Elutia Announces FDA Clearance of EluPro®: The First Antibiotic-Eluting BioEnvelope Designed to Protect Patients with Implantable Cardiac Pacemakers and Defibrillators
Elutia announced that its Antibiotic-Eluting BioEnvelope, EluPro, has received FDA clearance. This innovative product is designed to protect patients with implantable cardiac devices from complications such as infection, migration, and skin erosion. EluPro is the only biologic solution in the $600 million U.S. implantable electronic device protection market. Additionally, EluPro has been cleared for use with neurostimulators and neuromodulators, opening up an $8 billion market opportunity. The product combines antibiotic therapy with advanced tissue engineering to create a regenerative pocket for the device. Elutia plans to launch EluPro nationwide in the second half of 2024.
- FDA clearance of EluPro for protecting implantable cardiac devices.
- EluPro is the only biologic solution in the $600 million U.S. market.
- Clearance for additional uses including neurostimulators and neuromodulators.
- Potential access to an $8 billion global market for additional indications.
- Product combines antibiotic therapy and tissue engineering for enhanced device protection.
- Over 600,000 devices implanted annually in the U.S. present a significant market opportunity.
- Elutia plans to launch EluPro nationwide in the second half of 2024.
- High complexity and development costs since inception in 2019.
- Potential risks of market acceptance and adoption by healthcare providers.
- Possible financial strain from the rapid expansion and market penetration efforts.
- Prolonged time to market might delay revenue realization.
Insights
The FDA clearance of EluPro® marks a significant milestone for Elutia Inc. and has important financial implications. Firstly, the U.S. market for implantable electronic device protection is worth
Secondly, the ability of EluPro to extend its applications to neurostimulators and neuromodulators opens up an additional
From a financial perspective, the protected intellectual property extending beyond 2032 provides a long-term competitive advantage, safeguarding future revenue streams against entrants in the market. In the short-term, investors should watch for the impact on Elutia's financial results post-launch in the latter half of 2024, where initial sales figures will provide a clear indicator of market acceptance.
One potential drawback could be the cost associated with scaling up manufacturing and marketing efforts to meet anticipated demand across multiple market segments. However, if managed effectively, these investments could yield substantial returns.
Finally, the healthcare cost savings due to reduced complications could be a strong selling point, likely resulting in favorable insurance coverage and adoption by healthcare providers.
EluPro's FDA clearance is a critical advancement in the field of implantable devices. The main medical benefit lies in its ability to reduce infection, migration and skin erosion, which are significant complications associated with pacemaker and defibrillator implants. By embedding antibiotics like rifampin and minocycline in the bioenvelope, EluPro provides extended protection directly at the surgical site.
The combination of tissue engineering and antibiotic delivery creates a stable, regenerative environment, which is important for reducing the body's foreign object response. This capability distinguishes EluPro from existing offerings and could set a new standard in post-operative care for implantable devices.
Additionally, the clearance for broader indications, including neurostimulators and neuromodulators, is noteworthy. These devices are used in a variety of conditions such as pain management, epilepsy and sleep apnea, all of which have high rates of implant-related complications. The ability to mitigate these complications could significantly improve patient outcomes and quality of life.
Nonetheless, it will be essential to monitor real-world data post-launch to gauge the long-term effectiveness and any unforeseen side effects of the product. The clinical success of EluPro could inspire further innovations in drug-eluting biomatrix technology.
Beyond the immediate financial and medical implications, EluPro’s entry into the market is strategically significant. The implantable electronic device protection market, primarily dominated by a single competitor until now, is poised for disruption. Elutia's unique positioning as the sole provider of a biologic envelope offers a compelling point of differentiation. This uniqueness should attract significant interest from healthcare providers looking for innovative solutions to reduce post-operative complications.
Moreover, the broader approval for neurostimulators and neuromodulators dramatically expands Elutia's addressable market. Given the substantial size of these markets and the lack of existing drug-eluting biomatrix solutions, EluPro can quickly capture a considerable market share. The company's strategy to prioritize these adjacent markets is sound, aligning with the growing demand for innovative, multifunctional medical devices.
It is also worth noting that the healthcare market is becoming increasingly value-driven. Products that not only enhance patient outcomes but also promise cost savings will have a competitive edge. Given EluPro’s potential to reduce hospitalization times and associated costs, it aligns well with this trend.
In the long-term, Elutia’s success with EluPro could pave the way for further advancements in this technology, reinforcing its position as a leader in drug-eluting biomatrix products.
EluPro becomes the only drug-eluting biologic envelope to receive FDA clearance in the
EluPro also granted clearance for indications beyond CIEDs, including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence, and sleep apnea
SILVER SPRING, Md., June 17, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today announced that its Antibiotic-Eluting BioEnvelope, EluPro® (referred to as CanGaroo®RM during development), has received clearance from the U.S. Food and Drug Administration (FDA). Specifically designed to prevent post-operative complications for devices such as pacemakers and defibrillators, EluPro incorporates powerful antibiotic therapy combined with advanced tissue engineering to create a BioEnvelope that over time regenerates into a protective pocket of the patient's own tissue. Infection, migration, and skin erosion are some of the most frequently encountered complications of pacemaker surgery, occurring in up to five to seven percent of cases. These cause significant patient morbidity and mortality, increase the length of hospitalization, and can add more than
The Company also announced that EluPro was granted clearance for indications beyond the cardiac implantable electronic devices (CIEDs), including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence, and sleep apnea. These additional markets, estimated to be
“When I implant a pacemaker or defibrillator, minimizing the risk of any future complications is crucial,” said Dr. Benjamin D’Souza, Associate Professor of Medicine at the University of Pennsylvania and Section Chief of Cardiac Electrophysiology at Penn Presbyterian Medical Center. “However, the body’s natural immunity can treat the device like a foreign object contributing to inflammation, causing device migration, potentially eroding through the skin, or sometimes causing a serious infection. Those are the specific problems EluPro was designed to solve. It combines the remodeling properties of regenerative medicine through extracellular matrix along with long-acting antibiotic delivery to create a healthy environment for every device implantation.”
The EluPro BioEnvelope is constructed from reinforced layers of natural extracellular tissue matrix and designed to create a conforming envelope with optimal stability for implantable electronic devices. The walls of EluPro are embedded with powerful antibiotics rifampin and minocycline, engineered for extended delivery directly into the surgical site long after closure. This unique combination of drug and biomatrix supports the regeneration of a healthy, vascularized pocket from the patient's own tissue, mitigating a long-term foreign body response.
“Post-operative infection, migration and erosion can result in significant morbidity and mortality for patients receiving a pacemaker or defibrillator. That is why we developed the antibiotic-eluting BioEnvelope,” said Dr. Randy Mills, Elutia’s Chief Executive Officer. "While the approval of EluPro is a major value inflection for Elutia, we believe it is just the tip of the iceberg. We have created a platform to protect patients from the foreign body response that can inevitably develop with any long-term implantable device. We intend to rapidly extend our product offering to other indications as we fulfill our mission to humanize medicine so patients can thrive without compromise.”
EluPro represents a significant opportunity in the
About Elutia
Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise,” “opportunity” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements regarding EluPro’s potential future success in the CIED protection market or in device protection for other types of implantable devices, like neurostimulators or neuromodulators, and statements regarding market size. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to continue as a going concern; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits; our ability to achieve or sustain profitability; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; the continued and future acceptance of our products by the medical community; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; and our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2023, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investors:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com
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