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Private company

Paragon 28, Inc.

Paragon 28, Inc. is an American surgical and medical instruments and apparatus company.2 It is headquartered in Engelwood, United States.2

Last updated Oct 21, 2026.

Overview

  • IndustrySurgical & Medical Instruments & Apparatus2
  • HeadquartersEngelwood, United States2
  • Incorporated inDE3
  • Business address14445 Grasslands Drive, Englewood, Co 801123
  • Filer categoryAccelerated filer3
  • Legal formCorporation2
  • LEI254900GM24PT1FMTRP662
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressc/o The Corporation Trust Company, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 62916602

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Paragon 28, Inc. (collectively with its subsidiaries, “we,” “us,” “our,” “P28” or the “Company”) is a leading medical device company exclusively focused on the foot and ankle orthopedic market and we are dedicated to improving patient lives. Our innovative orthopedic solutions, procedural approaches and instrumentation cover a wide range of foot and ankle ailments including fracture fixation, forefoot, ankle, progressive collapsing foot deformity (PCFD) or flatfoot, charcot foot and orthobiologics. To treat these painful, debilitating or even life-threatening conditions, we provide a comprehensive portfolio of solutions that includes surgical implants and disposables, as well as surgical instrumentation. We design each of our products with both the patient and surgeon in mind, with the goal of improving outcomes, reducing ailment recurrence and complication rates, and making the procedur…5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2024

74.7%Gross margin6
-15.9%Operating margin6
-21.3%Net margin6
18.4%Revenue growth, 20246
-41.8%Return on equity6
0.84×Debt to equity6

Where the money goes

Where each dollar of revenue went, fiscal 2024

  • Cost of revenue22¢$64.7M
  • Research and development9¢$27.1M
  • Selling, general and admin69¢$205.2M
  • Income tax0¢$1.2M

Out of $256.2M in revenue.6 The company lost money this year.

Financial statements

Revenue7896$256.2M in 2024+141% since 2019
0$100.0M$200.0M$300.0M2019: $106.3M$106.3M20192020: $111.0M$111.0M2020+4%2021: $147.5M$147.5M2021+33%2022: $181.4M$181.4M2022+23%2023: $216.4M$216.4M2023+19%2024: $256.2M$256.2M2024+18%
Gross profit7896$191.5M in 2024+119% since 2019
0$50.0M$100.0M$150.0M$200.0M2019: $87.4M$87.4M20192020: $85.9M$85.9M2020−2%2021: $119.4M$119.4M2021+39%2022: $149.3M$149.3M2022+25%2023: $164.4M$164.4M2023+10%2024: $191.5M$191.5M2024+16%
Operating income7896-$40.8M in 2024
-$80.0M-$60.0M-$40.0M-$20.0M0$20.0M2019: $2.7M$2.7M20192020: $2.1M$2.1M2020−24%2021: -$10.8M-$10.8M20212022: -$61.7M-$61.7M2022+473%2023: -$45.7M-$45.7M2023−26%2024: -$40.8M-$40.8M2024−11%
Net income7896-$54.6M in 2024
-$80.0M-$60.0M-$40.0M-$20.0M0$20.0M2019: $3.1M$3.1M20192020: $3.5M$3.5M2020+12%2021: -$13.7M-$13.7M20212022: -$65.6M-$65.6M2022+379%2023: -$57.5M-$57.5M2023−12%2024: -$54.6M-$54.6M2024−5%
Fiscal year2018201920202021202220232024
Revenue$106.3M7$111.0M8$147.5M9$181.4M6$216.4M6$256.2M6
Cost of revenue$18.8M7$25.1M8$28.0M9$32.1M6$52.0M6$64.7M6
Gross profit$87.4M7$85.9M8$119.4M9$149.3M6$164.4M6$191.5M6
Research and development$10.3M7$11.2M8$16.1M9$24.6M6$30.1M6$27.1M6
Selling, general and admin$74.4M7$72.6M8$114.1M9$159.3M6$180.0M6$205.2M6
Operating expenses$130.2M9$211.0M6$210.1M6$232.3M6
Operating income$2.7M7$2.1M8-$10.8M9-$61.7M6-$45.7M6-$40.8M6
Income before tax-$13.0M9-$65.7M6-$57.3M6-$53.5M6
Income tax-$1.1M7$1.5M8$713.0K9-$64.0K6$213.0K6$1.2M6
Net income$3.1M7$3.5M8-$13.7M9-$65.6M6-$57.5M6-$54.6M6
Earnings per share$0.077$0.068-$0.269-$0.866-$0.706-$0.666
Earnings per share (diluted)$0.057$0.048-$0.269-$0.866-$0.706-$0.666
Shares (weighted, basic)52.9M shares976.8M shares682.1M shares683.3M shares6
Shares (weighted, diluted)52.9M shares976.8M shares682.1M shares683.3M shares6

Compare Paragon 28, Inc. with another company

Corporate structure

Paragon 28, Inc. is part of a group headed by Zimmer Biomet Holdings. 160 entities, 49 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Paragon 28, Inc.

  • Zimmer Biomet Holdings Warsaw, Indiana, United States
    • Paragon 28, Inc. Engelwood, Colorado, United States
      • Disior Oy 1 Subsidiary · Finland
      • Paragon 28 Australia PTY LTD 2 Subsidiary · Australia
      • Paragon 28 DE Gmbh 1 Subsidiary · Germany
      • Paragon 28 Italia SRL 1 Subsidiary · Italy
      • Paragon 28 Medical Devices Trading Limited 1 Subsidiary · Ireland
      • Paragon 28 UK, LTD 1 Subsidiary · United Kingdom
      • Paragon Advanced Technologies, Inc. 1 Subsidiary · Delaware, United States
    • Zimmer Wilmington, Delaware, United States
    • Zimmer Biomet (Germany) Subsidiary · Berlin, Germany
    • Zimmer Biomet (Switzerland) Subsidiary · Winterthur, Switzerland
    • Zimmer Biomet (United Kingdom) Subsidiary · Bridgend, United Kingdom
    • zimmer biomet Subsidiary · 100% · Warsaw, United States
    • 3-102-910623 Sociedad de Responsabilidad Limitada Subsidiary · Costa Rica
    • A&E Medical Corp. Subsidiary · New Jersey, United States
    • Alto Development Corp. Subsidiary · New Jersey, United States
    • Avitus Orthopaedics, Inc. Subsidiary · Delaware, United States
    • Beijing Montagne Medical Device Co., Ltd. Subsidiary · China
    • Biomet Argentina SA Subsidiary · Argentina
    • Biomet Biologics, LLC Subsidiary · Indiana, United States
    • Biomet C.V. Subsidiary · Netherlands
    • Biomet Chile SA Subsidiary · Chile
    • Biomet China Co., Ltd. Subsidiary · China
    • Biomet CV Holdings, LLC Subsidiary · Delaware, United States
    • Biomet Deutschland GmbH Subsidiary · Germany
    • Biomet Fair Lawn LLC Subsidiary · Indiana, United States
    • Biomet France Sarl Subsidiary · France
    • BIOMET GLOBAL SUPPLY CHAIN CENTER BV Subsidiary · Warsaw, Indiana, United States
    • Biomet Hong Kong Holding Ltd. Subsidiary · Hong Kong
    • Biomet International, Inc. Subsidiary · Delaware, United States
    • Biomet Manufacturing, LLC Subsidiary · Indiana, United States
    • Biomet Mexico S.A. de C.V. Subsidiary · Mexico
    • and 127 more

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; subsidiaries, stakes and holdings from Wikidata (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Paragon 28, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$130.2M6 Dec 31, 2024$118.0M6 Dec 31, 2023+10.4%
Accumulated depreciation$58.8M6 Dec 31, 2024$43.8M6 Dec 31, 2023+34.1%
Property and equipment, net$71.4M6 Dec 31, 2024$74.1M6 Dec 31, 2023−3.7%
Operating-lease assets (leased space)$1.8M6 Dec 31, 2024$1.5M6 Dec 31, 2023+20.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$34.6M6 Dec 31, 2024$75.6M6 Dec 31, 2023−54.3%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$25.5M6 Dec 31, 2024$25.5M6 Dec 31, 20230%
Intangible assets, net (excluding goodwill)$20.4M6 Dec 31, 2024$21.7M6 Dec 31, 2023−6.1%
Accumulated amortization$9.0M6 Dec 31, 2024$6.7M6 Dec 31, 2023+34.3%
Finite-lived intangibles, net$19.7M6 Dec 31, 2024

Inventory

ItemLatestA year beforeChange
Inventory, total$90.0M6 Dec 31, 2024$90.0M6 Dec 31, 20230%

Properties, in its own words

Our corporate headquarters are located in Englewood, Colorado, where we own and occupy approximately 105,000 square feet of office space. We also maintain offices domestically in Michigan and internationally in Ireland, South Africa, Australia, Finland, Germany, and the U.K. We believe that our existing facilities are sufficient for our near-term needs.

Item 2 of the 10-K filed Mar 6, 2025.5

Leadership

Who has led Paragon 28, Inc., and when. Pick a name to see everywhere that person has worked.

Chief financial officer

  1. Stephen Deitsch2021–now
2025
Board members and other officers (20)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Disior Oy 1 Finland4
  • Paragon 28 Australia PTY LTD 2 Australia4
  • Paragon 28 DE Gmbh 1 Germany4
  • Paragon 28 Italia SRL 1 Italy4
  • Paragon 28 Medical Devices Trading Limited 1 Ireland4
  • Paragon 28 UK, LTD 1 United Kingdom4
  • Paragon Advanced Technologies, Inc. 1 Delaware4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Apr 21, 20258-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer33
  2. Apr 17, 20258-K Shareholder vote; Other events34
  3. Apr 10, 20258-K Other events35
  4. Mar 11, 20258-K Other events36
  5. Jan 29, 20258-K Other events37
  6. Jan 29, 20258-K Entered a material agreement38
  7. Jan 13, 20258-K Results of operations39
  8. Dec 11, 20248-K Executive or director change; Regulation FD disclosure40
  9. Nov 12, 20248-K Results of operations41
  10. Sep 20, 20248-K Executive or director change42
  11. Aug 8, 20248-K Results of operations; Executive or director change; Regulation FD disclosure43
  12. Jul 30, 20248-K Results of operations; Earlier financial statements no longer reliable44
  13. Oct 8, 2021Founded Paragon 28, Inc. is founded2

Calendar

When it reported results

  1. Jan 13, 2025Reported quarterly or annual results39
  2. Nov 12, 2024Reported quarterly or annual results41
  3. Aug 8, 2024Reported quarterly or annual results43
  4. Jul 30, 2024Reported quarterly or annual results44
  5. May 8, 2024Reported quarterly or annual results45
  6. Apr 4, 2024Reported quarterly or annual results46
  7. Feb 29, 2024Reported quarterly or annual results47
  8. Jan 8, 2024Reported quarterly or annual results48

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

315 filings to the SEC since October 2021: 6 annual reports, 11 quarterly reports, 43 major events, 174 insider forms, 18 large holders, 63 other. The latest 20:

  1. May 15, 2025SCHEDULE 13G/A EDGAR
  2. May 12, 2025SCHEDULE 13G/A EDGAR
  3. May 1, 202515-12G EDGAR
  4. Apr 24, 2025EFFECT EDGAR
  5. Apr 21, 202510-K/A EDGAR
  6. Apr 21, 20254 EDGAR
  7. Apr 21, 20254 EDGAR
  8. Apr 21, 20254 EDGAR
  9. Apr 21, 20254 EDGAR
  10. Apr 21, 20254 EDGAR
  11. Apr 21, 20254 EDGAR
  12. Apr 21, 20254 EDGAR
  13. Apr 21, 20254 EDGAR
  14. Apr 21, 20254 EDGAR
  15. Apr 21, 20254 EDGAR
  16. Apr 21, 20254 EDGAR
  17. Apr 21, 20254 EDGAR
  18. Apr 21, 20254 EDGAR
  19. Apr 21, 2025S-8 POS POST-EFFECTIVE AMENDMENT NO. 1 EDGAR
  20. Apr 21, 2025S-8 POS POST-EFFECTIVE AMENDMENT NO. 1 EDGAR

The 315 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

100 open-market trades by officers, directors and large owners since October 2021: 2 buys and 98 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Mar 13, 2025MVM Partners, LLC10% ownerSale1,044,295$13.04$13.6MForm 4
Mar 6, 2025MVM Partners, LLC10% ownerSale164,664$13.01$2.1MForm 4
Mar 5, 2025MVM Partners, LLC10% ownerSale590,224$13.02$7.7MForm 4
Mar 4, 2025MVM Partners, LLC10% ownerSale619,747$12.99$8.1MForm 4
Jan 28, 2025MVM Partners, LLC10% ownerSale84,323$11.94$1.0MForm 4
Jan 27, 2025MVM Partners, LLC10% ownerSale27,142$11.62$315.4KForm 4
Jan 24, 2025MVM Partners, LLC10% ownerSale25,026$11.60$290.3KForm 4
Jan 23, 2025MVM Partners, LLC10% ownerSale20,136$11.63$234.2KForm 4
Dec 9, 2024MVM Partners, LLC10% ownerSale14,403$10.05$144.8KForm 4
Dec 6, 2024WRIGHT KRISTINADirectorSale2,360$10.00$23.6KForm 4
Dec 6, 2024MVM Partners, LLC10% ownerSale25,485$10.07$256.6KForm 4
Dec 5, 2024MVM Partners, LLC10% ownerSale55,818$10.13$565.4KForm 4
Dec 4, 2024MVM Partners, LLC10% ownerSale18,109$10.14$183.6KForm 4
Nov 27, 2024MVM Partners, LLC10% ownerSale4,256$10.00$42.6KForm 4
Nov 26, 2024MVM Partners, LLC10% ownerSale44,014$10.03$441.5KForm 4
Nov 25, 2024MVM Partners, LLC10% ownerSale10,835$10.09$109.3KForm 4
Nov 22, 2024MVM Partners, LLC10% ownerSale72,133$10.16$732.9KForm 4
Nov 21, 2024MVM Partners, LLC10% ownerSale107,366$10.41$1.1MForm 4
Nov 20, 2024MVM Partners, LLC10% ownerSale147,581$10.28$1.5MForm 4
Nov 13, 2024WRIGHT KRISTINADirectorSale4,181$10.00$41.8KForm 4

All 100 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$3.7M 2020–2020
Money received by yearMoney received by year, 2020–2020: $3.7M in all. PPP loans $3.7M.$0$1M$2M$3M$4M2020 · PPP loans: $3.7M2020
Figures by year
YearPPP loansTotal
2020$3.7M$3.7M

PPP loans

Paycheck Protection Program loans of $150,000 and up, approved April 2020 to July 2021, from the SBA56. Matched to this company by name and state.

  1. Apr 5, 2020$3.7M PPP loan (first draw) from Zions Bank, A Division of56To PARAGON 28 INC, Englewood CO; $3.8M forgiven Jun 11, 2021

SEC filer profile

How Paragon 28, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARParagon 28, Inc.1
  • CIK0001531978
  • Employer ID (EIN)27-31701865
  • Filer statusAccelerated filer not an emerging growth company; not a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address14445 Grasslands Drive, Englewood, CO 801121
  • Phone720-912-13321
  • Shares outstanding84,152,663 as of Apr 15, 202557
  • Public float$317.6M as of Jun 30, 20245
  • AuditorDeloitte & Touche LLP, Denver, Colorado PCAOB ID 34; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceOct 31, 20111
  • Filings329 in all: 4 (145), 8-K (43), 3 (22), 144 (16), DEFA14A (13), 10-Q (10), SCHEDULE 13G/A (7), 4/A (6)1
    All 41 form types

    CORRESP (6), SC 13G (5), SC 13G/A (5), UPLOAD (5), 10-K (4), DEF 14A (3), EFFECT (3), S-1/A (3), S-8 (3), S-8 POS (3), 10-K/A (2), 424B5 (2), D (2), DFAN14A (2), 10-Q/A (1), 144/A (1), 15-12G (1), 25-NSE (1), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), D/A (1), DEFM14A (1), DRS (1), DRS/A (1), DRSLTR (1), POS AM (1), PRE 14A (1), PREM14A (1), S-1 (1), S-3 (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 6, 2025
    Quarterly report (10-Q) Nov 12, 2024
    Proxy statement (DEF 14A) Apr 5, 2024
    Latest 8-K (8-K) Apr 21, 2025

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.01 par value per shareFNANew York Stock Exchange

From the cover page of the 10-K filed Mar 6, 2025 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Paragon 28, Inc. names in Item 1A of its 10-K filed Mar 6, 2025: 72 risks under these headings, as written.5

  • Risks Related to the Merger
  • The conditions for consummation under the Merger Agreement may not be satisfied at all or in the anticipated timeframe.
  • The announcement of, or a failure to consummate, the Merger could negatively impact our business, financial condition, results of operations or our stock price.
  • The Merger Agreement contains provisions that could make it difficult for a third-party to acquire us prior to the completion of the Merger.
  • If the Merger is not consummated by the Outside Date, either we or Zimmer may terminate the Merger Agreement, subject to certain exceptions.
  • Risks Related to Our Business and Industry
  • Our business is dependent upon the broad adoption of our products by hospitals, physicians and patients.
  • Our long-term growth depends on our ability to enhance our products, expand our indications and develop and commercialize additional products in a timely manner. If we cannot innovate, we may not be able to develop or exploit new products in time to remain competitive.
  • If we fail to manage our growth effectively, our business could be materially and adversely affected.
  • Our business plan relies on certain assumptions about the market for our products; however, the size and expected growth of our addressable market has not been established with precision and may be smaller than we estimate, and even if the addressable market is as large as we have estimated, we may not be able to capture additional market share.
  • We operate in a very competitive business environment, and if we are unable to compete successfully against our existing or potential competitors, our business, financial condition and results of operations may be adversely affected.
  • We may expend our limited resources to pursue a particular product or indication and fail to capitalize on product or indications that may be more profitable or for which there is a greater likelihood of success.
The other 62 risks
  • We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business. We may not be able to maintain adequate product liability insurance.
  • Industry trends have resulted in increased downward pricing pressure on medical services and products, which may affect our ability to sell our products at prices necessary to support our current business strategy.
  • Our employees and independent contractors, including independent sales representatives and any other consultants, any future service providers and other vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
  • Risks Related to Our Financial and Capital Requirements
  • Additional capital, if needed, may not be available on acceptable terms, if at all.
  • The terms of our loan agreements require us to meet certain operating and financial covenants and place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.
  • Risks Related to Administrative, Organizational and Commercial Operations and Growth
  • If hospitals, ambulatory surgery centers and other health care facilities do not approve the use of our products, our sales may not increase.
  • If we fail to receive access to hospital facilities, our sales may decrease.
  • Performance issues, service interruptions or price increases by shipping carriers could adversely affect our business and harm our reputation and ability to provide our products on a timely basis.
  • If coverage or adequate levels of reimbursement from third-party payors for procedures using our products, or any future products we may seek to commercialize, are not obtained or maintained, foot and ankle specialists and patients may be reluctant to use our products and our business will suffer.
  • The majority of our sales force consists of independent sales representatives, and if we are unable to maintain and expand our network of independent sales representatives, we may be unable to generate anticipated sales.
  • We depend on third-party contract manufacturers and suppliers, some of which are single source, to produce and package all elements comprising our foot and ankle products, and if these suppliers and manufacturers fail to supply us, our products or their components or subcomponents in sufficient quantities or at all, it may have a material adverse effect on our business, financial condition, and results of operations.
  • Our results of operations will be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory.
  • We may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships with third-parties that may not result in the development of commercially viable products, product improvements or the generation of significant future revenues.
  • We may seek to grow our business through acquisitions or investments in new or complementary businesses, products or technologies, through the licensing of products or technologies from third-parties or other strategic alliances, and the failure to manage acquisitions, investments, licenses or other strategic alliances, or the failure to integrate them with our existing business, could have a material adverse effect on our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.
  • We may not be able to establish or strengthen our brand.
  • Our inability to maintain contractual relationships with health care professionals could have a negative impact on our research and development and medical education programs.
  • We may be unable to continue to successfully demonstrate to foot and ankle specialists or key opinion leaders the merits of our products and technologies compared to those of our competitors, which may make it difficult to establish our products and technologies as a standard of care and achieve market acceptance.
  • If foot and ankle specialists fail to safely and appropriately use our products, or if we are unable to train podiatrists and orthopedic surgeons on the safe and appropriate use of our products, we may be unable to achieve our expected sales, growth or profitability.
  • The loss of any member on our executive management team or our inability to attract and retain highly skilled members of our sales management and marketing teams and engineers could have a material adverse effect on our business, financial condition and results of operations.
  • Risks Related to Our Intellectual Property
  • If we or our licensors are unable to obtain and maintain significant patent or other intellectual property protection for our products, or if the scope of our patents and other intellectual property rights is not sufficiently broad and does not adequately protect our products, our competitors could develop and commercialize products similar or identical to ours and we may be unable to gain significant market share and be unable to operate our business profitably.
  • Obtaining and maintaining intellectual property protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental agencies, and our intellectual property protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
  • We are dependent on patents and other intellectual property licensed from others and may become dependent on other patents or other intellectual property licensed from others in the future. If we lose our licenses for intellectual property that is important to our business, we may not be able to continue developing or selling our products.
  • We have previously been party to lawsuits involving patents and other intellectual property and the possibility exists that we may in the future be party to other lawsuits or administrative proceedings involving patents or other intellectual property. If we were to lose any intellectual property lawsuits, a court could require us to pay significant damages and/or prevent us from selling our products.
  • If we fail to execute invention assignment agreements with our employees and contractors involved in the development of intellectual property or are unable to protect the confidentiality of our trade secrets, the value of our products and our business and competitive position could be harmed.
  • If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our competitive position may be harmed.
  • Patent terms may not be sufficient to effectively protect our products and business for an adequate period of time.
  • Changes in U.S. or foreign patent laws or their interpretation may limit our ability to obtain, maintain, defend and/or enforce our patents.
  • We have limited foreign intellectual property rights and may be unable to enforce our intellectual property rights throughout the world.
  • We are and in the future may be subject to claims that we or our employees have misappropriated the intellectual property of a third-party, including trade secrets or know-how, or are in breach of non-competition or non-solicitation agreements with our competitors and third-parties may claim an ownership interest in intellectual property that we regard as our own.
  • If our third-party manufacturing partners do not respect our intellectual property and trade secrets and produce competitive products using our designs or intellectual property, our business, financial condition and results of operations would be harmed.
  • Risks Related to Regulatory Matters
  • We are subject to substantial government regulation that could have a material adverse effect on our business.
  • Our relationships with customers, physicians and third-party payors are subject to federal, state, and foreign health care fraud and abuse laws, false claims laws, physician payment transparency laws and other health care laws and regulations. If we or our employees, independent contractors, consultants, commercial partners, or vendors violate these laws, we could face substantial penalties.
  • We may not receive, or may be delayed in receiving, the necessary clearances, approvals or certifications for our future products or modifications to our current products, and failure to timely obtain necessary clearances, approvals or certifications for our future products or modifications to our current products would adversely affect our ability to grow our business.
  • Modifications to our marketed medical device products may require new 510(k) clearances, PMAs, or certifications or may require us to cease marketing or recall the modified products until clearances, approvals or certifications are obtained.
  • Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market.
  • Legislative or regulatory reforms may have a material adverse effect on us.
  • Our products must be manufactured in accordance with federal and state quality regulations and are subject to FDA and foreign inspection, and our failure to comply with these regulations could result in fines, product recalls, product liability claims, limits on future product clearances, reputational damage and other adverse impacts.
  • The misuse or off-label use of our products may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
  • Our medical device products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA or foreign regulatory authorities, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
  • Disruptions at the FDA, other government agencies and notified bodies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • The clinical study process is lengthy and expensive with uncertain outcomes, and the results of earlier studies may not be predictive of future clinical trial or clinical study results or provide favorable safety or efficacy data for our products.
  • If the third-parties on which we rely to conduct our clinical studies and to assist us with pre-clinical development do not perform as required or expected, we may not be able to obtain regulatory clearance, approval or certification for or commercialize our products.
  • Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations and financial condition.
  • Risks Related to Ownership of Our Common Stock
  • The market price of our common stock may fluctuate substantially or may decline regardless of our operating performance, which could result in the loss of part or all of your investment.
  • If our operating and financial performance in any given period does not meet any guidance that we provide to the public, the market price of our common stock may decline.
  • If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors’ views of us and, as a result, the value of our common stock.
  • If securities analysts do not publish research or reports about our business or if they publish negative or inaccurate research about our business, our common stock price and trading volume could decline.
  • We have not paid dividends in the past and do not expect to pay dividends in the future, and, as a result, any return on investment may be limited to the appreciation in the price of our stock.
  • Future sales and issuances of our capital stock or rights to purchase capital stock could result in additional dilution of the percentage ownership of our stockholders and could cause the price of our common stock to decline.
  • Insiders have substantial influence over us, which could limit your ability to affect the outcome of key transactions, including a change of control.
  • Anti-takeover provisions in our amended and restated certificate of incorporation, as amended and second amended and restated bylaws, and Delaware law, could discourage a change in control of our company or a change in our management.
  • Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
  • Our Certificate of Incorporation and second amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ abilities to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • General Risk Factors
  • Unfavorable global and regional economic, political and health conditions could adversely affect our business, financial condition or results of operations.
  • Our operations are vulnerable to interruption or loss due to natural or other disasters, power loss, strikes and other events beyond our control.
  • We are subject to U.S. anti-bribery, anti-corruption, and anti-money laundering laws, including the U.S. Foreign Corrupt Practices Act, as well as export control, customs laws sanctions and other trade laws and regulations (collectively, the Trade Laws). We can face serious consequences for violations.
  • We, along with our suppliers, are dependent on various information technology systems, and failures of, interruptions to, or unauthorized tampering of those systems could have a material adverse effect on our business.
  • Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.
  • Our results may be impacted by changes in foreign currency exchange rates.
  • Governmental export or import controls could limit our ability to compete in foreign markets and subject us to liability if we violate them.
  • Changes in tax laws or regulations that are applied adversely to us or our customers may seriously harm our business.

Legal proceedings

The Company may in the ordinary course of business face various claims brought by third-parties and the Company may, from time to time, make claims or take legal actions to assert its rights, including intellectual property rights as well as claims relating to employment matters and the safety or efficacy of its products. Any of these claims could cause the Company to incur substantial costs and, while the Company generally believes that it has adequate insurance to cover many different types of liabilities, its insurance carriers may deny coverage, may be inadequately capitalized to pay on valid claims, or the Company’s policy limits may be inadequate to fully satisfy any associated costs, damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the Company’s operations, cash flows and financial position. Additionally, any such claims, whether or not successful, could damage the Company’s reputation and business.

Class Action Litigation

On September 30, 2024, and October 18, 2024, respectively, two putative class action complaints were filed in the U.S. District Court for the District of Colorado. These complaints allege that the Company and certain current and former officers violated federal securities laws. The cases are captioned Ellington v. Paragon 28, Inc., et al., and Tiedt v. Paragon 28, Inc., et al., and a lead plaintiff has not yet been appointed. We believe the allegations in the complaint are without merit and intend to vigorously defend the litigation.

The opening of Item 3, Legal Proceedings.5

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