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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 (OTC: BSEM) announces nationwide launch of Vendaje AC® with Venture Medical following Medicare reimbursement approval across all MAC regions, effective October 1, 2024. This marks the company's second product available nationwide for treating chronic, non-healing wounds. The launch will begin in Q4 2024, leveraging Venture Medical as the exclusive sales and marketing partner. Vendaje AC®, manufactured using the BioREtain® process, retains important placental tissue elements for wound healing, including structural components, growth factors, and anti-inflammatory cytokines.
BioStem Technologies (OTC: BSEM), a MedTech company specializing in placental-derived biologics for advanced wound care, has scheduled its Third Quarter 2024 financial results release for Tuesday, November 12, 2024. The company will host a conference call and webcast at 4:30 PM ET, featuring CEO Jason Matuszewski and CFO Michael Fortunato discussing quarterly results. The event will be accessible via phone and webcast, with both domestic and international dial-in options available.
BioStem Technologies (OTC: BSEM) announces its participation in the 17th Annual LD Micro Main Event, scheduled for October 28-30, 2024, at the Luxe Sunset Boulevard Hotel in Los Angeles. Jason Matuszewski, Founder and CEO, will deliver a live presentation on October 30 at 9:30 AM PT and conduct one-on-one meetings.
The company has reported significant achievements in 2024, including record-breaking revenue of $116 million in the first six months. Recent milestones include breakthrough results in diabetic foot ulcer studies, establishing national pricing for Vendaje AC®, initiating the BR-AC-DFU-101 clinical trial, filing Form 10 with SEC, submitting a Nasdaq uplisting application, and receiving IRB approval for Vendaje® clinical study.
BioStem Technologies (OTC: BSEM) has announced that the Center for Medicare Services (CMS) has established national pricing for its allograft product, Vendaje AC® in all Medicare Administrative Contractor (MAC) regions, effective October 1, 2024. This allows BioStem to begin marketing Vendaje AC nationwide within the MAC regions.
The company will commercialize Vendaje AC through Venture Medical , a premier commercialization provider in the U.S. wound care market. Venture Medical, which has an extensive wound care sales team, is currently supporting BioStem with the successful launch of AmnioWrap2® and will now lead the distribution and marketing efforts for Vendaje AC nationwide.
BioStem Technologies has initiated the BR-AC-DFU-101 clinical trial to evaluate its BioREtain technology against standard care for non-healing diabetic foot ulcers (DFUs). The study involves 60 patients at 10 U.S. sites, with a completion target by the end of 2025. The trial aims to demonstrate that weekly applications of BioREtain will result in a higher rate of complete wound healing within 12 weeks compared to standard care alone.
Primary outcomes focus on the probability of complete wound closure, while secondary outcomes measure time to closure, wound area reduction, and the number of applications needed. BioStem aims to leverage successful results to enhance insurance coverage and market growth, building on its record revenue of over $100 million in the first half of 2024. DFUs are a significant health issue, affecting 15% of diabetics, with substantial risks for amputation and high treatment costs.
BioStem Technologies, Inc. (OTC: BSEM), a leading MedTech company focused on placental-derived biologics, has filed a Form 10 registration statement with the SEC on September 27, 2024. This marks a important step in the company's strategy to uplist to Nasdaq, reflecting its commitment to transparency and strong corporate governance. Once effective, BioStem will become a fully reporting company, enhancing its credibility and positioning for greater visibility and access to capital.
The company has also strengthened its compliance and reporting framework by completing two years of audited financial statements. CEO Jason Matuszewski emphasized that this move aligns with their strategic initiatives to enhance market visibility, financial transparency, and access to capital during a period of continued revenue growth. BioStem aims to drive revenue growth and market expansion for its products while pursuing its listing objectives.
BioStem Technologies (OTC: BSEM), a leading MedTech company in advanced wound care, will present at the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, at the Lotte New York Palace Hotel.
Jason Matuszewski, the CEO, will present on September 9th at 3:30 PM ET and be available for one-on-one meetings.
BioStem recently reported a record second-quarter revenue of $116.4M for H1, 2024. Qualified investors can register for the conference and schedule meetings via H.C. Wainwright's platform or by contacting BioStem directly through email at Jramson@pcgadvisory.com.
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.
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