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FinanceNeuroPace discusses FDA feedback on PMA supplement for IGE indication expansion
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NeuroPace held a conference call to discuss the status of its PMA Supplement seeking FDA approval to expand the indication for its RNS System to include patients with antiseizure medication-resistant idiopathic generalized epilepsy (IGE). The call featured CEO Joel Becker and Chief Medical Officer Dr. Martha Morrell, with CFO Patrick Williams also present. The company had issued a press release earlier that day providing an update on the regulatory process. The call included forward-looking statements regarding FDA review expectations and the company's submission strategy. This update is significant for NeuroPace as it seeks to broaden the market for its RNS neurostimulation device beyond its current approved indications.
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Conference Call Transcript Summary
Operator: I will now turn the call over to Scott Schaper, Head of Investor Relations. Please go ahead.
Scott Schaper Head of Investor Relations
Good afternoon, and thank you for joining today's conference call. On the call, you will hear from:
- Joel Becker, NeuroPace's President and Chief Executive Officer
- Dr. Martha Morrell, NeuroPace's Chief Medical Officer
- Patrick Williams, NeuroPace's Chief Financial Officer (also on the line)
Earlier today, NeuroPace issued a press release providing an update on the status of the company's PMA Supplement seeking to expand the indication for the RNS System to include patients with antiseizure medication-resistant idiopathic generalized epilepsy (IGE). A copy of the press release is available on the Investor Relations section of our website.
Forward-Looking Statements
Before we begin, I would like to remind you that certain statements made on today's call may constitute forward-looking statements within the meaning of federal securities laws. These statements include, among others, comments regarding our expectations and beliefs with respect to regulatory matters, including FDA review of our PMA supplement through IGE, and our submission issue request.
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NeuroPace Discusses FDA Feedback on PMA Supplement for IGE Indication Expansion