Pivotal trial

Protembis Announces First Patient Enrolled in the PROTEMBO IDE Pivotal Trial

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Tuesday, April 2, 2024
General Health, Professional Services, Venture Capital, Medical Devices, Hospitals, Small Business, Clinical Trials, Surgery, Cardiology, Biotechnology, Finance, Health, Brain, Boston Scientific, Aortic stenosis, Cerebral arteries, NewYork-Presbyterian Hospital, Patient, Pivotal trial, IDE, Trial of the century, Hospital, DW, TAVR, Study, CEP, Medical imaging

Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the enrollment of the first patient in the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816).

Key Points: 
  • Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the enrollment of the first patient in the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816).
  • The trial will enroll between 250-500 randomized patients undergoing transcatheter aortic valve replacement (TAVR) in the USA and Europe with the ProtEmbo® System, an innovative next generation cerebral embolic protection device (CEP) providing complete 3-vessel coverage of the cerebral arteries.
  • The primary safety endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) assessed at 30-days.
  • This significant progress reflects the close collaboration between our study executive committee, our clinical research organization, and core lab partners in planning this complex trial,” said Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis.

Protembis Announces Completion of € 30 Million Series B Financing Round and the Addition of Keith D Dawkins MD to the Board of Directors

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Tuesday, March 26, 2024
General Health, Professional Services, Venture Capital, Medical Devices, Hospitals, Small Business, Clinical Trials, Cardiology, Biotechnology, Finance, FDA, Health, Brain, Boston Scientific, Growth, Aortic stenosis, Trust, Risk, Patient, Pivotal trial, Research, IDE, Doctor of Philosophy, Stanford University, CMO

Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the completion of a € 30 million Series B financing round to support the enrollment of the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816).

Key Points: 
  • Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the completion of a € 30 million Series B financing round to support the enrollment of the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816).
  • The funding round was structured in two separate capital increases which have both been completed.
  • It was co-led by a European consortium of VC investors including Sweden-based Segulah Medical Acceleration, Italy-based XGEN Venture, and Germany-based TechVision Fund.
  • Other investors include Coparion, several large family offices, angel investors and a multinational medical device strategic.

Talphera Announces $26 Million Capital Commitment Through a Combination of a Non-Dilutive Royalty Monetization and Equity Offering

Retrieved on: 
Thursday, January 18, 2024
ACT, Lou Angotti, Research, Regulation D, Sale, The Act, Pivotal trial, FDA, PMA, Security (finance)

"Finally, being able to secure a non-dilutive royalty capital solution from XOMA to focus our resources on Niyad while still being able to participate in the DSUVIA royalty and milestone stream is an ideal transaction for Talphera.

Key Points: 
  • "Finally, being able to secure a non-dilutive royalty capital solution from XOMA to focus our resources on Niyad while still being able to participate in the DSUVIA royalty and milestone stream is an ideal transaction for Talphera.
  • The total additional capital available to the Company should all outstanding Series A and Series B common stock warrants be exercised is $14.4 million.
  • Talphera has completed a partial monetization of its DSUVIA royalties and milestones with XOMA for $8 million.
  • Talphera expects the committed funding to provide sufficient capital to fund Talphera through a potential approval of Niyad, targeted in the first half of 2025.

Florida Cancer Specialists & Research Institute Contributing to Cutting-Edge Advancements in Hematology Science

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Wednesday, December 13, 2023
Annual Reviews (publisher), ASH, BTK, Research, Bortezomib, Omicron, Conference, Bangladesh Technical Education Board, Poster, Mantle cell lymphoma, SLL, Risk, Science, Abstract, Drug development, Tyrosine kinase, Society, B-cell lymphoma, FACP, Rituximab, Reversibility, Delta, Phase, Nivolumab, Hospital, Safety, DRD, MCL, FCS, FDA, Lymphocytosis, Pivotal trial, Chronic lymphocytic leukemia, Meta-analysis, Artery, Bias, Coronary thrombosis, NHL, CLL, Pharmaceutical industry, Dietary supplement, Vaccine, Birth control, Incidence, Patient, Dexamethasone, Lenalidomide, Hematology, Relapse, Dacarbazine, MD, Doxorubicin

FORT MYERS, Fla., Dec. 13, 2023 /PRNewswire/ -- Research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) was presented in the cutting-edge advancements being shared at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition in San Diego on Dec. 9 - 12, 2023. Scientific abstracts submitted by FCS hematologists and medical oncologists were among the 7,000 accepted submissions selected through an extensive peer review process.

Key Points: 
  • FORT MYERS, Fla., Dec. 13, 2023 /PRNewswire/ -- Research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) was presented in the cutting-edge advancements being shared at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition in San Diego on Dec. 9 - 12, 2023.
  • Scientific abstracts submitted by FCS hematologists and medical oncologists were among the 7,000 accepted submissions selected through an extensive peer review process.
  • Pirtobrutinib has also been approved for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
  • Once again, FCS is proud to have a strong presence, sharing the latest and most promising research and science that is moving the field forward."

First Round of Late-Breaking Clinical Trial Results Announced at VIVA23

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Tuesday, October 31, 2023
Atheroma, Peripheral artery disease, Diabetes, Pivotal trial, Ulcer, Transducer, Male, Disease, PAP, Buerger's test, Classification, The Unreconstructed M, IVUS, Amputation, Stent, PAD, PP, Thorpe tube flowmeter, TUS, Calf, Chin Na, Vein, Telephone, TASC, Bare, Vibrato, Life, SP, W. L. Gore & Associates, VIVA, Safety, Patient, Dyslipidemia, Blood vessel, Plaque, History, CLTI, Coronary artery disease, Perfusion, Restenosis, Research, Foot, Spur, Atherectomy, Șaeș, Artery, Education, DCB, Doppler effect, Dialysis, Hypertension, FP, Freedom, Wynn Las Vegas, Wound healing, Medical imaging, Pharmaceutical industry, Birth control, Surveying, Medtronic

Below are highlights of this morning's 5 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this morning's 5 late-breaking clinical trial presentations.
  • At 20 centers without roll-ins across the United States, 105 no-option CLTI patients were enrolled in a nonrandomized manner.
  • The median age was 70 years, two-thirds of the patients were male, and one-quarter of patients were Hispanic or Latino.
  • 1-Year Results of the DEEPER OUS Trial: The Bare Temporary Spur Stent System in Combination With a Paclitaxel-Coated Balloon
    The DEEPER OUS trial is a prospective, nonrandomized, multicenter, single-arm trial taking place in New Zealand, Germany, and Switzerland.

ImmunityBio Announces Biological License Application Resubmission for N-803 in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Carcinoma-In-Situ

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Monday, October 23, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, CR, Survival, CIS, FDA, Patient, Bladder cancer, Food, E pluribus unum, Treatment, Vol, Safety, The New England Journal of Medicine, Pivotal trial, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Maintenance, Literature, Immune system, NK, Massachusetts Medical Society, NEJM, Probability, Case series, PMID, Cystectomy, BCG, NMIBC, BLA, Exception, Vaccine, ImmunityBio COVID-19 vaccine, Tolerability

The BLA is supported by the results of ImmunityBio’s studies in bladder cancer including the pivotal QUILT-3.032 study (NCT03022825), published in NEJM Evidence1 in November 2022.

Key Points: 
  • The BLA is supported by the results of ImmunityBio’s studies in bladder cancer including the pivotal QUILT-3.032 study (NCT03022825), published in NEJM Evidence1 in November 2022.
  • Of the nine subjects, two were deceased from causes other than bladder cancer and one was lost to follow-up.
  • Final clinical Results of Pivotal Trial of IL-15rαfc Superagonist N-803 with BCG in BCG-Unresponsive CIS and Papillary Non-Muscle Invasive Bladder Cancer (NMIBC).
  • Phase II/III Clinical Results of IL-15rαfc Superagonist N-803 with BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma in Situ (CIS) Patients.

PercAssist Announces First Patient Treated in EUREKA Study of PSCA System for Hemodynamic Support in Chronic Heart Failure

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Thursday, September 28, 2023
Technology, Medical Devices, Clinical Trials, Cardiology, Software, Hardware, Health, General Health, Data Management, Acute decompensated heart failure, Heart failure, Cardiogenic shock, Heart, Pivotal trial, Cardiac output, Trial of the century, PSCA, Patient, IDE, EUREKA, FESC, Medical device, Pharmaceutical industry

PercAssist, Inc ., a medical device company developing innovative technology for a minimally invasive, extravascular platform to provide hemodynamic support for chronic heart failure patients, today announced the successful completion of its first patient in the EUREKA First-in-Human clinical study.

Key Points: 
  • PercAssist, Inc ., a medical device company developing innovative technology for a minimally invasive, extravascular platform to provide hemodynamic support for chronic heart failure patients, today announced the successful completion of its first patient in the EUREKA First-in-Human clinical study.
  • The PSCA System was successfully deployed and provided hemodynamic stability immediately following implantation and throughout the implant period.
  • “We are extremely excited to lead the First-in-Human clinical investigation of the PercAssist PSCA System for chronic heart failure patients requiring hemodynamic support,” said Professor Neuzil.
  • This extravascular ventricular assist technology has tremendous potential for providing hemodynamic support for heart failure patients without the need for anticoagulation therapy.

Shape Memory Medical Receives FDA IDE Approval to Initiate AAA-SHAPE, a Head-to-Head Trial

Retrieved on: 
Thursday, September 7, 2023
Medical Supplies, Medical Devices, FDA, Health, Other Health, General Health, Area studies, Technique, Columbia University Irving Medical Center, CE, Abdominal aortic aneurysm, University, Beth Israel Deaconess Medical Center, Aneurysm, Expansion, Section, Pivotal trial, Food and Drug Administration, Journal, AAA, PMDA, Patient, Blood, Randomized controlled trial, Mortality, IDE, EVAR, MPH, Memory, Vascular surgery, Food, Safety, Pharmaceutical industry, Medical imaging, EU, MD

Study participants will be randomized 2:1, either to EVAR plus sac management with IMPEDE-FX RapidFill (the treatment arm) or to standard EVAR (the control arm).

Key Points: 
  • Study participants will be randomized 2:1, either to EVAR plus sac management with IMPEDE-FX RapidFill (the treatment arm) or to standard EVAR (the control arm).
  • Key endpoints will compare sac diameter and volume change, endoleak rates, secondary interventions, and mortality through five years.
  • The investigational device, IMPEDE-FX RapidFill, incorporates the novel shape memory polymer, a proprietary, porous, polyurethane scaffold that is crimped for catheter delivery and self-expands upon contact with blood.
  • The AAA-SHAPE Pivotal Trial is preceded by the AAA-SHAPE early feasibility studies which enrolled a combined 35 patients in New Zealand and the Netherlands.

First-on-Podium Data from 20 Vascular and Venous Clinical Trials to Be Presented at The VEINS and VIVA 2023

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Wednesday, August 30, 2023
Learning, Wynn Las Vegas, Atherectomy, Subgroup analysis, Pivotal trial, Perfusion, VIVA, Bare, Physician, Vein, Blood vessel, Diagnosis, Patient, Moyamoya disease, Nursing, Birth control, Medical imaging

PALM SPRINGS, Calif., Aug. 30, 2023 /PRNewswire/ -- Leading physicians and researchers will present results from 20 clinical trials from Monday, October 30, to Wednesday, November 1, at the annual VIVA and The VEINS conferences at Wynn Las Vegas.

Key Points: 
  • PALM SPRINGS, Calif., Aug. 30, 2023 /PRNewswire/ -- Leading physicians and researchers will present results from 20 clinical trials from Monday, October 30, to Wednesday, November 1, at the annual VIVA and The VEINS conferences at Wynn Las Vegas.
  • VIVA (Vascular InterVentional Advances) is a vascular education symposium that emphasizes innovation and multidisciplinary learning.
  • The 2023 conference will mark VIVA's 21st anniversary as a premier educational event for peripheral vascular disease specialists.
  • The VEINS (Venous Endovascular INterventional Strategies) is a comprehensive symposium focused on the diagnosis, intervention, and management of venous disorders.

Annexon Highlights Recent Pipeline and Business Progress and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Monday, August 7, 2023
Molecule, HD, Drug development, Geographic atrophy, ARCHER, G&A, Regulatory Agencies, Inflammation, Pivotal trial, LN, Differentiation, Complement component 1q, HIV disease progression rates, Investment, Appointment, Annual general meeting, GBS, R, Research, Visual acuity, ALS, Society, ASRS, Fine chemical, Pharmaceutical industry, EU, Patient

BRISBANE, Calif., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today highlighted recent progress across its business and portfolio of complement therapies and reported second quarter 2023 financial results.

Key Points: 
  • Together, these data demonstrate the differentiated mechanism of inhibiting C1q to provide functional benefits for patients living with complement-mediated diseases.
  • Annexon plans to provide pipeline updates and outline key milestones across its business and portfolio of complement-targeted therapies during an R&D Day in the second half of 2023.
  • Following encouraging preliminary results which showed slowing of disease progression, additional data are expected in the second half of 2023.
  • General and administrative (G&A) expenses: G&A expenses were $7.4 million for the quarter ended June 30, 2023, compared to $8.3 million for the quarter ended June 30, 2022.