Pulse Biosciences Lead Therapeutic System Scores FDA Approval For Sebaceous Hyperplasia

  • The FDA has granted 510(k) clearance to Pulse Biosciences Inc's PLSE CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. 
  • Sebaceous hyperplasia is a very common non-contagious skin condition. It causes small bumps on the skin. These bumps are often skin-colored and can be smooth, slightly uneven, and coarse.
  • This specific indication clearance enhances the CellFX System's general indication FDA clearance. It enables the company to support clinics in marketing and promoting CellFX treatments specifically for patients with sebaceous hyperplasia. 
  • The clearance was based on clinical data from the company's IDE-approved study.
  • The company also recently received FDA 510(k) clearance for two additional treatment tips with larger spot sizes, specifically 7.5mm and 10mm tip sizes, for treating larger benign lesions. 
  • These treatment tips broaden the portfolio of previously available 1.5mm, 2.5mm, and 5.0mm treatment tip sizes.
  • Last week, the company announced a shift in focus to advance core NPS technology in the cardiac and oncology sectors.
  • The company has also reduced its headcount from 121 to 66, with most layoffs in dermatological sales, marketing, and related support activities. 
  • Price Action: PLSE shares are up 7.79% at $1.66 on the last check Monday.
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