Biostem Technologies (BSEM) investor relations material

Strategic vision and platform development

• Focused on building a differentiated regenerative medicine platform targeting advanced wound healing technologies and transformational outcomes in medicine.

• Platform built on three pillars: differentiated technology, strong operational/clinical/scientific foundation, and scalable growth engine.

• Expanded addressable market to six core segments, including orthopedics, chronic wound care, foot and ankle, urology, spine, and women's health, representing a $23B+ opportunity.

• Recent acquisition of BioTissue and its Neox and Clarix product families diversified the portfolio and extended reach into surgical settings.

• Transitioned from a single-product to a platform company, emphasizing resilience and growth.

Technology, clinical evidence, and product pipeline

• Core technologies include BioRetain (proprietary dehydration of placental tissue), CryoTek (cryopreserved wet tissue), and SteriTek (room temperature wet tissue).

• Over 90 clinical publications support the portfolio, with recent DFU study showing 53% healing vs. 31% for standard care; VLU study results forthcoming.

• Ambulatory study on severe chronic wounds showed 66% closure at 26 weeks with an average of 1.6 applications.

• Pipeline includes a particulated umbilical cord/placental product pending 510(k) clearance, with milestone payment tied to approval.

• Focus on generating real-world and retrospective data to support reimbursement and clinical adoption.

Commercialization, reimbursement, and operational expansion

• Expanded commercial team to 18 direct sales reps and 32 independent agents, leveraging GPO agreements with Premier, Vizient, and HPG.

• Broadened reimbursement portfolio, reducing payer mix risk by combining Medicare and commercial payer coverage.

• New CMS reimbursement methodology shifts from bundled rates to $127/sq cm plus application fee, enabling treatment of larger wounds and supporting hospital/ASC channels.

• Facility in Pompano Beach, FL, with 100,000 sq cm monthly capacity, recently added clean room for tech transfer of BioTissue products.

• Leadership strengthened with new Chief Commercial Officer and VP of Sales, both with prior BioTissue experience.