BIOSTEM TECHNOLOGIES INC Miami, Florida--(Newsfile Corp. - July 16, 2024) - Innovation is the lifeblood of the MedTech sector. Literally. Discoveries made are more than value drivers for the companies behind them; they can be life savers to millions needing better and more effective healthcare solutions. While that need is straightforward enough, history shows that, in most cases, it's not an easy deliverable. A scrutinizing FDA, the capital-intensive nature of discovery, and the lengthy timelines to earn marketing approvals often keep a lid on a company's ability to turn ambition into products and, better still, revenues. The excellent news, however, is that some companies, including Florida-based BioStem Technologies Inc. (OTC Pink: BSEM), are overcoming these formidable challenges. Getting to that point is not from coincidence.
For BioStem, it results from navigating the meticulous steps required to satisfy regulators, meet a compelling need with effective products, and successfully targeting open doors of opportunity to generate potential ROI from commercialization approvals. Despite its small-cap classification, BioStem appears well-positioned to capitalize on and maximize value from products that target specialized indications in the regenerative medicine and MedTech sector.
BioStem's growth is attributed to sticking to its mission of discovering, developing, and producing the most effective regenerative medicine products in the world. That intent isn't going unnoticed. Recent milestones and successfully navigating strategic initiatives have led to BioStem earning the prioritization of the examination of the patent for one of its key value drivers, BioRetain technology, by the U.S. Patent Office, a pivotal asset in the production of BioStem's best-in-class placental tissue allografts.
Advancing An Impressive Pipeline
Patent approvals protect development, market position, and the rewards of commercialization. But they aren't the primary value drivers. Tangible assets, and their potentials, take on that role, which BioStem assigns from its robust list of clinical programs that include VENDAJE™, VENDAJE™ AC, VENDAJE™ OPTIC, and AMNIOWRAP2, products that are processed at the company's FDA-registered and AATB-accredited site in Pompano Beach, Florida. The company is not short on optimism related to the potential of these assets. The VENDAJE™ and AMNIOWRAP2 products have been described as best-in-class placental tissue allografts that are more than innovative-they are transformative.
BioStem is backing that claim. AmnioWrap2® posted what BioStem called Breakthrough Results in its Retrospective Wound Care Study in a June 2024 update. Results were compelling, even published in a peer-reviewed journal, which noted that BioStem's products offer better overall treatment efficiency and greater efficiency in general wound closure. These results are timely.
Regenerative medicine, which harnesses the body's natural healing abilities, is set to revolutionize healthcare, ushered in part by the global stem cell market projected to reach $18.4 billion by 2028. That puts BioStem in the right markets at the right time, particularly regarding the growing interest and investment in stem cell research, which is in BioStem's development wheelhouse from its focus on perinatal tissue allografts, particularly those derived from the human placenta.
Familiarity with that specialization helps position BioStem at the forefront of this growing and essential sector. That's where the recent patent prioritization review adds value since BioStem's proprietary BioRetain® processing method maintains growth factors and preserves tissue structure, a competitive advantage over existing products that would be strengthened upon patent approvals.
Recognizing Pipeline and Project Potential
BioStem's progress has earned analyst attention. Zacks Small Cap Research models (ZSCR) for shares to reach $23.25 within the next twelve months, roughly 131% higher than its current $10.03. They support that forecast by noting in its report an expectation for unprecedented revenue growth, resulting from BioStem doing the essential groundwork to solidify its position as a top clinical-stage MedTech company by leveraging cutting-edge technology to develop and commercialize advanced therapies that address critical healthcare needs.
Optimism is warranted. BioStem's operational progress in 2023 has been remarkable. The company reported a year-over-year net revenue increase of 1,355% to $11.5 million in Q4, with a gross profit margin reaching 95%, up from 84% the previous year. These figures underscore BioStem's ability to scale its operations efficiently while maintaining high profit margins.
Additional value comes from acquiring assets from Auxocell Laboratories and the nationwide launch of AmnioWrap2 with Venture Medical LLC. These strategic initiatives have significantly expanded BioStem's capabilities and market reach. The initiation of a clinical trial for DFU and the commercialization agreements for Avenova Allograft with NovaBay further highlight BioStem's commitment to advancing its product pipeline and bringing additional innovative solutions to patients in a timeline it hopes will be sooner rather than later.
Also capturing attention is BioStem posting $41.9 million in revenues-a nearly 71-fold increase over the same period last year. This growth reflects BioStem's adept navigation through the complex regulatory landscape and ability to capitalize on market opportunities. Recognizing the growth velocity led to Zacks Small Cap Research raising its price target for the third time over the past few months. Included in the report is Zacks saying, "We reiterate our belief that BSEM is still underpriced even after its recent move higher and continues to represent a good opportunity at recent prices for investors to get in before what we believe will be a more aggressive move higher in the not-too-distant future."
Supporting Their Bullish Thesis
Reasons support ZSCPs bullish presumption. In addition to excellent products, they highlight BioStem's highly experienced commercial team focused on monetizing two major markets: diabetic wound care and surgical wound care. The global wound care market, valued at $20.8 billion in 2022, is projected to reach $27.2 billion by 2027. The diabetic foot ulcer treatment market, valued at $4.67 billion in 2021, is expected to grow at a compound annual growth rate (CAGR) of 5.9% from 2022 to 2030. BioStem's innovative solutions position it to significantly impact, and reap the potential spoils, from these markets.
Keep in mind that BioStem Technologies Inc. is not just another MedTech company but a pioneering force in regenerative medicine. Furthermore, they are generating impressive financial headlines, capitalizing on strategic market initiatives, and advancing what may be one of the most innovative product pipelines in the space. The potentially better news is that BioStem has notable support, including value from collaboration with distinguished clients and partners, including the Center for Medicare Services (CMS) and the U.S. Department of Veterans Affairs (V.A.). Those relationships can do more than accelerate study timelines; they instill market credibility, a valuable inclusion in the resume of a company looking to penetrate the multibillion-dollar soft tissue repair market, which is expected to reach around $8.6 billion by 2030.
BioStem's listing with the U.S. Department of Defense and Veterans' Administration, along with achieving CMS reimbursement for Vendaje AC® and AmnioWrap2, could help the company tap into that potential, noting they indicate the company's strong market position that's earned from achievements validating the efficacy and importance of BioStem's products.
Moving Ahead In 2024
It would be remiss not to factor in a leadership team that brings focus and marketing vision. Leading BioStem forward into an ambitious 2024 are CEO Jason Matuszewski and Chief Operating Officer Andrew Van Vurst, who co-founded the company in 2014. Both are driven by a passion for regenerative medicine, which contributes to the company's clear mission and understanding of how to take ideas and transform them into products that can save lives.
BioStem has also retained an experienced clinical research professional to lead its Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU) trials. These trials are proactive measures to address potentially changing reimbursement requirements by Medicare Administrative Contractors. With the healthcare landscape constantly evolving, BioStem's forward-thinking approach could ensure it remains ahead of regulatory and market changes, proving that great things can emerge from smallcap companies.
But keep in mind that while BioStem is "small," it isn't tiny. It currently holds a market cap of over $163 million with shares priced at $10.03. That makes BioStem nimble enough to move quickly toward opportunities and at the same time attract interest from institutional investors. Both are important for growth stocks. And with signs supporting the premise of this company shifting its growth pace into a higher gear, they can each contribute toward reaching the Zacks Small Cap Research price target that's 131% higher from here.
About BioStem Technologies, Inc. (OTC Pink: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain® processing method. BioREtain® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies' quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks ("AATB"). These systems and procedures are established per current Good Tissue Practices ("cGTP") and current Good Manufacturing Processes ("cGMP"). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE®, VENDAJE AC®, and VENDAJE OPTIC®. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida. For more information visit biostemtechnologies.com and follow us on Twitter and Linkedin.
AW2Trial Overview:
BioStem has received IRB approval to proceed with the clinical study evaluating AW2 in patients with diabetic foot ulcers. The primary endpoint of the study is the percentage of subjects whose target ulcer achieve complete wound closure within 12 weeks. Secondary endpoints comparing differences between treatment groups include the time to closure, percent change in wound area and volume at 12-weeks, total number of applications used to achieve complete wound closure, and time to closure for subjects that crossover. The safety endpoint will evaluate spontaneously reported and elicited adverse events, and the exploratory endpoint will assess the differences between treatment groups in clinical signs and symptoms of infection.
AW2 consists of unseparated amnion and chorion membranes, including the intact intermediate layer. The allografts contain collagen, extracellular matrix, and a wide array of regulatory proteins such as growth factors, cytokines, and chemokines. AW2 is a minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds.
BioStem recently announced breakthrough results using AmnioWrap2 in a retrospective wound care study. The article was published in the international, peer-reviewed journal, Health Science Reports, and validated its proprietary processing method and its placental allograft products. The article, titled Assessing placental membrane treatment efficiency in diabetic foot ulcers: Processing for retention versus lamination, provides a retrospective analysis of wound care in 41 subjects, and can be read HERE.
Forward-Looking Statements: Except for statements of historical fact, this release also contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified using words such as "forecast," "intend," "seek," "target," "anticipate," "believe," "expect," "estimate", "plan," "outlook," and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the reimbursement levels for the Company's products; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company's products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete;(4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company's ability to raise funds to expand its business; (6) the Company has incurred significant losses since inception and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company's ability to maintain production of its products in sufficient quantities to meet demand; and (10) the COVID-19 pandemic and its impact, if any, on the Company's fiscal condition and results of operations; You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
About BioStem Technologies, Inc. (OTC Pink: BSEM): BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies. The Company is focused on manufacturing products that change lives, leveraging its proprietary BioREtain® processing method. BioREtain® has been developed by applying the latest research in regenerative medicine, focused on maintaining growth factors and preserving tissue structure. BioStem Technologies' quality management system and standard operating procedures have been reviewed and accredited by the American Association of Tissue Banks ("AATB"). These systems and procedures are established per current Good Tissue Practices ("cGTP") and current Good Manufacturing Processes ("cGMP"). Our portfolio of quality brands includes AmnioWrap2™, VENDAJE®, VENDAJE AC®, and VENDAJE OPTIC®. Each BioStem Technologies placental allograft is processed at the Company's FDA registered and AATB accredited site in Pompano Beach, Florida. For more information visit biostemtechnologies.com and follow on Twitter and Linkedin.
AW2Trial Overview:
BioStem has received IRB approval to proceed with the clinical study evaluating AW2 in patients with diabetic foot ulcers. The primary endpoint of the study is the percentage of subjects whose target ulcer achieve complete wound closure within 12 weeks. Secondary endpoints comparing differences between treatment groups include the time to closure, percent change in wound area and volume at 12-weeks, total number of applications used to achieve complete wound closure, and time to closure for subjects that crossover. The safety endpoint will evaluate spontaneously reported and elicited adverse events, and the exploratory endpoint will assess the differences between treatment groups in clinical signs and symptoms of infection.
AW2 consists of unseparated amnion and chorion membranes, including the intact intermediate layer. The allografts contain collagen, extracellular matrix, and a wide array of regulatory proteins such as growth factors, cytokines, and chemokines. AW2 is a minimally manipulated dehydrated tissue allograft that serves as a protective covering for soft tissue wounds.
BioStem recently announced breakthrough results using AmnioWrap2 in a retrospective wound care study. The article was published in the international, peer-reviewed journal, Health Science Reports, and validated its proprietary processing method and its placental allograft products. The article, titled Assessing placental membrane treatment efficiency in diabetic foot ulcers: Processing for retention versus lamination, provides a retrospective analysis of wound care in 41 subjects, and can be read HERE.
Forward-Looking Statements: Except for statements of historical fact, this release also contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified using words such as "forecast," "intend," "seek," "target," "anticipate," "believe," "expect," "estimate", "plan," "outlook," and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the reimbursement levels for the Company's products; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company's products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete;(4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company's ability to raise funds to expand its business; (6) the Company has incurred significant losses since inception and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company's ability to maintain production of its products in sufficient quantities to meet demand; and (10) the COVID-19 pandemic and its impact, if any, on the Company's fiscal condition and results of operations; You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
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