What changed in this filing

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Item 1. Business

2026-03-05 compared with 2025-03-11 · 101 added, 71 removed, 541 unchanged (24% of the section changed)

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Our portfolio of products is comprised of five patient-focused areas, grouped into three businesses based on clinical use:

(i) Pain Treatments, (ii) Surgical Solutions and (iii) Restorative Therapies.

• Pain Treatments, comprised of:

◦ Knee Osteoarthritis (“KOA”) area :

(i) Pain Treatments & PRP (“Pain Treatments”), (ii) Surgical Solutions and (iii) Restorative Therapies.

• Pain Treatments , consisting of:

◦ Knee Osteoarthritis (“KOA”) :

Our product portfolio includes a range of intra-articular, hyaluronic acid (“HA”) injections that help relieve patient discomfort and improve quality of life.

◦ Peripheral Nerve Stimulation (“PNS”) area:

We are focused on developing a full portfolio of peripheral nerve stimulation products with solutions for acute, temporary and chronic pain.

• Surgical Solutions, comprised of:

In the U.S., we also distribute the XCELL Platelet-Rich Plasma (“PRP”) system, a technology that is synergistic with our existing physician call points, as many surgeons who use HA also use PRP.

◦ Peripheral Nerve Stimulation (“PNS”) :

We are focused on developing and commercializing a full portfolio of peripheral nerve stimulation products with solutions for acute, temporary and chronic pain.

• Surgical Solutions , consisting of:

◦ Ultrasonics:

Our Ultrasonics business offers precision bone resection for patients with degenerative spine conditions and spinal deformities.

This portfolio also enables precision ultrasonic neuro and general surgery to address brain tumors and pathologies of the liver and other organs.

This portfolio also enables precision bone cutting in ultrasonic neuro and general surgery to address brain tumors and pathologies of the liver and other organs.

◦ Bone Graft Substitutes (“BGS”) :

Our product portfolio includes a range of products that facilitate optimal bone fusion following a surgical procedure.

• Restorative Therapies, comprised of:

Our BGS product portfolio includes a range of products that facilitate optimal bone fusion following a surgical procedure.

• Restorative Therapies , consisting of:

◦ Fracture Care:

We provide low-intensity pulse ultrasound to help patients who suffer from bone fractures that do not heal through traditional methods.

We plan to expand our United States clinical indications to address the healing of fresh fractures, especially for high-risk patients.

We plan to expand our U.S.

clinical fracture care indications to address the healing of additional fresh fractures, especially for high-risk patients.

Financial information regarding our reportable business segments is included in Part II, Item 7.

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The four-pronged strategy to reach our goals across our patient-focused areas includes the following:

1) Further develop and market our surgical solutions business .

1) Strengthen our leading positions in our core markets.

We are focused on continued market share growth of our differentiated HA, BGS and Fracture Care products, which account for the majority of our sales today, through targeted high-potential account execution.

This will provide investment for the continued expansion of our Ultrasonics and International businesses and enable growth in our emerging markets in PNS and PRP.

2) Continued investment in our new emerging technologies .

We plan to initiate full commercial launches of StimTrial and Talismann, while the PRP system will be sold through our existing HA sales force.

3) Further develop and expand our Ultrasonics platform business .

We are focused on establishing BoneScalpel as a standard of care for spine applications by accelerating market penetration in spinal surgery through increased surgeon education and awareness.

In parallel, we plan to leverage the versatility of our neXus platform and its existing install base to expand into additional specialties like neurosurgery and general surgery.

To continue expanding our presence in target surgical markets, we plan to leverage our clinical data to solidify our BGS portfolio as a sustainable alternative to higher-priced premium biologics.

4) Strategically grow our international markets .

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We also plan to strategically expand to new markets with our existing portfolio and intend to selectively pursue new market opportunities.

3) Strengthen our leading position in Knee Osteoarthritis.

We are focused on continued market share growth of HA in the United States through targeted high-potential account execution.

To increase pull-through, we plan to increase HCP awareness of the clinical differences of our single injection product, Durolane.

We intend to expand beyond our unique positioning as the only company to offer one-, three- and five- injection treatment regimens by evaluating further potential portfolio opportunities in the KOA area.

4) Expand our portfolio through strategic partnerships and internal development .

We are focused on broadening and innovating our portfolio of products within key market segments for our patient-focused areas.

To achieve this, we will prioritize opportunities for strategic partnerships that provide the biggest benefit for patients, customers, and our business.

Internally, we rely on a team of highly trained individuals to develop new products, conduct clinical investigations and assist in training healthcare providers on the clinical benefits and the safe and effective use of our products.

Table of C o ntents

We offer a diverse portfolio of products to support physicians in relieving pain and addressing musculoskeletal challenges across indications and clinical areas, including knee, hand and upper extremities, foot and ankle, podiatry, trauma, general surgery, spine and neurosurgery.

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Our PNS product targets peripheral nerve pain at its source without the use of drugs and its small profile allows the system to be implanted in many locations on the body, depending on patient needs.

We also are the exclusive distributor of the XCELL PRP System in the U.S., specifically for the orthopedic and sports medicine markets.

Durolane is an U.S.

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Durolane contains high levels of HA and is injected directly into the joints affected by OA to relieve pain and restore lubrication and cushioning.

This may improve joint function and help to potentially avoid or delay knee replacement surgery.

This may improve joint function and help to potentially delay knee replacement surgery.

Physicians administer Durolane to the affected knee joint in a single injection and it has been observed to provide a benefit for pain reduction in patients with OA in the knee for up to 26 weeks.

Durolane’s injection schedule results in economic advantages and greater patient convenience and compliance compared to other HA viscosupplementation therapies which require weekly injections over a period of three to five weeks.

Durolane is highly purified and based upon a natural and patented non-animal stabilized HA (“NASHA”), expanding use to patients who are allergic to animal-derived solutions.

Durolane is highly purified and based upon a natural and patented non-animal stabilized HA, expanding its use to patients who are allergic to animal-derived solutions.

We currently market Durolane in the United States and internationally.

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We currently market SUPARTZ FX in the United States.

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Our StimRouter Peripheral Nerve Stimulation system is a permanent option that provides relief for chronic peripheral pain, including nerve pain, neuroma, neuropathic pain, post-stroke shoulder pain and neuralgia.

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We currently market StimRouter in the United States and internationally.

Developmental and clinical pipeline for Pain Treatments

The TalisMann Pulse Generator and Receiver is an accessory to the StimRouter PNS system and is designed to provide more powerful stimulation to the targeted peripheral nerve, potentially enabling physicians to address chronic pain of a peripheral nerve origin in larger, deeper, or damaged nerves.

TalisMann has a small profile and is attached to the StimRouter lead intraoperatively and pocketed under the skin after the StimRouter lead electrodes are placed near the targeted peripheral nerve.

Though not currently available, the 510(k) submission to the FDA for market clearance of the TalisMann was completed in the fourth quarter of 2024.

FDA 510(k) clearances for both TalisMann and StimTrial were received in July 2025, expanding our innovative growth portfolio of PNS solutions for chronic pain management.

These clearances mark an important step forward and represent a substantial growth opportunity as we look to expand in the PNS market.

With TalisMann and StimTrial now FDA-cleared, we offer a comprehensive PNS portfolio that empowers physicians to potentially treat a broader spectrum of patients—from initial assessment to long-term therapy—with greater confidence and flexibility.

This development also reinforces our commitment to delivering non-opioid, minimally invasive therapies designed to address real-world clinical needs.

TalisMann combines our patented electric field conduction technology with an integrated pulse generator to potentially reach deeper, larger nerves.

This combination is designed to provide long-term relief from chronic nerve pain for patients, potentially increasing the number of patients who respond to neuromodulation therapy.

From a physician's perspective, the increase in power allows for easier lead placement and potentially broadens addressable nerves.

StimTrial provides physicians the ability to evaluate patient response to PNS therapy, which we expect will facilitate physician adoption and payer reimbursement where trial assessments are required.

We began a limited commercial release of both TalisMann and StimTrial in select U.S.

markets during the third quarter of 2025.

The broader market launch of these products commenced in early 2026.

In 2025, we entered into an agreement with Apex Biologix to be the exclusive distributor of their XCELL PRP System in the United States, specifically for orthopedic and sports medicine markets.

The XCELL PRP System is a benchtop device that processes whole blood to produce high-yield PRP with a 10-minute single-spin cycle.

The system offers leukocyte-rich and leukocyte-poor PRP preparations in one platform.

Designed to capture the entire buffy coat, the system is engineered to provide consistent processing results.

The XCELL PRP System delivers customized treatments from an advanced benchtop processing station with a hand-controlled dial to allow physicians to tailor treatment based on each patient’s needs.

The XCELL PRP System creates a highly synergistic opportunity for us to leverage our strong HA sales force as the majority of surgeons using HA are also treating patients with PRP.

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Surgical Solutions

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The neXus Ultrasonic Surgical System (“neXus”) is a leading ultrasonic surgical platform that combines all the features of our Surgical Solutions applications, including BoneScalpel, BoneScalpel Access, SonaStar Elite, SonicOne and SonaStar into a single fully integrated system, setting a foundation for future developments to fulfill unmet customer needs.

The neXus platform is driven by a proprietary digital algorithm designed to deliver more power, efficiency, and control for the surgeon.

The neXus platform is driven by a proprietary digital algorithm designed to deliver power, efficiency, and control for the surgeon.

The device incorporates technology that allows for intuitive set-up and use.

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In addition to soft tissue applications, SonaStar may be used with hard tissue tips to enable precise shaping or shaving of bony structures that prevent access to partially or completely hidden soft tissue masses.

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Our SonaStar Elite handpiece and accessories expand the frequency capabilities of the neXus System, adding 36 kHz capabilities.

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The tissue-specific capability is, in part, due to healthy and viable tissue structures’ higher elasticity and flexibility than necrotic tissue and resistance to destruction from the impact effects of ultrasound.

The ultrasonic debridement process separates devitalized tissue from viable tissue layers, allowing for a more defined treatment and, usually, a reduced pain sensation.

The ultrasonic debridement process separates devitalized tissue from viable tissue layers, allowing for a more defined treatment.

We believe that SonicOne establishes a new standard in wound bed preparation, the essential first step in the healing process, while contributing to faster patient healing.

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We currently market PUREBONE in the United States.

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Reficio Demineralized Bone Matrix (“Reficio DBM”) is a putty comprised of human demineralized bone matrix and a biocompatible, bioabsorbable carrier, carboxymethylcellulose, mixed into a putty-like consistency for ease of use during surgery.

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Products from our Pain Treatments, Restorative Therapies and Surgical Solutions groups are sold by direct sales teams in the United States and a complementary indirect sales team for Surgical Solutions.

That team is supported by a broad management team in addition to a market access team focused on expanding approvals with integrated healthcare delivery networks (“IDNs”), GPOs and payers.

That team is supported by a broad management team in addition to a market access team focused on expanding approvals with integrated healthcare delivery networks (“IDNs”), group purchasing organizations (“GPOs”) and payers.

Internationally, we sell our products through a mix of direct and indirect sales teams and distributors.

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The speed with which we can develop products, complete clinical testing and regulatory clearance processes and supply commercial quantities of our products to the market are therefore important competitive factors.

We compete with many companies having more significant capital resources, greater R&D resources and more extensive distribution systems than we do.

Our Pain Treatments that we own or distribute compete with products from Ferring Pharmaceutical Inc., Fidia Farmaceutici S.p.A., DePuy Orthopaedics, Inc.

(Johnson & Johnson), Zimmer Biomet Holdings, Inc.

and Sanofi S.A, OrthogenRx Inc.

(Avanos) and for peripheral nerve stimulation specifically we compete with SPR Therapeutics, Nalu and Stimwave.

We compete with many companies that have significant capital resources, greater R&D resources and more extensive distribution systems than we do.

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Our Pain Treatments that we own or distribute compete with products from Ferring Pharmaceutical Inc., Fidia Farmaceutici S.p.A., Johnson & Johnson, Zimmer Biomet Holdings, Inc., Arthrex, Inc., Emcyte Corporation and Channel-Markers Medical, and for peripheral nerve stimulation specifically, we compete with SPR Therapeutics, Nalu and Curonix.

Our Surgical Solutions products compete with products from Medtronic, DePuy Orthopaedics, Inc.

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We own numerous patents and/or patent applications which relate to our material products.

Although in the aggregate our intellectual property is of material importance to our business, we do not believe that any single patent is of material importance to our product portfolio.

Although in the aggregate our intellectual property is material to our business, we do not believe that any single patent is material to our product portfolio.

As of December 31, 2025, we owned 99 issued U.S.

patents and four pending U.S.

patents and six pending U.S.

patent applications relating to our material products.

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Our patents and patent applications as of December 31, 2025 directed to our material products are summarized below.

We own three issued U.S.

We own two issued U.S.

patents and one issued foreign patent in Australia directed to our EXOGEN system.

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We also own 48 issued U.S.

patents, 50 issued foreign patents, and 11 pending foreign patent applications directed to our BoneScalpel system, including foreign patents and patent applications in Australia, Canada, Europe, and Japan.

patents, 3 pending U.S.

patent applications, 64 issued foreign patents, and 24 pending foreign patent applications directed to our BoneScalpel system, including foreign patents and patent applications in Asia, Canada, and Europe.

patents are expected to expire between 2026 and 2044, and the foreign patents are expected to expire between 2027 and 2039.

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We also own 19 issued U.S.

patents, 20 issued foreign patents, and six pending foreign patent applications directed to our SonicOne System, including foreign patents and patent applications in Australia, Canada, and Europe.

patents, 26 issued foreign patents, and two pending foreign patent applications directed to our SonicOne System, including foreign patents and patent applications in Asia, Canada, and Europe.

patents are expected to expire between 2026 and 2039, and the foreign patents are expected to expire between 2026 and 2038.

The pending patent applications, if issued, are expected to expire between 2037 and 2038, without accounting for potential patent term extensions and adjustments.

We also own two issued U.S.

patents, two issued foreign patent, and one pending foreign patent application directed to our Sonastar System.

patents are expected to expire between 2030 and 2037, and the foreign patents are expected to expire in 2037.

We also own two issued U.S.

We also own six issued U.S.

patents, five issued foreign patents, and one pending U.S.

patent application directed to our Sonastar System.

patents are expected to expire between 2030 and 2045, and the foreign patents are expected to expire between 2031 and 2037.

We also own three issued U.S.

patents and one pending U.S.

patent application, and four pending foreign patent applications directed to our TalisMann product, including foreign patent applications in Australia, Canada, Europe, and Japan.

patent application, four issued foreign patents, and five pending foreign patent applications directed to our TalisMann product, including foreign patent applications in Australia, Canada, Europe, and Asia.

patents are expected to expire between 2039 and 2040.

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Our patents and pending patent applications directed to our material products are further detailed in Exhibit 99.1 to this Annual Report.

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We own registered trademarks for Bioventus, BoneScalpel, BoneScalpel Access, Durolane, EXOGEN, GELSYN-3, Misonix, neXus, OSTEOAMP, Osteofuse, PureBone, SIGNAFUSE, Sonastar, SonaStar Elite, SonicOne, TalisMann and StimRouter in the United States.

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We seek to protect our proprietary technology and manufacturing process, in part, by confidentiality and invention assignment agreements with employees, consultants, scientific advisors and contractors, under which they are bound to assign to us certain inventions that are made during the course of performing work for us and relate to our business.

These agreements further restrict the use and disclosure of Bioventus’ confidential information and proprietary information belonging to any third party.

These agreements further restrict the use and disclosure of our confidential information and proprietary information belonging to any third party.

These agreements further prohibit our employees from using, disclosing, or bringing onto the premises any proprietary information belonging to any third party.

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Manufacturing and Supply

We largely manufacture and assemble our medical device products at our production facility located in Cordova, Tennessee.

We mostly manufacture and assemble our medical device products at our production facility located in Cordova, Tennessee.

We believe our manufacturing operations comply with regulations mandated by the FDA.

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Some of our products and product components are manufactured exclusively by single-source third-party manufacturers, pursuant to multi-year supply agreements that may include minimum order volumes.

We work closely with each of our manufacturing partners and provide them with a forecast, which enables them to better capacity plan and sequence their production efficiently.

We work closely with each of our manufacturing partners and provide them with forecasts, which enables them to have a better capacity plan and sequence their production efficiently.

We may encounter difficulty in obtaining materials, supplies and components adequate for our anticipated short-term needs.

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The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, servicing, recordkeeping, premarket clearance or approval, adverse event reporting, advertising, promotion, marketing and distribution, and import and export of medical devices and biological products to ensure that such products distributed domestically are safe and effective for their intended uses and otherwise meet the applicable requirements of the FDCA and PHSA.

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Regulation of Medical Devices

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If the device presents a non-significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate approval from the FDA, but must still follow abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping requirements.

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In addition to clinical and preclinical data, the PMA must contain a full description of the device and its components, a full description of the methods, facilities, and controls used for manufacturing, and proposed labeling.

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• medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;

• correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;

• correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce the risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;

• complying with requirements governing Unique Device Identifiers on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Device Identification Database;

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• post-market surveillance activities and regulations, which apply when the FDA deems them necessary to protect the public health or to provide additional safety and effectiveness data for the device.

Table of C o ntents

Certain of our products are regulated as “HCT/P”, which is an acronym for human cell, tissue, and cellular and tissue-based products.

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• FDA review and approval of the BLA or NDA to permit commercial marketing of the product for particular indications for use in the United States.

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Prior to beginning clinical trials of a new drug or biologic product in the United States, an IND must be submitted to the FDA.

An IND is a request for authorization from the FDA to administer an investigational new drug product to humans.

An IND must become effective before human clinical trials may begin.

An IND must become effective before human clinical trials begin.

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of an NDA or BLA requesting approval to market the product for one or more indications.

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complete withdrawal of the product from the market, product recalls, fines, warning letters, untitled letters, clinical holds on clinical studies, refusal of the FDA to approve pending applications or supplements to approved applications, product seizures or detention, refusal to permit the import or export of products, consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs, the issuance of corrective information, injunctions, or the imposition of civil or criminal penalties.

In addition, the FDA closely regulates the marketing, labeling, advertising and promotion of drugs, biologics (including Section 361 HCT/Ps) and medical devices.

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In addition, the FDA regulates the marketing, labeling, advertising and promotion of drugs, biologics (including Section 361 HCT/Ps) and medical devices.

A company can make only those claims relating to safety and efficacy, purity and potency that are cleared or approved by the FDA and in accordance with the provisions of the authorized label.

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There are also harmonized standards relating to design and manufacture.

While not mandatory, compliance with these standards is viewed as the easiest way to satisfy the essential requirements as a practical matter as it creates a rebuttable presumption that the device satisfies that essential requirement.

While not mandatory, compliance with these standards is viewed as the easiest way to satisfy the essential requirements because it creates a rebuttable presumption that the device satisfies that essential requirement.

To demonstrate compliance with the essential requirements in Annex I to the EU Medical Devices Directive, medical device manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk) classification.

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Throughout the term of the certificate of conformity, the manufacturer will be subject to periodic surveillance audits to verify continued compliance with the applicable requirements.

In particular, there will be a new audit by the notified body before it will renew the relevant certificate(s).

In particular, there will be a new audit by the notified body before it renews the relevant certificate(s).

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Medical Device Regulation

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The EU Medical Devices Regulation became effective on May 26, 2021.

The new regulation among other things:

Among other things, the new regulation does the following:

• strengthens the rules on placing devices on the market (e.g., reclassification of certain devices and wider scope than the EU Medical Devices Directive) and reinforces surveillance once they are available;

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• sets up a central database (“Eudamed”) to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU;

• strengthens rules for the assessment of certain high-risk devices, such as implants, which may have to undergo a clinical evaluation consultation procedure by experts before they are placed on the market.

• strengthens rules for the assessment of certain high-risk devices, such as implants, which may undergo a clinical evaluation consultation procedure by experts before they are placed on the market.

Devices lawfully placed on the market pursuant to the EU Medical Devices Directive prior to May 26, 2021 may generally continue to be made available on the market or put into service until their EU Medical Devices Directive certificate expires, provided that the requirements of the transitional provisions are fulfilled.

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However, even in this case, manufacturers must comply with a number of new or reinforced requirements set forth in the EU Medical Devices Regulation, in particular the obligations described below.

Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

The Regulation introduces a staggered extension of the transition period provided for in Regulation (EU) 2017/745 on medical devices (MDR), subject to certain conditions.

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(iii) a national competent authority has required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 97 of the MDR.

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The EU Medical Devices Regulation requires that before placing a device, other than a custom-made device, on the market, manufacturers (as well as other economic operators such as authorized representatives and importers) must register by submitting identification information to Eudamed, unless they have already registered.

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a device identifier (“UDI-DI”) specific to a device, and a production identifier (“UDI-PI”) to identify the unit producing the device.

Manufacturers are also notably responsible for entering the necessary data on Eudamed, which includes the UDI database, and for keeping it up to date.

Manufacturers are also notably responsible for entering the necessary data on Eudamed, which includes the UDI database, and for keeping it updated.

The obligations for registration in Eudamed will become applicable at a later date (as Eudamed is not yet fully functional).

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Under this system, serious incidents and Field Safety Corrective Actions (“FSCAs”) must be reported to the relevant authorities of the EU member states.

Manufacturers are required to take FSCAs defined as any corrective action for technical or medical reasons to prevent or reduce a risk of a serious incident associated with the use of a medical device that is made available on the market.

Manufacturers are required to take FSCAs defined as any corrective action for technical or medical reasons to prevent or reduce the risk of a serious incident associated with the use of a medical device that is made available on the market.

An FSCA may include the recall, modification, exchange, destruction or retrofitting of the device.

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In the event of either of these occurrences, we could be instructed to recall products, cease distribution and/or be subject to civil or criminal penalties.

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Anti-kickback Statute, False Claims Act and Other Healthcare Laws

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Rather, the government must evaluate such arrangements on a case-by-case basis, taking into account all facts and circumstances, including the parties’ intent and the arrangement’s potential for abuse, and those arrangements may be subject to greater scrutiny by enforcement agencies.

Criminal penalties and administrative sanctions for violating the AKS include civil penalties exceeding $130,000 per violation plus three times the amount of the improper remuneration, criminal penalties up to $100,000 per violation, prison terms, and exclusion from participation in the federal health care programs.

Criminal penalties and administrative sanctions for violating the AKS include civil penalties of $127,973 per violation plus three times the amount of the improper remuneration, criminal penalties up to $100,000 per violation, prison terms, and exclusion from participation in the federal health care programs.

Under the Civil Monetary Penalties statute, physicians who pay or accept kickbacks also face substantial civil penalties and treble damages.

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FCA liability can include three times the amount of damages sustained by the government due to the fraudulent activity, possible civil monetary penalties up to $23,331 (adjusted annually for inflation) per claim, exclusion from participating in federal healthcare programs, and possible criminal charges, resulting in additional fines and imprisonment.

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Further, the Civil Monetary Penalties Statute authorizes the imposition of civil monetary penalties, assessments, and exclusion against an individual or entity based on a variety of prohibited conduct, including, but not limited to offering remuneration to a federal healthcare program beneficiary that the individual or entity knows or should know is likely to influence the beneficiary to order or receive healthcare items or services from a particular provider (also known as “beneficiary inducements”).

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Many states in which we operate have also adopted similar fraud and abuse laws to those described above.

The scope of these laws and the interpretations of them vary from state to state and are enforced by state courts and regulatory authorities, each with broad discretion.

The scope of these laws and their interpretations vary from state to state and are enforced by state courts and regulatory authorities, each with broad discretion.

Some state fraud and abuse laws apply to items or services reimbursed by any payer, including patients, employers and commercial insurers, not just those reimbursed by a federally or state funded healthcare program.

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By way of example, the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (“MMA”), requires that manufacturers report data to CMS on pricing of covered drugs reimbursed under Medicare Part B.

These are generally drugs and biologicals, such as injectable products, that are administered “incident to” a physician service and in general are not self-administered.

These are generally drugs and biologicals, such as injectable products, which are administered “incident to” a physician service and in general are not self-administered.

Effective January 1, 2005, average selling price (“ASP”), became the basis for reimbursement to physicians and suppliers for drugs and biologicals covered under Medicare Part B, replacing the average wholesale price (“AWP”), provided and published by pricing services.

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Our SUPARTZ FX, GELSYN-3 and Durolane products are reimbursed under Medicare Part B and, as a result, we provide ASP data on these products to CMS on a quarterly basis.

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Foreign Corrupt Practices Act

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The FCPA prohibits U.S.

companies and their representatives from processing, offering, or making payments of money or anything of value to foreign officials with the intent to obtain or retain business or seek a business advantage.

In certain countries, the health care professionals we or our distributors regularly interact with may meet the definition of a foreign government official for the purposes of the FCPA.

companies and their representatives from promising, offering, or making payments of money or anything of value to foreign officials with the intent to obtain or retain business or seek a business advantage.

In certain countries, the health care professionals with whom we or our distributors regularly interact may meet the definition of a foreign government official for the purposes of the FCPA.

Our international activities create the risk of unauthorized payments or offers of payments by our employees, consultants and agents, including distributors, even though they may not always be subject to our control.

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Other internal or governmental investigations or legal or regulatory proceedings, including lawsuits brought by private litigants, may also follow as a consequence.

We are also subject to the United Kingdom and Brazilian equivalents, the United Kingdom Bribery Act and the Brazil Clean Company Act.

We are also subject to other jurisdictions including the United Kingdom and Brazilian equivalents, the United Kingdom Bribery Act and the Brazil Clean Company Act.

ISO Standards

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Privacy and data 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.

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Coverage and Reimbursement

Our products may be reimbursed by third-party payors, such as government programs, including Medicare and Medicaid, or private insurance plans and healthcare networks.

As a result, demand for our products is and will continue to be dependent in part on the coverage and reimbursement policies of these payors.

The manner in which reimbursement is sought and obtained varies based upon the type of payor involved and the setting in which the product is furnished and utilized.

Reimbursement from Medicare, Medicaid and other third-party payors may be subject to periodic adjustments as a result of legislative, regulatory and policy changes, as well as budgetary pressures.

Possible reductions in, or eliminations of, coverage or reimbursement by third-party payors, or denial of, or provision of uneconomical reimbursement for new products may affect our customers’ revenue and ability to purchase our products.

Our products may be reimbursed by third-party payers, such as government programs, including Medicare and Medicaid, or private insurance plans and healthcare networks.

As a result, demand for our products is and will continue to be dependent in part on the coverage and reimbursement policies of these payers.

The manner in which reimbursement is sought and obtained varies based upon the type of payer involved and the setting in which the product is furnished and utilized.

Reimbursement from Medicare, Medicaid and other third-party payers may be subject to periodic adjustments as a result of legislative, regulatory and policy changes, as well as budgetary pressures.

Possible reductions in, or eliminations of, coverage or reimbursement by third-party payers, or denial of, or provision of uneconomical reimbursement for new products may affect our customers’ revenue and ability to purchase our products.

Any changes in the healthcare regulatory, payment or enforcement landscape relative to our customers’ healthcare services have the potential to significantly affect our operations and revenue.

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Bone growth therapy devices are currently exempt from this competitive bidding process.

The current federal administration has granted the U.S.

DOGE Service Temporary Organization, broad discretionary authority to eliminate inefficiency, fraud, waste, and abuse in government and to eliminate excessive regulation.

It is unclear what effect these efforts at overhauling the federal administrative state will have on the administration or viability of federal healthcare programs and FDA and CMS’ ability to oversee and administer those programs.

Outside of the United States, the pricing of medical devices and prescription pharmaceuticals is subject to governmental control in many countries.

7 unchanged sentences

Most of these employees are located in the United States with approximately 94 located outside the United States.

We believe that our relations with our employees are generally good.

We believe that our relations with our employees are generally positive.

We value our employees and regularly benchmark total rewards we provide, such as short and long term compensation, 401(k) contributions, health, welfare and quality of life benefits, paid time off and personal leave, against our industry peers to ensure we remain competitive and attractive to potential new hires.

7 unchanged sentences

Bioventus Inc.

is a Delaware corporation formed on December 22, 2015 and functions as a holding company with no direct operations and our principal asset is the equity interest in BV LLC.

is a Delaware corporation formed on December 22, 2015 and functions as a holding company with no direct operations whose principal asset is the equity interest in BV LLC.

We are headquartered in Durham, North Carolina.

5 unchanged sentences

• the acquisition, by merger, of certain members of BV LLC (“Former LLC Owners”), for which we issued shares of Class A common stock as merger consideration (“Merger”);

Table of C o ntents

• we amended and restated our certificate of incorporation to authorize Class A common stock, Class B common stock and undesignated preferred stock.

44 unchanged sentences

D’Adamio holds a Juris Doctor from Howard University School of Law and a Bachelor of Arts from the State University of New York at Binghamton.

Table of C o ntents

Katrina Church has served as our Chief Compliance Officer since August 2020.

12 unchanged sentences

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.

What changed 10-K

Item 1. Business