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Item 1. Business

2025-03-11 compared with 2024-03-12 · 155 added, 203 removed, 457 unchanged (44% of the section changed)

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Company overview

We are a global medical device company focused on developing and commercializing clinically differentiated, cost efficient and minimally invasive treatments that engage and enhance the body’s natural healing process.

We are a global medical device company focused on helping patients recover and live life to the fullest by relieving pain and addressing musculoskeletal challenges through a diverse portfolio of high-quality, innovative, and clinically-proven solutions.

We manage our business through two reporting segments, U.S.

and International, which accounted for 88% and 12%, respectively, of our total net sales during the fiscal year ended December 31, 2024.

Our portfolio of products is grouped into three areas:

• Pain Treatments is comprised of non-surgical pain injection therapies as well as peripheral nerve stimulation (“PNS”) products to help the patient get back to their normal activities.

• Surgical Solutions is comprised of bone graft substitutes (“BGS”) that increase bone formation to stimulate bone healing in spinal fusions and other orthopedic surgeries, as well as a portfolio of ultrasonic products used for precise bone cutting and sculpting, soft tissue management (i.e., tumor and liver resections) and tissue debridement, in various surgeries, including minimally invasive applications.

• Restorative Therapies is comprised of a bone stimulation system, as well as devices designed to help patients regain leg or hand function due to stroke, multiple sclerosis or other central nervous system disorders.

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 :

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:

◦ 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.

◦ 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:

◦ 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.

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

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Our growth strategy

We intend to pursue the following strategies to build a market-leading and customer-focused company centered on our three product groupings, Pain Treatments, Surgical Solutions and Restorative Therapies, to deliver profitable growth:

• Continue to expand market share in Hyaluronic Acid (“HA”) viscosupplementation .

We intend to increase sales of our HA viscosupplementation therapies and extend our market leadership in this category by building on our unique positioning as the only company to offer a one, three and five injection treatment regimen.

Our product, Durolane, is known to have the highest molecular weight in the single injection market, which is an important differentiator.

• Further develop and commercialize our surgical solutions portfolio.

We intend to grow our presence in the Surgical Solutions target markets and expand our reach into the operating room as we look to commercialize recent product launches of Bone Scalpel Access for minimally invasive spine procedures.

In the near-term, we plan to maintain and selectively expand our product lines, driving profitability through the expansion of our distributor and direct surgical sales team including the introduction of a Capital Sales Team.

We intend to launch product line enhancements and invest in the development of next-generation surgical solution therapies to continue to grow our market share.

• Invest in research and development.

We are focused on broadening and innovating our portfolio of products, and rely on a small team of highly trained individuals to develop new products, conduct clinical investigations and help educate health-care providers on using our products and prioritize the opportunities that could drive the biggest benefit for patients, customers, and our business.

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 .

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.

2) Strategically grow our international markets .

We intend to focus our international business on current markets which present the greatest growth opportunities, and where our existing portfolio can maintain and increase profitable growth over time, either through direct or distributor based channels.

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

We offer a diverse portfolio of products to serve physicians spanning the orthopedic continuum, including knee, hand and upper extremities, foot and ankle, podiatry, trauma, general surgery, spine and neurosurgery, in the physician’s office or clinic, ambulatory surgical centers (“ASCs”) or in the hospital setting.

Our portfolio of products is grouped into three areas based on clinical use:

We intend to focus our international business on current markets which present the greatest growth opportunities, and where our portfolio can maintain and increase profitable growth over time, either through direct or distributor-based channels.

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.

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.

Our portfolio of products helps patients across care settings, such as a physician’s office or clinic, ambulatory surgical centers (“ASCs”) or in the hospital setting, and is grouped based on clinical use:

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

Pain Treatments

Our Pain Treatment products include hyaluronic acid-based (“HA”) products for knee osteoarthritis and peripheral nerve stimulation (“PNS”) devices.

Our Pain Treatment portfolio includes HA products for KOA and PNS devices for pain relief.

Our HA products are designed to work with the body’s biological processes, providing a natural lubricant into the joint and providing relief for mild to moderate pain, improving mobility, and helping the patient return to their normal activities.

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.

Durolane is an FDA-approved, sterile, transparent and viscoelastic gel that is a single injection therapy that is indicated in the United States for the symptomatic treatment of osteoarthritis (“OA”) in the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy and simple analgesics.

Durolane is an U.S.

Food & Drug Administration-approved, sterile, transparent and viscoelastic gel that is a single injection therapy that is indicated in the United States for the symptomatic treatment of osteoarthritis (“OA”) in the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy and simple analgesics.

Durolane is also indicated in certain markets outside the United States for the hip, ankle and shoulder, as well as for treatment of other small orthopedic joints.

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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.

We currently market Durolane in the United States and Europe.

We currently market Durolane in the United States and internationally.

GELSYN-3 is an FDA-approved sterile, buffered solution of highly purified sodium hyaluronate that is administered as a three injection HA viscosupplementation therapy.

It is indicated for the treatment of pain due to knee OA in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

The solution treats knee OA by providing temporary replacement for the diseased synovial fluid and restoring the lubricity of bearing joint surfaces.

It is indicated for the treatment of pain due to KOA in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

The solution treats KOA by providing temporary replacement for the diseased synovial fluid and restoring the lubricity of bearing joint surfaces.

Physicians administer GELSYN-3 to the affected knee joint once a week for three consecutive weeks.

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SUPARTZ is an FDA-approved sterile and viscoelastic solution of HA that is administered as a five-injection HA viscosupplementation therapy.

It is indicated for the treatment of pain in patients with knee OA who failed to adequately respond to conservative nonpharmacological therapy and simple analgesics.

The solution treats knee OA by providing temporary replacement for the diseased synovial fluid and restoring the lubricity of the bearing joint surfaces.

It is indicated for the treatment of pain in patients with KOA who failed to adequately respond to conservative nonpharmacological therapy and simple analgesics.

The solution treats KOA by providing temporary replacement for the diseased synovial fluid and restoring the lubricity of the bearing joint surfaces.

Physicians administer SUPARTZ FX to the affected knee joint once a week for five consecutive weeks.

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We currently market SUPARTZ FX in the United States.

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

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.

StimRouter is implanted during a minimally invasive outpatient procedure performed under local anesthetic and delivers gentle electrical pulses directly to target peripheral nerve pain at its source.

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StimRouter is programmed with up to eight different stimulation programs from which the patient is able to select, turn off/on and increase or decrease the stimulation intensity.

We currently market StimRouter in the United States and internationally.

Developmental and clinical pipeline for Pain Treatments

The TalisMann® Pulse Generator and Receiver (not yet cleared by FDA) 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.

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.

Trice Medical, Inc.

On August 23, 2021, we made a strategic investment in Trice Medical, Inc.

Trice is a privately held company that develops and commercializes minimally invasive technologies for sports medicine and orthopedic surgical procedures.

Trice combines its handheld arthroscope and portable ultrasound visualization technologies with its surgical devices to treat a range of sports medicine and orthopedic conditions, including tendinopathy, planter fasciitis and carpel tunnel, in order to improve patient recovery time, reduce pain, minimize scarring and move surgical procedures out of higher cost points of care.

Trice’s established and growing presence in sports medicine and orthopedics is directly aligned with our strategy of expanding our offerings.

Our investment resulted in exclusive sales and distribution rights to Trice’s products outside of the United States.

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.

Surgical Solutions

Our Surgical Solutions product portfolio is comprised of clinically efficacious and cost-effective bone graft solutions to meet a broad range of patient needs and procedures.

Our Surgical Solutions portfolio is comprised of two patient-focused areas – Ultrasonics and Bone Graft Substitutes.

Our Ultrasonics products are used for precise bone cutting and sculpting, soft tissue management (i.e., tumor and liver resections) and tissue debridement in various surgeries including minimally invasive applications, primarily in the areas of orthopedic surgery, neurosurgery, general surgery, wound, plastics/reconstruction, and cranio-maxillo-facial surgery.

Our surgical product portfolio is also comprised of clinically efficacious bone graft solutions to meet a broad range of patient needs and procedures.

Bone grafting is a surgical procedure used to promote fusion of spinal vertebrae, fill bone voids, fix bones that are damaged from trauma or problem joints, or to facilitate growing bones around an implanted device, such as spinal hardware (i.e., cages and rods), total knee replacements and long bone fixation.

Our products are designed to improve bone fusion rates following spine and other orthopedic surgeries, including trauma and reconstructive foot and ankle procedures.

Our portfolio is also comprised of an ultrasonic surgical system.

These products are used for precise bone cutting and sculpting, soft tissue management (i.e., tumor and liver resections) and tissue debridement, in various surgeries including minimally invasive applications, primarily in the areas of neurosurgery, orthopedic surgery, general surgery, wound, plastics/reconstruction, and cranio-maxillo-facial surgery.

OSTEOAMP® is an allograft-derived bone graft with growth factors used for orthopedic, neurosurgical and reconstructive bone grafting procedures.

OSTEOAMP is an allogeneic bone graft that is available in multiple formats (fibers, putty, sponge and granules) that is processed with bone marrow cells to maintain the wide array of growth factors present in native bone.

We currently market OSTEOAMP in the United States.

We launched OSTEOAMP Flowable in 2021, which is designed to be moldable and easy to use, with a convenient, ready to use syringe.

Additionally, a customized cannula-based delivery system is currently in development, which is designed to enhance delivery of the product further enabling use in minimally invasive surgical procedures.

FDA 510(k) submission for the cannula-based delivery system was accepted during the fourth quarter of 2023.

We have successfully implanted almost half of the subjects for our Level-I study of OSTEOAMP vs.

Infuse and continue to drive enrollment of the study.

EXPONENT provides an osteoconductive scaffold with osteoinductive potential while providing optimal handling characteristics indicated for posterolateral spine procedures.

EXPONENT is derived from human allograft bone tissue and is combined with a migration-resistant resorbable carrier and formulated into a putty that is ready-to-use out of the syringe.

EXPONENT is highly malleable and easy to mold and pack into the surgical defect.

Donor bone is sourced from AATB-certified and FDA-registered tissue banks in the United States.

All tissues are screened for the standard panel of infectious viruses.

We currently market EXPONENT in the United States.

PUREBONE provides a natural osteoconductive scaffold that facilitates cellular ingrowth and revascularization which is indicated for orthopedic, neurosurgical and reconstructive bone grafting procedures.

PUREBONE is 100% human bone, and is available as demineralized cortical fibers, demineralized cancellous strips and blocks, and mineralized cancellous chips.

Demineralized cortical fibers are easy to mold, shape and pack, and provide osteoinductive potential.

The fibers demonstrate high fluid retention and expansion properties, which potentially increases the opportunity for bone-on-bone contact.

Demineralized block and strip formats provide interconnected porosity with compressible, sponge-like handling characteristics, and provide osteoinductive potential.

Mineralized cancellous chips range from 1-4 mm and 4-10 mm granule size for optimal void packing capabilities.

Demineralized PUREBONE formats provide osteoinductive potential to recruit and differentiate bone-forming cells.

Donor bone is sourced from AATB-certified and FDA-registered tissue banks in the United States.

All tissues are screened for the standard panel of infectious viruses.

We currently market PUREBONE in the United States.

SIGNAFUSE contains a synergistic combination of biomaterials that supports new bone formation which is indicated for standalone posterolateral spine, extremities and pelvis, as well as a bone graft extender in the posterolateral spine.

SIGNAFUSE is a synthetic bone graft made up of bioglass and a biphasic mineral (60% hydroxyapatite, 40% β-tricalcium phosphate) available in putty and strip formats.

Bioactive synthetic bone graft substitute is comprised of a mixture of calcium phosphate granules and bioglass granules suspended in a resorbable polymer carrier that facilitates handling and delivery of the granule components to fill spaces of missing bone.

The unique and synergistic combination of biomaterials in SIGNAFUSE is designed to help accelerate cellular activity and kick-start osteogenesis.

Bioventus has recently received FDA clearance for expanded indications for the use of SIGNAFUSE in spinal procedures, specifically for filling cages.

We expect this expanded indication will continue to drive sales of the product.

We currently market SIGNAFUSE in the United States.

INTERFACE is designed to facilitate a rapid biologic response that stimulates the bone healing process and is used for posterolateral spine when mixed with autograft, extremities and pelvis.

INTERFACE’s patented particle technology is designed for enhanced bone graft performance through irregularly shaped synthetic bioglass granules that provide an osteoconductive scaffold for new osseous ingrowth and tissue generation.

The patented bioglass component stimulates the formation of an apatite layer as early as seven days after application on the surface of the granules.

The apatite surface layer that is formed is equivalent in composition and structure to the hydroxyapatite found in bone and provides an osteoconductive bioactive scaffold that supports the generation of new osseous tissue.

New bone infiltrates around the granules, allowing the repair of the defect as the granules are absorbed.

The patented INTERFACE Bioactive Bone Graft particle size of 210-420 microns is designed for a faster speed of bone fill than glass particles with a broader particle size distribution of 90-710 microns and smaller particles below 210 microns.

INTERFACE features consistent composition without variability inherently found in particle size and porosity of tissue based grafts.

INTERFACE Bioactive Bone Graft conforms to ASTM speciﬁcation F1538 for 45S5 bioactive glass.

INTERFACE is packed in a sterile, single use vial.

We currently market INTERFACE in the United States.

OSTEOMATRIX+ is a synthetic bone graft with exceptional handling, rapid hydration and a biphasic composition for sustained performance used on the posterolateral spine, extremities and pelvis.

OSTEOMATRIX+ is a moldable bone graft substitute consisting of biphasic granules designed to produce a reliable, porous scaffold and sustained osteoconductivity throughout bone remodeling.

The OSTEOMATRIX+ biphasic granules are composed of 60% hydroxyapatite and 40% beta-tricalcium phosphate (“β-TCP”), a ratio demonstrated to have advantageous bone remodeling properties.

The long-term stability of hydroxyapatite and the solubility of β-TCP provide an osteoconductive graft with an optimal resorption profile.

Interconnected macropores provide a porous, osteoconductive matrix that mimics a natural scaffold for cellular ingrowth and revascularization.

Three-dimensional micropores enhance the flow and circulation of biological fluids.

We currently market OSTEOMATRIX+ in the United States.

EXTRACTOR is a complementary and cost-effective solution designed to add needed cells and signals to aid in bone healing.

EXTRACTOR provides a six-ported cannula with a simplistic design for more flexible positioning and enhanced marrow extraction.

The large side port design of EXTRACTOR allows for better access and retrieval of the bone marrow aspirate which contains the cells and signals needed for solid bone formation.

The “twin peaks” tip design allows for easy insertion through the hard wall of the cortical bone.

An ergonomically designed handle allows the clinician to apply consistent pressure for greater control.

We currently market EXTRACTOR in the United States.

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 in surgical use.

Reficio DBM is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability to the bony structure, specifically for the treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.

Reficio DBM can be used for extremities, posterolateral spine and pelvis.

The neXus Ultrasonic Surgical System (“neXus”) is a next generation integrated ultrasonic surgical platform that combines all the features of our existing Surgical Solutions applications, including BoneScalpel®, BoneScalpel Access™, 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 provide more power, efficiency, and control for the surgeon.

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

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In addition, neXus provides users a simple and intuitive system enabled via a digital touchscreen display and smart system set-up across all applications.

This allows a hospital to access all of our Surgical Solutions product offerings on this all-in-one console.

The neXus Ultrasonic Surgical System has been commercialized successfully in several global markets.

This allows a hospital to access all of our Ultrasonic product offerings in this all-in-one console.

We currently market the neXus Ultrasonic Surgical System in the United States and internationally.

The BoneScalpel is a state of the art, surgical solution enabling precise cuts in hard tissue (e.g., bone).

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We believe the BoneScalpel allows surgeons to improve on existing surgical techniques by creating new approaches to bone cutting, sculpting, and removal, leading to substantial time-savings and increased operation efficiencies.

In addition to BoneScalpel, the Company received 510(k) clearance for its neXus ® BoneScalpel ® Access ™ system in December 2021.

Specifically, the BoneScalpel Access handpiece and its accessories provide surgeons with a new option for confined spaces during minimally invasive surgery, enabling safe and powerful bone removal with maximum visualization.

In addition, BoneScalpel Access allows for en-bloc resection and the shaving and sculpting of bone, with built-in irrigation and aspiration with improved ergonomics for the end user.

The BoneScalpel Access handpiece represents best-in-class among ultrasonic surgical platforms, and surgeon feedback following the U.S.

market roll out has been positive.

In addition, the BoneScalpel Access handpiece and its accessories provide surgeons with a new option for confined spaces during minimally invasive surgery, enabling safe and powerful bone removal with maximum visualization.

BoneScalpel Access allows for en bloc resection and the shaving and sculpting of bone, with built-in irrigation and aspiration with improved ergonomics for the end user.

We currently market BoneScalpel and BoneScalpel Access in the United States and certain international markets.

The SonaStar System provides powerful and precise ablation and removal of soft tissue.

The SonaStar has been used for a wide variety of surgical procedures applying both open and minimally invasive approaches, including neurosurgery and general surgery.

SonaStar has been used for a wide variety of surgical procedures applying both open and minimally invasive approaches, including neurosurgery and general surgery.

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.

In addition to SonaStar, Bioventus received FDA 510(k) approval in July 2022 for its neXus ® SonaStar Elite ® handpiece and accessories, which expanded the frequency capabilities of the neXus System, adding 36 kHz.

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

While the neXus system can be used in many clinical applications including neurosurgery, the SonaStar Elite handpiece has been cleared for resection of tumors with varying consistencies ranging from soft to firm, including the removal of brain and spinal tumors.

The SonaStar Elite handpiece represents the latest innovation in the neXus ultrasonic surgical pipeline.

We currently market SonaStar System and SonaStar Elite in the United States.

The SonicOne Ultrasonic Cleansing and Debridement System is a highly innovative, tissue-specific approach for the removal of devitalized or necrotic tissue and fibrin deposits while sparing viable, surrounding cellular structures.

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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.

Developmental and clinical pipeline for Surgical Solutions (including Investments)

We currently market SonicOne primarily in the United States.

OSTEOAMP is an allograft-derived bone graft with growth factors used for orthopedic, neurosurgical and reconstructive bone grafting procedures.

OSTEOAMP is an allogeneic bone graft that is available in multiple formats (e.g., fibers, putty, sponge and granules) that is processed with bone marrow cells to maintain the wide array of growth factors present in native bone.

OSTEOAMP Flowable is designed to be moldable and easy to use, with a convenient, ready to use syringe.

In the second quarter of 2024, we received FDA approval for the cannula-based delivery system, which allows us to target minimally invasive spine and other key orthopedic surgeries with enhanced delivery of our Flowable product.

Donor bone is sourced from AATB-certified and FDA-registered tissue banks in the United States.

All tissues are screened for the standard panel of infectious viruses.

We currently market OSTEOAMP in the United States.

SIGNAFUSE contains a synergistic combination of biomaterials that supports new bone formation which is indicated for standalone spine, extremities and pelvis, as well as a bone graft extender in the posterolateral spine.

SIGNAFUSE is a synthetic bone graft made up of bioglass and a biphasic mineral (60% hydroxyapatite, 40% β-tricalcium phosphate) available in putty and strip formats.

The unique and synergistic combination of biomaterials in SIGNAFUSE is designed to help accelerate cellular activity and kick-start osteogenesis.

In 2023, Bioventus received FDA clearance for expanded indications.

We expect our expanded indication for the use of SIGNAFUSE in spinal procedures, specifically for filling cages, to continue driving growth of the product.

We currently market SIGNAFUSE in the United States.

PUREBONE provides a natural osteoconductive scaffold that facilitates cellular ingrowth and revascularization, which is indicated for orthopedic, neurosurgical and reconstructive bone grafting procedures.

PUREBONE is 100% human bone, and is available as demineralized cortical fibers, demineralized cancellous strips and blocks, and mineralized cancellous chips.

Demineralized cortical fibers are easy to mold, shape and pack, and provide osteoinductive potential.

The fibers demonstrate high fluid retention and expansion properties, which potentially increases the opportunity for bone-on-bone contact.

Demineralized block and strip formats provide interconnected porosity with compressible, sponge-like handling characteristics, and provide osteoinductive potential.

Demineralized PUREBONE formats provide osteoinductive potential to recruit and differentiate bone-forming cells.

Donor bone is sourced from AATB-certified and FDA-registered tissue banks in the United States.

All tissues are screened for the standard panel of infectious viruses.

We currently market PUREBONE in the United States.

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.

Reficio DBM is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure, specifically for the treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.

Reficio DBM can be used in the extremities, posterolateral spine and pelvis.

We currently market Reficio DBM in the United States.

Developmental and clinical pipeline for Surgical Solutions

As we build the body of clinical evidence supporting our products, we continue to look for and execute on opportunities to innovate in our Surgical Solutions portfolio.

To meet growing market demand and specifically the needs of surgeons, we continue to develop product extensions on our surgical technology platforms, including the OsteoAmp and neXus platform.

To meet growing market demand and specifically the needs of surgeons, we continue to partner or develop product extensions on our surgical technology platforms, including the neXus, OSTEOAMP and SIGNAFUSE platforms.

Restorative Therapies

Our Restorative Therapies product portfolio consists of an ultrasonic bone stimulation system and a portfolio of products comprised of Advanced Rehabilitation devices designed to help patients regain leg or hand function due to stroke, multiple sclerosis or other central nervous system disorders.

Our Restorative Therapies business focuses on addressing patients whose healing is at-risk due to metabolic disorders and comorbidities, such as diabetes, smoking and osteoporosis.

Our portfolio is positioned to expand our impact for patients by leveraging EXOGEN to serve as an adjunctive and preventative therapy for healthcare professionals to incorporate into their practice during early-stage fracture treatment.

EXOGEN is an ultrasound bone stimulation system for the non-invasive treatment of established nonunion fractures and certain fresh fractures.

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EXOGEN is marketed in the United States, Canada, Europe and Japan, and approved for marketing in Australia, New Zealand, Saudi Arabia, Turkey and the UAE.

L300 GO is a functional electrical stimulation that produces measurable mobility improvements for patients living with foot drop and thigh weakness.

A 3-axis gyroscope and accelerometer are embedded in the Stimulator to monitor user movement in all three kinematic planes and deploy stimulation in 0.01 seconds of detecting a valid gait event.

Through an adaptive, learning algorithm, L300 Go is designed to detect gait events, providing stimulation precisely when needed making it easier for users to clear their foot at different walking speeds, on stairs, ramps, and while navigating uneven terrain.

H200 Wireless is a hand rehabilitation system that supports the wrist in a functioning position, allowing the fingers and thumb to move efficiently while reaching, grasping and pinching.

H200 Wireless has two main parts that communicate wirelessly with each other:

the functional stimulation support (“orthosis”) and the control unit (“microprocessor”).

These are designed to increase hand function, increase or maintain hand range of motion, reduce muscle spasms, prevent muscle loss, reeducate muscles and/or increase blood circulation.

H200 Wireless is programmed by a clinician to stimulate the appropriate nerves and muscles of the forearm and hand.

We believe this helps to re-educate electrical brain signals, stimulating weak or paralyzed muscles.

Vector is a body weight support system designed to accelerate physical rehabilitation of patients with severe gait and/or balance impairment.

The system unloads a programmed amount of weight to enable the patient to practice walking with less than his or her full body weight.

Vector is designed to alleviate the risk of falling and provides a feeling of security, instilling confidence in patients and empowering clinicians to develop effective and challenging rehabilitation regimens.

Vector is designed to reduce safety risks so clinicians can remain focused on their patient’s execution of an activity.

Designed for both physical and occupational therapy, Vector is designed to provide a safe environment and real-world experience for adult and pediatric patients recovering from stroke, amputations, and orthopedic, brain and spinal cord injuries.

The Bioness Integrated Therapy System ® (“BITS”) is an affordable and versatile solution for vision, motor and balance training for individuals, including those with deficits resulting from traumatic injuries and movement disorders as well as competitive athletes.

BITS is a multi-disciplinary therapy solution designed to motivate patients and enhance clinician efficiency.

BITS’s interactive touchscreen and diverse program options challenge patients to improve performance through the use of visual motor activities, visual and auditory processing, cognitive skills, endurance and balance training.

Standardized assessments and progress reports make documenting outcomes quick and easy.

With the large variety of BITS programs, therapists can choose activities that are tailored to each individual.

BITS programs can be further modified to accommodate varying degrees of difficulties.

With hundreds of possible parameter combinations, BITS can be customized even further to provide a unique therapy experience for each patient.

BITS is optimized for occupational therapy, physical therapy and speech language pathology.

Developmental and clinical pipeline for Restorative Therapies

Our expansive direct sales and distribution channel across our product portfolio provides us with broad and differentiated customer reach and allows us to serve physicians spanning the orthopedic continuum, including sports medicine, total joint reconstruction, hand and upper extremity, foot and ankle, and podiatric surgery, trauma, spine and neurosurgery.

We believe our products or procedures using our products are widely reimbursed by both public and private health insurers and are sold in the physician’s office or clinic, ASCs, and in the hospital setting in the United States and across approximately 52 other countries.

Our sales team and distributors work directly with our physician customers on a frequent basis.

Product revenue

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 IDNs, GPOs and payers.

Internationally our products are sold through a mix of direct and indirect sales teams and distributors.

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.

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

We support our entire sales organization with extensive training to help them excel, and we have a performance culture built on serving our core orthopedic patient customers and delivering our products to a variety of physicians and care settings.

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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, larger research laboratories and more extensive distribution systems than we do.

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), and Sanofi S.A, OrthogenRx 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.

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

(Johnson & Johnson), Stryker Corporation, NuVasive, Inc., Orthofix Medical Inc., Zimmer Biomet Holdings, Inc.

and Globus Medical Inc., Johnson & Johnson, Integra Life Sciences, Inc., and Söering.

Our Restorative Therapies compete with products marketed by Orthofix Medical Inc., Zimmer Biomet Holdings, Inc., Enovis, MiMedx, Hanger Orthopedics, XFT Medical, Rewalk Robotics, Ekso Bionics, Aretech LLC and DIH Medical.

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

(Johnson & Johnson), Stryker Corporation, NuVasive, Inc., Orthofix Medical Inc., Zimmer Biomet Holdings, Inc., Globus Medical Inc., Johnson & Johnson, Integra Life Sciences, Inc., and Söering.

Our Restorative Therapies compete with products marketed by Orthofix Medical Inc., Zimmer Biomet Holdings, Inc., Enovis and XFT Medical.

We strive to protect and enhance the proprietary technologies, inventions and improvements that we believe are important to our business, including seeking, maintaining and defending patent rights, whether developed internally or licensed from third-parties.

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As of December 31, 2024, we owned 77 issued U.S.

patents and six pending U.S.

patents and four pending U.S.

patent applications relating to our material products.

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We own two issued U.S.

patents, ten issued foreign patents, and eight pending foreign patent applications directed to our OsteoAMP product, including foreign patents and patent applications in Europe, Asia, Canada and Australia.

patents, and 18 issued foreign patents directed to our OSTEOAMP product, including foreign patents in Europe, Asia, Canada and Australia.

The issued U.S.

patent is expected to expire in 2029.

patents are expected to expire in 2029.

The issued foreign patents are expected to expire in 2029.

The pending patent applications, if issued, are expected to expire in 2029, without accounting for potential patent term extensions and adjustments.

We also own ten issued U.S.

patents and twelve issued foreign patents in Australia, Canada, Europe, and Japan directed to our StimRouter system.

We also own 11 issued U.S.

patents and 17 issued foreign patents in Australia, Canada, Europe, and Japan directed to our StimRouter system.

patents are expected to expire between 2026 and 2031, and the foreign patents are expected to expire between 2028 and 2030.

We also own twenty-three issued U.S.

patents, two pending U.S.

patent applications, fifty-seven issued foreign patents, and three pending foreign patent applications directed to our L300 system, including foreign patents and patent applications in Australia, Canada, Europe, and Japan.

We also own 39 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 are expected to expire between 2025 and 2039, and the foreign patents are expected to expire between 2027 and 2039.

The pending patent applications, if issued, are expected to expire between 2034 and 2039, without accounting for potential patent term extensions and adjustments.

We also own fifteen issued U.S.

patents, three pending U.S.

patent applications, seventeen issued foreign patents, and five pending foreign patent applications directed to our Vector Gait and Safety System, including foreign patents and patent applications in in Australia, Canada, Europe, and Japan.

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 are expected to expire between 2025 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 one issued U.S.

patent, one issued foreign patent in Australia and one issued foreign patent in Canada directed to our Bioness Integrated Therapy System (“BITS”).

patent is expected to expire in 2037, and the foreign patents are expected to expire in 2036.

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.

patents and one pending U.S.

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The pending patent applications, if issued, are expected to expire between 2039 and 2040, without accounting for potential patent term extensions and adjustments.

We also own twenty-nine issued U.S.

patents, thirty-one issued foreign patents and seven pending foreign patents directed to our BoneScalpel product.

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

We own registered trademarks for Bioventus, Bioness, BITS, Bonescalpel, BoneScalpel Access, Cellxtract, Durolane, Exogen, Exponent, Gelsyn-3, LiveOn, L300 Go, Misonix, Ness, Ness L300, neXus, OsteoAMP, Osteofuse, Prohesion, PureBone, SAFHS, Signafuse, Sonastar, SonaStar Elite, StimRouter and the Vector Gait and Safety System in the United States.

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.

Trade secrets

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Manufacturing and supply

We largely manufacture and assemble our medical device products at our production facilities located in Cordova, TN, Farmingdale, NY, Valencia, CA and Hod Hasharon, Israel.

We believe our manufacturing operations are in compliance with regulations mandated by the FDA.

We largely 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.

We are an FDA-registered medical device manufacturer.

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

We intend to maintain sufficient supplies of the products and components from these single-source suppliers in the event that one or more of these suppliers were to encounter certain interruptions in supply of products including L360 and H200 both of which are manufactured in Israel.

Government regulation

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In the United States, the majority of our products are regulated as medical devices by the FDA.

Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket notification, or approval of a PMA application.

Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket notification or approval of a premarket approval (“PMA”) application.

Under the FDCA, medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness.

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The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance.

Class III devices require approval of a premarket approval application, or PMA, evidencing safety and effectiveness of the device.

Class III devices require approval of a PMA, evidencing safety and effectiveness of the device.

To obtain 510(k) clearance, a manufacturer must submit a premarket notification demonstrating to the FDA’s satisfaction that the proposed device is “substantially equivalent” to another legally marketed device that itself does not require PMA approval (a predicate device).

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 (pre-amendment device) 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.

A predicate device is a legally marketed device that is not subject to PMA, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendment device) 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.

The FDA’s 510(k) clearance process usually takes from three to twelve months, but often takes longer.

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The FDA may or may not accept the panel’s recommendation.

In addition, the FDA will generally conduct a pre-approval inspection of the applicant or its third-party manufacturers’ or suppliers’ facilities to ensure compliance with the QSR.

The FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s).

In addition, the FDA will generally conduct a pre-approval inspection of the applicant or its third-party manufacturers’ or suppliers’ facilities to ensure compliance with the Quality System Regulation (“QSR”).

The FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA constitutes valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s).

The FDA may approve a PMA with post-approval conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion, sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported PMA approval or requirements to conduct additional clinical studies post-approval.

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• QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process;

• labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced and provide adequate directions for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling;

• labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced and provides adequate directions for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling;

FDA guidance on off-label dissemination of information and responding to unsolicited requests for information;

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HCT/Ps regulated as “Section 361” HCT/Ps are subject to requirements relating to registering facilities and listing products with the FDA, screening and testing for tissue donor eligibility, current Good Tissue Practices (“cGTPs”) when processing, storing, labeling and distributing HCT/Ps, including required labeling information, stringent record keeping and adverse event reporting, among other applicable requirements and laws.

Section 361 HCT/Ps do not require 510(k) clearance, PMA approval, BLAs, or other premarket authorization from the FDA before marketing.

Section 361 HCT/Ps do not require 510(k) clearance, PMA approval, Biological License Applications (“BLAs”), or other premarket authorization from the FDA before marketing.

However, to be regulated as a Section 361 HCT/P, the product must, among other things, be “minimally manipulated,” which for structural tissue products means that the manufacturing processes do not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement and which for cells or nonstructural tissue products, means that the manufacturing processes do not alter the relevant biological characteristics of cells or tissues.

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The FDA may require one or more post-market studies or post-market surveillance to further assess and monitor the product’s safety and effectiveness after commercialization, and may limit further marketing of the product based on the results of these post-marketing studies.

Any drugs or biologics manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product.

Any drugs or biologics manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse events, periodic reporting, product sampling and distribution, and advertising and promotion of the product.

After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval.

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International regulation of medical devices

Sales of medical devices outside the United States are subject to foreign government regulations, which vary substantially from country to country.

Sales of medical devices outside the United States are subject to foreign government regulations, which vary substantially by country.

In order to market our products in other countries, we must obtain regulatory approvals or certifications and comply with extensive safety and quality regulations in other countries.

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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.

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 the electronic system (“Eudamed”), unless they have already registered.

The information to be submitted by manufacturers (and authorized representatives) also includes the name, address and contact details of the person or persons responsible for regulatory compliance.

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We are subject to a number of U.S.

laws regulating healthcare fraud, waste, and abuse (“FWA”) including without limitation the federal Anti-Kickback Statute and the federal Physician Self-Referral Law (known as the Stark Law), the Civil False Claims Act, the civil prohibition on beneficiary inducements, and the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as well as numerous state laws regulating healthcare and insurance.

laws regulating healthcare fraud, waste, and abuse (“FWA”) including without limitation the federal Anti-Kickback Statute (“AKS”) and the federal Physician Self-Referral Law (known as the Stark Law), the Civil False Claims Act, the civil prohibition on beneficiary inducements, and the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), as well as numerous state laws and regulations regarding healthcare and insurance services.

These laws are enforced by, without limitation, CMS, other divisions of the U.S.

Department of Health and Human Services (“HHS”), including without limitation the HHS Office of Inspector General (“OIG”), the U.S.

Department of Health and Human Services (“HHS”), including the HHS Office of Inspector General (“OIG”), the U.S.

Department of Justice and individual U.S.

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Among other things, these laws, and others aimed at curbing FWA, generally:

(1) prohibit the provision of anything of value in exchange for the referral of patients or for the purchase, order, or recommendation of any item or service reimbursed by a federal healthcare program, (including Medicare and Medicaid);

(1) prohibit providing anything of value in exchange for the referral of patients or for the purchase, order, or recommendation of any item or service reimbursed by a federal healthcare program, (including Medicare and Medicaid);

(2) require that claims for payment submitted to federal healthcare programs be truthful;

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Many states have similar FWA statutes or regulations that may be broader in scope and may apply regardless of payer, in addition to items and services reimbursed under Medicaid and other state programs.

The federal Anti-Kickback Statute (“AKS”) prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, in cash or kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid.

The federal AKS prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, in cash or kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid.

A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

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Failure to meet the requirements of an applicable AKS exception or safe harbor, however, does not render an arrangement illegal.

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 may be subject to greater scrutiny by enforcement agencies.

Criminal penalties and administrative sanctions for violating the AKS include civil penalties of up to $120,816 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 penalties of up to $50,000 per kickback plus three times the amount of the prohibited remuneration.

The Stark Law prohibits a physician who has a financial relationship, or who has an immediate family member who has a financial relationship, with entities providing designated health services (“DHS”) from referring Medicare and Medicaid patients to such entities for the furnishing of DHS, unless an exception applies.

The Stark Law also prohibits the entity from billing for any such prohibited referral.

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.

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

Any physician who has a financial relationship, or who has an immediate family member who has a financial relationship, with entities providing designated health services (“DHS”) is prohibited by the Stark Law from referring Medicare and Medicaid patients to such entities for the furnishing of DHS, unless an exception applies.

The Stark Law also prohibits the entity from billing for any prohibited referral.

Unlike the AKS, the Stark Law is a strict liability statute, meaning that the law has been violated if the financial arrangement does not meet an applicable exception regardless of any intent by the parties to induce or reward referrals or the reasons for the financial relationship and the referral.

If the Stark Law applies and the elements of an applicable exception have not been met, then the government is prohibited from making payment for such services and any amount paid pursuant to a non-compliant financial relationship must be reimbursed to the government.

In addition to reimbursing the government any associated overpayment, violations of the Stark Law can lead to:

(1) civil penalties of nearly $29,000 per claim (in 2023, adjusted annually for inflation);

(2) three times the amount of damages suffered by the government;

and (3) potential exclusion from participation in federal healthcare programs.

The Federal False Claims Act (“FCA”) prohibits a person from knowingly presenting, or caused to be presented, a false or fraudulent request for payment from the federal government, or from making a false statement or using a false record to have a claim approved.

If the Stark Law applies and the elements of an applicable exception have not been met, then the government is prohibited from paying for such services and any amount paid pursuant to a non-compliant financial relationship must be reimbursed to the government.

In addition to reimbursing the government any associated overpayment, violations of the Stark Law can lead to civil penalties of $15,000 per claim or $100,000 per willful violation, depending on the nature of the violation.

The FCA prohibits a person from knowingly presenting, or causing to be presented, a false or fraudulent request for payment from the federal government, or from making a false statement or using a false record to have a claim approved.

A claim includes “any request or demand” for money or property presented to the United States government.

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Penalties for a violation of the FCA include fines for each false claim, plus up to three times the amount of damages caused by each false claim.

Private individuals, known as qui tam relators, also have the ability to bring actions under these false claims laws in the name of the government alleging false and fraudulent claims presented to or paid by the government (or other violations of the statutes).

Such realtors, often current or former employees or competitors, share in any amounts paid to the government in fines or settlement.

Private individuals, known as qui tam relators, are also able to bring actions under these false claims laws in the name of the government alleging false and fraudulent claims presented to or paid by the government (or other violations of the statutes).

Such relators, often current or former employees or competitors, share in any amounts paid to the government in fines or settlement.

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.

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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Although this prohibition applies only to federal healthcare program beneficiaries, the routine waivers of co-payments and deductibles offered to patients covered by commercial payers may implicate applicable state laws related to, among other things, unlawful schemes to defraud, excessive fees for services, tortious interference with patient contracts and statutory or common law fraud.

The Health Insurance Portability and Accountability Act (“HIPAA”) also established federal criminal statutes that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payers, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

HIPAA also established federal criminal statutes that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payers, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

Similar to the AKS, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

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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.

Violation of any of these laws or any other governmental regulations that apply may result in significant penalties, including, without limitation, administrative civil and criminal penalties, damages, disgorgement, fines, additional reporting requirements and compliance oversight obligations, in the event that a corporate integrity agreement or other agreement is required to resolve allegations of noncompliance with these laws, the curtailment or restructuring of operations, exclusion from participation in government healthcare programs and/or individual imprisonment.

Violation of any of these laws or any other governmental regulations that apply may result in significant penalties, including, without limitation, administrative civil and criminal penalties, damages, disgorgement, fines, additional reporting requirements and compliance oversight obligations (if a corporate integrity agreement or other agreement is required to resolve allegations of noncompliance with these laws), the curtailment or restructuring of operations, exclusion from participation in government healthcare programs, and/or individual imprisonment.

We also participate in state government-managed Medicaid programs as well as certain other qualifying federal and state government programs where discounts and mandatory rebates are provided to participating state and local government entities.

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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.

Effective January 1, 2005, 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.

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.

In general, we must comply with all reporting requirements for any drug that is separately reimbursable under Medicare.

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

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.

Foreign Corrupt Practices Act

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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 UK and Brazilian equivalents, the UK Bribery Act and the Brazil Clean Company Act.

We are also subject to 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 protection laws

We are subject to a number of federal, state and foreign laws and regulations that govern the collection, use, disclosure, and protection of health-related and other personal information, including health information privacy and security laws, data breach notification laws, and consumer protection laws and regulations (e.g., Section 5 of the Federal Trade Commission Act).

We are subject to a number of federal, state and foreign laws and regulations that govern the collection, use, disclosure, and protection of health-related and other personal information, including health information privacy and data security laws, data breach notification laws, and consumer protection laws and regulations (e.g., Section 5 of the Federal Trade Commission Act).

For example, HIPAA imposes obligations on “covered entities,” including certain healthcare providers, such as us, health plans, and healthcare clearinghouses, and their respective “business associates” that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, as well as their covered subcontractors with respect to safeguarding the privacy, security and transmission of individually identifiable health information.

Entities that are found to be in violation of HIPAA, which may occur in connection with, among other things, a breach of unsecured protected health information (“PHI”), a complaint about privacy practices, or an audit by HHS, may be subject to significant civil, criminal, and administrative fines, penalties, and damages and/or additional reporting and oversight obligations if required to enter into a resolution agreement and corrective action plan with HHS to settle allegations of HIPAA non-compliance.

In addition, certain state and foreign laws, including without limitation the California Consumer Privacy Act (“CCPA”), the California Privacy Rights Act (“CPRA”), General Data Protection Regulation (“GDPR”) and the United Kingdom General Data Protection Regulation (“UK GDPR”), govern the privacy and security of personal information, including health-related information in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

In addition, certain state and foreign laws, including without limitation the California Consumer Privacy Act (“CCPA”), the California Privacy Rights Act (“CPRA”), General Data Protection Regulation (“GDPR”) and the United Kingdom General Data Protection Regulation (“UK GDPR”), govern the privacy and data security of personal information, including health-related information in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation.

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.

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.

Coverage and reimbursement

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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.

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• 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”).

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

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

Class B common stock has voting rights but no economic rights.

We have a majority economic interest, the sole voting interest in, and control the management of, BV LLC.

As a result, we will consolidate the financial results of BV LLC and reports a non-controlling interest representing the LLC Interests held by Smith & Nephew, Inc.

As a result, we will consolidate the financial results of BV LLC and reports a noncontrolling interest representing the LLC Interests held by Smith & Nephew, Inc.

(“Continuing LLC Owner”).

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Katrina Church 63 Senior Vice President and Chief Compliance Officer

Robert Claypoole joined Bioventus in January 2024 from Mölnlycke Health Care (“Mölnlycke”), a world-leading medical products and solutions company, where he served as Executive Vice President of Wound Care since July 2021.

Robert Claypoole joined Bioventus in January 2024 as President and Chief Executive Officer and as a member of the Board of Directors from Mölnlycke Health Care (“Mölnlycke”), a world-leading medical products and solutions company, where he served as Executive Vice President of Wound Care since July 2021.

In this role, Mr.

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Claypoole received his Bachelor of Arts and his Masters of Business Administration from Cornell University.

The Company’s Board of Directors (the “Board”) believes that Mr.

Claypoole is well-qualified to serve on the Board considering the breadth of his experience across multiple global medical device markets and his extensive expertise in accelerating innovation, driving operational excellence, enhancing go-to-market strategies, and driving commercial execution and organizational effectiveness.

Mark Singleton has served as our Senior Vice President and Chief Financial Officer since March 2022.

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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.

What changed 10-K

Item 1. Business