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): March 9, 2020
|(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||Nasdaq Global Market|
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 March 9, 2020, OrthoPediatrics Corp. (“the Company”) issued a press release announcing the domestic launch of its 34th surgical system, the Large Fragment Cannulated Screw System. This innovative system was designed to address trauma procedures, as well as treating children with a condition knows as Slipped Capital Femoral Epiphysis ("SCFE") and includes specific design elements to address the unique needs of the pediatric population. 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: March 9, 2020||By:||/s/ Daniel J. Gerritzen|
|Daniel J. Gerritzen, |
General Counsel and Secretary
OrthoPediatrics Corp. Announces U.S. Launch of Large Fragment Cannulated Screw System
WARSAW, Indiana, March 9, 2020 — OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, is pleased to announce the limited U.S. launch of its Large Fragment Cannulated Screw System, which would represent the Company’s 34th surgical system. The innovative system was designed to address trauma procedures, as well as treating children with a condition known as Slipped Capital Femoral Epiphysis (“SCFE”) and includes specific design elements to address the unique needs of the pediatric population.
These unique design features include:
–Screws in 2mm increments for more precision
–Screw thread run out in the head of screw to aid in hardware removal
–Dual lead threads to accelerate screw insertion
–Threaded cannulation to facilitate implant removal
Large Fragment Cannulated Screws (available in 6.5mm and 7.3mm diameters) are intended for pediatric fracture fixation of large bones and large bone fragments such as slipped capital femoral epiphysis, femoral neck fractures, tibial plateau fractures, sacroiliac joint disruption, intercondylar femur fractures, subtalar arthrodesis and fixation of pelvis and iliosacral joint.
Jeff Mebel, OrthoPediatrics’ Trauma Product Director, commented, “We are excited about the domestic beta release of our new Large Fragment system and look forward to supporting physician adoption. This launch represents our continued commitment to provide our surgeon customers with innovative technology to treat a wide variety of pathologies that are unique to children. We have the privilege of partnering with excellent physicians and their input has represented a valuable part in bringing this system to market.”
The OrthoPediatrics development team worked closely with four pediatric orthopedic surgeons from prominent institutions globally on the design of the screw implants and instruments. Dr. Scott Hoffinger, pediatric orthopedic surgeon in San Francisco, shared his interest in the platform, stating, “The engineering group at OrthoPediatrics completely reconfigured the screw system and precisely designed it specifically for the pediatric patient. This will help overcome challenges we encounter in the operating room every day.”
About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 34 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & 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. For more information, please visit www.orthopediatrics.com.
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|