Overview
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- TickerVJET on NYSE1
- IndustrySurgical & Medical Instruments & Apparatus1
- HeadquartersFort Mill, South Carolina1
- Incorporated inDE2
- Business address1670 Highway 160 West, Suite 205, Fort Mill, Sc 297082
- Filer categoryNon-accelerated filer, Smaller reporting company2
- Legal formCorporation
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The registrant (together with our consolidated operating subsidiary, the “Company” or “Catheter”) was incorporated under the name “Ra Medical Systems, Inc.” as a Delaware corporation in July 2018. A predecessor had been incorporated in California in September of 2002, but was reincorporated in 2018 in connection with our initial public offering. The Company was initially formed to develop, commercialize and market an excimer laser-based platform for use in the treatment of vascular and dermatological immune-mediated inflammatory diseases, including the DABRA product line.4 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 2025
92.3%Gross margin5
-2581.6%Operating margin5
-2098.0%Net margin5
95.0%Revenue growth, 20255
-243.6%Return on equity5
0.44×Debt to equity5
-$8.3MFree cash flow5
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Cost of revenue0¢$63.0K
- Selling, general and admin87¢$12.1M
- Income tax13¢$1.8M
Out of $819.0K in revenue.5 The company lost money this year.
Financial statements
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Revenue | $7.2M6 | $259.0K7 | $22.0K8 | $14.0K8 | $442.0K9 | $420.0K5 | $819.0K5 |
| Cost of revenue | $8.8M6 | $5.5M6 | $1.6M8 | $161.0K10 | $30.0K10 | $42.0K5 | $63.0K5 |
| Gross profit | -$1.7M6 | -$1.9M7 | -$1.5M8 | -$147.0K10 | $412.0K9 | $378.0K5 | $756.0K5 |
| Research and development | $4.5M6 | $9.0M7 | $12.3M8 | $6.4M10 | $475.0K9 | $272.0K9 | |
| Selling, general and admin | $51.5M6 | $24.5M7 | $15.5M8 | $16.2M10 | $17.1M9 | $11.3M5 | $12.1M5 |
| Operating expenses | $27.7M8 | $26.8M10 | $78.5M9 | $11.6M5 | $21.9M5 | ||
| Operating income | -$57.7M6 | -$35.4M7 | -$29.3M8 | -$27.0M10 | -$78.1M9 | -$11.2M5 | -$21.1M5 |
| Interest | $250.0K6 | $108.0K6 | |||||
| Income before tax | -$27.3M8 | -$26.9M10 | -$70.6M9 | -$13.5M5 | -$19.5M5 | ||
| Income tax | $15.0K6 | $7.0K7 | $4.0K8 | $3.0K10 | $09 | $3.1M5 | -$1.8M5 |
| Net income | -$57.0M6 | -$36.0M7 | -$25.1M8 | -$26.9M10 | -$70.6M9 | -$16.6M5 | -$17.2M5 |
| Earnings per share | -$248.228 | -$25.988 | -$129.889 | -$126.915 | -$15.905 | ||
| Earnings per share (diluted) | -$248.228 | -$25.988 | |||||
| Shares (weighted, basic) | 101.0K shares8 | 1.0M shares8 | 549.5K shares9 | 171.8K shares5 | 1.1M shares5 | ||
| Shares (weighted, diluted) | 101.0K shares8 | 1.0M shares8 |
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Cash | $14.6M6 | $23.9M7 | $15.0M8 | $15.9M8 | $3.6M9 | $2.9M5 | $88.0K5 |
| Receivables | $21.0K8 | $010 | $137.0K9 | $70.0K5 | $155.0K5 | ||
| Inventory | $986.0K8 | $010 | $44.0K9 | $33.0K5 | $86.0K5 | ||
| Current assets | $36.0M6 | $27.6M7 | $17.1M8 | $16.8M10 | $4.2M9 | $3.3M5 | $390.0K5 |
| Property, plant and equipment | $1.8M8 | $010 | $70.0K9 | $91.0K5 | $64.0K5 | ||
| Goodwill | $010 | $09 | |||||
| Intangible assets | $010 | $26.3M9 | $24.3M5 | $15.2M5 | |||
| Total assets | $44.1M6 | $33.4M7 | $21.0M8 | $16.8M10 | $30.7M9 | $27.8M5 | $15.9M5 |
| Accounts payable | $988.0K8 | $92.0K10 | $464.0K9 | $230.0K5 | $1.5M5 | ||
| Current liabilities | $6.8M6 | $7.8M7 | $5.4M8 | $7.6M10 | $2.5M9 | $2.2M5 | $3.9M5 |
| Long-term debt | $558.0K13 | $3.1M5 | |||||
| Total liabilities | $10.9M6 | $12.3M7 | $7.4M8 | $7.6M10 | $9.5M9 | $16.0M5 | $9.2M5 |
| Retained earnings | -$178.3M8 | -$205.1M10 | -$275.7M9 | -$292.4M5 | -$309.5M5 | ||
| Shareholders’ equity | $33.1M7 | $21.1M8 | $13.7M10 | $9.3M9 | $21.2M9 | $11.8M5 | $7.1M5 |
| Shares outstanding | 550.8K shares6 | 3.2K shares7 | 140.0K shares8 | 2.2M shares10 | 702.7K shares9 | 421.3K shares5 | 1.7M shares5 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Cash from operations | -$33.2M6 | -$28.3M7 | -$27.6M8 | -$22.6M10 | -$20.6M9 | -$9.3M5 | -$8.3M5 |
| Depreciation and amortization | $1.6M8 | $421.0K10 | $2.1M9 | $2.1M5 | $2.1M5 | ||
| Stock-based compensation | $2.2M8 | $447.0K10 | $1.2M9 | $54.0K5 | $338.0K5 | ||
| Capital spending | $268.0K6 | $67.0K7 | $265.0K8 | $17.0K10 | $76.0K9 | $67.0K5 | $17.0K5 |
| Free cash flow | -$33.4M | -$28.4M | -$27.9M | -$22.6M | -$20.7M | -$9.3M | -$8.3M |
| Cash from investing | $3.8M8 | $21.0K10 | -$61.0K9 | -$67.0K5 | $167.0K5 | ||
| Cash from financing | $15.0M8 | $23.4M10 | $8.4M9 | $8.6M5 | $5.3M5 |
Corporate structure
Flyte Aviation, Inc. sits at the top of its group. 5 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Flyte Aviation, Inc.
- C/M CAPITAL PARTNERS, LP Filed SCHEDULE 13G on Flyte Aviation, Inc., latest Aug 21, 2026 (3 filings since Feb 13, 2026)
- SEG JETS SPV I, LLC Filed SCHEDULE 13G on Flyte Aviation, Inc., latest Jul 20, 2026
- Gregory Castaldo Filed SCHEDULE 13G on Flyte Aviation, Inc., latest Feb 11, 2026
- Joseph Reda Filed SCHEDULE 13G on Flyte Aviation, Inc., latest Feb 11, 2026
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on Flyte Aviation, Inc., latest Aug 14, 2025 (5 filings since Feb 14, 2024)
- David A. Jenkins Filed SCHEDULE 13D/A on Flyte Aviation, Inc., latest Feb 3, 2025 (3 filings since Mar 29, 2023)
- Casey A. Jenkins Filed SCHEDULE 13D/A on Flyte Aviation, Inc., latest Jan 3, 2025 (2 filings since Sep 9, 2024)
- INTRACOASTAL CAPITAL, LLC Filed SC 13G/A on Flyte Aviation, Inc., latest Nov 13, 2024 (2 filings since Sep 12, 2024)
- Family Charitable Institute Jenkins Filed SC 13D/A on Flyte Aviation, Inc., latest Oct 30, 2024
- R. Randall Rollins Voting Trust U/A dated August 25, 1994 Filed SC 13G on Flyte Aviation, Inc., latest Mar 31, 2023
- Laurence W. Lytton Filed SC 13G/A on Flyte Aviation, Inc., latest Feb 15, 2022
- Flyte Aviation, Inc. Fort Mill, South Carolina
- Volato Group, Inc. Stake · North Canton, Ohio
- Cardionomix, Inc. Subsidiary · Nevada, United States
- Catheter Precision, LLC Subsidiary · Delaware, United States
- KardioNav, Inc. Subsidiary · Nevada, United States
Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G; stakes of 5% or more it reported on Schedules 13D and 13G (1 companies). Each entity in the chart links to its source.
What it owns
What Flyte Aviation, 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
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $233.0K5 Dec 31, 2025 | $188.0K5 Dec 31, 2024 | +23.9% |
| Accumulated depreciation | $169.0K5 Dec 31, 2025 | $97.0K5 Dec 31, 2024 | +74.2% |
| Property and equipment, net | $64.0K5 Dec 31, 2025 | $91.0K5 Dec 31, 2024 | −29.7% |
| Operating-lease assets (leased space) | $162.0K5 Dec 31, 2025 | $105.0K5 Dec 31, 2024 | +54.3% |
Investments
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Finite-lived intangibles, gross | $19.4M5 Dec 31, 2025 | $28.4M5 Dec 31, 2024 | −31.5% |
| Accumulated amortization | $4.2M5 Dec 31, 2025 | $4.1M5 Dec 31, 2024 | +2.5% |
| Finite-lived intangibles, net | $15.2M5 Dec 31, 2025 | $24.3M5 Dec 31, 2024 | −37.2% |
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $86.0K5 Dec 31, 2025 | $33.0K5 Dec 31, 2024 | +160.6% |
| Raw materials | $37.0K5 Dec 31, 2025 | $18.0K5 Dec 31, 2024 | +105.6% |
| Finished goods | $49.0K5 Dec 31, 2025 | $15.0K5 Dec 31, 2024 | +226.7% |
Properties, in its own words
Our manufacturing, inventory and order fulfillment activities for VIVO are performed in our approximate 2,000 square foot headquarters facility in Fort Mill, South Carolina under a lease that expires in January 2029. We conduct administrative and accounting activities in an approximate 1,100 square foot facility in Augusta, New Jersey under a lease that expires in December 2027. Administrative activities are also conducted in an approximate 1,200 square foot facility in Park City, Utah under a lease that expires in April 2026.
We believe that our existing facilities are sufficient to meet our current needs and that suitable additional space will be available as and when needed.
Item 2 of the 10-K filed Mar 31, 2026.4
Leadership
Who has led Flyte Aviation, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
20202025
- Chief executive officerJonathan Will McGuire Apr 1, 2020 to Mar 15, 202314
- Chief executive officerAndrew C. Jackson Dec 5, 2019 to Dec 26, 201915
- PresidentJeffrey J. Kraws Sep 26, 2018 to Nov 24, 202016
- Chief financial officerPhilip J. Anderson Jan 13, 2025 to now17
- Chief financial officerMargrit Thomassen Jan 8, 2024 to Jan 10, 202418
- Chief financial officerSteven K. Passey Apr 11, 2023 to Apr 11, 202319
- Chief financial officerBrian Conn Jul 21, 2022 to Jul 21, 202220
- Chief financial officerAndrew C. Jackson Sep 26, 2018 to May 24, 202221
Board members and other officers (17)
- Chief Commercial OfficerMarie-Claude Jacques May 3, 2024 to now22
- OfficerDean Irwin Sep 26, 2018 to Jul 22, 201923
- Executive Vice PresidentMelissa Burstein Sep 26, 2018 to Sep 26, 201824
- OfficerThomas G. Fogarty Dec 20, 2018 to May 20, 201925
- Board memberJohn P. Francis Jan 10, 2024 to Jan 10, 202426
- Board memberAndrew Arno Nov 8, 2024 to now27
- Board memberSusanne Meline Feb 5, 2021 to Mar 27, 202328
- Board memberJonathan Will McGuire Apr 1, 2020 to Mar 15, 202314
- Board memberJoan Stafslien Apr 29, 2020 to Jun 8, 202129
- Board memberDean Irwin Sep 26, 2018 to Jul 22, 201923
- Board memberMark E. Saad Sep 26, 2018 to Jan 7, 202130
- Board memberMartin J. Colombatto Sep 26, 2018 to now31
- Board memberMaurice Buchbinder Sep 26, 2018 to Jun 7, 201932
- Board memberMelissa Burstein Sep 26, 2018 to Sep 26, 201824
- Board memberRichard Mejia Jr. Sep 26, 2018 to Jun 8, 202133
- Board memberWilliam R. Enquist Sep 26, 2018 to Jun 8, 202134
- General counselDaniel Horwood Oct 24, 2018 to Nov 24, 202035
Named in SEC Form D filings
People the company listed in its private-offering notices.
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Former names
Timeline
- Oct 14, 20268-K Regulation FD disclosure38
- Oct 13, 20268-K Results of operations39
- Oct 9, 20268-K Unregistered sale of shares; Other events40
- Oct 5, 20268-K Regulation FD disclosure; Other events41
- Oct 2, 20268-K Change to shareholders' rights; Executive or director change; Bylaws or fiscal year changed42
- Sep 25, 20268-K Other events43
- Jul 31, 20268-K Unregistered sale of shares; Change to shareholders' rights; Bylaws or fiscal year changed44
- Jul 29, 20268-K Financial statements and exhibits45
- Jul 15, 20268-K Unregistered sale of shares; Change to shareholders' rights; Bylaws or fiscal year changed46
- Jun 8, 20268-K Entered a material agreement47
- May 18, 20268-K Results of operations48
- Apr 23, 20268-K Unregistered sale of shares; Change to shareholders' rights; Bylaws or fiscal year changed49
- Apr 1, 2020New chief executive Jonathan Will McGuire becomes CEO14
- Dec 5, 2019New chief executive Andrew C. Jackson becomes CEO15
Calendar
Coming up
- Nov 12, 2026Reports results for the quarter ending Sep/202650
When it reported results
- Oct 13, 2026Reported quarterly or annual results39
- May 18, 2026Reported quarterly or annual results48
- Mar 31, 2026Reported quarterly or annual results51
- Nov 14, 2025Reported quarterly or annual results52
- Aug 11, 2025Reported quarterly or annual results53
- May 19, 2025Reported quarterly or annual results54
- Apr 23, 2025Reported quarterly or annual results55
- Apr 1, 2025Reported quarterly or annual results56
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
354 filings to the SEC since October 2021: 8 annual reports, 15 quarterly reports, 116 major events, 47 insider forms, 21 large holders, 2 private raises, 145 other. The latest 20:
- Oct 14, 20268-K EDGAR
- Oct 13, 20268-K EDGAR
- Oct 9, 20268-K EDGAR
- Oct 5, 20268-K EDGAR
- Oct 2, 20268-K EDGAR
- Sep 25, 20268-K EDGAR
- Aug 31, 2026DEF 14A EDGAR
- Aug 21, 2026424B3 EDGAR
- Aug 21, 2026PRE 14A EDGAR
- Aug 21, 2026SCHEDULE 13G EDGAR
- Aug 14, 202610-Q EDGAR
- Jul 31, 20268-K EDGAR
- Jul 29, 20268-K/A EDGAR
- Jul 20, 2026SCHEDULE 13G EDGAR
- Jul 15, 20268-K EDGAR
- Jul 10, 2026EFFECT EDGAR
- Jul 10, 2026424B3 EDGAR
- Jul 6, 2026S-1/A EDGAR
- Jun 22, 2026S-1 EDGAR
- Jun 8, 20268-K EDGAR
The 354 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
8 open-market trades by officers, directors and large owners since October 2021: 5 buys and 3 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jan 29, 2025 | COLOMBATTO MARTIN JDirector | Sale | 3 | $0.40 | $1 | Form 4 |
| Jan 23, 2024 | JENKINS DAVID AChairman of the Board and CEO | Buy | 9,528 | $0.60 | $5.7K | Form 4 |
| Jan 22, 2024 | JENKINS DAVID AChairman of the Board and CEO | Buy | 9,528 | $0.43 | $4.1K | Form 4 |
| Jan 19, 2024 | JENKINS DAVID AChairman of the Board and CEO | Buy | 8,470 | $0.42 | $3.6K | Form 4 |
| Jan 18, 2024 | JENKINS DAVID AChairman of the Board and CEO | Buy | 8,470 | $0.41 | $3.5K | Form 4 |
| Jan 16, 2024 | JENKINS DAVID AChairman of the Board and CEO | Buy | 16,263 | $0.39 | $6.3K | Form 4 |
| Nov 22, 2021 | Jackson Andrew C.CFO | Sale | 2,684 | $2.62 | $7.0K | Form 4 |
| Nov 22, 2021 | McGuire Jonathan WillCEO & Secretary | Sale | 8,149 | $2.62 | $21.4K | Form 4 |
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.
- C/M CAPITAL PARTNERS, LPSCHEDULE 13G, 3 filings Feb 13, 2026 to Aug 21, 202657
- SEG JETS SPV I, LLCSCHEDULE 13G, 1 filing Jul 20, 202658
- Gregory CastaldoSCHEDULE 13G, 1 filing Feb 11, 202659
- Joseph RedaSCHEDULE 13G, 1 filing Feb 11, 202660
- ARMISTICE CAPITAL, LLCSCHEDULE 13G/A, 5 filings Feb 14, 2024 to Aug 14, 202561
- David A. JenkinsSCHEDULE 13D/A, 3 filings Mar 29, 2023 to Feb 3, 202562
- Casey A. JenkinsSCHEDULE 13D/A, 2 filings Sep 9, 2024 to Jan 3, 202563
- INTRACOASTAL CAPITAL, LLCSC 13G/A, 2 filings Sep 12, 2024 to Nov 13, 202464
- Family Charitable Institute JenkinsSC 13D/A, 1 filing Oct 30, 202465
- R. Randall Rollins Voting Trust U/A dated August 25, 1994SC 13G, 1 filing Mar 31, 202366
- Laurence W. LyttonSC 13G/A, 1 filing Feb 15, 202267
Stakes it holds
Flyte Aviation, Inc. has told the SEC it owns more than 5% of 1 company, latest first (Schedules 13D and 13G).
- Volato Group, Inc.SCHEDULE 13G Jun 26, 202668
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | David A. Jenkins | 68 | $300.0K | $519.2K69 |
| 2025 | Philip AndersonCFO | 59 | $197.8K | $406.3K69 |
| 2025 | Marie-Claude Jacques | $200.0K | $241.8K69 | |
| 2025 | Margrit Thomassen | $150.0K | $173.8K69 | |
| 2024 | Former CCO | $266.7K | $397.3K69 | |
| 2024 | Executive Chairman and CEO | $300.0K69 |
Money raised
Private offerings the company reported to the SEC on Form D.
SEC filer profile
How Flyte Aviation, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARFlyte Aviation, Inc.1
- CIK0001716621
- Employer ID (EIN)38-36618264
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- 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 address1670 Highway 160 West, Suite 205, Fort Mill, SC 297081
- Phone973-691-20001
- Shares outstanding14,391,944 as of Aug 10, 202612
- Public float$3.9M as of Jun 30, 20254
- AuditorWithumSmith+Brown, PC, East Brunswick, New Jersey PCAOB ID 100; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceSep 20, 20171
- Filings602 in all: 8-K (155), 4 (111), DEFA14A (34), 3 (26), CORRESP (25), 10-Q (24), UPLOAD (19), EFFECT (17)1
All 47 form types
DEF 14A (13), S-1/A (13), SC 13G (13), S-8 (11), 425 (10), PRE 14A (10), SC 13G/A (10), 424B3 (9), 8-K/A (9), 10-K (8), S-1 (7), S-3 (7), FWP (6), NT 10-Q (6), SCHEDULE 13G (6), D (5), 10-K/A (4), 424B5 (4), SCHEDULE 13G/A (4), 424B4 (3), ARS (3), POS AM (3), S-1MEF (3), SC 13D (3), 424B1 (2), 8-A12B (2), CERT (2), SC 13D/A (2), SCHEDULE 13D/A (2), SD (2), 10-Q/A (1), 25 (1), D/A (1), DRS (1), DRS/A (1), DRSLTR (1), PREM14A (1), PRER14A (1), S-3/A (1)
- Latest filingsAnnual report (10-K) Mar 31, 2026
Quarterly report (10-Q) Aug 14, 2026
Proxy statement (DEF 14A) Aug 31, 2026
Latest 8-K (8-K) Oct 14, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.0001 par value | VTAK | NYSE American |
From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Flyte Aviation, Inc. names in Item 1A of its 10-K filed Mar 31, 2026: 51 risks under these headings, as written.4
- Risks Related to Our Financial Position and Need for Additional Capital
- We will be required to raise additional funds to finance our operations and continue as a going concern; We may not be able to do so when necessary, and/or the terms of any financings may not be advantageous to us.
- Our business has a history of losses and will incur additional losses, and we may never achieve profitability.
- Risks Related to Our Internal Controls
- Compliance with Section 404 of the Sarbanes-Oxley Act could have a material adverse impact on our business.
- Risks Related to Our Business and Products
- We will not be able to reach profitability unless we are able to achieve our product expansion and growth goals.
- Our research and development and commercialization efforts may depend on entering into agreements with corporate collaborators.
- Economic uncertainty or downturns, and related tariffs, particularly as they impact particular industries, could adversely affect our business and results of operations.
- Artificial intelligence-based platforms may present new risks and challenges to our business.
- We have previously entered into joint marketing agreements with respect to our products and may enter into additional joint marketing agreements that will reduce our revenues from product sales.
- Royalty agreements with respect to LockeT, our surgical vessel closing pressure device, will reduce any future profits from this product.
The other 42 risks
- If we experience significant disruptions in our information technology systems, our business may be adversely affected.
- The rate of technological innovation of our products might not keep pace with the rest of the market.
- Litigation and other legal proceedings may adversely affect our business.
- If we make acquisitions or divestitures, we could encounter difficulties that harm our business.
- Failure to attract and retain sufficient qualified personnel could also impede our growth.
- Our revenues may depend on our customers’ receipt of adequate reimbursement from private insurers and government sponsored healthcare programs.
- We may be unable to compete successfully with companies in our highly competitive industry, many of whom have substantially greater resources than we do.
- Our future operating results depend upon our ability to obtain components in sufficient quantities on commercially reasonable terms or according to schedules, prices, quality and volumes that are acceptable to us, and suppliers may fail to deliver components, or we may be unable to manage these components effectively or obtain these components on such terms.
- If hospitals, physicians and patients do not accept our current and future products or if the market for indications for which any product candidate is approved is smaller than expected, we may be unable to generate significant revenue, if any.
- A variety of risks associated with marketing our products internationally could materially adversely affect our business.
- The impact of the ongoing Russia-Ukraine, Israel-Gaza and Iran military conflicts, and other actions that have been and could be taken by other countries, including new and stricter sanctions and actions taken in response to such sanctions, have affected, and may continue to affect, our business and results of operations, including our supply chain.
- If the third parties on which we rely for the conduct of our clinical trials and results do not perform our clinical trial activities in accordance with good clinical practices and related regulatory requirements, we may be unable to obtain regulatory approval for or commercialize our product candidates.
- We may be adversely affected by product liability claims, unfavorable court decisions or legal settlements.
- Our ability to use our net operating loss carryforwards may be limited.
- Risks Related to Governmental Regulation and our Industry
- We are subject to pervasive and continuing regulation by the FDA and other regulatory agencies.
- Product clearances and approvals can often be denied or significantly delayed.
- Although we have obtained regulatory clearance for our VIVO and LockeT products in the U.S. and certain non-U.S. jurisdictions, our business plans include expanding uses for our products, which will require additional clearances; and even after clearance is obtained, our products will remain subject to extensive regulatory scrutiny.
- Our products may be subject to additional recalls, revocations or suspensions after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation, and adversely affect our business.
- If we or our suppliers fail to comply with the FDA’s Quality System Regulation, or QSR, or any applicable state equivalent, our operations could be interrupted, and our potential product sales and operating results could suffer.
- If any of our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be required to report under applicable medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.
- Healthcare reform initiatives and other administrative and legislative proposals may adversely affect our business, financial condition, results of operations and cash flows in our key markets.
- Healthcare cost containment pressures and legislative or administrative reforms resulting in restrictive coverage and reimbursement practices of third-party payors could decrease the demand for our products and the number of procedures performed using our devices, which could have an adverse effect on our business.
- We are regulated by federal Anti-Kickback Statutes.
- We are regulated by the federal Stark Law.
- We must comply with Health Information Privacy and Security Standards.
- If a breach of our measures protecting personal data covered by HIPAA, as amended by the HITECH Act, occurs, we may incur significant liabilities.
- A cyber security incident could cause a violation of HIPAA and/or state consumer privacy laws, breach of customer and patient privacy, or other negative impacts.
- We must comply with environmental and Occupational Safety and Health Administration Regulations.
- We must comply with a range of other Federal and State Healthcare Laws.
- 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 trade policies among the U.S. and other countries, in particular the imposition of new or higher tariffs, could place pressure on our average selling prices as our customers seek to offset the impact of increased tariffs on their own products. Increased tariffs or the imposition of other barriers to international trade could have a material adverse effect on our revenues and operating results.
- Risks Related to our Intellectual Property
- If we are unable to obtain and maintain patent protection for our products, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our existing products and any products we may develop, and our technology may be adversely affected.
- We may not be able to protect our intellectual property and proprietary rights throughout the world.
- Third parties may assert that we are infringing their intellectual property rights, and any defense of such assertions may be unsuccessful and expensive, even if we are successful.
- Expensive intellectual property litigation is frequent in the medical device industry and may cause to incur substantial expenses to defend.
- Risks Related to Ownership of Our Common Stock
- The price of our stock has been and may continue to be volatile, which could result in substantial losses for investors. Further, an active, liquid and orderly trading market for our common stock may not be sustained and we do not know what the market price of our common stock will be, and as a result it may be difficult for you to sell your shares of our common stock.
- We are a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to smaller reporting companies will make our common stock less attractive to investors.
- Future sales and issuances of a substantial number of shares of our common stock or rights to purchase common stock by our stockholders in the public market could result in additional dilution of the percentage ownership of our stockholders and cause our stock price to fall.
- Anti- takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove members of our board of directors or our current management and may adversely affect the market price of our common stock.
- Our certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the U.S. are the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- We are subject to the continued listing requirements of the NYSE American. If we are unable to comply with such requirements, our common stock would be delisted from the NYSE American, which would limit investors’ ability to effect transactions in our common stock and subject us to additional trading restrictions.
- We have not paid dividends in the past and have no immediate plans to pay dividends.
Legal proceedings
In the normal course of business, we are at times subject to pending and threatened legal actions. In management’s opinion, any potential loss resulting from the resolution of these matters will not have a material effect on our results of operations, financial position or cash flows.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 16SEC EDGARJeffrey J. Kraws, President
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- 20SEC EDGARBrian Conn, Chief financial officer
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- 23SEC EDGARDean Irwin, Officer
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- 25SEC EDGARThomas G. Fogarty, Officer
- 26SEC EDGARJohn P. Francis, Board member
- 27SEC EDGARAndrew Arno, Board member
- 28SEC EDGARSusanne Meline, Board member
- 29SEC EDGARJoan Stafslien, Board member
- 30SEC EDGARMark E. Saad, Board member
- 31SEC EDGARMartin J. Colombatto, Board member
- 32SEC EDGARMaurice Buchbinder, Board member
- 33SEC EDGARRichard Mejia Jr., Board member
- 34SEC EDGARWilliam R. Enquist, Board member
- 35SEC EDGARDaniel Horwood, General counsel
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- 38SEC EDGARRegulation FD disclosure
- 39SEC EDGARResults of operations
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- 43SEC EDGAROther events
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- 45SEC EDGARFinancial statements and exhibits
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- 47SEC EDGAREntered a material agreement
- 48SEC EDGARResults of operations
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- 50NasdaqNasdaq calendar
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