PRISM CEO CORNER

Jason Matuszewski, BioStem Technologies

BioStem Technologies: Large and Growing Opportunity for Innovative Wound Care Products in Multiple Markets

Jason Matuszewski

Chronic wounds are a significant clinical, social, and economic challenge, impacting the lives of nearly 2.5% of the population in the United States. An aging population along with the rising incidence of diabetes and obesity means an increasing need for wound care solutions for a growing patient group.

BioStem Technologies, a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental-derived allografts for advanced wound care, is working to change lives for the better with its innovative technology and products.

BioStem’s allografts harness the natural properties of perinatal tissue and support the body’s innate biology to repair or regenerate damaged tissues. The company’s products,  including VENDAJE, VENDAJE AC, VENDAJE OPTIC and AmnioWrap2™ are trusted by top clinicians across a range of specialties.

We spoke to BioStem’s CEO, Jason Matuszewski, to find out more.

BioStem currently has four portfolio products that are available to healthcare professionals at private offices, surgical centers, wound care clinics, hospitals and VA medical centers. They are Vendaje®, a structural tissue allograft composed of the amnion layer of the placental membrane, Vendaje AC®, a thicker structural allograft for soft tissue wounds, Vendaje Optic®, an allograft that works as a protective covering during the repair of ocular surfaces, and AmnioWrap2™. AmnioWrap2, which we launched in 2023, is an allograft product comprised of unseparated amnion and chorion membranes and supports the healing cascade in acute and chronic wounds. We also expect to launch four additional wound care products in the next two years.

We harness the natural properties of perinatal tissue in the development, manufacture, and commercialization of tissue allografts for regenerative therapies. We do this using our patented six-step BioRetain process, which allows us to deliver a product that maintains the structural integrity of the tissue, and differentiates us from our competitors. Some of our competitors’ processing involves scraping of the tissue, which damages structural components, cleaning using hypo or hypertonic solutions, the use of antibiotics, and exposing the tissue to low and high temperatures and gamma irradiation, all of which can have a negative effect on the factors embedded in the tissue.

The BioRetain process preserves the natural integrity of the amniotic tissue which contains components critical for promoting wound healing. It includes minimally invasive disinfection to eliminate pathogens, manual hematopoietic reduction, the removal of blood components by hand, cold isotonic cleansing, gentle dehydration, precise cutting die placement and low-dose E-beam terminal sterilization to deactivate microbes. BioStem’s products are then individually packed and have a five year shelf life. We are proud to have distributed more than 100,000 allografts to date.

 

BioStem-solutions

It was important to us to be able to demonstrate the efficacy of our products in a clinical setting to substantiate the inherent advantages of our proprietary BioRetain® process. We initiated a 100-patient clinical trial in 2023, evaluating our Vendaje® tissue allograft in the treatment of diabetic foot ulcers, and opened the first clinical site in October. We expect to open four additional sites in the first half of this year. We’re excited about the trial and believe it will provide invaluable real-world support for healthcare professionals and underscore our commitment to deploying Vendaje in the treatment of patients with chronic wounds.

We are excited to be addressing multiple billion-dollar commercial opportunities. BioStem’s products have applications in the wound care market, which was valued at $1.1 billion in 2022 and is expected to reach $2.0 billion by 2026, and the surgical care market, which was $0.9 billion in 2022 and projected at $1.3 billion in 2026. We also see significant opportunity for our products in the skin substitutes segment of the advanced wound care market, which had a total value of $1.1 billion in 2021 and is expected to sit at $2.2 billion in 2026. BioStem is already operating in the diabetic and ocular wound care spaces and we look forward to entering new markets in 2024 and beyond.

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About the Author

BioStem Technologies: Large and Growing Opportunity for Innovative Wound Care Products in Multiple Markets

Catie Corcoran

Biotech Editor