−Removed: We are a commercial-stage medical technology company focused on designing, developing and marketing innovative tissue reinforcement materials to address unmet needs in soft tissue reconstruction.
−Removed: We are committed to providing patients with advanced, economically effective biologic material repair solutions to patients to minimize long-term exposure to permanent synthetic materials and improve clinical outcomes.
−Removed: Our products are purposefully designed to address the shortcomings of existing reinforcement materials in hernia repair, abdominal wall reconstruction and plastic and reconstructive surgery.
+Added: We are a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions that optimize clinical outcomes by prioritizing the preservation and restoration of the patient’s own anatomy.
+Added: Our growing product portfolio is purposefully designed to leverage the patient’s natural healing response while minimizing long-term exposure to permanent synthetic materials.
+Added: We are committed to delivering our advanced technologies with a strong economic value proposition to assist surgeons and institutions in providing next-generation soft-tissue repair solutions to more patients worldwide.
+Added: We are dedicated to building true partnerships with surgeons and healthcare providers to deliver solutions that provide both clinical and economic improvements.
+Added: We believe that genuine collaboration with surgeons and healthcare providers results in the development of new solutions that empower patient care.
Our first portfolio of products, the OviTex Reinforced Tissue Matrix (“OviTex”), addresses unmet needs in hernia repair and abdominal wall reconstruction by combining the benefits of biologic matrices and polymer materials while minimizing their shortcomings, at a cost-effective price.
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Food and Drug Administration (“FDA”) which clearance was obtained and is currently held by Aroa, our exclusive manufacturer and supplier.
−Removed: Interim results of our ongoing prospective, single arm, multicenter post-market clinical study, which we refer to as our BRAVO study, suggest that OviTex is safe and clinically effective for the treatment of ventral hernias.
−Removed: Our BRAVO study was fully enrolled at 92 patients.
−Removed: The interim analysis includes patient cohorts at the 90-day, 12-month and 24-month follow-up periods.
−Removed: At 90 days post-operative, there were no recurrences or reoperations among the 84 patients analyzed and one implant removal due to a bowel perforation.
−Removed: The final 12-month analysis includes 76 patients, of whom two patients experienced a recurrence, both adjacent to the original repair, with the OviTex repairs remaining intact.
−Removed: Of the 51 patients that have reached 24-month follow-up, one patient experienced a surgical site occurrence from a superficial infection and none experienced a recurrence or long-term complication.
−Removed: Additional results from the 30-day and 24-month patient cohorts showing low rates of surgical site occurrences requiring treatment were presented in September 2020 at the Americas Hernia Society Annual Meeting.
+Added: Interim results of our single arm, multicenter post-market clinical study, which we refer to as our BRAVO study, were recently published in the Journal of Clinical Medicine.
+Added: The interim analysis of patients reaching 12-month follow-up suggests that OviTex is safe and clinically effective for treatment of ventral hernias.
+Added: The recurrence rate was 2.7% at 12 months.
+Added: Twenty-four month follow-up has been completed for all possible patients in our BRAVO study, and the recurrence rate remains below 5%.
+Added: Final analysis is underway and full results will be presented in a future peer-reviewed publication.
Our second portfolio of products, the OviTex PRS Reinforced Tissue Matrix (“OviTex PRS”), addresses unmet needs in plastic and reconstructive surgery.
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We began commercialization of our OviTex products in the U.S.
−Removed: in July 2016, and they are now used in more than 325 hospitals.
+Added: in July 2016, primarily for hernia repair.
Hernia repair is one of the most common surgeries performed in the U.S., representing approximately 1.1 million procedures annually.
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In addition, to address the significant increase in the number of robotic-assisted hernia repairs over the last several years, we have designed an OviTex product specifically for use in laparoscopic and robotic-assisted surgery called OviTex LPR, which we began commercializing in November 2018.
−Removed: We subsequently expanded the OviTex LPR product line in December 2019.
OviTex PRS is indicated for use in implantation to reinforce soft-tissue where weakness exists in patients requiring soft-tissue repair or reinforcement in plastic and reconstructive surgery.
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is approximately $600 million.
−Removed: We commenced a limited launch in May 2019 and have gathered clinical feedback from our initial surgeon users.
−Removed: Based on this feedback, we expanded our commercial launch in June 2020 and expect to continue to expand our surgeon network.
−Removed: We will also evaluate new generation products.
−Removed: We also intend to engage in discussions with the FDA regarding an Investigational Device Exemption (“IDE”) protocol to study the safety and effectiveness of our OviTex PRS product for an indication in breast reconstruction surgery.
+Added: We commenced a limited launch in May 2019 and gathered clinical feedback from our initial surgeon users.
+Added: Based on this feedback, we expanded our commercial launch in June 2020 and expect to continue to expand our access to surgeons.
+Added: We have also engaged in discussions with the FDA regarding an Investigational Device Exemption (“IDE”) protocol to study the safety and effectiveness of our OviTex PRS product for an indication in breast reconstruction surgery.
The FDA has stated that a PMA, rather than 510(k) clearance will be required for such an indication.
−Removed: We have a broad portfolio of intellectual property protecting our products, which we believe, when combined with our proprietary manufacturing processes and know-how, provides significant barriers to entry.
+Added: We have a broad portfolio of intellectual property protecting our products that we believe, when combined with our proprietary manufacturing processes and know-how, provides significant barriers to entry.
Our intellectual property applies to our differentiated product construction and materials.
−Removed: In addition, we believe our exclusive manufacturing and long-term supply and license agreement (the “Aroa License”) with Aroa creates a competitive advantage by allowing us
−Removed: to secure an exclusive supply of ovine rumen at a low cost.
−Removed: Ovine rumen, the forestomach of a sheep, is the source of the biologic material used in our products.
+Added: In addition, we believe our exclusive manufacturing and long-term supply and license agreement (the “Aroa License”) with Aroa creates a competitive advantage by allowing us to secure an exclusive supply of ovine rumen at a low cost.
+Added: Ovine rumen, the forestomach of a sheep, is the source of the
+Added: biologic material used in our products.
In manufacturing the product, we use biologic material from ovine rumen because of its plentiful supply, optimal biomechanical profile and open collagen architecture that allows for rapid cellular infiltration.
We purchase product from Aroa at a fixed cost equal to 27% of our net sales of licensed products.
−Removed: We market our products through a single direct sales force, predominantly in the U.S.
−Removed: We have invested in our direct sales and marketing infrastructure in order to expand our presence and to promote awareness and adoption of our products.
+Added: We market our products through a single direct sales force, predominantly in the U.S., augmented by distributors in certain European countries.
+Added: We have invested in our direct sales and marketing infrastructure to expand our presence and to promote awareness and adoption of our products.
As of December 31, 2021, we had 46 sales territories in the U.S.
−Removed: As part of our commercial strategy, we plan to continue to invest in our commercial organization by hiring additional account managers, clinical development specialists and administrative support staff in order to support and service new accounts for soft tissue reconstruction procedures.
+Added: As part of our commercial strategy, we plan to continue to invest in our commercial organization by hiring additional account managers, clinical development specialists and administrative support staff to support and service new accounts for soft-tissue reconstruction procedures.
We believe we can enhance the productivity of our sales force by improving customer segmentation and targeting, leveraging digital channels to engage customers, and utilizing engagement analytics to support development.
We plan to continue to contract with GPOs and IDNs to increase access to and penetration of hospital accounts.
−Removed: We will adjust our commercial expansion plan, as appropriate, as we continue to better understand the effects of the pandemic resulting from COVID-19 on our sales and marketing efforts.
−Removed: Our business has been impacted by the COVID-19 pandemic.
−Removed: We began to see an adverse impact on the number of surgical procedures using our OviTex products in the second half of March 2020.
−Removed: Since mid-April 2020, the number of procedures using our products and our corresponding sales have increased in a gradual, non-linear fashion.
−Removed: While our procedural volumes improved relative to the second quarter of 2020, we are continuing to be impacted by postponements in non-emergent procedures in areas of the country where COVID-19 infections are rising, however, at a less drastic pace than the second quarter of 2020.
+Added: However, we will adjust our commercial expansion plan, as appropriate, as we continue to better understand the effects of the pandemic resulting from COVID-19 on our sales and marketing efforts.
+Added: Our business has been impacted by the ongoing COVID-19 pandemic and the development of variants of COVID-19.
+Added: We believe our revenue was slightly impacted during the first quarter of 2021, mostly in January 2021, due to COVID-19 resurgences and the resulting lower surgical procedural volumes, though not at the levels seen in early 2020.
+Added: This impact subsided throughout the remaining months of the first quarter and the second quarter of 2021.
+Added: However, we believe our revenue was also impacted in September 2021 and December 2021 due to the surge of new COVID-19 cases relating to new variants and the impact of the surge on surgical procedural volumes.
+Added: We are continuing to be impacted by postponements in non-emergent procedures in areas of the country where COVID-19 infections are rising or remain high, however, at a less drastic pace than early 2020.
Our revenue for the years ended December 31, 2021 and 2020 was $29.5 million and $18.2 million, respectively, which represents an increase of $11.3 million, or 62%.
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As of December 31, 2021, we had an accumulated deficit of $229.9 million.
−Removed: The vast majority of our revenue to date has been generated from sales of our OviTex products in the U.S., with the remainder generated from sales of our OviTex products in Europe, and sales of our OviTex PRS products in the U.S.
−Removed: In November 2019, we closed our initial public offering (“IPO”) in which we issued and sold 4,398,700 shares of our common stock at a public offering price of $13.00 per share, including 398,700 shares of our common stock sold pursuant to the underwriters’ option to purchase additional shares.
−Removed: We received net proceeds of $50.6 million after deducting underwriting discounts, commissions and other offering expenses.
−Removed: In June 2020, we completed a follow-on public offering in which we issued and sold 3,000,000 shares of our common stock at a public offering price of $16.00 per share.
−Removed: We received net proceeds of $44.7 million after deducting underwriting discounts, commissions and other offering expenses.
−Removed: Our common stock is listed on the Nasdaq Global Market (“Nasdaq”) under the trading symbol “TELA.”
+Added: The vast majority of our revenue to date has been generated from sales of our OviTex and OviTex PRS products in the U.S., with the remainder generated from sales of our OviTex products in Europe.
+Added: We announced, in November 2021, that we entered into a distribution agreement with Next Science Technologies Pty Limited (“Next Science”), a medical technology company, granting us the exclusive rights to sell and market Next Science’s proprietary antimicrobial surgical wash with XBIO ® technology across the U.S.
+Added: plastic reconstructive market.
+Added: We will commence private label marketing of the solution for plastic surgery in 2022.
+Added: Next Science’s XBIO Technology delivers an advanced option for surgical infection control by addressing the biofilms that make bacteria more resistant to traditional antimicrobial agents, disinfectants, and host immune defenses.
+Added: We believe the infection control solution will expand our service offerings and diversify our supplier base as we continue to create a soft tissue restoration portfolio.
Market Opportunity
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We estimate that there are approximately 40,000 hiatal hernia repairs annually in the U.S.
−Removed: Approximately 90% of all hernia repairs are treated with a tissue reinforcement material.
The healthcare burden of hernia disease to patients, insurers and employers is significant.
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Pain is the most common cause of delay in returning to work, followed by wound problems.
−Removed: Long-term pain
−Removed: or discomfort at the hernia repair site is one of the most serious complications of hernia surgery and may, in some cases, persist for years.
−Removed: In addition, for third-party payors, the costs related to hernia are significant.
−Removed: The number of annual physician office visits in the U.S.
−Removed: related to hernia were approximately 2.5 million in 2016 according to the National Ambulatory Medical Care Survey.
−Removed: Hernia repair and abdominal wall reconstruction inpatient per procedure costs in the U.S.
−Removed: ranged from approximately $6,117 to $29,615 in 2018 according to the national average Medicare Severity Diagnosis Related Groups (“MS-DRG”) rate which does not account for surgeon fees involved with such procedures.
−Removed: Hernias are prone to recurrence, which often require multiple repair procedures and additional healthcare expenditures.
−Removed: In the U.S., the economic burden of hernia repair accounts for approximately $48.0 billion of healthcare expenditures annually.
+Added: Long-term pain or discomfort at the hernia repair site is one of the most serious complications of hernia surgery and may, in some cases, persist for years.
Given the limitations of and lack of innovation in existing hernia repair products, we believe a significant market opportunity exists for our portfolio of OviTex products.
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In breast reconstruction, biologic matrices are utilized for prosthetic based reconstruction following the removal of cancerous breast tissue.
−Removed: Breast reconstructions can be performed either using a sub-pectoral or pre-pectoral technique.
−Removed: In a sub-pectoral technique, the upper portion of the breast implant is placed below the pectoralis muscle and a biologic matrix is placed around the lower portion of the breast implant.
−Removed: In a pre-pectoral technique, the entire breast implant is placed above the
−Removed: pectoralis muscle and the full top surface of the breast implant is covered.
−Removed: The pre-pectoral technique utilizes a larger biologic matrix compared to that needed with the sub-pectoral technique.
−Removed: For patients who undergo autologous reconstruction, the donor site of the autologous tissue, typically the abdomen, may require soft tissue reinforcement.
Based on the current sales of biologic matrices in the U.S., we estimate the annual U.S.
current addressable market opportunity for our OviTex PRS products to be approximately $600 million.
−Removed: This market continues to grow as surgeon and patient preferences shift from sub-pectoral to pre-pectoral techniques.
Given the limitations of and lack of innovation in existing biologic matrices for plastic and reconstructive surgical procedures, we believe a significant market opportunity exists for our OviTex PRS portfolio products.
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Surgical instruments and devices, such as mesh products, are then delivered to the surgical site through a trocar, which is an access port to the patient’s abdomen or groin.
−Removed: Robotic-assisted surgery is also performed using small incisions in the patient’s abdomen or groin and a trocar, but the surgeon sits at a console in the operating room and operates the robotic instruments remotely.
+Added: assisted surgery is also performed using small incisions in the patient’s abdomen or groin and a trocar, but the surgeon sits at a console in the operating room and operates the robotic instruments remotely.
At the advent of hernia repair, all procedures were performed using an open surgical technique in which an incision is made through the body to access and repair the hernia.
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In robotic-assisted repair, the surgeon enjoys greater instrument dexterity and precision, and is able to achieve primary closure of the hernia defect.
−Removed: This has contributed to a significant increase in the number of robotic-assisted hernia repair over the last several years.
+Added: This has contributed to a significant increase in the number of robotic-assisted hernia repairs over the last several years.
It is estimated that about 90% of hernia repairs today use a form of reconstruction material to provide long-term support at the repair site.
Reconstruction materials include synthetic mesh, which can be either permanent or resorbable, and biologic matrices made from tissue material.
−Removed: In October 2020, we surveyed a group of 71 surgeons to better understand their receptivity to nature repair solutions, their technique preferences across their hernia practice and their views on the risks associated with plastic mesh.
+Added: In October 2020, we surveyed a group of 71 surgeons to better understand their receptivity to natural repair solutions, their technique preferences across their hernia practice and their views on the risks associated with plastic mesh.
Feedback was gathered across inguinal hernia, simple ventral, moderate-to-complex ventral and hiatal hernia repair.
Included in the group were 43 general surgeons (61%), 19 plastic reconstructive surgeons (27%) and the remainder were colorectal and trauma surgeons.
−Removed: These surgeons indicated they believe there is a role for natural repair products across all hernia segments, and expect to increase their usage of those products in the next 24-months.
+Added: These surgeons indicated they believe there is a role for natural repair products across all hernia segments and they expect to increase their usage of those products in the next 24 months.
Almost 60% of surgeons stated that they are aware of the risks associated with plastic mesh and reported approximately 20% of their hernia patients have voiced concern about the use of plastic mesh within the past 12 months.
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Permanent synthetic mesh, the oldest category of hernia repair materials, is made of plastic materials that are also used in industrial and consumer products.
−Removed: These products have gained popularity with surgeons because they are relatively inert,
−Removed: can be readily sterilized, exhibit biomechanical strength and durability and are available at relatively low upfront cost.
+Added: These products have gained popularity with surgeons because they are relatively inert, can be readily sterilized, exhibit biomechanical strength and durability and are available at relatively low upfront cost.
Limitations of permanent synthetic mesh products may include:
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● migration of the permanent synthetic mesh which can result in organ erosion or perforation.
−Removed: Many of these complications caused by permanent synthetic mesh require additional surgical intervention, including, explantation of the mesh or repair of hernia recurrence or the abdominal wall.
+Added: Many of these complications caused by permanent synthetic mesh require additional surgical intervention, including, explantation of the mesh or repair of hernia recurrence or of the abdominal wall.
Based on longitudinal data from the Danish Hernia Database, in an analysis of approximately 2,900 patients who received a hernia repair using a permanent synthetic mesh, the observed rate of surgical intervention due to either recurrence or mesh-related complications at five years post operatively was approximately 17%.
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● considerably more expensive upfront costs than permanent synthetic mesh, typically limiting their use to complex hernia repairs or abdominal wall reconstructions.
−Removed: Though hernia recurrence occurs with the use of all types of soft tissue reconstruction, biologic matrices have the highest rates of recurrence, in part as a result of being commonly used in complex hernia repairs or abdominal wall reconstructions.
−Removed: The RICH study, a multicenter, prospective study sponsored by LifeCell Corporation (“LifeCell”) that evaluated the performance of Strattice, the current market-leading biologic matrix, in open ventral incisional hernia
−Removed: repair in contaminated abdominal wall defects, demonstrated post-operative hernia recurrence rates of 19% and 28% at 12-months and 24-months follow-up, respectively.
+Added: Though hernia recurrence occurs with the use of all types of soft-tissue reconstruction, biologic matrices have the highest rates of recurrence, partly due to common use in complex hernia repairs or abdominal wall reconstructions.
+Added: The RICH study, a multicenter, prospective study sponsored by LifeCell Corporation (“LifeCell”) that evaluated the performance of Strattice, the industry leader for biological tissue matrices in complex abdominal wall reconstruction, in open ventral incisional hernia repair in contaminated abdominal wall defects, demonstrated post-operative hernia recurrence rates of 19% and 28% at 12-months and 24-months follow-up, respectively.
Resorbable Synthetic Mesh
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Many of these complications can require additional surgical intervention including explantation of the resorbable synthetic mesh or repair of hernia recurrence or the abdominal wall.
−Removed: Data from a recently published, multicenter, prospective study sponsored by C.R.
+Added: Data from a published, multicenter, prospective study sponsored by C.R.
(now a subsidiary of Becton, Dickinson and Company) that evaluated the performance of Phasix, the current market-leading resorbable synthetic mesh, in CDC Class I, high risk ventral and incisional hernia repair, showed a post-operative hernia recurrence rate of 9% at 18-months follow-up and 18% at 36-month follow-up.
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Our portfolio of products, designed with over 95% biologic material, combines the benefits of both biologic and polymer materials while addressing their limitations by interweaving polymer fibers through layers of a minimally-processed biologic material.
−Removed: These products are priced competitively, and designed for use with a range of surgical techniques, allowing the benefits of an advanced biologic repair to be available to more patients for use in accordance with the 510(k) clearances and the instructions for use.
+Added: These products are priced competitively and designed for use with a range of surgical techniques, allowing the benefits of an advanced biologic repair to be available to more patients for use in accordance with the products’ 510(k) clearances and instructions for use.
The biologic material serves as the natural building block from which we can fabricate devices that meet specific clinical and surgical handling requirements.
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Our reinforced tissue matrices are designed to improve the outcomes of soft-tissue reconstructions by reinforcing tissue while allowing rapid tissue integration, revascularization and biomechanical control.
−Removed: In addition to overall strength, a key property that we engineer into our products is the degree to which they stretch, known as compliance.
+Added: In addition to overall strength, a
+Added: key property that we engineer into our products is the degree to which they stretch, known as compliance.
Each of our products is designed to exhibit a degree of compliance appropriate for its intended clinical application.
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The biologic material largely surrounds the polymer and helps attenuate and localize inflammation to zones immediately surrounding the polymer.
−Removed: In our non-human primate comparative study in which we compared our OviTex products to several commercially available synthetic mesh and biologic matrix products, our OviTex products demonstrated a minimal foreign body inflammatory response, similar to biologic matrices, and less foreign body inflammatory response than all of the synthetic mesh tested at 24 weeks.
+Added: In our non-human primate comparative study in which we compared our OviTex products to several commercially available synthetic mesh and biologic matrix products, our OviTex products demonstrated a minimal
+Added: foreign body inflammatory response similar to that of biologic matrices, and less foreign body inflammatory response than all of the synthetic mesh tested at 24 weeks.
● Enhanced remodeling of soft-tissue and rate of healing.
Our reinforced tissue matrices are constructed to provide increased surface area and permeability, allowing for rapid absorption of wound fluids and blood during implantation and enabling improved supply of oxygen, cellular infiltration, migration, and repopulation for revascularization and functional tissue remodeling during healing.
−Removed: In our non-human primate comparative study, at 24 weeks the pattern of collagen formation in our OviTex products was reminiscent of connective tissue as opposed to the random fibers typical of scar tissue that were seen adjacent to the synthetic mesh.
+Added: In our non-human primate comparative study, at 24 weeks the pattern of collagen formation in our OviTex products resembled connective tissue as opposed to the random fibers typical of scar tissue that were seen adjacent to the synthetic mesh.
By contrast, the synthetic mesh showed no signs of remodeling of soft-tissue and exhibited a high level of mesh contraction.
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We believe this early cell infiltration may reduce the potential for bacterial colonization and the risk for infection, although we have not conducted comparative studies in humans.
−Removed: ● Highly engineered biomechanical properties with durability of results.
+Added: ● Highly engineered biomechanical properties supported by clinical evidence.
Our reinforced tissue matrices are reinforced with interwoven polymer fibers to provide mid-term and long-term strength.
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Data from our strength testing demonstrated that our OviTex products meet or exceed that of published data from market-leading permanent and resorbable synthetic mesh.
−Removed: In our BRAVO study, there were two hernia recurrences in the 76 patients who reached
−Removed: one year follow-up, despite approximately 85% of these patients having one or more factors known to increase the risk of recurrence.
+Added: In our BRAVO study, there were two hernia recurrences in the 76 patients who reached one year follow-up, despite approximately 79% of these patients having one or more factors known to increase the risk of recurrence.
Based on this data, we believe that this 2.7% recurrence rate is the lowest reported rate in any prospective study that includes either our biologic or resorbable synthetic mesh competitors.
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In addition, based upon our survey of approximately 50 surgeons, our OviTex products conform readily to the contours of surgical sites and are easy to handle, trim, suture and tack in all surgical approaches.
−Removed: In interim data presented from our BRAVO study, of 26 subjects who received minimally invasive surgery, 100% of the surgeons who operated on those subjects cited the product as being easy to place and the average surgeon satisfaction with the product was 9.7/10 at both 30 and 90 days.
−Removed: In addition, we have designed OviTex LPR for use in laparoscopic and robotic-assisted surgery.
+Added: In interim data presented from our BRAVO study, 29 of the 76 subjects reaching 12 months follow-up received minimally invasive surgery, 11 received laparoscopic repair and 18 received robotic repair.
+Added: Of the subjects who received minimally invasive surgery, 26 had surgeon satisfaction scores, with 100% of those surgeons citing the product as being easy to place and the average surgeon satisfaction with the product was 9.7/10 at both 30 and 90 days.
+Added: In May 2021, we also enrolled our first patient in the BRAVO II study, a prospective study evaluating the robotic repair of ventral hernias with OviTex.
+Added: This study will utilize OviTex LPR, which has been purposefully designed for minimally invasive procedures, as well as OviTex Core Permanent and OviTex 1S Permanent.
● Lower upfront cost products.
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For example, our OviTex devices are currently available in sizes ranging from 4 × 8 cm to 25 × 40 cm, and our OviTex LPR devices are designed with specific thickness, handling properties and shapes optimized for use in laparoscopic and robotic-assisted surgery.
−Removed: ● Disruptive technology supported by compelling clinical evidence.
−Removed: The safety, efficacy and durability of our OviTex products are supported by compelling clinical evidence that includes studies in more than 200 non-human primates, and our BRAVO study.
−Removed: Our non-human primate data demonstrated that use of our OviTex products resulted in more rapid tissue integration and revascularization compared to biologic matrices and lower inflammatory response and better functional tissue remodeling compared to permanent and resorbable synthetic mesh.
+Added: ● Disruptive technology supported by compelling pre-clinical and clinical evidence.
+Added: OviTex product technology is supported by extensive pre-clinical research, including bench testing, in vitro and in vivo studies.
+Added: These studies have demonstrated appropriate physiologic strength for the repair, compliance within the physiologic range of the human abdominal wall, retention of extracellular matrix proteins which may aid in tissue remodeling and porosity and permeability to promote fluid transfer.
+Added: Our in vivo non-human primate data demonstrated that use of our OviTex products resulted in more rapid tissue integration and revascularization compared to biologic matrices, as well as lower inflammatory response and better functional tissue remodeling compared to permanent and resorbable synthetic mesh.
+Added: This preclinical data is supported by our compelling clinical evidence showing the safety and efficacy of our OviTex products in published data on over 1,000 hernia patients.
● Long-term supply agreement that provides pricing flexibility.
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Our pricing flexibility allows us to sell our OviTex and OviTex PRS products to hospitals and healthcare systems at prices substantially below competitive products based on national average competitive pricing.
−Removed: Our OviTex products are sold at prices
−Removed: approximately 20% to 40% lower than other biologic matrices and resorbable synthetic mesh.
+Added: Our OviTex products are sold at prices approximately 20% to 40% lower than other biologic matrices and resorbable synthetic mesh.
We believe our pricing flexibility will drive greater adoption of our products.
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The ability to predictably control the biomechanical properties of a biologic matrix is the cornerstone of our product portfolio.
−Removed: Our intellectual property also covers the development of extracellular matrix scaffolds derived from ovine rumen, methods for isolating these scaffolds from ovine rumen, layering multiple sheets of these ovine rumen scaffolds together, sewing in an anti-adhesive layer into a scaffold, and adding unique patterns sewn or embroidered into these scaffolds using different polymers to impart reinforcing strength.
+Added: Our intellectual property also covers the development of extracellular matrix scaffolds derived from ovine rumen, methods for isolating these scaffolds from ovine rumen, layering multiple sheets of
+Added: these ovine rumen scaffolds together, sewing in an anti-adhesive layer into a scaffold, and adding unique patterns sewn or embroidered into these scaffolds using different polymers to impart reinforcing strength.
Through the Aroa License and our issued or allowed patents and patent applications, we have a broad portfolio of intellectual property that is leveraged in all of our reinforced tissue matrix products.
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Our executive team has led and managed companies through significant growth and introduction and commercialization of multiple new products, including driving surgeon adoption of biologic and biosurgery technologies.
−Removed: Members of our team have held leading positions with medical technology companies such as Orthovita Inc., Stryker Corporation, Integra LifeSciences, LifeCell and Medtronic plc.
+Added: Members of our team have held leading positions with medical technology companies such as Orthovita Inc., Stryker Corporation, OraSure Technologies, Inc., LifeCell and Medtronic plc.
We believe this team is well-positioned to lead us through the commercial expansion of our products and development and launch of future products.
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As of December 31, 2021, we had 46 sales territories in the U.S.
−Removed: and approximately 325 active hospital accounts, which are supported by 64 employees in our U.S.
+Added: which are supported by 84 employees in our U.S.
based commercial organization.
We plan to continue to invest in our commercial organization by adding account managers, clinical development specialists and administrative support staff in order to support and service new accounts for soft-tissue reconstruction procedures.
−Removed: We believe we can also enhance the productivity of our sales force by improving customer segmentation and targeting, leveraging digital channels to engage customers and utilize engagement analytics to support development.
+Added: We believe we can also enhance the productivity of our sales force by improving customer segmentation and targeting, leveraging digital channels to engage customers and utilizing engagement analytics to support development.
● Promote awareness of our products to drive surgeon use.
We educate surgeons regarding the value proposition of our products through presentations and exhibits at industry conferences, medical education symposia, direct training and education, webinars and publishing additional clinical data demonstrating the benefits of our products and establishing online peer-to-peer communities.
−Removed: In response to the restrictions resulting from the COVID-19 pandemic, we developed a virtual marketing sales solution as well.
−Removed: our sales professionals have used this solution, which includes virtual sales calls with physicians, peer-to-peer discussions with key opinion leaders, physician webinars and sales professional training, instead of in-person sales and marketing programs.
+Added: In response to the restrictions resulting from the ongoing COVID-19 pandemic, we developed a virtual marketing sales solution as well.
+Added: Most of our sales professionals have used this solution, which includes virtual sales calls with physicians, peer-to-peer discussions with key opinion leaders, physician webinars and sales professional training, instead of in-person sales and marketing programs.
We plan to continue to drive awareness of our products through these programs and continue to compliment the in-person visits with our virtual programs, while expanding their geographic reach and increasing the number of surgeon interactions.
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We are committed to evidence-based medicine and investing in clinical data to support the use of our products.
−Removed: We submitted our complete 12-month follow-up data from our BRAVO study in March 2021, and expect the complete study results by the end of 2021.
−Removed: In addition, we are tracking the health economic outcomes within our BRAVO study.
−Removed: We are in the process of starting the next post-market study of our OviTex products in robotic-assisted ventral hernia repair surgeries in early 2021.
−Removed: We also intend to support independent investigator-led post-market clinical studies on the effectiveness and safety of our OviTex PRS products.
+Added: Our interim analysis of patients in the BRAVO study reaching 12-month follow-up was published in the
+Added: Journal of Clinical Medicine in 2021 and demonstrated a low recurrence rate of 2.7%.
+Added: Twenty-four month follow-up has been completed for all possible patients in our BRAVO study, and the recurrence rate remains below 5%.
+Added: We have begun our next post-market prospective study, BRAVO II, which evaluates OviTex LPR, OviTex Core Permanent and OviTex 1S Permanent in the robotic repair of ventral hernias over 24 months.
● Advance our portfolio of reinforced tissue matrices with the introduction of new product features and designs.
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We strengthen these reinforced tissue matrix layers with interwoven polymers, that are either permanent, polypropylene, or resorbable, PGA.
−Removed: These polymers were selected because they are well characterized suture materials with a history of significant clinical use and recognized safety profile.
+Added: These polymers were selected because they are well characterized suture materials with a history of significant clinical use and recognized safety profiles.
Polypropylene has a high tensile strength and a low inflammatory response in small quantities.
PGA is the fastest resorbing polymer and within three months it tends to be fully absorbed into the body.
−Removed: Our highly specialized and customizable textile engineering capability allows us to tailor the degree and direction of stretch, overall strength, handling properties, permeability, thickness, texture, size and shape of each reinforced tissue
−Removed: matrix to suit the needs of particular clinical applications and surgical techniques.
+Added: Our highly specialized and customizable textile engineering capability allows us to tailor the degree and direction of stretch, overall strength, handling properties, permeability, thickness, texture, size and shape of each reinforced tissue matrix to suit the needs of particular clinical applications and surgical techniques.
Our textile engineering utilizes a computer-controlled fabrication method that is scalable, reproducible, efficient and customizable.
This embroidery process uses steel gauge needles to interweave the polymer while also creating hundreds of micro-channels to allow the multi-directional passage of the patients’ native cells and fluids throughout the product.
−Removed: The interwoven polymers are embroidered using a lockstitch pattern, which allows for the device to be trimmed without fraying, and we can use a patented corner-lock pattern, which creates a stable polymer fabric within the biologic material.
+Added: The interwoven polymers are embroidered using a lockstitch pattern, which allows for the device to be trimmed without fraying, and we use a patented corner-lock pattern, which creates a stable polymer fabric within the biologic material.
We manipulate the polymer thread patterns to control the degree and stretch of our products.
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The product is provided in a dry and hydratable form and packaged in a double pouched configuration.
−Removed: The product can be stored at room temperature and only needs five minutes from rehydration to use.
+Added: The product can be stored at room temperature and only needs five minutes of rehydration for use.
To be used in surgery our OviTex product is placed in a sterile dish, rehydrated with sterile saline for five minutes, trimmed to fit the site, if needed, and then positioned to achieve maximum contact between the device and the surrounding tissue.
52 unchanged sentences
The device may be trimmed to a desired shape to further accommodate individual anatomy.
−Removed: The current shelf life of permanent OviTex PRS is 24 months and the current shelf life of resorbable OviTex PRS is 8 to 12 months.
+Added: The current shelf life of permanent OviTex PRS is 36 months and the current shelf life of resorbable OviTex PRS is 12 months.
Product Pipeline and Research and Development
6 unchanged sentences
We believe these technology enhancements will continue to bolster our portfolio and expand the successful use of our products.
−Removed: Clinical Results and Studies
+Added: Scientific Evidence
Overview of Preclinical and Clinical Programs
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We expect our clinical evidence will provide surgeons with safety and efficacy data on the appropriate use of our products and we plan to obtain further clinical evidence to support additional regulatory clearances or approvals of our reinforced tissue matrices for additional indications for use in the future.
−Removed: We believe we have completed the largest non-human primate preclinical studies conducted in soft tissue reconstruction surgery and we expect to conduct additional non-human primate preclinical studies as part of our product development process.
−Removed: Non-human primates are considered the most suitable animal model to predict the human immune and inflammatory responses to soft tissue reconstruction devices.
−Removed: Although not required for FDA clearance of our reinforced tissue matrices, we completed these preclinical studies prior to implantation of our products in human patients.
+Added: Preclinical Program
+Added: Our pre-clinical program is paramount in the design of our products.
+Added: Our program starts with bench performance characterization to ensure proper strength and compliance for the indication, followed by in vitro and in vivo studies to ensure proper biological performance to help promote remodeling of the repair site.
+Added: We have developed an extensive pre-clinical research library on our devices, as well as on competitor devices.
+Added: We continue to evaluate new and existing technologies for safety and biocompatibility as part of our product development process.
+Added: We believe we have completed the largest non-human primate preclinical studies conducted in soft-tissue reconstruction surgery.
In these studies, we compared our OviTex and OviTex PRS products to market leading competitive materials.
−Removed: In these studies, our reinforced tissue matrices exhibited a minimal inflammatory response, rapid cellular infiltration and revascularization and demonstrated early and complete remodeling into functional tissue.
−Removed: We are currently sponsoring our BRAVO study.
+Added: The results showed our reinforced tissue matrices exhibited a minimal inflammatory response, rapid cellular infiltration and revascularization and demonstrated early and complete remodeling into functional tissue.
+Added: The OviTex results have been published in the peer-reviewed journal Hernia (https://doi.org/10.1007/s10029-019-02119-z).
+Added: We are currently in the process of preparing the OviTex PRS results for a future peer-reviewed publication.
+Added: Clinical Program
+Added: We are committed to obtaining evidence to support the safety and efficacy of our products across their indications.
+Added: Clinical data has been published on over 1,000 patients treated with OviTex across four hernia types including ventral, inguinal, hiatal, and abdominal wall reconstruction.
+Added: As part of our clinical research program, we have developed two post-market studies, BRAVO, a multi-center prospective study of ventral hernia repair and BRAVO II, a multi-center prospective study of robotic ventral hernia repair.
+Added: This commitment to generating clinical data through controlled prospective studies with 24-month follow-up will allow us to understand the short- and long-term benefits of using OviTex in hernia repair.
+Added: Our BRAVO study concluded with the last patient completing their 24-month follow-up.
+Added: We are currently in the process of preparing the BRAVO 24-month study data for a future peer-reviewed publication.
+Added: The 12-month analysis was published in the Journal of Clinical Medicine.
The study was fully enrolled at 92 patients.
−Removed: The interim analysis includes patient cohorts at the 90-day, 12-month and 24-month follow-up periods.
−Removed: At 90 days post-operative, there were no recurrences or reoperations among 84 of the patients analyzed.
+Added: At 90 days post-operative, there were no recurrences among the 84 patients analyzed.
There was one implant removal due to a bowel perforation.
−Removed: The final 12-month analysis includes 76 patients, of whom two patients experienced a recurrence, both adjacent to the original repair, with the OviTex repairs remaining intact.
−Removed: Twenty patients experienced a surgical site
−Removed: occurrence of whom ten required a procedural intervention such as wound debridement or percutaneous drainage.
−Removed: None required a surgical intervention.
−Removed: Of the 51 patients that have reached 24-month follow-up, one patient experienced a surgical site occurrence and none experienced a recurrence or long-term complication.
−Removed: Additional results from the 30-day and 24-month patient cohorts showing low rates of surgical site occurrences requiring treatment were presented in September 2020 at the Americas Hernia Society Annual Meeting.
−Removed: This clinical study included patients with a range of comorbidities, prior hernia repairs and history of surgical infections, predisposing them to complications.
−Removed: Excluded were morbidly obese patients (BMI > 40 kg/m 2 ) and those with a CDC wound class 4 (dirty/infected).
−Removed: The patients were treated using either an open or minimally invasive surgical approach.
−Removed: These findings are generally corroborated by similar clinical data from multiple published retrospective studies in a variety of hernia repairs utilizing our OviTex products.
−Removed: Our OviTex PRS products, designed for plastic and reconstructive surgery, utilize the same ovine rumen biologic material and interwoven polymer fibers as our OviTex products, but differ in their overall design.
−Removed: Our OviTex PRS reinforced tissue matrices have also been evaluated in a non-human primate model and demonstrated less inflammation and earlier remodeling into functional tissue than the leading biologic matrix used in plastic and reconstructive surgical procedures.
+Added: At 12 months post-operative, there were 76 patients analyzed, of whom twenty-six (34%) had a prior ventral hernia repair and sixty (79%) had factors known to increase the risk of recurrence.
+Added: Twenty patients (26%) experienced a surgical site occurrence of whom ten (13%) required a procedural intervention such as wound debridement or percutaneous drainage.
+Added: At 12 months, two patients (2.7%) experienced a recurrence, both adjacent to the original repair.
+Added: The low recurrence rate observed in our subjects reaching 12-month follow-up continues to remain below 5% through 24-month follow-up.
Surgeons are beginning to utilize our OviTex PRS reinforced tissue matrices in their surgeries and we plan to collect, analyze and support the presentation of clinical data to characterize the performance of our reconstructive reinforced tissue matrices.
−Removed: We also intend to support independent investigator initiated retrospective clinical studies on the effectiveness and safety of our OviTex PRS products.
−Removed: Preclinical In Vivo Evaluation of our OviTex Product in Non-Human Primates
−Removed: We evaluated the biologic performance of two configurations of our OviTex reinforced tissue matrices in comparison to five currently available reconstruction materials and two other reconstruction materials that are no longer commercially available, including permanent synthetic mesh, resorbable synthetic mesh and biologic matrices in non-human primate studies, with 73 non-human primates.
−Removed: We selected the African Green monkeys for use in this study because this primate is closely related to and shares greater than 98% of their genetic code with humans.
−Removed: This non-human primate model has been used extensively to evaluate clinical and immune responses to pathogens, vaccines, and pharmaceuticals, and to predict xenograft biocompatibility for abdominal wall repair.
−Removed: In accordance with the study protocol, the animals were anesthetized and a 7 × 3 cm full thickness “window” defect was created in the midline of the abdominal wall.
−Removed: The defect was then repaired with a reconstruction material of equal size, which was sutured in place to repair the defect and the skin was then sutured closed.
−Removed: Next the animals were euthanized at four, 12 or 24 weeks and the skin of the abdomen was dissected back to expose the site of the device.
−Removed: The graft site was evaluated for signs of herniation, inflammation, adhesions, contractions or other abnormalities.
−Removed: Then the length and width of the grafts were measured and the entire grafts and surrounding tissues were removed and photographed.
−Removed: Samples of the grafts were then prepared for analysis by an independent histopathologist.
−Removed: The most relevant data from this study came from the 24 week analysis.
−Removed: Test Articles, Material Classification, Source Materials and Explant Time Points
−Removed: Classification
−Removed: Source Materials
−Removed: Explant Time Point (weeks)
−Removed: OviTex PGA 1S
−Removed: Reinforced Biologic
−Removed: Ovine rumen embroidered with polyglycolic acid
−Removed: Reinforced Biologic
−Removed: Ovine rumen embroidered with polypropylene
−Removed: Resorbable Synthetic
−Removed: Poly-4-hydroxybutyrate (P4HB)
−Removed: Ventralight ST
−Removed: Permanent Synthetic
−Removed: Polypropylene with hydrogel barrier
−Removed: Permanent Synthetic
−Removed: Polypropylene laminated between polyglecaprone-25 films bond with polydioxanone film
−Removed: Strattice Firm
−Removed: LifeCell Corporation (now Allergan)
−Removed: Porcine dermis
−Removed: SurgiMend 1.0
−Removed: TEI Biosciences (now Integra)
−Removed: Fetal bovine dermis
−Removed: Gentrix Surgical Matrix Plus
−Removed: Porcine urinary bladder matrix
−Removed: Hybrid Biologic
−Removed: Porcine small intestinal submucosa
−Removed: At 24 weeks, our OviTex reinforced tissue matrices best preserved their original geometry and exhibited limited contraction, had minimal inflammation, had rapid cellular infiltration and vascularization, and the grafts fully remodeled into host tissue (fastest rate of remodeling) with a higher degree of organized collagen than synthetics and biologics (on average).
−Removed: Biologic Matrices
−Removed: At 24 weeks, the biologics significantly contracted in length and expanded in width, had minimal inflammation, slow cellular infiltration and vascularization, and the grafts fully remodeled into host tissue (slower rate of remodeling than our OviTex product) and exhibited varying degrees of organized remodeled collagen.
−Removed: Resorbable Synthetics
−Removed: At 24 weeks, the resorbable synthetic material exhibited significant contraction, had mild to moderate inflammation (which persisted at elevated levels throughout the study), showed a substantial layer of early amorphous inflamed tissue adjacent to the device, and given that they contain no biologic material that can be remodeled, the scar-like collagen formed adjacent to the persistent synthetic mesh material, separated by a layer of loose connective and adipose tissue, which was also present between the mesh fibers.
−Removed: Permanent Synthetics
−Removed: At 24 weeks, the permanent synthetics exhibited a high degree of contraction in length and width, had mild to moderate inflammation (which persisted at elevated levels throughout the study), showed substantial layers of early amorphous tissue formed next to the device, and given that they have no biologic that can be remodeled, they exhibited disorganized and scar-like collagen surrounding the persistent synthetic mesh material.
−Removed: Other Clinical Studies Using Our OviTex Products
−Removed: A growing body of clinical evidence supports the safety, durability and effectiveness of our OviTex products for use in a range of hernia repair procedures including hiatal, inguinal and ventral hernia repairs and abdominal wall reconstruction.
−Removed: Preclinical Animal Testing of OviTex PRS
−Removed: Our resorbable and permanent OviTex PRS products were evaluated in a non-human primate study, in which our OviTex PRS product was compared to AlloDerm at two, four, 12 and 24 weeks for differences in healing kinetics, as evidenced through inflammatory response, cellular infiltration, and the morphological quality of the newly remodeled tissue associated with each device.
−Removed: The inflammatory response for both the OviTex PRS groups and AlloDerm was minimal throughout, though the histiocytic response was higher in AlloDerm at the 4- and 12-week time points, decreasing by 24 weeks, but still slightly higher than in our resorbable OviTex PRS product.
−Removed: At four weeks, the highly permeable nature of our OviTex PRS product design enhanced fluid exchange evidenced by more effective and rapid infiltration of host cells in the collagen network.
−Removed: In comparison, the collagen network of AlloDerm developed a superficial layer of fibroblasts, covering the device, which macroscopically appeared white and largely inert.
−Removed: The earlier infiltration and faster recruitment of fibroblasts and host cells in our OviTex PRS product helped “jump start” the
−Removed: remodeling process into host tissue.
−Removed: At 12 weeks, our OviTex PRS product was fully remodeled and the maturation of the product was slightly ahead of that of AlloDerm at all time points.
−Removed: At 24 weeks, significant contraction was seen in all AlloDerm devices, as well as calcifications.
−Removed: The collagen in the AlloDerm specimens showed signs of maturation, much like our OviTex PRS products, which remodeled into mature collagen, consistent of compact lamellar bundles of low cellularity, occupying the entire defect site with functional tissue.
−Removed: After 24 weeks our OviTex PRS product was associated with a favorable tissue response, demonstrating rapid infiltration, earlier and more rapid tissue integration and slightly more advanced tissue remodeling in comparison to AlloDerm.
Intellectual Property
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In August 2012, we entered into the Aroa License, which was amended and restated in July 2015, pursuant to which we obtained an exclusive license to certain patents and know-how to develop, commercialize and sell bovine and ovine extracellular matrix products for hernia repair, abdominal wall and breast reconstruction in North America and Europe, which we refer to as the Licensed Territory.
−Removed: In addition, under the Aroa License, Aroa is our exclusive manufacturer and supplier for the development of our products.
+Added: In addition, under the Aroa License, Aroa is our exclusive manufacturer and supplier for the development of our bovine and ovine extracellular matrix products.
Pursuant to the terms of the Aroa License, we made upfront payments to Aroa totaling $2.3 million and granted Aroa 74,316 newly issued shares of our restricted common stock.
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patents that will expire in 2029 and 2031.
−Removed: We own ten U.S.
+Added: We own twelve U.S.
issued or allowed patents which will expire between 2035 and 2038 and eight pending U.S.
1 unchanged sentence
In addition to our U.S.
−Removed: intellectual property, we also own four non-U.S.
+Added: intellectual property, we also own three issued non-U.S.
+Added: patents and four pending non-U.S.
patent applications, which, subject to issuance, would be projected to expire between 2036 and 2037 and have exclusively licensed issued patents in Europe and Canada that will expire in 2029.
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We also rely on trademarks and trade designs to develop and maintain our competitive position.
−Removed: TELA Bio ® , OviTex ® and OviTex PRS ® are registered trademarks of ours in the U.S.
+Added: TELA Bio ® , OviTex ® and A More Natural Hernia Repair ® are registered trademarks of ours in the U.S.
For more information regarding the risks related to our intellectual property, please see the section titled “Risk Factors — Risks Related to Intellectual Property Matters.”
4 unchanged sentences
We have a number of design improvements for our reinforced tissue matrices in various stages of development that are expected to enhance our current products and increase surgeon adoption of our products.
−Removed: In addition, we intend to engage in discussions with the FDA regarding an
−Removed: IDE protocol to study the safety and effectiveness of our OviTex PRS portfolio for an indication in breast reconstruction surgery.
+Added: In addition, we have engaged in discussions with the FDA regarding an IDE protocol to study the safety and effectiveness of our OviTex PRS portfolio for an indication in breast reconstruction surgery.
The FDA has stated that a PMA, rather than 510(k) clearance, will be required for such an indication.
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We have invested in our direct sales and marketing infrastructure in order to expand our presence to promote awareness and adoption of our products.
−Removed: There are currently more than 325 active hospital accounts in the U.S.
−Removed: that have incorporated our products into their practices.
We market our products to hospitals, ambulatory surgery centers, surgeons, GPOs, IDNs and medical device supply chain participants primarily through our direct sales force.
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Aroa’s facility is approximately 25,000 square feet of which approximately 10,000 square feet is dedicated to manufacturing.
−Removed: This facility recently completed a short-term expansion to increase capacity with additional process equipment and work shifts, and a further intermediate-term expansion is planned in 2021, with approximately 15,000 square feet of additional manufacturing space available.
−Removed: Expansions are mutually agreed between us and Aroa, and under the terms of the Aroa License we share 50% of the expansion cost, which we may later offset against our revenue share payment to Aroa.
+Added: Aroa is in the process of expanding manufacturing capacity, with approximately 15,000 square feet of additional manufacturing space being constructed in a neighboring facility, which we expect to be available in 2022.
The Auckland facility is FDA registered and ISO 13485 certified.
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New Zealand cattle and sheep are considered by the USDA to be free of prion disease (progressive neurodegenerative disorders, including scrapie).
−Removed: The sheep receive veterinary inspection prior to slaughter and then each carcass is inspected post-mortem for the presence of disease according to USDA approved standards.
+Added: The sheep receive veterinary inspection prior to slaughter and then each
+Added: carcass is inspected post-mortem for the presence of disease according to USDA approved standards.
Only sheep which pass full inspection can be used as a raw tissue source for our products and all the ovine rumen is processed in compliance with the FDA’s regulations for Medical Devices Containing Materials Derived from Animal Sources.
Once the ovine rumen is procured, our reinforced tissue matrix products are then manufactured by Aroa at its facility in Auckland, New Zealand.
−Removed: All of our products are shipped directly from Auckland, New Zealand to our headquarters in Malvern, Pennsylvania.
+Added: The majority of our products are shipped directly from Auckland, New Zealand to our headquarters in Malvern, Pennsylvania.
We sell our products directly to our customers, which are hospitals and ambulatory surgery centers.
70 unchanged sentences
The Food and Drug Administration Modernization Act of 1997, or FDAMA, established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the de novo classification procedure.
−Removed: This procedure allows a manufacturer whose novel device is automatically classified into Class III to request down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a PMA application.
+Added: This procedure allows a manufacturer whose novel device is automatically classified into Class III to request down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk,
+Added: rather than requiring the submission and approval of a PMA application.
Prior to the enactment of the Food and Drug Administration Safety and Innovation Act of 2012, or FDASIA, a medical device could only be eligible for de novo classification if the manufacturer first submitted a 510(k) pre-market notification and received a determination from the FDA that the device was not substantially equivalent to a predicate device.
24 unchanged sentences
The FDA also may determine that additional tests or clinical trials are necessary, in which case the PMA approval may be delayed for several months or years while the trials are conducted and data is submitted in an amendment to the PMA, or the PMA is withdrawn and resubmitted when the data are available.
−Removed: The FDA may condition PMA approval on some form of post-market surveillance when deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population or for a longer period of use.
+Added: The FDA may condition PMA approval on some form of post-market
+Added: surveillance when deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population or for a longer period of use.
In such cases, the manufacturer might be required to follow certain patient groups for a number of years and to make periodic reports to the FDA on the clinical status of those patients.
23 unchanged sentences
● the FDA’s Quality Systems Regulations (“QSR”), which requires manufacturers, including third party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during all aspects of the manufacturing process;
−Removed: ● labeling and marketing regulations which require that promotion is truthful, not misleading, fairly balanced and provide adequate directions for use and that all claims are substantiated;
+Added: ● labeling and marketing regulations which require that promotion is truthful, not misleading, fairly balanced and provides adequate directions for use and that all claims are substantiated;
● complying with new requirements for Unique Device Identifiers on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Device Identification Database;
23 unchanged sentences
This directive has been separately enacted in more detail in the national legislation of the individual member states of the EU.
−Removed: The system of regulating medical devices operates by way of a certification for each medical device.
+Added: On April 5, 2017, the European Parliament passed the Medical Devices Regulation (Regulation 2017/745) (“MDR”), which repeals and replaces the MDD and the Active Implantable Medical Devices Directive.
+Added: The MDR went into effect on May 26, 2021, and it:
+Added: ● strengthens the rules on placing devices on the market and reinforces surveillance once they are available;
+Added: ● establishes explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;
+Added: ● improves the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;
+Added: ● sets up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU;
+Added: ● strengthens rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.
+Added: Under both the MDD and the MDR, the system of regulating medical devices operates by way of a certification for each medical device.
Each certificated device is marked with a CE mark which shows that the device has a Certificat de Conformité, also referred to as a Certificate of Conformance.
−Removed: There are national bodies known as Competent Authorities in each member state which oversee the implementation of the MDD within their jurisdiction.
+Added: There are national bodies known as Competent Authorities in each member state which oversee the implementation of the MDD (and now the MDR) within their jurisdiction.
The means for achieving the requirements for CE mark varies according to the nature of the device.
1 unchanged sentence
The class of a product determines the requirements to be fulfilled before a CE mark can be placed on a product, known as a conformity assessment.
−Removed: Conformity assessments for products are carried out as required by the MDD.
−Removed: Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can self-certify compliance with the MDD based on a self-assessment of the conformity of its products with the essential requirements of the EU Medical Devices Directive, a conformity assessment procedure requires the intervention of an organization accredited by a member state of the EEA to conduct conformity assessments, or a Notified Body.
+Added: Conformity assessments for products are carried out as required by the MDD (and now the MDR).
+Added: Except for low-risk medical devices (Class I
+Added: non-sterile, non-measuring devices), where the manufacturer can self-certify compliance with the MDD (and now the MDR) based on a self-assessment of the conformity of its products with the essential requirements of the EU Medical Devices Directive, a conformity assessment procedure requires the intervention of an organization accredited by a member state of the EEA to conduct conformity assessments, or a Notified Body.
If a Notified Body of one member state has issued a Certificat de Conformité, the device can be sold throughout the EU without further conformance tests being required in other member states.
−Removed: On April 5, 2017, the European Parliament passed the Medical Devices Regulation (Regulation 2017/745), which repeals and replaces the MDD and the Active Implantable Medical Devices Directive.
−Removed: The Medical Devices Regulation will be fully implemented in May 2021.
−Removed: The new regulations will among other things:
−Removed: ● strengthen the rules on placing devices on the market and reinforce surveillance once they are available;
−Removed: ● establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;
−Removed: ● improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;
−Removed: ● set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU;
−Removed: ● strengthen rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.
+Added: Under transitional provisions provided in the MDR, medical devices that had valid CE Certificates of Conformity issued under the MDD prior to May 26, 2021 may, provided related obligations are respected, continue to be placed on the EEA market for the remaining validity of the certificate, and until May 27, 2024 at the latest.
+Added: After the expiry of any applicable transitional period, only devices that have been CE marked on the basis of the MDR may be placed on the market in the EEA.
+Added: Post-Brexit, the MDR does not apply in the United Kingdom (except for Northern Ireland, which under the Northern Irish Protocol is bound by certain E.U.
+Added: The medical device legislative framework in the United Kingdom is set out in the Medical Devices Regulations 2002.
+Added: These Regulations are based on the previous medical device directives of the E.U.
+Added: but have been amended so that they function properly now the United Kingdom is no longer part of the E.U.
+Added: The Medical Devices Regulations 2002 have introduced several changes including (but not limited to) replacing the CE mark with a UKCA marking (although E.U.
+Added: CE marks will be recognized until June 30, 2023), requiring manufacturers outside of the United Kingdom to appoint a “UK Responsible Person” if they place devices on the market in the United Kingdom and more wide-ranging device registration requirements.
Privacy and Security Laws
13 unchanged sentences
The CCPA has been amended from time to time, and it remains unclear what, if any, further modifications will be made to this legislation or how it will be interpreted.
−Removed: We may be subject to other state and federal privacy laws, including laws that prohibit unfair privacy and security practices and deceptive statements about privacy and security, laws that place specific requirements on certain types of activities, such as data security and texting, and laws requiring holders of personal information to maintain safeguards and to take certain actions in response to a data breach.
−Removed: EU member states, the United Kingdom, Switzerland and other jurisdictions have also adopted data protection laws and regulations, which impose significant compliance obligations.
−Removed: In the EEA and the United Kingdom, the collection and use of personal data, including clinical trial data, is governed by the provisions of the General Data Protection Regulation (“GDPR”).
−Removed: The GDPR became effective on May 25, 2018, repealing its predecessor directive and increasing responsibility and liability of pharmaceutical and medical device companies in relation to the processing of personal data of EU data subjects.
−Removed: The GDPR, together with national legislation, regulations and guidelines of the EU member states and the United Kingdom governing the processing of personal data, impose strict obligations and restrictions on the ability to collect, analyze and transfer personal data, including health data from clinical trials and adverse event reporting.
−Removed: In particular, these obligations and restrictions concern the consent of the individuals to whom the personal data relates, the information provided to the individuals, the transfer of personal data out of the EEA or the United Kingdom, security breach notifications, security and confidentiality of the personal data and imposition of substantial potential fines for breaches of the data protection obligations.
+Added: And the CPRA, which will take effect in most material respects on January 1, 2023, modifies the CCPA significantly, potentially resulting in further uncertainty and requiring us to incur additional costs and expenses to comply.
+Added: We may be subject to other state and federal privacy laws, including laws that prohibit unfair privacy and security practices and deceptive statements about privacy and security, laws that place specific requirements on certain types of
+Added: activities, such as data security and texting, and laws requiring holders of personal information to maintain safeguards and to take certain actions in response to a data breach.
+Added: Foreign data protection laws, including the General Data Protection Regulation, (“GDPR”) may also apply to health-related and other personal information belonging to individuals who reside outside of the U.S.
+Added: The GDPR went into effect in the European Union in May 2018 and introduced strict requirements for processing the personal data of data subjects residing in the European Economic Area.
+Added: Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million or 4% of the annual global revenues of the noncompliant company, whichever is greater.
+Added: Among other requirements, the GDPR regulates cross-border transfers of personal data and requires transferee countries to have protections equivalent to protections available in the EU.
+Added: Because of the uncertainty created by the Court of Justice of the European Union’s decision invalidating the EU/US Privacy Shield (the primary mechanism to effectuate the flow of data from the EU to the United States), there continues to be uncertainty as to appropriate transfer mechanism for the transfer of data from the EU to the United States.
+Added: Further, the United Kingdom’s exit from the European Union, referred to as Brexit, has created uncertainty regarding data protection regulation in the United Kingdom.
+Added: The United Kingdom has transposed the GDPR into domestic law with a United Kingdom version of the GDPR that took effect in January 2021 (“UK GDPR”).
+Added: The UK GDPR could expose us or our collaborators to two parallel regimes, each of which potentially authorizes similar fines and other potentially divergent enforcement actions for violations.
European data protection authorities may interpret the GDPR and national laws differently and impose additional requirements, which add to the complexity of processing personal data in or from the EEA or United Kingdom.
6 unchanged sentences
Prosecutors may infer intent from the surrounding circumstances and, because courts have interpreted the statute to be violated if even one purpose of a payment is to induce the purchase of items or services paid for by federal healthcare programs, prosecutors have broad discretion in choosing arrangements to prosecute under the statute.
−Removed: There are statutory exceptions and regulatory “safe harbors” available to protect certain appropriately structured arrangements that otherwise would implicate the Anti-Kickback
−Removed: Statute and those who structure their business arrangements to satisfy all of the criteria of a safe harbor are protected from liability under the statute.
+Added: There are statutory exceptions and regulatory “safe harbors” available to protect certain appropriately structured arrangements that otherwise would implicate the Anti-Kickback Statute and those who structure their business arrangements to satisfy all of the criteria of a safe harbor are protected from liability under the statute.
Our business is subject to these laws.
4 unchanged sentences
The federal False Claims Act imposes liability on any individual or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal healthcare program.
−Removed: The qui tam or “whistleblower” provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant has violated the False Claims Act and to share in any monetary recovery.
+Added: The qui tam or “whistleblower” provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal
+Added: government alleging that the defendant has violated the False Claims Act and to share in any monetary recovery.
In recent years, the number of lawsuits brought against healthcare industry participants by private individuals has increased dramatically.
20 unchanged sentences
Other Federal Healthcare Fraud and Abuse Laws
−Removed: We may also be subject to other federal healthcare fraud and abuse laws, including provisions of HIPAA, which prohibit knowingly and recklessly executing a scheme or artifice to defraud any healthcare benefit program, including private payors, as well as knowingly and willfully falsifying, concealing or covering up a material fact by any trick, scheme or device or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
+Added: We may also be subject to other federal healthcare fraud and abuse laws, including provisions of HIPAA, which imposes criminal liability and amends provisions on the reporting, investigation, enforcement, and penalizing of civil liability for, among other things, knowingly and recklessly executing a scheme or artifice to defraud any healthcare benefit program, including private payors, as well as knowingly and willfully falsifying, concealing or covering up a material fact by any trick, scheme or device or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
A violation of this statute is a felony and may result in fines, imprisonment or exclusion from government-sponsored programs.
−Removed: Similar to the federal Anti-Kickback Statute, a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation.
+Added: As with the federal Anti-Kickback Statute, a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation.
Foreign Corrupt Practices Act
3 unchanged sentences
to comply with accounting provisions requiring us to maintain books and records, which in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the corporation, including international subsidiaries, if any, and to devise and maintain a system of internal accounting controls sufficient to provide reasonable assurances regarding the reliability of financial reporting and the preparation of financial statements.
−Removed: The scope of the FCPA includes interactions with certain healthcare professionals in many countries.
+Added: Our industry is heavily regulated and therefore involves significant interaction with public officials, including officials of non-U.S.
+Added: Additionally, in many other countries, the health care providers who prescribe pharmaceuticals are employed by their government, and the purchasers of pharmaceuticals are government entities;
+Added: therefore, our dealings with these prescribers and purchasers are subject to regulation under the FCPA.
+Added: Recently, the SEC and Department of Justice have increased their FCPA enforcement activities with respect to pharmaceutical companies.
+Added: Violations could result in fines, criminal sanctions against us, our officers, or our employees, the closing down of our facilities, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions on the conduct of our business.
+Added: Enforcement actions may be brought by the Department of Justice or the SEC, and recent enacted legislation has expanded the SEC’s power to seek disgorgement in all FCPA cases filed in federal court and extended the statute of limitations in SEC enforcement actions in intent-based claims such as those under the FCPA from five years to ten years.
International Laws
5 unchanged sentences
Healthcare Reform
−Removed: The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system.
−Removed: The United States government, state legislatures and foreign governments also have shown significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls and restrictions on reimbursement.
−Removed: In the United States, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively the Affordable Care Act, substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacts the healthcare industry.
+Added: and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system.
+Added: government, state legislatures and foreign governments also have shown significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls and restrictions on reimbursement.
+Added: In the U.S., the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively the Affordable Care Act, substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacts the healthcare industry.
The Affordable Care Act is intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on pharmaceutical and medical device manufacturers, and impose additional health policy reforms.
−Removed: There have been significant ongoing efforts to modify or eliminate the Affordable Care Act.
−Removed: On January 20, 2017, President Trump signed an executive order directing federal agencies to exercise existing authorities to reduce burdens associated with the Affordable Care Act pending further action by Congress.
−Removed: In October 2017, he signed an Executive Order which directed federal agencies to modify how the Affordable Care Act is implemented.
−Removed: The Tax Act, enacted on December 22, 2017, repealed the shared responsibility payment for individuals
−Removed: who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, as amended, or the Code, commonly referred to as the individual mandate.
−Removed: Further legislative and regulatory changes under the Affordable Care Act remain possible, although the new Presidential administration has signaled that it plans to build on the Affordable Care Act and expand the number of people who are eligible for subsidies under it.
−Removed: President Biden indicated that he intends to use executive orders to undo changes to the Affordable Care Act made by the Trump administration and would advocate for legislation to build on the Affordable Care Act.
−Removed: It is unknown what form any such changes or any law would take, and how or whether it may affect our business in the future.
+Added: There have been significant ongoing judicial, administrative, executive and legislative efforts to modify or eliminate the Affordable Care Act.
+Added: For example, the Tax Act enacted on December 22, 2017, repealed the shared responsibility payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code, commonly referred to as the individual mandate.
+Added: Other legislative changes have been proposed and adopted since passage of the Affordable Care Act.
+Added: The Budget Control Act of 2011, among other things, created the Joint Select Committee on Deficit Reduction to recommend proposals in spending reductions to Congress.
+Added: The Joint Select
+Added: Committee did not achieve its targeted deficit reduction of an amount greater than $1.2 trillion for the fiscal years 2012 through 2021, triggering the legislation’s automatic reductions to several government programs.
+Added: These reductions included aggregate reductions to Medicare payments to healthcare providers of up to 2.0% per fiscal year, which went into effect in April 2013.
+Added: Subsequent litigation extended the 2% reduction, on average, to 2030 unless additional Congressional action is taken.
+Added: The Coronavirus Aid, Relief and Economic Security Act, or the CARES Act, which was designed to provide financial support and resources to individuals and businesses affected by the COVID-19 pandemic, suspended the 2% Medicare sequester from May 1, 2020 to December 31, 2021.
+Added: The sequester will remain in place through 2030.
+Added: On January 2, 2013, the American Taxpayer Relief Act was signed into law, which, among other things, reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
The Affordable Care Act has been subject to challenges in the courts.
4 unchanged sentences
An appeal was taken to the U.S.
−Removed: Supreme Court which heard oral arguments in the case on November 10, 2020.
−Removed: A ruling is expected in 2021.
+Added: Supreme Court.
+Added: On June 17, 2021, the Supreme Court ruled that the plaintiffs lacked standing to challenge the law as they had not alleged personal injury traceable to the allegedly unlawful conduct.
+Added: As a result, the Supreme Court did not rule on the constitutionality of the ACA or any of its provisions.
+Added: Further changes to and under the Affordable Care Act remain possible, but it is unknown what form any such changes or any law proposed to replace or revise the Affordable Care Act would take, and how or whether it may affect our business in the future.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control healthcare costs, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
12 unchanged sentences
government, state legislatures and foreign governments have shown significant interest in implementing cost containment programs to limit the growth of government-paid health care costs, including price controls, restrictions on reimbursement and requirements for substitution of less costly products.
−Removed: Adoption of government controls and measures, and tightening of restrictive policies in jurisdictions with existing controls and measures, could limit payments for our products.
+Added: Adoption of government controls and measures,
+Added: and tightening of restrictive policies in jurisdictions with existing controls and measures, could limit payments for our products.
The marketability of any products for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement.
15 unchanged sentences
and that offer choice where possible so they can customize their benefits to meet their needs and the needs of their families.
−Removed: In response to the COVID-19 pandemic, we implemented significant changes that we determined were in the best interest of our employees, as well as the communities in which we operate, and which comply with government regulations.
−Removed: This includes having employees work from home, while implementing additional safety measures for employees continuing critical on-site work.
+Added: In response to the ongoing COVID-19 pandemic, we implemented significant changes that we determined were in the best interest of our employees, as well as the communities in which we operate, and which comply with government regulations.
We strive to provide a competitive mix of pay, benefits and services that help meet the needs of our employees.
In addition to salaries, these programs include variable incentive compensation plans, potential annual discretionary bonuses, stock awards, a 401(k) Plan, healthcare and insurance benefits, health savings and flexible spending accounts, paid time off, family leave, and flexible work schedules, among others.
−Removed: In addition to our broad-based equity award programs, we have used targeted equity-based grants with vesting conditions to facilitate retention of personnel.
+Added: In addition to our broad-based equity award programs, we have used targeted equity-based grants with vesting conditions to enhance retention of personnel.
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.