Terumo

R3 Vascular Announces $87 Million in Series B Financing and Appoints Christopher M. Owens as new President and CEO

Retrieved on: 
Thursday, May 9, 2024
FDA, Bangladesh Technical Education Board, Capital, PAD, Terumo, Health, Heart, Moyamoya disease, Research, Abbott Laboratories, Development, Patient, Worldwide, Venture round, Bausch & Lomb, ELITE, Series, Growth, Atomic mass, American Heart Association, BTK, Pharmaceutical industry

The company also announced that veteran medical device executive Christopher M. Owens will serve as its new President and Chief Executive Officer.

Key Points: 
  • The company also announced that veteran medical device executive Christopher M. Owens will serve as its new President and Chief Executive Officer.
  • The Series B financing was led by affiliates of Deerfield Management with participation from existing shareholders including 415 Capital and a strategic investor.
  • R3 Vascular will use the proceeds to support the ELITE FDA IDE pivotal trial of its best-in-class bioresorbable scaffold, MAGNITUDE®, for below-the-knee (BTK) PAD.
  • Commenting on the financing and the appointment of Mr. Owens, Jack Springer, Executive Chairman of R3 Vascular said, “On behalf of the R3 Vascular Board of Directors, we are very pleased to complete this exciting Series B financing and welcome Chris Owens as President and CEO.

Orchestra BioMed Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 13, 2023
Beat (music), Food and Drug Administration, Hypertension, Safety, Food, HOPE, Security (finance), Medtronic, Insurance, Patient, ISR, Research, FDA, Orchestra, SAB, Heart failure, Medication, IDE, Partnership, Airline, Pharmaceutical industry, Cryptocurrency, Terumo

“This past quarter marked two major regulatory milestones for Orchestra BioMed, with the FDA granting IDE approval for pivotal studies for both BackBeat CNT (AVIM therapy) and Virtue SAB.

Key Points: 
  • “This past quarter marked two major regulatory milestones for Orchestra BioMed, with the FDA granting IDE approval for pivotal studies for both BackBeat CNT (AVIM therapy) and Virtue SAB.
  • Financial Results for the Third Quarter Ended September 30, 2023
    Cash and cash equivalents and Marketable securities totaled $108.5 million as of September 30, 2023.
  • Revenue for the third quarter of 2023 was $0.4 million, compared with $1.2 million for the same period in 2022.
  • Net loss for the third quarter of 2023 included non-cash stock-based compensation expense of $3.5 million, compared with $2.2 million for the same period in 2022.

MicroVention Celebrates 10-Year Anniversary and Legacy of SOFIA™ Aspiration Catheters; More than 500,000 Procedures Performed Worldwide Across 170 Countries

Retrieved on: 
Thursday, November 16, 2023
Medical Devices, Health, Hospitals, Surgery, Other Health, Biotechnology, Anatomy, Investment, BOBBY, Multimedia, Legacy, Catheter, Terumo, Stroke, Physician, Medical device

The announcement was made today at the 2023 SVIN Annual Meeting in Miami, Florida, where MicroVention is exhibiting in booth number 304.

Key Points: 
  • The announcement was made today at the 2023 SVIN Annual Meeting in Miami, Florida, where MicroVention is exhibiting in booth number 304.
  • MicroVention’s SOFIA Aspiration Catheter is designed for tracking to the occlusion site and the aspiration of thrombus.
  • The device’s hybrid braid coil design provides enhanced control while its coil reinforcement provides lumen integrity, flexibility and excellent shape retention.
  • “Ten years ago, MicroVention set the standard and re-envisioned catheter innovation through the development of SOFIA Catheters.

Terumo Medical Corporation's New AZUR HydroPack™ Peripheral Coil System Provides a Soft-Packing, Long-Lasting Solution to Embolotherapy

Retrieved on: 
Monday, December 11, 2023
Food, FACC, Reperfusion, Patient, TIS, Food and Drug Administration, Ambient occlusion, Terumo, Physician, Electric motor, AZUR, MD

SOMERSET, N.J., Dec. 11, 2023 /PRNewswire/ -- Terumo Medical Corporation is pleased to announce the launch of its new AZUR HydroPack Peripheral Coil System in the United States. The AZUR HydroPack Coil System is a soft, universal-shaped platinum and hydrogel coil designed to find and fill empty space within the vessel. It is also the only packing coil to use proprietary designed hydrogel technology to create a gel core for mechanical occlusion, a unique feature of AZUR peripheral coils.[1] Terumo received Food and Drug Administration clearance for the AZUR HydroPack Coil System earlier this year; it is fully available starting today.

Key Points: 
  • The AZUR HydroPack Coil System is a soft, universal-shaped platinum and hydrogel coil designed to find and fill empty space within the vessel.
  • [1] Terumo received Food and Drug Administration clearance for the AZUR HydroPack Coil System earlier this year; it is fully available starting today.
  • "The AZUR HydroPack Peripheral Coil System provides optimized stability and precise delivery.
  • The AZUR HydroPack Peripheral Coil System – the latest addition to the TIS embolotherapy portfolio – is designed to fill volume behind the Terumo AZUR™ CX Peripheral Coil System for vessel occlusion and to fill volume inside of the AZUR™ Framing Coil System for aneurysm occlusion.

908 Devices and Terumo Blood and Cell Technologies Collaborate to Add On-line Analytics to Quantum Flex Cell Expansion System

Retrieved on: 
Monday, November 6, 2023
Other Health, Other Science, Pharmaceutical, Research, Software, Medical Devices, Internet, Electronic Design Automation, Genetics, Data Management, Professional Services, Science, Technology, General Health, Data Analytics, Biotechnology, Health, Health Technology, TrafFix Devices, Inc. v. Marketing Displays, Inc., Horizon Fuel Cell Technologies, MAVEN, MASS, Exosome, Risk, Automation, Medical device, Vaccine, Terumo

908 Devices Inc. (Nasdaq: MASS), a pioneer of purpose-built handheld and desktop devices for chemical and biochemical analysis, and medical technology company Terumo Blood and Cell Technologies (Terumo BCT) announce a collaboration to enable on-line monitoring of critical process parameters in Terumo BCT’s Quantum Flex Cell Expansion System.

Key Points: 
  • 908 Devices Inc. (Nasdaq: MASS), a pioneer of purpose-built handheld and desktop devices for chemical and biochemical analysis, and medical technology company Terumo Blood and Cell Technologies (Terumo BCT) announce a collaboration to enable on-line monitoring of critical process parameters in Terumo BCT’s Quantum Flex Cell Expansion System.
  • Cell and gene therapy developers are increasingly looking to automation to improve manufacturing efficiency, simplify workflows and reduce costs.
  • “Combining our Quantum Flex platform with 908 Devices’ on-line monitoring will help cell therapy manufacturers reduce time-consuming manual steps that increase manufacturing costs and risks,” said Kathie Schneider, Director, Global Commercial Lead, Cell Therapy Technologies at Terumo BCT.
  • “We continue to collaborate with industry experts to further enhance our solution offering to solve industry challenges.”

MicroVention Enters Transradial Access Therapy; Receives FDA Clearance of SOFIA™ EX 5F 115cm Intracranial Support Catheter

Retrieved on: 
Thursday, September 21, 2023
Biotechnology, Medical Supplies, Surgery, Health, FDA, Medical Devices, Hospitals, Other Health, Wrist, Radial artery, Terumo, Transradial catheterization, EX, Patient, PTFE, Soft, Femoral artery, Groin, Medical device

MicroVention, Inc., a global neurovascular company and wholly owned subsidiary of Terumo Corporation, today announced that the SOFIA™ EX 5F 115 cm Intracranial Support Catheter (Soft TOrqueable catheter For Intracranial Access) has received FDA 510(k) clearance on September 15, 2023, for transradial access in addition to transfemoral access.

Key Points: 
  • MicroVention, Inc., a global neurovascular company and wholly owned subsidiary of Terumo Corporation, today announced that the SOFIA™ EX 5F 115 cm Intracranial Support Catheter (Soft TOrqueable catheter For Intracranial Access) has received FDA 510(k) clearance on September 15, 2023, for transradial access in addition to transfemoral access.
  • The SOFIA™ EX 5F radial access clearance proudly marks MicroVention’s first radial access product and signifies our commitment to innovation.
  • MicroVention believes providers should have the ability to feel confident in our SOFIA™ EX 5F in either the transradial or transfemoral access approach.
  • “We are pleased to receive FDA clearance for MicroVention’s SOFIA™ EX 5F Intracranial Support Catheter for transradial access,” said Carsten Schroeder, CEO, MicroVention.

Orchestra BioMed™ Granted FDA Approval of IDE for U.S. Pivotal Study of Virtue® Sirolimus AngioInfusion Balloon™ in Patients with Coronary In-Stent Restenosis

Retrieved on: 
Tuesday, August 8, 2023
SAB, Ohio State University, Orchestra, Partnership, Institutional review board, HOPE, Virtue, FACC, ISR, Sirolimus, SABRE, Medicine, Angioplasty, Patient, Christ Hospital, IDE, Coronary artery disease, Principal, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, POBA, Terumo

“We believe that Virtue SAB has the potential to address a significant unmet clinical need and improve outcomes for a patient population with suboptimal treatment options.

Key Points: 
  • “We believe that Virtue SAB has the potential to address a significant unmet clinical need and improve outcomes for a patient population with suboptimal treatment options.
  • “This IDE approval and forthcoming pivotal study reflect our commitment to accelerating innovation through our differentiated, partnership-enabled business model.
  • The Virtue ISR-US pivotal study is a randomized, prospective, double-blind, multi-center, controlled study of Virtue SAB vs.
  • The conditional approval also requires the Company to submit additional information to the FDA.

Terumo Blood and Cell Technologies' Reveos® Automated Whole Blood Processing System Cleared by FDA for U.S. Commercial Use

Retrieved on: 
Tuesday, August 1, 2023
RBC, Food and Drug Administration, Cancer, Apheresis, Terumo, Plasma, Patient, Investment, Collection, Blood, Horizon Fuel Cell Technologies, FDA, Trauma, Food, Medical device, Blood product, Pharmaceutical industry

LAKEWOOD, Colo., Aug. 1, 2023 /PRNewswire/ -- Terumo Blood and Cell Technologies (Terumo BCT) announces U.S. Food and Drug Administration (FDA) clearance of the Reveos Automated Whole Blood Processing System, the first whole blood automation device available in the U.S. that processes whole blood into platelets and other components in a single centrifugation cycle. Automated processing of whole blood on the Reveos system, the only device of its kind globally, will enhance the blood and platelet supply for patients in the U.S.

Key Points: 
  • [2] FDA's clearance of the automated Reveos system gives blood centers the added capacity to collect platelets from existing whole blood donations efficiently.
  • In Reveos, Terumo BCT brings to the U.S. a platform with an established track record following deployment in 52 countries over the past decade.
  • Reveos is the only automated device to process whole blood into platelets, plasma and red blood cell (RBC) components in a single centrifugation cycle.
  • By automating whole blood processing, Reveos can reduce the working hours needed by laboratory staff by up to 30%.

MicroVention Announces 5-Year Clinical Trial Data and Size Additions for its WEB Aneurysm Embolization System; WEB is Most Well-Studied Intrasaccular Device Available Today

Retrieved on: 
Monday, July 31, 2023
Surgery, Medical Devices, Neurology, Hospitals, Clinical Trials, Cardiology, Biotechnology, Radiology, Health, Neuroradiology, Bleeding, Aneurysm, Clinical trial, GCP, SL, Multimedia, Neck, Terumo, Patient, Physician, University, WEB, University of Tennessee Health Science Center, Radiation exposure, Safety, Pharmaceutical industry, Medical imaging, Neurosurgery

With this five-year clinical trial data just recently published, WEB is the most well studied intrasaccular device available in the marketplace today, with 7 good clinical practice (GCP) studies and over 200 peer-reviewed publications.

Key Points: 
  • With this five-year clinical trial data just recently published, WEB is the most well studied intrasaccular device available in the marketplace today, with 7 good clinical practice (GCP) studies and over 200 peer-reviewed publications.
  • WEB is also now available in two new sizes (SL 6x2 and SL 7x2), continuing to allow for the treatment of different sizes and shapes of aneurysms.
  • Additionally, the WEB device provides proven, long-term durability with its five-year follow-up results demonstrating long-term safety and effectiveness and is the only 17-system compatible intrasaccular flow disruptor.
  • At this time, there is no device that has been shown to be safer for aneurysm patients than WEB.

MicroVention Celebrates One-Year Anniversary of FRED™ X Flow Diverter with Over 1,000 Patients Treated Across the U.S.

Retrieved on: 
Monday, July 31, 2023
Health, Medical Devices, Neurology, Hospitals, Surgery, Health Technology, Cardiology, Neuroradiology, Society, HI, The Queen's Medical Center, American Journal of Neuroradiology, Thomas Jefferson University, Journal of NeuroInterventional Surgery, Multimedia, Research, Journal, American Journal, Publishing, Manchester Grand Hyatt Hotel, Patient, Physician, Symposium, Aneurysm, FRED, FDA, AJNR, Safety, Nightclub, Medical imaging, Terumo

MicroVention FRED™ X -- The Next Advancement in Flow Diversion Technology (Photo: Business Wire)

Key Points: 
  • MicroVention, Inc., a global neurovascular company and wholly owned subsidiary of Terumo Corporation, is celebrating the one-year anniversary of the company’s FRED™ X Flow Diverter.
  • In close collaboration with physician partners across the United States, over 1,000 patients have been successfully treated with the FRED X device.
  • FRED X offers the same precise, predictable placement and immediate opening of the FRED™ device – now with X Technology.
  • “We have seen great success with the FRED X Flow Diverter in the over 80 patients we have treated,” said Dr. Jonathan Zhang, Neurosurgeon at Queens Medical Center in Honolulu, HI.