A filing-by-filing record of the US biotech, medical device, diagnostics and healthcare services companies that priced IPOs since July 2025. Each entry links to the original SEC documents and shows which clinical, regulatory, quality, commercial and financial evidence the final prospectus discloses
Compiled from SEC EDGAR and first published on this site in September 2026, updated October 2026 with filings through 1 October 2026. Event dates are the filing dates SEC records; they are not the dates this page was written
Priced IPOs39
SEC filing records410
Quarters5 complete
Data through1 October 2026
01 / sector evidence
Same SEC process, different things to prove
Biotech, device and services prospectuses go through the same registration review but make different kinds of case. The counts below come from the 39 final prospectuses on this page
Biotech and pharma · 26 prospectuses
Show the path from trial data to an approvable product
These prospectuses are built around the clinical programme. Every one discusses the investigational new drug (IND) stage and the marketing application ahead (NDA or BLA). 25 of 26 discuss topline data readouts and 19 of 26 discuss pivotal studies. Manufacturing is mostly outsourced: 26 of 26 describe reliance on contract manufacturers. The financial case is about runway: 21 of 26 say how long the cash will fund operations, and 9 of 26 include an auditor going-concern paragraph
What a reviewer asks: which data supports the next milestone, and does the cash reach it?
Medical device and diagnostics · 11 prospectuses
Show clearance, quality systems and a route to payment
These prospectuses name a specific FDA pathway: 10 of 11 discuss 510(k) clearance and 11 of 11 discuss PMA or De Novo. Quality-system regulation or ISO 13485 appears in 11 of 11, and 9 of 11 address CE marking or EU device regulation. Reimbursement is part of the case: 7 of 11 discuss CPT or HCPCS billing codes. Material weaknesses in internal control were disclosed by 3 of 11
What a reviewer asks: is the product cleared, can it be made consistently, and who pays for it?
Healthcare services · 2 prospectuses
Show a lawful operating model and payer economics
Only two services companies priced in this window, so they are two case records rather than a pattern. Both address HIPAA, the Anti-Kickback Statute and the Stark Law. One discusses the corporate practice of medicine and one discusses certificate-of-need rules. Here the evidence is about the operating structure and who pays, not about clinical trials
What a reviewer asks: is the operating structure compliant, and is the payer mix durable?
Across all 39
The same review process, very different evidence
38 of 39 issuers started with a confidential draft registration statement. The median time from that first submission to pricing was 161 days across the four complete quarters, and the median issuer filed 2 public S-1 amendments. The SEC process is shared. What differs by sector is what goes into it
These counts describe 39 filings. They do not describe the whole market
02 / signal matrix
Where each evidence theme shows up
Each signal is a fixed phrase searched in the final prospectus text. Risk factors often mention a topic as a possibility, so a hit shows the topic is disclosed, not that it happened. The dictionary is on the methodology page
Final prospectuses containing each signal, by sector. A count means the topic is disclosed, not that it is material
Signal
Biotech and pharma (26)
Medical device and diagnostics (11)
Healthcare services (2)
Clinical evidence
Phase 1
26 / 26
0 / 11
0 / 2
Phase 2
26 / 26
1 / 11
0 / 2
Phase 3
26 / 26
1 / 11
0 / 2
Pivotal study
19 / 26
4 / 11
0 / 2
Topline data
25 / 26
1 / 11
0 / 2
Clinical hold
26 / 26
4 / 11
0 / 2
Clinical validation
14 / 26
6 / 11
0 / 2
Regulatory pathway
IND
26 / 26
1 / 11
0 / 2
NDA or BLA
26 / 26
1 / 11
0 / 2
Expedited designation
25 / 26
0 / 11
0 / 2
510(k)
3 / 26
10 / 11
0 / 2
PMA or De Novo
4 / 26
11 / 11
0 / 2
Breakthrough Device
0 / 26
4 / 11
0 / 2
CLIA or LDT
0 / 26
2 / 11
0 / 2
CE mark or EU MDR/IVDR
3 / 26
9 / 11
0 / 2
Quality and manufacturing
cGMP
26 / 26
11 / 11
0 / 2
Contract manufacturer
26 / 26
9 / 11
0 / 2
QSR, QMSR or ISO 13485
2 / 26
11 / 11
0 / 2
Form 483 or warning letter
25 / 26
11 / 11
0 / 2
Recall
25 / 26
11 / 11
1 / 2
Commercial operations
Reimbursement
26 / 26
11 / 11
2 / 2
CPT or HCPCS coding
2 / 26
7 / 11
1 / 2
Medicare or Medicaid
25 / 26
11 / 11
2 / 2
Payer contracts
25 / 26
11 / 11
2 / 2
Value-based care
0 / 26
4 / 11
1 / 2
Sales force
25 / 26
11 / 11
1 / 2
Healthcare compliance
HIPAA
25 / 26
11 / 11
2 / 2
Anti-Kickback Statute
23 / 26
11 / 11
2 / 2
Stark Law
0 / 26
3 / 11
2 / 2
Corporate practice of medicine
1 / 26
3 / 11
1 / 2
Certificate of need
0 / 26
0 / 11
1 / 2
Financial disclosure
Auditor going-concern paragraph
9 / 26
4 / 11
0 / 2
Material weakness identified
8 / 26
3 / 11
1 / 2
Emerging growth company
26 / 26
9 / 11
2 / 2
Cash runway statement
21 / 26
3 / 11
0 / 2
Dual-class or controlled company
4 / 26
5 / 11
1 / 2
03 / all issuers
The full cohort, with sources
Every row links to the final prospectus on SEC.gov. Profiles are one-line editor summaries of each prospectus overview, not quotations. Days to price run from the first draft or public registration submission shown on EDGAR
Priced
Issuer
Sector
Profile
Days to price
S-1/A
Source
CapsoVision, IncLSH-2025Q3-78325 · CIK 1378325
Medical device and diagnostics
Commercial-stage capsule endoscopy imaging with AI-assisted reading