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We believe that genuine collaboration with surgeons and healthcare providers results in the development of new solutions that empower patient care.
−Removed: 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.
−Removed: Our OviTex products have received 510(k) clearance from the U.S.
−Removed: 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 single arm, multicenter post-market clinical study, which we refer to as our BRAVO study, were recently published in the Journal of Clinical Medicine.
−Removed: The interim analysis of patients reaching 12-month follow-up suggests that OviTex is safe and clinically effective for treatment of ventral hernias.
−Removed: The recurrence rate was 2.7% at 12 months.
−Removed: Twenty-four month follow-up has been completed for all possible patients in our BRAVO study, and the recurrence rate remains below 5%.
−Removed: Final analysis is underway and full results will be presented in a future peer-reviewed publication.
−Removed: Our second portfolio of products, the OviTex PRS Reinforced Tissue Matrix (“OviTex PRS”), addresses unmet needs in plastic and reconstructive surgery.
−Removed: In April 2019, our OviTex PRS products received 510(k) clearance from the FDA, which clearance was obtained by Aroa and is currently held by us.
−Removed: We began commercialization of our OviTex products in the U.S.
−Removed: in July 2016, primarily for hernia repair.
+Added: Our first portfolio of products, the OviTex Reinforced Tissue Matrix (“OviTex”), which we first commercialized in the U.S.
+Added: in July 2016, 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.
Hernia repair is one of the most common surgeries performed in the U.S., representing approximately 1.1 million procedures annually.
−Removed: Our OviTex portfolio consists of multiple products that can be used for ventral hernia repair and abdominal wall reconstruction, inguinal hernia repair and hiatal hernia repair.
−Removed: 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.
+Added: Based on the volume weighted average selling price of our OviTex products, we estimate the annual U.S.
+Added: total addressable market opportunity for our OviTex products to be approximately $1.5 billion.
+Added: Our OviTex portfolio consists of multiple product configurations intended to address various surgical procedures within hernia repair and abdominal wall reconstruction, including ventral, inguinal, and hiatal hernia repair.
+Added: In addition, we have also designed an OviTex product specifically for use in laparoscopic and robotic-assisted hernia repair, which we market as OviTex LPR and began commercializing this product in November 2018.
+Added: We recently launched two new, larger configurations of OviTex LPR, designed for ventral and incisional hernias.
+Added: We have also focused on evaluating and publishing clinical data on the effectiveness and safety of our OviTex products.
+Added: To date, there have been thirty published or presented works relating to these clinical findings, either by us or a third-party evaluating the OviTex product.
+Added: Recently in October 2022, the 24-month results of our single arm, multicenter post-market clinical study, which we refer to as our BRAVO study, were published in the Annals of Medicine and Surgery .
+Added: The BRAVO study was designed to evaluate the clinical performance of OviTex for primary or recurrent ventral hernias using open, laparoscopic, or robotic techniques in 92 enrolled patients.
+Added: The recurrence rate at the 24-month time point was 2.6%, and surgical site occurrences (“SSOs”) were observed in 38% of the study population.
+Added: Of the enrolled patients, 78% were characterized as high risk for experiencing an SSO based on at least one known risk factor, which included obesity, active smoking, COPD, diabetes mellitus, coronary artery disease, or advanced age (≥75 years).
+Added: The results also indicated that BRAVO patients experienced statistically significant and clinically meaningful improvements in their quality of life and perceived health based on patient responses to the EuroQol-5 Dimension (EQ-5D) health assessment and the validated 12-question Hernia-Related Quality of Life survey (HerQLes).
+Added: In addition to the BRAVO study and other current clinical initiatives, we also commenced enrollment in May 2021 for our BRAVO II study, a prospective study evaluating the use of OviTex in robot-assisted ventral and inguinal hernia repairs.
+Added: Our second portfolio of products, the OviTex PRS Reinforced Tissue Matrix (“OviTex PRS”), which we first commercialized in the U.S.
+Added: in May 2019, addresses unmet needs in plastic and reconstructive surgery.
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.
Our OviTex PRS portfolio is supported by non-human primate data that demonstrated more rapid tissue integration and tissue remodeling compared to the market leading biologic matrix used in this indication.
−Removed: The current annual market for biologic matrices used for plastic and reconstructive surgery in the U.S.
−Removed: is approximately $600 million.
−Removed: We commenced a limited launch in May 2019 and 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 access to surgeons.
+Added: Based on the current sales of biologic matrices in the U.S., we estimate the annual U.S.
+Added: current addressable market opportunity for our OviTex PRS products to be approximately $700 million.
+Added: Our OviTex products have received 510(k) clearance from the U.S.
+Added: Food and Drug Administration (“FDA”), which clearance was obtained and is currently held by our exclusive contract manufacturer of these products, Aroa.
+Added: In April 2019, our OviTex PRS products received 510(k) clearance from the FDA, which clearance was obtained by Aroa and is currently held by us.
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 that we believe, when combined with our proprietary manufacturing processes and know-how, provides significant barriers to entry.
+Added: We have also commenced a retrospective clinical study evaluating the effectiveness and safety of our OviTex PRS products.
+Added: We also continue to expand our service offerings and diversify our supplier base as we continue to create a soft tissue restoration portfolio, including through the development of complimentary solutions targeting surgical wound management and infection control.
+Added: In January 2023, we announced an exclusive development and distribution partnership with Collagen Matrix, Inc.
+Added: (“CMI”), pursuant to which we launched the commercialization of our NIVIS Fibrillar Collagen Pack, an absorbent matrix of Type I and Type III bovine collagen designed to manage moderately to heavily exudating wounds and to control minor bleeding.
+Added: We also previously commercialized through a distribution agreement with Next Science Technologies Pty Limited (“Next Science”), a proprietary antimicrobial surgical wash in the U.S.
+Added: plastic reconstructive market.
+Added: We are assessing additional strategic partnerships with medical device companies whereby we may enter into distribution, product development and/or licensing agreements for new products complimentary to, or related to, existing and future products in our distribution channel.
+Added: We have a broad portfolio of intellectual property protecting our products that we believe, when combined with the proprietary manufacturing processes associated with our products and our know-how, provides significant barriers to entry.
Our intellectual property applies to our differentiated product construction and materials.
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.
−Removed: Ovine rumen, the forestomach of a sheep, is the source of the
−Removed: biologic material used in our products.
+Added: Ovine rumen, the forestomach of a sheep, is the source of the biologic material used in our OviTex portfolio 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., augmented by distributors in certain European countries.
+Added: We market our products through a single direct sales force, predominantly in the U.S., as augmented by a smaller number of sales representatives and distributors in certain European countries.
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, 2022, we had 67 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 to support and service new accounts for soft-tissue reconstruction procedures.
−Removed: 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.
−Removed: We plan to continue to contract with GPOs and IDNs to increase access to and penetration of hospital accounts.
−Removed: 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.
−Removed: Our business has been impacted by the ongoing COVID-19 pandemic and the development of variants of COVID-19.
−Removed: 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.
−Removed: This impact subsided throughout the remaining months of the first quarter and the second quarter of 2021.
−Removed: 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.
−Removed: 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.
−Removed: 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%.
−Removed: Our net loss for the same time periods was $33.3 million and $28.8 million, respectively, which represents an increase of $4.5 million, or 16%.
+Added: As part of our commercial strategy, we plan to continue to invest in our commercial organization by hiring additional territory managers and administrative and field-based support employees to support and service new accounts for soft-tissue reconstruction procedures.
+Added: We believe we can enhance the productivity of our sales force by improving customer segmentation and targeting, implementing and further refining our proprietary training programs leveraging support from our medical education and clinical development functions to drive physician awareness and education on our products, and utilizing engagement analytics to support product development.
+Added: Additionally, we have contracted with three national GPOs covering our OviTex portfolio and plan to continue to contract with additional GPOs and other integrated delivery networks (“IDNs”) to increase access to and penetration of hospital accounts.
+Added: Our business was directly impacted by the COVID-19 pandemic.
+Added: We experienced volatility in demand for our products which primarily resulted from government and hospital restrictions, as well as patient health and safety concerns, decreasing the volume of elective procedures using our products.
+Added: We saw improvement in our business during the second half of 2022 and anticipate that procedure volumes will continue to normalize to pre-pandemic levels;
+Added: however, we continue to monitor the potential impact of COVID-19 on labor and hospital staffing levels, procedural volumes and ultimately on our financial results.
+Added: Our revenue for the years ended December 31, 2022 and 2021 was $41.4 million and $29.5 million, respectively, which represents an increase of $12.0 million, or 41% for the year ended December 31, 2022.
+Added: Our net loss for the same time periods was $44.3 million and $33.3 million, respectively, which represents an increase of $11.0 million, or 33% for the year ended December 31, 2022.
As of December 31, 2022, we had an accumulated deficit of $274.2 million.
−Removed: 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.
−Removed: 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.
−Removed: plastic reconstructive market.
−Removed: We will commence private label marketing of the solution for plastic surgery in 2022.
−Removed: 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.
−Removed: 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.
+Added: 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 and the sale of other products.
Market Opportunity
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There are an estimated 1.1 million hernia repairs annually in the U.S.
−Removed: including recurrences, which we categorize as approximately (i) 60,000 complex/moderate ventral hernia repairs and abdominal wall reconstructions, (ii) 345,000 simple ventral hernia repairs and (iii) 665,000 inguinal hernia repairs.
−Removed: We estimate that there are approximately 40,000 hiatal hernia repairs annually in the U.S.
+Added: including recurrences, which we categorize as approximately (i) 60,000 complex/moderate ventral hernia repairs and abdominal wall reconstructions, (ii) 345,000 simple ventral hernia repairs and (iii) 665,000 inguinal hernia repairs, and (iv) 40,000 hiatal hernia repairs.
The healthcare burden of hernia disease to patients, insurers and employers is significant.
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scalp defects and defects of the fibrous membrane covering the brain and spinal cord referred to as dura.
−Removed: In chest wall reconstruction, biologic matrices are used to repair defects from oncologic resections.
+Added: In chest wall
+Added: reconstruction, biologic matrices are used to repair defects from oncologic resections.
In pelvic reconstruction, biologic matrices are utilized as an adjunct in the reconstruction of acquired pelvic defects caused by resections for colorectal, gynecologic and urologic malignancies.
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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: 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: 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.
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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As a result of these complications and litigation involving these complications, the number of adverse events reported to the FDA for permanent synthetic mesh hernia repairs has risen from 1,484 in 2016, 3,220 in 2017, 9,887 in 2018 to 18,072 in 2019.
−Removed: Synthetic mesh products have been the subject of an increasing number of lawsuits with over 13,000 cases filed in the state of Rhode Island alone.
+Added: Synthetic mesh products have been the subject of an increasing number of lawsuits with over 24,000 cases filed in federal and state courts across the U.S.
+Added: as of September 2022.
Biologic Matrices
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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 products’ 510(k) clearances and instructions for use.
+Added: These products are priced competitively and designed for use with a range of surgical techniques, allowing the benefits
+Added: 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.
This material consists of an intact, minimally-processed extracellular matrix derived from ovine rumen, which is the forestomach of a sheep.
−Removed: Polymer fibers are interwoven through the layers of biologic material in unique embroidered patterns and contribute to less than 5% of the overall device by mass.
+Added: Polymer fibers are interwoven through the layers of biologic material in unique embroidered patterns and contribute to approximately 5% of the overall device by mass.
The interwoven polymer utilized can be either permanent, made from polypropylene, or resorbable, made from polyglycolic acid (“PGA”).
The embroidering pattern varies between our OviTex and OviTex PRS portfolios to impart different biomechanical properties tailored for their respective intended clinical applications.
−Removed: Our OviTex products are designed with a lockstitch embroidery pattern that is sewn in a grid pattern to create a ripstop effect and minimize stretch.
+Added: Our OviTex products are designed with a lockstitch embroidery pattern that is sewn in a grid pattern to create a ripstop effect and minimize unraveling (when cut).
Our OviTex PRS products are designed with a patented corner-lock stitch pattern designed to resist deformation and to control the degree and direction of stretching of the product.
−Removed: Our capabilities in polymer science, biologics, textile engineering and analytical testing enable us to quickly design, manufacture and develop innovative products.
+Added: Our capabilities in polymer science, biologics, textile engineering and analytical testing enable us to quickly design innovative products for development and manufacture.
These competencies also allow our technical team to tailor the degree of stretch, 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.
−Removed: This expertise has been utilized in the development of our OviTex and OviTex PRS products and is currently being leveraged in the development of our pipeline products.
+Added: This expertise has been utilized in the development of our OviTex and OviTex PRS products and is currently being leveraged in the development of our additional OviTex product pipeline seeking to enhance product features for various applications within our indications.
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
−Removed: 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 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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● Reduced foreign body inflammatory response.
−Removed: The biologic material utilized in our reinforced tissue matrices acts to reduce the body’s inflammatory response to the device.
+Added: The biologic material utilized in our reinforced tissue matrices is designed to minimize the body’s inflammatory response to the device.
Our unique embroidered patterns create a macroporous grid within the biologic material.
−Removed: 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
−Removed: 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.
+Added: In our non-human primate study in which we compared our OviTex products to several commercially available synthetic mesh and biologic matrix products, at 24 weeks, our OviTex products demonstrated a minimal foreign body inflammatory response similar to that of biologic matrices, and less foreign body inflammatory response than all of the synthetic mesh tested.
● Enhanced remodeling of soft-tissue and rate of healing.
−Removed: 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.
+Added: 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 oxygen supply, cellular infiltration, migration, and repopulation for revascularization and functional tissue remodeling during healing.
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.
−Removed: ● Ability to tolerate a contaminated wound environment.
−Removed: Our reinforced tissue matrices are engineered to create hundreds of micro-channels to promote fluid exchange to allow host cells and new blood vessels to penetrate the reinforced tissue matrix.
−Removed: In our non-human primate comparative study, at four weeks our OviTex products had host cells between and within the layers of the reinforced tissue matrix.
−Removed: 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.
● Highly engineered biomechanical properties supported by clinical evidence.
−Removed: Our reinforced tissue matrices are reinforced with interwoven polymer fibers to provide mid-term and long-term strength.
+Added: Our reinforced tissue matrices are reinforced with interwoven polymer fibers to provide mid-term and long-term support.
The interwoven polymer increases the strength of our OviTex products by approximately 25% compared to the biologic material alone.
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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 one year follow-up, despite approximately 79% of these patients having one or more factors known to increase the risk of recurrence.
−Removed: 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.
+Added: In our BRAVO study, the recurrence rate at the 24-month time point was 2.6%, and SSOs were observed in 38% of the study population.
+Added: Of the enrolled patients, 78%
+Added: were characterized as high risk for experiencing an SSO based on at least one known risk factor, which included obesity, active smoking, COPD, diabetes mellitus, coronary artery disease, or advanced age (≥75 years).
+Added: Based on this data, we believe that this recurrence rate is the lowest reported rate in any published study, including our biologic or resorbable synthetic mesh competitors.
The addition of polymer to our reinforced tissue matrices allows each product to maintain its physiologic compliance properties, while resisting stretching and elongation.
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● Enhanced surgeon handling and satisfaction.
−Removed: Each of our embroidery patterns was designed specifically to allow the surgeon to trim and shape the product without the polymer unraveling.
−Removed: 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, 29 of the 76 subjects reaching 12 months follow-up received minimally invasive surgery, 11 received laparoscopic repair and 18 received robotic repair.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: Each of our embroidery patterns was designed specifically to allow the surgeon to trim and shape the product while minimizing the potential for unraveling of the polymer.
+Added: 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.
+Added: In addition, in our BRAVO study, 32 of the 92 enrolled subjects received minimally invasive surgery, of whom 12 received laparoscopic repair and 20 received robotic repair.
+Added: Of the surgeons who performed minimally invasive surgery, all reported at the time of surgery that the product was easy or very easy to place.
+Added: The average surgeon satisfaction with the product was 9.7/10 at 30 days for the minimally invasive cohort and remained consistent over 24 months of follow-up.
+Added: We are also actively enrolling patients in our BRAVO II study, a prospective study evaluating robot-assisted ventral and inguinal hernia repairs with OviTex, including our OviTex LPR, OviTex Core Permanent and OviTex 1S Permanent configurations.
+Added: During the fourth quarter of 2022, 40% of reported cases using OviTex were performed robotically and 20% were completed laparoscopically, showing growing use of our OviTex product in these minimally invasive settings.
● Lower upfront cost products.
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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.
−Removed: 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.
−Removed: 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.
+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 pure 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
+Added: 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 OviTex products are sold at prices approximately 20% to 40% lower than other biologic matrices and resorbable synthetic mesh.
−Removed: We believe our pricing flexibility will drive greater adoption of our products.
−Removed: Our OviTex PRS products are priced below leading biologic matrices, and as we continue our launch of our OviTex PRS portfolio, we anticipate that our customers will realize cost savings over biologic matrices based on national average competitive pricing.
+Added: We believe our pricing flexibility will continue to drive greater adoption of our products.
+Added: Our OviTex PRS products are priced below leading biologic matrices, and as we further commercialize our OviTex PRS portfolio, we anticipate that our customers will realize cost savings over biologic matrices based on national average competitive pricing.
We believe that the average selling prices across our products will provide financial benefits to our customers in addition to improving clinical outcomes.
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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
−Removed: 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 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 portfolio also includes patents covering implants with gripping strands, and implants with multivesicular liposomes that may be used to deliver drugs.
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.
In addition, we believe that the trade secrets developed with Aroa create additional barriers to entry.
−Removed: ● Industry leading executive team with proven track record.
+Added: ● Highly accomplished executive team with proven track record.
Our executive team consists of seasoned medical device professionals with deep industry experience, and a broad network of relationships within the industry and the medical community.
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based commercial organization.
−Removed: 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 utilizing engagement analytics to support development.
+Added: We plan to continue to invest in our commercial organization by hiring additional territory managers and administrative and field-based support employees to support and service new accounts for soft-tissue reconstruction procedures.
+Added: We believe we can also enhance the productivity of our sales force by improving customer segmentation and targeting, implementing and further refining our proprietary training programs, leveraging support from our medical education and clinical development functions to drive physician awareness and education on our products, and utilizing engagement analytics to support product 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 ongoing COVID-19 pandemic, we developed a virtual marketing sales solution as well.
−Removed: 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.
−Removed: 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.
+Added: We plan to continue to drive awareness of our products through in-person and virtual versions of these programs, while expanding their geographic reach and increasing the number of surgeon interactions.
We will continue to increase our digital marketing efforts as well to build brand awareness with event marketing engagement, targeted ads and emails, various social media efforts and patient education and outreach efforts.
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We are focused on partnering with our existing GPO- and IDN-contracted customers to promote implementation of our contracts, increase our access to surgeon customers, broaden awareness of products and help drive utilization of our products within associated hospitals and healthcare systems.
+Added: To date, we have contracted with three national GPOs covering our OviTex and OviTex PRS products.
In addition, we continue to pursue contracts with additional GPOs and IDNs.
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We are committed to evidence-based medicine and investing in clinical data to support the use of our products.
−Removed: Our interim analysis of patients in the BRAVO study reaching 12-month follow-up was published in the
−Removed: Journal of Clinical Medicine in 2021 and demonstrated a low recurrence rate of 2.7%.
−Removed: Twenty-four month follow-up has been completed for all possible patients in our BRAVO study, and the recurrence rate remains below 5%.
−Removed: 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.
+Added: In our BRAVO study, the recurrence rate at the 24-month time point was 2.6%, and SSOs were observed in 38% of the study population.
+Added: 78% of all enrolled patients were characterized as high risk for experiencing an SSO based on at least one known risk factor, which included obesity, active smoking, COPD, diabetes mellitus, coronary artery disease, or advanced age (≥75 years).
+Added: Our analysis of patients in the BRAVO study reaching 24-month follow-up was published in the Annals of Medicine and Surgery in October 2022.
+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 and inguinal 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 believe these technology enhancements will continue to bolster our portfolio and expand the successful use of our products.
+Added: ● Expand our service offerings and diversify our supplier base to create a broader soft tissue preservation and restoration portfolio.
+Added: We plan to continue assessing internal development strategies and strategic partnerships with medical device companies whereby we may enter into distribution, product development and/or licensing agreements for new soft tissue preservation and restoration products complimentary to, or related to, existing and future products in our distribution channel.
+Added: For example, in January 2023, we announced the commercial launch of our NIVIS Fibrillar Collagen Pack, an absorbent matrix of Type I and Type III bovine collagen designed to manage moderately to heavily exudating wounds and to control minor bleeding.
+Added: Similarly, we continue to evaluate additional product opportunities that address patient health and unmet needs within the indications in which we operate.
Our Technology Platform
−Removed: Our advanced reinforced tissue matrix technology consists of multiple layers of minimally-processed, acellular extracellular matrix derived from ovine rumen with interwoven polymer fibers in a unique embroidered pattern.
+Added: Our advanced reinforced tissue matrix technology consists of multiple layers of minimally-processed, decellularized extracellular matrix derived from ovine rumen with interwoven polymer fibers in a unique embroidered pattern.
The extracellular matrix is the collagen component of the rumen that is retained following removal of the epithelium, muscle and cellular content, and has an optimal biomechanical profile and open collagen architecture that allows for rapid cellular infiltration.
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Our textile engineering utilizes a computer-controlled fabrication method that is scalable, reproducible, efficient and customizable.
−Removed: 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 use a patented corner-lock pattern, which creates a stable polymer fabric within the biologic material.
+Added: This embroidery process creates hundreds of micro-channels to allow the multi-directional passage of the patients’ native cells and fluids throughout the product.
+Added: The interwoven polymers are embroidered using a lockstitch pattern, which allows for the device to be trimmed while minimizing unraveling (when cut), 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.
Denser grid patterns increase the amount of reinforcement and less dense patterns of different geometry allow for greater stretch.
−Removed: We are also able to manufacture products with smooth external layers that minimize the amount of exposed polymer to allow for direct contact with patients’ internal organs.
+Added: We are also able to manufacture products with smooth external layers that minimize the amount of exposed polymer such that the product can be placed in contact with the viscera.
OviTex Reinforced Tissue Matrix
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Our OviTex products are sterile reinforced tissue matrices derived from ovine rumen with either polypropylene or PGA.
−Removed: The product is provided in a dry and hydratable form and packaged in a double pouched configuration.
+Added: The product is provided in a dry, hydratable form and packaged in a double pouched configuration.
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.
−Removed: The device may be sutured, stapled or tacked into place to avoid excess tension.
+Added: The device may be sutured, stapled or tacked into place.
All of our OviTex products were designed to minimize the amount of polymer material implanted in patients.
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OviTex Laparoscopic and Robotic Procedures
−Removed: Our OviTex for Laparoscopic and Robotic Procedures (“OviTex LPR”) is a sterile reinforced tissue matrix derived from ovine rumen with polypropylene fiber intended to be used in laparoscopic and robotic-assisted hernia surgical repairs.
+Added: Our OviTex LPR product was specifically designed for use in laparoscopic and robotic-assisted hernia surgical repairs.
OviTex LPR was designed for use with a trocar and requires the same rehydration and fixation as our other OviTex products.
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4 × 8 cm to 25 × 40 cm* (Rectangle or Square)
−Removed: 12 × 18cm (Ellipse);
+Added: 12 × 18 cm to 15 x 25 cm ˄ (Ellipse);
9 cm to 15 cm (Round)
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25 x 30 cm and 25 x 40 cm sizes currently only available with permanent (polypropylene) polymer.
+Added: 15 x 20 cm and 15 x 25 cm sizes currently only available in the U.S.
Denotes relative level of strength
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The data from our preclinical and clinical studies strengthens our ability to raise surgeon awareness and drive adoption of our products as a new category of soft-tissue reconstruction products.
−Removed: 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.
+Added: We expect our clinical evidence will provide surgeons with safety and efficacy data on
+Added: 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.
Preclinical Program
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We continue to evaluate new and existing technologies for safety and biocompatibility as part of our product development process.
−Removed: We believe we have completed the largest non-human primate preclinical studies conducted in soft-tissue reconstruction surgery.
+Added: We believe we have completed the largest collection of 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.
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The OviTex results have been published in the peer-reviewed journal Hernia (https://doi.org/10.1007/s10029-019-02119-z).
−Removed: We are currently in the process of preparing the OviTex PRS results for a future peer-reviewed publication.
+Added: The OviTex PRS results have been published in the peer-reviewed journal ePlasty (ePlasty 2022;22:e43).
Clinical Program
We are committed to obtaining evidence to support the safety and efficacy of our products across their indications.
−Removed: 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.
−Removed: 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: Clinical data has been published on over 1,000 patients treated with OviTex in ventral hernia, inguinal hernia, hiatal hernia, and abdominal wall reconstruction.
+Added: As part of our clinical research program, we have developed two post-market studies, BRAVO and BRAVO II.
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.
−Removed: Our BRAVO study concluded with the last patient completing their 24-month follow-up.
−Removed: We are currently in the process of preparing the BRAVO 24-month study data for a future peer-reviewed publication.
−Removed: The 12-month analysis was published in the Journal of Clinical Medicine.
−Removed: The study was fully enrolled at 92 patients.
−Removed: At 90 days post-operative, there were no recurrences among the 84 patients analyzed.
−Removed: There was one implant removal due to a bowel perforation.
−Removed: 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.
−Removed: Twenty patients (26%) experienced a surgical site occurrence of whom ten (13%) required a procedural intervention such as wound debridement or percutaneous drainage.
−Removed: At 12 months, two patients (2.7%) experienced a recurrence, both adjacent to the original repair.
−Removed: The low recurrence rate observed in our subjects reaching 12-month follow-up continues to remain below 5% through 24-month follow-up.
−Removed: 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.
+Added: In October 2022, the 24-month results of our BRAVO study were published in the Annals of Medicine and Surgery .
+Added: The BRAVO study was designed to evaluate the clinical performance of OviTex for primary or recurrent ventral hernias using open, laparoscopic, or robotic techniques in 92 enrolled patients.
+Added: The recurrence rate at the 24-month time point was 2.6%, and SSOs were observed in 38% of the study population.
+Added: 78% of all enrolled patients were characterized as high risk for experiencing an SSO based on at least one known risk factor, which included obesity, active smoking, COPD, diabetes mellitus, coronary artery disease, or advanced age (≥75 years).
+Added: The results also indicated that BRAVO patients experienced statistically significant and clinically meaningful improvements in their quality of life and perceived health.
+Added: Surgeons continue to use our OviTex PRS reinforced tissue matrices in their surgeries and, in addition to a potential IDE study, we have also commenced a retrospective clinical study evaluating the effectiveness and safety of our OviTex PRS products.
Intellectual Property
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We also rely on know-how and continuing technological innovation to develop and maintain our competitive position.
−Removed: 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.
+Added: 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,
+Added: which we refer to as the Licensed Territory.
In addition, under the Aroa License, Aroa is our exclusive manufacturer and supplier for the development of our bovine and ovine extracellular matrix products.
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In addition, we paid Aroa $4.0 million in revenue-based milestone payments upon our achievement of certain net sales thresholds for sales of our products within the Licensed Territory.
−Removed: An additional $1.0 million payment will be made to Aroa when cumulative product net sales of our products in the European territory reach certain amounts.
−Removed: We are responsible for marketing the products manufactured for us by Aroa.
+Added: As of December 31, 2022, we have satisfied all milestone payment obligations under the Aroa License.
+Added: We are responsible for commercializing the products manufactured for us by Aroa.
We pay Aroa for the supply and manufacturing of our products through a revenue sharing agreement.
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Our share of such expansion costs may be offset by us against future revenue share payments.
−Removed: The initial term of the Aroa License terminates on the later of (i) August 3, 2022, or (ii) the expiration of the last patent covering bovine and ovine products currently April 19, 2031, with an option to extend for an additional ten-year period.
+Added: The initial term of the Aroa License terminates on the expiration of the last patent covering the OviTex and OviTex PRS products, currently March 9, 2031, with an option to extend for an additional ten-year period.
Either party may terminate the Aroa License upon the other party’s material breach, subject to a ninety-day notice and cure period or upon thirty-days written notice in the event of bankruptcy.
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patents that will expire in 2029 and 2031.
−Removed: We own twelve U.S.
−Removed: issued or allowed patents which will expire between 2035 and 2038 and eight pending U.S.
+Added: We own fifteen U.S.
+Added: issued or allowed patents which will expire between 2035 and 2038 and nine pending U.S.
patent applications, which subject to issuance, are projected to expire between 2035 and 2042, without taking into account potential patent term extensions or adjustments.
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Patent and Trademark Office in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over a commonly owned patent or a patent naming a common inventor and having an earlier expiration date.
−Removed: We cannot be sure that our pending patent applications that we have filed or may file in the future will result in issued patents, and we can give no assurance that any patents that have issued or might issue in the future will protect our current or future products, will provide us with any competitive advantage, and will not be challenged, invalidated, or circumvented.
+Added: We cannot be sure that our pending patent applications that we have filed or may file in the future will result in issued patents, and we can give no assurance that any patents that have been issued or might issue in the future will protect our current or future products, will provide us with any competitive advantage, and will not be challenged, invalidated, or circumvented.
Trade Secrets
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We also rely on trademarks and trade designs to develop and maintain our competitive position.
−Removed: TELA Bio ® , OviTex ® and A More Natural Hernia Repair ® are registered trademarks of ours in the U.S.
+Added: TELA Bio ® , OviTex ® , Minimize the Foreign Body Footprint ® , and A More Natural Hernia Repair ® are registered trademarks of ours in the U.S.
+Added: and TELA Bio ® and OviTex ® are registered trademarks in the foreign jurisdictions in which we conduct our business.
For more information regarding the risks related to our intellectual property, please see the section titled “Risk Factors — Risks Related to Intellectual Property Matters.”
Research and Development
−Removed: We invest in research and development to advance our reinforced tissue matrix products with the goal of improving upon and supplementing our existing product offerings.
−Removed: We believe our ability to rapidly develop, manufacture and obtain regulatory approval or clearance of our products is attributable to the dynamic product innovation process that we have implemented, the versatility and leveragability of our core technology and the management philosophy behind that process.
+Added: We invest in research and development to advance our reinforced tissue matrix products and to develop complimentary soft tissue preservation and restoration products, with the goal of improving upon and supplementing our existing product offerings.
+Added: We believe our ability to rapidly develop new products and product configurations is attributable to the dynamic product innovation process that we have implemented, the versatility and leveragability of our core technology and the management philosophy behind that process.
We have recruited and retained engineers and scientists with significant experience in the development of polymer science, biologics, textile engineering and analytical testing.
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As part of our overall commercial strategy, we intend to contract with GPOs and IDNs to increase access and penetration with hospital accounts.
+Added: To date, we have contracted with three national GPOs for coverage of our OviTex and OviTex PRS products.
We have invested in our direct sales and marketing infrastructure in order to expand our presence to promote awareness and adoption of our products.
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As of December 31, 2022, we had 123 employees in our U.S.
−Removed: based commercial organization in 46 sales territories, which includes account managers and administrative support staff.
−Removed: We plan to continue to invest in our commercial organization by adding account managers, clinical development specialists and administrative support staff in order to cover the highest potential of accounts for soft-tissue reconstruction procedures.
+Added: based commercial organization in 67 sales territories, which includes sales management, territory managers, marketing and administrative and field-based support staff.
+Added: We plan to continue to invest in our commercial organization by hiring additional territory managers and administrative and field-based support employees to support and service new accounts for soft-tissue reconstruction procedures.
Manufacturing
All our raw materials are sourced through and manufactured by Aroa in their Auckland, New Zealand facility under the terms of the Aroa License.
−Removed: Aroa’s facility is approximately 25,000 square feet of which approximately 10,000 square feet is dedicated to manufacturing.
−Removed: 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.
+Added: Aroa’s facility is approximately 40,000 square feet of which approximately 25,000 square feet is dedicated to manufacturing, including an additional 15,000 square feet of additional manufacturing space in a neighboring facility.
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
−Removed: 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 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.
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In the plastic and reconstructive surgery market, our primary competitor is LifeCell, a subsidiary of AbbVie, which produces AlloDerm.
−Removed: Many of these competitors are large, well-capitalized companies with significantly greater market share and resources than we have.
−Removed: As a consequence, they are able to spend more on product development, marketing, sales and other product initiatives than we can.
+Added: Many of these competitors are large, well-capitalized companies with significantly greater market share and resources than we have, selling products that have been on the market prior to the commercialization of our products.
+Added: As a consequence, they are able to spend more on product development, marketing, sales and other product initiatives than we can, while also benefiting from greater brand awareness.
We also compete with smaller medical device companies that have single products or a limited range of products.
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Our current products are subject to premarket notification and clearance under section 510(k) of the FDCA.
−Removed: When a 510(k) clearance is required, we must submit a pre-market notification to the FDA demonstrating that our proposed device is substantially equivalent to a predicate device, which is a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before 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.
−Removed: By regulation, a pre-market notification must be submitted to the FDA at least 90 days before we intend to distribute a device.
+Added: When a 510(k) clearance is required, we must submit a premarket notification to the FDA demonstrating that our proposed device is substantially equivalent to a predicate device, which is a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before 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: By regulation, a premarket notification must be submitted to the FDA at least 90 days before we intend to distribute a device.
As a practical matter, clearance often takes nine to twelve months, but may take significantly longer.
−Removed: To demonstrate substantial equivalence, the manufacturer must show that the proposed device has the same intended use as the predicate device, and it either has the same technological characteristics, or different technological characteristics and the information in the pre-market notification demonstrates that the device is equally safe and effective and does not raise different questions of safety and effectiveness.
+Added: To demonstrate substantial equivalence, the manufacturer must show that the proposed device has the same intended use as the predicate device, and it either has the same technological characteristics, or different technological characteristics and the information in the premarket notification demonstrates that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.
The FDA may require further information, including clinical data, to make a determination regarding substantial equivalence.
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After a device receives 510(k) marketing 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) marketing clearance or, depending on the modification, a de novo classification or PMA approval.
−Removed: The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k) or a PMA in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination.
+Added: The FDA requires each manufacturer to determine whether the proposed change requires a premarket submission in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination.
Many minor modifications today are accomplished by a manufacturer documenting the change in an internal letter-to-file.
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The FDA can always review these letters-to-file in an inspection.
−Removed: If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until 510(k) marketing clearance or PMA approval is obtained.
+Added: If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until marketing authorization is obtained.
Also, in these circumstances, we may be subject to significant regulatory fines or penalties.
−Removed: The FDA has undertaken efforts to modernize the 510(k) clearance process.
−Removed: In January 2019, the agency finalized guidance outlining the framework for the Safety and Performance Based Pathway.
−Removed: This option for 510(k) clearance will allow manufacturers to use objective performance criteria established or recognized by the FDA to facilitate demonstration of substantial equivalence of their new products to legally marketed devices.
−Removed: This new pathway will ensure that the performance characteristics of new devices are evaluated against a set of objective, transparent and well-validated safety and performance metrics.
−Removed: Devices using this pathway will still have to meet current standards for reasonable assurance of safety and effectiveness before they can be marketed.
De Novo Classification
Medical device types that the FDA has not previously classified as Class I, II or III are automatically classified into Class III regardless of the level of risk they pose.
−Removed: 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,
−Removed: rather than requiring the submission and approval of a PMA application.
−Removed: 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.
−Removed: FDASIA streamlined the de novo classification pathway by permitting manufacturers to request de novo classification directly without first submitting a 510(k) pre-market notification to the FDA and receiving a not substantially equivalent determination.
−Removed: Under FDASIA, the FDA is required to classify the device within 120 days following receipt of the de novo application.
+Added: 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
+Added: 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.
+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, rather than requiring the submission and approval of a PMA application.
+Added: 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) premarket notification and received a determination from the FDA that the device was not substantially equivalent to a predicate device.
+Added: FDASIA streamlined the de novo classification pathway by permitting manufacturers to request de novo classification directly without first submitting a 510(k) premarket notification to the FDA and receiving a not substantially equivalent determination.
+Added: Under FDASIA, the FDA is required to classify the device within 120 days following receipt of the de novo application, although the review of an application can occur over a significantly longer period of time.
If the manufacturer seeks reclassification into Class II, the manufacturer must include a draft proposal for special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device.
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If the FDA evaluation of a PMA is favorable, the FDA will issue either an approval letter, or an approvable letter, the latter of which usually contains a number of conditions that must be met in order to secure final approval of the PMA.
−Removed: When and if those conditions have been fulfilled to the satisfaction of the FDA, the agency will issue a PMA approval letter authorizing commercial marketing of the device, subject to the conditions of approval and the limitations established in the approval letter.
+Added: When and if those conditions have been fulfilled to the satisfaction of the FDA, the agency will issue a PMA approval
+Added: letter authorizing commercial marketing of the device, subject to the conditions of approval and the limitations established in the approval letter.
If the FDA’s evaluation of a PMA application or manufacturing facilities is not favorable, the FDA will deny approval of the PMA or issue a not approvable letter.
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
−Removed: 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 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.
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The IDE will automatically become effective 30 days after receipt by the FDA unless the FDA notifies the company that the investigation may not begin.
−Removed: If the FDA determines that there are deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a conditional approval.
+Added: If the FDA determines that there are deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under an approval with conditions.
The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound.
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During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial monitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the promotion of investigational devices or on making safety or effectiveness claims for them.
−Removed: The clinical investigators in the clinical study are also subject to FDA good clinical practice regulations and must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition of the investigational device, and comply with all reporting and recordkeeping requirements.
+Added: The clinical investigators in the clinical study are also subject to FDA good clinical practice regulations and must obtain patient informed consent, rigorously follow the investigational plan and study
+Added: protocol, control the disposition of the investigational device, and comply with all reporting and recordkeeping requirements.
Additionally, after a trial begins, we, the FDA or the IRB could suspend or terminate a clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits.
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● 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;
−Removed: ● 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;
+Added: ● complying with 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;
● advertising and promotion requirements, including FDA prohibitions against the promotion of products for uncleared, unapproved or off-label uses and FDA guidance on off-label dissemination of information and responding to unsolicited requests for information;
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The FDA has broad post-market and regulatory enforcement powers.
−Removed: Medical device manufacturers are subject to unannounced inspections by the FDA and other state, local and foreign regulatory authorities to assess compliance with the QSR and other applicable regulations, and these inspections may include the manufacturing facilities of any suppliers.
+Added: Medical device manufacturers are subject to unannounced inspections by the FDA and other state, local and foreign regulatory authorities to assess compliance with
+Added: the QSR and other applicable regulations, and these inspections may include the manufacturing facilities of any suppliers.
Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:
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Regulatory System for Medical Devices in Europe
−Removed: The European Union (“EU”) and the European Economic Area (“EEA”) (which is comprised of the 27 Member States of the EU plus Norway, Liechtenstein and Iceland and, until 2021, the United Kingdom) has a coordinated system for the authorization of medical devices.
−Removed: The European Union Medical Devices Directive (“MDD”) sets out the basic regulatory framework for medical devices in the EU.
−Removed: This directive has been separately enacted in more detail in the national legislation of the individual member states of the EU.
−Removed: 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 European Union (“EU”) and the European Economic Area (“EEA”) (which is comprised of the 27 Member States of the EU plus Norway, Liechtenstein and Iceland) has a coordinated system for the authorization of medical devices.
+Added: Until May 25, 2021, medical devices were regulated by the Council Directive 93/42/EEC, or the Medical Devices Directive (“MDD”), which has been repealed and replaced by Regulation (EU) No 2017/745, or the Medical Devices Regulation (“MDR”).
+Added: There is a transition period during which certificates issued under the MDD remain valid, however, when such certificates expire (or, if earlier, by 27 May 2024) the devices must be certified under the new regime set forth in the MDR.
+Added: However, in response to concerns raised about notified body capacity and the ability for devices to be re-certified within such time period, the European Commission has adopted a proposal to extend the transition period by some years, depending on the risk class of the device.
+Added: Such proposal is currently being considered for adoption by the European Parliament and Council.
The MDR went into effect on May 26, 2021, and it:
2 unchanged sentences
● improves the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;
−Removed: ● sets up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU;
+Added: ● sets up a central database (Eudamed) to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU;
● strengthens rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.
−Removed: Under both the MDD and the MDR, the system of regulating medical devices operates by way of a certification for each medical device.
−Removed: 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 (and now the MDR) within their jurisdiction.
−Removed: The means for achieving the requirements for CE mark varies according to the nature of the device.
+Added: Under the MDR, the system of regulating medical devices operates by way of a certification for each medical device, which confirms that the device meets the relevant general safety and performance requirements laid down in Annex I of
+Added: 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 conformity.
+Added: The means for achieving the requirements for a CE mark varies according to the nature of the device.
Devices are classified in accordance with their perceived risks, similarly to the U.S.
−Removed: 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 (and now the MDR).
−Removed: Except for low-risk medical devices (Class I
−Removed: 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.
−Removed: 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: 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.
−Removed: 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.
−Removed: 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 class of a product determines the requirements to be fulfilled in accordance with the MDR before a CE mark can be placed on a product.
+Added: The procedure by which a device is assessed to confirm if it complies with the applicable safety and performance requirements is known as a conformity assessment.
+Added: Conformity assessment procedures require an assessment of available clinical evidence, literature data for the product, and post-market experience in respect of similar products already marketed.
+Added: 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.
+Added: Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can self-certify compliance with the MDR based on a self-assessment of the conformity of its products with the applicable requirements of the MDR, a conformity assessment procedure requires the intervention of an independent organization accredited by a member state of the EEA to conduct conformity assessments, known as a notified body.
+Added: If satisfied that the relevant product conforms to the relevant general safety and performance requirements, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity.
+Added: The manufacturer may then apply the CE mark to the device, which allows the device to be placed on the market throughout the EEA.
+Added: The MDR 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, and manufacturers must assign a unique identifier to the device and provide it along with other core data to the unique device identifier, or UDI, database.
+Added: These new requirements aim at ensuring better identification and traceability of the devices.
+Added: Manufacturers are responsible for entering the necessary data on Eudamed, which includes the UDI database, and for keeping it up to date.
+Added: Eudamed is not yet fully functional, however the European Commission is aiming to have a fully functional version of the Eudamed medical device database available in the second quarter of 2024.
+Added: The Medical Device Coordination Group (MDCG) has published guidance on administrative practices for manufacturers until Eudamed is fully functional.
+Added: Post-Brexit, the MDR does not apply in the United Kingdom (except for Northern Ireland, which under the Northern Ireland Protocol is bound by certain EU laws).
The medical device legislative framework in the United Kingdom is set out in the Medical Devices Regulations 2002.
−Removed: These Regulations are based on the previous medical device directives of the E.U.
−Removed: but have been amended so that they function properly now the United Kingdom is no longer part of the E.U.
−Removed: 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.
−Removed: 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.
+Added: These Regulations are based on the previous medical device directives of the EU but have been amended so that they function properly now the United Kingdom is no longer part of the EU.
+Added: The amended Medical Devices Regulations 2002 have introduced several changes including (but not limited to) replacing the CE mark with a UKCA marking, 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.
+Added: Manufacturers can continue placing CE marked medical devices on the Great Britain market for the time being, however from July 2024, transitional arrangements will apply for CE marked medical devices placed on the Great Britain market.
+Added: These transitional arrangements have not yet been brought into force through the UK medical devices regulations, but the UK Government intends to introduce legislation by Spring 2023 that will bring these into force.
Privacy and Security Laws
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federal and state laws and regulations related to the privacy and security of personal information, including health information.
−Removed: Among others, the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act and their implementing regulations (collectively referred to as “HIPAA”) establish privacy and security standards that limit the use and disclosure of protected health information, or PHI, and require covered entities and business associates to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity and availability of individually identifiable health information in electronic form, among other requirements.
+Added: Among others, the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act and their implementing regulations (collectively referred to as “HIPAA”) establish privacy and security standards that limit the use and disclosure of protected health information (“PHI”) and require covered entities and business associates to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity and availability of individually identifiable health information in electronic form, among other requirements.
Violations of HIPAA may result in civil and criminal penalties.
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Department of Health and Human Services (“HHS”) and in certain cases of media outlets, in the case of a breach of unsecured PHI.
−Removed: The regulations also require business associates of covered entities to notify the covered entity of breaches by the business associate.
+Added: regulations also require business associates of covered entities to notify the covered entity of breaches by the business associate.
State attorneys general also have the right to prosecute HIPAA violations committed against residents of their states, and HIPAA standards have been used as the basis for the duty of care in state civil suits, such as those for negligence or recklessness in misusing personal information.
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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.
−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
−Removed: 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: 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.
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.
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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”).
−Removed: 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.
−Removed: 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.
+Added: Currently, the GDPR and UK GDPR remain largely aligned, but the United Kingdom has announced plans to reform the country’s data protection legal framework in its Data Reform Bill, which will introduce significant changes from the GDPR.
+Added: This may lead to divergence between the GDPR and UK GDPR.
+Added: EU member states have introduced national laws implementing the GDPR which impose additional requirements;
+Added: this adds to the complexity of processing personal data in or from the EEA or United Kingdom.
Guidance on implementation and compliance practices are often updated or otherwise revised.
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Courts have interpreted the Anti-Kickback Statute quite broadly, holding that the statute will be violated if even one purpose of a payment — though not its sole or primary purpose — is to induce an act prohibited by the statute with a willful intent to act improperly.
−Removed: The statute prohibits many arrangements and practices that are otherwise lawful in businesses outside of the healthcare industry.
+Added: The statute prohibits many arrangements and practices that are otherwise lawful in
+Added: businesses outside of the healthcare industry.
A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
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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
−Removed: 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 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.
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Transparency Laws
−Removed: The federal Physician Payment Sunshine Act (“Sunshine Act”) which was enacted as part of the Patient Protection and Affordable Care Act (“PPACA”) generally requires certain manufacturers of a drug, device, biologic or other medical supply that is covered by Medicare, Medicaid or the Children’s Health Insurance Program and applicable GPOs to report on an annual basis:
+Added: The federal Physician Payments Sunshine Act (“Sunshine Act”) which was enacted as part of the Patient Protection and Affordable Care Act (“PPACA”) generally requires certain manufacturers of a drug, device, biologic or other medical supply that is covered by Medicare, Medicaid or the Children’s Health Insurance Program and applicable GPOs to report on an annual basis:
(i) certain payments and other transfers of value given to certain healthcare professionals and teaching hospitals and (ii) any ownership or investment interest that certain healthcare professionals, or their immediate family members, have in their company.
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Many of these laws contain ambiguities as to what is required to comply with the laws.
−Removed: For example, several states have enacted legislation requiring manufacturers to, among other things, establish and implement commercial compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities and/or register their sales representatives.
+Added: For example, several states have enacted legislation requiring manufacturers to, among other things, establish and implement commercial compliance programs, file periodic reports with the state, make periodic
+Added: public disclosures on sales, marketing, pricing, clinical trials and other activities and/or register their sales representatives.
Certain state laws also regulate manufacturers’ use of physician and patient identifiable data.
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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.
−Removed: The Joint Select
−Removed: 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: The Joint Select 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.
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.
Subsequent litigation extended the 2% reduction, on average, to 2030 unless additional Congressional action is taken.
−Removed: 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 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, which was further extended through March 31, 2022.
+Added: Following the suspension, a 1% payment reduction began April 1, 2022 and remained through June 30, 2022.
+Added: The 2% payment reduction resumed on July 1, 2022.
The sequester will remain in place through 2030.
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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,
−Removed: 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, 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.
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has increased and will continue to increase the pressure on medical product and service pricing.
−Removed: Corporate Information
−Removed: We were incorporated on April 17, 2012.
−Removed: Our primary executive offices are located at 1 Great Valley Parkway, Suite 24, Malvern, Pennsylvania 19355 and our telephone number is (484) 320-2930.
−Removed: Our website address is www.telabio.com.
−Removed: The information contained in, or that can be accessed through, our website is not part of this Annual Report.
Human Capital Resources
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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 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.
+Added: 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.
We strive to provide a competitive mix of pay, benefits and services that help meet the needs of our employees.
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In addition to our broad-based equity award programs, we have used targeted equity-based grants with vesting conditions to enhance retention of personnel.
+Added: Corporate Information
+Added: We were incorporated on April 17, 2012.
+Added: Our primary executive offices are located at 1 Great Valley Parkway, Suite 24, Malvern, Pennsylvania 19355 and our telephone number is (484) 320-2930.
+Added: Our website address is www.telabio.com.
+Added: The information contained in, or that can be accessed through, our website is not part of this Annual Report.
+Added: We make available, free of charge and through our website, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and any amendments to any such reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after they are electronically filed with or furnished to the SEC.
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.