SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 15, 2019
|(Exact name of registrant as specified in its charter)|
|(State or other jurisdiction of incorporation)|
|(Commission File Number)||(I.R.S. Employer Identification Number)|
|2850 Frontier Drive|
|(Address of principal executive offices)||(Zip Code)|
Registrant’s telephone number, including area code: (574) 268-6379
|(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(s)||Name of each exchange on which registered|
|Common Stock, $0.00025 par value per share||KIDS||The NASDAQ Stock Market LLC|
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))|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 under the Securities Act (17 CFR 230.405) or Rule 12b-2 under the Exchange Act (17 CFR 240.12b-2).
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 [X]
Item 7.01. Regulation FD Disclosure.
On November 15, 2019, OrthoPediatrics Corp. (“the Company”) issued a press release announcing the domestic launch of its 32nd surgical system, the PediFoot Deformity Correction System ("PediFoot") following U.S. Food and Drug Administration (FDA) 501(k) clearance in August. The PediFoot system is the first pediatric-specific system to treat deformities of the foot. A copy of the press release is furnished as Exhibit 99.1 to this Current Report.
The Company does not intend for this Item 7.01 or Exhibit 99.1 to be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
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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.
|Date: November 15, 2019||By:||/s/ Daniel J. Gerritzen|
|Daniel J. Gerritzen, |
General Counsel and Secretary
OrthoPediatrics Corp. Announces U.S. Launch of PediFoot Deformity Correction System
WARSAW, Indiana, November 15, 2019 — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, is pleased to announce the domestic launch of the PediFoot Deformity Correction System (“PediFoot”), following 510(k) clearance by the U.S. Food and Drug Administration (FDA) in August.
The PediFoot system is the first pediatric-specific system to treat deformities of the foot. Within the OrthoPediatrics product portfolio, this system offers the smallest plates and screws, which enable greater effectiveness in addressing cavus foot, flatfoot, clubfoot, and hallux valgus foot deformities. More specifically, the sophisticated system is designed to focus on lateral column lengthening, calcaneal slide osteotomies, opening and closing wedge osteotomies, and arthrodesis procedures. To optimize fixation in these procedures, PediFoot is the first OrthoPediatrics system to offer StarLoc™, a variable angle locking screw technology. In addition, patients will benefit from the innovative instrumentation which flexibly follows the anatomic movement of the bones during the correction process.
The system also includes PediPedal, a combination of non-slip platforms and handle that assist the surgeon in taking repeatable, simulated weight bearing x-rays intraoperatively during surgery.
“We are excited to commence the domestic launch of our PediFoot Deformity Correction System,” commented Joe Hauser, OrthoPediatrics’ Vice President of Trauma & Deformity Correction. “Designed with a team of eminent pediatric orthopedic surgeons, this system addresses four of the most common pediatric foot deformities. With a heightened focus on instrumentation and intra-operative ease, the entire system is contained in one tray with innovative instrumentation that aids in reproducible correction and optimizes time in the operating room. This is the first of many launches to address pediatric foot and ankle procedures.”
About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 32 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 43 countries outside the United States.
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
firstname.lastname@example.org / email@example.com
|2850 Frontier Drive|
Warsaw, Indiana 46582
|TRAUMA & DEFORMITY||SPINE||SPORTS MEDICINE||CLINICAL EDUCATION|