BioCardia and StemCardia Announce Biotherapeutic Delivery Partnership
BioCardia, Inc. (BCDA) and StemCardia, Inc. partner to advance investigational stem cell therapy for heart failure, leveraging BioCardia's biotherapeutic delivery system. The partnership aims to accelerate clinical development and broaden future commercial access to an off-the-shelf heart regeneration treatment.
The partnership between BioCardia and StemCardia represents a significant advancement in the field of cardiovascular therapeutics, particularly in addressing heart failure, a condition that remains a leading cause of morbidity and mortality worldwide. The collaboration leverages BioCardia's Helix biotherapeutic delivery system , which has a proven safety profile and enables the direct transplantation of cardiac muscle cells into the heart. This system's minimally invasive nature is a critical factor as it may reduce patient recovery time and associated healthcare costs compared to more invasive procedures.
StemCardia's investigational pluripotent stem cell product candidate aims to re-muscularize the failing heart, which could potentially revolutionize the standard of care for heart failure patients. The success of this therapy in large animal models suggests a promising translational potential to human clinical trials. The partnership's goal to achieve FDA approval for an IND and move into Phase I/II clinical development is a crucial step, as it will provide the necessary regulatory framework to ensure patient safety and efficacy of the treatment.
From a research perspective, the combination of StemCardia's cell therapy candidate with BioCardia's delivery system could provide synergistic benefits, thereby enhancing the overall therapeutic efficacy. However, it is important to note that the path from IND approval to a successful Phase I/II trial and subsequent phases involves significant challenges, including demonstrating safety and efficacy in a larger human population and potential regulatory hurdles.
The strategic partnership between BioCardia and StemCardia is poised to have a notable impact on the financial health of both companies. BioCardia's role as the exclusive biotherapeutic delivery partner for StemCardia's cell therapy candidate could lead to diversified revenue streams through shared revenue, particularly if the therapy proves successful in clinical trials and gains market approval. The mention of offsetting the costs of biotherapeutic delivery development for BioCardia's own programs indicates a strategic financial move that could optimize R&D expenditures.
For investors, the partnership may be seen as a value-creating initiative, as it not only has the potential to bring a novel heart failure treatment to market but also demonstrates BioCardia's ability to form synergistic alliances that can accelerate clinical development. This could enhance investor confidence and potentially lead to an increase in stock market valuation for both companies, assuming positive progress is reported in the development of the therapy. However, investors should be aware of the inherent risks in biotechnology investments, particularly in the clinical stage where success is not guaranteed and capital is extensively required.
It is also worth considering that the heart failure treatment market is highly competitive, with several other companies and research institutions working on alternative therapies. The success of BioCardia and StemCardia's partnership will depend not only on the efficacy and safety of the treatment but also on their ability to navigate the market dynamics, including pricing, accessibility and reimbursement challenges.
In the context of the broader healthcare market, the partnership between BioCardia and StemCardia taps into the growing demand for regenerative medicine treatments. Heart failure affects millions of individuals globally, creating a substantial market opportunity for effective treatments. The development of off-the-shelf cardiac muscle cells could address a significant unmet need in the market, offering a potential competitive advantage over existing treatments that are often limited by availability, compatibility, or the need for highly invasive procedures.
Market penetration will hinge on the clinical success of the therapy, its cost-effectiveness and the ability to scale production to meet demand. The partnership's emphasis on an 'off-the-shelf' solution suggests a focus on scalability and accessibility, which are key factors for widespread adoption. Additionally, the therapeutic landscape for heart failure is evolving with advancements in personalized medicine and biotechnology and the entry of a new therapy could disrupt existing treatment paradigms, potentially leading to a re-evaluation of standard care practices.
Long-term, the partnership's success could also influence investment and strategic decisions across the biotechnology sector, as companies may seek to emulate the collaborative approach to accelerate the development and commercialization of innovative therapies. The ability to successfully navigate the regulatory landscape and demonstrate clear patient benefits will be pivotal in determining the partnership's impact on the market.
03/13/2024 - 07:00 AM
Partnership targets heart failure, the leading cause of death and a condition with limited treatment options BioCardia’s biotherapeutic delivery system with established safety profile enables minimally invasive transplantation of StemCardia’s off-the-shelf cardiac muscle cells SUNNYVALE, Calif., March 13, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, and StemCardia, Inc. , a biotechnology company focused on cell and gene therapy to re-muscularize the failing heart, today announced a long-term partnership to advance StemCardia’s investigational pluripotent stem cell product candidate for the treatment of heart failure.
Under the partnership, BioCardia is the exclusive biotherapeutic delivery partner for StemCardia’s cell therapy candidate through studies expected to result in FDA approval of an investigational new drug application (IND) and the anticipated Phase I/II clinical development to follow.
“BioCardia has established safe and minimally invasive delivery of cellular medicines directly into the heart,” said Chuck Murry, MD, PhD, StemCardia’s Founder and CEO. “Having worked with BioCardia to successfully deliver our bona fide cardiac muscle cells in large animal models of heart failure, we are excited for this partnership to accelerate clinical development and broaden future commercial access to an off-the-shelf heart regeneration treatment.”
“StemCardia’s team encompasses recognized leaders in the field of cardiac regenerative medicine who are pursuing an elegant strategy to repair the failing heart. We look forward to supporting their efforts with our experienced team and proven, proprietary Helix™ biotherapeutic delivery system,” said BioCardia CEO Peter Altman, PhD. “This partnership is expected to enhance future treatment options for millions of people suffering from heart failure, offset the costs of biotherapeutic delivery development for our own programs, and provide our investors with meaningful revenue sharing should our efforts together contribute to StemCardia’s successful therapeutic development.”
About StemCardia
StemCardia, Inc., is developing cell and gene therapies engineered to repair the heart. The company’s mission is to advance off-the-shelf treatments for heart failure, bringing together leading experts in heart regeneration, cell manufacturing, and genetic medicine. Few treatments are available today, and none are curative. Inspired by the observation that the heart does not regenerate itself, our unique approach is to manufacture and transplant cardiac muscle cells to directly re-muscularize the failing heart and restore its function.
About BioCardia
BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also works with partners to provide its proprietary Helix transendocardial biotherapeutic delivery system, as well as technology and services for the development and commercialization of partners’ therapeutic agents.
About Helix
The Helix transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart. Helix empowers a seamless transition from bench to commercialization for partners.
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, the potential for the therapy and the partnership, future revenues and cost offsetting and future clinical trials. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 29, 2023, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
BioCardia Investor Relations and Media Contact: investors@biocardia.com , 650-226-0120
StemCardia Investor Relations and Media Contact: info@stemcardia.com
What is the partnership between BioCardia and StemCardia focused on?
The partnership aims to advance StemCardia's investigational pluripotent stem cell product candidate for the treatment of heart failure.
What is BioCardia's role in the partnership?
BioCardia is the exclusive biotherapeutic delivery partner for StemCardia's cell therapy candidate.
Who is Chuck Murry in relation to StemCardia?
Chuck Murry is StemCardia's Founder and CEO.
What is the anticipated outcome of the partnership?
The partnership aims to result in FDA approval of an investigational new drug application (IND) and subsequent Phase I/II clinical development.
What is the significance of this partnership for BioCardia?
The partnership is expected to enhance future treatment options for heart failure patients, offset biotherapeutic delivery development costs, and provide revenue sharing for investors.
