01 / issuers, in pricing order
7 priced offerings
Each record shows the SEC-assigned industry code and why the issuer sits in its sector, the filing timeline from first submission to the final prospectus, and the evidence signals found in the 424B4 text. Signal counts are phrase occurrences, not a quality score
Medical device and diagnosticsCapsoVision, Inc
Commercial-stage capsule endoscopy imaging with AI-assisted reading
Classification basis SEC SIC 3845 (Electromedical & Electrotherapeutic Apparatus); prospectus business description read and consistent
- First submission
- Draft (DRS) 7 Feb 2025
- Public S-1
- 9 May 2025
- S-1/A amendments
- 3
- Priced (424B4)
- 3 Jul 2025
- Days, first submission to pricing
- 146
- Staff letters released
- 3
- Clinical evidencePivotal study 44
- Regulatory pathway510(k) 145PMA or De Novo 38Breakthrough Device 7CE mark or EU MDR/IVDR 11
- Quality and manufacturingcGMP 2Contract manufacturer 16QSR, QMSR or ISO 13485 2Form 483 or warning letter 2Recall 13
- Commercial operationsReimbursement 55CPT or HCPCS coding 2Medicare or Medicaid 24Payer contracts 37Sales force 15
- Healthcare complianceHIPAA 6Anti-Kickback Statute 7
- Financial disclosureAuditor going-concern paragraph 1Material weakness identified 4Emerging growth company 21Cash runway statement 4
Final prospectus (424B4) ↗First public S-1, 9 May 2025 ↗First released staff letter ↗All filings, CIK 1378325 ↗
LSH-2025Q3-78325 · accession 0001193125-25-155088 · checked September 2026 · verified
Medical device and diagnosticsCARLSMED, INC.
Commercial-stage personalized spine surgery implants and planning software
Classification basis SEC SIC 3841 (Surgical & Medical Instruments & Apparatus); prospectus business description read and consistent
- First submission
- Draft (DRS) 24 Apr 2025
- Public S-1
- 26 Jun 2025
- S-1/A amendments
- 1
- Priced (424B4)
- 24 Jul 2025
- Days, first submission to pricing
- 91
- Staff letters released
- 2
- Clinical evidenceClinical hold 1
- Regulatory pathway510(k) 66PMA or De Novo 46Breakthrough Device 15CE mark or EU MDR/IVDR 1
- Quality and manufacturingcGMP 6Contract manufacturer 62QSR, QMSR or ISO 13485 7Form 483 or warning letter 6Recall 34
- Commercial operationsReimbursement 91Medicare or Medicaid 66Payer contracts 77Sales force 4
- Healthcare complianceHIPAA 6Anti-Kickback Statute 10Corporate practice of medicine 2
- Financial disclosureEmerging growth company 23
Final prospectus (424B4) ↗First public S-1, 26 Jun 2025 ↗First released staff letter ↗All filings, CIK 1794546 ↗
LSH-2025Q3-94546 · accession 0000950170-25-098125 · checked September 2026 · verified
Medical device and diagnosticsSHOULDER INNOVATIONS, INC.
Commercial-stage shoulder replacement systems
Classification basis SEC SIC 3841 (Surgical & Medical Instruments & Apparatus); prospectus business description read and consistent
- First submission
- Draft (DRS) 17 Apr 2025
- Public S-1
- 7 Jul 2025
- S-1/A amendments
- 3
- Priced (424B4)
- 1 Aug 2025
- Days, first submission to pricing
- 106
- Staff letters released
- 4
- Clinical evidenceClinical hold 1Clinical validation 1
- Regulatory pathway510(k) 57PMA or De Novo 65CE mark or EU MDR/IVDR 2
- Quality and manufacturingcGMP 6Contract manufacturer 9QSR, QMSR or ISO 13485 14Form 483 or warning letter 7Recall 36
- Commercial operationsReimbursement 41CPT or HCPCS coding 5Medicare or Medicaid 39Payer contracts 58Value-based care 1Sales force 6
- Healthcare complianceHIPAA 5Anti-Kickback Statute 11
- Financial disclosureEmerging growth company 30
Final prospectus (424B4) ↗First public S-1, 7 Jul 2025 ↗First released staff letter ↗All filings, CIK 1699350 ↗
LSH-2025Q3-99350 · accession 0001628280-25-037109 · checked September 2026 · verified
Medical device and diagnosticsHeartflow, Inc.
Commercial-stage AI software for non-invasive coronary artery disease diagnosis from CT scans
Classification basis SEC SIC 3841 (Surgical & Medical Instruments & Apparatus); prospectus business description read and consistent
- First submission
- Draft (DRS) 6 Feb 2025
- Public S-1
- 17 Jul 2025
- S-1/A amendments
- 2
- Priced (424B4)
- 8 Aug 2025
- Days, first submission to pricing
- 183
- Staff letters released
- 4
- Clinical evidenceClinical hold 1Clinical validation 27
- Regulatory pathway510(k) 30PMA or De Novo 48Breakthrough Device 4CE mark or EU MDR/IVDR 16
- Quality and manufacturingcGMP 2QSR, QMSR or ISO 13485 10Form 483 or warning letter 4Recall 17
- Commercial operationsReimbursement 78CPT or HCPCS coding 22Medicare or Medicaid 60Payer contracts 67Sales force 4
- Healthcare complianceHIPAA 28Anti-Kickback Statute 18Stark Law 2Corporate practice of medicine 1
- Financial disclosureEmerging growth company 21
Final prospectus (424B4) ↗First public S-1, 17 Jul 2025 ↗First released staff letter ↗All filings, CIK 1464521 ↗
LSH-2025Q3-64521 · accession 0001628280-25-039265 · checked September 2026 · verified
Biotech and pharmaCuranex Pharmaceuticals Inc
Development-stage botanical drugs for inflammatory diseases
Classification basis SEC SIC 2834 (Pharmaceutical Preparations); prospectus business description read and consistent
- First submission
- Draft (DRS) 20 Jun 2024
- Public S-1
- 16 Oct 2024
- S-1/A amendments
- 6
- Priced (424B4)
- 26 Aug 2025
- Days, first submission to pricing
- 432
- Staff letters released
- 5
- Clinical evidencePhase 1 11Phase 2 15Phase 3 5Clinical hold 3
- Regulatory pathwayIND 25NDA or BLA 2Expedited designation 2
- Quality and manufacturingcGMP 9Contract manufacturer 4
- Commercial operationsReimbursement 1
- Healthcare complianceno dictionary signal
- Financial disclosureEmerging growth company 16Cash runway statement 1Dual-class or controlled company 15
Final prospectus (424B4) ↗First public S-1, 16 Oct 2024 ↗First released staff letter ↗All filings, CIK 2025942 ↗
LSH-2025Q3-25942 · accession 0001493152-25-012350 · checked September 2026 · verified
Medical device and diagnosticsPicard Medical, Inc.
Total artificial heart systems through its SynCardia subsidiary
Classification basis SEC SIC 3841 (Surgical & Medical Instruments & Apparatus); prospectus business description read and consistent
- First submission
- Draft (DRS) 23 Aug 2024
- Public S-1
- 1 Apr 2025
- S-1/A amendments
- 7
- Priced (424B4)
- 2 Sep 2025
- Days, first submission to pricing
- 375
- Staff letters released
- 10
- Clinical evidenceno dictionary signal
- Regulatory pathwayPMA or De Novo 110CE mark or EU MDR/IVDR 74
- Quality and manufacturingcGMP 4Contract manufacturer 4QSR, QMSR or ISO 13485 9Form 483 or warning letter 1Recall 16
- Commercial operationsReimbursement 47Medicare or Medicaid 25Payer contracts 14Sales force 5
- Healthcare complianceHIPAA 2Anti-Kickback Statute 3
- Financial disclosureAuditor going-concern paragraph 2Emerging growth company 22Dual-class or controlled company 18
Final prospectus (424B4) ↗First public S-1, 1 Apr 2025 ↗First released staff letter ↗All filings, CIK 2030617 ↗
LSH-2025Q3-30617 · accession 0001829126-25-006957 · checked September 2026 · verified
Biotech and pharmaLB PHARMACEUTICALS INC
Clinical-stage therapies for schizophrenia and other neuropsychiatric diseases
Classification basis SEC SIC 2834 (Pharmaceutical Preparations); prospectus business description read and consistent
- First submission
- Draft (DRS) 20 May 2024
- Public S-1
- 22 Aug 2025
- S-1/A amendments
- 1
- Priced (424B4)
- 12 Sep 2025
- Days, first submission to pricing
- 480
- Staff letters released
- 4
- Clinical evidencePhase 1 13Phase 2 105Phase 3 51Pivotal study 12Topline data 10Clinical hold 4Clinical validation 1
- Regulatory pathwayIND 26NDA or BLA 3Expedited designation 14
- Quality and manufacturingcGMP 19Contract manufacturer 25Form 483 or warning letter 3Recall 8
- Commercial operationsReimbursement 79Medicare or Medicaid 79Payer contracts 54Sales force 3
- Healthcare complianceHIPAA 7Anti-Kickback Statute 13
- Financial disclosureAuditor going-concern paragraph 2Material weakness identified 1Emerging growth company 33Cash runway statement 1Dual-class or controlled company 6
Final prospectus (424B4) ↗First public S-1, 22 Aug 2025 ↗First released staff letter ↗All filings, CIK 1691082 ↗
LSH-2025Q3-91082 · accession 0001193125-25-201757 · checked September 2026 · verified