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MIMEDX Announces Launch of HELIOGEN™ Fibrillar Collagen Matrix

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MIMEDX Group, Inc. (Nasdaq: MDXG) has announced the commercial launch of HELIOGEN™ Fibrillar Collagen Matrix, a particulate xenograft product designed for complex wounds in surgical settings. This shelf-stable offering contains Type I and Type III collagen, mimicking the native composition of structural connective tissue. HELIOGEN marks MIMEDX's first xenograft option and 510(k) cleared product, complementing their existing placental-based solutions in the surgical market.

CEO Joseph H. Capper stated that this launch aligns with the company's strategic initiative to expand its surgical footprint, following the introduction of two new surgical products in late 2022. Eric Smith, SVP of Marketing & International, highlighted HELIOGEN's potential to improve patient outcomes in various surgical settings, backed by initial case studies and real-world evidence.

MIMEDX Group, Inc. (Nasdaq: MDXG) ha annunciato il lancio commerciale del HELIOGEN™ Fibrillar Collagen Matrix, un prodotto xenograft particolato progettato per ferite complesse in contesti chirurgici. Questa offerta stabile a scaffale contiene collagene di Tipo I e Tipo III, replicando la composizione naturale dei tessuti connettivi strutturali. HELIOGEN segna la prima opzione xenograft di MIMEDX e un prodotto approvato 510(k), completando le loro soluzioni basate su placenta già esistenti nel mercato chirurgico.

Il CEO Joseph H. Capper ha dichiarato che questo lancio si allinea con l'iniziativa strategica dell'azienda di espandere la sua presenza nel settore chirurgico, dopo l'introduzione di due nuovi prodotti chirurgici alla fine del 2022. Eric Smith, SVP di Marketing e Internazionale, ha sottolineato il potenziale di HELIOGEN di migliorare i risultati per i pazienti in vari contesti chirurgici, supportato da studi di casi iniziali e evidenze del mondo reale.

MIMEDX Group, Inc. (Nasdaq: MDXG) ha anunciado el lanzamiento comercial de HELIOGEN™ Fibrillar Collagen Matrix, un producto xenoinjerto particulado diseñado para heridas complejas en entornos quirúrgicos. Esta oferta estable en estante contiene colágeno tipo I y tipo III, imitando la composición nativa del tejido conectivo estructural. HELIOGEN marca la primera opción de xenoinjerto de MIMEDX y un producto aprobado por 510(k), complementando sus soluciones basadas en placenta existentes en el mercado quirúrgico.

El CEO Joseph H. Capper afirmó que este lanzamiento se alinea con la iniciativa estratégica de la compañía para expandir su presencia quirúrgica, tras la introducción de dos nuevos productos quirúrgicos a finales de 2022. Eric Smith, SVP de Marketing e Internacional, destacó el potencial de HELIOGEN para mejorar los resultados de los pacientes en diversos entornos quirúrgicos, respaldado por estudios de casos iniciales y evidencia del mundo real.

MIMEDX Group, Inc. (Nasdaq: MDXG)는 복합 상처를 위한 입자 외국 이식 제품인 HELIOGEN™ Fibrillar Collagen Matrix의 상업적 출시를 발표했습니다. 이 제품은 제1형 및 제3형 콜라겐을 포함하고 있으며, 구조적 결합 조직의 원래 구성을 모방합니다. HELIOGEN은 MIMEDX의 첫 번째 외국 이식 옵션이자 510(k) 승인 제품으로, 수술 시장에서 기존의 태반 기반 솔루션을 보완합니다.

CEO Joseph H. Capper는 이 출시가 2022년 말 두 가지 새로운 수술 제품의 도입에 이어 회사의 수술 분야 확대 전략과 일치한다고 밝혔습니다. 마케팅 및 국제 담당 SVP Eric Smith는 HELIOGEN이 다양한 수술 환경에서 환자 결과를 개선할 수 있는 잠재력을 강조하며, 초기 사례 연구와 실제 증거에 의해 뒷받침된다고 말했습니다.

MIMEDX Group, Inc. (Nasdaq: MDXG) a annoncé le lancement commercial de HELIOGEN™ Fibrillar Collagen Matrix, un produit xenogreffe particulaire conçu pour des blessures complexes dans des environnements chirurgicaux. Cette offre stable présente une durée de conservation de Type I et Type III collagène, imitant la composition native du tissu conjonctif structurel. HELIOGEN marque la première option de xenogreffe de MIMEDX et un produit approuvé 510(k), complétant leurs solutions basées sur le placenta existantes sur le marché chirurgical.

Le PDG Joseph H. Capper a déclaré que ce lancement s'aligne sur l'initiative stratégique de l'entreprise pour étendre son empreinte chirurgicale, après l'introduction de deux nouveaux produits chirurgicaux à la fin de 2022. Eric Smith, SVP Marketing et International, a souligné le potentiel de HELIOGEN pour améliorer les résultats des patients dans divers environnements chirurgicaux, soutenu par des études de cas initiales et des preuves concrètes.

MIMEDX Group, Inc. (Nasdaq: MDXG) hat den kommerziellen Start von HELIOGEN™ Fibrillar Collagen Matrix angekündigt, einem Partikel-Xenotransplantat-Produkt, das für komplexe Wunden in chirurgischen Umgebungen entwickelt wurde. Dieses lagerstabile Angebot enthält Typ I und Typ III Kollagen, das die natürliche Zusammensetzung des strukturellen Bindegewebes nachahmt. HELIOGEN ist die erste Xenotransplantat-Option von MIMEDX und ein 510(k) genehmigtes Produkt, das die bestehenden plazentabasierten Lösungen auf dem chirurgischen Markt ergänzt.

CEO Joseph H. Capper erklärte, dass dieser Launch mit der strategischen Initiative des Unternehmens zur Erweiterung seines chirurgischen Fußabdrucks übereinstimmt, nach der Einführung von zwei neuen chirurgischen Produkten Ende 2022. Eric Smith, SVP für Marketing und Internationales, hob das Potenzial von HELIOGEN hervor, die Patientenresultate in verschiedenen chirurgischen Umgebungen zu verbessern, gestützt durch erste Fallstudien und Beweise aus der Praxis.

Positive
  • Launch of HELIOGEN™ Fibrillar Collagen Matrix, expanding product portfolio
  • First xenograft and 510(k) cleared product for the company
  • Aligns with strategic initiative to expand surgical market presence
  • Backed by initial case studies and real-world evidence
Negative
  • None.

The launch of HELIOGEN™ Fibrillar Collagen Matrix marks a significant expansion in MIMEDX's product portfolio, potentially impacting the company's market position and revenue streams. As a xenograft product, HELIOGEN introduces a new category for MIMEDX, diversifying their offerings beyond placental-based solutions.

The product's composition of Type I and Type III collagen mimics native connective tissue, which could provide a competitive edge in the complex wound care market. Its shelf-stable nature is a practical advantage for healthcare providers, potentially increasing adoption rates.

However, it's important to note that this is a market release, indicating a cautious approach by MIMEDX. This strategy allows for real-world data collection and refinement before a full-scale launch, mitigating risks associated with new product introductions.

The 510(k) clearance from the FDA is a positive regulatory milestone, suggesting the product meets safety and efficacy standards. This clearance could expedite market acceptance and integration into surgical protocols.

While the launch is promising, investors should be aware that market penetration and revenue impact may take time to materialize. The success of HELIOGEN will depend on factors such as clinical performance, pricing strategy and the company's ability to leverage its existing customer relationships in the surgical market.

MIMEDX's strategic move to expand its surgical footprint with HELIOGEN™ aligns with the company's previously communicated objectives. This product launch could potentially drive revenue growth and market share expansion in the competitive wound care sector.

The introduction of a xenograft product diversifies MIMEDX's portfolio, potentially reducing reliance on placental-based solutions and mitigating supply chain risks. This diversification strategy could enhance the company's resilience to market fluctuations and regulatory changes.

Investors should note that while new product launches can be catalysts for growth, they also involve upfront costs related to marketing, sales force training and initial production. The market release approach suggests a measured investment, which could help manage these costs effectively.

The surgical market represents a significant opportunity, given its typically higher margins compared to outpatient settings. If HELIOGEN gains traction, it could positively impact MIMEDX's profit margins over time.

However, it's important to consider that the wound care market is highly competitive, with established players and emerging technologies. MIMEDX will need to demonstrate clear clinical and economic benefits to drive adoption and justify potential premium pricing.

While this launch is a positive development, investors should monitor key performance indicators in upcoming quarterly reports to assess HELIOGEN's market reception and its contribution to overall revenue growth.

Limited market release marks first xenograft addition to Company’s portfolio of leading Wound and Surgical products

MARIETTA, Ga., July 31, 2024 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today announced the commercial launch of HELIOGEN™ Fibrillar Collagen Matrix, a particulate xenograft product aimed at addressing complex wounds primarily in the surgical setting. HELIOGEN is a shelf-stable offering that contains Type I and Type III collagen and mimics the native composition of structural connective tissue.

“We are pleased to introduce our first xenograft option and 510(k) cleared product to complement our leading placental-based solutions in the surgical market,” stated Joseph H. Capper, MIMEDX Chief Executive Officer. “As we have been messaging, one of our strategic initiatives is the continued expansion of our surgical footprint, following the successful introduction of two new products designed for this care setting at the end of 2022. This initial market release of HELIOGEN represents another important step in pursuit of this objective.”

Eric Smith, MIMEDX Senior Vice President, Marketing & International, added, “HELIOGEN—named for the product’s triple helical collagen structure—is an exciting addition to our portfolio and provides another tool to help our customers manage complex wounds. With a solid foundation of initial case studies and real-world evidence, we are excited for customers in various surgical settings to build on this evidence and realize improved outcomes for their patients.”

About HELIOGEN
HELIOGEN is a 510(k) cleared, bovine-derived collagen matrix product indicated for the management of moderately to heavily exudating wounds and to control minor bleeding. The collagen in this product serves as a dressing that allows for cell adhesion and migration into the wound site and supports wound healing. It is provided in particulate form allowing it to be molded or packed to conform to various wound types such as pressure ulcers, venous stasis ulcers, diabetic ulcers, acute wounds, for example trauma and surgical wounds, and partial-thickness burns. To learn more about HELIOGEN, please visit: www.mimedx.com/heliogen/

About MIMEDX
MIMEDX is a pioneer and leader focused on helping humans heal. With more than a decade of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX is dedicated to providing a leading portfolio of products for applications in the wound care, burn, and surgical sectors of healthcare. The Company’s vision is to be the leading global provider of healing solutions through relentless innovation to restore quality of life. For additional information, please visit www.mimedx.com.

Contact:
Matt Notarianni
Investor Relations
470-304-7291
mnotarianni@mimedx.com


FAQ

What is HELIOGEN™ Fibrillar Collagen Matrix and how does it relate to MIMEDX (MDXG)?

HELIOGEN™ Fibrillar Collagen Matrix is a new particulate xenograft product launched by MIMEDX (MDXG). It's designed for complex wounds in surgical settings and contains Type I and Type III collagen, mimicking the structure of connective tissue.

How does the HELIOGEN launch align with MIMEDX's (MDXG) strategic goals?

The launch of HELIOGEN aligns with MIMEDX's strategic initiative to expand its surgical footprint. It's the company's first xenograft option and 510(k) cleared product, complementing their existing placental-based solutions in the surgical market.

What evidence supports the efficacy of MIMEDX's (MDXG) new HELIOGEN product?

MIMEDX reports that HELIOGEN is backed by initial case studies and real-world evidence. The company expects customers in various surgical settings to build on this evidence and potentially realize improved outcomes for their patients.

When did MIMEDX (MDXG) introduce other new surgical products prior to HELIOGEN?

According to the press release, MIMEDX introduced two new products designed for the surgical care setting at the end of 2022, preceding the launch of HELIOGEN in July 2024.

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