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): January 5, 2021
| OrthoPediatrics Corp. | ||
| (Exact name of registrant as specified in its charter) | ||
| Delaware | ||
| (State or other jurisdiction of incorporation) | ||
| 001-38242 | 26-1761833 | ||||
| (Commission File Number) | (I.R.S. Employer Identification Number) | ||||
2850 Frontier Drive Warsaw, Indiana | 46582 | ||||
| (Address of principal executive offices) | (Zip Code) | ||||
Registrant’s telephone number, including area code: (574) 268-6379
| Not Applicable | ||
| (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 ☒
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 January 5, 2021, OrthoPediatrics Corp. (“the Company”) issued a press release announcing the domestic launch of its first sterile-packed implants for the Pediatric Nailing Platform| FEMUR (“PNP|FEMUR”). The PNP|FEMUR system, now available in 4 countries, was designed for use in pediatric and small stature adult patients to address femoral shaft fractures, subtrochanteric femur fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions, malunions, and fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. 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.
| (d) | Exhibits | |||||||
| Exhibit No. | Description | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
* * * * * *
SIGNATURE
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.
| OrthoPediatrics Corp. | ||||||||
| Date: January 5, 2021 | By: | /s/ Daniel J. Gerritzen | ||||||
| Daniel J. Gerritzen, General Counsel and Secretary | ||||||||
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2850 Frontier Drive Warsaw, Indiana 46582 www.orthopediatrics.com 877.268.6339 574.268.6379 574.269.3692 TOLL-FREE PHONE FAX SCOLIOSIS SPORTS MEDICINE TRAUMA & DEFORMITY CLINICAL EDUCATION OrthoPediatrics Corp. Launches Sterile Implants for PNP | FEMUR System WARSAW, Indiana, January 5, 2021 — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced the 510(k) approval, and limited U.S. launch of its first sterile-packed implants for the Pediatric Nailing Platform | FEMUR (“PNP|FEMUR”). The PNP|FEMUR system, now available in 4 countries, was designed for use in pediatric patients to address femoral shaft fractures, subtrochanteric femur fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions, malunions, and fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Worldwide, the PNP|FEMUR system has been used to treat over 1,000 children since its launch in 2018. With the introduction of sterile nails, the next generation PNP|FEMUR system continues to add more options and new flexibility for surgeons and hospital systems. Now, the most comprehensive pediatric specific PNP|FEMUR implant offering will be made available sterile. The 510(k) clearance and availability of this implant helps hospitals improve patient safety and better trace implant usage while lowering Sterile Processing Departments’ turnover burden and costs. Joe Hauser, OrthoPediatrics’ Vice President of Trauma & Deformity Correction, stated, “The introduction of sterile implants represents an important addition to our portfolio of sterile implant offerings. We are committed to adding sterile implants to the systems that can provide real value to our customers. We are strategically aligned with our customers to decrease the overall footprint of all our systems while balancing and ensuring intraoperative efficiency.” 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 35 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This product 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. For more information, please visit www.orthopediatrics.com. Investor Contact The Ruth Group Jan Medina, CFA (646) 536-7035 jmedina@theruthgroup.com