UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition. |
On March 21, 2024, TELA Bio, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter of 2023 and the fiscal year ended December 31, 2023. A copy of this press release is furnished as Exhibit 99.1 hereto.
The information furnished pursuant to this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 7.01 | Regulation FD Disclosure. |
On March 21, 2024, the Company updated information reflected in a corporate slide deck, which representatives of the Company will use in various meetings with investors from time to time. A copy of the presentation is attached hereto as Exhibit 99.2 and incorporated herein by reference.
The information furnished pursuant to Item 7.01, including Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 8.01 | Other Events. |
On March 21, 2024, the Company issued a press release announcing the U.S. commercial launch of LIQUIFIX FIX8™ Laparoscopic and LIQUIFIX Precision™ Open Hernia Mesh Fixation Devices. A copy of this press release is filed as Exhibit 99.3 hereto and incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
The following exhibits are being furnished herewith:
| Exhibit No. | Document | |
| 99.1 | Press Release of TELA Bio, Inc., dated March 21, 2024. | |
| 99.2 | Corporate Slide Deck, dated March 21, 2024. | |
| 99.3 | Press Release of TELA Bio, Inc., dated March 21, 2024. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| TELA BIO, INC. | ||
| By: | /s/ Antony Koblish | |
| Name: | Antony Koblish | |
| Title: | President, Chief Executive Officer and Director | |
Date: March 21, 2024
Exhibit 99.1
TELA Bio Achieves Record Fourth Quarter and Full Year 2023 Revenues and Reports Complete Financial Results
MALVERN, PA, March 21, 2024 -- TELA Bio, Inc. ("TELA Bio"), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions that optimize clinical outcomes by prioritizing the preservation and restoration of the patient's own anatomy, today reported financial results for the fourth quarter and full year ended December 31, 2023.
Recent Highlights
| · | Reported revenue of $17.0 million in the fourth quarter and $58.5 million for the full year 2023, representing growth of 46% and 41%, respectively, over the corresponding periods of 2022; | |
| · | Delivered the 12th consecutive quarter and third consecutive year of at least 35% year-over-year growth; | |
| · | Increased demand for OviTex® and OviTex PRS Reinforced Tissue Matrix products during the full year 2023, resulting in a year-over-year revenue increase for each product of approximately 36% and 51%, respectively; | |
| · | Commenced full U.S. commercial launch of LIQUIFIX FIX8™ Laparoscopic and LIQUIFIX Precision™ Open Hernia Mesh Fixation Devices, the only FDA-Approved liquid adhesive for internal use in hernia surgery, through partnership with Advanced Medical Solution; | |
| · | Sold distribution rights of the NIVIS® Fibrillar Collagen Pack to MiMedx Group in exchange for at least $8 million and up to $12 million in total cash consideration; | |
| · | Finalized preparations for a Q2 2024 U.S. commercial launch of OviTex IHR Reinforced Tissue Matrix, a new OviTex configuration designed to enhance utility in inguinal hernia repairs performed robotically and laparoscopically; and | |
| · | Provided full year 2024 revenue guidance of $74.0 million to $76.0 million, representing 27% to 30% year-over-year growth. |
“Our team has executed on our initiatives to drive market penetration, resulting in yet another year with over 40% year-over-year growth,” said Antony Koblish, co-founder, President, and Chief Executive Officer of TELA Bio. “The recalibration of our sales force over 2023 has led to increased productivity and an improved mix of sales across our product portfolio. At this week’s National Sales Meeting, we were thrilled to announce the formal launch of the LIQUIFIX devices, which we believe advances the future of hernia repair fixation in robotic, laparoscopic, and open cases with it novel, atraumatic approach. Beyond LIQUIFIX, the upcoming launch of our OviTex IHR suite of products should drive deeper penetration into the inguinal hernia space, generating greater awareness and adoption of products across our entire hernia franchise. Finally, the sale of distribution rights to our NIVIS product to MiMedx for $8 million to $12 million is a non-dilutive contribution to our cash position that should provide additional confidence about our pathway to profitability. 2023 was a great year that sets TELA Bio up for even more achievement in 2024!”
Fourth Quarter 2023 Financial Results
Revenue was $17.0 million in the fourth quarter of 2023, an increase of 46% compared to the same period in 2022. The increase was due to an increase in unit sales of our products and the continued expansion of the commercial organization, which resulted in increased penetration of existing customer accounts, the addition of new customers, and growing international sales.
Gross profit was $11.6 million in the fourth quarter of 2023, or 68% of revenue, compared to $8.2 million, or 70% of revenue, in the same period in 2022. The slight decrease in gross margin was primarily due to an increase in our excess and obsolete inventory adjustments.
Operating expenses were $23.9 million in the fourth quarter of 2023, compared to $17.6 million in the same period in 2022. The increase was due to higher compensation costs and employee-related expenses from additional headcount as we continue to expand our organization, as well as increased travel, consulting and professional fees.
Loss from operations was $12.3 million in the fourth quarter of 2023, compared to a loss from operations of $9.4 million in the same period in 2022.
Net loss was $12.9 million in the fourth quarter of 2023, compared to a net loss of $10.0 million in the same period in 2022.
Full Year 2023 Financial Results
Revenue was $58.5 million for the full year 2023, an increase of 41% compared to the same period in 2022. The increase was primarily due to an increase in unit sales of our products and the continued expansion of the commercial organization, which resulted in increased penetration of existing customer accounts, the addition of new customers, and growing international sales.
Gross profit was $40.1 million in the full year 2023, or 69% of revenue, compared to $27.0 million, or 65% of revenue, in 2022. The increase in gross margin was primarily due to improved inventory management processes and lower amortization of intangible assets.
Operating expenses were $84.2 million in the full year of 2023, compared to $66.1 million in 2022. The increase was due to higher compensation costs and employee-related expenses from additional headcount as we continue to expand our organization, as well as increased travel, consulting and professional fees.
Loss from operations was $44.1 million in the full year 2023, compared to a loss from operations of $39.0 million in 2022.
Net loss was $46.7 million in the full year 2023, compared to a net loss of $44.3 million in 2022.
Cash and cash equivalents on December 31, 2023 totaled $46.7 million.
2024 Financial Guidance
Full year 2024 revenue is projected to range from $74.0 million to $76.0 million, representing growth of 27% to 30% over full year 2023.
Conference Call
TELA Bio will host a conference call at 4:30 p.m. Eastern Time on Thursday, March 21, 2024 to discuss its fourth quarter and full year 2023 financial results. Investors interested in listening to the conference call should register online. Participants are required to register a day in advance or at minimum 15 minutes before the start of the call. A replay of the webcast can be accessed via the Events & Presentations page of the investor section of TELA Bio's website.
About TELA Bio, Inc.
TELA Bio, Inc. (NASDAQ: TELA) is a commercial-stage medical technology company focused on providing innovative technologies that optimize clinical outcomes by prioritizing the preservation and restoration of the patient's own anatomy. The Company is committed to providing surgeons with advanced, economically effective soft-tissue reconstruction solutions that leverage the patient's natural healing response while minimizing long-term exposure to permanent synthetic materials. For more information, visit www.telabio.com.
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the current beliefs of TELA Bio's management. Such forward-looking statements include statements relating to our expected revenue and revenue growth for the full year 2024. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: the impact to our business from macroeconomic conditions, including any lingering effects of the COVID-19 pandemic and other public health crises, recessionary concerns, banking instability, increasing market interest rates, and inflationary pressures, potentially impacting our ability to market our products, demand for our products due to the deferral of elective procedures, the labor and staffing environment in the healthcare industry, disruption in our supply chain, or pricing pressures concerning our products or the procedures using our products; our ability to achieve or sustain profitability; our ability to gain market acceptance for our products and to accurately forecast and meet customer demand; our ability to compete successfully; that data from earlier studies related to our products and interim data from ongoing studies may not be replicated in later studies or indicative of future data; that data obtained from clinical studies using our product may not be indicative of outcomes in other surgical settings; our ability to enhance our product offerings; development and manufacturing problems; capacity constraints or delays in production of our products; maintenance of coverage and adequate reimbursement for procedures using our products; product defects or failures. These risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and TELA Bio assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.
Investor
Contact
Louisa Smith
ir@telabio.com
TELA Bio, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 46,729 | $ | 42,019 | ||||
| Accounts receivable, net of allowances of $416 and $143 | 9,737 | 6,621 | ||||||
| Inventory | 13,162 | 11,792 | ||||||
| Prepaid expenses and other assets | 2,098 | 2,015 | ||||||
| Total current assets | 71,726 | 62,447 | ||||||
| Property and equipment, net | 1,984 | 1,682 | ||||||
| Intangible assets, net | 2,119 | 2,499 | ||||||
| Right-of-use assets | 1,954 | 1,227 | ||||||
| Restricted cash | 265 | — | ||||||
| Total assets | $ | 78,048 | $ | 67,855 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,667 | $ | 1,534 | ||||
| Accrued expenses and other current liabilities | 15,300 | 10,869 | ||||||
| Total current liabilities | 16,967 | 12,403 | ||||||
| Long-term debt | 40,515 | 39,916 | ||||||
| Other long-term liabilities | 1,685 | 1,231 | ||||||
| Total liabilities | 59,167 | 53,550 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock; $0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding | — | — | ||||||
| Common stock; $0.001 par value: 200,000,000 shares authorized; 24,494,675 and 19,165,027 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 24 | 19 | ||||||
| Additional paid-in capital | 339,655 | 288,361 | ||||||
| Accumulated other comprehensive income | 91 | 150 | ||||||
| Accumulated deficit | (320,889 | ) | (274,225 | ) | ||||
| Total stockholders’ equity | 18,881 | 14,305 | ||||||
| Total liabilities and stockholders’ equity | $ | 78,048 | $ | 67,855 | ||||
TELA Bio, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue | $ | 16,998 | $ | 11,622 | $ | 58,453 | $ | 41,418 | ||||||||
| Cost of revenue (excluding amortization of intangible assets) | 5,279 | 3,351 | 17,961 | 13,570 | ||||||||||||
| Amortization of intangible assets | 95 | 95 | 380 | 804 | ||||||||||||
| Gross profit | 11,624 | 8,176 | 40,112 | 27,044 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Sales and marketing | 17,164 | 11,647 | 59,681 | 43,252 | ||||||||||||
| General and administrative | 4,053 | 3,242 | 14,887 | 13,862 | ||||||||||||
| Research and development | 2,685 | 2,726 | 9,619 | 8,937 | ||||||||||||
| Total operating expenses | 23,902 | 17,615 | 84,187 | 66,051 | ||||||||||||
| Loss from operations | (12,278 | ) | (9,439 | ) | (44,075 | ) | (39,007 | ) | ||||||||
| Other (expense) income: | ||||||||||||||||
| Interest expense | (1,345 | ) | (1,174 | ) | (5,223 | ) | (4,051 | ) | ||||||||
| Loss on extinguishment of debt | — | — | — | (1,228 | ) | |||||||||||
| Other income (expense) | 733 | 634 | 2,634 | (10 | ) | |||||||||||
| Total other expense | (612 | ) | (540 | ) | (2,589 | ) | (5,289 | ) | ||||||||
| Net loss | $ | (12,890 | ) | $ | (9,979 | ) | $ | (46,664 | ) | $ | (44,296 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.53 | ) | $ | (0.52 | ) | $ | (2.04 | ) | $ | (2.72 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 24,490,066 | 19,159,649 | 22,868,663 | 16,267,678 | ||||||||||||
Exhibit 99.2
INVESTOR PRESENTATION March 2024
Forward Looking Statements This presentation contains forward - looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 . All statements other than statements of historical facts contained in this document, including but not limited to statements regarding possible or assumed future res ults of operations, business strategies, development plans, regulatory activities, market opportunity competitive position, potential growth opportunities, and the ef fec ts of competition, are forward - looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause TELA B io, Inc.’s (the “Company”) actual results, performance or achievements to be materially different from any future results, performance or achievements expresse d o r implied by the forward - looking statements. In some cases, you can identify forward - looking statements by terms such as “may,” “will,” “should,” “expect,” “plan ,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these term s o r other similar expressions. The forward - looking statements in this presentation are only predictions. The Company has based these forward - looking statements largely on its curr ent expectations and projections about future events and financial trends that it believes may affect the Company’s business, financial condition and results of operations. These forward - looking statements speak only as of the date of this presentation and are subject to a number of risks, uncertainties and assumptions , s ome of which cannot be predicted or quantified and some of which are beyond the Company’s control, including, among others: the impact to the Company’s business fro m macroeconomic conditions, including any lingering effects of the COVID - 19 pandemic or other public health crises, recessionary concerns, banking instabili ty, increasing market interest rates, and inflationary pressures, potentially impacting our ability to market our products, demand for our products due to the deferral of elective procedures, the labor and staffing environment in the healthcare industry, disruption in our supply chain, or pricing pressures concerning our products or the p roc edures using our products; our ability to achieve or sustain profitability; the Company's ability to gain market acceptance for the Company's products and to accuratel y f orecast and meet customer demand; the Company's ability to compete successfully; that data from earlier studies related to the Company’s products and interim data fro m ongoing studies may not be replicated in later studies or indicative of future data, that data obtained from clinical studies utilizing the Company’s pr odu cts may not be indicative of outcomes in other surgical settings; the Company's ability to enhance the Company's product offerings; development and manufacturing prob lem s; capacity constraints or delays in production of the Company's products; maintenance of coverage and adequate reimbursement for procedures using the Company's p rod ucts; product defects or failures. These and other risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in the Co mpany's filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward - looking statements as predictions of futu re events. The events and circumstances reflected in the Company’s forward - looking statements may not be achieved or occur, and actual results could diffe r materially from those projected in the forward - looking statements. Moreover, the Company operates in a dynamic industry and economy. New risk factors and uncertain ties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that the Company may face. Except a s r equired by applicable law, we do not plan to publicly update or revise any forward - looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
TELA Bio, Inc. • Advanced reinforced tissue matrix portfolio supported by compelling clinical evidence • $2.2B US market opportunity 1 – still in early stages of growth • Driving commercial adoption with targeted direct - sales approach • Recent product launches in growing markets: robotic hernia surgery, plastic and reconstructive surgery • Broad intellectual property portfolio • Established DRG - based reimbursement pathway for hernia repair and robust GPO access • Highly accomplished executive team with proven track record 1 Management estimate. $2.2B total includes $1.5B hernia & abdominal wall reconstruction, $0.7B plastic reconstructive surgery. Redefining soft tissue preservation and restoration with a differentiated category of tissue reinforcement materials and supportive products
Complex, Moderate Ventral / Abdominal Wall Reconstruction Simple Ventral Hernia Repair Inguinal Hernia Repair Hiatal Hernia Repair ~60,000 ~345,000 ~665,000 ~40,000 $360M $515M $600M $40M 1 Sources: Millennium Research Group Reports, IMS Health Data; iData Research MedSKU 2 Management estimate. Market size based on volume and weighted average selling price for OviTex Annual Procedures 1 $1.5B 2 Robotic / Minimally Invasive Surgery Opportunity U.S. Hernia Surgery Market: ~$1.5 Billion Annual Opportunity Robotic / MIS compatible procedures total over 1M annually and have a potential market opportunity of up to $1.2B 2
OviTex Portfolio: Designed for a Range of Hernia Patients and Surgical Techniques • Coated resorbable synthetic meshes • Biologic meshes • Biologic meshes CONFIGURATION OviTex 2S 8 - layer device, with 2 “smooth sides” suitable for intraperitoneal placement Robot Compatible 1 : No Strength 2 : +++ Viscera Contact 3 : Yes OviTex 1S 6 - layer device, with “smooth side” suitable for intraperitoneal placement Robot Compatible 1 : Yes Strength 2 : ++ Viscera Contact 3 : Yes, smooth side COMPETITIVE SET • Coated resorbable synthetic meshes • Biologic meshes OviTex LPR 4 - layer device, with “smooth side” suitable for intraperitoneal placement Robot Compatible 1 : Yes Strength 2 : + Viscera Contact 3 : Yes, smooth side • Resorbable synthetic meshes • Biologic meshes OviTex 4 - layer device, not intended for intraperitoneal placement Robot Compatible 1 : Yes Strength 2 : + Viscera Contact 3 : Not recommended Images represent permanent polymer OviTex products. Resorbable polymer products have clear polymer. All trademarks and regist ere d marks are property of their respective owners. 1. Robot compatibility based on use of 10mm trocar. Robot compatibility of LPR and OviTex include sizes 400 cm 2 or less. Robot compatibility of OviTex 1S includes sizes 200 cm 2 or less 2. Biomechanical data on file. 3. Devices with a smooth side were shown to not adhere in an animal model. Rabbit data on file. Correlation to results in hum ans has not been established. Animal test results may not necessarily be indicative of human clinical performance. . Strattice Laparoscopic Phasix ST Bio - A SurgiMend Phasix Strattice XenMatrix SurgiMend Strattice XenMatrix SurgiMend Strattice XenMatrix Phasix ST
Lawsuits against permanent synthetic meshes estimated to be assembled across the U.S. 3 of surgeons agree that use of permanent synthetic mesh puts patients at long - term risk of complications 1 1. Hernia and Abdominal Surgeries Survey (Oct 2020). A group of 71 surgeons were surveyed regarding use of mesh in various hernia repai r surgeries. 2. Figures derived from Company - sponsored poll of approximately 1,100 potential patients for hernia procedures. 3. www.drugwatch.com (September 2022) 59% Hernia patients want proactive control in their care 2 3 of 4 ~ 24 K Need for Alternative to Permanent Synthetic Mesh
LOW RECURRENCE ALL APPLICATIONS WITH OVITEX Ankney , Szotek et al. – 2021 4 * 54 patients Follow - up 3 - 38 months Ferzoco – 2018 3 * 31 patients Average follow up 13 months INGUINAL 0% Ankney , Szotek et al. – 2021 4 * 306 patients Follow up 1 - 36 months INGUINAL 1.6% Sawyer – 2018 1 * 25 patients Average follow up 14 months HIATAL 0% DeNoto – 2022 2 * 22 patients Average follow up 23 months BRIDGED 16% AWR 1.9% Parker, et al. - 2021 8 50 patients Follow - up 12 months VENTRAL 6% DeNoto, et al. – 2022 7 * 92 patients Follow - up 24 months VENTRAL 2.6% Ankney , Szotek et al. – 2021 4 * 259 patients Follow - up 1 - 58 months VENTRAL 0.8% Sivaraj , Nazerali et al. – 2022 5 * 36 patients Average Follow - up 29 months VENTRAL 2.8% Source: Refer to “ Ovitex Clinical References” in this presentation. * Indicates one or more surgeons are paid consultants of Tela Bio, Inc. Sivaraj , Nazerali et al. – 2022 6 * 50 patients Average Follow - up 29 - 34 months VENTRAL 4.0%
Parker et al. 8 Sivaraj et al. 5 Total enrolled patients 50 OviTex 50 Polypropylene 36 OviTex 51 Strattice 17 Permacol 37 Surgimend Length of follow - up 12 months 12 months 28.6 months (median) 34.6 months (median) 58.4 months (median) 37.5 months (median) mVHWG 32% grade 2 68% grade 3 a 94% grade 2 6% grade 3 33% grade 1 58% grade 2 8% grade 3 17% grade 1 79% grade 2 4% grade 3 18% grade 1 71% grade 2 12% grade 3 40% grade 1 51% grade 2 9% grade 3 CDC wound class 70% CDC class II+ a 94% CDC class I 89% class I - II 86% class I - II 94% class I - II 91% class I - II Incidence of SSO 36%* 22%* 16.7%* 47.1%* 52.9%* 43.2%* Incidence of SSI - - 2.8% b 12.5% 11.8% 5.4% Recurrence rate 6% 12% 2.8% c 13.7% c 29.4% 24.3% Source: Refer to “Clinical References” in this presentation. Favorable Results of OviTex in Ventral Hernia Repair: Comparisons to synthetic mesh and leading generation one biologics *Overall complications including SSI a – OviTex patients were more complicated with a significantly higher mVHWG distribution and CDC wound classification compared to polypropylene patients b – OviTex patients experienced significantly less complications than patients receiving the other three biologics c - OviTex and Strattice patients had a statistically lower recurrence rate than patients receiving the other two biologics
* Kaplan - Meier survival estimate **No head - to - head clinical studies have been conducted. Due to differences in patient population, surgeons, surgical technique, and other variables, no direct comparisons of results can be made. For a comparative discussion of these studies, please see G. DeNoto , E.P. Ceppa , S.J. Pacella, M. Sawyer, G. Slayden , M. Takata, G. Tuma , J. Yunis, 24 - Month results of the BRAVO study: A prospective, multi - center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex ® 1S permanent reinforced tissue matrix, Ann Medicine Surg 2022, 83, 104745 . Positive 24 - month BRAVO results in ventral hernia: OviTex performance contextualized alongside recent publications for leading competitive products DeNoto et al. (BRAVO) 7 Harris et al. (PRICE) 10 Roth et al. 11 Hope et al. (ATLAS) 12 Total enrolled patients 92 OviTex 82 Strattice 83 Ventralight ST or Bard Soft Mesh 121 Phasix 120 Phasix ST Length of follow - up 24 months 26 months 36 months 24 months mVHWG 78% grade 2 - 3 - - - CDC wound class 95% class I - II 90% class l - ll 93% class l - ll 100% class I 100% class I Surgical technique Open (65%) Laparoscopic (13%) Robotic (22%) Open Open Open Laparoscopic (55.8%) Robotic (44.2%) Incidence of SSO 38% (includes SSI) 21% (excludes SSI) 22% (excludes SSI) - 0.8% (includes SSI) Incidence of SSI 20.7% 39% 34% 9% * 0% Recurrence rate 2.6% * 40% (overall) 34% (class I wounds) 22% (overall) 28% (class I wounds) 17.9% * 31.7% * (overall) 18.6% * (defects < 7cm 2 ) Source: Refer to “Clinical References” in this presentation.
Permanent Synthetic Biologic Biosynthetic Resorbable Reinforced Tissue Matrix Sources for Sales Market Share (%): 2009 - 2013 = IMS Hospital Supply Index; 2018 - 2021 = iData Research MedSKU ; 2027 = Management Estimate Sources for Total US Market Size: 2021 - 2027 = DRG Hernia Repair Devices Report – 2021; 2013 - 2018 = Management Estimate Sources for % Robotic Procedures ( Px ): 2018 - 2027 = DRG Hernia Repair Devices Report – 2021: 2013 = Management Estimate 2027 2021 2018 2013 Sales Market Share Biosynthetic Resorbable and Reinforced Tissue Matrix strengths : Clinical Evidence Robot Compatibility Cost - effectiveness Patient Choice & Shared Decision - making <1% Robotic Procedures ( Px ) 7% Robotic Px 12% Robotic Px 21% Robotic Px Hernia Market Evolution TELA Bio is gaining from a market shift by providing our reinforced “natural repair” solutions as an alternative to traditional Permanent Synthetics or Biologics
U.S. Plastic and Reconstructive Surgery Market: ~$700 Million Annual Opportunity Surgeons use products to reinforce soft tissue during various reconstructive surgeries 1 , including: ▫ Head and neck surgery ▫ Chest wall reconstruction ▫ Pelvic reconstruction ▫ Extremities reconstruction ▫ Breast reconstruction 1 OviTex PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or rei nfo rcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one - time use. OviTex PRS has not been tested in breast surgical procedures. 2 Management estimate. Source: iData Research MedSKU , Q3 2021. Market size based on sales of current biologics Cosmetic Plastic & Reconstructive Surgery $600M 2 $100M 2 Market dominated by human acellular dermal matrices (HADMs): ▫ Prone to high degree of stretch ▫ Expensive, putting pressure on hospital systems ▫ Can experience supply shortages, particularly when large pieces of material are required
OviTex PRS: Specifically Designed for Plastic and Reconstructive Surgery An innovative reinforced tissue matrix designed to improve outcomes by facilitating fluid management and controlling degree and direction of stretch Product Features: ▫ Layers composed of biologic building block retain biologically significant macromolecules for tissue regeneration 1,2 ▫ Diamond embroidery pattern and stents allow for directional flexibility or sawtooth embroidery pattern to accommodate bi - directional stretch while providing stretch resistance. ▫ Distinct permeability elements in various configurations – e.g., micropores, macropores, and stents – designed to facilitate fluid management Available in both 2 - layer resorbable (polyglycolic acid) polymer, 3 - layer permanent (polypropylene) polymer, or 3 - layer resorbable (polylactic - co - glycolic acid) polymer reinforcing the same biologic material 1 . Certain configurations available in two or three layers, see product catalog more information. 2. Lun S, Irvine S.M., Johnson K.D., Fisher N.J., Floden E. W., Negron L., Dempsey S.G. , McLaughlin R.J., Vasudevamurthy M. , Ward B.R., May B.C., A functional extracellular matrix biomaterial derived from ovine forestomach, Biomaterials 31(16) ( 20 10) 4517 - 29. 3. ADM: Acellular Dermal Matrix. Overbeck N, Beierschmitt A, May BC, Qi S, Koch J. In - Vivo Evaluation of a Reinforced Ovine Biologic for Plastic and Reconstructi ve Procedures in a Non - human Primate Model of Soft Tissue Repair. Eplasty . 2022 Sep 14;22:e43. PMID: 36160663; PMCID: PMC9490877. Animal testing results may not be indicative of clinical performance. OviTex PRS compared to market leading human ADM 3 : ▫ Exhibited earlier host cell proliferation, collagen deposition and neovascularization ▫ Demonstrated tissue remodeling into mature, functional and organized collagen
Leading - edge atraumatic hernia mesh fixation devices
LIQUIFIX FIX8 Œ and LIQUIFIX Precision Œ Atraumatic liquid fixation device s • Reduce the need for penetrating mechanical fixation for inguinal and femoral hernia repair • Provide p rec ise , controlled adhesive application Fills an unmet need in the market, less damage to tissue • D esigned to minimize the risk of mechanical tissue trauma 1 • S trong and secure mesh fixation 2,3 • P re - assembled device • Adhesives polymerize in ~ 10 seconds • Provides versatile liquid anchors at multiple angles 1 - 3. Data on file: Advanced Medical Solutions LIQUIFIX FIX8 is indicated for minimally invasive femoral and inguinal hernia repairs and for approximation of the peritoneum; LIQUIFIX Precision is indicated for open inguinal and femoral hernia repairs.
TELA Bio is growing each factor that contributes to sales, providing for multi - year, long - term growth 2021: 40 - 45 reps 2022: 61 reps 2023: 86 reps 2/29/24: 86 reps + 6 asst. reps Driving Revenue Growth Rep Productivity Sales Force Size Product Portfolio GPO Access Clinical Data $ ales • Playbook90 training and assessment • 3 - 6 mos. to breakeven • TELA LIVE • Cadaver Labs • Clinical Development Specialists • AboutHernia website • BRAVO 24 - month data: 2.6% recurrence • >30 published or presented works >1,600 hospitals ~4,400 hospitals R&D and BD Third National GPO More to come
Delivering Revenue Growth and Margin Improvement Q4 2023 Performance ▫ Revenue of $17.0M grows 46% over corresponding period of 2022 ▫ 68% Gross Margin ▫ Cash and Cash Equivalents at December 31 , 2023: $46.7M ▫ Does not include $5M 1Q24 proceeds from divestment of NIVIS or additional $3M to $7M expected in next two years +58% +116% +44% +48% +40% +38% +46% +39% +45% +39% +35% +46% 58% 63% 68% 73% 78% $0 $2 $4 $6 $8 $10 $12 $14 $16 $18 $20 1Q21 2Q21 3Q21 4Q21 1Q22 2Q22 3Q22 4Q22 1Q23 2Q23 3Q23 4Q23 Gross Margin Revenue ($M) Quarterly Revenue and Gross Margin Revenue Gross Margin $29.5M, +62% $41.4M, +41% $58.5M, +41%
CLINICAL REFERENCES 1. Sawyer, M.A.J. New Ovine Polymer - Reinforced Bioscaffold in Hiatal Hernia Repair. Jsls J Soc Laparoendosc Surg 2018, 22, e2018.00057, doi:10.4293/jsls.2018.00057. 2. DeNoto, G. Bridged Repair of Large Ventral Hernia Defects Using an Ovine Reinforced Biologic: A Case Series. Ann Medicine Sur g 7 5, 103446, doi:10.1016/j.amsu.2022.103446. 3. Ferzoco, S. Available and Emerging Technologies for Assessing Intraoperative Tissue Perfusion during Complex Ventral Hernia R epa ir Procedures. Open Access Surg 2013, 1, doi:10.2147/oas.s55335. 4. Ankney , C.; Banaschak , C.; Sowers, B.; Szotek , P. Minimizing Retained Foreign Body in Hernia Repair Using a Novel Technique: Reinforced Biologic Augmented Repair ( ReBAR ). J Clin Medical Res 2021, doi:10.37191/mapsci - 2582 - 4333 - 3(4) - 073. 5. Sivaraj , D.; Henn, D.; Fischer, K.S.; Kim, T.S.; Black, C.K.; Lin, J.Q.; Barrera, J.A.; Leeolou , M.C.; Makarewicz , N.S.; Chen, K.; et al. Reinforced Biologic Mesh Reduces Postoperative Complications Compared to Biologic Mesh after Ventral Hernia Repair. Plastic Reconstr Surg - Global Open 2022, 10, e4083, doi:10.1097/gox.0000000000004083. 6. Sivaraj , D.; Henn, D.; Fischer, K.S.; Kim, T.S.; Black, C.K.; Lin, J.Q.; Barrera, J.A.; Leeolou , M.C.; Makarewicz , N.S.; Chen, K.; et al. Reinforced Biologic Mesh Reduces Postoperative Complications Compared to Biologic Mesh after Ventral Hernia Repair. Plastic Reconstr Surg - Global Open 2022, 10, e4083, doi:10.1097/gox.0000000000004083. 7. DeNoto, G.; Ceppa, E.P.; Pacella, S.J.; Sawyer, M.; Slayden, G.; Takata, M.; Tuma, G.; Yunis, J. 24 - Month Results of the BRAVO S tudy: A Prospective, Multi - Center Study Evaluating the Clinical Outcomes of a Ventral Hernia Cohort Treated with OviTex ® 1S Permanent Reinforced Tissue Matrix. Ann Medicine Surg 2022, 83, 104745, doi:10.1016/j.amsu.2022.104745. 8. Parker, M.J.; Kim, R.C.; Barrio, M.; Socas , J.; Reed, L.R.; Nakeeb , A.; House, M.G.; Ceppa, E.P. A Novel Biosynthetic Scaffold Mesh Reinforcement Affords the Lowest Hernia Recurrence in the Highest - Risk Patients. Surg Endosc 2021, 35, 5173 – 5178, doi:10.1007/s00464 - 020 - 08009 - 1. 9. Banaschak , C.; Szotek, P. Robotic Reinforced Biologic Augmented Repair ( ReBAR ) of Over 150 Inguinal Hernias: 2 Year Outcomes. Presented at: 2022 American Hernia Society (AHS) Meeting, September 14 - 16, 2022, Charlotte, NC. 10. Harris, H.W.; Primus, F.; Young, C.; Carter, J.T.; Lin, M.; Mukhtar, R.A.; Yeh, B.; Allen, I.E.; Freise , C.; Kim, E.; et al. Preventing Recurrence in Clean and Contaminated Hernias Using Biologic Versus Synthetic Mesh in Ventral Hernia Repair: The PRICE Randomized Clinical Trial. Ann Surg 2021, 273, 648 – 655, doi:10.1097/sl a.0000000000004336. 11. Roth, J.S.; Anthone , G.J.; Selzer, D.J.; Poulose , B.K.; Pierce, R.A.; Bittner, J.G.; Hope, W.W.; Dunn, R.M.; Martindale, R.G.; Goldblatt, M.I.; et al. Prospective, Multicent er Study of P4HB (PhasixTM) Mesh for Hernia Repair in Cohort at Risk for Complications: 3 - Year Follow - Up. Ann Medicine Surg 2021, 61, 1 – 7, doi:10 .1016/j.amsu.2020.12.002. 12. Hope, W.W.; El - Ghazzawy , A.G.; Winterstein , B.A.; Blatnik , J.A.; Davis, S.S.; Greenberg, J.A.; Sanchez, N.C.; Pauli, E.M.; Tseng, D.M.; LeBlanc, K.A.; et al. A Prospective, Multicent er Trial of a Long - Term Bioabsorbable Mesh with Sepra Technology in Cohort of Challenging Laparoscopic Ventral or Incisional Hernia Repairs (ATLAS Trial). Ann Medicine Surg 2022, 73 , 103156, doi:10.1016/j.amsu.2021.103156.
Exhibit 99.3
TELA Bio Announces U.S. Commercial Launch of LIQUIFIX™ – the Only FDA-Approved Liquid Adhesive for Internal Use in Hernia Surgery
Strong and secure, LIQUIFIX is the first approved adhesive-based product to affix mesh without penetrating patient tissue.
MALVERN, Pa., March 21, 2024 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ: TELA), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced the U.S. launch of LIQUIFIX FIX8™ Laparoscopic and LIQUIFIX Precision™ Open Hernia Mesh Fixation Devices. LIQUIFIX FIX8 is indicated for minimally invasive femoral and inguinal hernia repairs; and LIQUIFIX Precision is indicated for open femoral and inguinal hernia repairs. The LIQUIFIX devices are the only FDA-approved devices that affix mesh and approximate peritoneal tissue with liquid anchors. Based on market research, there are over 1.2 million hernia procedures performed each year in the United States (U.S.), the most common being inguinal hernia repair.
LIQUIFIX hernia mesh fixation devices eliminate the need for penetrating mechanical tacks, sutures, or staples by delivering a liquid adhesive that allows for precise and controlled mesh fixation. The products are designed to reduce risk of mechanical tissue trauma as they do not breach patient tissue, allowing surgeons to affix the mesh and minimize risks of complications. The LIQUIFIX products may offer greater utility for surgical mesh in inguinal hernia repair by enabling mesh fixation to sensitive areas, such as the “triangle of doom” and “triangle of pain” – regions containing sensitive arteries, veins, and nerves where traditional traumatic fixation methods could result in major vascular or nerve injuries leading to chronic pain.
“Aligned with our mission to prioritize the preservation and restoration of the patient’s own anatomy, this novel device is a natural addition to our fast-growing commercial portfolio,” said Antony Koblish, President and Chief Executive Officer of TELA Bio. “We’re excited to help surgeons across the U.S. advance the future of hernia repair fixation in robotic, laparoscopic, and open cases with this atraumatic approach.”
“Based on my experience, the device is easy to use and is safe and effective,” said Mr. Paul Wilson, Consultant General Surgeon, who has used LIQUIFIX in over 1500 laparoscopic hernia repairs in the United Kingdom (U.K.). “The fixation strength is very impressive. I have seen a significant benefit to the patient, with a major reduction in both acute post-op pain and chronic pain after surgery. This has been a game-changer for me.”
LIQUIFIX products are manufactured by U.K.-based Advanced Medical Solutions Limited (AMS), a world-leading specialist in tissue-healing technologies. AMS entered into an agreement with TELA Bio in 2023 to commercialize the LIQUIFIX products in the U.S., leveraging the company’s rapidly expanding hernia repair specialty salesforce and its focus on new technologies.
“Given the consistent strong performance of the LIQUIFIX products in Europe and other international markets over the past three years, we look forward to working with TELA Bio to grow adoption in the U.S.,” said Chris Meredith, Chief Executive Officer of AMS.
To learn more, visit liquifixation.com
About TELA Bio, Inc.
TELA Bio, Inc. (NASDAQ: TELA) is a commercial-stage medical technology company focused on providing innovative technologies that
optimize clinical outcomes by prioritizing the preservation and restoration of the patient's own anatomy. The Company is committed to
providing surgeons with advanced, economically effective soft-tissue reconstruction solutions that leverage the patient's natural healing
response while minimizing long-term exposure to permanent synthetic materials. For more information, visit www.telabio.com.
About LIQUIFIXTM Devices
Indications for Use
The LIQUIFIX FIX8™ device is intended for use in laparoscopic surgical repair of groin (femoral and inguinal) hernias, achieved through the fixation of prosthetic polypropylene or polyester mesh to the abdominal wall and the approximation of the peritoneum.
The LIQUIFIX Precision™ Open Hernia Mesh Fixation device is intended for use in open surgical repair of groin (inguinal and femoral) hernias, achieved through the fixation of prosthetic polypropylene or polyester mesh to the abdominal wall.
Contraindications
The LIQUIFIX FIX8™ and LIQUIFIX Precision™ devices are not intended for use when prosthetic material fixation is contraindicated. Do not use on patients with a hypersensitivity to cyanoacrylate adhesives, formaldehyde or D&C Violet No. 2 dye. Do not use for the fixation of meshes constructed with polytetrafluoroethylene (PTFE) or materials other than polypropylene or polyester. Do not use the devices for closure or fixation of cerebral tissues, blood vessels or peripheral nerves.
Relevant Warnings
The use of LIQUIFIX is limited to those healthcare providers who are qualified to perform laparoscopic and open hernia repairs. A thorough understanding of the operating principles, risks versus benefits, and hazards involved in utilizing an endoscopic approach or surgical approach is necessary to avoid possible hazards to the user and/or patient. It is recommended that any healthcare provider who intends to use LIQUIFIX read the instructions for use in full, including directions, precautions, and warnings. Accidental bonding of unwanted tissue may occur due to misapplication of adhesive.
Potential Adverse Effects of the Device on Health
As with the majority of implanted devices, adverse reactions associated with the use of this device may include transient local irritation at the implant site and a transitory inflammatory foreign body response. Advanced Medical Solutions has determined the potential adverse effects (e.g. complications) listed below may be associated with the use of the LIQUIFIX device. These potential adverse events include, but are not limited to, the following:
| · | Toxic reaction | |
| · | Allergic reaction |
Reference the LIQUIFIX FIX8™ Laparoscopic Hernia Mesh Fixation Device and LIQUIFIX Precision™ Open Hernia labeling for Additional Important Safety Information.
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Words
such as "may," "might," "will," "should," "believe," "expect," "anticipate,"
"estimate," "continue," "predict," "forecast," "project," "plan," "intend"
or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the
current beliefs of TELA's management, including with respect to the launch of LIQUIFIX Non-Penetrating Fixation products. These statements
are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results
and events to differ materially and adversely from those indicated by such forward-looking statements including, among others the impact
to our business from macroeconomic conditions, including the impact of pandemics or epidemics, recessionary concerns, banking instability,
and inflationary pressures, potentially impacting our ability to market our products, demand for our products due to the deferral of
elective procedures, the labor and staffing environment in the healthcare industry, disruption in our supply chain, or pricing pressures
concerning our products or the procedures using our products; our ability to achieve or sustain profitability; our ability to gain market
acceptance for our products and to accurately forecast and meet customer demand; our ability to compete successfully; that data from
earlier studies related to our products and interim data from ongoing studies may not be replicated in later studies or indicative of
future data; that data obtained from clinical studies using our product may not be indicative of outcomes in other surgical settings;
our ability to enhance our product offerings; development and manufacturing problems; capacity constraints or delays in production of
our products; maintenance of coverage and adequate reimbursement for procedures using our products; product defects or failures. These
and other risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with
the Securities and Exchange Commission and available at www.sec.gov, including in our Annual Report on Form 10-K and Quarterly Reports
on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release,
and TELA assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise
after the date of this press release, except as required under applicable law.
Investor Contact
Greg Chodaczek
347-620-7010
ir@telabio.com
Media Contact
Lisa Novy-Wikowski
484-354-6782
lnovywikowski@telabio.com