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BioStem Technologies Signs Letter of Intent to Acquire Wound Care Products and Technologies from ProgenaCare Global

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BioStem Technologies (OTC: BSEM) has signed a Letter of Intent to acquire commercial-stage products and development technologies from ProgenaCare Global. The acquisition includes ProgenaMatrix, the first commercially available human keratin matrix for wound care, and revyve Antimicrobial Wound Gel. The deal aims to expand BioStem's wound care portfolio and leverage its commercial infrastructure. ProgenaMatrix is FDA 510(k) cleared for various indications including venous stasis ulcers and diabetic foot ulcers. The transaction is expected to be finalized within 60 days, subject to regulatory approvals and Board consent.

BioStem Technologies (OTC: BSEM) ha firmato una Lettera di Intenti per acquisire prodotti in fase commerciale e tecnologie di sviluppo da ProgenaCare Global. L'acquisizione include ProgenaMatrix, la prima matrice di cheratina umana disponibile in commercio per la cura delle ferite, e il gel antimicrobico revyve. L'accordo mira ad ampliare il portafoglio di BioStem per la cura delle ferite e a sfruttare la sua infrastruttura commerciale. ProgenaMatrix è autorizzato dalla FDA 510(k) per varie indicazioni, tra cui le ulcere da stasi venosa e le ulcere del piede diabetico. Si prevede che la transazione venga finalizzata entro 60 giorni, soggetta ad approvazioni normative e al consenso del Consiglio.

BioStem Technologies (OTC: BSEM) ha firmado una Carta de Intención para adquirir productos en etapa comercial y tecnologías de desarrollo de ProgenaCare Global. La adquisición incluye ProgenaMatrix, la primera matriz de queratina humana disponible comercialmente para el cuidado de heridas, y el gel antimicrobiano revyve. El acuerdo tiene como objetivo ampliar el portafolio de cuidado de heridas de BioStem y aprovechar su infraestructura comercial. ProgenaMatrix está aprobado por la FDA 510(k) para varias indicaciones, incluidas las úlceras por estasis venosa y las úlceras del pie diabético. Se espera que la transacción se finalize en un plazo de 60 días, sujeta a aprobaciones regulatorias y al consentimiento de la Junta.

BioStem Technologies (OTC: BSEM)은 ProgenaCare Global로부터 상업적 단계의 제품과 개발 기술을 인수하는 양해각서를 체결했습니다. 인수에는 상처 치료를 위한 첫 번째 상업적으로 이용 가능한 인간 케라틴 매트릭스인 ProgenaMatrix와 항균 상처 젤인 revyve가 포함됩니다. 이번 거래의 목표는 BioStem의 상처 치료 포트폴리오를 확장하고 상업 인프라를 활용하는 것입니다. ProgenaMatrix는 정맥 정체성 궤양과 당뇨 발 궤양을 포함한 다양한 적응증에 대해 FDA 510(k) 승인을 받았습니다. 이 거래는 규제 승인과 이사회 동의가 조건으로 60일 이내에 마무리될 것으로 예상됩니다.

BioStem Technologies (OTC: BSEM) a signé une lettre d'intention pour acquérir des produits de stade commercial et des technologies de développement de ProgenaCare Global. L'acquisition comprend ProgenaMatrix, la première matrice de kératine humaine disponible sur le marché pour le soin des plaies, et le gel antimicrobien revyve. L'accord vise à élargir le portefeuille de soins des plaies de BioStem et à tirer parti de son infrastructure commerciale. ProgenaMatrix est approuvé par la FDA 510(k) pour diverses indications, notamment les ulcères de stase veineuse et les ulcères du pied diabétique. La transaction devrait être finalisée dans les 60 jours, sous réserve des approbations réglementaires et de l'accord du conseil d'administration.

BioStem Technologies (OTC: BSEM) hat ein Absichtserklärung unterzeichnet, um kommerziell verfügbare Produkte und Entwicklungstechnologien von ProgenaCare Global zu erwerben. Die Übernahme umfasst ProgenaMatrix, die erste kommerziell erhältliche menschliche Keratinmatrix zur Wundversorgung, sowie das antimikrobielle Wundgel revyve. Ziel des Deals ist es, das Wundversorgungsportfolio von BioStem zu erweitern und die kommerzielle Infrastruktur zu nutzen. ProgenaMatrix ist von der FDA 510(k) für verschiedene Indikationen, darunter venöse Stauungsulzera und diabetische Fußgeschwüre, freigegeben. Der Abschluss der Transaktion wird innerhalb von 60 Tagen, vorbehaltlich regulatorischer Genehmigungen und des Board-Zustimmung, erwartet.

Positive
  • Acquisition expands product portfolio with FDA 510(k) cleared products
  • Enhances market position in hospital-based segments
  • Provides access to proprietary keratin technology platform
  • Broadens addressable patient population
  • Creates opportunities for channel expansion
Negative
  • Transaction subject to regulatory approvals and due diligence
  • Integration costs and challenges may impact operations
  • Financial terms not disclosed

Additions of ProgenaMatrix® and revyve™ Antimicrobial Wound Gel part of planned expansion of BioStem’s commercial product portfolio

POMPANO BEACH, Fla., Nov. 20, 2024 (GLOBE NEWSWIRE) -- BioStem Technologies Inc. (OTC: BSEM), a leading MedTech company focused on the development, manufacture, and commercialization of placental-derived biologics, today announced the signing of a Letter of Intent (LOI) to acquire commercial-stage products and development technologies from ProgenaCare Global LLC (“ProgenaCare”), a pioneering medical device company leveraging cutting-edge advances in biomaterials to provide effective, affordable advanced wound care solutions. The acquisition of ProgenaMatrix and revyve Antimicrobial Wound Gel reflects the Company’s continued commitment to building a diverse portfolio of complementary wound care products that enable BioStem to leverage its commercial infrastructure.

BioStem expects to finalize definitive agreements within 60 days following customary due diligence. The transaction is subject to regulatory approvals and Board consent. BioStem and ProgenaCare will work together to integrate ProgenaCare’s products into BioStem’s portfolio.

Jason Matuszewski, CEO of BioStem, stated: “ProgenaCare represents a significant opportunity for us as part of our portfolio expansion initiatives. The products align perfectly with our goal to provide wound-care solutions across the entire continuum of care. The addition of ProgenaCare’s 510(k) cleared products will enhance our position in the hospital-based segments of the market, while ProgenaCare’s proprietary technology platforms and product pipeline offer significant opportunities for us to help drive future growth. With revyve, we could address wounds early in the treatment continuum, greatly broadening the patient population BioStem supports and offering multiple opportunities for channel expansion. We believe this acquisition will not only strengthen our existing commercial activities but also position ProgenaCare for accelerated growth and operational efficiency. This partnership will enable both of our organizations to unlock new potential, fostering talent and innovation to deliver meaningful wound care solutions.”

Howard Wathall, CEO of ProgenaCare, stated: “We believe that joining the BioStem family will significantly enhance the value of ProgenaCare’s products and provide a strong platform for expansion in the growing active and advanced healing segments. This partnership not only promises improved growth prospects and enhanced product development capabilities but also operational efficiencies that will benefit both organizations. We are particularly optimistic about the potential of our keratin protein and hydrogel product pipelines and are confident that BioStem’s experience and resources will help us finalize development and achieve commercial success. Together, we are poised to make a meaningful impact in the wound care market.”

ProgenaCare Product Portfolio:
ProgenaCare’s innovative approach to wound care leverages scientific advancements in biomaterials to deliver effective products for a range of wound types, from acute injuries to chronic conditions. The company’s proprietary human keratin technology supports the body’s natural healing processes, making ProgenaMatrix an invaluable asset in the wound care market. Revyve is a premium hydrogel that provides scientifically proven efficacy in an easy-to-use thermo-reversible pluronic gel.

ProgenaCare’s portfolio includes:

ProgenaMatrix:
ProgenaCare’s flagship product, ProgenaMatrix, is the first and only commercially available human keratin matrix for wound care. Constructed from robust and degradation resistant human keratin protein, ProgenaMatrix is a hydrated, non-cellular biomaterial that supports the body’s natural healing processes. Keratin protein has been shown to activate keratinocytes and fibroblasts, modulating the response to injury and offering clinicians a unique solution for complex wounds.

This advanced wound care solution is FDA 510(k) cleared for a broad range of indications, including:

  • Venous stasis ulcers
  • Diabetic foot ulcers
  • Pressure ulcers
  • Partial-thickness burns
  • Surgical wounds
  • Donor sites and grafts

To learn more about ProgenaMatrix, visit HERE

revyve:
revyve is a premium hydrogel that combines Kane Biotech’s patented coactiv+™ technology with PHMB, resulting in a thermo-reversible gel that is easy to apply. This innovative product creates a moist environment ideal for wound healing and provides broad-spectrum antimicrobial activity. Indicated for various wound types, revyve is effective for:

  • Diabetic foot ulcers
  • Leg ulcers
  • Pressure ulcers
  • 1st and 2nd degree burns
  • Partial and full thickness wounds
  • Large surface area wounds
  • Surgical incisions

To learn more about revyve, visit HERE

Join BioStem’s Distribution List & Social Media:
To follow the latest developments at BioStem, sign-up for the Company’s email distribution list HERE, and follow us on Twitter and LinkedIn.

About BioStem Technologies:
BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain ® processing method. BioREtain ® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies’ quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks (“AATB”). These systems and procedures are established per current Good Tissue Practices (“cGTP”) and current Good Manufacturing Processes (“cGMP”). Our portfolio of quality brands includes AmnioWrap ™, VENDAJE ® , VENDAJE AC ® , and VENDAJE OPTIC ® . Each BioStem Technologies placental allograft is processed at the Company’s FDA registered and AATB accredited site in Pompano Beach, Florida.

For more information visit biostemtechnologies.com and follow us on Twitter and LinkedIn.

Forward-Looking Statements:
Except for statements of historical fact, this release also contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified using words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the reimbursement levels for the Company’s products; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete;(4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred significant losses since inception and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production of its products in sufficient quantities to meet demand; and (10) the COVID-19 pandemic and its impact, if any, on the Company’s fiscal condition and results of operations; You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.

BioStem Technologies, Inc.
Phone: 954-380-8342
Website: http://www.biostemtechnologies.com
E-Mail: info@biostemtech.com
Twitter: @BSEM_Tech
Facebook: BioStemTechnologies

Investor Contact:

PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
646-863-6893

Media Contact:

Russo Partners
Madeline Stabinski or David Schull
Madeline.stabinski@russopartnersllc.com
David.schull@russopartnersllc.com
858-717-2310


FAQ

What products is BioStem Technologies (BSEM) acquiring from ProgenaCare?

BioStem Technologies is acquiring ProgenaMatrix, a human keratin matrix for wound care, and revyve Antimicrobial Wound Gel from ProgenaCare Global.

What are the main applications of ProgenaMatrix acquired by BSEM?

ProgenaMatrix is FDA 510(k) cleared for venous stasis ulcers, diabetic foot ulcers, pressure ulcers, partial-thickness burns, surgical wounds, and donor sites and grafts.

When will BSEM complete the ProgenaCare acquisition?

BioStem Technologies expects to finalize definitive agreements within 60 days following customary due diligence, subject to regulatory approvals and Board consent.

What is the strategic importance of the ProgenaCare acquisition for BSEM?

The acquisition enhances BioStem's position in hospital-based markets, expands its wound care portfolio, and provides access to proprietary technology platforms for future growth.

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