Dental $8.79M and Medical $0.18M. The Q2 2026 10-Q calls Dental the company’s primary source of revenue and Medical a strategic growth area; Medical was about 2% of FY2025 product sales (183,250 / 8,973,982). Product sales were $8.63M in FY2024.
10-K, acc. 0001493152-26-014117
NYSE American: MLSS · Roseland, New Jersey
Computer-controlled injections, from the dental chair to the epidural space.
Milestone Scientific develops and sells computer-controlled drug delivery systems built on its DPS Dynamic Pressure Sensing technology, which controls flow rate and measures pressure at the needle tip in real time. Dental handpieces and instruments carry the revenue. The latest filings disclose substantial doubt about the company’s ability to continue as a going concern.
- Product sales, FY ended Dec 31, 2025$9.0M
- Cash, Jun 30, 2026$2.1M
- Going concernDoubt disclosed
MedicalCompuFlo® Epidural System
DentalSTA® Single Tooth Anesthesia
Snapshot
The record, in filed numbers
Every figure here cites its filing. Periods are labelled by the date they end.
Against ($4.7M) in 2024, which included a $1.98M gain on the sale of net operating losses.
10-K, acc. 0001493152-26-014117After the April 2026 private placement.
10-Q, acc. 0001493152-26-03776188,739,185 as of Aug 11, 2026, from the 10-Q cover. Warrants and unconverted notes are not included.
10-Q, acc. 0001493152-26-037761Given since STA’s introduction in early 2007, together with its predecessor C-CLAD devices, “globally” per Item 1. A company-reported figure, not audited.
10-K, acc. 0001493152-26-014117Company
What Milestone makes, and what it sells
Milestone Scientific was incorporated in Delaware in August 1989. In its 10-K it describes itself as developing and commercializing proprietary computer-controlled drug delivery systems designed to enhance the safety, precision and patient experience of subcutaneous injections and fluid aspiration.
It says it was the first company to commercialize a product designed to deliver a virtually painless subcutaneous injection, which it introduced in 1997. The company does not manufacture its own devices. A U.S. supplier, working on individual purchase orders, builds the Wand/STA instruments and the epidural devices, and a manufacturer in the People’s Republic of China supplies the dental handpieces.
…drug delivery procedures that currently rely upon the over 160-year-old hypodermic syringe technology and the tactile senses and delivery expertise of the administrator.
Dental segment
STA® Single Tooth Anesthesia System and CompuDent®
Both use The Wand®, a single-use disposable handpiece, to deliver local anesthetic in dental procedures. STA was commercially introduced in early 2007. Sold in the United States, Canada and over 33 other countries, per the Q2 2026 10-Q, which also calls Dental the company’s primary source of revenue.
FY2025 product sales: $8,790,732, or 98.0% of the total.
Medical segment
CompuFlo® Epidural Computer Controlled Anesthesia System
Shows the pressure at the needle tip in real time to help locate the epidural space in labor and delivery and back-pain procedures. FDA 510(k) clearance in 2017, expanded in 2023. The 10-K expects CompuFlo to generate substantially all medical revenue in the near term, and the Q2 2026 10-Q calls Medical a strategic growth area.
FY2025 product sales: $183,250, or 2.0% of the total.
Technology
A needle that reads pressure.
DPS Dynamic Pressure Sensing is the platform inside both product lines. In the company’s description, it controls the flow rate of an injection and measures the pressure at the needle tip while the injection is made.
Left to right: skin and soft tissue, the ligamentum flavum, then the epidural space. The trace stays low, rises through the ligamentum flavum, falls on entering the epidural space, then pulses.
Schematic of the principle, not measured data. No pressure values are implied. The 10-K says CompuFlo’s real-time pressure feedback helps identify and confirm placement in the epidural space; the company’s CompuFlo web page describes a pulsatile waveform on its display.
Controls the flow rate
Regulates how fast the drug leaves the syringe. The 10-K ties painless delivery to this control.
Measures pressure at the tip
Senses pressure in real time at the needle tip, so tissue type and target are read as the needle moves.
Feeds back and records
Gives visual and audible feedback and, per the 10-K, can provide a digital record of the time and volume injected.
Markets
How it is sold, and how CompuFlo gets paid for
No market-size estimate is shown: this page does not supply one.
United States $4,969,215 (55.4%), international excluding China $3,694,767 (41.2%) and China $310,000 (3.5%) of $8,973,982. Shares are derived from the filed figures and rounded.
In the U.S. the company sells STA directly to dental offices and groups through an online portal; e-commerce was 49% of net product sales in FY2025 and 60% in FY2024 (10-K), and 41% in the quarter ended Jun 30, 2026 against 53% a year earlier (10-Q). Abroad it has granted exclusive marketing and distribution rights for the Wand/STA system to select dental suppliers in certain regions of Asia, Africa, South America and Europe.
10-K, acc. 0001493152-26-01411710-Q, acc. 0001493152-26-037761- FDA 510(k) clearance for epidural injections in the lumbar region.
- AMA Category III CPT® code 0777T takes effect, assigned in 2022 for tracking and reimbursement submissions.
- Clearance expanded to the thoracic region, including the cervicothoracic junction.
- Medicare Administrative Contractors in Florida and other jurisdictions set Part B payment determinations for 0777T.
Medical product sales were $214,000 in the six months ended Jun 30, 2026, against $83,350 a year earlier.
10-Q, acc. 0001493152-26-037761Flow rate and exit pressure together
The company says it built the first subcutaneous delivery platform that regulates and monitors both in real time.
A patent estate
About 305 issued U.S. and foreign patents, with applications pending, per the 10-K.
A reimbursement code for CompuFlo
CPT 0777T is technology-specific. The company says a CPT code expands the potential for reimbursement of epidural procedures that use CompuFlo.
A direct dental channel
E-commerce sells STA and handpieces straight to U.S. dental offices; the model began on Jan 3, 2023.
Milestones
Since incorporation, to scale
Each marker sits where its year falls between 1989 and 2026. Every entry is from the company’s filings.
- 1989
Incorporated in Delaware in August.
10-K, Item 1 - 1997
Introduces a product designed to deliver a virtually painless subcutaneous injection; the 10-K says the company was the first to commercialize one.
10-K, Item 1 - 2007
The STA Single Tooth Anesthesia System is commercially introduced, in early 2007.
10-K, Item 1 - 2015
Common stock listed under the symbol MLSS on June 1 (NYSE American, per the 10-K).
10-K, Item 5 - 2017
CompuFlo receives its first FDA 510(k) clearance, for lumbar epidural injections.
10-K, Item 1 - 2023
CPT code 0777T takes effect on Jan 1; the 510(k) is expanded to the thoracic region.
10-K, Item 1 - 2024
Medicare Part B determinations for 0777T in Florida and other jurisdictions; Notices of Allowance in the U.S. and Europe for next-generation DPS technology.
10-K, Item 1 - 2026
April 20: private placement of 7,962,963 units at $0.27 closes, for gross proceeds of $2,150,000.
8-K, acc. 0001493152-26-018231
Financials
Revenue, losses and cash, as filed
Years ended December 31. Revenue for FY2017 to FY2025 carries one XBRL tag and FY2016 and earlier another; only FY2019 to FY2025 are shown.
RevenueNet loss
The last bar is the Jun 30, 2026 balance, after the April 2026 private placement.
| Year ended | Revenue | Net loss | Cash at year end | Filing |
|---|---|---|---|---|
| Dec 31, 2025 | $8,973,982 | ($5,722,216) | $1,112,642 | 10-K, acc. 0001493152-26-014117 |
| Dec 31, 2024 | $8,629,928 | ($4,713,597) | $3,258,058 | 10-K, acc. 0001493152-26-014117 |
| Dec 31, 2023 | $9,827,444 | ($6,929,104) | $2,977,713 | 10-K, acc. 0001437749-25-012050 |
| Dec 31, 2022 | $8,805,906 | ($8,706,131) | $8,715,279 | 10-K, acc. 0001437749-24-010029 |
| Dec 31, 2021 | $10,304,711 | ($6,818,317) | $14,764,346 | 10-K, acc. 0001437749-23-008658 |
| Dec 31, 2020 | $5,437,236 | ($7,337,273) | $14,223,917 | 10-K, acc. 0001437749-22-007873 |
| Dec 31, 2019 | $8,374,501 | ($7,524,368) | $1,516,272 | 10-K, acc. 0001437749-21-007838 |
FY2024 net loss includes a $1,983,095 gain on the sale of net operating losses. Each row links to the filing its figure was taken from; for earlier years that is a later 10-K carrying the figure as a comparative. Cash is cash and cash equivalents.
| Line | 2026 | 2025 |
|---|---|---|
| Product sales, net | $5,003,071 | $4,555,886 |
| Gross profit | $3,474,191 | $3,265,041 |
| Total operating expenses | $5,363,836 | $6,747,525 |
| Net loss | ($1,899,185) | ($3,477,696) |
| Net cash used in operating activities | ($498,285) | ($2,772,273) |
10-Q, acc. 0001493152-26-037761. The 10-Q attributes lower operating expenses mainly to lower consulting and professional service fees, research and development expenses, and quality and regulatory expenses.
Material disclosure
Going concern and NYSE American status
The first quotation below is the company’s own filed language. The rest summarises its filings and cites each one.
“The Company’s recurring losses from operations, negative cash flows, and accumulated deficit raise substantial doubt about its ability to continue as a going concern. The completion of the private placement in April 2026 has improved the Company’s liquidity position; however, the Company’s ability to continue as a going concern is dependent upon its ability to generate sufficient revenue, manage operating expenses, and, if necessary, obtain additional financing.”
- Losses since inception
- $135.7M
- Cash, Jun 30, 2026
- $2.1M
- Working capital, Jun 30, 2026
- about $3.7M
- Stockholders’ equity, Jun 30, 2026
- $3,470,877
Listing standards
On October 8, 2025 the company received a letter from NYSE American stating that it is not in compliance with Sections 1003(a)(ii) and 1003(a)(iii) of the Company Guide. Its Q2 2026 10-Q says these sections require minimum stockholders’ equity of $4 million and $6 million, respectively, for companies with sustained operating losses.
It submitted a plan of compliance. If it has not regained compliance by April 8, 2027, or does not make progress consistent with the plan, NYSE American will initiate delisting procedures as appropriate.
8-K, Item 3.01, acc. 0001493152-25-01791910-K, Item 1A, acc. 0001493152-26-01411710-Q, Part II Item 1A, acc. 0001493152-26-037761Financing and dilution
The April 20, 2026 private placement sold 7,962,963 units at $0.27, each one share and one three-year warrant exercisable at $0.3375. Gross proceeds were $2,150,000 ($1,799,000 in cash and $351,000 from converting bridge notes), with up to $2,687,500 more if every warrant is exercised.
On July 24, 2026 three directors gave notice to convert their remaining bridge notes ($465,982 of principal at Jun 30, 2026, per the 10-Q balance sheet). Under the 8-K, the conversions become effective automatically once the notes’ defined Fair Value of the common stock is not less than $0.50 per share and the holder may trade under the company’s insider trading policy; no shares had been issued when it was filed. The company’s Aug 26, 2026 release headline reports a debt-free balance sheet; that is a release, not a filing.
On Sep 8, 2026 the company filed a Form S-3 shelf registration statement. Its prospectus says the company may sell any combination of securities, in one or more offerings, up to a total aggregate offering price of $45,000,000. EDGAR lists an SEC notice of effectiveness on Sep 28, 2026.
8-K, Item 1.01, acc. 0001493152-26-0182318-K, Item 8.01, acc. 0001493152-26-03526410-Q, acc. 0001493152-26-037761S-3, acc. 0001493152-26-041795Other risks and changes in the filings
- The Wand/STA system and epidural devices are made by one U.S. supplier on individual purchase orders with no minimum volume; dental handpieces come from a manufacturer in the People’s Republic of China.
- Tariffs and trade measures involving China could raise costs the company may not be able to offset.
- The company has a history of net losses in every period since inception and says its operating losses are expected to continue.
- A change in auditor took effect May 15, 2026, from CBIZ CPAs P.C. to Grassi & Co., CPAs, P.C. (8-K, Item 4.01).
Filings and releases
What the company has put on record
2026
- SEC notice of effectivenessEFFECT
- Amendment to the shelf registration statementS-3/A
- Shelf registration statement, up to $45,000,000S-3
- Quarterly report, six months ended Jun 30, 202610-Q
- Annual meeting results; director committee roles8-K
- Three directors give notice to convert bridge notes8-K
- Quarterly report, three months ended Mar 31, 202610-Q
- Change in independent auditor8-K
- Private placement of 7,962,963 units at $0.278-K
- Annual report, year ended Dec 31, 202510-K
2025
Selected filings. EDGAR also lists, in 2026, a Form S-3 (Jun 2), a 424B1 prospectus (Jun 9), a 10-K/A (May 5) and a Form D (Apr 23).
All filings on SEC EDGAR
Recent releases, from the company’s investor page
Milestone Scientific Highlights Building a Scalable Growth Platform for CompuFlo® Medical Business
Milestone Scientific Announces Pain and Spine Specialists and Dr. Sudhir Rao as CompuFlo® Development Partner and Advisor
Milestone Scientific Achieves Debt-Free Balance Sheet Through Debt-to-Equity Conversion by Three Directors
Headlines as shown on the company’s page on Oct 1, 2026. These releases are not filings and were not checked against one.
Company press releasesInvestor relations
Contact and alerts
Details as published on the company’s investor page. This concept page does not collect or store email.
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