CORRECTING and REPLACING OARtrac® Radiation Dose Monitoring System Receives Expanded FDA Clearance for Electron Radiation Therapy
The corrected release reads:
OARtrac® RADIATION DOSE MONITORING SYSTEM RECEIVES EXPANDED FDA CLEARANCE FOR ELECTRON RADIATION THERAPY
The additional indications clear the OARtrac System for use with patient-specific, pre-calibrated Plastic Scintillating Detector (PSD) sensors used during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning. The OARtrac System allows clinicians to measure and validate radiation doses targeted to a specific area of a patient’s body, allowing for more accurate and informed dosing.
The OARtrac System was previously cleared for use in the real-time monitoring and measurement of photon radiation and high dose rate (HDR) brachytherapy during cancer treatments on both the skin surface and with endorectal balloon (ERB) applications. The expanded Indication for Use now provides radiation oncologists and medical physicists with a tool to monitor and measure radiation doses in patients who receive electron radiation therapy, one of the most common radiotherapy treatments.
The system is also indicated for use with photon and electron energy when adhered to the skin or inserted into the rectum, allowing physicians to utilize a specifically designed OARtrac endorectal balloon device to take measurements at the rectal wall during cancer treatment.
“This expanded clearance provides us the opportunity to address an unmet
need for patients in three of the most common types of radiation
therapy, allowing for significantly improved outcomes,” said
Safe Harbor
This release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. All statements
regarding AngioDynamics' expected future financial position, results of
operations, cash flows, business strategy, budgets, projected costs,
capital expenditures, products, competitive positions, growth
opportunities, plans and objectives of management for future operations,
as well as statements that include the words such as "expects,"
"reaffirms," "intends," "anticipates," "plans," "believes," "seeks,"
"estimates," "optimistic," or variations of such words and similar
expressions, are forward-looking statements. These forward-looking
statements are not guarantees of future performance and are subject to
risks and uncertainties. Investors are cautioned that actual events or
results may differ from AngioDynamics' expectations. Factors that may
affect the actual results achieved by AngioDynamics include, without
limitation, the ability of AngioDynamics to develop its existing and new
products, technological advances and patents attained by competitors,
infringement of AngioDynamics' technology or assertions
that AngioDynamics' technology infringes the technology of fourth
parties, the ability of AngioDynamics to effectively compete against
competitors that have substantially greater resources, future actions by
the FDA or other regulatory agencies, domestic and foreign health care
reforms and government regulations, results of pending or future
clinical trials, overall economic conditions, the results of on-going
litigation, challenges with respect to fourth-party distributors or
joint venture partners or collaborators, the results of sales efforts,
the effects of product recalls and product liability claims, changes in
key personnel, the ability of AngioDynamics to execute on strategic
initiatives, the effects of economic, credit and capital market
conditions, general market conditions, market acceptance, foreign
currency exchange rate fluctuations, the effects on pricing from group
purchasing organizations and competition, the ability
of AngioDynamics to integrate acquired businesses, as well as the risk
factors listed from time to time in AngioDynamics' SEC filings,
including but not limited to its Annual Report on Form 10-K for the year
ended
View source version on businesswire.com: https://www.businesswire.com/news/home/20190328005660/en/
Source:
Investor Relations Contact:
AngioDynamics, Inc.
Michael
Greiner
518-795-1821
mgreiner@angiodynamics.com
Media Contact:
AngioDynamics, Inc.
Saleem Cheeks
518-795-1174
scheeks@angiodynamics.com