1, 9:30 a.m., Plenary Hall
Engineering FVIII protein for enhancing expression and secretion profile to achieve normal level of FVIII in plasma utilizing noninvasive transcutaneous ultrasound mediated gene delivery by Ivan Krivega, SonoThera, United States – Late Breakthrough Session 1.2, 9:45 a.m., Plenary Hall
Evaluation of recombinant human prourokinase in the treatment of acute pulmonary embolism (ERUPTE): A randomized, single-blinded, multicenter, phase 2 trial, by Zhi-Cheng Jing, Guangdong Provincial People’s Hospital, China – Late Breakthrough Session 1.3, 10:00 a.m., Plenary Hall
EMA601, a novel humanised fab inhibits platelet glycoprotein VI with unprecedented potency and protects mice from arterial thrombosis and ischemic stroke, by Stefano Navarro, University of Würzburg, Germany – Late Breakthrough Session 1.4, 10:15 a.m., Plenary Hall
Efficacy and safety of Mim8 prophylaxis in adults and adolescents with hemophilia A with or without inhibitors: Phase 3, open-label, randomized, controlled FRONTIER2 study, by Maria Elisa Mancuso, IRCCS Humanitas Research Hospital, Italy – Late Breakthrough Session 1.5, 10:30 a.m., Plenary Hall

Due to limited space, the ISTH 2024 Congress will not hold a press conference this year.For more information about the ISTH 2024 Congress, visit www.isth2024.org and for all other media needs, visit the virtual press room: www.isth2024.org/pressroom
About the International Society on Thrombosis and Haemostasis (ISTH)  Founded in 1969, the ISTH is the leading worldwide not-for-profit organization dedicated to advancing the understanding, prevention, diagnosis, and treatment of conditions related to thrombosis and hemostasis. ISTH is an international medical-scientific professional membership organization with more than 7,000 clinicians, researchers, and educators working together to improve the lives of patients in more than 110 countries around the world. Among its highly regarded activities and initiatives are education and standardization programs, clinical and laboratory practice guidelines and guidance, research activities, meetings and congresses, peer-reviewed publications, expert committees, and World Thrombosis Day on 13 October. Visit ISTH online at www.isth.org. 
SOURCE International Society on Thrombosis and Haemostasis

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