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Initially dedicated to the research and development of products used in interventional radiology, the Company soon became well established as a producer of diagnostic catheters for non-coronary angiography and thrombolytic delivery systems.
−Removed: The Company grew over the following years as a result of acquisitions of companies including RITA Medical Systems in January 2007, Oncobionic in May 2008, Vortex Medical, Inc.
−Removed: in October 2012, Clinical Devices in August 2013, the assets of Diomed in June 2008 and the assets of Microsulis Medical Limited in January 2013.
+Added: The Company grew over the following years as a result of acquisitions of companies including RITA Medical Systems in January 2007, Oncobionic in May 2008, the assets of Diomed in June 2008, Vortex Medical, Inc.
+Added: in October 2012, the assets of Microsulis Medical Limited in January 2013, and Clinical Devices in August 2013.
These acquisitions added product lines
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AngioDynamics is publicly traded on the NASDAQ stock exchange under the symbol ANGO.
−Removed: Our product offerings fall within three Global Business Units (GBUs):
−Removed: Endovascular Therapies (“VIT”), Oncology/Surgery (“OS”) and Vascular Access (“VA).
−Removed: As the Company has previously announced, the Company is focused on its ongoing transformation from a company with a broad portfolio of largely undifferentiated products to a more focused medical technology company that delivers unique and innovative health care solutions.
−Removed: As such, we believe the growth in the near to mid-term will be driven by our high technology products including Auryon, the Thrombectomy platform (which includes AngioVac, AlphaVac and thrombolytics) and NanoKnife.
−Removed: We will refer to these high technology product lines as our Med Tech business and we will refer to the remainder of the portfolio as our Med Device business.
+Added: Our product offerings fall within two segments, Med Tech and Med Device.
All products discussed below have been cleared for sale in the United States by the Food and Drug Administration.
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Regardless of lesion type, the Auryon system provides safety and efficacy.
−Removed: The Auryon system is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR).
+Added: The Auryon system is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infrainguinal arteries.
Our Thrombus Management portfolio includes the AlphaVac Mechanical Thrombectomy System, AngioVac venous drainage cannula and circuit, as well as catheter directed thrombolytic devices, including the Uni-Fuse system, the Uni-Fuse+ system, the Pulse Spray system and SpeedLyser infusion catheters.
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• SmartPort, SmartPort+, SmartPort Plastic :
−Removed: The SmartPort power-injectable port with Vortex technology offers the ability for a clinician to access a vein for both the delivery of medications or fluids and for administering power-injected contrast to perform a CT scan.
+Added: The SmartPort power-injectable port with Vortex technology offers the ability for a clinician to access a vein for both the delivery of medications or fluids and for administering power-
+Added: injected contrast to perform a CT scan.
The ability to access a port for power-injected contrast studies eliminates the need for additional needle sticks in the patient’s arm and wrist veins.
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The PASV Valve Technology is designed to automatically resist backflow and reduce blood reflux that could lead to catheter-related complications.
−Removed: The LifeGuard Safety Infusion Set and The LifeGuard Vision are used to infuse our ports and complement our port and vascular access catheters.
−Removed: The needles’ low profile design is intended to allow clinicians to easily dress the site.
Dialysis Products
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Precision Concepts is manufacturing, storing, and handling certain products for the Company and is registered with the FDA and certified to the ISO 13485 standard.
+Added: The Company also relies on third party manufacturers for the manufacturing of certain products.
We have historically kept sufficient inventory on hand to ship product within 24-48 hours of order receipt to meet customer demand.
−Removed: In fiscal year 2022, COVID-19 related issues including the Company's ability to manufacture products, the reliability of our supply chain, labor shortages, backlog and inflation (including the cost and availability of raw materials, direct labor and shipping) have impacted our business and resulted in a backlog of $8.4 million at the end of the fourth quarter.
+Added: In fiscal year 2023, the Company's ability to manufacture products, the reliability of our supply chain, labor shortages, backlog and inflation (including the cost and availability of raw materials, direct labor and shipping) have impacted our business and resulted in a backlog of $2.7 million at the end of the fourth quarter.
We continue to focus on meeting the demand for our product and working towards standard inventory and backlog levels in fiscal year 2024.
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(iv) or a 510(k) exempt device.
−Removed: After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance.
+Added: After a device receives 510(k) clearance, any modification that could significantly affect
+Added: its safety or effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance.
The 510(k) clearance procedure including questions and responses may take up to 12 months.
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As part of the PMA application review, the FDA will inspect the manufacturer’s facilities for compliance with its Quality System Regulation, or QSR.
−Removed: As part of the PMA approval the FDA may place
−Removed: restrictions on the device, such as requiring additional patient follow-up for an indefinite period of time.
+Added: As part of the PMA approval the FDA may place restrictions on the device, such as requiring additional patient follow-up for an indefinite period of time.
If the FDA’s evaluation of the PMA application or the manufacturing facility is not favorable, the FDA may deny approval of the PMA application or issue a “not approvable” letter.
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In order to distribute and sell products into the European Union as well as a number of other countries including many Central European Free Trade Agreement participants, Scandinavian, and Middle Eastern countries, a CE Mark is required.
−Removed: New products must be compliant with the Medical Device Regulation ("MDR") as of May 2021 and previously CE Marked products must become compliant when their certification expires, with a transition period ending May 2025.
+Added: products must be compliant with the Medical Device Regulation ("MDR") as of May 2021 and previously CE Marked products must become compliant when their certification expires, with a transition period ending December 2027 for higher classification devices, or December 2028 for lower classification devices.
Products with an expiring certification must be in distribution before certification expiration dates to continue to be sold.
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Additionally, there can be extended time frames under MDR for product certifications that can be 12-18 months or longer.
−Removed: Similar regulations are in place for Canada, Japan, China and most other countries.
+Added: During that time period, significant design modifications cannot be made.
+Added: Similar regulations are in place for Canada, Japan, China, Brazil and most other countries.
In some cases, we rely on our international distributors to obtain regulatory approvals, complete product registrations, comply with clinical trial requirements and complete those steps that are customarily taken in the applicable jurisdictions.
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ENVIRONMENTAL, HEALTH AND SAFETY
−Removed: We are subject to federal, state and local laws, rules, regulations and policies governing the use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of certain hazardous and potentially hazardous substances used
−Removed: in connection with our operations.
+Added: We are subject to federal, state and local laws, rules, regulations and policies governing the use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of certain hazardous and potentially hazardous substances used in connection with our operations.
Our operations are also subject to laws and regulations related to occupational health and safety.
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Laura Piccinini 53 Senior Vice President and General Manager, International
−Removed: Rosenzweig 55 Senior Vice President, General Counsel and Secretary
Clemmer became our President and Chief Executive Officer (CEO) in April 2016.
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Clemmer began his career at Sage Products, Inc.
−Removed: Clemmer currently serves on the Board of Directors for AngioDynamics and previously served on the Board of Directors for Lantheus Medical Imaging.
+Added: Clemmer currently serves on the Board of Directors for
+Added: AngioDynamics and previously served on the Board of Directors for Lantheus Medical Imaging.
Clemmer is a graduate of the Massachusetts College of Liberal Arts, where he served as interim president from August 2015 until March 2016.
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Piccinini is a graduate of the Parma University of Medicine, where she received a nursing degree with specializations in ICU, Anesthesia, and First Aid as a Helicopter Flight Coordinator.
−Removed: Rosenzwei g joined AngioDynamics as Senior Vice President, General Counsel and Secretary in February 2021.
−Removed: Rosenzweig brings to his role more than 20 years of experience in executive leadership providing legal guidance, governance and compliance oversight, and strategic business direction to global medical device and health care companies, including C.
−Removed: Bard for more than ten years where he most recently served as Vice President, Law, and Assistant Secretary, Phibro Animal Health Corporation and Impath, Inc.
−Removed: as Senior Vice President, General Counsel and Secretary, and Johnson & Johnson as Director, Licensing and Acquisitions.
−Removed: Prior to AngioDynamics, Mr.
−Removed: Rosenzweig advised companies in the medical device industry as an independent consultant on corporate development initiatives.
−Removed: Rosenzweig received his Bachelor of Arts in Psychology from Brandeis University and his Juris Doctor from Boston University School of Law.
−Removed: He serves as Vice Chair and Chair-Elect of the Director’s Leadership Council of the Rutgers Cancer Institute of New Jersey, and is a member of the Director’s Leadership Council for Rutgers Biomedical and Health Sciences, an academic medical center.
AVAILABLE INFORMATION
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Accordingly, investors should monitor our website, in addition to following our press releases, SEC filings and public conference calls and webcasts.
−Removed: We use these channels as well as social media and blogs to communicate with the public about our company, our services and other issues.
+Added: We use these channels as well
+Added: as social media and blogs to communicate with the public about our company, our services and other issues.
It is possible that the information we post on social media and blogs could be deemed to be material information.
−Removed: Therefore, we encourage
−Removed: investors, the media, and others interested in our Company to review the information we post on the social media channels and blogs listed on our website.
+Added: Therefore, we encourage investors, the media, and others interested in our Company to review the information we post on the social media channels and blogs listed on our website.
Any stockholder also may obtain copies of these documents, free of charge, by sending a request in writing to our Corporate headquarters, Attention:
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.