4Dx Motion 510K Application in April 2017

4DX has recently released their company newsletter for August 2017. This month features an Update from the Chairman, FDA Status, Virtual CFO, Clinical Study Update, U.S Operations.

KEY TAKEAWAYS: 

• 4Dx collaborators from Cedars-Sinai Medical Centre in Los Angeles travelled to the 4Dx Melbourne office in June to conduct studies on the 4Dx preclinical scanner.
• The company has continued to raise capital on the back of interest from both domestic investor in addition to significant interest coming from the United Kingdom.

FDA Status

• 4Dx Motion 510(k) application in April 2017.
• 4Dx received a Request for Additional Information (AI) from the FDA.
• 4Dx is currently working closely with our US regulatory consultant (Emergo) to draft a response to the AI;
• Intends to keep investors updated on progress as it occurs.

Virtual CFO

• Continued and growing relationship with Ernst & Young.
• One of the “Big 4”, Ernst & Young brings a wealth of experience to 4Dx.
• The new virtual CFO position will be a full-service engagement.

Clinical Study Update

• 4Dx is currently receiving additional datasets on a weekly basis for the clinical study conducted at a major U.S hospital.
• Initial subjects are entering the second stage of the study, which will allow the assessment of how subjects’ lung health is changing as a result of treatment.

U.S Operations

• The company has developed its international presence with a new office in Los Angeles.
• Having a permanent office in the U.S strengthens the presences for 4Dx to engage and develop stronger relationships with U.S based clients.

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