SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 15, 2020
TELA Bio, Inc.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction of
incorporation or organization)
|(Primary Standard Industrial
Classification Code Number)
|1 Great Valley Parkway, Suite 24, Malvern,
|(Address of principal executive offices)||(Zip Code)|
Registrant’s telephone number, including area code: (484) 320-2930
(Former name or former address, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
|Title of Each Class||Trading Symbol||Name of Exchange on Which Registered|
|Common Stock, par value $0.001 per share||TELA||Nasdaq Global Market|
Securities registered pursuant to Section 12(g) of the Act:
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 (see General Instruction A.2. below):
|¨||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))|
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 7.01||Regulation FD Disclosure.|
On June 15, 2020, TELA Bio, Inc. (the “Company”) issued a press release announcing that two abstracts focused on evaluating the Company’s OviTex® products have been accepted for presentation at the 20th annual Minimally Invasive Surgery Symposium. The first poster presentation, “Reinforced Biologics in MIS Ventral Hernia Repair,” provides one-year follow-up results for 31 ventral hernia patients repaired minimally invasively and the second poster presentation, “Using a Reinforced Biologic Mesh in a Minimally Invasive Technique for Ventral Hernia Repair,” describes a novel single incision technique using Ovitex® to repair ventral hernias in 27 complex patients.
The information furnished pursuant to Item 7.01, 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, or the Exchange Act, except as expressly set forth by specific reference in such filing.
|Item 9.01||Financial Statements and Exhibits.|
The following exhibit is being furnished herewith:
|99.1||Press Release, dated June 15, 2020.|
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|
|Title:||President, Chief Executive Officer and Director|
Date: June 15, 2020
TELA Bio, Inc. Announces Poster Presentations
at the 2020 Minimally Invasive
Surgery Symposium (MISS)
MALVERN, Pa., June 15, 2020 (GLOBE NEWSWIRE) -- TELA Bio, Inc. ("TELA") (Nasdaq: TELA), a commercial stage medical technology company focused on designing, developing and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction, today announced that two abstracts focused on evaluating OviTex® products have been accepted for poster presentations at the 20th annual Minimally Invasive Surgery Symposium (MISS). The MISS conference will take place virtually from June 9 through June 24, 2020.
In one poster presentation, titled, “Reinforced Biologics in MIS Ventral Hernia Repair,” author Geoffrey Slayden, MD, FACS, on behalf of the BRAVO study group, provides results for the 31 ventral hernia patients repaired minimally invasively, either robotically or laparoscopically, at approximately one-year follow-up. Low rates were reported for both surgical site occurrence (SSO) and hernia recurrence. All investigators additionally found OviTex to be easy to use and place in the surgical field.
“We are thankful to the MISS for accepting our abstract to present updated results from our ongoing BRAVO study,” said Dr. Slayden. “The results are very encouraging, especially with an overall incidence rate of SSOs that is lower than those reported in literature and data that continue to reinforce that OviTex products are easy to use in minimally invasive techniques. We look forward to further exploring the performance of OviTex products in robotic hernia repair with the initiation of an additional prospective post-market study.”
In a second poster presentation, titled, “Using a Reinforced Biologic Mesh in a Minimally Invasive Technique for Ventral Hernia Repair,” lead author Paul Szotek, MD, Medical Director of the Indiana Hernia Center, describes a novel single incision technique using OviTex to repair ventral hernias in 27 complex patients. Dr. Szotek reports no cases of recurrence and a low rate of SSO at an average follow-up of 9 months despite a challenging patient population.
“Over the past 18-months, hernia patients in my practice continue to ask about minimally invasive surgical approaches and increasingly express concern about permanent synthetic mesh based on what they see and hear in the news,” said Dr. Szotek. “These results are exciting because they demonstrate that surgeons can achieve excellent clinical outcomes utilizing the minimally invasive repair techniques desired by patients while reaching a shared decision on a reinforcement option designed to minimize the risks related to permanent synthetic materials.”
Additional details for the MISS virtual conference are available online at:
About TELA Bio, Inc.
TELA Bio, Inc. is a commercial stage medical technology company focused on designing, developing, and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction. TELA's products are designed to improve on shortcomings of existing biologics and minimize long-term exposure to permanent synthetic material. TELA's portfolio is supported by quality, data-driven science and extensive pre-clinical research that has consistently demonstrated advantages over other commercially available products.
TELA Bio Contact
President, Corporate Development and Investor Relations
TELA Bio, Inc.