FIH

Cardiawave Announces the Publication in The Lancet of First-In-Human Clinical Studies Results With 40 Aortic Stenosis Patients Treated With Its Innovative Non-invasive Ultrasound Therapy (NIUT)

Retrieved on: 
Wednesday, November 15, 2023

The patients were treated with Cardiawave’s NIUT investigational device in one session.

Key Points: 
  • The patients were treated with Cardiawave’s NIUT investigational device in one session.
  • “Clinically, the patients experienced a considerable improvement in their clinical status suggesting a better quality of life.
  • These early findings can represent a change in the paradigm of CAS treatment especially for patients who have no other options.
  • In July 2023, Cardiawave successfully completed the patient enrolment with no procedure or device-related mortality up to 30 days.

Vivani Medical Provides Business Update and Reports Third Quarter Financial Results

Retrieved on: 
Tuesday, November 14, 2023

Vivani Medical, Inc. (Nasdaq: VANI ) (“Vivani” or the “Company”), an innovative, preclinical-stage biopharmaceutical company developing novel, long-term drug implants, today reported financial results for the third quarter of 2023 and provided a business update.

Key Points: 
  • Vivani Medical, Inc. (Nasdaq: VANI ) (“Vivani” or the “Company”), an innovative, preclinical-stage biopharmaceutical company developing novel, long-term drug implants, today reported financial results for the third quarter of 2023 and provided a business update.
  • In addition, we are announcing parallel plans to pursue the initiation of the FIH study in Australia.
  • Third Quarter ended September 30, 2023, Financial Results
    Cash Balance: As of September 30, 2023, Vivani had cash, cash equivalents and restricted cash totaling $26.2 million compared to $46.4 million as of December 31, 2022.
  • Research and development expense increased by $0.5 million, or 15%, to $4.4 million in the third quarter of 2023 from $3.9 million in the third quarter of 2022.

Avstera Therapeutics Announces FDA Clearance of IND Application for AVS100, a Novel Highly Selective HDAC6 Inhibitor Targeting Solid Tumors

Retrieved on: 
Monday, December 18, 2023

AVS100 is a novel, orally bioavailable selective HDAC6i targeting locally advanced or metastatic solid tumors, including in combination with pembrolizumab.

Key Points: 
  • AVS100 is a novel, orally bioavailable selective HDAC6i targeting locally advanced or metastatic solid tumors, including in combination with pembrolizumab.
  • "The FDA clearance of our IND for AVS100 marks an amazing step for our company towards the fulfillment of our mission.
  • "FDA clearance of our IND for AVS100 represents a significant milestone for Avstera's mission in providing state of the art oncological agents to tackle solid tumors.
  • Undoubtedly, the IND approval of AVS100 selective HDAC6 inhibitor will open new opportunities to potentially enhance response rates for patients."

HELLAS SELECTED AS THE EXCLUSIVE DISTRIBUTOR FOR HATKO HYBRIDGRASS PRODUCTS IN THE US IN ADVANCE OF THE 2026 FIFA WORLD CUP™

Retrieved on: 
Wednesday, December 6, 2023

"As the exclusive distributor of HATKO Hybridgrass in the US, we're introducing the market to a product that will forever change the landscape of playing surfaces."

Key Points: 
  • "As the exclusive distributor of HATKO Hybridgrass in the US, we're introducing the market to a product that will forever change the landscape of playing surfaces."
  • Together, Hellas and HATKO are combining experience, technology, and a shared commitment to excellence, to make game-changing hybridgrass solutions available to organizations and stadiums across the US.
  • "As the exclusive distributor of HATKO Hybridgrass in the US, we're introducing the market to a product that will forever change the landscape of playing surfaces."
  • FIFA Club World Cup brings together the winners of each confederation's premier club competition to compete for an international title.

inQB8 Medical Technologies LLC and Peijia Medical Limited Report Successful First-in-Human (FIH) Implantation of MonarQ Transcatheter Tricuspid Valve Replacement (TTVR) System in The United States of America

Retrieved on: 
Tuesday, December 5, 2023

and SUZHOU, China, Dec. 5, 2023 /PRNewswire/ -- inQB8 Medical Technologies LLC (inQB8), in partnership with Peijia Medical Limited (Peijia, (9996.HK)), announced that it has successfully implanted the MonarQ Transcatheter Tricuspid Valve (TTV) in a patient suffering from torrential tricuspid regurgitation (TR) and no other available therapy available to her.

Key Points: 
  • and SUZHOU, China, Dec. 5, 2023 /PRNewswire/ -- inQB8 Medical Technologies LLC (inQB8), in partnership with Peijia Medical Limited (Peijia, (9996.HK)), announced that it has successfully implanted the MonarQ Transcatheter Tricuspid Valve (TTV) in a patient suffering from torrential tricuspid regurgitation (TR) and no other available therapy available to her.
  • Dr. Wilson V. Szeto, interventional cardiologist Dr. Jean Chang MD., echo cardiologist Dr. Roy MD., and the attending anesthesiologist Dr. Thal.
  • "Due to multiple risk factors and anatomical restrictions, neither traditional tricuspid valve surgery, nor edge-to-edge transcatheter tricuspid repair were options for this patient.
  • "The successful FIH MonarQ implantation in USA marks an exciting step in bringing this life-saving and life-enhancing technology to more and more patients around the world."

Aeglea BioTherapeutics Announces Name Change to Spyre Therapeutics, Appoints CEO and Additional Directors, and Expands Leadership Team to Develop Next-Generation Therapeutic Combinations for the Treatment of IBD

Retrieved on: 
Monday, November 27, 2023

WALTHAM, Mass., Nov. 27, 2023 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE) (the "Company" or "Spyre"), a development-stage biotechnology company, today announced its name change to Spyre Therapeutics, Inc. Effective as of market open on November 28, 2023, Spyre will trade on Nasdaq under the ticker symbol "SYRE". The name change follows the acquisition of privately held Spyre Therapeutics, Inc. by the Company in June of 2023. Named to reflect the Company's ambition to achieve new heights in efficacy and convenience of Inflammatory Bowel Disease (IBD) therapies, Spyre aims to create a next-generation of IBD products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision patient selection approaches to enhance efficacy for patients.

Key Points: 
  • Effective as of market open on November 28, 2023, Spyre will trade on Nasdaq under the ticker symbol "SYRE".
  • The name change follows the acquisition of privately held Spyre Therapeutics, Inc. by the Company in June of 2023.
  • The Company also announced today the appointment of Cameron Turtle, DPhil as Chief Executive Officer (CEO) and member of the Board of Directors.
  • SPY001 is currently progressing through IND-enabling studies and is expected to enter first-in-human ("FIH") studies in the first half of 2024.

ST Pharm Presented '100-Day Expedite Strategy', Preparedness and Proactive Measures for Future Pandemic at Korea-CEPI R&D Workshop

Retrieved on: 
Tuesday, November 21, 2023

During the main speaker session, Joo-Sung James Yang, Ph.D., SVP Head of Biotechnology R&D at ST Pharm, addressed the strategy, which aims to develop pandemic vaccines against emerging infectious diseases within 100 days.

Key Points: 
  • During the main speaker session, Joo-Sung James Yang, Ph.D., SVP Head of Biotechnology R&D at ST Pharm, addressed the strategy, which aims to develop pandemic vaccines against emerging infectious diseases within 100 days.
  • ST Pharm highlighted its mRNA platform technologies as a key success factor of '100-Day Expedite Strategy', which are proprietary 5'-capping analogs, marketed as SmartCap®, and LNP drug delivery system, STLNP®.
  • Also, ST PHARM has two different RNA therapeutic biotech companies in the United States, which creates synergistic effects on both CDMO business and new drug/vaccine development.
  • -Vernagen (Atlanta, USA) specialized in the development of mRNA vaccines and antibody-encoding RNA (AER) platform technology for infectious diseases.

New Published Study Demonstrates Safety and Feasibility of Filterlex Medical's CAPTIS® Device in Providing Embolic Protection During TAVR

Retrieved on: 
Wednesday, November 15, 2023

CAESAREA, Israel, Nov. 15, 2023 /PRNewswire/ -- Filterlex Medical Ltd., a cardiovascular medical device startup, announced today the publication of a first-in-human (FIH) study in the peer-reviewed cardiovascular journal, EuroIntervention. The study validates the safety and feasibility of the next generation CAPTIS® full-body embolic protection device during TAVR procedures.

Key Points: 
  • The study validates the safety and feasibility of the next generation CAPTIS® full-body embolic protection device during TAVR procedures.
  • In the published study, the CAPTIS® system captured a high number of embolic debris particles, providing embolic protection and enhancing safety during TAVR procedures.
  • The study, which included 20 patients undergoing TAVR procedures with the CAPTIS® device, demonstrated a 100% success rate in the use of the device.
  • This study sheds light on the capability of the CAPTIS® device to deliver neurovascular and systemic embolic protection, crucial for lowering the risk of stroke and other embolic events during TAVR procedures.

New Published Study Demonstrates Safety and Feasibility of Filterlex Medical's CAPTIS® Device in Providing Embolic Protection During TAVR

Retrieved on: 
Wednesday, November 15, 2023

CAESAREA, Israel, Nov. 15, 2023 /PRNewswire/ -- Filterlex Medical Ltd., a cardiovascular medical device startup, announced today the publication of a first-in-human (FIH) study in the peer-reviewed cardiovascular journal, EuroIntervention. The study validates the safety and feasibility of the next generation CAPTIS® full-body embolic protection device during TAVR procedures.

Key Points: 
  • The study validates the safety and feasibility of the next generation CAPTIS® full-body embolic protection device during TAVR procedures.
  • In the published study, the CAPTIS® system captured a high number of embolic debris particles, providing embolic protection and enhancing safety during TAVR procedures.
  • The study, which included 20 patients undergoing TAVR procedures with the CAPTIS® device, demonstrated a 100% success rate in the use of the device.
  • This study sheds light on the capability of the CAPTIS® device to deliver neurovascular and systemic embolic protection, crucial for lowering the risk of stroke and other embolic events during TAVR procedures.

Xencor Presents Preclinical Data from Multiple XmAb® Research Programs at the SITC Annual Meeting

Retrieved on: 
Friday, November 3, 2023

We are also developing additional CD3 and CD28 T cell engaging bispecific antibodies against solid tumor targets.”

Key Points: 
  • We are also developing additional CD3 and CD28 T cell engaging bispecific antibodies against solid tumor targets.”
    Posters will be available in the poster hall and virtually to registrants of the SITC Annual Meeting.
  • In the poster hall, odd-numbered posters will be displayed on Friday, November 3, and even-numbered posters will be displayed on Saturday, November 4.
  • Xencor’s posters will be archived under "Events & Presentations" in the Investors section of the Company's website located at www.xencor.com .
  • To enhance the anti-tumor activity, Xencor engineered multi-specific NK cell-engaging antibodies that simultaneously target MICA/B antigens and an orthogonal activating receptor on NK cells, NKp46.