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BIOSTEM TECHNOLOGIES NEW - BSEM STOCK NEWS

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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.

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BioStem Technologies (OTC: BSEM) has received a Notice of Allowance from the USPTO for its patent application covering sterile human placental allografts with slits, openings, and fenestrations. The patent (No. 12,144,831) will grant on November 19, 2024, marking the first patent granted for tabular fenestrated allografts. The technology features flaps that allow exudate escape while maintaining surface area, suitable for acute and chronic wound care. The company's IP portfolio now includes 42 issued patents and 27 pending applications. The product, utilizing BioStem's BioREtain® process, is under development and will follow the HCT/P regulatory pathway.

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BioStem Technologies (OTC: BSEM) has signed a Letter of Intent to acquire commercial-stage products and development technologies from ProgenaCare Global. The acquisition includes ProgenaMatrix, the first commercially available human keratin matrix for wound care, and revyve Antimicrobial Wound Gel. The deal aims to expand BioStem's wound care portfolio and leverage its commercial infrastructure. ProgenaMatrix is FDA 510(k) cleared for various indications including venous stasis ulcers and diabetic foot ulcers. The transaction is expected to be finalized within 60 days, subject to regulatory approvals and Board consent.

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BioStem Technologies (BSEM) reported record Q3 2024 revenue of $82.6 million, up from $3.5 million in Q3 2023, marking their third consecutive quarter of record growth. The company achieved $199.0 million in revenue for the first nine months of 2024, with a gross profit margin of 94.9%. Q3 net income reached $6.8 million ($0.42 per share), compared to a loss of $1.5 million in Q3 2023. The growth was primarily driven by strong sales of AmnioWrap2® allografts. The company has filed for Nasdaq uplisting and initiated nationwide launch of Vendaje AC® following Medicare reimbursement approval.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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FAQ

What is the current stock price of BIOSTEM TECHNOLOGIES NEW (BSEM)?

The current stock price of BIOSTEM TECHNOLOGIES NEW (BSEM) is $14.44 as of December 20, 2024.

What is the market cap of BIOSTEM TECHNOLOGIES NEW (BSEM)?

The market cap of BIOSTEM TECHNOLOGIES NEW (BSEM) is approximately 251.0M.

What sets BioStem Technologies apart from competitors?

BioStem Technologies differentiates itself with the proprietary BioREtain® processing method that preserves tissue structure and growth factors, ensuring effective regenerative therapies.

What products does BioStem Technologies offer?

BioStem Technologies' portfolio includes quality brands like AmnioWrap2™, VENDAJE®, VENDAJE AC®, and VENDAJE OPTIC®, all aimed at providing cutting-edge regenerative solutions.

Where are BioStem Technologies' products processed?

All BioStem Technologies placental allografts are processed at the FDA-registered and AATB-accredited site in Pompano Beach, Florida, ensuring quality and safety.

How does BioStem Technologies contribute to the wound care market?

BioStem Technologies plays a significant role in the wound care market by leveraging natural properties of perinatal tissue to develop allografts that support wound healing and tissue regeneration.

What is the significance of BioStem Technologies' recent patent approval?

BioStem Technologies' patent approval for their method of processing human amniotic tissue strengthens their intellectual property and positions them as a leader in regenerative medicine.

BIOSTEM TECHNOLOGIES NEW

OTC:BSEM

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251.01M
9.35M
Biotechnology
Healthcare
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United States of America
Pompano Beach