Surmodics
NasdaqGM:SRDX
$
42,98
$
+
$0,15 (0,35%)
42,98
$
+$0,15 (0,35%)
End-of-day quote: 11/19/2025
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Surmodics Company Info
EPS Growth 5Y
-16,11%
Market Cap
$0,62 B
Long-Term Debt
$0,03 B
Short Interest
4,72%
Quarterly earnings
04/30/2026 (E)
Dividend
$0,00
Dividend Yield
0,00%
Founded
1979
Industry
Country
ISIN Number
Website
Analyst Price Target
The Analyst Price Target shows the analysts’ low, high, and average target at a glance.
There are currently no price targets available for this stock.
In the last five quarters, Surmodics’s Price Target has risen from $58,50 to $58,50 - a 0,00% increase. Two analysts predict that Surmodics’s share price will fall in the coming year, reaching $0,00. This would represent a decrease of -100,00%.
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What does Surmodics do?
Surmodics, Inc. (Surmodics) provides performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic (‘IVD’) immunoassay tests and microarrays.
Surmodics also develops and commercializes highly differentiated vascular intervention medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the company’s expertise in prop...
Surmodics, Inc. (Surmodics) provides performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic (‘IVD’) immunoassay tests and microarrays.
Surmodics also develops and commercializes highly differentiated vascular intervention medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the company’s expertise in proprietary surface modification and drug-delivery coating technologies, along with its device design, development and manufacturing capabilities.
Segments
Medical Device
This segment engages in the manufacture and licensing of performance coatings, including surface modification coating technologies to improve access, deliverability and predictable deployment of medical devices and drug-delivery coating technologies to provide site-specific drug-delivery from the surface of a medical device, with end markets that include neurovascular, peripheral, coronary, and structural heart, among others.
This segment engages in the manufacture of vascular intervention medical devices, including drug-coated balloons, mechanical thrombectomy devices, and radial access balloon catheters and guide sheaths.
In Vitro Diagnostics (‘IVD’)
This segment engages in the manufacture of chemical and biological components used in in vitro diagnostic immunoassay and molecular tests within the diagnostic and biomedical research markets. Component products include protein stabilizers, surface coatings, substrates and antigens.
Medical Device segment
The company’s Medical Device segment consists of two interrelated product platforms:
Vascular Intervention Medical Devices. The company develops and manufactures its own proprietary vascular intervention medical device products, which leverages the combination of the company’s expertise in proprietary surface modification and drug-delivery coating technologies, along with the company’s device design, development and manufacturing capabilities. The company’s strategy of developing its own medical device products has increased, and will continue to increase, the company’s relevance in the medical device industry.
Performance Coatings. Surmodics is an established market leader in proprietary surface modification coating technologies that impart lubricity, pro-healing and biocompatibility characteristics, as well as drug-delivery capabilities (together, ‘performance coatings’ or ‘performance coating technologies’) to medical devices and delivery systems. The company develops and commercializes its performance coatings through license agreements with medical device manufacturers for use in their medical devices.
Vascular Intervention Medical Devices
Medical Device Segment
The company’s strategy is to develop a portfolio of highly differentiated medical devices for vascular interventional treatment. The company invests in the development and commercialization of devices that serve large, under-penetrated markets; address unmet clinical needs; and improve clinical outcomes for patients. The company’s portfolio and pipeline of vascular intervention medical device products includes the following primary platforms:
Drug-coated balloons (‘DCBs’) which combine a pharmaceutical drug with a medical device to treat narrowing of the blood vessels supplying the extremities (most commonly in the legs), known as peripheral artery disease (‘PAD’);
Mechanical thrombectomy devices to remove clots from arteries and veins in the peripheral arterial and venous vasculatures; and
Radial access devices to enable access and treatment of stenosed (narrowed) arteries from the thigh to the foot via radial (wrist) access, and which can also be used in alternative access sites, including femoral and pedal access.
In addition to these primary platforms, the company’s device manufacturing operations include:
Specialty Catheters. The company has successfully developed, received the U.S. and European Union (‘E.U.’) regulatory approvals, and executed commercialization partnerships for several specialty catheter products. The company has partnered with Medtronic plc (‘Medtronic’) to distribute its Telemark microcatheter in the U.S. and Europe for coronary applications. The company has partnered with Cook Medical to distribute its 0.014’ and 0.018’ low-profile percutaneous transluminal angioplasty (‘PTA’) balloon catheters in the U.S. and Europe.
In addition, the company leverages its proprietary balloon catheter technology to deliver contract-manufactured balloon catheter products to original equipment manufacturers (‘OEMs’) on a limited scale.
The company commercializes its medical device products using two strategies:
Direct sales. The company has a direct salesforce, which was established in fiscal 2022, that sells its mechanical thrombectomy and radial access devices directly to healthcare providers.
Strategic partnerships. For certain of the company’s products, including its DCB products, the company’s clinical development and commercialization strategy utilizes distribution partnerships with large, strategic medical device companies. The exclusive distribution partner for the company’s SurVeil DCB is Abbott Vascular, Inc.
Vascular Intervention Medical Devices – Drug Coated Balloons (‘DCBs’)
Medical Device Segment
The company has leveraged its performance coating technologies to successfully develop multiple DCB devices for use in vascular interventions for the treatment of PAD. DCBs are used by physicians to expand the diameter (lumen) of a narrowed vessel, thus improving or restoring blood flow. The drug coating helps to prevent the vessel from narrowing again (restenosis) after treatment. PAD is a serious and under-diagnosed circulatory condition caused by build-up of plaque, most commonly in the legs. Over 8 million Americans are affected by PAD, which increases risk of coronary artery disease, heart attack and stroke. PAD can impair the ability to walk, and if left untreated, can lead to gangrene and limb amputation.
The following is a brief description of each of these devices and their stage of clinical development, with additional information about each device provided further below.
SurVeil DCB is a paclitaxel-coated DCB to treat PAD in the upper leg (superficial femoral artery). The company’s SurVeil DCB utilizes a proprietary paclitaxel drug-excipient formulation for a durable balloon coating and is manufactured using an innovative process to improve coating uniformity. In June 2023, the SurVeil DCB received U.S. Food and Drug Administration (‘FDA’ or the ‘Agency’) premarket approval (‘PMA’) and may now be marketed and sold in the U.S. by the company’s exclusive distribution partner, Abbott Vascular, Inc. (‘Abbott’), under the company’s exclusive worldwide distribution agreement.
In the first quarter of fiscal 2024, the company completed shipment of Abbott’s initial stocking order of commercial units of the SurVeil DCB, resulting in recognition of product sales. Beginning in January 2024, the SurVeil DCB is a commercial product available in the U.S. through Abbott. Throughout fiscal 2024, the company continued to manufacture and ship commercial units to Abbott in the support of Abbott’s commercialization of the product.
Sundance DCB is a sirolimus-coated DCB used for the treatment of below-the-knee PAD, including critical limb ischemia (‘CLI’). The company’s SWING first-in-human, 35-patient, 36-month clinical study was designed to evaluate the safety and performance of the company’s Sundance DCB when used to treat occlusive disease of the infra-popliteal arteries. SWING study data at 24 months demonstrated an excellent safety profile and promising signals of potential performance. The company continues to evaluate its strategy for further clinical investment in the Sundance DCB based on the experience the company has gained from the PMA application process for the SurVeil DCB and market interest.
The company’s DCB products are required to go through clinical studies in order for the company to obtain regulatory approval or clearance to market the product in the U.S. Each clinical study includes one or more primary endpoints, which measure the effectiveness and/or safety of a device based on the product’s ability to achieve one or more pre-specified outcomes. Primary endpoints are selected based on the proposed intended use of the medical device. A pivotal trial is a definitive study designed to gather evidence to evaluate the safety and effectiveness of a product prior to its marketing.
SurVeil DCB. The company’s SurVeil DCB product is a paclitaxel-coated DCB to treat PAD in the upper leg (superficial femoral artery). The SurVeil DCB is a next-generation device that utilizes best-in-class technology for the treatment of PAD, including a proprietary paclitaxel drug-excipient formulation for a durable balloon coating manufactured using an innovative process to improve coating uniformity. The design of the SurVeil DCB is intended to provide more uniform drug distribution, better efficiency of drug transfer, and fewer downstream particulates and downstream embolization.
The company’s SurVeil DCB product has the necessary regulatory approval for commercialization in the U.S. (PMA from the FDA was received in June 2023). Beginning in January 2024, the SurVeil DCB is a commercial product available in the U.S. through Abbott. Throughout fiscal 2024, the company continued to manufacture and ship commercial units to Abbott in support of Abbott’s commercialization of the product.
TRANSCEND Pivotal Clinical Trial. The TRANSCEND pivotal clinical trial has been used to support the regulatory approval for the SurVeil DCB in the U.S. by providing the data necessary to evaluate the safety and effectiveness of the company’s SurVeil DCB compared with the Medtronic IN.PACT Admiral DCB in treating PAD in the upper leg (superficial femoral artery). The trial enrolled 446 subjects at 65 global sites. The trial’s primary efficacy endpoint is primary patency, defined as a composite of freedom from restenosis and clinically-driven target lesion revascularization through 12 months post-index procedure. TRANSCEND enrollment was completed in 2019, and all randomized subjects will be followed through 60 months post-index procedure.
In January 2021, the company announced the TRANSCEND 12-month pivotal clinical trial met both the primary safety and primary efficacy endpoints, and the SurVeil DCB was found to be non-inferior in those endpoints to the Medtronic IN.PACT Admiral DCB, while delivering a substantially lower drug dose.
TRANSCEND 36-month data demonstrated comparable, sustained clinical outcomes between the SurVeil DCB and IN.PACT Admiral DCB cohorts through 36 months, including rates of clinically driven target lesion revascularization, major limb amputation, thrombosis at the target lesion, and major adverse events.
Abbott Agreement. In 2018, the company entered into a Development and Distribution Agreement with Abbott (the ‘Abbott Agreement’), which provided Abbott with exclusive worldwide commercialization rights for the SurVeil DCB.
The company anticipates the completion of the TRANSCEND pivotal clinical trial in the second quarter of fiscal 2025; consequently, the company expects no further recognition of SurVeil DCB license fee revenue subsequent to March 31, 2025.
Under the Abbott Agreement, the company supplies commercial units of the SurVeil DCB to Abbott, and Abbott has exclusive worldwide distribution rights. In the first quarter of fiscal 2024, the company completed shipment of Abbott’s initial stocking order of commercial units of the SurVeil DCB, and throughout fiscal 2024, the company continued to manufacture and ship commercial units to Abbott in the support of Abbott’s commercialization of the product.
Surmodics is responsible for conducting all necessary clinical trials and other activities required to obtain and maintain the U.S. and E.U. regulatory clearances for the SurVeil DCB, including completion of the ongoing TRANSCEND pivotal clinical trial. Expenses related to these activities are paid by Surmodics. Abbott and Surmodics participate on a joint development committee charged with providing guidance on the company’s clinical and regulatory activities related to the SurVeil DCB product.
Sundance DCB. The company’s sirolimus-coated Sundance DCB is used for the treatment of below-the-knee PAD, including CLI.
Sirolimus has potent anti-inflammatory and anti-proliferative effects to inhibit cell division, without creating vascular toxicity, and has a proven history of safety and efficacy in vascular anatomy. The company leveraged its expertise in performance coatings in the innovative design of the company’s Sundance DCB, which in pre-clinical benchtop and animal testing has shown clear advantages over competitive technologies, including superior drug coating durability, higher levels of drug transfer, and a unique ability to achieve sustained therapeutic levels in the tissue.
Below is a summary of the company’s clinical and regulatory progress related to the Sundance DCB.
In October 2019, the FDA designated the Sundance DCB as a ‘Breakthrough Device’ under the FDA’s Breakthrough Devices Program, which is designed to streamline the market clearance/approval process for products that have the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The company’s SWING first-in-human, 35-patient, 36-month clinical study was designed to evaluate the safety and performance of the company’s Sundance DCB when used to treat occlusive disease of the infra-popliteal arteries. Enrollment and six-month follow up visits were completed in fiscal 2021. The clinical report for the SWING study was completed in fiscal 2022, which demonstrated promising early safety data and performance insights. SWING study data demonstrated an excellent safety profile at 24 months, with no major amputations and low rates of major adverse events. There were no clinically driven target lesion revascularizations in study participants between six- and 24-months post procedure. SWING study data also showed promising signals of potential performance of the device, with target lesion primary patency maintained in 80% of per protocol patients at 12 months and in 71% of per protocol patients at 24 months.
The company continues to evaluate its strategy for further clinical investment in the Sundance DCB based on the experience the company has gained from the PMA application process for the SurVeil DCB and market interest.
Vascular Intervention Medical Devices – Mechanical Thrombectomy
Medical Device Segment
The company has successfully developed, internally and through acquisitions, multiple FDA 510(k)-cleared mechanical thrombectomy devices for the non-surgical removal of thrombi and emboli (clots) from the peripheral arterial and venous vasculatures, while minimizing the need for thrombolytics. The ease of use, intuitive design and performance of the company’s thrombectomy systems make these devices attractive first-line treatment options for interventionalists. These devices include:
Pounce Thrombectomy Platform, intended for the peripheral arterial vasculature, is a suite of mechanical thrombectomy systems designed for the capture and non-surgical removal of thrombi and emboli (clots) without the need for capital equipment or aspiration while minimizing the use of thrombolytics. During 2022, the company established a direct salesforce and commenced commercial sales of the company’s Pounce Thrombectomy Platform to hospitals and clinics.
Pounce Venous Thrombectomy System is a mechanical thrombectomy system indicated for mechanical de-clotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vasculature. The Pounce Venous Thrombectomy System is designed to remove mixed-morphology, wall-adherent venous clot in a single session, minimizing the need for thrombolytics and without the need for capital equipment. The company conducted limited market evaluations of the Pounce Venous Thrombectomy System in fiscal 2023 and in the first half of fiscal 2024 to obtain physician feedback across a variety of cases and clinical conditions. In the second quarter of fiscal 2024, the company completed limited market evaluations for the Pounce Venous Thrombectomy System, and the product was commercially launched.
The company’s thrombectomy devices represent a core offering within the company’s vascular intervention product strategy, providing the opportunity for rapid growth in large, under-penetrated markets; and improved clinical outcomes and reduced healthcare costs, with single session treatment for removal of difficult clots, no capital equipment, and the potential to reduce the need for thrombolytic drugs.
Peripheral arterial occlusion (‘PAO’), the blocking of arteries by clots, is a peripheral vascular condition commonly associated with CLI. Often, these arterial clots require surgical intervention and have proven difficult to remove with available medical device technologies. Depending on the age and magnitude of the occlusion and the viability of the threatened limb, existing treatments for this condition may include catheter-directed thrombolysis, surgical embolectomy, and/or percutaneous mechanical thrombectomy. In cases in which the occlusion has caused irreversible damage to the limb, acute limb ischemia can result in the amputation of a lower extremity.
Venous thromboembolism (‘VTE’), a blood clot in the veins, is an under-diagnosed and serious, yet treatable, medical condition that can cause disability and death. VTE affects approximately 1.2 million U.S. patients each year. The current standard of care for treating VTE is conservative medical management with anticoagulant drugs designed to prevent further blood clotting. While anticoagulation remains the most widespread therapy for VTE, interventional treatment has demonstrated the potential for better outcomes in select patients.
The company’s proprietary Pounce Thrombectomy and Pounce Venous thrombectomy devices provide physicians with the opportunity to remove peripheral arterial and venous clots in a more effective, cost-efficient manner than other available treatments. The devices offer innovative designs that may reduce the need for the use of thrombolytic drugs. Thrombolytic drugs are often associated with complications, which can include bleeding complications, longer hospital stays and higher cost of treatment. The company’s Pounce Thrombectomy and Pounce Venous thrombectomy devices are designed to reduce procedure time, efficiently remove large volumes of clot, and eliminate the need for additional external capital equipment, thereby providing an easy-to-use, on-the-table, single-session solution for clinicians.
Pounce Thrombectomy Platform, intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature, is a suite of mechanical thrombectomy systems designed to remove clots without the need for capital equipment or aspiration while minimizing the use of thrombolytics. Three different-sized systems are commercially available.
The original Pounce (mid profile) Thrombectomy System is indicated for use in peripheral arterial vessels 3.5 mm to 6 mm in diameter, such as those found above the knee. Commercial sales of the Pounce Thrombectomy System began in fiscal 2022.
The Pounce LP (Low Profile) Thrombectomy System is indicated for use in peripheral arterial vessels 2 mm to 4 mm in diameter, such as those found below the knee. The Pounce LP Thrombectomy System received FDA 510(k) regulatory clearance in the third quarter of fiscal 2023, and the company began limited market evaluations of the product in the first quarter of fiscal 2024. In the third quarter of fiscal 2024, the company completed limited market evaluations for the Pounce LP Thrombectomy System, and the product was commercially launched.
The Pounce XL Thrombectomy System is indicated for use in peripheral arterial vessels 5.5 mm to 10 mm in diameter, making it suitable for iliac, femoral, and other arteries within this range. The Pounce XL Thrombectomy System received FDA 510(k) regulatory clearance in the fourth quarter of fiscal 2024. The company plans to initiate limited market evaluations of the product in the first half of fiscal 2025, with commercialization following the completion of the limited market release.
The Pounce Thrombectomy Platform device systems consist of three components: a 5 Fr basket delivery catheter, a basket wire, and a funnel assembly. After the basket wire is delivered distal to the location of the thrombus, two nitinol self-expanding baskets are deployed to collect and entrain the clot into a funnel-shaped nitinol wire mesh. With the clot entrained, the funnel assembly is then collapsed into a 7 Fr procedure guide sheath through which the clot is withdrawn and removed from the body. Physician feedback indicates the Pounce Thrombectomy Platform device systems are capable of achieving positive outcomes with minimal blood loss and with minimal use of thrombolytics. The devices offer an intuitive, grab-and-go design to simplify setup and reduce the physician’s learning curve.
Pounce Venous Thrombectomy System. The company’s Pounce Venous Thrombectomy System, which received FDA 510(k) clearance in 2021, is a mechanical thrombectomy catheter for use in peripheral venous vascular beds that is specifically designed to remove large, mixed-morphology blood clots. The device’s dual-action technology features a constant spring tension basket, which provides optimal wall apposition over a range of vessel diameters, to engage and collect the clot, while the motor-driven Archimedes screw macerates and removes the collected clot. As with the company’s Pounce Thrombectomy Platform devices, the Pounce Venous Thrombectomy System is intuitive and approachable to facilitate widespread adoption, with a low learning curve for the physician.
The company acquired the venous thrombectomy device technology with the company’s 2021 acquisition of Vetex Medical Limited (‘Vetex’), which was privately held and based in Galway, Ireland.
The company conducted limited market evaluations of the Pounce Venous Thrombectomy System in fiscal 2023 and in the first half of fiscal 2024 to obtain physician feedback across a variety of cases and clinical conditions. In the second quarter of fiscal 2024, the company completed limited market evaluations for the Pounce Venous Thrombectomy System, and the product was commercially launched.
Vascular Intervention Medical Devices – Radial Access
Medical Device Segment
The company has successfully developed and received FDA 510(k) regulatory clearance for the company’s Sublime portfolio of devices designed for vascular intervention via radial (wrist) access that can also be used via alternative access sites, including femoral (thigh) and pedal (foot) access. The company’s Sublime devices are used to access and treat stenosed (narrowed) arteries both above and below the knee, commonly associated with PAD. During 2022, the company established a direct salesforce and commenced commercial sales of the company’s Sublime device portfolio to hospitals and clinics. These radial access devices include:
Sublime guide sheath provides the conduit for peripheral intervention with an access point at the wrist that enables treatment all the way to the pedal loop of the foot.
Sublime .014 RX PTA dilatation catheter treats lesions in peripheral arteries below the knee all the way to the patient’s foot and around the pedal loop.
Sublime .018 RX PTA dilatation catheter treats lesions in peripheral arteries above and below the knee.
Sublime microcatheters (0.14, .018 and .035) facilitate guidewire placement for difficult to access and treat arterial lesions above and below the knee using radial, femoral, or alternate access sites. Limited market evaluations of the company’s Sublime microcatheters began in the third quarter of fiscal 2023. In the third quarter of fiscal 2024, the company completed limited market evaluations for the Sublime microcatheter, and the product was commercially launched.
The company’s Sublime device portfolio is unique in that each of these devices are purpose built for above and below the knee peripheral interventions that can employ a transradial approach and alternative access sites, including conventional femoral access and pedal access. The company’s Sublime guide sheath performance is enhanced by the company’s recent generation hydrophilic coating. The company’s Sublime device portfolio meets an unmet clinical need by providing longer, lower-profile devices that are robust enough to deliver treatment from the wrist all the way to the pedal loop in the foot.
The Sublime device portfolio is uniquely positioned to lead the market for dedicated devices that facilitate a radial-to-peripheral approach. Below are a few of the unique advantages of the company’s Sublime devices.
The company’s Sublime guide sheath is the only 5F guide sheath available in a length up to 150cm, making it an ideal device for operators who seek a smaller profile sheath to help minimize radial artery spasm or to treat smaller patients when performing peripheral interventions via radial access. Physician feedback has indicated the company’s Sublime guide sheath offers a low-profile design for patient comfort, superior trackability through tortuous anatomy, and resistance to kinking when compared to alternative devices.
The company’s Sublime .014 RX PTA dilatation catheter is the longest catheter of its kind in the U.S. market, at 250 cm. Physician feedback has indicated both the company’s Sublime .014 and .018 catheters provide superb deliverability and the ability to cross challenging lesions.
Performance Coatings
Medical Device Segment
Surmodics’ industry-leading performance coatings are used in a minimally invasive procedure every minute of every day. Surmodics’ surface-enhancing performance coatings add differentiated value to more than 150 medical, biotechnology and pharmaceutical product families worldwide. The company’s customers use Surmodics’ performance coatings to enable, optimize and differentiate their device products. These performance coatings include:
Hydrophilic coatings enable vascular device performance and maneuverability by reducing friction by imparting the necessary lubricity (smoothness or slipperiness) for minimally invasive, intravascular procedures. Surmodics’ low-particulate, hydrophilic coatings have a proven track record, meeting demanding regulatory requirements in the following clinical segments: neurovascular, peripheral, coronary, and structural heart devices.
Drug-delivery coatings enable a device to achieve the desired biological effect through the precisely controlled transfer of a pharmaceutical drug to targeted tissues. Surmodics possesses expertise across a range of compounds to meet a variety of clinical needs.
Hemocompatible coatings improve the safety and function of devices by reducing the risk of thrombus (clot) formation actively (heparin) or passively (non-heparin).
Surmodics generates royalties and license fee revenue by licensing the company’s performance coating technologies to medical device manufacturers, product revenue from sales to licensees of the chemical reagents used in coatings, and R&D revenue from commercial development feasibility services and contract coating services.
The company’s performance coatings are differentiated by their flexibility, durability and ease of use. In terms of flexibility, coatings can be applied to many kinds of surfaces and can immobilize a variety of chemical, pharmaceutical and biological agents. Additionally, the surface modification process can be tailored to provide customers with the ability to improve their devices’ performance by choosing the specific coating properties desired for particular applications. The company’s performance coating technologies can also be combined to deliver multiple surface-enhancing characteristics on the same device.
Hydrophilic Coatings. The company’s proprietary PhotoLink coating technology (‘PhotoLink Technology’) is a versatile, easily applied, coating technology that modifies medical device surfaces by creating covalent bonds between device surfaces and a variety of chemical agents. PhotoLink Technology can impart many performance-enhancing characteristics, such as advanced lubricity (slipperiness or smoothness) and hemocompatibility (preventing blood clot formation), when bound onto surfaces of medical devices or other biological materials without materially changing the dimensions or other physical properties of devices.
PhotoLink Technology reagents can be applied to a range of substrates. The coating formulations are easily applied to the material surface by a variety of methods including, but not limited to, dipping, spraying, roll-coating and ink-jetting. The company continues to expand its proprietary reagent portfolio for use by the company’s customers. These reagents enable the company’s customers to develop novel surface features for their devices, satisfying the expanding healthcare industry requirements. The company is also continually working to expand the list of materials that are compatible with its surface modification and device drug-delivery reagents. Additionally, the company develops coating processes and coating equipment to meet the device quality, manufacturing throughput, and cost requirements of the company’s customers.
The PhotoLink Technology coating process is relatively simple to use and is easily integrated into the customer’s manufacturing operations. In addition, the process does not subject the coated products to harsh chemical or temperature conditions, produces no hazardous byproducts, and does not require lengthy processing or curing time. Further, coatings incorporating the PhotoLink Technology are generally compatible with accepted sterilization processes, so the surface attributes are not lost when the medical device is sterilized.
The company’s Serene hydrophilic coating platform, which uses the company’s Photolink Technology, improves lubricity and durability, while significantly reducing particulates generation. This PhotoLink Technology-enabled coating has demonstrated excellent lubricity on a wide range of substrates and has been used on FDA-cleared coronary, peripheral and structural heart devices.
In October 2023, the company announced the commercial launch of its most advanced hydrophilic medical device coating technology, Preside hydrophilic coatings. Preside hydrophilic coatings complement the company’s existing Serene hydrophilic coatings by providing customers with a unique low-friction and low-particulate generation coating to further enhance distal access for neuro-vascular applications, as well as improved crossing for challenging coronary lesions or chronic total occlusions. Preside hydrophilic coatings are specifically formulated to meet the challenge of achieving the right balance of enhanced lubricity (reduction in friction) and excellent coating durability (resulting in low particulates) for the next generation of neurovascular, coronary and peripheral vascular devices. The company’s Preside and Serene hydrophilic coatings both allow customers to leverage their existing coating process to apply these innovative surface treatments.
Drug-delivery Coatings. The company’s device drug-delivery coating technologies allow therapeutic drugs to be incorporated within the company’s proprietary polymer matrices to provide controlled, site-specific release of the drug into the surrounding environment. The drug release can be tuned to elute quickly (within minutes to a few days) or slowly (from several months to over a year), illustrating the wide range of release profiles that can be achieved with the company’s coating systems. On a wide range of devices, drug-eluting coatings can help improve device performance, increase patient safety, and enable innovative new treatments. DCBs are a typical example of short-term use drug-delivery devices. An example of longer-term drug-delivery devices is drug-eluting stents. The company works with companies in the medical device and biotechnology industries to develop specialized coatings that allow for the controlled release of drugs from device surfaces.
Performance Coatings – Licensing Arrangements
Medical Device Segment
The company commercializes its performance coating technologies primarily through licensing arrangements with medical device manufacturers. This approach allows the company to focus its resources on further developing new technologies and expanding the company’s licensing activities. Many of the company’s technologies have been designed to allow manufacturers to implement them easily into their own manufacturing processes so customers can control production and quality internally without the need to send their products to a contract manufacturer. The company generates the largest proportion of its revenue through licensing arrangements.
The licensing process for the company’s performance coating technologies begins with the customer specifying a desired product feature to be created, such as lubricity or drug delivery. The company often supports its customers by providing coating assistance for parts required in animal tests and human clinical trials. Typically, the company completes a technology transfer to most customers which enables those customers to apply the coating at their own facilities. The company also generates revenue from reagent chemical product sales to licensees for use in their coating processes, as well as from providing contract coating services.
The company’s license agreements may include certain license fees and/or milestone payments. Substantially all the company’s licensed performance coating technology applications are nonexclusive, allowing the company to license each technology to multiple customers. Moreover, even exclusive performance coating technology licenses generally are limited to a specific ‘field of use,’ allowing the company the opportunity to further license technology to other customers. The royalty rate on a substantial number of the coatings agreements has traditionally been in the range of two to three percent, but there are certain contracts with lower or higher rates. In certain agreements, the company’s royalty is based on an agreed-upon amount per unit. License fees, milestone payments, and royalty rates are based on various factors, including the licensed product’s or technology’s stage of development, the perceived value of the company’s technology to the customer’s product, the size of the potential market, and whether the arrangement is exclusive or nonexclusive. The company’s agreements often incorporate a minimum royalty to be paid by the licensee. Royalty payments generally commence one quarter after the customer’s actual product sales occur because of the delay in reporting sales by the company’s licensees. The company estimates and recognizes sales-based royalties revenue from its performance coating licensees in the same quarter that the underlying customer product sale occurs.
The company has over 150 licensed product classes (customer products utilizing Surmodics technology) already in the market generating royalties and greater than 100 customer product classes incorporating the company’s technology in various stages of pre-commercialization.
Under the company’s performance coating technology license agreements, the responsibility for securing regulatory approval for and ultimately commercializing these products rests with the company’s customers.
The company’s licensing agreements generally require the company to keep its customers’ identities confidential, unless they approve of such disclosure. Licensed customers that allow the use of their name include: Abbott Laboratories and Abbott Vascular, Inc., Boston Scientific Corporation (‘Boston Scientific’), Cook Medical, Cordis Corporation, Covidien PLC (a subsidiary of Medtronic), Edwards Lifesciences Corporation, Evalve, Inc. (a subsidiary of Abbott), ev3 Inc. (a subsidiary of Medtronic), Medtronic, OrbusNeich Medical, Inc., and Spectranetics Corporation (a subsidiary of Koninklijke Philips N.V.).
Performance Coatings – R&D Services for Customers
Medical Device Segment
For the company’s medical device performance coating customers, the company has distinct, specifically-dedicated R&D facilities and personnel to support delivery of R&D services. The company works with its customers to integrate the best possible surface modification and device drug-delivery technologies with their products, not only to meet their performance requirements, but also to perform services quickly so that the product may reach the market ahead of the competition. To quickly solve problems that might arise during the development and optimization process, the company offers extensive capabilities in analytical chemistry and surface characterization within the company’s R&D organization. The company’s instrumentation and extensive experience allow the company to test the purity of coating reagents, to monitor the drug elution rate from coatings, to measure coating thickness and smoothness, and to map the distribution of chemicals throughout coatings. The company’s capabilities in this area exceed those of its competitors. The company’s R&D staff support its business development staff and business units in performing feasibility studies, as well as providing technical assistance to existing and potential customers. These services, which generate R&D and other revenue, include optimizing the relevant technologies for specific customer applications; supporting clinical trials; training customers; and integrating the company’s technologies and know-how into customer manufacturing operations.
In Vitro Diagnostics Segment
Surmodics’ In Vitro Diagnostics (‘IVD’) segment provides leading in vitro diagnostic companies with the critical components for developing sensitive, reproducible immunoassays to enable the company’s customers’ diagnostic tests to detect the absence or presence of disease. The company develops, manufactures, and sells chemical and biological components for in vitro diagnostic immunoassay tests and molecular diagnostic tests for the diagnostic and biomedical research markets.
The company’s portfolio of IVD chemical and biological component products includes:
Protein Stabilizers. The company offers a full line of stabilization products for the IVD market. These products increase sensitivity and specificity and reduce false positive and false negative results, while extending the diagnostic test’s shelf life, thereby producing more consistent assay results. The company’s stabilization products are ready-to-use, eliminating the in-house manufacturing preparation time and cost of producing stabilization and blocking reagents.
Surface Coatings for Molecular Diagnostic Applications. The company offers custom coatings for molecular diagnostic applications, including DNA, RNA and protein microarrays. The company’s TRIDIA surface coatings bind molecules to a variety of surfaces and geometries and may be customized for selectivity using passivating polymers and reactive groups. This proprietary technology immobilizes DNA and protein to adhere to testing surfaces. The company offers other surface coatings that improve flow characteristics through membranes and microfluidic channels on diagnostic devices, including point-of-care components.
Substrates. The company provides colorimetric and chemiluminescent substrates to the IVD market under the company’s BioFX trademark. A substrate is the diagnostic test kit component that detects and signals that a reaction has taken place so that a result can be recorded. Colorimetric substrates signal a positive diagnostic result through a color change. Chemiluminescent substrates signal a positive diagnostic result by emitting light. The company’s substrates offer a high level of stability, sensitivity and consistency.
Antigens and Antibodies. The company is the exclusive distributor in the U.S., Canada and Puerto Rico (and non-exclusive distributor in Japan) of the BBI Solutions’ DIARECT line of antigens and antibodies (‘DIARECT’). DIARECT produces the majority of these antigens and antibodies using recombinant technology.
The company’s IVD products address the following customer needs:
Immunoassay Diagnostics. Surmodics develops, manufactures and sells high-performing, consistent-quality and stable immunoassay component products to enable the company’s customers’ diagnostic tests to detect the absence or presence of disease. An immunoassay is a biochemical test that measures the presence or concentration of a target molecule, or analyte, in a biological fluid or sample. Analyte levels are correlated to the patient’s disease state or medical condition to diagnose the presence, absence or severity of disease. Analytes can range from large molecules such as proteins to small molecules such as hormones. Immunoassays are developed and produced using multiple components. The component’s selection and optimization confer the quality and performance of the assay in terms of sensitivity and specificity. IVD companies select these critical biochemical and reagent components to meet the assay’s diagnostic specifications.
Molecular Diagnostics – DNA and Protein Immobilization. Surmodics has developed various surface chemistries for both DNA and protein immobilization. The company’s TRIDIA product optimizes DNA, RNA, protein, and cell attachment for molecular diagnostic and immunoassay applications, reducing non-specific background and improving sensitivity. Surmodics’ versatile coatings bind molecules to a variety of surfaces and geometries and may be customized for selectivity using passivating polymers and reactive groups. Both DNA and protein microarrays are useful tools for the pharmaceutical, diagnostic and research industries. During a DNA gene analysis, typically thousands of different probes need to be placed in a pattern on a surface, called a DNA microarray. These microarrays are used by the pharmaceutical industry to screen for new drugs; by genome mappers to sequence human, animal or plant genomes; or by diagnostic companies to search a patient sample for disease-causing bacteria or viruses. However, DNA does not readily adhere to most surfaces. Protein microarrays are used as diagnostic and research tools to determine the presence and/or quantity of proteins in a biological sample. The most common type of protein microarray is the antibody microarray, where antibodies are spotted onto a surface and used as capture molecules for protein detection.
Customer R&D. The sales cycle for the company’s IVD products generally begins when an IVD company initiates the process to develop a new, or improve a current, diagnostic test. During product development, these companies seek to source the test’s critical components with reagents that it produces internally or with reagents from a supplier, such as Surmodics.
Patents and Proprietary Rights
As of September 30, 2024, Surmodics owned or had exclusive rights to 162 issued U.S. patents and 273 issued international patents. As of September 30, 2024, the company also owned or had exclusive rights to 26 U.S. pending patent applications and 65 foreign pending patent applications.
The company has licensed its PhotoLink Technology on a non-exclusive basis to a number of the company’s customers for use in a variety of medical device surface applications, including those described above. In particular, the company has 35 issued U.S. patents, five pending U.S. patent applications, 80 issued international patents, and 10 pending international patent applications protecting various aspects of these technologies, including compositions, methods of manufacture and methods of coating devices. The expiration dates for these patents and anticipated expiration dates of the patent applications range from fiscal 2025 to 2042.
Significant Customers
Revenue from Abbott and Medtronic represented approximately 16% and 12%, respectively, of the company’s consolidated revenue for the fiscal year ended September 30, 2024 (fiscal 2024). Revenue from these customers was generated from multiple products and fields of use, including revenue from the Abbott Agreement, substantially all of which were recognized in the company’s Medical Device segment.
With respect to the company’s Medical Device segment, revenue from Abbott and Medtronic represented approximately 20% and 16%, respectively, of the company’s Medical Device segment revenue for fiscal 2024, and revenue from one additional customer represented approximately 10% of the company’s Medical Device segment revenue for fiscal 2024.
With respect to the company’s IVD segment, revenue from two customers represented approximately 24% and 11%, respectively, of the company’s IVD segment revenue for fiscal 2024.
Government Regulation
In the support of the company’s customers’ and its own regulatory filings, the company maintains various confidential Device Master Files with the FDA and provides technical information to other regulatory agencies outside the U.S. regarding the nature, chemical structure and biocompatibility of the company’s reagents.
Research and Development (R&D)
The company's R&D expense was $38.4 million in fiscal 2024.
History
SurModics, Inc. was founded as a Minnesota corporation in 1979.
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