Florida-based BioStem Technologies, Inc. BSEM is a biotech company focused on developing and manufacturing structural-tissue allografts derived from perinatal tissues and intended for use as a protective covering for soft-tissue wounds.
Perinatal tissue – an abundant source of extracellular matrix proteins and growth factors – is extracted from the placenta and its derivatives, including the amniotic membrane, chorionic membrane, and umbilical cord from full-term births.
Perinatal tissue allografts can provide the scaffolding required for cells to connect and develop, which has a beneficial effect on the healing process. Upon application of the allograft, growth factors within the allograft become immediately available to surrounding cells and tissues, initiating regenerative activity.
BioStem’s allografts use a proprietary regenerative approach called Local MicroEnvironment Activation™ that uses combinations of small molecules, cytokines and growth factors to activate the local microenvironment of cells and create repair signals in the tissue. BioStem’s proprietary BioRetain® process helps in creating a suitably dehydrated human amniotic membrane allograft that is capable of preserving the natural integrity of amniotic tissue, something which has previously been challenging to achieve in the allograft space.
BioStem has developed three perinatal tissue allograft products for wound care — Vendaje®, Vendaje AC®, and Vendaje Optic® — intended for homologous use as a protective covering for soft-tissue wounds. The company says its initial commercial strategy heavily focuses on its products being sold and reimbursed within the Medicare system.
Here’s a look at the company’s product pipeline:
Vendaje® is a dehydrated placental allograft that can be used for advanced wound care –- as a substitute for skin grafts or placed over open wounds to speed up and improve the healing process after surgery. In Vendaje, only the amnion Layer of the placenta is retained.
In July last year, the United States Centers for Medicare & Medicaid Services (CMS) awarded a Q-code for Vendaje which allowed for greater access for patients and providers to the tissue allograft through the Medicare and the CMS system. The Q-code enabled its customers to appropriately bill and code for Vendaje resulting in significant growth opportunities for the company.
Vendaje AC® is a thicker multilayer dehydrated placental allograft that retains all native layers of the placenta – the Amnion, Chorion and Spongy layers –- which creates the thicker graft needed for use in more complex cases such as burns or advanced surgical wound care recovery and ulcers.
BioStem expects a final decision regarding the Q-Code issuance for Vendaje AC in the first quarter of 2023 and says it looks forward to expanding its CMS reimbursable product portfolio and total addressable market once the Q-code is awarded for Vendaje AC.
BioStem expects to receive the Q-code for Vendaje AC in 2023.
Vendaje Optic® is a dehydrated placental allograft used in the ocular space - to repair wounds or heal surgery incisions on the eye. Vendaje Optic is made up of the amnion layer alone.
All Vendaje products have a 3 year shelf life and need to be stored at room temperature.
“We will soon be engaging with several market development focus groups, industry thought leaders, and key stakeholders to accelerate the adoption of our product offerings. Our BioRetain process is a competitive advantage over our competition, as internal data analysis has shown that our allograft products retain elevated levels of the inherent beneficial biologic qualities and components of allograft products.” Jason Matuszewski, CEO and co-founder of BioStem said.
In 2023, BioStem says it aims to achieve sales growth of 75% with its current product line in the Veterans Health Administration. As one of the steps to achieve this, BioStem plans to expand its domestic footprint by growing its team of sales representatives from four to 25.
In addition to expanding its team of direct sales representatives, BioStem also has plans to build out its marketing and customer support capabilities.
This would involve expanding BioStem’s “Care Partner Program” to support the adoption of its products in all Medicare Administrative Contractor (MAC) regions through CMS, gaining data and other approval requirements to promote the Vendaje suite of products through private payers or other healthcare networks.
BioStem is looking to launch four new products in 2023 and 2024 including two new products in the advanced wound care space and two in the surgical recovery space.
The company also plans to initiate a random control trial of its Vendaje AC allograft for the treatment of diabetic foot ulcer.
Looking ahead beyond 2024 – BioStem will aim to launch further new products and invest additionally in research and development R&D. The company will also continue with its sales force expansion and optimization in order to penetrate additional sites of care. In addition, BioStem says it will focus on manufacturing and infrastructure enhancements to improve its gross margins.
Speaking about BioStem’s 3rd Quarter results and plans going forward, Matuszewski says “We have put our company on a tremendous long-term growth trajectory. In the third quarter we executed on the fundamentals of this growth strategy. We look forward to continuing this progress into 2023 as we hone our focus on the advanced wound care market and establishing ourselves as an industry leader in the space.”