Neural Noise

Renerva FDA IDE for PNM-CAP device for neuroma pain

2 min read

  • Renerva received FDA IDE approval to commence a first-in-human study of its Renerva PNM-CAP device for neuroma pain.1
  • The device is a peripheral neuromodulation approach; the IDE illustrates the regulatory pathway for first-in-human neuro device trials.1 1

Weekly enrichment (2026-07-20)

  • Renerva announced (Dec 3, 2025) that it received FDA Investigational Device Exemption approval to begin a first-in-human clinical study of its Renerva PNM-CAP nerve-capping device for neuroma pain, transitioning the company to clinical-stage.23
  • Renerva was founded in 2017 by University of Pittsburgh Swanson School of Engineering researchers; it is led by Chief Technology Officer Bryan Brown, PhD, and CEO Lorenzo Soletti, PhD.2
  • PNM-CAP is designed to inhibit disorganized nerve growth (neuroma) that forms after a nerve is transected — a common event in extremity amputations — by guiding tissue repair to stop uncontrolled axonal growth before pain develops.34
  • The company cites a large addressable population: over 2 million amputees in the U.S. with roughly 500,000 new amputations annually, each involving multiple transected nerves and thus multiplied neuroma risk.3
  • IDE approval was supported by preclinical data published in npj Regenerative Medicine, in which PNM-CAP reduced nerve growth by as much as 16-fold versus standard-of-care control and produced a 3.5-fold reduction in average pain behavior over a four-month period.24
  • The first-in-human pilot study is designed to enroll about 10 patients over roughly one year, targeting patients undergoing nerve-management procedures for intractable neuropathic pain, with primary endpoints of pain reduction, reduced opioid consumption, and improved quality of life.23
  • The study is being conducted at The Ohio State University Wexner Medical Center, led by Principal Investigator Amy M. Moore, MD.5
  • Renerva reported (May 13, 2026) that it implanted the first patient in the study, moving from IDE approval to first-in-human implantation in just a few months and anticipating U.S. market clearance in the near term.6

Footnotes

  1. https://news.google.com/rss/articles/CBMi_gFBVV95cUxNazdYRzZqZkVMZW1LcE5QbDdIck93Z0E3YTZFazFpcGdPQ3lTTVlGeVlUNmNySDFSWk1yQk5KaWJ3VTJuTDJlS09oWmplc09WUmJfUVhQd2VobUd2Z2Z0Zm5YZmh3ckJDQ0h5QjJDeU5sREp4eW1mQjVyLVZHakZTT2tfYjg3a05kZUo0UnJubDNraGh1clpha2R3aWZ2OUpBc0F5OE1FRkpScEtOd1cxN0RvdlQ5V093ak1wR2NRMDBNME9QWXhpVUlzZnQzd3N0VTFPWE82S0dSSVBtR1A5NlZWc1huZ3ZmR3gyeG9CWHJLWTExSEt5cXBqNUx4UQ?oc=5 ↩ ↩2 ↩3

  2. https://news.engineering.pitt.edu/renerva-inc-approved-for-first-in-human-fda-clinical-trials/ ↩ ↩2 ↩3 ↩4

  3. https://www.prnewswire.com/news-releases/renerva-receives-fda-ide-approval-to-commence-first-in-human-study-of-its-renerva-pnm-cap-device-for-neuroma-pain-302631463.html ↩ ↩2 ↩3 ↩4

  4. https://lifescienceventures.cornell.edu/2025/12/03/renerva-begins-first-in-human-study-for-novel-device-to-prevent-neuroma-pain/ ↩ ↩2

  5. https://news.engineering.pitt.edu/pitt-founded-startup-achieves-first-in-human-implant-of-nerve-pain-device/ ↩

  6. https://www.prnewswire.com/news-releases/renerva-achieves-first-in-human-implant-of-pnm-cap-device-for-neuroma-pain-302768652.html ↩

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