Atherectomy

Ra Medical Systems Reports 2021 Fourth Quarter and Full Year Financial Results

Retrieved on: 
Wednesday, March 23, 2022
Diabetes, Health, Cardiology, Medical Devices, EBITDA, Private Securities Litigation Reform Act, Regulation, Lithotripsy, Lipid, Vascular disease, Sale, Marketing, Trial of the century, Forward-looking statement, Paycheck Protection Program, Growth, NYSE, GAAP, Patient, Laser, SEC, Investor relations, Research, Degenerative disease, Lists of disasters, Dermatology, PPP, U.S. Securities and Exchange Commission, Catheter, Industry, Technology, Review, Depreciation, COVID-19, Disclosure, Time, CA, Physician, Fracture, Income, Adjustment, Regulation Fair Disclosure, News, FDA, Atherectomy, Engineering, Protein, Annual report, Table, Security (finance), Medical device, Pharmaceutical industry, Video game, Lithium, Bookkeeping, Fossil fuel, Animal, Ridesharing company

Net revenue for the fourth quarter of 2021 consisted of product sales of $5,000, compared with no net revenue for the fourth quarter of 2020.

Key Points: 
  • Net revenue for the fourth quarter of 2021 consisted of product sales of $5,000, compared with no net revenue for the fourth quarter of 2020.
  • Total cost of revenue for the fourth quarter of 2021 was $0.3 million, compared with $0.4 million for the fourth quarter of 2020.
  • Research and development expenses for the fourth quarter of 2021 were $3.7 million, which included $0.1 million in stock-based compensation, compared with $3.4 million for the fourth quarter of 2020, which included $0.1 million in stock-based compensation.
  • Adjusted EBITDA for the fourth quarter of 2021 was negative $7.8 million, compared with negative $8.8 million for the fourth quarter of 2020.

Ra Medical Systems to Report 2021 Fourth Quarter and Full Year Financial Results on March 23, 2022

Retrieved on: 
Tuesday, March 15, 2022
Diabetes, Health, Cardiology, Medical Devices, Laser, Atherectomy, FDA, Degenerative disease, Catheter, Patient, Medical device, Baking, Medical imaging

Ra Medical Systems manufactures the DABRA excimer laser and catheters for the treatment of certain vascular diseases.

Key Points: 
  • Ra Medical Systems manufactures the DABRA excimer laser and catheters for the treatment of certain vascular diseases.
  • In addition, DABRA has been granted CE mark clearance for the endovascular treatment of infrainguinal arteries via atherectomy and for crossing total occlusions.
  • DABRA excimer lasers and catheters are manufactured in a 32,000-square-foot facility located in Carlsbad, California.
  • The vertically integrated facility is ISO 13485 certified and is licensed by the State of California to manufacture sterile, single-use catheters in clean room environments.

Ra Medical Systems Files 510(k) Application for the DABRA Catheter with Braided Overjacket and Six-Month Shelf Life

Retrieved on: 
Monday, February 28, 2022
Diabetes, Health, Cardiology, Medical Devices, Physician, COVID-19, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Security (finance), Annual report, Anatomy, Vascular disease, Industry, Private Securities Litigation Reform Act, NYSE, Knee, U.S. Securities and Exchange Commission, Review, Regulation Fair Disclosure, Food, News, Catheter, Degenerative disease, FDA, Laser, Disclosure, Atherectomy, Forward-looking statement, Patient, Marketing, Engineering, Lists of disasters, Solution, Regulation, SEC, Medical device

The overjacket design increases the overall catheter robustness for improved kink-resistance and trackability to better navigate tortuous anatomy.

Key Points: 
  • The overjacket design increases the overall catheter robustness for improved kink-resistance and trackability to better navigate tortuous anatomy.
  • This 510(k) filing is a highly significant engineering and regulatory steppingstone toward our flagship commercial DABRA catheter, which will be a guidewire-compatible design.
  • I would like to thank the entire Ra Medical team and our physician partners who have helped us achieve this milestone, he added.
  • Ra Medical Systems manufactures the DABRA excimer laser and catheters for the treatment of certain vascular diseases.

Global Atherectomy Devices Market Research Report 2022-2027 - Evolution of Drug-Coated Balloons, Comprehensive R&D Activities, Advancements in the Healthcare Infrastructure - ResearchAndMarkets.com

Retrieved on: 
Friday, February 25, 2022
Health, Medical Devices, Cardiology, Risk, Stent, Abbott Laboratories, Sand, Pads, Diabetes, Atherosclerosis, Trauma, COVID-19, PAD, Industry, Company, Paola Lattus, Becton, Dickinson and Company headquarters, Peripheral artery disease, Transport, Coronavirus, US, Adoption, B. Braun, Medtronic, CABG, Coronary artery disease, Research report, DCB, Obesity, R, Atherectomy, Patient, MI, CAGR, Research, Cardinal Health, Hospital, Medical imaging, Pharmaceutical industry, Growth

The Global Atherectomy Devices Market will reach US$ 1.8 billion by 2027.

Key Points: 
  • The Global Atherectomy Devices Market will reach US$ 1.8 billion by 2027.
  • Moreover, the growing preference for MI atherectomy surgical procedures among patients and healthcare providers is creating a positive outlook.
  • Other factors, including comprehensive research and development (R&D) activities and advancements in the healthcare infrastructure, are also expected to push the market further.
  • As per our analysis, the hospital segment accounts for the largest market share in the atherectomy devices market.

Ra Medical Systems Provides an Update on Enrollment in Its Pivotal Atherectomy Clinical Trial

Retrieved on: 
Friday, February 18, 2022
Health, FDA, Medical Devices, Diabetes, Surgery, Clinical Trials, Cardiology, Atherectomy, NYSE, Regulation, Patient, CTO, Food, Regulation Fair Disclosure, Incidence, Angiography, SEC, Forward-looking statement, Rutherford, U.S. Securities and Exchange Commission, Solution, Review, Security (finance), Private Securities Litigation Reform Act, Annual report, Safety, Catheter, Degenerative disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PAD, Disclosure, FDA, Laser, Marketing, Moyamoya disease, Lists of disasters, Physician, Operational technology, COVID-19, News, Industry, Pharmaceutical industry, Risk management

Our request to increase subject enrollment in the atherectomy trial was primarily due to subject fallout for follow-up visits during the ongoing COVID-19 pandemic.

Key Points: 
  • Our request to increase subject enrollment in the atherectomy trial was primarily due to subject fallout for follow-up visits during the ongoing COVID-19 pandemic.
  • To this end, we are pleased the FDA has approved our protocol amendment, said Will McGuire, Ra Medical Systems CEO.
  • The open-label pivotal atherectomy clinical trial can enroll subjects with symptoms of PAD (Rutherford Class 2-5) at up to 10 sites.
  • Ra Medical Systems manufactures the DABRA excimer laser and catheters for the treatment of certain vascular diseases.

Ra Medical Systems Granted U.S. Patent for a Support Catheter for use Supporting a Liquid Core Ablation Catheter

Retrieved on: 
Thursday, February 10, 2022
Communications, Medical Devices, FDA, Health, Surgery, Public Relations, Investor Relations, Private Securities Litigation Reform Act, Industry, News, Disclosure, Patent, U.S. Securities and Exchange Commission, Use, Lists of disasters, United States Patent and Trademark Office, Solution, Marketing, Annual report, COVID-19, Method, FDA, Regulation, Patient, Catheter, Review, Security (finance), NYSE, Atherectomy, SEC, Degenerative disease, Physician, Laser, Regulation Fair Disclosure, Forward-looking statement

This is the 10th U.S. patent issued to Ra Medical and further strengthens protection of the companys novel liquid core ablation catheters.

Key Points: 
  • This is the 10th U.S. patent issued to Ra Medical and further strengthens protection of the companys novel liquid core ablation catheters.
  • U.S. patent 11,241,519 B2, Small Flexible Liquid Core Catheter for Laser Ablation in Body Lumens and Methods for Use, describes a support catheter used in conjunction with the DABRA liquid core ablation catheter.
  • Bench studies conducted by Ra Medical have demonstrated the utility of combining the DABRA ablation catheters with support catheters in navigating difficult peripheral vasculature.
  • We now have patent protection for a support catheter that could expand the range of solutions for physicians who want to utilize our DABRA liquid core ablation catheters in challenging anatomies, said Will McGuire, Ra Medical Systems CEO.

Ra Medical Systems CEO Issues Letter to Stockholders

Retrieved on: 
Thursday, January 20, 2022
General Health, Diabetes, Medical Devices, Health, Cardiology, Fracture, CTO, Patient, Clinical trial, Lipid, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, COVID-19, Blood vessel, Anatomy, Letter, Operational technology, NYSE, Knee, Protein, PAD, Peripheral artery disease, Risk, Food, Calcium, FDA, Engineering, Physician, Trial of the century, Atherectomy, 3D printing, Medical device, Pharmaceutical industry

Ra Medical Systems, Inc. (NYSE American: RMED) announces that Chief Executive Officer Will McGuire has issued the following Letter to Stockholders:

Key Points: 
  • Ra Medical Systems, Inc. (NYSE American: RMED) announces that Chief Executive Officer Will McGuire has issued the following Letter to Stockholders:
    Im very proud of the Ra Medical teams significant progress in implementing engineering enhancements to improve the performance and extend the shelf life of our DABRA catheter.
  • What remains unchanged at Ra Medical is confidence in our DABRA excimer laser systems photoablation mechanism of action.
  • Additionally, our systems smaller footprint and lighter weight relative to competitive laser systems are important features that can benefit smaller or more crowded facilities where procedures are performed.
  • I also thank our stockholders for their continued support as we look toward building value and a brighter future.

Ra Medical Systems Reports 2021 Third Quarter Financial Results

Retrieved on: 
Monday, November 15, 2021
Diabetes, Health, Cardiology, Medical Devices, Dermatology, Adjustment, Industry, Private Securities Litigation Reform Act, News, Calcium, Paycheck Protection Program, PAD, Regulation Fair Disclosure, Atherectomy, Fracture, Engineering, Investor relations, Lipid, Security (finance), Artery, Technology, Income, Trial of the century, Growth, Depreciation, Research, Forward-looking statement, Table, Annual report, EBITDA, Sale, Protein, Catheter, U.S. Securities and Exchange Commission, Disclosure, Degenerative disease, GAAP, SEC, NYSE, PPP, Physician, Review, Time, Vascular disease, Laser, Marketing, Patient, Regulation, FDA, Medical device, Pharmaceutical industry, Video game, Lithium, Bookkeeping, Life insurance, Animal

(NYSE American: RMED), a medical device company focusing on developing its excimer laser system to treat vascular disease, reports financial results for the three and nine months ended September 30, 2021 and provides a business update.

Key Points: 
  • (NYSE American: RMED), a medical device company focusing on developing its excimer laser system to treat vascular disease, reports financial results for the three and nine months ended September 30, 2021 and provides a business update.
  • Total cost of revenue for the third quarter of 2021 was $0.2 million, compared with $0.6 million for the third quarter of 2020.
  • Adjusted EBITDA for the third quarter of 2021 was negative $6.9 million, compared with negative $6.1 million for the third quarter of 2020.
  • Research and development expenses for the third quarter of 2021 were $0.1 million compared with $21,000 for the third quarter of 2020.

Ra Medical Systems to Report Third Quarter 2021 Financial Results on November 15, 2021

Retrieved on: 
Monday, November 8, 2021
Surgery, Medical Devices, Hospitals, Diabetes, Cardiology, Biotechnology, Other Health, Health, General Health, Protein, Catheter, Laser, Patient, FDA, Degenerative disease, Lipid, Atherectomy, Medical device, Baking, Medical imaging

Ra Medical Systems manufactures the DABRA excimer laser and catheters for the treatment of vascular diseases.

Key Points: 
  • Ra Medical Systems manufactures the DABRA excimer laser and catheters for the treatment of vascular diseases.
  • In addition, DABRA has been granted CE mark clearance for the endovascular treatment of infrainguinal arteries via atherectomy and for crossing total occlusions.
  • DABRA excimer lasers and catheters are manufactured in a 32,000-square-foot facility located in Carlsbad, Calif.
  • The vertically integrated facility is ISO 13485 certified and is licensed by the State of California to manufacture sterile, single-use catheters in clean room environments.

Centers For Medicare & Medicaid Services Increases Hospital Outpatient Payment for Peripheral Intravascular Lithotripsy

Retrieved on: 
Wednesday, November 3, 2021
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We appreciate CMSs collaborative relationship and their swift action in reassigning payment levels for IVL performed above the knee, as the data acknowledge the resources associated with performing IVL in these patients.

Key Points: 
  • We appreciate CMSs collaborative relationship and their swift action in reassigning payment levels for IVL performed above the knee, as the data acknowledge the resources associated with performing IVL in these patients.
  • We would like to acknowledge CMS for making an exception to this years standard ratesetting process by considering calendar year 2020 data when determining appropriate payment levels for the new peripheral IVL code set.
  • We are also grateful for the support that came from CMS Hospital Outpatient Physician Advisory panel and medical societies during the public comment period.
  • Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated.