May 16 (Reuters) - Onward Medical NV ONWD.BR :
* COMPANY HAS BEEN ISSUED 10 NEW PATENTS DURING Q1 2023,
BRINGING
TOTAL NUMBER OF ISSUED OR PENDING PATENTS TO MORE THAN 340 AND
STRENGTHENING ITS FIRST-MOVER ADVANTAGE
* NEW BREAKTHROUGH DEVICE DESIGNATION AWARDED BY U.S. FDA
FOR ARC
THERAPY™, BRINGING TOTAL TO 9
* OUTLOOK: ONWARD EXPECTS TO CONTINUE STEADY AND CONSISTENT
EXECUTION OF ITS STRATEGY IN 2023 AND BEYOND WITH ACHIEVEMENT OF
FOLLOWING MILESTONES
* COMPANY REPORTED CASH AND CASH EQUIVALENTS OF EUR 53
MILLION AS
OF MARCH 31, 2023 AND REITERATED ITS GUIDANCE OF EXPECTED CASH
RUNWAY THROUGH END OF 2024
* OUTLOOK: COMPANY PLANS TO SUBMIT A DE NOVO APPLICATION FOR
FDA
CLEARANCE FOR ARC-EX SYSTEM THIS YEAR AND AIMS TO SUBMIT AN
APPLICATION FOR EUROPEAN AUTHORIZATION IN SAME PERIOD
* OUTLOOK: COMPANY ALSO PLANS TO BEGIN ITS PIVOTAL CLINICAL
STUDY
IN NEXT YEAR TO EVALUATE SAFETY AND EFFECTIVENESS OF IMPLANTABLE
ARC-IM SYSTEM TO BETTER REGULATE BLOOD PRESSURE AFTER SCI
* OUTLOOK: PLANS TO BEGIN CLINICAL FEASIBILITY STUDIES TO
INVESTIGATE ABILITY FOR A BRAIN-COMPUTER INTERFACE (BCI) TO
COMMUNICATE WITH ARC-IM SYSTEM TO ENABLE A PERSON WITH SCI TO
MORE NATURALLY CONTROL WHEN AND HOW THEY MOVE. THIS PROGRAM IS
SUPPORTED BY A GRANT FROM EUROPEAN INNOVATION COUNCIL
* OUTLOOK: PLANS TO CONTINUE TO BUILD ORGANIZATIONAL
CAPABILITIES
IN PREPARATION FOR EXPECTED LAUNCH OF ARC-EX LATER THIS YEAR OR
EARLY NEXT YEAR, RECRUITING FIELD SALES AND SERVICE
PROFESSIONALS AND ADDING OPERATIONAL SYSTEMS THAT WILL ENABLE IT
TO CONDUCT COMMERCE ONCE IT RECEIVES FDA CLEARANCE AND CE MARK
* OUTLOOK: ANTICIPATES ITS CURRENT CASH POSITION WILL FUEL
OPERATIONS THROUGH END OF 2024
* IN 2023, IT PLANS TO PURSUE OPPORTUNITIES TO FURTHER
STRENGTHEN
CASH POSITION TO SUPPORT FUTURE INVESTMENTS IN PRODUCT
DEVELOPMENT, CLINICAL TRIALS, AND OPERATIONAL AND COMMERCIAL
CAPABILITIES
Source text for Eikon: ID:nGNEbVkhhh
Further company coverage: ONWD.BR
(Gdansk Newsroom)
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