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Milestone Scientific Announces Strategic Partnership with Axial Biologics to Distribute CompuFlo® in New Jersey, Texas, and Florida

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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) ha annunciato una partnership strategica con Axial Biologics per distribuire il suo CompuFlo® Epidural System nel New Jersey, Texas e Florida. Questo accordo arriva dopo le recenti approvazioni delle tariffe di pagamento per i medici di Medicare Parte B per il sistema, sotto il codice CPT® della Categoria III dell'AMA CPT0777T da parte di Novitas Solutions, Inc. e First Coast Service Options Inc.

La partnership mira a sfruttare l'ampia esperienza e le relazioni di Axial Biologics nel settore della gestione del dolore per accelerare l'adozione del CompuFlo®. Questa collaborazione rappresenta un approccio mirato per espandere la portata di Milestone in stati chiave, potenzialmente guidando la crescita e migliorando i risultati per i pazienti.

Il CompuFlo® Epidural System è progettato per fornire un'identificazione precisa dello spazio epidurale, riducendo le complicazioni associate ai metodi tradizionali. L'assegnazione recente del Prezzo Medicare è prevista per facilitare una più ampia adozione negli Stati Uniti.

Milestone Scientific Inc. (NYSE: MLSS) ha anunciado una asociación estratégica con Axial Biologics para distribuir su CompuFlo® Epidural System en Nueva Jersey, Texas y Florida. Esto sigue a las recientes aprobaciones de tarifas de pago de Medicare Parte B para el sistema bajo el código CPT® de la Categoría III de la AMA CPT0777T por Novitas Solutions, Inc. y First Coast Service Options Inc.

La asociación tiene como objetivo aprovechar la amplia experiencia y las relaciones de Axial Biologics en el sector de la gestión del dolor para acelerar la adopción de CompuFlo®. Esta colaboración representa un enfoque centrado en expandir el alcance de Milestone en estados clave, lo que potencialmente impulsará el crecimiento y mejorará los resultados de los pacientes.

El CompuFlo® Epidural System está diseñado para proporcionar una identificación precisa del espacio epidural, reduciendo las complicaciones asociadas con los métodos tradicionales. Se espera que la reciente asignación de precios de Medicare facilite una adopción más amplia en los Estados Unidos.

Milestone Scientific Inc. (NYSE: MLSS)는 뉴저지, 텍사스 및 플로리다에서 CompuFlo® Epidural System을 배급하기 위해 Axial Biologics와 전략적 파트너십을 발표했습니다. 이는 Novitas Solutions, Inc.와 First Coast Service Options Inc.에 의해 AMA의 카테고리 III CPT® 코드 CPT0777T에 따른 시스템의 Medicare Part B 의사 지불률 승인이 최근에 있었기 때문입니다.

이 파트너십은 Axial Biologics의 광범위한 경험과 통증 관리 부문에서의 관계를 활용하여 CompuFlo®의 채택을 가속화하는 것을 목표로 하고 있습니다. 이 협업은 Milestone이 주요 주에서의 영향력을 확장하기 위한 집중적인 접근 방식을 나타내며, 이는 잠재적으로 성장 촉진 및 환자 결과 향상에 기여할 것입니다.

CompuFlo® Epidural System은 전통적인 방법과 관련된 합병증을 줄이며 경막외 공간을 정밀하게 식별하도록 설계되었습니다. 최근 Medicare 가격 할당은 미국 전역에서의 폭넓은 채택을 촉진할 것으로 예상됩니다.

Milestone Scientific Inc. (NYSE: MLSS) a annoncé un partenariat stratégique avec Axial Biologics pour distribuer son CompuFlo® Epidural System dans le New Jersey, au Texas et en Floride. Cela fait suite aux récentes approbations des taux de paiement des médecins de Medicare Partie B pour le système sous le code CPT® de la Catégorie III de l'AMA CPT0777T par Novitas Solutions, Inc. et First Coast Service Options Inc.

Le partenariat vise à tirer parti de l'expérience et des relations étendues d'Axial Biologics dans le secteur de la gestion de la douleur afin d'accélérer l'adoption de CompuFlo®. Cette collaboration représente une approche ciblée pour étendre la portée de Milestone dans des États clés, ce qui pourrait potentiellement stimuler la croissance et améliorer les résultats pour les patients.

Le CompuFlo® Epidural System est conçu pour fournir une identification précise de l'espace épidural, réduisant les complications associées aux méthodes traditionnelles. L'affectation récente des prix de Medicare devrait faciliter une adoption plus large à travers les États-Unis.

Milestone Scientific Inc. (NYSE: MLSS) hat eine strategische Partnerschaft mit Axial Biologics angekündigt, um das CompuFlo® Epidural System in New Jersey, Texas und Florida zu vertreiben. Dies folgt den kürzlichen Genehmigungen der Medicare Teil B Zahlsätze für das System unter dem AMA Kategorie III CPT® Code CPT0777T durch Novitas Solutions, Inc. und First Coast Service Options Inc.

Das Ziel der Partnerschaft ist es, die umfangreiche Erfahrung und die Beziehungen von Axial Biologics im Bereich Schmerzkontrolle zu nutzen, um die Annahme von CompuFlo® zu beschleunigen. Diese Zusammenarbeit stellt einen fokussierten Ansatz dar, um die Reichweite von Milestone in wichtigen Bundesstaaten zu erweitern, was potenziell das Wachstum fördern und die Patientenergebnisse verbessern könnte.

Das CompuFlo® Epidural System ist darauf ausgelegt, den epiduralen Raum präzise zu identifizieren, wodurch Komplikationen, die mit traditionellen Methoden verbunden sind, reduziert werden. Es wird erwartet, dass die kürzliche Preiszuweisung von Medicare eine breitere Akzeptanz in den Vereinigten Staaten erleichtert.

Positive
  • Strategic partnership with Axial Biologics for distribution in three key states
  • Recent Medicare Part B Physician payment rate approval for CompuFlo® Epidural System
  • Potential for accelerated market penetration and adoption of CompuFlo®
  • Leveraging partner's established clinician relationships instead of building own sales force
Negative
  • None.

Insights

This partnership between Milestone Scientific and Axial Biologics is a strategic move that could significantly boost CompuFlo® Epidural System's market penetration. The focus on key states like New Jersey, Texas and Florida is particularly shrewd, aligning with recent Medicare Part B coverage in these areas. This targeted approach, leveraging Axial's existing relationships, should accelerate adoption more efficiently than a broad distribution strategy or in-house sales force.

The recent Medicare Price Assignment is a important development, potentially opening doors to a vast patient population. This could be a game-changer for Milestone, as it addresses a significant barrier to adoption in the pain management sector. However, success will depend on Axial's ability to effectively communicate the system's benefits and navigate the complex healthcare purchasing landscape.

The Medicare Part B Physician payment rate for CompuFlo® under the Category III CPT® code CPT0777T is a significant regulatory win. This coverage decision by Novitas and FCSO for real-time pressure-sensing epidural guidance could set a precedent for other Medicare Administrative Contractors nationwide. It's a strong validation of the technology's clinical utility and could pave the way for broader insurance coverage.

However, it's important to note that Category III codes are typically temporary, used for emerging technologies. Milestone should aim to gather substantial clinical and economic data to support an eventual transition to a permanent Category I code, which would further solidify reimbursement. The partnership with Axial could be instrumental in collecting this real-world evidence needed for long-term reimbursement stability.

While this partnership shows promise, investors should temper short-term expectations. The agreement's financial terms aren't disclosed, making it difficult to quantify immediate revenue impact. However, the targeted approach in three key states could lead to more efficient capital allocation and potentially faster path to profitability compared to a broad, resource-intensive national rollout.

The Medicare coverage is a significant de-risking event, potentially expanding the addressable market and improving the sales pitch to healthcare providers. Investors should monitor adoption rates and revenue growth in these initial states as indicators of the strategy's success and potential for expansion. If successful, this model could be replicated in other regions, potentially accelerating Milestone's growth trajectory without significant increases in operating expenses.

ROSELAND, N.J., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today announced a strategic partnership with Axial Biologics, a premier medical device company with a vast distribution network. Under the agreement, Axial Biologics will serve as the distributor of Milestone Scientific's CompuFlo® Epidural System in New Jersey, Texas, and Florida.

This partnership immediately follows the recent announcements that the Company has been granted a Medicare Part B Physician payment rate for the CompuFlo® Epidural System under the American Medical Association’s (AMA) technology-specific Category III CPT® code CPT0777T (real-time pressure-sensing epidural guidance system when used in conjunction with a primary ESI procedure) by Novitas Solutions, Inc. (Novitas) and First Coast Service Options Inc. (FCSO), the Jurisdictional Medicare Administrative Contractors (JMAC) in New Jersey, Texas and Florida. The Medicare Price Assignment marks a significant milestone for the CompuFlo® technology, enabling broader access and adoption within the pain management community, particularly for Medicare patients.

Arjan Haverhals, CEO and President of Milestone Scientific, commented, "We are excited to partner with Axial Biologics, whose extensive experience and deep relationships within the pain management sector make them an ideal collaborator. This partnership represents a strategic, laser-focused approach to expanding our reach, leveraging Axial’s established clinician relationships in key states like New Jersey, Texas, and Florida. By aligning with a specialized partner instead of a broad distributor or building our own sales force, we can accelerate the penetration and adoption of the CompuFlo® Epidural System more effectively. This collaboration marks the next phase of our sales strategy, and we are confident that it will drive growth and enhance patient outcomes."

Ryan Paul, CEO of Axial Biologics, further noted, "We are honored to partner with Milestone Scientific and bring the CompuFlo® Epidural System to pain management professionals across New Jersey, Texas, and Florida. The recent Medicare Price Assignment is a potential game-changer, positioning CompuFlo® to disrupt the market with its unparalleled safety and economic benefits. We look forward to working closely with Milestone to ensure that more physicians and patients have access to this innovative technology."

The CompuFlo® Epidural System is a revolutionary instrument designed to provide precise and objective identification of the epidural space, significantly reducing the risk of complications associated with traditional methods. The system’s recent Medicare Price Assignment is expected to facilitate its broader adoption across the United States.

About Axial Biologics:
Axial Biologics is an advance biologics and life sciences company specializing in research and development of innovative regenerative medicine solutions. Our core focus is on delivering novel autologous and orthobiologic solutions to enhance patient healing and improve quality of life. For more information visit www.axialbiologics.com.

About Milestone Scientific Inc.
Milestone Scientific Inc. (MLSS) is a technology-focused medical research and development company that patents, designs and develops innovative injection technologies and instruments for medical and dental applications. Milestone Scientific’s computer-controlled systems are designed to make injections precise and efficient, as well as increase overall patient comfort and safety. The Company’s proprietary DPS Dynamic Pressure Sensing Technology® provides a platform to advance the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions involving subcutaneous drug delivery of local anesthetic. To learn more, view the MLSS brand video or visit milestonescientific.com.

Safe Harbor Statement

This press release contains forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues, timing of regulatory approvals and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions, future business decisions and regulatory developments, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and the risk factors detailed from time to time in Milestone's periodic filings with the Securities and Exchange Commission, including without limitation, Milestone's Annual Report for the year ended December 31, 2022. The forward-looking statements in this press release are based upon management's reasonable belief as of the date hereof. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

Contact:
Crescendo Communications, LLC
Email: mlss@crescendo-ir.com
Tel: 212-671-1020


FAQ

What is the new partnership announced by Milestone Scientific (MLSS)?

Milestone Scientific (MLSS) has announced a strategic partnership with Axial Biologics to distribute its CompuFlo® Epidural System in New Jersey, Texas, and Florida.

What recent approval did Milestone Scientific (MLSS) receive for CompuFlo®?

Milestone Scientific (MLSS) recently received Medicare Part B Physician payment rate approval for the CompuFlo® Epidural System under the AMA's Category III CPT® code CPT0777T by Novitas Solutions, Inc. and First Coast Service Options Inc.

How does the CompuFlo® Epidural System by Milestone Scientific (MLSS) work?

The CompuFlo® Epidural System is designed to provide precise and objective identification of the epidural space, significantly reducing the risk of complications associated with traditional methods.

What is the significance of the Medicare Price Assignment for Milestone Scientific's (MLSS) CompuFlo®?

The Medicare Price Assignment is expected to facilitate broader adoption of the CompuFlo® Epidural System across the United States, enabling greater access for Medicare patients and potentially disrupting the market.

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