Milestone Scient Stock Price, News & Analysis

Milestone Scientific Inc. (NYSE: MLSS) reported financial results for Q2 2024 and provided a business update. Key highlights include:

1. Secured Medicare price assignment for CompuFlo® Epidural System in multiple U.S. states.
2. Gross margin increased to 76.1% from 65.0% year-over-year.
3. U.S. e-commerce sales rose to $1.3 million in Q2 2024.
4. Revenues were $1.9 million, down from $2.9 million in Q2 2023.
5. Net income was $0.2 million, compared to a net loss of $1.3 million in Q2 2023.
6. Cash and cash equivalents stood at $5.8 million as of June 30, 2024.

The company's focus on reimbursement strategy and e-commerce platform has improved margins, despite challenges in international sales.

Milestone Scientific Inc. (NYSE:MLSS), a developer of computerized drug delivery instruments for painless and precise injections, has announced a conference call scheduled for Thursday, August 15th, 2024, at 8:30 AM Eastern Time. The call will discuss the company's financial results for the second quarter ended June 30, 2024, along with corporate progress and other developments.

Investors can access the call via telephone by dialing 888-506-0062 (U.S. toll-free) or +1 973-528-0011 (international) with the access code: 959238. A webcast will also be available. An audio replay will be accessible until August 29th, 2024, by dialing 877-481-4010 (U.S.) or +1 919-882-2331 (international) with the access code: 51045.

Milestone Scientific Inc. (NYSE: MLSS) has announced a strategic partnership with Axial Biologics to distribute its CompuFlo® Epidural System in New Jersey, Texas, and Florida. This follows recent Medicare Part B Physician payment rate approvals for the system under the AMA's Category III CPT® code CPT0777T by Novitas Solutions, Inc. and First Coast Service Options Inc.

The partnership aims to leverage Axial Biologics' extensive experience and relationships in the pain management sector to accelerate the adoption of CompuFlo®. This collaboration represents a focused approach to expand Milestone's reach in key states, potentially driving growth and enhancing patient outcomes.

The CompuFlo® Epidural System is designed to provide precise identification of the epidural space, reducing complications associated with traditional methods. The recent Medicare Price Assignment is expected to facilitate broader adoption across the United States.

Milestone Scientific Inc. (NYSE: MLSS) has received multiple Notices of Allowance for key patent applications in the U.S. and Europe. These patents cover the company's next-generation Dynamic Pressure Sensing® (DPS) technology for real-time pressure-sensing guidance in manual injection systems and the new CompuPulse System for identifying pulsatile pressure waveforms.

The DPS technology enables fluid-pressure analysis to compare pressure signals, alert pressure thresholds, and display pressure graphs, enhancing the safety and precision of manual injections. The CompuPulse System improves the reliability and safety of drug delivery using manual syringes.

CEO Arjan Haverhals stated that these patent approvals significantly broaden the company's intellectual property foundation and reinforce its leadership in the computerized injection market, while opening new avenues for their technology in diverse markets and applications.

Milestone Scientific (NYSE: MLSS) has secured Medicare price assignment for its CompuFlo® Epidural System in 12 states through Novitas Solutions. This covers Medicare regions Jurisdiction L and H, following a recent approval in Florida. The decision applies to the AMA's Category III CPT® code CPT0777T for real-time pressure-sensing epidural guidance systems.

This expansion represents a significant market opportunity, with an estimated 3.0 million epidural steroid injection procedures performed annually in these jurisdictions, accounting for about one-third of total U.S. procedures. The initial addressable market among Medicare patients in these regions is approximately $250 million. The CompuFlo® system uses Dynamic Pressure Sensing® technology to enhance patient safety and outcomes in epidural procedures.

Milestone Scientific announced that its CompuFlo® Epidural System received favorable Medicare pricing from First Coast Service Options (FCSO) in Florida. This marks a critical milestone in Milestone's strategy to enhance coverage and payment for its technology. The decision impacts an estimated $125 million market among Florida Medicare patients. CEO Arjan Haverhals highlighted the strategic and methodical approach to achieving this reimbursement. The FDA-cleared CompuFlo® System uses Dynamic Pressure Sensing® technology to ensure accurate needle placement, enhancing patient safety and comfort. Milestone plans to expand its reimbursement strategy to other Medicare jurisdictions nationwide.

Milestone Scientific has received approval from Brazil's National Health Surveillance Agency (ANVISA) to market its CompuFlo® Epidural System in Brazil. This system uses patented Dynamic Pressure Sensing® technology for accurate, safe, and comfortable epidural needle placement, applicable to lumbar, thoracic, and cervical-thoracic areas. Brazil, being the 9th largest economy, has over 21 million people with chronic back pain and performs an estimated 4-5 million epidural procedures annually. The company has established key relationships with medical institutions and commercial entities in Brazil, expecting to expand the addressable market and improve patient safety and provider experience. This approval follows prior FDA approval in the U.S. and marks a significant step in Milestone's global expansion.

Milestone Scientific (NYSE: MLSS) reported $2.2 million in revenue for Q1 2024, down from $2.6 million in Q1 2023. The company's gross margin increased to 74.5%, up from 72.7%. The increase is attributed to a 31% rise in sales through their new online portal.

However, international revenues fell by $274,000. The company continues to advance its CompuFlo® Epidural System and has submitted over 160 claims for reimbursement. Operating loss for the quarter was $1.5 million, slightly higher than the $1.3 million loss in Q1 2023. Milestone Scientific ended the quarter with $5 million in cash and marketable securities.

Milestone Scientific Inc. (NYSE:MLSS) is set to announce its first-quarter 2024 financial results and business updates on May 16th, 2024. The company specializes in computerized drug delivery instruments for painless and precise injections. The conference call will cover financial performance, corporate progress, and recent developments.