PRISM Q&A CORNER

"We had a phenomenal start to the year, which is the direct result of the dedication and hard work of our talented team over the past 18 months. The successful commercial launch of our AmnioWrap2 product is primarily responsible for our enormous achievement in revenue growth, and the increase in our gross margin to 95%, up from 82% in the first quarter of 2023. This marks the first time that BioStem has reported positive net income on a US GAAP basis, an important milestone for investors as we successfully transitioned from a net shareholders’ deficit position into a net positive equity position. Looking ahead, our focus remains on driving sustainable growth and continuing to innovate within the MedTech industry. We’re committed to increasing our presence in hospital wound care and other settings by broadening our product offerings and geographical footprint to meet the growing needs of wound care patients worldwide. We are very confident in our strategic direction as we move towards 2025."

"An uplisting has been an important goal for BioStem since the company’s inception. We believe that trading on a senior exchange will provide the company with increased market visibility, improved credibility, and the opportunity to engage with institutional investors. To facilitate this move, we have completed a rigorous two-year audit to meet the high standards required of us by the senior exchanges, enhancing our transparency and reinforcing our commitment to robust corporate governance. We are actively preparing our Form 10 registration, a key component of our strategy to transition from the OTC to a senior exchange. This uplisting will bolster our ongoing efforts to extend our market presence and deliver our innovative wound care solutions to a broader audience. We’re very excited about this significant milestone in our growth trajectory."

"We recently announced our intention to launch two clinical trials to evaluate the effectiveness of our products, Vendaje® and AmnioWrap2®, in treating non-healing Diabetic Foot Ulcers (DFU) and Venous Leg Ulcers (VLU), respectively. Both trials are designed as multi-center, randomized, controlled studies, and are expected to initiate in the fourth quarter of 2024. BioStem has engaged McCoy Clinical Consulting to lead these clinical trials. We believe that Nick McCoy’s extensive industry experience will be an asset as we work to expedite our trial processes. These studies will allow BioStem to showcase the effectiveness of our tissue allograft products in a real-world clinical setting."

"The proposed LCDs suggest limiting the number of applications of a skin substitute within a 12-week episode of treatment for a particular wound to only four applications, a move that could significantly impact patient care. We believe that these caps are contrary to clinical evidence and may result in harm to patients. Wound care clinicians, drawing from years of experience, argue that many large wounds need more than the proposed four applications to heal completely, and that some wounds may require up to six weeks of weekly applications before showing improvement. This suggests the need for a reevaluation of the proposed limitation.Also, the reduction in covered products from more than 200 to just 15 could lead to shortages of skin substitutes, which will significantly impact patients, increasing the risk of severe complications and even amputation.We are taking a multi-faceted approach to respond to the proposed LCDs. We submitted our formal comments to all of the MACs proposed LCDs on June 8, and we have initiated advocacy efforts, collaborations with industry partners, public awareness campaigns, and potential legal challenges to protect patient access to our products. We are in the process of initiating several randomized controlled trials (RCTs) to support the clinical efficacy and superiority of our BioREtain products."