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and International, which accounted for 88% and 12%, respectively, of our total net sales during the fiscal year ended December 31, 2023.
−Removed: Our portfolio of products is grouped into three verticals:
−Removed: • Pain Treatments is comprised of non-surgical joint pain injection therapies as well as peripheral nerve stimulation (“PNS”) products to help the patient get back to their normal activities.
−Removed: • Surgical Solutions is comprised of bone graft substitutes (“BGS”) to fuse and grow bones, improve results following spinal and other orthopedic surgeries as well as minimally invasive ultrasonic medical devices used for precise bone sculpting, removing tumors and tissue debridement, in various surgeries.
−Removed: • Restorative Therapies is comprised of a bone healing system, skin allografts and products used to support healing of wounds as well as devices designed to help patients regain leg or hand function due to stroke, multiple sclerosis or other central nervous system disorders.
+Added: Our portfolio of products is grouped into three areas:
+Added: • 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.
+Added: • 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.
+Added: • 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.
Financial information regarding our reportable business segments is included in Part II, Item 7.
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Segments of this Annual Report.
−Removed: Our verticals and the products within each vertical are described in additional detail below under “Our products.”
−Removed: COVID-19 update and outlook
−Removed: Refer to Item 1A.
−Removed: Risk Factors and Part II, Item 7.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations for a discussion of the effects of the global COVID-19 pandemic on our business in 2021 and 2022.
+Added: Our products are described in additional detail below under “Our products.”
Our growth strategy
−Removed: We intend to pursue the following strategies to build a market-leading and customer-focused company centered on our three verticals, Pain Treatments, Surgical Solutions and Restorative Therapies, and to continue to grow our net sales and Adjusted EBITDA:
+Added: 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.
−Removed: We offer the highest molecular weight single injection product known as Durolane®.
−Removed: • Introduce new pain treatment products as well as complementary products within sports medicine.
−Removed: We plan to expand our offering beyond HA viscosupplementation, and nerve stimulation into sports medicine by building a comprehensive portfolio for pain and sports medicine treatments for launch over the next several years.
+Added: 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.
−Removed: We intend to grow our presence in the surgical solutions market and expand our reach into the operating room in both ambulatory surgical centers (“ASCs”) and hospitals.
−Removed: In the near-term, we plan to maintain and selectively expand our profitable product lines by expanding our direct surgical sales team over time.
+Added: 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.
+Added: 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.
−Removed: We are focused on internal research and development to broaden our portfolio of Pain Treatments, Surgical Solutions and Restorative Therapies.
−Removed: We rely on a team of highly trained individuals to develop new products, conduct clinical investigations and help educate health care providers using our products.
−Removed: We collaborate with academic centers of excellence, leading contract research organizations and other industry groups to complement and expedite execution of our research and development programs and minimize fixed costs.
−Removed: • Opportunistically grow our international markets.
−Removed: We intend to focus our international business on markets where our existing portfolio can maintain profitable growth over time, either through direct or distributor based channels.
−Removed: We plan to selectively expand to new markets and intend to pursue further opportunities in the Asia Pacific markets.
−Removed: We offer a diverse portfolio of products to serve physicians spanning the orthopedic continuum, including sports medicine, total joint reconstruction, hand and upper extremities, foot and ankle, podiatric surgery, trauma, spine and neurosurgery, in the physician’s office or clinic, ASCs or in the hospital setting.
−Removed: Our portfolio of products is grouped into three verticals based on clinical use:
+Added: 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.
+Added: • Strategically grow our international markets.
+Added: 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.
+Added: We also plan to strategically expand to new markets with our existing portfolio and intend to pursue further new market opportunities selectively.
+Added: 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.
+Added: Our portfolio of products is grouped into three areas based on clinical use:
(i) Pain Treatments, (ii) Surgical Solutions and (iii) Restorative Therapies.
Pain Treatments
−Removed: Our joint Pain Treatment products include peripheral nerve stimulation (“PNS”) and hyaluronic acid-based (“HA”) products for knee osteoarthritis.
−Removed: Our HA products are designed to work with the body’s biological processes, providing a natural lubricant into the joint, that relieve mild to moderate pain, improves mobility, and helps the patient get back to their normal activities.
−Removed: Our PNS product targets peripheral nerve pain at its source without drugs and its small profile allows the system to be implanted in many locations on the body, depending on patient needs.
−Removed: 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 OA in the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy and simple analgesics.
−Removed: Durolane is also indicated for the hip, ankle and shoulder, as well as for treatment of other small orthopedic joints outside the United States.
+Added: Our Pain Treatment products include hyaluronic acid-based (“HA”) products for knee osteoarthritis and peripheral nerve stimulation (“PNS”) devices.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
Durolane contains high levels of HA and is injected directly into the joints affected by OA to relieve pain and restore lubrication and cushioning.
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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.
−Removed: The solution treats knee OA by providing temporary replacement for the diseased synovial fluid and restoring lubricity of bearing joint surfaces.
+Added: The solution treats knee OA 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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We currently market SUPARTZ FX in the United States.
−Removed: Our StimRouter® Peripheral Nerve Stimulation (“PNS”) system is a permanent option that provides relief for chronic peripheral pain including:
−Removed: Nerve Pain, Neuroma, Neuropathic Pain, Post-Stroke Shoulder Pain and Neuralgia.
+Added: 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.
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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Trice’s established and growing presence in sports medicine and orthopedics is directly aligned with our strategy of expanding our offerings.
−Removed: Our investment resulted in exclusive sales and distribution rights to Trice’s products outside of the U.S.
−Removed: and a seat on the Trice board of directors.
−Removed: We also entered into a co-development arrangement to explore the integration of Trice technologies with our current and future PNS products in order to accelerate the adoption of both of our products.
+Added: Our investment resulted in exclusive sales and distribution rights to Trice’s products outside of the United States.
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.
−Removed: Bone grafting is a surgical procedure used to fuse spinal vertebrae, replace missing bones, fix bones that are damaged from trauma or problem joints, or to facilitate growing bones around an implanted device, such as a total knee replacement.
−Removed: Our products are designed to improve bone fusion rates following spinal and other orthopedic surgeries, including trauma and reconstructive foot and ankle procedures.
−Removed: Our portfolio is also comprised of surgical ultrasonic systems.
−Removed: These products are used for precise bone sculpting, removal of soft and hard tumors, and tissue debridement, primarily in the areas of neurosurgery, orthopedic surgery, plastic surgery, wound care and maxillo-facial surgery.
+Added: 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.
+Added: Our products are designed to improve bone fusion rates following spine and other orthopedic surgeries, including trauma and reconstructive foot and ankle procedures.
+Added: Our portfolio is also comprised of an ultrasonic surgical system.
+Added: 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.
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We launched OSTEOAMP Flowable in 2021, which is designed to be moldable and easy to use, with a convenient, ready to use syringe.
−Removed: Additionally, a customized cannula-based delivery system is currently in development, which will enhance handling properties of the device further enabling use in minimally invasive surgical procedures.
−Removed: FDA 510K submission for this device is planned for the fourth quarter of 2023.
+Added: 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.
+Added: FDA 510(k) submission for the cannula-based delivery system was accepted during the fourth quarter of 2023.
+Added: We have successfully implanted almost half of the subjects for our Level-I study of OSTEOAMP vs.
+Added: 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.
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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.
−Removed: The unique and synergistic combination of biomaterials in SIGNAFUSE is designed to help accelerate cellular activity and kickstart osteogenesis.
+Added: The unique and synergistic combination of biomaterials in SIGNAFUSE is designed to help accelerate cellular activity and kick-start osteogenesis.
+Added: Bioventus has recently received FDA clearance for expanded indications for the use of SIGNAFUSE in spinal procedures, specifically for filling cages.
+Added: We expect this expanded indication will continue to drive sales of the product.
We currently market SIGNAFUSE in the United States.
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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.
−Removed: The patented bioglass component stimulates the formation of an apatite layer as early as seven days on the surface of the granules.
+Added: 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.
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We currently market OSTEOMATRIX+ in the United States.
−Removed: CELLXTRACT is a bone marrow aspirate without dilution or centrifugation.
−Removed: CELLXTRACT provides high levels of cells and their associated signals to deliver optimum clinical results.
−Removed: Independently reviewed clinical data shows the number of stem cells collected by CELLXTRACT, as counted by fibroblast-like colony-forming units (“CFU-f”), were greater than aspirations from a standard needle of similar volumes and was comparable or greater than final products after centrifugation.
−Removed: Autologous bone marrow aspirate (“BMA”) contains the needed cells and growth factors to enhance bone healing.
−Removed: There is no waste of biologic material or discard of viable cells compared to inherent inefficiencies in centrifuge-based systems.
−Removed: We believe potential savings can be realized as compared to the centrifuge-based competitors.
−Removed: Generally, the cost of CELLXTRACT is less than the disposable kit associated with those systems.
−Removed: No additional personnel is needed to operate equipment as no centrifugation is required.
−Removed: The aspirated fluid is not required to leave the sterile field for centrifugation, creating less risk for contamination or infection.
−Removed: Traditional needles require repositioning via an additional insertion point(s) or angling in order to access a fresh channel of BMA increasing the risk of infection, blood loss, and operative time.
−Removed: CELLXTRACT, on the other hand, only requires one insertion point minimizing the risks to the patient.
−Removed: We currently market CELLXTRACT in the United States.
EXTRACTOR is a complementary and cost-effective solution designed to add needed cells and signals to aid in bone healing.
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Reficio DBM can be used for extremities, posterolateral spine and pelvis.
−Removed: The neXus Ultrasonic Surgical System (“neXus”) is a next generation integrated ultrasonic surgical platform that combines all the features of our existing solutions, including BoneScalpel, SonicOne and SonaStar, into a single fully integrated system that serves to power future solutions.
−Removed: The neXus platform is driven by a proprietary digital algorithm that results in more power, efficiency, and control for the surgeon.
−Removed: The device incorporates technology that allows for intuitive setup and use.
−Removed: The neXus system allows for safe and efficient resection of hard and soft tissue, limiting collateral damage to adjacent tissue than conventional surgical instruments, and can be used in a variety of different surgical specialties.
−Removed: In addition, neXus’ ease of use enables physicians to fully leverage neXus’ capabilities via its digital touchscreen display and smart system setup.
−Removed: Our current ultrasonic applications, which include BoneScalpel, BoneScalpel Access™, Sonastar and SonicOne, all work on the neXus generator.
−Removed: This allows a hospital to access all of our product offerings on this all-in-one console.
−Removed: The neXus Ultrasonic Aspirator System has been commercialized successfully in the United States, Canada, Europe and Australia.
−Removed: The BoneScalpel® is a state of the art, ultrasonic surgical system capable of enabling precise cutsin hard tissue (e.g.
−Removed: The device is also capable of preserving surrounding soft tissue structures because of its ability to differentiate soft tissue from rigid bone.
−Removed: This device can make precise linear or curved cuts, on any plane, with precision not normally associated with powered instrumentation.
+Added: 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.
+Added: The neXus platform is driven by a proprietary digital algorithm designed to provide more power, efficiency, and control for the surgeon.
+Added: The device incorporates technology that allows for intuitive set-up and use.
+Added: The neXus system allows for safe and efficient resection of hard and soft tissue, limiting collateral damage to adjacent tissue as compared to conventional surgical instruments, and can be used in a variety of different surgical specialties.
+Added: In addition, neXus provides users a simple and intuitive system enabled via a digital touchscreen display and smart system set-up across all applications.
+Added: This allows a hospital to access all of our Surgical Solutions product offerings on this all-in-one console.
+Added: The neXus Ultrasonic Surgical System has been commercialized successfully in several global markets.
+Added: The BoneScalpel ® is a state of the art, surgical solution enabling precise cuts in hard tissue (e.g., bone).
+Added: The device allows for the preservation of surrounding soft tissue structures because of its mechanism-of-action, which is micro-reciprocating movements.
+Added: This device enables precise linear or curved cuts, on any plane, with precision not normally associated with powered instrumentation.
We believe that BoneScalpel offers the speed and convenience of a powered instrument without the dangers associated with conventional rotary devices.
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In addition to BoneScalpel, the Company received 510(k) clearance for its neXus ® BoneScalpel ® Access ™ system in December 2021.
−Removed: Specifically, the BoneScalpel Access handpiece and its accessories provides surgeons with a new option for confined spaces during minimally invasive surgery, enabling safe and powerful bone removal with maximum visualization.
+Added: 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.
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market roll out has been positive.
−Removed: The SonaStar System provides powerful and precise aspiration following the ultrasonic ablation of soft tissue.
+Added: 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.
−Removed: The SonaStar may also be used with OsteoSculpt ® probe tips, which enable the precise shaping or shaving of bony structures that prevent open access to partially or completely hidden soft tissue masses.
−Removed: In addition to SonaStar, the Company received FDA 510K approval in July 2022 for its neXus ® SonaStar Elite ® handpiece and accessories, which combines all the features of soft and hard (including bone) tissue removal into a single fully integrated platform capable of operating at multiple frequencies, including the newly approved 36 kHz SonaStar Elite Handpiece.
−Removed: 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 malignant and benign brain and spinal tumors.
−Removed: The SonaStar Elite handpiece represents the latest innovation in our neXus ultrasonic surgical pipeline.
−Removed: Launch of the product is planned for the fourth quarter of 2023.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The SonaStar Elite handpiece represents the latest innovation in the neXus ultrasonic surgical pipeline.
+Added: 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.
+Added: 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.
+Added: The ultrasonic debridement process separates devitalized tissue from viable tissue layers, allowing for a more defined treatment and, usually, a reduced pain sensation.
+Added: 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)
−Removed: 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 Solution portfolio.
−Removed: To meet growing market demand and specifically the needs of surgeons, we continue to develop product extensions on all of our surgical technology platforms, including OsteoAmp and the neXus platform.
+Added: 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.
+Added: 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.
Restorative Therapies
−Removed: Our Restorative Therapies product portfolio is comprised of an Ultrasonic bone healing system and skin allografts and products used to support healing of wounds.
−Removed: Our Restorative Therapies product portfolio is also 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.
−Removed: EXOGEN® is an ultrasound bone healing system for the non-invasive treatment of established nonunion fractures and certain fresh fractures.
+Added: 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.
+Added: EXOGEN ® is an ultrasound bone stimulation system for the non-invasive treatment of established nonunion fractures and certain fresh fractures.
A nonunion fracture is considered to be established when the fracture site shows no visibly progressive signs of healing.
EXOGEN has been sold commercially for over 25 years and is FDA-approved for the accelerated healing of fresh, closed posteriorly displaced distal fractures of the radius and fresh, closed or Grade I open long bone fractures.
−Removed: EXOGEN utilizes low-intensity pulsed ultrasound technology to stimulate the body’s natural bone healing process.
+Added: EXOGEN utilizes low-intensity pulsed ultrasound technology to stimulate the body’s natural bone stimulation process.
EXOGEN is used to administer treatment in a location of convenience with an easy to use interface that tracks treatment use and promotes compliance.
−Removed: EXOGEN is indicated in the United States.
−Removed: for the non-invasive treatment of established nonunions, excluding skull and vertebra, and for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open long bone fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization.
−Removed: EXOGEN is marketed in the United States., Canada, Europe and Japan.
−Removed: EXOGEN is also approved for marketing in Australia, New Zealand, Saudi Arabia, Turkey and the UAE.
−Removed: TheraSkin ® is a biologically active human skin allograft that has all of the relevant characteristics of human skin needed to heal wounds, including living cells, growth factors, and a collagen matrix.
−Removed: TheraSkin is derived from human skin tissue and is an HCT/P.
−Removed: LifeNet processes and supplies TheraSkin to us under a supply and distribution agreement that gives us exclusive rights to sell TheraSkin in the United States.
−Removed: TheraSkin is used on all external skin tissue wounds, including but not limited to difficult to heal diabetic foot ulcers, venous leg ulcers, dehisced surgical wounds, necrotizing fasciitis, burns, Mohs and wounds with exposed structures.
−Removed: TheraGenesis ® is a Bilayer Wound Matrix and Meshed Bilayer Wound Matrix consisting of a porcine collagen sponge layer and a silicone film layer that provides a scaffold for cellular invasion and capillary growth for management of wounds including partial and full-thickness wounds, chronic wounds, surgical wounds, trauma wounds and draining wounds.
−Removed: We obtain TheraGenesis under an exclusive supply and distribution agreement with Gunze Limited that gives us exclusive rights to distribute the product in the United States.
−Removed: 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.
−Removed: The tissue specific capability is, in part, due to the fact that healthy and viable tissue structures have a higher elasticity and flexibility than necrotic tissue and are more resistant to destruction from the impact effects of ultrasound.
−Removed: The ultrasonic debridement process separates devitalized tissue from viable tissue layers, allowing for a more defined treatment and, usually, a reduced pain sensation.
−Removed: We believe that SonicOne establishes a new standard in wound bed preparation, the essential first step in the healing process, while contributing to a faster patient healing.
+Added: EXOGEN is indicated in the United States for the non-invasive treatment of established nonunion fractures excluding skull and vertebra fractures, and for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open long bone fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization.
+Added: 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.
−Removed: Through an adaptive, learning algorithm, the 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.
+Added: 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.
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the functional stimulation support (“orthosis”) and the control unit (“microprocessor”).
−Removed: These 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.
+Added: 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.
−Removed: We believe this helps to reeducate electrical brain signals, stimulating weak or paralyzed muscles.
+Added: 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.
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Developmental and clinical pipeline for Restorative Therapies
−Removed: 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 extremities, foot and ankle, podiatric surgery, trauma, spine and neurosurgery.
−Removed: 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 65 countries.
+Added: 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.
+Added: 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
−Removed: Products from our Pain Treatments, Restorative Therapies and Surgical Solutions verticals are sold by direct sales teams in the United States and a complementary distributor team for Surgical Solutions.
+Added: 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.
−Removed: Internationally our products are sold through a mix of direct and indirect sales teams.
+Added: Internationally our products are sold 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.
−Removed: The medical device industry is highly competitive, subject to change and significantly affected by activities of industry participants.
−Removed: We believe that the principal competitive factors in our markets are product features, value-added solutions, reliability, clinical evidence, reimbursement coverage, and price.
+Added: The medical device industry is highly competitive, subject to change and significantly affected by the activities of industry participants.
+Added: We believe that the principal competitive factors in our markets are product features, value-added solutions, reliability, clinical and economic evidence, reimbursement coverage, and price.
Customer support, reputation, and efficient distribution are also important factors.
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(Johnson & Johnson), and Sanofi S.A, OrthogenRx Inc.
−Removed: and for peripheral nerve stimulation specifically we compete with SPR Therapeutics, Nalu and Stimwave.
+Added: (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.
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and Globus Medical Inc., Johnson & Johnson, Integra Life Sciences, Inc., and Söering.
−Removed: Our Restorative Therapies compete with products marketed by Orthofix Medical Inc., Zimmer Biomet Holdings, Inc., Enovis, MiMedx, Integra Life Sciences, Organogenesis, Hanger Orthopedics, XFT Medical, Rewalk Robotics, Ekso Bionics, Aretech LLC and DIH Medical.
+Added: 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.
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.
6 unchanged sentences
As of December 31, 2023, we owned 118 issued U.S.
−Removed: patents and nine pending U.S.
+Added: patents and six pending U.S.
patent applications relating to our material products.
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The pending patent applications, if issued, are expected to expire in 2029, without accounting for potential patent term extensions and adjustments.
−Removed: We also own one pending U.S.
−Removed: patent application and one pending Patent Cooperation Treaty application directed to MOTYS.
−Removed: Patents issuing from these applications, if any, are expected to expire in 2040, without accounting for potential patent term extensions and adjustments.
We also own ten issued U.S.
1 unchanged sentence
patents are expected to expire between 2026 and 2031, and the foreign patents are expected to expire between 2028 and 2030.
−Removed: We also own twenty-two issued U.S.
+Added: We also own twenty-three issued U.S.
patents, two pending U.S.
−Removed: patent applications, fifty-one issued foreign patents, and five pending foreign patent applications directed to our L300 system, including foreign patents and patent applications in Australia, Canada, Europe, and Japan.
+Added: 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.
patents are expected to expire between 2026 and 2037, and the foreign patents are expected to expire between 2026 and 2037.
The pending patent applications, if issued, are expected to expire between 2032 and 2037, without accounting for potential patent term extensions and adjustments.
−Removed: We also own fourteen issued U.S.
+Added: We also own fifteen issued U.S.
patents, three pending U.S.
−Removed: patent applications, sixteen issued foreign patents, and nine 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.
+Added: 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.
patents are expected to expire between 2033 and 2038, and the foreign patents are expected to expire between 2034 and 2037.
1 unchanged sentence
We also own one issued U.S.
−Removed: patent, one issued foreign patent in Australia and one pending foreign application in Canada directed to our Bioness Integrated Therapy System (“BITS”).
−Removed: patent is expected to expire in 2037, and the foreign patent is expected to expire in 2036.
−Removed: The pending patent application, if issued, is expected to expire in 2036, without accounting for potential patent term extensions and adjustments.
−Removed: We also own one issued U.S.
−Removed: patent and one pending U.S.
−Removed: patent application and four pending foreign patent applications directed to our TalisMann product, including foreign patent applications in Australia, Canada, Europe, Japan and one pending Patent Cooperation Treaty application.
−Removed: patent is expected to expire in 2039.
+Added: patent, one issued foreign patent in Australia and one issued foreign patent in Canada directed to our Bioness Integrated Therapy System (“BITS”).
+Added: patent is expected to expire in 2037, and the foreign patents are expected to expire in 2036.
+Added: We also own two issued U.S.
+Added: patents and one pending U.S.
+Added: patent application and four pending foreign patent applications directed to our TalisMann product, including foreign patent applications in Australia, Canada, Europe, and Japan.
+Added: patents are expected to expire between 2039 and 2040.
The pending patent applications, if issued, are expected to expire between 2039 and 2040, without accounting for potential patent term extensions and adjustments.
−Removed: We also own twenty-four issued U.S.
−Removed: patents and four pending U.S.
−Removed: patent applications directed to our BoneScalpel product.
+Added: We also own twenty-nine issued U.S.
+Added: 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.
−Removed: 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, TheraSkin, Therion and Vector Gait and Safety System in the United States.
+Added: 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.
Trade secrets
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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.
−Removed: These agreements further restrict the use and disclosure of proprietary information belonging to any third-party.
+Added: These agreements further restrict the use and disclosure of Bioventus’ 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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We typically acquire rights under such assignments or licenses in exchange for lump-sum payments or arrangements under which we pay a percentage of sales to the licensor.
−Removed: However, while assignments or licenses to us generally are irrevocable, no assurance can be given that these arrangements will continue to be made available to us on terms that are acceptable to us, or at all.
−Removed: The terms of our license and assignment agreements vary in length from a specified number of years to the life of product patents or the economic life of the product.
+Added: However, while such rights are irrevocable, no assurance can be given that these arrangements will continue to be made available to us on financial terms that are acceptable to us, or at all.
+Added: The terms of our license agreements vary in length from a specified number of years to the life of product patents or the economic life of the product.
These agreements generally provide for royalty payments and termination rights in the event of a material breach.
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Our products include components manufactured by other companies in the United States and elsewhere.
−Removed: Some of our products and product components are manufactured exclusively by single-source third-party manufacturers, pursuant to multi-year supply agreements and may include minimum order volumes.
+Added: 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 may encounter difficulty in obtaining materials, supplies and components adequate for our anticipated short-term needs.
−Removed: In addition, supply disruptions resulting from the COVID-19 pandemic may increase the price of, and make more difficult to obtain, materials, supplies or components.
−Removed: 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.
+Added: 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
3 unchanged sentences
Regulation of Medical Devices
−Removed: The majority of our products are regulated by the FDA as medical devices in the United States.
+Added: 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.
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.
−Removed: Devices deemed by the FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed into Class III.
+Added: Devices deemed by the FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are typically placed into Class III.
While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device.
2 unchanged sentences
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).
−Removed: 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-amendments 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.
+Added: 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.
The FDA’s 510(k) clearance process usually takes from three to twelve months, but often takes longer.
3 unchanged sentences
If the FDA determines that the device is “not substantially equivalent,” the device is automatically designated as a Class III device.
−Removed: The device sponsor must then fulfill more rigorous PMA requirements, or can request a risk-based classification determination for the device in accordance with the de novo classification process, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.
+Added: In such cases, the device sponsor must then fulfill more rigorous PMA requirements, or can request a risk-based classification determination for the device in accordance with the de novo classification process, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval or de novo classification.
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In addition, the study must be approved by, and conducted under the oversight of, an Institutional Review Board (“IRB”), for each clinical site.
−Removed: The IRB is responsible for the initial and continuing review of the IDE, and may pose additional requirements for the conduct of the study.
+Added: The IRB is responsible for the initial and continuing review of the IDE, and may impose additional requirements for the conduct of the study.
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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• the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations;
−Removed: • post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.
−Removed: Certain of our products are regulated as HCT/P.
+Added: • 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.
+Added: Certain of our products are regulated as HCT/P, which is an acronym for human cell, tissue, and cellular and tissue-based products.
Section 361 of the PHSA authorizes the FDA to issue regulations to prevent the introduction, transmission or spread of communicable disease.
1 unchanged sentence
Section 361 HCT/Ps do not require 510(k) clearance, PMA approval, BLAs, or other premarket authorization from the FDA before marketing.
−Removed: 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 for cells or nonstructural tissue products, means that the manufacturing processes do not alter the relevant biological characteristics of cells or tissues.
+Added: 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.
A Section 361 HCT/P must also be intended for “homologous use,” which refers to use in the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.
HCT/Ps that do not meet the criteria of Section 361 are regulated under Section 351 of the PHSA.
−Removed: Unlike 361 HCT/Ps, HCT/Ps regulated as “351” HCT/Ps are subject to premarket review and/or approval by the FDA, as required.
+Added: Unlike Section 361 HCT/Ps, HCT/Ps regulated as “Section 351” HCT/Ps are subject to premarket review and/or approval by the FDA, as required.
In November 2017, the FDA released a guidance document entitled “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue—Based Products:
Minimal Manipulation and Homologous Use—Guidance for Industry and Food and Drug Administration Staff.” The guidance outlined the FDA’s position that all lyophilized amniotic products are more than minimally manipulated and would therefore require a BLA to be lawfully marketed in the United States.
−Removed: The guidance also indicated that the FDA would exercise enforcement discretion, using a risk-based approach, with respect to the IND application and pre-market approval requirements for certain HCT/Ps that had been marketed without marketing authorization, including, among others, lyophilized amniotic products, for a period of 36 months from the issuance date of the guidance to allow manufacturers to pursue INDs and/or seek marketing authorizations.
+Added: The guidance also indicated that the FDA would exercise enforcement discretion, using a risk-based approach, with respect to the Investigational New Drug ("IND") application and pre-market approval requirements for certain HCT/Ps that had been marketed without marketing authorization, including, among others, lyophilized amniotic products, for a period of 36 months from the issuance date of the guidance to allow manufacturers to pursue INDs and/or seek marketing authorizations.
Under this approach, the FDA indicated that high-risk products and uses could be subject to immediate enforcement action.
24 unchanged sentences
The FDA may delay or refuse approval of a BLA or NDA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.
−Removed: If regulatory approval of a product is granted, such approval will be granted for particular indications and may include limitations on the indicated uses for which such product may be marketed.
+Added: If regulatory approval of a product for human therapeutic or prophylactic use is granted, such approval will be granted for particular indications and may include limitations on the indicated uses for which such product may be marketed.
The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications.
Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace.
−Removed: The FDA may require one or more post-market studies and 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.
+Added: 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.
6 unchanged sentences
Post-market Enforcement
−Removed: The FDA may withdraw marketing authorizations for drugs, biologics (including Section 361 HCT/Ps) or medical devices if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
+Added: The FDA may withdraw marketing authorizations for drugs, biologics (including Section 361 HCT/Ps) and/or medical devices if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-market studies or clinical studies to assess new safety risks, or imposition of distribution restrictions or other restrictions.
16 unchanged sentences
Medical Devices Directive
−Removed: Under the EU Medical Devices Directive, all medical devices placed on the market in the EU must meet the relevant essential requirements laid down in Annex I to the EU Medical Devices Directive, including the requirement that a medical device must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users and others.
+Added: Under the EU Medical Devices Directive, all medical devices placed on the market in the EU must meet the relevant essential requirements in Annex I to the EU Medical Devices Directive, including the requirement that a medical device must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users and others.
In addition, the device must achieve the performance intended by the manufacturer and be designed, manufactured, and packaged in a suitable manner.
3 unchanged sentences
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.
−Removed: To demonstrate compliance with the essential requirements laid down 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.
−Removed: As a general rule, demonstration of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use.
+Added: 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.
+Added: Generally, demonstration of conformity of medical devices and their manufacturers with the essential requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use.
Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.
14 unchanged sentences
The new Regulation among other things:
−Removed: • strengthens the rules on placing devices on the market (e.g.
−Removed: reclassification of certain devices and wider scope than the EU Medical Devices Directive) and reinforces surveillance once they are available;
+Added: • 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;
• establishes explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;
7 unchanged sentences
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.
+Added: 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.
+Added: 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.
+Added: The transition period of medical devices to MDR has been extended until December 31, 2027 or December 31, 2028 depending on the classification of the medical device.
+Added: The transition provisions covers products with CE certificates issued under the Medical Devices Directive (MDD) set to expire before the date of application.
+Added: The amended Article 120(2), the extension of validity for these devices will, however, apply only if one of the following conditions is met:
+Added: (i) The manufacturer has signed a written agreement with a Notified Body for the conformity assessment of the device in question at the moment of expiry,
+Added: (ii) a national competent authority has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59 of the MDR;
+Added: (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.
−Removed: The new Regulation also requires that before placing a device, other than a custom-made device, on the market, manufacturers must assign a unique identifier to the device and provide it along with other core data to the unique device identifier (“UDI”) database.
+Added: The new EU Medical Devices Regulation also requires that before placing a device, other than a custom-made device, on the market, manufacturers must assign a unique identifier to the device and provide it along with other core data to the unique device identifier (“UDI”) database.
These new requirements aim at ensuring better identification and traceability of the devices.
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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.
−Removed: Anti-kickback, false claims and other healthcare laws
+Added: Anti-kickback Statute, False Claims Act and other healthcare laws
We are subject to a number of U.S.
−Removed: laws regulating healthcare fraud and abuse including the federal Anti-Kickback Statute and the federal Physician Self-Referral Law (known as the Stark Law), the Civil False Claims Act, and the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as well as numerous state laws regulating healthcare and insurance.
+Added: 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.
These laws are enforced by, without limitation, CMS, other divisions of the U.S.
−Removed: Department of Health and Human Services (“HHS”), the U.S.
+Added: Department of Health and Human Services (“HHS”), including without limitation the HHS Office of Inspector General (“OIG”), the U.S.
Department of Justice and individual U.S.
Attorney offices within the Department of Justice, as well as state and local governments.
−Removed: Among other things, these laws and others 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);
+Added: Among other things, these laws, and others aimed at curbing FWA, generally:
+Added: (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);
(2) require that claims for payment submitted to federal healthcare programs be truthful;
and (3) require the maintenance of certain government licenses and permits.
−Removed: Many states have similar fraud and abuse 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.
+Added: 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.
1 unchanged sentence
Several courts have interpreted the AKS’s intent requirement to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the AKS has been violated.
−Removed: The AKS includes statutory exceptions and regulatory safe harbors that protect certain arrangements.
−Removed: Failure to meet the requirements of an applicable AKS safe harbor, however, does not render an arrangement illegal.
−Removed: Rather, the government may 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.
+Added: The AKS includes statutory exceptions and regulatory safe harbors that protect certain arrangements that would otherwise be prohibited by the statute.
+Added: Failure to meet the requirements of an applicable AKS exception or safe harbor, however, does not render an arrangement illegal.
+Added: 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.
+Added: 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.
+Added: 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.
−Removed: Unlike the AKS, the Stark Law is 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.
+Added: 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.
+Added: 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.
+Added: In addition to reimbursing the government any associated overpayment, violations of the Stark Law can lead to:
+Added: (1) civil penalties of nearly $29,000 per claim (in 2023, adjusted annually for inflation);
+Added: (2) three times the amount of damages suffered by the government;
+Added: 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.
1 unchanged sentence
Moreover, the government may assert that a claim including items and services resulting from a violation of the AKS or the Stark Law constitutes a false or fraudulent claim for purposes of the civil False Claims Act.
+Added: In addition, knowingly concealing or decreasing an obligation to pay the government (or reimburse, in the case of an overpayment) can create liability under the reverse false claims provision of the statute.
+Added: Overpayments must be repaid to the government within 60 days of the time the provider or supplier determines (or reasonably should have determined through the exercise of reasonable diligence) that it received an overpayment.
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.
−Removed: Private individuals 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) and to share in any amounts paid by the entity to the government in fines or settlement.
−Removed: 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.
−Removed: Moreover, in certain cases, providers who routinely waive copayments and deductibles for Medicare and Medicaid beneficiaries can also be held liable under the AKS and civil FCA.
−Removed: One of the statutory exceptions to the prohibition is non-routine, unadvertised waivers of copayments or deductible amounts based on individualized determinations of financial need or exhaustion of reasonable collection efforts.
−Removed: The Department of Health and Human Services Office of Inspector General emphasizes, however, that this exception should only be used occasionally to address special financial needs of a particular patient.
−Removed: Although this prohibition applies only to federal healthcare program beneficiaries, the routine waivers of copayments 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.
+Added: 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).
+Added: Such realtors, often current or former employees or competitors, share in any amounts paid to the government in fines or settlement.
+Added: 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”).
+Added: Moreover, in certain cases, providers who routinely waive co-payments and deductibles for Medicare and Medicaid beneficiaries can also be held liable under the AKS and civil FCA.
+Added: One of the statutory exceptions to the beneficiary inducements prohibition is non-routine, unadvertised waivers of co-payments or deductible amounts based on individualized determinations of financial need or exhaustion of reasonable collection efforts.
+Added: The OIG emphasizes, however, that this exception should only be used occasionally to address special financial needs of a particular patient.
+Added: 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.
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.
+Added: Many states in which we operate have also adopted similar fraud and abuse laws to those described above.
+Added: 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.
+Added: 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.
+Added: 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.
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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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.
−Removed: Several states in which we operate have also adopted similar fraud and abuse laws as described above.
−Removed: 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.
−Removed: 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 funded healthcare program.
−Removed: 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.
Foreign Corrupt Practices Act
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Our existing safeguards may prove to be less than effective, and our employees, consultants, and agents may engage in conduct for which we might be held responsible.
+Added: The FCPA also requires us to maintain accurate books and records and have a system of internal controls sufficient to, among other things, provide reasonable assurances that transactions are executed and assets are accessed and accounted for in accordance with management’s authorization.
A determination that our operations or activities are not, or were not, in compliance with U.S.
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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.
+Added: We are also subject to the UK and Brazilian equivalents, the UK Bribery Act and the Brazil Clean Company Act.
ISO Standards
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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.
−Removed: Entities that are found to be in violation of HIPAA, whether as the result of 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 and penalties 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.
−Removed: In addition, certain state and foreign laws, such as the California Consumer Privacy Act (“CCPA”) California Privacy Rights Act (“CPRA”), General Data Protection Regulation (“GDPR”) and the United Kingdom General Data Protection Regular (“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.
+Added: 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.
+Added: 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.
Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penalties and private litigation.
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Financial Statements and Supplementary Data—Notes to the Consolidated Financial Statements—Note 8.
−Removed: Organization of this Annual Report for additional information about the organizational transactions completed as part of the IPO.
+Added: Stockholders’ equity of this Annual Report for additional information about the organizational transactions completed as part of the IPO.
+Added: Information about our Executive Officers
+Added: The following table sets forth information concerning our executive officers as of March 1, 2024:
+Added: Claypoole 52 President and Chief Executive Officer
+Added: Singleton 55 Senior Vice President and Chief Financial Officer
+Added: Anthony D’Adamio 63 Senior Vice President and General Counsel
+Added: Katrina Church 62 Senior Vice President and Chief Compliance Officer
+Added: 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.
+Added: In this role, Mr.
+Added: Claypoole had full responsibility for a $1.2 billion business.
+Added: Before that, Mr.
+Added: Claypoole served in several leadership positions with Mölnlycke from March 2017 to July 2021, including Executive Vice President and President, US for Mölnlycke and as an Officer of Mölnlycke Health Care US, LLC and Mölnlycke Manufacturing US, LLC.
+Added: Prior to joining Mölnlycke in 2017, Mr.
+Added: Claypoole served in various leadership roles at Medtronic Ltd.
+Added: (now Medtronic plc (NYSE:
+Added: MDT)), a global healthcare technology company, and Covidien, before it was acquired by Medtronic.
+Added: Claypoole was Global Vice President & General Manager, Obesity & Metabolic Health (April 2016 to March 2017) and Global Vice President & General Manager of the Soft Tissue Repair & Hemostats business (December 2012 to April 2016).
+Added: Before that, he was the Vice President, Executive Operations after serving as Vice President, Global Marketing while located in Trevoux, France.
+Added: Prior to his time in France, Mr.
+Added: Claypoole was the Vice President, US Marketing for the company’s Endomechanical & Intelligent Device business.
+Added: Before joining Covidien in 2007, Mr.
+Added: Claypoole held various marketing roles with increasing responsibility at Johnson & Johnson’s Vision Care division.
+Added: Claypoole previously served on the board of directors of ZetrOz Inc.
+Added: (January 2014 to January 2016) and the Association of periOperative Registered Nurses (December 2017 to December 2020).
+Added: Claypoole received his Bachelor of Arts and his Masters of Business Administration from Cornell University.
+Added: The Company’s Board of Directors (the “Board”) believes that Mr.
+Added: 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.
+Added: Mark Singleton has served as our Senior Vice President and Chief Financial Officer since March 2022.
+Added: Singleton previously served as Vice President of Finance, Americas Strategic Business Units at Teleflex Inc.
+Added: (“Teleflex”), a provider of specialty medical devices, from February 2021 to March 2022 and prior to that, served as Teleflex’s Vice President of Finance, Vascular Strategic Business Unit from 2014 to 2020.
+Added: Prior to Teleflex, Mr.
+Added: Singleton held multiple leadership roles at Lenovo Group Limited, a multinational technology company, including as Executive Director, Think Business Group Chief Financial Officer (2013-2014), Executive Director, Western Europe Chief Financial Officer (2011-2012), Executive Director, North America Chief Financial Officer (2007-2011) and Director, U.S.
+Added: Finance Manager (2005-2007).
+Added: Singleton received his Bachelor of Science from Purdue University and his Master of Business Administration from Duke University, Fuqua School of Business.
+Added: Anthony D’Adamio has served as our Senior Vice President and General Counsel since August 2017.
+Added: Previously, Mr.
+Added: D’Adamio was General Counsel and Secretary at Siemens Healthcare (now known as Siemens Healthineers AG) from January 2010 to August 2017 and served as Deputy General Counsel and Secretary of Siemens Healthcare Diagnostics from January 2007 to January 2010.
+Added: Prior to that, Mr.
+Added: D’Adamio was Senior Counsel within the Diagnostics Division of Bayer Healthcare LLC (now known as Siemens Healthineers Diagnostics) from January 2001 to December 2006.
+Added: D’Adamio began his legal career at the law firm of Bond, Schoeneck & King before taking corporate legal positions with companies within the health insurance, pharmaceutical and biotechnology industries, including Group Health Incorporated, Quest Diagnostics and Covance Inc.
+Added: 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.
+Added: Katrina Church has served as our Chief Compliance Officer since August 2020.
+Added: Prior to joining us, Ms.
+Added: Church served in corporate counsel and compliance roles within the Merz Group of companies, most recently as Global Compliance Officer for Merz Pharma GmbH & Co KGaA, a privately-held pharmaceutical company, from March 2015 to August 2020.
+Added: From June 1998 to December 2008, Ms.
+Added: Church was Executive Vice President and General Counsel of Connetics Corporation, a specialty pharmaceutical company that was acquired by Stiefel Laboratories, Inc.
+Added: Church began her career as an attorney at Hopkins & Carley, a San Jose-based law firm.
+Added: Church was nominated for several industry awards for compliance training and received the 2020 Women in Compliance Award for “Most Impactful Compliance Training Programme of the Year” and the Brandon Hall 2020 Gold Medal for Excellence in Training.
+Added: Church holds a Juris Doctor from New York University School of Law and a Bachelor of Arts in Comparative Literature from Duke University.
Available Information
−Removed: Our filings with the Securities and Exchange Commission (“SEC”), including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, Proxy Statements for Meetings of Shareholders, any registration statements, and amendments to those reports, are available free of charge on our website as soon as reasonably practicable after they are filed with, or furnished to, the SEC.
+Added: Our filings with the Securities and Exchange Commission (“SEC”), including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, proxy statements for stockholder meetings, any registration statements, and amendments to those reports, are available free of charge on our website as soon as reasonably practicable after they are filed with, or furnished to, the SEC.
Information on our website or connected to our website is not incorporated by reference into this Annual Report.
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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.