Organogenesis Holdings Inc.
ORGO evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for ORGO—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · ORGO
Organogenesis Holdings Inc. is a regenerative medicine company focused on developing, manufacturing, and commercializing advanced wound care and surgical & sports medicine products, with a portfolio of FDA-cleared or approved products and a pipeline including ReNu.
Key risk: Regulatory uncertainty for ReNu
BioSniper Score
Based on 3 of 6 signals
Limited data coverage
Financial data as of Jun 30, 2026.
Organogenesis Holdings Inc. is a regenerative medicine company focused on developing, manufacturing, and commercializing advanced wound care and surgical & sports medicine products, with a portfolio of FDA-cleared or approved products and a pipeline including ReNu.
- Organogenesis is a regenerative medicine company focused on advanced wound care and surgical & sports medicine [sec_mda · as of 2026-02-26].
- The company offers a portfolio of products with PMA approval or 510(k) clearance from the FDA [sec_mda · as of 2026-08-06].
- As of 2026-06-30, the company reported cash & equivalents of $46.8M, total revenue of $43.8M, and a net loss of -$96.3M [sec].
- The company is pursuing regulatory approval for ReNu, a pipeline product, but faces risks including potential FDA requirements for additional evidence [sec · filed 2025-09-25].
- Organogenesis plans to expand its sales organization and geographic footprint, including outside the U.S., though substantially all sales are currently domestic [sec_mda · as of 2025-02-27].
What works
- The company holds FDA PMA approvals or 510(k) clearances for several products, which it views as a competitive advantage due to the time and cost required for competitors to obtain similar approvals [sec_mda · as of 2026-08-06].
- Organogenesis has established technology platforms and a robust product pipeline, supporting future product development [sec_mda · as of 2026-02-26].
- The company is generating clinical trial, real-world outcomes, and health economics data to validate the efficacy and value of its products [sec_mda · as of 2026-08-06].
What to weigh
- The company faces significant competition and rapid technological change, which could adversely affect its business and financial condition [sec · filed 2024-11-22].
- Regulatory approval for ReNu is uncertain; the FDA may require additional evidence before a BLA can be submitted or approved [sec · filed 2025-09-25].
- Changes in coverage and reimbursement levels, including recent LCDs, could impact the company's product sales [sec · filed 2024-11-22].
- The company reported a net loss of -$96.3M as of 2026-06-30, indicating ongoing financial challenges [sec].
From the filings
Quoted directly from source documents.
The company's products have FDA PMA or 510(k) clearance.
“Several of our existing and pipeline products in our portfolio have PMA, or 510(k) clearance from the FDA.”
SEC MD&A · August 6, 2026
ReNu regulatory approval is uncertain and may require additional evidence.
“the FDA may require additional evidence for ReNu before we can submit a BLA or get a BLA approved, which we may not be able to obtain”
SEC filings · September 25, 2025
The company faces significant competition.
“the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition”
SEC filings · November 22, 2024
The company plans to expand internationally but most sales are currently in the U.S.
“We also plan to increase our focus on sales outside of the United States, including the European Union and the Middle East. Currently, substantially all of our sales are in the United States.”
SEC MD&A · February 27, 2025
Risks & what to watch (4)›
Key risks
- Regulatory uncertainty for ReNu — FDA may require additional evidence for ReNu before BLA submission or approval, which may not be obtainable [sec · filed 2025-09-25]
- Intense competition — Significant and continuing competition could adversely affect business, results, and financial condition [sec · filed 2024-11-22]
- Coverage and reimbursement changes — Changes to coverage and reimbursement levels, including recent LCDs, could impact product sales [sec · filed 2024-11-22]
- Technological obsolescence — Rapid technological change could render products obsolete if the company does not enhance its offerings [sec · filed 2024-11-22]
What to watch
- Regulatory developments for ReNu, including any FDA requests for additional evidence or BLA submission timelines [sec · filed 2025-09-25]
- Quarterly financial results, particularly revenue trends and net loss, given the recent -$96.3M net loss as of 2026-06-30 [sec]
- Updates on coverage and reimbursement policies, including any changes to LCDs that could affect product sales [sec · filed 2024-11-22]
- Progress in international expansion efforts, as the company plans to increase focus outside the U.S. [sec_mda · as of 2025-02-27]
Sources: SEC filings · SEC MD&A · Generated August 24, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
No clinical pipeline tracked — this score reflects financial & catalyst signals only.
8.8 months
D/E 0.80 · 0% dilution
No tracked pipeline phase
No tracked pipeline candidates
No upcoming catalysts tracked
2 buys · 0 sells (180d)
Runway
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
119
Total value held
$111.6M
| Holder | Shares | Value |
|---|---|---|
| morgan stanley | 11,616,795 | $27.5M |
| vanguard capital management llc | 5,801,632 | $13.7M |
| blackrock, inc. | 4,899,751 | $11.6M |
| dimensional fund advisors lp | 2,891,006 | $6.9M |
| d. e. shaw & co., inc. | 2,297,974 | $5.4M |
| geode capital management, llc | 1,783,964 | $4.2M |
| deutsche bank ag\ | 1,705,681 | $4.0M |
| state street corp | 1,525,108 | $3.6M |
| vanguard portfolio management llc | 1,449,092 | $3.4M |
| renaissance technologies llc | 1,068,538 | $2.5M |
Showing top 10 of 119 institutional holders of Organogenesis Holdings Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 22, 2026- % of float
- 19.4%
- Days to cover
- 7.5
- Shares short
- 15,855,307
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
ORGO short interestGovernance
Frequently asked questions
What is the AI investment thesis for Organogenesis Holdings Inc.?
Organogenesis Holdings Inc. is a regenerative medicine company focused on developing, manufacturing, and commercializing advanced wound care and surgical & sports medicine products, with a portfolio of FDA-cleared or approved products and a pipeline including ReNu.
Who is the CEO of Organogenesis Holdings Inc.?
Mr. Gary S. Gillheeney Sr. is the chief executive officer of Organogenesis Holdings Inc. (ORGO).
Where is Organogenesis Holdings Inc. headquartered?
Organogenesis Holdings Inc. (ORGO) is headquartered in Canton, MA, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.