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Form 8-K MYOMO INC For: May 14

May 14, 2018 8:13 AM

 

 

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): May 14, 2018

 

 

MYOMO, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38109   47-0944526

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

One Broadway, 14th Floor

Cambridge, MA 02142

  02142
(Address of Principal Executive Offices)   (Zip Code)

(617) 996-9058

(Registrant’s telephone number, including area code)

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 (see General Instructions 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  ☒

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 May 14, 2018, Myomo, Inc. (the “Company”) issued a press release entitled “Myomo Application for Medicare Codes Receives Favorable Preliminary Decision.” A copy of the press release is furnished with this Current Report on Form 8-K as Exhibit 99.1.

The information contained in Item 7.01 of this Current Report on Form 8-K is being furnished and shall not be deemed “filed” for the 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. The information contained in Item 7.01 of this Current Report on Form 8-K shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

 

Item 9.01 Financial Statements and Exhibits

(d) Exhibits.

 

Exhibit

No.

  

Description

99.1    Press Release, dated May 14, 2018.


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.

 

    Myomo, Inc.
Date: May 14, 2018     By:  

/s/ Paul R. Gudonis

     

Paul R. Gudonis

Chairman, Chief Executive Officer and President

Exhibit 99.1

Myomo® Application for Medicare Codes Receives Favorable Preliminary Decision

CAMBRIDGE, Mass., May 14, 2018 – Myomo, Inc. (NYSE American: MYO) (“Myomo,” or the “Company”), a wearable medical robotics company, announces that the Centers for Medicare & Medicaid Services (“CMS”) has published a favorable preliminary decision regarding the Company’s application for Healthcare Common Procedure Coding System (HCPCS) “L” codes. Myomo had filed its application in December 2017, to have CMS establish two new Level II HCPCS codes to describe “microprocessor-controlled, custom fabricated upper extremity braces.”

“We are very grateful to CMS and the whole HCPCS Workgroup for their preliminary decision to assign L codes for our MyoPro line of powered orthoses,” said Myomo Chief Medical Officer Dr. Brandon Green. “The MyoPro has already helped so many patients with neurological/neuromuscular injury and illness by supporting their weakened arms, restoring control over their range of motion, reducing their healthcare costs, and giving them back their independence. It is important for clinically qualified Medicare and Medicaid beneficiaries to have access to this technology too”.

If the decision is made permanent, the codes will become effective January 1, 2019.

The assignment of unique L-codes, if followed by appropriate payment terms (which are still pending), would offer greater access to the MyoPro for Medicare beneficiaries.

The CMS preliminary decision on the MyoPro orthoses can be viewed on the following website: https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/2018-06-18-HCPCS-Public-Meeting-Agenda.pdf

About Myomo

Myomo, Inc. is a wearable medical robotics company that offers expanded mobility for those suffering from neurological disorders and upper limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper limb orthosis designed to support the arm and restore function to the weakened or paralyzed arms of patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS or other neuromuscular disease or injury. It is currently the only marketed device that, sensing a patient’s own EMG signals through non-invasive sensors on the arm, can restore an individual’s ability to perform activities of daily living, including feeding themselves, carrying objects and doing household tasks. Many are able to return to work, live independently and reduce their cost of care. Myomo is headquartered in Cambridge, Massachusetts, with sales and clinical professionals across the U.S. For more information, please visit www.myomo.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding the Company’s future business expectations, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors, and include statements regarding the therapeutic benefit of our products, and the preliminary decision published by CMS relating to our application for HCPCS codes and the potential for greater access to MyoPro for Medicare beneficiaries. Our actual results could differ materially from those anticipated in these forward looking statements for many reasons, including, without limitation, risks related to regulatory approval and market acceptance of our products, including that there can be no assurance that the CMS decision will be made permanent and that receipt of this preliminary decision or any permanent decision by CMS would result in any greater access to our products or reimbursement therefor, and the other risk factors contained in our filings made with the Securities and Exchange Commission. More information about factors that potentially could affect Myomo’s financial results is included in Myomo’s filings with the Securities and Exchange Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements,


which speak only as of the date made. The Company disclaims any obligation subsequently to revise any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.

For Myomo:

[email protected]

Investor Relations:

Vivian Cervantes

PCG Advisory

212-554-5482

[email protected]

Public Relations:

Rachel Robbins

Greenough

617-275-6521

[email protected]

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