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BioStem Technologies is a leading innovator in regenerative therapies, utilizing perinatal tissue to develop and commercialize allografts that change lives. Their proprietary BioREtain® processing method preserves tissue structure and growth factors, setting them apart in the market. With quality brands like AmnioWrap2™ and VENDAJE®, BioStem Technologies is at the forefront of regenerative medicine.
BioStem Technologies Inc. (OTC: BSEM) has received Institutional Review Board (IRB) approval for a clinical study evaluating Vendaje® against standard care for non-healing diabetic foot ulcers (DFUs). The study aims to accelerate product adoption by providing data to healthcare professionals and payers on Vendaje's benefits. Vendaje is a placental-derived allograft using BioStem's proprietary BioREtain technology.
The multi-center, randomized, controlled study will assess the percentage of subjects achieving complete wound closure within 12 weeks as its primary endpoint. Secondary endpoints include time to closure, percent change in wound area, and total applications used. This research supports BioStem's growth strategy and aims to secure broader payer coverage, including Medicare.
BioStem Technologies (OTC: BSEM) reported record Q2 2024 revenue of $74.5 million, contributing to a total of $116.4 million for H1 2024. This marks a significant increase from $1.6 million in H1 2023. The company achieved its second consecutive quarter of positive net income, reaching $6.3 million. AmnioWrap2 continues to be a major growth driver with a 56.5% sequential revenue increase from Q1 2024.
Key financial highlights include:
- Q2 2024 gross profit of $70.7 million (95% margin)
- Adjusted Q2 2024 EBITDA of $10.0 million
- Cash position increased to $6.6 million, up $6 million from Q1
The company received IRB approval for a study evaluating AmnioWrap2 in diabetic foot ulcers, aiming to expand payer insurance coverage in the advanced wound care market.
BioStem Technologies (OTC: BSEM), a leading medtech company specializing in placental-derived allografts for advanced wound care, has announced it will release its second quarter 2024 financial results on Monday, August 12, 2024, after market close. The company will host a conference call and webcast at 4:30 PM ET to discuss the results.
The webcast will feature an overview of the quarter from CEO Jason Matuszewski and CFO Michael Fortunato. Interested parties can register for the event through the provided link. The live and archived webcast will also be available on the BioStem Technologies website under the Investors section.
BioStem Technologies Inc. (OTC Pink: BSEM) is making significant strides in the MedTech sector with innovative wound-care treatments. The company's focus on regenerative medicine and placental tissue allografts has led to impressive developments, including the prioritization of its BioRetain technology patent by the U.S. Patent Office. BioStem's product lineup, including VENDAJE™ and AMNIOWRAP2, has shown promising results in wound care studies.
The company reported a remarkable 1,355% year-over-year increase in Q4 net revenue to $11.5 million, with a gross profit margin of 95%. BioStem's strategic initiatives and product launches have expanded its market reach, positioning it to capitalize on the growing global wound care market, projected to reach $27.2 billion by 2027.
BioStem Technologies (OTC: BSEM) has received Institutional Review Board (IRB) approval for a clinical study of AmnioWrap2™ (AW2) in treating diabetic foot ulcers (DFU). DFU is a severe complication of diabetes, leading to amputations and high healthcare costs. The study aims to evaluate the efficacy of AW2, targeting complete wound closure within 12 weeks. Secondary endpoints include time to closure, reduction in wound area and volume, and safety assessments. BioStem’s AW2 uses BioREtain™ technology, which includes unseparated amnion and chorion membranes. This trial follows promising retrospective results published in Health Science Reports. Upon successful completion, BioStem plans to seek expanded payer insurance coverage for AW2 in the DFU market.
BioStem Technologies (OTC: BSEM) announced the publication of a study in Health Science Reports, showcasing the effectiveness of its AmnioWrap2® for diabetic foot ulcers (DFUs). The study analyzed 41 subjects and compared BioStem's RE-AC, processed with the BioREtain® method, with a competitor's L-AC. Results showed that RE-AC reduced DFU areas by 67.3% over 12 weeks, compared to 52.6% for L-AC, and required fewer applications. Both methods had similar probabilities for complete wound closure. CEO Jason Matuszewski highlighted the clinical advantages and cost-efficiency of BioStem's products. Clinical studies are planned for 2024.
BioStem Technologies (OTC: BSEM) is sponsoring the MRO Better Half Dash, a popular annual NASCAR event, on May 29, 2024, at Trackhouse Motorplex in Mooresville, NC. This event features wives and girlfriends of professional racing drivers in competitive go-kart races, showcasing their talents and providing a unique spectacle for fans. Key participants include Ariana Jencik and Parker Retzlaff. Ariana, who has a background in racing and graduated from the NASCAR Technical Institute, will be competing part-time in the Late Model division. Parker Retzlaff, a prominent driver in the NASCAR Xfinity Series, praised the event for giving women a platform to shine. The event supports Darby's Warrior Support, a cause dedicated to assisting soldiers. CEO of BioStem Technologies, Jason Matuszewski, emphasized the company's pride in supporting this meaningful cause. The event will be aired on Fox Sports 1 on June 5th.
BioStem Technologies reported a record first quarter revenue of $41.9 million for 2024, marking a significant 71-fold increase from $0.6 million in Q1 2023. This impressive growth is attributed to the commercial success of AmnioWrap2®, a placental-derived allograft product. Gross profit surged to $39.7 million, representing 95% of revenue, up from 82% in the same period last year. The company also achieved a positive GAAP net income for the first time, reflecting strong financial health. Operationally, BioStem completed a two-year audit, expanded processing capacity, and enhanced its clinical capabilities. Key developments include the USPTO's prioritized examination of a critical patent and the engagement of McCoy Clinical Consulting for clinical trials.
BioStem Technologies Inc. (OTC: BSEM) will report its first quarter 2024 financial results on Tuesday, May 14, 2024. The leading biotechnology company specializes in placental derived allografts for advanced wound care. A conference call and webcast discussing the financial results and corporate updates will be held at 4:30 pm ET on the same day.
BioStem Technologies Inc. (OTC: BSEM) has been granted Prioritized Examination by the USPTO for its patent application on STERILE HUMAN PLACENTAL ALLOGRAFTS AND METHODS OF MAKING THEREOF. This patent protects BioStem's method of processing human amniotic tissue, important for wound care treatment. The global wound care dressing market is projected to grow at a CAGR of 4.16% from 2024 to 2030.
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