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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): March 21, 2022

 

TELA Bio, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-37526   45-5320061

(State or other jurisdiction of

incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

1 Great Valley Parkway, Suite 24

Malvern, Pennsylvania

 

19355
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (484) 320-2930

 

Not Applicable

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $0.001 per share   TELA   Nasdaq Global Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On March 21, 2022, TELA Bio, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter of 2021 and the fiscal year ended December 31, 2021. 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, 2022, 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.

 

In addition, the Company expects that revenues for the three months ended March 31, 2022 will be approximately $8 million. This estimate is preliminary and subject to change. Accordingly, investors should not place undue reliance on this preliminary estimate. 

 

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 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, 2022.
99.2   Corporate Slide Deck, dated March 21, 2022.
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, 2022

 

  

 

 

Exhibit 99.1 

 

 

 

TELA Bio Reports Fourth Quarter and Full Year 2021 Financial Results

 

MALVERN, PA, March 21, 2022 -- TELA Bio, Inc. ("TELA") (Nasdaq: TELA), 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, 2021.

 

Recent Highlights

 

·Reported revenue of $8.4 million for the fourth quarter and $29.5 million for the full year 2021, representing growth of 48% and 62%, respectively, over the corresponding periods of 2020
·Announced publication of 12-month results from the BRAVO Study with continued positive outcomes through 24 months
·Entered into an exclusive distribution agreement with Next Science to market its proprietary SiteGuard™ No Rinse Antimicrobial Solution across the US plastic reconstructive market

 

“2021 was an outstanding year for TELA Bio, and despite the December 2021 emergence of the Omicron variant, we finished the year with a very strong fourth quarter,” said Antony Koblish, co-founder, President and Chief Executive Officer of TELA Bio. “Throughout 2021 our Company made significant progress across the board – increasing market share, growing our customer base, producing further strong clinical data, and strengthening our leadership team. As we enter 2022, we believe we are well positioned for significant growth as our novel preservation and restoration products are gaining significant mindshare with patients, surgeons, and payors.”

 

Fourth Quarter 2021 Financial Results

 

Revenue was $8.4 million in the fourth quarter of 2021, an increase of 48% compared to the prior year. The increase was due to the expansion of the commercial organization and a faster productivity ramp from the Company’s most recent sales hires stemming from its “Playbook90” training and performance measurement program.

 

Gross profit was $5.7 million in the fourth quarter of 2021, or 68% of revenue, compared to $3.7 million, or 65% of revenue, in the same period in 2020. The increase in gross margin was due primarily to a decrease in the reserve for excess and obsolete inventory as a percentage of revenue as compared to the prior year.

 

Operating expenses were $13.3 million in the fourth quarter of 2021, compared to $10.4 million in the same period in 2020. The increase was due to the expansion of our commercialization activities, increased compensation and higher research and development investment.

 

Loss from operations was $7.7 million in the fourth quarter of 2021, compared to a loss from operations of $6.7 million in the same period in 2020.

 

 

 

 

Net loss was $8.6 million in the fourth quarter of 2021, compared to a net loss of $7.8 million in the same period in 2020.

 

Full Year 2021 Financial Results

 

Revenue was $29.5 million for the full year 2021, an increase of 62% compared to the full year 2020. This increase was due primarily to the commercial organization's expansion and to increased penetration within existing customer accounts.

 

Gross profit was $18.8 million for the full year 2021, or 64% of revenue, compared to $11.2 million, or 62% of revenue, for the full year 2020. The gross margin increase was due primarily to a decrease in the reserve for excess and obsolete inventory as a percentage of revenue as compared to the prior year.

 

Operating expenses were $48.3 million for the full year 2021, compared to $36.5 million in the prior year. The increase was due to the expansion of our commercialization activities, higher professional, consulting and legal expenses and increased research and development investment. The prior year also included cost containment actions taken in response to the COVID-19 pandemic which were not repeated in 2021.

 

Loss from operations was $29.5 million for the full year 2021, compared to a loss from operations of $25.3 million for the full year 2020.

 

Net loss was $33.3 million for the full year 2021, compared to a net loss of $28.8 million for the full year 2020.

 

Cash and cash equivalents on December 31, 2021 totaled $43.9 million.

 

2022 Financial Guidance

 

We continue to monitor and evaluate the impact the COVID-19 pandemic has had and will continue to have on our results of operations. Despite these challenges, full year 2022 revenue is projected to range from $40 million to $45 million, reflecting growth of 36% to 53% over full year 2021. A higher than expected impact from the COVID-19 pandemic in 2022 could materially affect this projection.

 

Conference Call

 

TELA Bio will host a conference call at 4:30 p.m. Eastern Time on Monday, March 21, 2022 to discuss its fourth quarter and full year 2021 financial results. The call may be accessed through an operator by dialing 855-548-1219 for domestic callers and 409-217-8881 for international callers, using conference ID number 5058747. A live and archived webcast of the event can be accessed via the Events & Presentations page of the investor section of TELA'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's management. Such forward-looking statements include statements relating to our expected revenue and revenue growth for the full year 2022. 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 of the ongoing COVID-19 pandemic and the development of new variants of COVID-19, including but not limited to any impact on our ability to market our products, demand for our products due to deferral of procedures using our products, the labor and staffing environment in the healthcare industry, or disruption in our supply chain, 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, 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 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
332-895-3230
ir@telabio.com   

 

 

 

 

TELA Bio, Inc.

Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

 

   December 31, 
   2021   2020 
Assets        
Current assets:          
Cash and cash equivalents  $43,931   $74,394 
Accounts receivable, net   4,234    2,683 
Inventory   7,658    3,907 
Prepaid expenses and other assets   3,232    2,241 
Total current assets   59,055    83,225 
Property and equipment, net   1,186    626 
Intangible assets, net   2,303    2,607 
Total assets  $62,544   $86,458 
           
Liabilities and stockholders’ equity          
Current liabilities:          
Accounts payable  $2,414   $652 
Accrued expenses and other current liabilities   8,161    5,953 
Total current liabilities   10,575    6,605 
Long-term debt with related party   31,491    30,827 
Other long-term liabilities   380     
Total liabilities   42,446    37,432 
           
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; 14,529,606 and 14,437,289 shares issued and 14,529,577 and 14,437,107 shares outstanding at December 31, 2021 and December 31, 2020, respectively   15    14 
Additional paid-in capital   250,064    245,736 
Accumulated other comprehensive loss   (52)   (71)
Accumulated deficit   (229,929)   (196,653)
Total stockholders’ equity   20,098    49,026 
Total liabilities and stockholders’ equity  $62,544   $86,458 

 

 

 

 

TELA Bio, Inc.

Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(Unaudited)

 

   Three Months Ended December 31,   Year Ended December 31, 
   2021   2020   2021   2020 
Revenue  $8,374   $5,667   $29,463   $18,213 
Cost of revenue (excluding amortization of intangible assets)   2,639    1,929    10,346    6,675 
Amortization of intangible assets   76    76    304    304 
Gross profit   5,659    3,662    18,813    11,234 
Operating expenses:                    
Sales and marketing   8,313    6,377    29,062    22,111 
General and administrative   3,275    2,869    12,459    10,143 
Research and development   1,725    1,163    6,743    4,255 
Total operating expenses   13,313    10,409    48,264    36,509 
Loss from operations   (7,654)   (6,747)   (29,451)   (25,275)
Other (expense) income:                    
Interest expense   (922)   (903)   (3,597)   (3,564)
Other (expense) income   (43)   (140)   (228)   45 
Total other expense   (965)   (1,043)   (3,825)   (3,519)
Net loss  $(8,619)  $(7,790)  $(33,276)  $(28,794)
Net loss per common share, basic and diluted  $(0.59)  $(0.54)  $(2.30)  $(2.23)
Weighted average common shares outstanding, basic and diluted   14,508,937    14,432,974    14,473,213    12,934,421 

 

 

 

 

 

 

 

 

Exhibit 99.2

 

Advancing Soft Tissue Reconstruction Investor Presentation March 2022

  

 

2 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 of the ongoing COVID - 19 pandemic and the development of new variants of COVID - 19, including but not limited to any impact on the Company's ability to market its products, demand for the Company's products due to deferral of procedures using the Company's products, the labor and staffing environment in the healthcare ind ust ry, or disruption in the Company's supply chain, the Company's ability to achieve or sustain profitability, the Company's ability to gain market acceptance for the Company's products and to accurately forecast and meet customer demand, the Company's ability to compete successfully, the Company's ability to enhance the Compan y's product offerings, development and manufacturing problems, capacity constraints or delays in production of the Company's products, maintenance of coverage a nd adequate reimbursement for procedures using the Company's products, product defects or failures. These and other risks and uncertainties are described m ore fully in the "Risk Factors" section and elsewhere in the Company's filings with the Securities and Exchange Commission and available at www.sec.gov. You should n ot rely on these forward - looking statements as predictions of future events. The events and circumstances reflected in the Company’s forward - looking statements m ay not be achieved or occur, and actual results could differ materially from those projected in the forward - looking statements. Moreover, the Company operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factor s a nd uncertainties that the Company may face. Except as required 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.

  

 

Redefining soft tissue reconstruction with a differentiated category of tissue reinforcement materials ~$2B U.S Market Opportunity 1 in hernia repair , abdominal wall reconstruction and plastic and reconstructive surgery 3 Innovative Products Compelling Clinical Evidence Products Offer Attractive Value Proposition for Hospitals 1 Management estimate. $2B total equals $1.5B hernia & abdominal wall reconstruction and $0.6B plastic reconstructive surgery.

  

 

4 Creating Advanced Biologic Materials Novel Biologic Tissue (derived from sheep) Polymer Fibers (permanent or resorbable) Innovative Textile Engineering Purposefully designed to address shortcomings & unmet clinical needs Issued patents protect underlying biologic tissue and product design Hernia & Ab Wall Reconstruction Plastic Reconstruction

  

 

5 OviTex: ~$1.5 Billion Annual U.S. Hernia Market Opportunity Simple Ventral Hernia Repair 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 Source: Millennium Research Group Reports, IMS Health Data 1 Management estimate. Market size based volume weighted average selling price for OviTex Annual Procedures $1.5B 1

  

 

6 Ventral Hernia Patients Range in Complexity • CDC Wound Class I (clean) • Healthier patients - no co - morbidities • Primary hernia repair • CDC Wound Class II (clean - contaminated) • Patient co - morbidities (i.e., obesity, diabetes, COPD) • May have prior hernia repair failure • CDC Wound Class III (contaminated) & IV (infected) • Large defects • Infected synthetic mesh removals • Multiple prior hernia repair failures COMPLEX MODERATE SIMPLE Ventral Hernia Complexity Objective: provide patients the best repair the first time to prevent the simple patient from becoming the complex

  

 

7 Current Ventral Hernia Treatment Options: No Perfect Product Persistent inflammatory response Encapsulation of implant Chronic post operative pain Scar tissue / lack of remodeling Mesh infections Significant costs of re - operation Organ erosion or perforation 6,000 related U.S. lawsuits PERMANENT SYNTHETIC MESH Strattice Œ RESORBABLE SYNTHETIC MESH Strattice Œ BIOLOGIC MESH Parietex 䉼 PROCEED ® GORE ® BIO - A ® SurgiMend ® XenMatrix 䉼 Natural Repair Products Simple Ventral Hernia Inguinal Hernia Complex, Moderate Ventral Repair / Abdominal Wall Reconstruction Hiatal Hernia Repair ProGrip 䉼 + Ventralight 䉼 P HASIX 䉼 Mesh Strattice 䉼 Gentrix ® ▫ Persistent inflammatory response ▫ Encapsulation of implant ▫ Chronic post operative pain ▫ Scar tissue / lack of remodeling ▫ Mesh infections / Significant costs of re - operation ▫ Organ erosion or perforation LIMITATIONS ▫ Inflammatory response until absorbed ▫ Encapsulation of implant or contraction until absorbed ▫ Scar tissue / lack of remodeling ▫ Mesh infection until resorbed ▫ Organ erosion or perforation ▫ Lack of mid - term and long - term reinforcement ▫ Lack of strength or durability ▫ Prone to laxity and stretching ▫ Challenges to surgeon handling ▫ Difficult to use in laparoscopic or robotic surgery ▫ High costs

  

 

8 Lawsuits against permanent synthetic meshes estimated to be assembled across the U.S. 2 of surgeons agree that use of permanent synthetic mesh puts patients at long - term risk of complications 1 Growing Need for Alternative to Permanent Synthetic Mesh 1 Hernia and Abdominal Surgeries Survey (Oct 2020). 2 www.drugwatch.com (October 2020) 59% Hernia patients have voiced concern over use of permanent synthetic mesh according to surgeons 1 1 in 5 ~15K

  

 

9 OviTex Reinforced Tissue Matrix: a More Natural Hernia Repair 䉼 An innovative reinforced tissue matrix designed to reduce stretch compared to biologic matrices and long - term complications experienced with resorbable and permanent synthetic meshes Unique permeable design facilitates rapid fluid transfer and movement of cells through the device Layers of biologic material enable functional tissue remodeling Interwoven polymer for added strength and improved handling Lockstitch embroidery pattern creates a ripstop effect and prevents unraveling when cut

  

 

10 OviTex LPR for Laparoscopic & Robotic Hernia Repair Tailored OviTex product designed for improved handling in MIS techniques and trocar accessibility Our Solution: OviTex LPR Increase in Robotic - Assisted Hernia Repair ▫ Surgeons have adopted robotic - assisted techniques, primarily for inguinal & simple ventral Hernia repair, due to perceived patient and technique benefits ▫ Legacy biologic products are difficult to use minimally invasively (MIS) due to their thickness and handling properties

  

 

11 Compelling Clinical Evidence Ventral Hernia Inguinal Hernia Hiatal Hernia Presentations / Publications 18 Presentations / Publications 5 Presentations / Publications 4 Low incidence of chronic post - operative pain Low hernia recurrence Low SSO / SSI Ease of use Low rate of surgical site occurrences & infections (SSO/SSI) Low hernia recurrence Ease of use Compatibility with MIS approaches Low hernia recurrence OviTex supported by data from ~500 hernia patients across multiple hernia types Moderate - to - complex ventral hernia patients Multi - center, post - market clinical study with 92 patients enrolled Patient follow - up at 3, 12 & 24 - months BRAVO Study

  

 

12 OviTex PRS: ~$600 Million Annual U.S. Plastic & Reconstructive Surgery Market Opportunity $600M 1 Market dominated by human acellular dermal matrices (HADMs) ▫ Prone to high degree of stretch ▫ Expensive, putting pressure on hospital systems ▫ Often experience supply shortages, particularly when large pieces of material are required Surgeons use products to reinforce soft tissue during various reconstructive surgeries, including: ▫ Breast reconstruction ▫ Head and neck surgery ▫ Chest wall reconstruction ▫ Pelvic reconstruction ▫ Extremities reconstruction 1 Management estimate. Market size based on sales of current biologics

  

 

13 OviTex PRS: Purposely Designed for Plastic and Reconstructive Surgery Layers of biologic material enable functional tissue remodeling Corner - lock diamond embroidery pattern allows the product to stretch while maintaining its shape Fenestrations and slits facilitate fluid management, allow for rapid cellular infiltration, and create a directional bias to the stretch Expanded commercial launch in June 2020 following limited launch initiated in 2019 An innovative reinforced tissue matrix designed to improve outcomes by facilitating fluid management and controlling degree and direction of stretch

  

 

14 Growth Strategy ▫ Promote broader awareness of OviTex & OviTex PRS products ▫ Employ virtual sales & marketing programs, including TELA LIVE ▫ Drive market awareness of risks of permanent synthetic mesh use ▫ Publish BRAVO clinical data INCREASE ADOPTION ▫ Scale direct sales force ▫ Drive account manager productivity ▫ Increase utilization within health systems under GPO contracts ▫ Secure additional contracts with high - potential IDNs and GPOs COMMERCIAL EXECUTION ▫ Launch new product features and designs for OviTex and OviTex PRS ▫ Initiate robotic hernia post - market study ▫ Support investigator - led clinical studies for OviTex PRS MARKET EXPANSION

  

 

15 Q4 2021 Performance ▫ Revenue growth of 62% year over year, up 9% from Q3:21 ▫ Cash and Cash equivalents (as of December 31, 2021): $43.9M Delivering Revenue Growth ($ millions) Annual Revenue Revenue CAGR: 62% Quarter Revenue FY 2021 Revenue Growth: 62% ($ millions) $4.3 $8.3 $15.4 $18.2 $29.5 2017 2018 2019 2020 2021 $3.7 $3.5 $5.3 $5.7 $5.9 $7.6 $7.7 $8.4 Q1 Q2 Q3 Q4 2020 2021

  

 

16 Investment Highlights Advanced reinforced tissue matrix portfolio supported by compelling clinical evidence Focused on ~$2.0 billion annual U.S. total addressable markets 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 Industry leading executive team with proven track record