At Elutia, our mission is to humanize medicine so that patients can thrive without compromise.
−Removed: As a commercial-stage company, we seek to leverage our unique understanding of biologics combined with local drug delivery to improve the interaction between implanted medical devices and patients by reducing complications associated with these surgeries.
−Removed: These complications include infection, device migration, erosion, implant rejection, non-union of implants, fibrosis and scar formation.
−Removed: We estimate that more than 700,000 surgical procedures were performed annually in the United States involving the implantation of medical devices such as pacemakers, defibrillators, neurostimulators or tissue expanders for breast reconstruction.
−Removed: This number has been driven by advances in medical device technologies, reimbursement models focused on patient outcomes, and an aging population with a growing incidence of comorbidities, including diabetes, obesity and cardiovascular and peripheral vascular diseases.
−Removed: These comorbidities can exacerbate various immune responses and contribute to other complications upon device implant.
−Removed: Our products are targeted to address unmet clinical needs with the goal of promoting healthy tissue formation and avoiding complications associated with medical device implants, such as scar tissue formation, capsular contraction, erosion, migration and infection.
−Removed: We currently focus on our priority markets – Device Protection and Women’s Health.
−Removed: In Device Protection, we sell EluPro, a unique bioenvelope designed to mitigate complications associated with the implantation of electronic medical devices such as pacemakers, internal defibrillators and neurostimulation devices.
−Removed: Complications addressed by EluPro include infection, device migration and erosion.
−Removed: The bioenvelope features a biomatrix comprised of extracellular matrix (“ECM”), which supports healthy wound healing and may facilitate re-operative procedures by reducing scar formation and fibrosis.
−Removed: Additionally, EluPro is embedded with the powerful antibiotics rifampin and minocycline, which are gradually released into the surrounding tissue over several weeks post-implantation
−Removed: to provide antimicrobial protection.
−Removed: EluPro is the only drug-eluting biomatrix (“DEB”) offering in the U.S.
−Removed: implantable electronic device protection market.
−Removed: Alongside EluPro, we market the CanGaroo bioenvelope, our first generation product, which uses the same biomatrix but does not contain antibiotics.
−Removed: In Women’s Health, we have developed both patented and proprietary technologies, culminating in the creation of SimpliDerm—a novel biological matrix that leverages the inherent science of natural healing processes.
−Removed: SimpliDerm’s design uses human-based hydrated acellular dermal matrix (“HADM”) with heightened structural integrity and superior handling capabilities, which may mitigate inflammation and enhance tissue incorporation, leading to a better healing experience as compared to other human acellular dermal matrices (“ADM”), both lyophilized and pre-hydrated.
−Removed: We believe that these acellular dermal matrices represent an ideal choice for tissue repair and reconstruction, finding applications in fields such as breast reconstruction, sports medicine, hernia repair and trauma reconstruction.
−Removed: We also sell legacy products into the Cardiovascular market.
−Removed: In Cardiovascular, we sell our specialized porcine small intestine submucosa, which is based on the same biomatrix used in EluPro and CanGaroo, for use as an intracardiac and vascular patch as well as for pericardial reconstruction.
−Removed: In addition, our TYKE product is designed for use in the neonatal patient population.
−Removed: These cardiovascular products are sold in the United States through an exclusive distribution agreement with LeMaitre Vascular.
−Removed: This agreement also provided LeMaitre with an option to acquire the Cardiovascular product line through March 2026.
−Removed: Our growth strategy is focused on increasing penetration in the Device Protection and Women’s Health markets.
−Removed: We believe we can grow our business by increasing our commercial footprint, developing clinically exceptional products and, when possible and appropriate, through inorganic opportunities.
−Removed: Our go-to-market strategy includes a combination of a direct sales force, commercial partners and independent sales agents.
−Removed: EluPro and CanGaroo are sold through both our internal sales force and independent sales agents and our commercial partner, Boston Scientific Corporation (“Boston Scientific”).
−Removed: As of December 31, 2024, we had 11 direct sales representatives and 31 independent sales agents focused on expanding market access and driving market penetration, not only by selling our products, but also, where appropriate, by managing commercial partners and providing technical expertise.
−Removed: SimpliDerm is sold through both independent sales agents and our distributor, Tiger Aesthetics Medical (“Tiger”).
−Removed: Through our direct sales force and leveraging our existing commercial partners and sales agents, we believe we can expand our customer base and further strengthen our existing customer relationships and increase penetration in our priority markets.
−Removed: We have a well-established and scalable internal manufacturing facility along with our corporate headquarters and other administrative location.
−Removed: Our Roswell, Georgia location is our processing, production and distribution facility for all of our implantable electronic Device Protection and Cardiovascular products.
−Removed: Our Silver Spring, Maryland location is our headquarters and functions as a research and development and corporate support center.
−Removed: Our San Diego, California location provides additional administrative oversight and support.
−Removed: With the sale of our Orthobiologics Business in November 2023 to Berkeley as described in further detail below, we no longer operate our former Richmond, California human tissue processing and distribution facility;
−Removed: however, we continue to have a contract manufacturing relationship with Berkeley under which we receive SimpliDerm.
+Added: We develop proprietary drug-eluting biomatrix products for use in surgical reconstruction and related applications.
+Added: These products are designed to improve the interaction between implanted medical devices and patients.
+Added: Our focus is on addressing unmet medical needs and reducing complications associated with surgery, including infection, migration, erosion, implant rejection, and fibrosis.
+Added: Our operations span research and development through the commercial distribution of biologic matrix products used in plastic and reconstructive surgery.
+Added: We have applied these capabilities to develop and commercialize products for specific surgical applications.
+Added: As more fully described below, on October 1, 2025, we divested one such product family through the sale of substantially all of the assets related to our business of developing, commercializing, manufacturing, selling and marketing our cardiac implantable electronic device (“CIED”) products, EluPro™ and CanGaroo®, to Boston Scientific Corporation (“BSC”) and Cardiac Pacemakers Inc (“CPI”) for an aggregate purchase price of up to $88.0 million in cash.
+Added: EluPro was the first antibiotic-eluting biologic matrix envelope for use with CIEDs.
+Added: This transaction reflects the technical and commercial value of solutions developed using our biologic matrices and local drug delivery capabilities.
+Added: Following the sale of the CIED business, we are focused on advancing our drug-eluting biomatrix (“DEB”) platform.
+Added: This platform builds on our biologic matrix and local drug delivery capabilities to address complications that lead to poor outcomes in reconstructive procedures and surgical repair.
+Added: EluPro demonstrated the commercial potential of combining a biologic scaffold with antibiotic drug delivery to reduce device-related complications.
+Added: We believe the same foundational technology can be applied to reconstructive and soft tissue repair markets where biologic matrix products are widely used, but where outcomes remain suboptimal due to complications such as infection, inflammation, and fibrosis.
+Added: Our lead development programs comprise NXT-41, a next-generation biologic matrix, and NXT-41x, which builds on the NXT-41 matrix by incorporating local antibiotic drug delivery.
+Added: NXT-41 is an advanced biomatrix designed to provide consistent handling and incorporation while enabling scalable manufacturing.
+Added: In NXT-41x, antibiotics are incorporated into the matrix and released locally over extended periods, offering broad-spectrum antimicrobial protection
+Added: against common causes of post-surgical infection.
+Added: See “Research and Development” below for a more detailed description of these anticipated future products in our reconstructive surgery portfolio.
+Added: Elutia continues to market and sell its proprietary biologic matrix products, including SimpliDerm, a human acellular dermal matrix (“hADM”) used in soft tissue reconstruction, and its cardiovascular repair portfolio, comprising ProxiCor, VasCure, and Tyke.
+Added: SimpliDerm is the primary commercial product in our Women’s Health segment, and the cardiovascular products reside in our Cardiovascular segment.
+Added: These products establish our commercial presence in surgical repair and reconstruction and provide a revenue base that supports development of our next-generation innovation.
+Added: These products are sold directly to healthcare facilities through independent sales agents.
+Added: In 2025, we leased approximately 26,598 square feet of production, laboratory, and administrative space in Gaithersburg, Maryland, which now serves as our headquarters and primary operations site.
+Added: This facility supports administrative functions as well as the development of NXT-41 and NXT-41x and, subject to obtaining the necessary FDA marketing authorizations, is expected to support the commercial production of these products.
+Added: We also maintain a corporate office in San Diego, California.
+Added: Our former Roswell, Georgia facility was acquired by Boston Scientific Corporation in connection with the sale of the CIED business in October 2025.
+Added: As part of the sale of our Orthobiologics Business to Berkeley Biologics, LLC (“Berkeley”) in November 2023, our former Richmond, California facility was transferred to Berkeley, and we no longer operate that facility.
+Added: Discontinued Operations - Sale of CIED Businesses
+Added: On September 8, 2025, we executed an Asset Purchase Agreement (the “APA”) with BSC and CPI (collectively the “CIED Buyers”).
+Added: On October 1, 2025, at the closing of the transactions contemplated by the APA, the CIED Buyers purchased from Elutia substantially all of the assets that are related to our business of researching, developing, administering, operating, commercializing, manufacturing, selling and marketing our CIED products, including the CanGaroo®, CanGaroo® RM, EluPro™ and CIED envelope products, including next generation CIED envelope products (collectively the “CIED Business”).
+Added: The APA provides for an aggregate purchase price, subject to certain adjustments pursuant to the terms of the APA, of up to $88.0 million in cash, with $80.4 million (which included an inventory adjustment of $0.4 million) that was paid in cash to Elutia at closing of the transactions and $8.0 million that was deposited at the closing of the transactions in escrow for a period of twelve months, which is subject to potential reduction in the event of certain post-closing breaches of representations and warranties within the APA by Elutia.
+Added: The assets of the CIED Business constituted substantially all of the assets previously held in Elutia’s Device Protection segment.
+Added: The CIED Buyers only assumed certain liabilities related to performance of the contracts transferred in the APA.
+Added: We recognized a gain, net of tax effect and divestiture costs, of $76.1 million on the sale of the CIED Business in 2025.
+Added: Prior to the divestiture, we marketed EluPro and CanGaroo in the United States through our direct sales force, supported by a commercial partner, BSC.
+Added: As part of the divestiture, the sales organization supporting the CIED business transferred to the CIED Buyers.
Discontinued Operations - Sale of Orthobiologics Business
On November 8, 2023, we completed the sale of substantially all of the assets relating to our former Orthobiologics Business to Berkeley.
−Removed: The Orthobiologics Business was comprised of assets relating to researching, developing, administering, insuring, operating, commercializing, manufacturing, selling and marketing our Orthobiologics products, and the business of contract manufacturing of particulate bone, precision milled bone, cellular bone matrix, acellular dermis, soft tissue and other products.
−Removed: The assets sold represent the entirety of our Orthobiologics segment.
−Removed: In the sale, we received approximately $14.6 million, and we may earn up to an additional $20 million, in the aggregate, in the form of earn-out payments.
+Added: The assets sold represented the entirety of our Orthobiologics segment.
+Added: We received approximately $14.6 million, and we may earn up to an additional $20.0 million, in the aggregate, in the form of earn-out payments.
The earn-out payments are equal to 10% of the actual revenue earned by Berkeley in each of the five years after the closing of the sale from sales of specified Orthobiologics products under the purchase agreement (including improvements, modifications, derivatives and enhancements related to those products).
There have been no earn-out payments made to date.
−Removed: Additionally, the purchase agreement provides for a customary indemnity holdback in
−Removed: the amount of $1.5 million to be retained by Berkeley for 24 months after close.
−Removed: In the purchase agreement, the Company has retained the liabilities arising out of the VBM and FiberCel matters, as described in Note 17, both of which products were part of the Orthobiologics Business.
+Added: In the purchase agreement, we have retained the liabilities arising out of the VBM and FiberCel recall matters, as described in Note 17 to the consolidated financial statements, both of which products were part of the Orthobiologics Business.
We recognized a gain of $6.0 million on the sale of the Orthobiologics Business in 2023 and an additional gain of $0.2 million in 2024 from an adjustment payment related to the final working capital received by Berkeley at the sale date.
−Removed: The indemnity holdback is available as a source of recovery for Berkeley for claims of indemnification under the purchase agreement, and some or all of the holdback may be retained by Berkeley if Berkeley is successful in asserting a claim or claims for indemnification against us.
−Removed: Should we receive incremental proceeds in the future through an earn-out payment or payment of the holdback amount, an additional gain will be recorded upon the receipt of such amounts.
+Added: Additionally, the purchase agreement provided for a customary indemnity holdback in the amount of $1.5 million to be retained by Berkeley for 24 months after closing of the transaction.
+Added: The indemnity holdback was available as a source of recovery for Berkeley for claims of indemnification under the purchase agreement, and some or
+Added: all of the holdback could be retained by Berkeley if Berkeley was successful in asserting a claim or claims for indemnification against us.
+Added: In March 2026, the indemnity holdback was resolved with Berkeley remitting $0.4 million to Elutia.
+Added: Such amount will be recognized as additional gain in the first quarter of 2026.
+Added: Should we receive incremental proceeds in the future through an earn-out payment, an additional gain will be recorded upon the receipt of such amounts.
Our Competitive Strengths
−Removed: Our mission is to provide advanced regenerative care products that improve the outcomes in patients primarily undergoing implantable device-related surgery.
−Removed: To accomplish this mission, we intend to establish our products as the standard of care for treating patients undergoing such procedures.
+Added: Our mission is to humanize medicine so patients can thrive without compromise.
+Added: We intend to establish our DEB products as the standard of care in reconstructive procedures, including surgeries involving implanted devices.
We believe our key competitive strengths position us well to execute on our growth strategy.
Our key competitive strengths are:
+Added: Focus on Unmet Medical Need.
+Added: Reconstructive surgeries, including implant-based procedures, are widely performed and play a critical role in restoring function and quality of life for patients.
+Added: Despite advances in surgical techniques and the widespread use of biologic matrices and other adjunctive materials, clinically significant complication rates persist.
+Added: Surgical site infection rates in certain settings reach approximately 15 to 20 percent.
+Added: These serious complications can result in rehospitalizations, procedure failure, prolonged recovery, and increased healthcare utilization.
+Added: In addition to infection, inflammatory responses, fibrosis, and foreign body reactions can adversely affect surgical outcomes and long-term implant performance.
+Added: We believe the complication rates reflect an ongoing unmet medical need for solutions that more effectively address the causes of surgical failure.
+Added: This unmet need drives continued demand for improved products that can help to improve clinical outcomes.
Pioneering Technology.
−Removed: We are developing and commercializing products in the unique and innovative category of DEB.
−Removed: Our commercial DEB offering, EluPro, is the world’s first and only antibiotic-eluting biologic envelope cleared by the U.S.
−Removed: Food and Drug Administration, and represents a breakthrough for implantable electronic device procedures.
−Removed: Through advanced tissue engineering, EluPro integrates clinically proven antibiotics with natural ECM to create a soft, conforming bioenvelope that provides optimal device stability and protection against infection.
−Removed: We believe that our DEB technology will redefine patient outcomes and procedural success.
−Removed: Our Integrated Company.
−Removed: Our end-to-end capabilities spanning research and development (“R&D”), manufacturing and commercialization enable us to continually advance our product portfolio and drive commercial growth.
−Removed: For example, our integrated structure allows us to receive market feedback from our sales team on unmet physician and patient needs, providing us with invaluable direction on our innovation priorities.
−Removed: It is this feedback, for example, that allowed us to refine our SimpliDerm product to have, what we believe to be, industry-leading handling properties.
+Added: We are developing and commercializing products in our DEB platform that integrates biologic matrices with localized drug delivery.
+Added: The goal of this approach is to address persistent, unresolved challenges associated with implant-based and reconstructive procedures, such as infection and inflammation, while preserving the regenerative benefits of biologic matrices.
+Added: We believe that combining these capabilities requires specialized expertise in regenerative materials, drug incorporation, manufacturing and regulatory development.
+Added: Our platform builds on the established markets of biologic matrix for tissue repair and soft tissue reconstruction, with the addition of localized delivery of therapeutic agents intended to address key underlying factors that lead to surgical complications.
+Added: By delivering drugs directly at the surgical site, this approach is designed to achieve localized therapeutic activity while limiting systemic exposure.
+Added: We are also designing these products to support extended release, extending the period during which the surgical site may be protected.
+Added: We believe this integrated platform can be adapted across multiple surgical applications where biologic matrices are widely used, and where there remains a need to improve clinical outcomes.
+Added: The development and commercialization of EluPro validated the technical feasibility of this approach.
+Added: EluPro was an antibiotic-eluting biologic matrix envelope designed to secure CIEDs and provide local antibiotic delivery at the implant site.
+Added: It was the first product of this type developed for use with CIEDs and demonstrated the commercial potential of combining a biologic matrix with localized drug delivery.
+Added: We believe this experience supports the broader applicability of our DEB platform across reconstructive and soft tissue repair markets.
+Added: Proven Commercialization.
+Added: Our first commercial DEB offering, EluPro, was fully launched in January 2025 and upon sale to BSC in October 2025, sales of EluPro and CanGaroo had achieved annualized revenues of approximately $19 million, with EluPro comprising approximately $14 million of the total.
+Added: We believe that this rapid sales growth rate demonstrates our ability to successfully and meaningfully commercialize our pioneering DEB product offerings.
Well-positioned in Large, Attractive and Growing Markets .
−Removed: We believe that the Device Protection, Women’s Health and Cardiovascular markets, which we believe currently represent a combined market opportunity of greater than $1 billion in the United States, will continue to experience significant growth, given advancements in implantable medical device technologies and surgical techniques;
−Removed: shifting global demographics that include an aging population with a greater incidence of comorbidities, and increasing procedure volumes.
−Removed: We believe there is growing adoption of regenerative medicine products by the medical community as physicians become aware of the benefits of natural products, including improved healing and reduced inflammation, scar-tissue formation and foreign body response.
−Removed: Large and Growing Body of Clinical Data .
−Removed: We have and continue to develop a body of pre-clinical, clinical and patient outcomes data, including third-party publications and patient registries that provide evidence supporting the technical and clinical attributes of our products.
−Removed: We believe that our extensive in vivo and clinical data give us a competitive advantage.
−Removed: Commercial Relationships with Major Medical Device Companies.
−Removed: We have commercial agreements with major medical device companies, including our strategic relationships with Boston Scientific, Tiger and LeMaitre Vascular, which we collectively refer to as our commercial partners, to promote or commercialize some of our products.
−Removed: These commercial partners use their own network of approximately 1,100 sales representatives, clinical specialists and independent sales agents, including approximately 1,000 of which are focused on our CanGaroo product.
−Removed: We leverage this additional presence in targeted markets to significantly increase our opportunity to cost-effectively penetrate these large markets.
−Removed: Executive Management Team with Extensive Experience in Regenerative Medicine.
−Removed: Our executive management team has extensive experience in the regenerative medicine and medical device industries, spanning R&D,
−Removed: operations, manufacturing and commercial.
+Added: We believe that the plastic and reconstructive surgery markets, the markets targeted by our next-generation antibiotic-eluting biomatrix products, NXT-41 and NXT-41x, currently represent a combined market opportunity of approximately $1.5 billion in the United States.
+Added: We believe these markets are characterized by procedures with relatively high per-procedure economic value, which supports the adoption of differentiated technologies that address meaningful clinical complications.
+Added: We also believe that the overall markets to which our DEB products can be applied will continue to experience significant growth given (i) advancements in implantable medical device technologies and surgical techniques, (ii) shifting demographics that include an aging population with a greater incidence of comorbidities, and (iii) increasing procedure volumes.
+Added: Integrated Operating Model.
+Added: Our operating model is designed to support integrated execution across research and development (“R&D”), manufacturing and commercialization, enabling close coordination among these functions and the incorporation of clinical and market feedback into product design and development.
+Added: As we advance our DEB platform and pipeline programs, we intend to maintain control over manufacturing to support product quality, manage cost of goods, and scale production as needed.
+Added: We believe this integrated approach supports disciplined development, operational flexibility, and efficient scaling.
+Added: Executive Management Team with Extensive Industry Experience Our executive management team has extensive experience in the regenerative medicine and medical device industries, spanning R&D, operations, manufacturing and commercial.
This experience allows us to operate with a deep understanding of the underlying trends in this industry and the intertwined scientific, clinical, regulatory, commercial and manufacturing functions that drive success.
−Removed: We believe our team has the necessary experience to lead us through our continued commercial expansion and the development and launch of our pipeline products.
+Added: This breadth of experience supports execution of our platform strategy.
Our Growth Strategy
−Removed: The key elements of our growth strategy are:
−Removed: Increase Penetration in Our Target Markets.
−Removed: We believe that the potential for growth in our target market segments presents a long-term opportunity to increase the use of our products.
−Removed: We plan to continue our growth and accelerate our penetration into our target markets through our direct sales force and by leveraging our relationships with our commercial partners, Boston Scientific, Tiger and LeMaitre Vascular, each of which have well-established and significant infrastructure and experience in our target markets.
−Removed: Pipeline of Innovative Drug-Eluting Biologics Products.
−Removed: In June 2024, EluPro was cleared for marketing by the FDA and is the only DEB offering in the U.S.
−Removed: for use with cardiac implantable electronic devices (“CIED”), such as pacemakers and internal defibrillators.
+Added: Our growth strategy is focused on advancing our DEB platform and pipeline programs to address unmet needs in reconstructive surgery, while maintaining a disciplined operating approach following recent divestitures.
+Added: Advance our Pipeline of Innovative Drug-Eluting Biologic Products.
We are pioneering DEBs to help solve problems unaddressed by available options.
−Removed: We intend to leverage our DEB platform technology by developing and commercializing products for markets with similar unmet needs, including breast reconstruction and neurostimulation.
−Removed: Our Proprietary Products/Solutions
−Removed: Our portfolio of regenerative medicine products has been developed to address the following specific markets:
−Removed: Device Protection and Cardiovascular Markets
−Removed: Market Opportunity
−Removed: We estimate, based on industry sources and other third-party estimates, that there were more than 600,000 procedures in the United States to install or replace implantable electronic devices (“IED”), such as pacemakers, pulse generators and defibrillators, as well as spinal cord neuromodulators and vagus nerve, deep brain and sacral nerve stimulators, which represents an estimated $600 million opportunity.
−Removed: Limitations of Existing Solutions
−Removed: CIEDs are used extensively to treat cardiac arrhythmias as well as heart failure.
−Removed: While these devices are generally well tolerated, they are not free from complications.
−Removed: In 2015, a group of third-party researchers published a systematic review and meta-analysis of 60 published reports, consisting of 21 prospective, nine case-control and 30 retrospective cohort studies published between 1981 and 2013, each of which examined the rate of infection associated with the implantation of electronic devices.
−Removed: The average rate of infection was between 1.0 and 1.3% and the reported rates of infection ranged from 0.3% to 16.4%.
−Removed: In 2019, a different group of third-party researchers published the results of a global, prospective randomized clinical study focused on infection complications of implantable electronic cardiovascular devices which identified a 1.2% infection rate during 12-month follow-up in the control arm (3,488 patients), and this was later reported by other third-party researchers in 2020 to rise to 1.9% at the 36 months follow-up.
−Removed: However, infection is not the only significant complication associated with implantation.
−Removed: Data from third-party studies published in 2011 and 2016 indicated that migration occurred in 0.5% to 10.9% of such procedures, and data from third-party studies published in 2001 and 2007 indicated that erosion of the device through the skin occurred in 0.2% to 5.0% of such procedures.
−Removed: Thus, migration and erosion have been shown to be similarly frequent and can both result in infection or require replacement of the device.
−Removed: Other complications include those associated with Twiddler’s syndrome, which is a malfunction of a pacemaker due to manipulation of the device by the patient, and discomfort at the implant site.
−Removed: Overall, we estimate the rate of complication for CIED placement ranges from 7% to 11%.
−Removed: As patients with implants live longer, device reoperations are ever more common, including those to replace or upgrade the device, or to replace or revise the wire leads.
−Removed: Due to an inflammatory response upon device implant, some patients may experience the formation of dense fibrotic tissue surrounding their device.
−Removed: This dense, under-vascularized capsule surrounding a device and its wire leads makes replacement or revision more difficult, increases the time needed for the extraction and replacement procedure and progressively increases the risk of infection.
−Removed: For neurostimulator devices, the common location of these devices, which is in the soft tissue of the abdomen or back, increases the risk of migration and erosion and that of patient discomfort when sleeping or sitting.
−Removed: Fibrotic tissue and scar can also encapsulate these devices.
−Removed: Device envelopes were originally designed to enhance stability and reduce migration of the implanted devices.
−Removed: To address the risk of infection, TyRx Pharma (“TyRx”) launched an antibiotic coated, resorbable synthetic envelope in 2013.
−Removed: In 2014, Medtronic acquired TyRx and now sells this product under the name TYRX ™ .
−Removed: The utilization of TYRX, a synthetic mesh, presents several challenges.
−Removed: Notably, the material's rigidity and limited sizes options require larger incisions during surgery or modification of the envelope, which may compromise its ability to stabilize the CIED.
−Removed: Furthermore, the foreign body response, which can lead to the formation of fibrous capsules around synthetic material, poses significant hurdles.
−Removed: Excessive scar tissue resulting from this response may extend surgery times and complicate future device replacement and revision surgeries.
−Removed: Our Solutions
−Removed: EluPro was created as a unique bioenvelope designed to secure implanted devices, mitigating complications such as migration and erosion.
−Removed: The bioenvelope features a biomatrix comprised of ECM, which supports healthy wound healing and may facilitate re-operative procedures by reducing scar formation and fibrosis.
−Removed: Additionally, EluPro is embedded with the powerful antibiotics rifampin and minocycline, which are gradually released into the surrounding tissue over several weeks post-implantation to provide antimicrobial protection.
−Removed: 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.
−Removed: Alongside EluPro, we continue to market CanGaroo which was designed to mitigate complications deriving from implantable electronic devices and the shortcomings of synthetic envelopes.
−Removed: Data supports that the biomatrix in our bioenvelope products forms a natural, systemically vascularized pocket that conforms to and securely holds implantable electronic devices.
−Removed: EluPro and CanGaroo are cleared for use with pacemaker pulse generators, defibrillators and other cardiac implantable electronic devices as well as vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
−Removed: EluPro and CanGaroo are both constructed from perforated, multi-laminate sheets of decellularized, non-crosslinked, lyophilized porcine small intestine submucosa (“SIS”) ECM, a natural biomaterial, which is rich in natural growth factors, structural proteins and collagens.
−Removed: This creates a soft, conforming envelope with excellent handling features and optimal stability for implantable electronic devices.
−Removed: The ECM is designed to mitigate the biologic foreign body response that normally occurs around the electronic device.
−Removed: The biomatrix is remodeled into a surrounding layer of vital, vascularized tissue, potentially reducing the risk of thick capsule formation, migration and erosion of the implantable device through the skin, and complications associated with Twiddler’s syndrome.
−Removed: Bioenvelopes may also enhance patient comfort and facilitate the process of implantation and of device removal during its replacement.
−Removed: EluPro has a shelf life of nine months and CanGaroo has a shelf life of 30 months.
−Removed: Development Pipeline
−Removed: EluPro received clearance by the FDA in June 2024, and we are building on this marketing authorization with stability studies to support a Special 510(k) filing for additional sizes.
−Removed: We also have ongoing initiatives to extend shelf life and reduce the cost to manufacture EluPro as production volumes increase.
−Removed: Commercial Approach
−Removed: We sell EluPro and CanGaroo in the United States using our direct sales force and our commercial partner, Boston Scientific, which acts as a sales agent and gives us access to approximately 900 sales representatives and clinical specialists to further expand our footprint and accelerate our sales.
−Removed: Our primary customers are electrophysiologists, cardiac surgeons and neurosurgeons.
−Removed: Our direct sales force is focused on gaining additional market access and driving market penetration, not only by selling our products, but also, where appropriate, by managing our commercial partners and providing technical assistance for selling our products.
−Removed: Our sales team provides the critical knowledge of the advantages that EluPro and CanGaroo provide for patients over those of our competitors.
−Removed: We ship the product directly to hospitals.
−Removed: Cardiovascular Products
−Removed: We also sell additional cardiovascular products derived from our specialized SIS ECM, all of which received 510(k) regulatory clearance as medical devices:
−Removed: ● ProxiCor for Cardiac Tissue Repair (“CTR”) is cleared for use as an intracardiac patch for repairs such as atrial and ventricular septal defects and suture-line buttressing, as well as for pledgets.
−Removed: ProxiCor CTR enables cardiac and congenital heart surgeons to reestablish the essential native anatomical structures of the heart by providing a natural bio-scaffold that allows the patient’s own cells to form a new tissue layer versus a synthetic patch which may calcify over time.
−Removed: ● ProxiCor for Pericardial Closure (“PC”) is used to reconstruct the pericardium after heart surgery.
−Removed: Data shows that post-operative complications associated with open-heart surgery are reduced in patients who have had their pericardium reconstructed.
−Removed: By providing a protective covering over the heart, ProxiCor PC may help protect the heart during repeat sternotomies.
−Removed: ● Tyke was developed based on a request by pediatric cardiovascular surgeons to deliver an ECM material that maintained the biomechanical properties found in our existing products, but was thinner, more pliable and better suited for intracardiac and branch pulmonary artery use in neonates and infants.
−Removed: Tyke is cleared for use in neonates and infants for the repair of pericardial structures;
−Removed: as an epicardial covering for damaged or repaired cardiac structures;
−Removed: and as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing and cardiac repair.
−Removed: Tyke is the only extracellular material that has been specifically cleared for use in neonates and infants to repair cardiac structures.
−Removed: ● VasCure is cleared for use, and is used by, cardiovascular, vascular and general surgeons as, a patch material to repair or reconstruct the peripheral vasculature, including the carotid, renal, iliac, femoral and tibial blood vessels, by modeling into site-specific tissue and conforming to repair defects easily.
−Removed: VasCure is also cleared and is used for the closure of vessels, as a pledget, or for suture line buttressing when repairing vessels.
−Removed: Unlike synthetic or cross-linked materials, VasCure approximates normal tissue and, we believe, is, therefore, less likely to provoke an immune response.
−Removed: In April 2023, we entered into an agreement with LeMaitre Vascular, a provider of vascular devices, implants and services, granting LeMaitre Vascular the exclusive U.S.
−Removed: distribution rights for the products within our cardiovascular segment:
−Removed: ProxiCor PC, ProxiCor CTR, Tyke and VasCure.
−Removed: The term of the collaboration is three years, and LeMaitre Vascular has the exclusive option to acquire the product line through March 2026.
−Removed: Clinical Data
−Removed: We have accumulated a substantial body of clinical and pre-clinical data for our Device Protection products.
−Removed: We believe that the reported outcomes from our studies help to differentiate our products in the marketplace.
−Removed: Pre-clinical Studies
−Removed: Recently published data in Frontiers in Drug Delivery by Garrigos et al.
−Removed: demonstrated that EluPro, the first FDA-cleared antibiotic-eluting biologic envelope, effectively reduces bacterial colonization associated with CIEDs.
−Removed: Using a well-established rabbit model of CIED infection, the study showed that EluPro achieved complete eradication of methicillin-resistant Staphylococcus aureus (“MRSA”) and other bacterial strains while providing sustained local antibiotic release for over a week with minimal systemic exposure.
−Removed: None of the animals receiving EluPro exhibited signs of infection, whereas the control group developed infections and associated complications.
−Removed: These findings highlight EluPro’s potential to address bacterial contamination, a major concern in CIED procedures, and support its role in reducing infection risk for patients receiving implantable devices.
−Removed: Earlier published pre-clinical data from a rabbit model showed that the CanGaroo Envelope was more successful in providing a barrier surrounding a CIED compared to a pacemaker canister alone.
−Removed: When implanted with a pacemaker, CanGaroo Envelopes promoted significantly greater stabilization of the device and more vascularized tissue ingrowth within the pocket compared to implantation with only standard fixation methods, such as sutures through the CIED header or no fixation at all.
−Removed: These data were initially presented as a live podium presentation at the American Society for Artificial Internal Organs (“ASAIO”) 2022 annual conference and published in abstract form in ASAIO Journal.
−Removed: Clinical Studies
−Removed: To evaluate our CanGaroo Envelope, we have conducted multiple post-market studies and are currently conducting prospective studies that comprise over 2,000 patients in total.
−Removed: We believe the results from the completed studies provide evidence supporting the benefits of the biomatrix in EluPro and CanGaroo when used for the implantation of CIEDs in humans.
−Removed: CARE Study and SECURE Study
−Removed: The CARE Study, a retrospective, post-market investigation, gathered data from 96 consecutive patients who underwent simultaneous implantation of CIED and CanGaroo Envelope at a single institution.
−Removed: The SECURE Study, a prospective, single-arm, observational, post-market study, included 1,026 patients from 39 centers who underwent CIED implantation within a CanGaroo Envelope.
−Removed: Combining data from both studies resulted in a comprehensive analysis involving a total of 1,102 patients from 40 centers across the United States.
−Removed: The dataset, with an average of 2.3 infection risk factors per patient and a mean follow-up time of 223 days, was utilized to evaluate overall clinical outcomes and adverse events.
−Removed: Common risk factors among the enrolled patients encompassed oral systemic anticoagulants, obesity, diabetes, congestive heart failure, device replacement/revision, and renal insufficiency.
−Removed: This real-world dataset revealed physician practice patterns for usage of the CanGaroo Envelope, and the type of hydration solutions that were chosen by the treating physician.
−Removed: Physicians demonstrated a preference for usage of an antibiotic hydration solution in higher infection risk patients (p<.05), particularly gentamicin, and those patients had an equivalent major infection rate to lower risk patients receiving a saline soaked CanGaroo (p=NS).
−Removed: Of the total sample population, 14 patients (1.3%) developed hematoma requiring intervention, and 12 patients (1.1%) developed a pocket infection - 10 of which (0.9%) came from the antibiotic without gentamicin hydration group.
−Removed: The use of gentamicin was associated with a threefold reduction in infection risk (OR 3.0, 95% CI, 1.0 – 10.0).
−Removed: A major contributing factor to pocket infection rate was whether the site also employed guideline recommended preoperative intravenous antibiotics (IV ABX) alongside use of an antibacterial envelope;
−Removed: sites utilizing IV ABX on ≥80% of their patients had significantly lower infection rates than sites that used it on <80% of their patients (0.8% vs.
−Removed: 5.6%, p=.008).
−Removed: There were no reports of device migration in the total dataset.
−Removed: These results were presented and published as separate sub-analyses of the dataset at multiple national conferences between 2017 – 2022, and collectively in a recent publication, and highlight the importance of evaluating real world evidence for CIED envelopes, and conjunctive use alongside other guideline recommendations for high infection risk patients.
−Removed: We believe the low rates of CanGaroo Envelope complications observed in the CARE and SECURE Studies support the safety of the product when used clinically in human CIED implantation.
−Removed: CARE Plus Study
−Removed: The CARE Plus Study, a single-center, post-market, retrospective cohort study, assessed outcomes in patients undergoing CIED implantation with either a biologic CanGaroo Envelope, Medtronic’s non-biologic TYRX envelope, or
−Removed: The study, published in Cureus in May 2022, included results from 455 patients (165 CanGaroo, 219 TYRX, and 71 no envelope).
−Removed: Analysis of adverse patient outcomes and events occurring up to 12 months post-implantation revealed that most patients with at least two infection risk factors received an antibacterial envelope (77.9% any envelope vs.
−Removed: 52.1% no envelope, p<.001).
−Removed: The overall rate of adverse events was 9.2% (n = 42), with low rates of pocket infection (0.4%) and hematoma (2.6%), and no significant differences between groups in overall or individual adverse event rates.
−Removed: The findings suggest the potential benefit of antibiotic-eluting CIED envelopes in reducing infection risk for high-risk patients.
−Removed: The study also presented a decision tree to aid clinical decision-making regarding CIED envelope usage.
−Removed: The HEAL Study was a retrospective cohort study of CIED patients who were presenting for reoperation after a prior implantation.
−Removed: The study was designed to compare the characteristics of soft tissue healing surrounding CIED implants with or without an envelope.
−Removed: A total of 46 patients were enrolled, categorized into three cohorts based on whether a biologic CanGaroo Envelope, Medtronic’s non-biologic TYRX Envelope, or no envelope was employed during their prior implantation.
−Removed: During reoperation, the current implant pockets of the patients were examined and compared using both a blinded histological biopsy and visual assessment through photographs.
−Removed: Positive outcomes from the HEAL Study, were presented at Heart Rhythm Society (HRS 2023).
−Removed: The study assessed patients who underwent CIED implantation with CanGaroo Envelope, Medtronic’s TYRX non-biologic envelope, or no envelope, returning for a revision procedure at least four months post-implantation.
−Removed: In the interim analysis of 43 patients, CanGaroo demonstrated statistically significant advantages, with reoperations scoring 46% easier in generator mobilization (p=.02), 41% easier in lead mobilization (p=.01), and 43% less overall procedural difficulty (p=.04) compared to the no-envelope group.
−Removed: CanGaroo required significantly fewer capsulectomy procedures (83% less, p=.04), and histologic evaluation revealed 30% thinner capsules compared to no envelope (p=0.12) and 32% thinner capsules compared to TYRX (p=.09).
−Removed: The study findings underscore the potential of CanGaroo to enhance CIED implantation outcomes and streamline subsequent reoperative procedures.
−Removed: CanGaroo S-ICD Pilot Study
−Removed: A retrospective, single-center, post-market pilot study was designed to evaluate whether low voltage lead impedance (“LVZ”), as routinely measured by subcutaneous implantable cardioverter defibrillators (“S-ICDs”), could be a clinically relevant assessment.
−Removed: These devices sense changes in impedance, which could be influenced by fibrotic tissue surrounding the S-ICD.
−Removed: Such encapsulation could complicate future procedures for patients.
−Removed: LVZ changes from 0 to 4 years post implantation of an S-ICD were analyzed in 24 patients, half of whom received CanGaroo Envelope and half received no envelope.
−Removed: LVZ measurements reliably detected changes in impedance over time and between groups.
−Removed: After an initial decrease in both groups in the first month, impedance changes appeared to increase more slowly in the CanGaroo cohort compared to patients in the no envelope cohort out to 30 months.
−Removed: The data, presented at the European Society of Cardiology 2022 Congress and published in European Heart Journal , suggest that LVZ may provide a non-invasive assessment of surrounding tissue quality.
−Removed: Further study is needed to determine whether use of a CanGaroo Envelope may stabilize impedance changes long-term.
−Removed: CanGaroo Registry Study
−Removed: The CanGaroo Registry Study is a prospective, multi-center registry that completed enrollment at 500 patients (329 CanGaroo and 171 no envelope) in December, 2022.
−Removed: The objective is to explore clinical profiles, procedural details, and post-implant outcomes of patients who received the CanGaroo Envelope or no envelope at time of initial ( de novo ) CIED implantation.
−Removed: All patients will be followed for three months postoperatively, and a subgroup of patients aged 65 years or younger at time of enrollment will undergo extended follow-up for up to five years.
−Removed: EluPro Registry Study
−Removed: The EluPro Registry Study is a prospective, multi-center, post-market study enrolling up to 100 participants undergoing CIED procedures utilizing the EluPro Antibiotic-Eluting BioEnvelope.
−Removed: The primary objective is to evaluate
−Removed: the real-world safety and performance of the bioenvelope.
−Removed: Data on rates of complications —including infection, hematoma, lead dislodgement, device migration or erosion, and implant site complications—over a 12-month follow-up period will be collected and analyzed.
−Removed: In addition to standard clinical endpoints, the study incorporates novel patient-centric measures, including post-implant pain and satisfaction, to provide a more comprehensive assessment of patient experience and quality of life following CIED implantation.
−Removed: By integrating both clinical and patient-reported outcomes, this registry aims to generate real-world evidence on the impact of the EluPro Antibiotic-Eluting BioEnvelope in routine clinical practice, and will offer insights into both safety and patient well-being.
+Added: We intend to leverage our DEB platform technology, and our demonstrated success related to these products, by developing and commercializing products for markets with similar unmet needs, including breast reconstruction.
+Added: We intend to prioritize investment in the development of our DEB platform and pipeline programs.
+Added: These programs build on our experience integrating biologic matrices with localized drug delivery and are designed to address persistent surgical complications, such as infection and inflammation, in reconstructive procedures.
+Added: We plan to advance these programs through continued research and development, preclinical evaluation, regulatory engagement, and clinical evaluation.
+Added: Focus on Surgical Applications with Significant Unmet Need.
+Added: We are focusing our development efforts on surgical applications characterized by high complication rates and significant procedural complexity.
+Added: We believe these factors create opportunities for differentiated solutions that can improve clinical outcomes while fitting within existing surgical workflows.
+Added: Our initial focus is on implant-based reconstructive surgeries and soft tissue repair applications, with the potential to expand into additional indications where our DEB platform may be applicable.
+Added: Maintain and Expand our Commercial Foundation.
+Added: We plan to continue to operate our existing commercial product portfolio and sales infrastructure to support ongoing operations and maintain market presence.
+Added: These commercial activities, which we anticipate growing significantly upon, and subject to, FDA clearances of NXT-41 and NXT-41x, also provide insight into surgeon needs, purchasing trends, and clinical practice patterns, which we believe can inform development priorities for our pipeline programs.
+Added: Over time, we may continue to assess the role of these products as we advance our proprietary platform technologies.
+Added: Our Proprietary Products
+Added: Our portfolio includes a combination of commercial biologic matrix products and development-stage drug-eluting biomatrix programs.
+Added: Our commercial products address established markets in surgical repair and reconstruction and provide a revenue base that supports ongoing operations and research and development.
+Added: Our development efforts are focused on advancing our drug-eluting biomatrix platform to address unmet needs in reconstructive surgery.
Women’s Health Market
Market Opportunity
−Removed: According to certain third-party estimates, the use of acellular dermal matrices in breast construction surgery in the United States grew 29% in 2022 versus 2020, with such surgeries now constituting an approximately $500 million market.
−Removed: Such surgery is performed to treat structures of the human body that are affected aesthetically or functionally due to defects, abnormalities, trauma, infection, burns, tumors or disease.
−Removed: Plastic and reconstructive surgery is generally performed to improve function and ability, but it may also be performed to achieve a natural appearing restoration of the affected anatomical structure.
−Removed: Clinical practice of plastic and reconstructive surgery includes excision of tumors of the skin, vasculature, chest, oral and oropharyngeal cavities and extremities and reconstructions of the same;
−Removed: debridement, skin grafting and skin flaps for burn reconstructions;
−Removed: trauma surgery for the hands, upper and lower limbs and facial region;
−Removed: congenital or acquired malformations related to the hands, face, skull and jaw;
−Removed: surgical removal of vascular abnormalities;
−Removed: a range of aesthetic surgeries;
−Removed: and reconstructions of the breast.
−Removed: One of the most common applications of biologic matrices in plastic and reconstructive surgery is breast reconstruction surgery after mastectomy.
−Removed: Mastectomy is surgical removal of the breast tissue, including the tumor, to treat breast cancer.
−Removed: It is estimated that more than 10% of women will develop invasive breast cancer in their lifetimes, which in 2022, led to approximately 150,000 post-mastectomy breast reconstructions in the U.S.
−Removed: Breast reconstruction surgery restores a breast to near normal shape and appearance and can be performed using either a prosthetic breast implant, referred to as implant-based reconstruction, or the patient’s own tissue, referred to as autologous reconstruction.
−Removed: In 2022, plastic surgeons used ADMs in approximately 76,000 women, reconstructing approximately 125,000 breasts.
−Removed: About two-thirds of these procedures involved reconstruction of both breasts.
−Removed: The use of these materials is well-characterized in the clinical literature and recommended by recent U.S.
−Removed: and European consensus guidelines for certain surgical techniques.
−Removed: As of January 2025, no biologic matrix or any other soft tissue reinforcement material, including our product, has been approved or cleared by the FDA specifically for use in breast reconstruction surgery.
−Removed: Limitations of Existing Solutions
−Removed: Autologous tissue repair procedures are options for stabilizing soft tissue defects in various applications.
−Removed: However, these methods have limitations.
−Removed: The procedure may not be surgically feasible or the patient may decline its use.
−Removed: In addition, autologous tissue reconstruction may cause complications, such as infection, extended recovery and healing time, loss of sensation or weakness at the donor site and prolonged time under anesthesia during surgery.
−Removed: Synthetic products provide a substitute when autologous reconstruction is not feasible or desired.
−Removed: Yet, they too have their limitations.
−Removed: Implantation of products not recognized by the body as “self” may trigger a foreign body reaction.
−Removed: The result of this signaling cascade is encapsulation of the foreign body in fibrotic tissue, which may impede tissue healing and lead to capsular contracture which occurs when scar tissue, or capsule, around the device tightens and squeezes the implant.
−Removed: This can cause both visible deformity as well as severe pain.
−Removed: Other major issues are damage to the surrounding soft tissue, altering of the mechanical properties or appearance of the original tissue and increased risk of infection.
−Removed: ADM products offer an “off the shelf” biologic choice for reconstructive procedures, but they have their own limitations.
−Removed: The use of harsh chemicals to remove the cells can damage the extracellular matrix.
−Removed: The products can lack uniformity as determined by pliability in each direction, elasticity and non-uniform thickness.
−Removed: Such issues can affect how
−Removed: rapidly, and the extent to which the implant is integrated, as well as the resulting tissue strength.
−Removed: In addition, there is a limited availability in larger sizes for some of these products.
−Removed: We designed SimpliDerm to offer improved biocompatibility and better tissue integration in the patient.
−Removed: It is marketed for use for the repair or replacement of damaged or insufficient integumental tissue or for the repair, reinforcement or supplemental support of soft tissue defects or any other homologous use of human integument.
−Removed: SimpliDerm is a pre-hydrated, human ADM manufactured with our patented cell removal technology, a process that maintains the biological and structural integrity of the tissue’s extracellular matrix components and is designed to allow for rapid integration, cellular repopulation and revascularization at the surgical site.
−Removed: Its structurally intact extracellular matrix is designed to closely resemble natural, healthy tissue.
−Removed: Development Pipeline
−Removed: Elutia is leveraging its DEB technology, first developed for EluPro, to create SimpliDermRM, a novel, next generation biomatrix for breast reconstruction.
−Removed: Clinical literature suggests that more than 10% of breast reconstruction patients experience post-operative infections, often requiring a major surgical procedure to remove the implant.
−Removed: SimpliDermRM is being developed to address this and other surgical complications by combining the structural benefits of porcine acellular dermis with antibiotic protection.
−Removed: As a Class III medical device, it will require FDA premarket approval (“PMA”) before commercialization.
−Removed: To advance this program, Elutia is preparing for an investigational device exemption (“IDE”) which we anticipate submitting by the end of 2025 to initiate a pilot clinical study.
−Removed: SimpliDermRM is designed to provide soft tissue reinforcement while targeting the high complication rates associated with implant-based breast reconstruction, which range from 26% to 31%.
−Removed: These complications include capsular contracture, delayed healing, and surgical site infections, some of which may lead to life-threatening sepsis.
−Removed: While biomaterial matrices are commonly used in reconstructive procedures, no FDA-approved medical device specifically addresses these risks.
−Removed: Existing options have not sufficiently reduced complication rates, leading to additional surgical interventions and negatively impacting patient quality of life.
−Removed: By integrating antibiotics within its biologically derived matrix, SimpliDermRM aims to mitigate bacterial colonization, enhance tissue integration, and improve long-term surgical outcomes for breast reconstruction patients.
+Added: Biologic matrices are widely used in reconstructive surgery to provide soft tissue support, reinforcement, and coverage in a range of clinical settings.
+Added: These procedures are performed to restore form and function following trauma,
+Added: tumor resection, congenital abnormalities, infection, or disease, and include applications involving the breast, chest wall, and other soft tissue defects.
+Added: The use of acellular dermal matrices (“ADMs”) in plastic and reconstructive surgery is well established in clinical practice and supported by published literature and consensus guidelines for certain surgical techniques.
+Added: Breast reconstruction following mastectomy represents a common application of biologic matrices within plastic and reconstructive surgery.
+Added: It is estimated that, in the United States, approximately one in eight women will develop invasive breast cancer during their lifetime, which results in approximately 163,000 post-mastectomy breast reconstruction procedures.
+Added: In these procedures, ADMs are frequently used in implant-based reconstruction to assist with implant positioning, provide soft tissue support, and facilitate tissue integration.
+Added: Despite widespread adoption of biologic matrices in this and other reconstructive applications, clinically meaningful complication rates persist, with reported serious infection rates in certain settings reaching approximately 15 to 20 percent, along with delayed healing and implant-related complications.
+Added: As of February 2026, no biologic matrix or other soft tissue reinforcement material has been indicated specifically for use in breast reconstruction surgery by the U.S.
+Added: Food and Drug Administration.
+Added: SimpliDerm is an hADM marketed for use in soft tissue repair, reinforcement, and reconstruction.
+Added: It is manufactured using a proprietary decellularization process designed to preserve the structural integrity of the extracellular matrix while reducing immunogenic components.
+Added: SimpliDerm is provided in a pre-hydrated form and terminally sterilized.
+Added: We sell SimpliDerm through a network of independent sales agents to plastic and reconstructive surgeons in the United States.
+Added: From March 2023 through October 2025, SimpliDerm was also distributed under a non-exclusive agreement with Sientra and its successor, Tiger Aesthetics Medical (“Tiger”), which was terminated in October 2025.
+Added: SimpliDerm is part of our current commercial product portfolio and supports our commercial presence in plastic and reconstructive surgery.
+Added: It provides operational and market insight relevant to the advancement of our drug-eluting biomatrix development programs and strengthens our commercial channel with reconstructive and plastic surgeons, who routinely use biologic matrices in surgical reconstruction.
+Added: Our NXT-41x development program is initially intended for use in reconstructive applications, and SimpliDerm supports the development of surgeon relationships, experience, and organizational capabilities relevant to the potential introduction of our next-generation biologic drug-eluting technologies.
+Added: Cardiovascular Market
+Added: Cardiovascular Products
+Added: We sell cardiovascular products derived from a biologic matrix based on porcine small intestinal submucosa extracellular matrix (“SIS-ECM”), all of which received 510(k) regulatory clearance as medical devices:
+Added: ● ProxiCor for Cardiac Tissue Repair is cleared for use as an intracardiac patch for repairs such as atrial and ventricular septal defects and suture-line buttressing, as well as for pledgets.
+Added: ● ProxiCor for Pericardial Closure is used to reconstruct the pericardium after heart surgery.
+Added: ● Tyke is a thinner, more pliable matrix cleared for use in neonates and infants for the repair of pericardial structures;
+Added: as an epicardial covering for damaged or repaired cardiac structures, and as a patch material for cardiac defects.
+Added: ● VasCure is cleared for use, and is used by cardiovascular, vascular and general surgeons as, a patch material to repair or reconstruct the peripheral vasculature, including the carotid, femoral and tibial blood vessels, by modeling into site-specific tissue and conforming to repair defects.
Commercial Approach
−Removed: We sell SimpliDerm through independent sales agents to plastic and reconstructive surgeons.
−Removed: Additionally, in March 2023, we entered into an agreement with Sientra, a medical aesthetics company uniquely focused on plastic surgery, to expand the distribution of SimpliDerm.
−Removed: In April 2024, such agreement was acquired by Tiger in connection with their asset acquisition of Sientra.
−Removed: Under the agreement terms, Elutia has granted Tiger certain non-exclusive rights in the United States to market, sell and distribute SimpliDerm.
−Removed: This agreement with Tiger gives us access to approximately 50 sales representatives to further expand our footprint and accelerate our sales.
−Removed: Clinical Data
−Removed: We have accumulated a substantial body of clinical and pre-clinical data for our Women’s Health products.
−Removed: We believe that the reported outcomes from our studies help to differentiate our products in the marketplace.
−Removed: Pre-clinical Studies
−Removed: In vitro studies were conducted to evaluate and compare SimpliDerm to native human dermis and two other commercially available HADMs, in terms of morphological structure, composition, physical characteristics and chemical and thermal stability.
−Removed: Histology slides of SimpliDerm and native dermal matrix were examined microscopically, using three different stains.
−Removed: Stained samples of SimpliDerm retained the collagen structure (density and orientation), elastin, blood vessels and basement membrane complex that was observed in the native dermal matrix.
−Removed: Transmission electron microscopy demonstrated intact collagen fibril structures in native dermis and SimpliDerm, supporting the conclusion that
−Removed: the decellularization process used to produce SimpliDerm did not damage the ultrastructural architecture of the collagen matrix.
−Removed: Additional testing was performed that compared the properties of SimpliDerm and alternative HADMs, AlloDerm RTU and DermACELL, to native dermis.
−Removed: These tests included glycosaminoglycan content, matrix protein stability and differential scanning calorimetry.
−Removed: The glycosaminoglycan content of SimpliDerm and AlloDerm RTU was similar, with a substantial reduction in the amount of glycosaminoglycans observed in DermACELL.
−Removed: Matrix protein stability was evaluated by determining acid-soluble collagen content and by performing collagenase degradation on the product samples.
−Removed: SimpliDerm was closest to native dermal matrix in both acid-soluble collagen content and collagenase degradation.
−Removed: Differential scanning calorimetry was performed on the samples, and SimpliDerm and AlloDerm RTU were equivalently close to native dermis, while DermACELL showed the largest difference.
−Removed: The combined testing indicates that SimpliDerm had a structurally intact matrix that was closest overall to native human dermis among the HADMs evaluated.
−Removed: In addition, a non-human primate study was conducted evaluating the ability of SimpliDerm and AlloDerm RTU to regenerate host tissue two weeks, four weeks and three months after implantation.
−Removed: Explanted samples were subjected to analysis that included histology, growth factor analysis and gene expression characterization.
−Removed: H&E and VVG stains and staining for macrosialin (“CD68”) were used to prepare tissue samples for microscopic observation.
−Removed: AlloDerm RTU samples demonstrated faster implant degradation and cell infiltration, and more inflammatory cells than SimpliDerm.
−Removed: Growth factor analysis of samples for tumor necrosis factor, an indicator for an inflammatory environment, was higher for AlloDerm RTU than SimpliDerm at three months.
−Removed: Gene expression analysis was performed for samples at all time points.
−Removed: Markers for evidence of an inflammatory response to the implants, including collagen synthesis, vascularization, fibrosis, myofibroblast presence and collagen crosslinking, were analyzed and compared.
−Removed: AlloDerm RTU was found to exhibit higher amounts of these inflammatory response markers.
−Removed: The histology, growth factor testing and gene expression data support the conclusion that compared to AlloDerm RTU, SimpliDerm showed less acute and chronic inflammation and less fibrosis, leading to a pro-remodeling microenvironment that promoted tissue repair and regeneration by three months post-implantation.
−Removed: Clinical Studies
−Removed: A retrospective, multi-center study evaluating patients who have undergone breast reconstruction post-mastectomy with SimpliDerm and patients receiving other HADMs has been published.
−Removed: A total of 107 patients (181 breasts) who underwent immediate, 2-stage breast reconstruction with tissue expanders and either SimpliDerm (n=38) or AlloDerm RTU (n=69) after mastectomy, were followed to exchange to permanent implant(s) or tissue expander(s) explant.
−Removed: Reconstructions were predominantly prepectoral (82.3%).
−Removed: Patients were followed for a median of 134 days.
−Removed: A total of 35 adverse events (“AEs”) occurred in 27 (25.2%) patients, with no difference in AE type or rates between ADM groups, and no AEs deemed related.
−Removed: The observed AE profiles and rates were similar to those published for other ADMs in breast reconstruction.
−Removed: These results demonstrate comparable clinical outcomes of SimpliDerm and AlloDerm RTU following 2-stage breast reconstruction.
+Added: From May 2017 through March 2023, these products were sold directly to hospitals and other healthcare facilities through our sales force and independent sales agents.
+Added: In April 2023, we entered into an exclusive distribution agreement with LeMaitre Vascular for these products in the United States.
+Added: This agreement with LeMaitre Vascular was terminated in April 2025, at which time we resumed selling these products directly to hospitals and other healthcare facilities through independent sales agents.
We operate in highly competitive markets that are subject to rapid technological change.
1 unchanged sentence
We believe that the demonstrated clinical efficacy of our products, the breadth of our product portfolio, our in-house customer support services, our customer relationships and our reputation offer us advantages over our competitors.
−Removed: Our products compete primarily with implantable electronic device envelopes and other cardiovascular repair and human-derived acellular dermis products.
−Removed: The EluPro and CanGaroo Envelopes compete with the synthetic envelope TYRX from Medtronic.
+Added: Our products compete primarily with other cardiovascular repair and human-derived acellular dermis products.
ProxiCor, Tyke and VasCure compete with bovine pericardium and synthetic patch materials produced by numerous companies, including Gore’s Gore-tex and Terumo’s Vascutek.
−Removed: SimpliDerm competes primarily against human-derived acellular dermis matrix meshes, including AbbVie’s AlloDerm, MTF’s FlexHD, Stryker’s
−Removed: DermACELL and Evergen’s (formerly RTI Surgical) Cortiva.
+Added: SimpliDerm competes primarily against human-derived acellular dermis matrix meshes, including AbbVie’s AlloDerm, MTF’s FlexHD, Stryker’s DermACELL and Evergen’s (formerly RTI Surgical) Cortiva.
SimpliDerm also competes against animal-derived biological mesh products, such as AbbVie’s Strattice and Integra’s SurgiMend, as well as various synthetic mesh products.
2 unchanged sentences
During this time, private payors have developed policies for coverage based on available data and literature.
−Removed: While there are certain national and regional third-party payors who cover SimpliDerm or procedures using SimpliDerm, the majority do not.
−Removed: We are aware of several companies that compete, or are developing technologies, in our current and future product areas.
+Added: While there are certain national and regional third-party payors who provide specific reimbursement for SimpliDerm or procedures using SimpliDerm, the majority do not.
+Added: We are aware of several companies that are developing technologies in our current and future product areas.
As a result, we expect competition to remain intense.
3 unchanged sentences
Sales and Marketing
−Removed: We have dedicated substantial resources to establishing a multi-faceted sales and marketing organization in the United States.
−Removed: We sell EluPro and CanGaroo in the United States using our direct sales force, which as of December 31, 2024, totaled 11 sales representatives and a network of 31 independent sales agents, and through our commercial partner, Boston Scientific, which acts as a sales agent, marketing EluPro and CanGaroo and obtaining orders, and gives us access to approximately 900 sales representatives and clinical specialists.
−Removed: Under the terms of this agreement, Boston Scientific receives a commission equal to a specified percentage of the end-user selling price for units they sell.
−Removed: Our direct sales representatives and distributors focus on gaining additional market access and driving market penetration, not only by selling our products, but also, by managing partnerships and providing technical expertise.
−Removed: These sales representatives and agents are supported by teams of professionals focused on sales management, sales operations, ongoing training, analytics and marketing.
−Removed: SimpliDerm, our Women’s Health product, is sold using independent sales agents and a partnership with Tiger, who Elutia has granted certain non-exclusive rights in the United States to market, sell and distribute SimpliDerm for select use in reconstruction surgery.
−Removed: This agreement with Tiger gives us access to approximately 50 sales representatives to further expand our footprint and accelerate our sales.
−Removed: Under the terms of this agreement, Tiger purchases SimpliDerm through a transfer fee and sells it to the end user hospital or healthcare facility.
−Removed: Our cardiovascular products, ProxiCor, Tyke and VasCure, are sold in the U.S.
−Removed: through LeMaitre Vascular.
−Removed: In April 2023, we entered into an agreement with LeMaitre Vascular granting them the exclusive U.S.
−Removed: distribution rights for our cardiovascular products.
−Removed: The term of the collaboration is three years, and LeMaitre Vascular has the exclusive option to acquire the product line following the first year or under certain other circumstances.
+Added: Both SimpliDerm and our Cardiovascular products are sold through independent sales agents.
+Added: In March 2023, we entered into a non-exclusive distribution agreement for SimpliDerm with Sientra.
+Added: In April 2024, Tiger assumed this agreement in connection with its acquisition of Sientra, and the agreement remained in effect until October 2025, at which point, it was terminated by Elutia.
+Added: In April 2023, we entered into an exclusive distribution agreement with LeMaitre Vascular for our Cardiovascular products, which was subsequently terminated in April 2025.
+Added: Following these contract terminations, our products resumed being marketed through our network of independent distributors.
We have historically focused our market development and commercial activities primarily in the United States.
−Removed: Sales generated in the United States represented greater than 96% of our net sales in 2024.
−Removed: Sales of our products outside of the United States ceased after May 2024 due to changes in certain international regulatory rules which required investment by us not warranted by the current level of sales in these markets.
−Removed: Research and Development
−Removed: Our research and development team has extensive experience in developing regenerative medicine and DEB products and works to design products that are intended to improve patient outcomes, simplify techniques, shorten procedures, reduce hospitalization and rehabilitation times, and, as a result, reduce costs.
−Removed: We have recruited and retained staff with significant experience and skills, gained through both industry experience and training at leading colleges and
−Removed: universities.
−Removed: In addition to our internal staff, our external network of development laboratories, testing laboratories and physicians aids us in our research and development process.
+Added: All of our sales in 2025, and greater than 96% of our net sales in 2024, were generated in the United States.
+Added: products outside of the United States ceased after May 2024 due to changes in certain international regulations which required investment by us not warranted by the then-current level of sales in these markets.
Manufacturing and Suppliers
−Removed: We manufacture CanGaroo and our cardiovascular products in our Roswell, Georgia facility and use Cook Biotech Incorporated (“Cook”), now owned by Evergen, as our sole porcine tissue supplier for these products.
−Removed: We have significant expansion capabilities in our in-house manufacturing facility.
−Removed: Cook has previously successfully expanded and, we believe, is well-positioned to support future expansion.
−Removed: However, they are our sole source, and we cannot guarantee that an interruption in supply will not occur.
−Removed: If necessary, we could engage an alternate supplier or set-up, validate and gain regulatory authorization to manufacture these products in our own facilities, although it would require significant time and expense.
−Removed: We have robust internal compliance processes to maintain the high quality and reliability of our products.
−Removed: We use annual internal audits, combined with external audits by regulatory agencies and commercial partners to monitor our quality control practices.
−Removed: Our Roswell, Georgia facility is registered with the FDA as a medical device manufacturing establishment.
−Removed: In addition to Cook, we use other third-party suppliers to support our internal manufacturing processes.
−Removed: We select our suppliers through a rigorous process to ensure high quality and reliability with the capacity to support our expanding production levels.
−Removed: To date, we have not experienced any significant difficulty locating and obtaining the suppliers or materials necessary to fulfill our production requirements.
−Removed: With the sale of our Orthobiologics Business in November 2023 to Berkeley, we no longer operate our former Richmond, California human tissue processing and distribution facility;
−Removed: however, we continue to have a contract manufacturing relationship with Berkeley under which we receive SimpliDerm.
−Removed: At present, Berkeley is our single source of supply for SimpliDerm, but we intend to develop our own in-house capability for the production of SimpliDerm.
−Removed: To this end, in March 2025, we signed a lease for 26,598 square feet in Gaithersburg, Maryland for purposes of, among other things, the internal production of SimpliDerm.
−Removed: We expect to be able to internally produce SimpliDerm by the third quarter of 2025.
−Removed: No contracted minimum purchase commitments are defined in the Berkeley agreement and Berkeley must comply with FDA current Good Tissue Practice (cGTP), American Association of Tissue Banks Standards and all applicable state and local regulations.
+Added: SimpliDerm was historically processed at our former Richmond, California facility, which was included in the divestiture of the Orthobiologics Business in 2023.
+Added: SimpliDerm is now supplied to Elutia through a supply agreement with Berkeley, the acquiror of our Orthobiologics Business.
+Added: The porcine SIS-ECM for our Cardiovascular products is supplied by Cook Biotech Incorporated (“Cook”), now owned by Evergen, through a long-term supply agreement.
+Added: Both Berkeley and Cook are currently our sole sources of supply within the respective product offerings, and we cannot guarantee that an interruption in supply will not occur.
+Added: We historically performed the minor finished goods conversion activities along with the stocking and distribution of our Cardiovascular products at our former manufacturing facility in Roswell, Georgia.
+Added: Our Roswell facility was acquired by BSC in connection with the sale of the CIED Business, and these logistics, along with order fulfillment of SimpliDerm, are now provided to us through a third-party logistics provider.
+Added: In March 2025, we signed a lease for 26,598 square feet of production, laboratory and administrative space in Gaithersburg, Maryland, which serves as our headquarters and primary operational site.
+Added: We are currently using this space for administrative purposes and development of NXT-41 and NXT-41x.
+Added: We anticipate utilizing this facility for the commercial production of these products, to the extent FDA marketing authorization is obtained.
+Added: Research and Development
+Added: Our research and development team has extensive experience in developing regenerative medicine and DEB products and works to design products that are intended to improve patient outcomes, simplify techniques, shorten procedures, reduce rehospitalizations, and as a result, reduce costs.
+Added: We have recruited and retained staff with significant experience and skills, gained through both industry experience and academic training.
+Added: In addition to our internal staff, our external network of development and testing laboratories and physicians aids us in our research and development process.
+Added: We are now focused on advancing our proprietary DEB platform for use in surgical reconstruction and related applications.
+Added: This platform combines our expertise in biologics and localized drug delivery to address complications that lead to poor outcomes in reconstructive procedures.
+Added: Our first commercial product under this platform, EluPro, which along with CanGaroo was sold to BSC in October 2025 for an aggregate purchase price of up to $88 million, demonstrated the clinical potential of combining a biologic scaffold with antibiotic drug delivery to reduce device-related complications.
+Added: We believe the same foundational technology can be applied to broader reconstructive and soft tissue repair markets where biologic matrix products are widely used but where outcomes remain suboptimal due to causes of failure, such as infection, inflammation, and fibrosis.
+Added: The clinical and economic need in these markets is substantial, reflecting both the volume of reconstructive surgery and the persistence of high complication rates.
+Added: For example, in implant-based breast reconstruction and complex abdominal wall repair, infection rates approximate 15 to 20 percent, leading to frequent reoperations and hospital readmissions.
+Added: Each year, in the United States, there are approximately 163,000 post-mastectomy breast reconstruction procedures, and roughly one in three experiences a serious complication such as infection, capsular contracture, or implant loss.
+Added: We believe biologic matrices represent an estimated $1.5 billion U.S.
+Added: market opportunity and account for more than 60% of reconstruction spending, yet meaningful innovation has been limited and significant unmet medical need remains.
+Added: Our lead development programs, NXT-41 and NXT-41x, are designed as next-generation biologic scaffolds combined with local antibiotic delivery.
+Added: NXT-41 features a porcine-derived engineered matrix that provides superior handling, consistency, and incorporation compared to human-derived acellular dermal matrices.
+Added: In NXT-41x, the antibiotics rifampin and minocycline are incorporated into the matrix, and the drugs are released locally over extended periods, offering broad-spectrum antimicrobial protection against the pathogens most associated with implant infections,
+Added: mitigating the risk of any systemic toxicity.
+Added: The objective is to materially reduce complications arising from contamination, biofilm formation, and inflammation while maintaining surgeon-preferred handling, flexibility, and soft-tissue reinforcement for implant support.
+Added: We believe Elutia is well-positioned to pioneer a new class of active biomatrices for reconstructive biosurgery, combining biologic innovation and localized pharmacologic activity to improve outcomes for patients at favorable economics for healthcare systems.
+Added: We expect FDA clearance of NXT-41 in the second half of 2026 and anticipate FDA clearance for NXT-41x by mid-2027.
Intellectual Property
−Removed: We rely on a combination of patents, trademarks, confidentiality agreements and security procedures to protect our proprietary products, preservation technology, trade secrets and know-how.
+Added: We rely on a combination of patents, license agreements, trademarks, confidentiality agreements and security procedures to protect our proprietary products, preservation technology, trade secrets and know-how.
We believe that our patents, trade secrets, trademarks and technology licensing rights provide us with important competitive advantages.
−Removed: We have also obtained additional rights through license agreements for additional products and technologies.
−Removed: As of December 31, 2024, we owned approximately 16 U.S.
−Removed: patents, eight U.S.
−Removed: patent applications, six foreign patents (in Australia, Germany, Spain, France, Great Britain and Italy), four foreign patent applications (in Australia, Canada, and Europe) and one Patent Cooperation Treaty application;
−Removed: and we in-licensed three U.S.
−Removed: patents, 12 foreign patents (in Australia, Canada, Japan, Denmark, Germany, Great Britain, Ireland, Italy and the Netherlands), and two U.S.
−Removed: and five foreign patent applications (in Brazil China and Japan, as well as an application with the European Patent Office).
−Removed: Our owned patent portfolio includes 15 U.S.
−Removed: patents and six U.S.
−Removed: patent applications that relate to our technology for EluPro and CanGaroo, including issued claims covering biological envelopes and pending claims covering their use.
+Added: Our intellectual property strategy is focused on supporting the development of our proprietary DEB platform and related technologies, while maintaining flexibility as our pipeline advances.
+Added: Our owned intellectual property includes patents and patent applications relating primarily to aspects of biologic matrix processing and related technologies, including technologies outside of our current commercial product portfolio.
+Added: We do not rely on patent protection for all aspects of our current commercial products, and certain products are protected primarily through manufacturing know-how, trade secrets, and regulatory barriers to entry.
+Added: In connection with the development and commercialization of EluPro, we created a substantial intellectual property portfolio specifically relating to antibiotic-eluting biologic envelopes.
+Added: That intellectual property portfolio was transferred to the CIED Buyers as part of the sale of our CIED business in October 2025 and contributed to the overall value of that transaction.
+Added: The transferred intellectual property did not include patents or patent applications relating to our NXT-41 or NXT-41x development programs or to our broader drug-eluting biomatrix platform.
+Added: As of December 31, 2025, our intellectual property portfolio relating to our next-generation biologic matrix technologies, including NXT-41 and NXT-41x, consists of patent filings directed to aspects of matrix design, drug incorporation, and related manufacturing methods.
In addition, we own one U.S.
−Removed: patent that relates to our technology for SimpliDerm that claims a method of preparing an acellular dermal matrix.
−Removed: Excluding any patent term extension, our issued patents relating to our technology for EluPro and CanGaroo are anticipated to expire starting in 2027, and our issued patent that relates to our technology for SimpliDerm is anticipated to expire in 2033.
+Added: patent that relates to our technology for SimpliDerm that claims a method of preparing an acellular dermal matrix that is anticipated to expire in 2033.
There can be no assurance that any pending patent applications will ultimately be issued as patents.
−Removed: We do not own or in-license any patents or patent applications covering our other products.
As with other medical device and regenerative medicine companies, our ability to maintain and solidify our proprietary and intellectual property position for our product candidates will depend on our success in obtaining effective patent claims and maintaining and enforcing claims that are granted.
−Removed: However, our owned and licensed patents could be invalidated or narrowed or otherwise fail to adequately protect our proprietary and intellectual property position and our
−Removed: pending owned and licensed patent applications, and any patent applications that we may in the future file or license from third parties may not result in the issuance of patents.
+Added: However, our owned and licensed patents could be invalidated or narrowed or otherwise fail to adequately protect our proprietary and intellectual property position and our pending owned and licensed patent applications, and any patent applications that we may in the future file or license from third parties may not result in the issuance of patents.
In addition, the term of individual issued patents depends upon the legal term for patents in the countries in which they are obtained.
1 unchanged sentence
The life of a patent, and the protection it affords, is therefore limited and once the patent lives of our issued patents have expired, we may face competition, including from other competing technologies.
−Removed: The term of a patent that covers a drug or biological product may also be eligible for patent term extension when FDA approval is granted for a portion of the term effectively lost as a result of the FDA regulatory review period, subject to certain limitations and provided statutory and regulatory requirements are met.
−Removed: Any such patent term extension can be for no more than five years, only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years from approval, and only those claims covering the approved drug or biological product, a method for using it or a method for manufacturing it may be extended.
−Removed: We may not receive an extension if we fail to exercise due diligence during the testing phase or regulatory review process, fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements.
−Removed: Moreover, the length of the extension could be less than we request.
−Removed: In the future, we expect to apply for patent term extensions on certain issued patents covering our products, depending upon the length of the clinical studies for each product and other factors.
−Removed: There can be no assurance that we will benefit from any patent term extension or favorable adjustment to the term of any of our patents.
As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
−Removed: For more information, see Part I, Item 1A.
+Added: We also maintain trademarks associated with our commercial products.
+Added: As of December 31, 2025, we had 11 registered trademarks, including trademark registrations for “ProxiCor®,” “Tyke®,” “VasCure®,” “SimpliDerm®,” and “SimpliDerm Ellipse®,” in the United States.
+Added: In addition to patents and licenses, we rely on confidentiality agreements with our employees, consultants, independent sales agents and third-party vendors to maintain the confidentiality of our trade secrets and proprietary information.
+Added: Despite all of the aforementioned measures, there can be no assurance that our intellectual property rights will not be challenged, circumvented, invalidated, or independently developed by third parties.
+Added: For a discussion of risks related to our intellectual property, see Part I, Item 1A.
“Risk Factors - Risks Related to Intellectual Property.”
−Removed: As of December 31, 2024, we had nine registered trademarks and ten pending trademark applications worldwide, including trademark registrations for “CanGaroo,” “ProxiCor,” “Tyke,” “VasCure,” “SimpliDerm,” and “SimpliDerm Ellipse,” in the United States, and for “CanGaroo” in the European Union, United Kingdom and Japan.
−Removed: Trademark applications have been filed for “Elutia” and “EluPro” in the United States, the European Union, United Kingdom and Japan, and for “Elutia” in Jamaica.
−Removed: We have confidentiality agreements with our employees, consultants, independent sales agents and third-party vendors to maintain the confidentiality of our trade secrets and proprietary information.
−Removed: There can be no assurance that the obligations of our employees, consultants, independent sales agents and third parties, with whom we have entered into confidentiality agreements, will effectively prevent disclosure of our confidential information or provide meaningful protection for our confidential information if there is unauthorized use or disclosure, or that our trade secrets or proprietary information will not be independently developed by our competitors.
−Removed: See Part I, Item 1A.
−Removed: “Risk Factors - Risks Related to Intellectual Property” for additional information regarding these and other risks related to our intellectual property portfolio and their potential effect on us.
License Agreement with Cook
−Removed: On May 31, 2017, we entered into a license agreement, which we refer to as the Cook License Agreement, with Cook under which Cook granted to us an exclusive worldwide sublicensable license under certain licensed patents to make, have made, use, offer for sale, sell and import CorMatrix ECM for Pericardial Closure, CorMatrix ECM for Cardiac Tissue Repair, CorMatrix ECM for Carotid Repair, CorMatrix ECM for Vascular Repair, TYKE Patch, Pledget and Intracardiac, and CanGaroo ECM Envelope (into which implantable cardiac pacemaker or defibrillator devices are to be inserted).
−Removed: Cook retained certain co-exclusive rights to the CorMatrix ECM for Vascular Repair.
−Removed: The Cook License Agreement was amended on December 21, 2017 to expand our field of use for SIS pouch devices to include other implantable electronic cardiac stimulation devices, electronic neurostimulation devices for deep brain stimulation, spinal nerve and sacral nerve stimulation to relieve chronic pain and nerve stimulation to control bladder, digestive, abdomen and bowel movements, and also add additional payment requirements.
−Removed: Under the Cook License Agreement, we agree to use commercially reasonable efforts to promote, solicit and expand the licensed products in certain fields of use.
−Removed: We are subject to a minimum purchase requirement for the SIS ECM for the fields of use added in connection with the December 21, 2017 amendment, or the Subfields, and certain diligence obligations for commercial sales in the Subfields.
−Removed: The license requires that we order and pay for a minimum of at least
−Removed: $500,000 of SIS ECM per calendar year for use in the Subfields.
−Removed: Cook has the right to terminate the license granted to us in the Subfields or convert such license to a non-exclusive license, if we fail to comply with such minimum purchase requirement or diligence obligations.
−Removed: We have the first right, but not the obligation to initiate legal proceedings against any patent infringement in our fields of use by a third-party product that is the same as one of the licensed products.
−Removed: Under the Cook License Agreement and SIS Material Supply Agreement, Cook is the exclusive supplier of the SIS ECM used in the licensed products.
−Removed: Under certain circumstances we will have the right to manufacture the SIS ECM used in the licensed products, provided that in such cases we are required to pay Cook a low single digit royalty on net sales of the licensed products that include the SIS ECM material manufactured by us and that are covered by a valid enforceable claim of a licensed patent.
−Removed: As consideration for the license, we paid Cook a $200,000 license fee in 2018 and are responsible for a yearly license fee of $100,000 until 2026.
−Removed: Upon a change in control transaction, which includes an acquisition of 50% or more of our then outstanding capital stock, we will be obligated to pay Cook the total amount of all license fees that have not yet been paid within a specified period after the consummation of such change in control transaction.
−Removed: The Cook License Agreement continues in effect until the date of expiration of the last to expire of the licensed patents, including any renewals or extensions.
−Removed: The expiration date for the last to expire of the licensed patents is currently expected to be 2031 (excluding any patent term adjustments or extensions).
−Removed: Either party may terminate the Cook License Agreement for any material breach by the other party uncured within a specified period.
−Removed: In addition, the Cook License Agreement terminates automatically if we no longer possess the rights to the licensed products sold by CorMatrix related to our acquisition of all of the commercial assets and related intellectual property of CorMatrix Cardiovascular, Inc.
−Removed: in 2017 (the “CorMatrix Acquisition”).
−Removed: Cook has the right to terminate the Cook License Agreement in its entirety, or convert the exclusive license of any field of use to a non-exclusive license if we fail to make any license fee when due.
+Added: We are party to a license agreement with Cook, which we refer to as the Cook License Agreement, that provides us with field-of-use rights to use porcine SIS-ECM technologies in specified cardiovascular applications.
+Added: The agreement supports our ability to manufacture, market, and sell our Cardiovascular products within defined fields of use.
+Added: The license agreement also provides us with the option to access newer-generation, patent-protected SIS technologies for use in the licensed fields.
+Added: We have elected not to utilize these patent-protected materials at this time;
+Added: however, the agreement provides flexibility to access such technologies in the future if we determine that doing so is commercially or strategically appropriate.
+Added: Under the license and related supply arrangements, Cook, now owned by Evergen, is our exclusive supplier of SIS material for the licensed fields of use.
+Added: The agreement includes minimum purchase requirements and other customary terms.
+Added: The amended supply agreement currently remains in effect through December 31, 2028 and automatically renews for two additional two-year periods unless either party provides notice of non-renewal.
+Added: The license agreement remains in effect until the earlier of the termination of the supply agreement or the expiration of the last licensed patent, which is currently expected to occur in 2031, excluding any patent term adjustments or extensions.
+Added: The Cook License agreement does not apply to our NXT-41 and NXT-41x development programs, which utilize different source material and is not procured from Evergen.
Regulatory Matters
7 unchanged sentences
Class II devices, of moderate risk, require FDA clearance through a 510(k) submission, involving compliance with general controls and potential imposition of special controls, such as performance standards and post-market surveillance.
−Removed: The Quality System Regulation (“QSR”) is a key aspect of general controls, ensuring adherence to quality standards in manufacturing processes.
+Added: The Quality Management System Regulation (“QMSR”) is a key aspect of general controls, ensuring adherence to quality standards in manufacturing processes.
For the highest-risk Class III devices, PMA is required, encompassing life-sustaining devices, those with new intended uses, or utilizing advanced technology not substantially equivalent to existing devices.
2 unchanged sentences
Certain of our ECM products are subject to premarket notification and clearance under Section 510(k) of the FDCA.
−Removed: To obtain 510(k) clearance, a product sponsor must submit to the FDA a premarket notification submission
−Removed: demonstrating that the proposed device is “substantially equivalent” to a predicate device already on the market.
+Added: To obtain 510(k) clearance, a product sponsor must submit to the FDA a premarket notification submission demonstrating that the proposed device is “substantially equivalent” to a predicate device already on the market.
A predicate device is a legally marketed device that is not subject to premarket approval, i.e., a device that was legally marketed prior to May 28, 1976 and for which a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent through the 510(k) process.
−Removed: The FDA’s 510(k) clearance process usually takes from three to twelve months, but often takes longer.
+Added: The FDA’s 510(k) clearance process usually takes from three to twelve months, but may take longer.
The FDA may require additional information, including clinical data, to make a determination regarding substantial equivalence.
9 unchanged sentences
FDA has 180 days for PMA review, often extending beyond, with the possibility of convening an expert advisory panel for recommendations.
−Removed: A pre-approval inspection ensures compliance with the QSR.
+Added: A pre-approval inspection ensures compliance with the QMSR.
FDA approves the device for commercial distribution if it deems PMA data as valid scientific evidence, ensuring reasonable assurance of safety and effectiveness.
9 unchanged sentences
An IDE application must be supported by relevant data, such as animal and laboratory test results, demonstrating safety for human testing and a scientifically sound protocol.
−Removed: Acceptance of an IDE application for review does not guarantee that the FDA will allow the IDE to become effective and, if it does become effective, the FDA may or may not determine that the data derived from the studies support the safety and effectiveness of the device.
The IDE becomes effective 30 days after FDA receipt unless modifications are required.
3 unchanged sentences
During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, study monitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the promotion of investigational devices.
−Removed: The clinical investigators in the clinical study are also subject to FDA’s regulations and must obtain patient informed consent, follow
−Removed: the investigational plan and study protocol, and comply with all reporting and recordkeeping requirements.
+Added: The clinical investigators in the clinical study are also subject to FDA’s regulations and must obtain patient informed consent, follow the investigational plan and study protocol, and comply with all reporting and recordkeeping requirements.
After a study begins, we, the FDA or the IRB could suspend or terminate a clinical study at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits.
3 unchanged sentences
● establishment registration and device listing with the FDA;
−Removed: ● QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures;
+Added: ● QMSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures;
● labeling and promotional regulations and FDA prohibitions against the promotion of investigational products, or the promotion of “off-label” uses of cleared or approved products;
28 unchanged sentences
HCT/Ps failing to meet Section 361 criteria are regulated under Section 351 of the PHSA, requiring FDA premarket review and approval.
−Removed: International Requirements
−Removed: Sales of medical devices and shipments of human tissues outside the United States are subject to international regulatory requirements that vary widely from country to country.
−Removed: Approval or certification of a product by comparable regulatory authorities of other countries or notified bodies must be obtained and compliance with applicable regulations for tissues must be met prior to commercial distribution of the products or human tissues in those countries.
−Removed: The time required to obtain these approvals or certifications may be longer or shorter than that required for FDA approval.
−Removed: Countries, in which we distribute products and tissue, may perform inspections or audits of our facilities to ensure compliance with local country regulations.
−Removed: Regulation of Medical Devices in the European Union
−Removed: The European Union (“EU”) has adopted specific directives and regulations regulating the design, manufacture, clinical investigation, conformity assessment, labeling and adverse event reporting for medical devices.
−Removed: We formerly had a CE mark for four of our cardiovascular products in the EU and had certification for updated labeling of our CanGaroo Envelope to allow for the addition of the antibiotic gentamicin.
−Removed: However, with the expiration of our CE mark on May 23, 2024, we no longer maintain our CE mark and do not market our products in the EU.
−Removed: We will maintain compliance with the transitional Medical Devices Regulation, or MDR, requirements as applicable, including post-market surveillance and vigilance requirements.
−Removed: Regulation of Medical Devices in the United Kingdom
−Removed: In the aftermath of Brexit, the Medicines and Healthcare products Regulatory Agency (“MHRA”) has become the sole regulator for medical devices in the UK.
−Removed: The MHRA's proposed amendments to the UK Medical Devices Regulations 2002 aim to foster innovation, regulate software and artificial intelligence in medical devices, reform in vitro diagnostic regulation, and promote sustainability.
−Removed: Manufacturers with valid EU certifications can market their devices in the UK under the CE mark during transitional periods.
−Removed: However, from July 2024, the UK Conformity Assessment (UKCA)
−Removed: mark will be required for medical devices sold in Great Britain.
−Removed: We do not intend to apply for the UKCA for our Cardiovascular and Device Protection products in the near future.
Regulations Governing Fraud and Abuse
16 unchanged sentences
A violation of this statute is a felony and may result in fines, imprisonment, and/or exclusion from government sponsored programs.
−Removed: The HIPAA false statements statute prohibits, among other things, knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation in connection with the delivery of, or payment for, healthcare benefits, items or services.
+Added: The HIPAA false statements statute prohibits, among other things,
+Added: knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation in connection with the delivery of, or payment for, healthcare benefits, items or services.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the Anti-Kickback Statute or specific intent in order to violate it to have committed a violation.
1 unchanged sentence
State, local, and foreign laws impact business practices in the medical device and pharmaceutical industries, including state anti-kickback and false claims laws affecting research, distribution, sales, and marketing.
−Removed: These laws also extend to claims involving healthcare items reimbursed by third-party payors or patients and may restrict payments to
−Removed: healthcare providers and referral sources.
+Added: These laws also extend to claims involving healthcare items reimbursed by third-party payors or patients and may restrict payments to healthcare providers and referral sources.
Additional regulations mandate pharmaceutical companies to comply with industry guidelines and federal guidance, while requiring drug manufacturers to report pricing and marketing information.
1 unchanged sentence
Violations of these laws, carrying potential criminal and civil penalties such as fines, exclusion from federal healthcare programs, disgorgement, and corporate integrity agreements, may be imposed on executives and employees, including imprisonment.
−Removed: Anti-Bribery Laws
−Removed: Our international operations are subject to compliance with a variety of complex foreign and United States laws that increase our costs of doing business in internal jurisdictions and could expose us or our employees to fines and penalties in the United States and abroad.
−Removed: Among others, we are subject to the United States Foreign Corrupt Practices Act of 1977 (the “FCPA”), which prohibits us, our officers, directors, employees, shareholders and agents acting on our behalf from offering, promising, authorizing or making corrupt payments to foreign officials for the purpose of influencing official decisions or securing an improper advantage to obtain or retain business.
Data Privacy and Security Laws
−Removed: Numerous state, federal and foreign laws, including consumer protection laws and regulations, govern the collection, dissemination, use, access to, confidentiality and security of personal information, including health-related information.
+Added: Numerous state and federal laws, including consumer protection laws and regulations, govern the collection, dissemination, use, access to, confidentiality and security of personal information, including health-related information.
In the United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy laws, and consumer protection laws and regulations govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our partners.
−Removed: In addition, certain foreign laws govern the privacy and security of personal data, including health-related data.
Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.
6 unchanged sentences
Our commercial success depends in part on the extent to which governmental authorities, private health insurers and other third-party payors provide coverage for and establish adequate reimbursement levels for the procedures during which our products are used.
−Removed: Failure by physicians, hospitals, ambulatory surgery centers and other users of our products to obtain sufficient coverage and reimbursement from third-party payors for procedures in which our products are used, or adverse changes in government and private third-party payors’ coverage and reimbursement policies.
+Added: Failure by physicians, hospitals, ambulatory surgery centers and other users of our products to obtain sufficient coverage and reimbursement from third-party payors for procedures in which our products are used, or adverse changes in government and private third-party payors’ coverage and reimbursement policies, could have a material adverse effect on our business, financial condition and results of operations.
In our experience, third-party payors typically reimburse for surgical procedures involving our products when patients meet established medical necessity criteria.
3 unchanged sentences
Reimbursement landscape variations exist from payor to payor in the United States.
−Removed: Third-party payors are increasingly auditing and challenging the prices charged for medical products and services with concern for upcoding, miscoding, using inappropriate modifiers, or billing for inappropriate
−Removed: care settings.
+Added: Third-party payors are increasingly auditing and challenging the prices charged for medical products and services with concern for upcoding, miscoding, using inappropriate modifiers, or billing for inappropriate care settings.
Some third-party payors must approve coverage for new or innovative devices or procedures before they will reimburse healthcare providers who use the products or therapies.
4 unchanged sentences
These changes may occur as the result of national coverage determinations issued by CMS or as the result of local coverage determinations by contractors under contract with CMS to review and make coverage and payment decisions.
−Removed: Medicaid programs are funded by both federal and state governments, and may vary from state to state and from year to year and will likely play an even larger role in healthcare funding pursuant to the Affordable Care Act.
+Added: Medicaid programs are funded by both federal and state governments, and may vary from state to state and from year to year and will likely play an even larger role in healthcare funding pursuant to the Affordable Care Act (“ACA”).
A key component in ensuring whether the appropriate payment amount is received for physician and other services, including those procedures using our products, is the existence of a Current Procedural Terminology (“CPT”) code, to describe the procedure in which the product is used.
1 unchanged sentence
CPT codes are assigned, maintained and annually updated by the American Medical Association and its CPT Editorial Board.
−Removed: If the CPT codes that apply to the procedures performed using our products are changed or deleted, reimbursement for performances of these procedures may be adversely affected.
+Added: If the CPT codes that apply to the procedures performed using our products are changed or deleted, reimbursement for performance of these procedures may be adversely affected.
In the United States, some insured individuals enroll in managed care programs, which monitor and often require pre-approval of the services that a member will receive.
5 unchanged sentences
Healthcare Reform
−Removed: Since its enactment, the Affordable Care Act (“ACA”) has faced challenges in the judicial, executive, and Congressional arenas.
+Added: Since its enactment, the ACA has faced challenges in the judicial, executive, and Congressional arenas.
On June 17, 2021, the U.S.
Supreme Court dismissed a challenge asserting the ACA's unconstitutionality on procedural grounds, affirming its continuation.
−Removed: President Biden's executive order, preceding the Supreme Court ruling, initiated a special enrollment period for ACA marketplace health insurance coverage from February 15, 2021, through August 15, 2021, prompting a review of healthcare access policies.
−Removed: The impact of other healthcare reform measures under the Biden administration on our business remains uncertain.
+Added: Former President Biden's executive order, preceding the Supreme Court ruling, initiated a special enrollment period for ACA marketplace health insurance coverage from February 15, 2021, through August 15, 2021, prompting a review of healthcare access policies.
+Added: The impact of other healthcare reform measures on our business remains uncertain.
Legislative changes, including aggregate reductions in Medicare payments to providers, have occurred since the ACA's inception.
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Human Capital
−Removed: As of December 31, 2024, we had 51 employees, nearly 100% of whom were full-time employees.
+Added: As of December 31, 2025, we had 26 employees, and 25 employees were employed full-time.
We believe our employee relations are good.
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We believe that we have been successful in attracting and retaining qualified personnel with the appropriate background and skills to support our business and its growth.
−Removed: We monitor recruiting efforts using a variety of metrics such as internal placement rates, employee referrals, information on the retention of business critical hires, and the percentage of budgeted openings filled on time and on budget.
−Removed: We also track voluntary and involuntary turnover rates.
Although we believe our recruiting efforts have been successful to date, headcount reductions taken as part of cost saving initiatives and as our business strategy evolves may negatively impact our ability to attract qualified personnel in the future.
Risk Factors - Risks Related to Our Business - Our success depends on our ability to retain and motivate key management personnel and other employees and consultants, to attract, retain and motivate additional qualified personnel and to effectively navigate changes in our senior management team.
+Added: Culture of Inclusion
+Added: We are committed to fostering an equitable and inclusive workplace that is free from discrimination, harassment, bias and prejudice and where every individual feels valued and included.
+Added: We foster an inclusive environment through respect, collaboration, and open communication.
+Added: We also aim to treat all individuals with respect and dignity and to provide all our employees with equal opportunity and fair treatment based on merit.
Compensation and Benefits
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We benchmark our benefits program against others in our industry to help us make decisions on the size and elements of our compensation program.
−Removed: Product Recalls
−Removed: FiberCel Recall
−Removed: On June 2, 2021, we issued a voluntary recall pertaining to a single donor lot of our FiberCel Fiber Viable Bone Matrix, a bone repair product formerly distributed by Medtronic PLC, after learning of post-surgical infections reported in several patients treated with the product, including some patients that tested positive for tuberculosis (the “FiberCel Recall”).
−Removed: After the recall, we worked with the FDA and the U.S.
−Removed: Centers for Disease Control and Prevention (“CDC”) to identify and secure all unused product, ascertain the medical status of patients treated with the recalled product, understand whether there is any relationship between the post-surgical infections and the recalled product lot and determine the medical cause of these infections.
−Removed: We identified the 154 units comprising the single product lot in question.
−Removed: Based on information from the CDC, 136 units within this product lot were implanted into 113 patients and the remaining 18 units were returned to either us or the CDC.
−Removed: The CDC advised us that the CDC, working with state health agencies, contacted all patients treated with the recalled lot of FiberCel to help ensure they were directed to appropriate medical treatment and informed us that all patients were started on standard four-drug treatment for tuberculosis.
−Removed: Samples of the recalled product underwent polymerase chain reaction (“PCR”) analysis by a lab contracted by the CDC and tested positive for the presence of Mycobacterium tuberculosis (“MTB”).
−Removed: Cell culture testing of the recalled product was also conducted by the same lab that showed the presence of MTB, and this testing corroborated the PCR testing results.
−Removed: Viable Bone Matrix Recall
−Removed: In July 2023, we announced a voluntary recall of a single lot of one of our viable bone matrix (“VBM”) products and the market withdrawal of all of our VBM products produced after a specified date (the “VBM Recall”).
−Removed: Notice of the voluntary recall was issued to centers after we learned of post-surgical MTB infections in two patients treated with product from a single donor lot of our VBM product.
−Removed: Consistent with the FiberCel Recall, after the VBM Recall, we worked with the FDA and CDC to identify and secure all unused product, ascertain the medical status of patients treated with the recalled product, understand whether there is any relationship between the post-surgical infections and the recalled product lot and determine the medical cause of these infections.
−Removed: Prior to release, samples from this specific lot had tested negative for MTB by an independent laboratory using a nucleic acid test that is designed to specifically
−Removed: detect the MTB organism.
−Removed: Additionally, in August and September 2023, c ell culture testing of the recalled product was conducted by the same lab and showed no presence of MTB.
−Removed: In October 2023, the CDC received the results of several MTB tests on the recalled VBM lot.
−Removed: Three cultures and five nucleic acid tests resulted in no detection of MTB, and two other cultures of the recalled VBM lot detected MTB.
−Removed: Based on our discussions with the CDC, we believe that a total of 36 patients were treated with product from the single donor lot.
−Removed: All VBM products, which includes FiberCel, were divested by us in connection with the sale of our Orthobiologics Business to Berkeley in November 2023.
−Removed: Berkeley did not assume any liabilities related to the FiberCel Recall or VBM Recall, our market withdrawal of all of our viable bone matrix products, or any claims or lawsuits related thereto.
−Removed: The FiberCel Recall and VBM Recall are described in further detail in Part I, Item 3, “Legal Proceedings” and Note 17 to the consolidated financial statements, included elsewhere in this Annual Report.
Available Information
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.