Kelyniam Global, Inc. OTC Trading & Business Matters Update

Rhea-AI Summary

Kelyniam Global (OTC: KLYG) has submitted all documentation to establish itself as a 'Pink Current' filer ahead of the September 30, 2021 deadline. This move reflects the company's commitment to transparency for its shareholders. Until the review is complete, Kelyniam will remain a 'Pink Limited' filer but will continue to have its stock actively traded. The company also reported advancements regarding its Integrated Fixation System (IFS) patent and a positive acknowledgment from the FDA concerning its remediation plan on earlier observations.

Positive

• Submission of documentation for 'Pink Current' status ahead of deadline could enhance market visibility.
• Progress on Integrated Fixation System (IFS) patent review strengthens intellectual property position.
• FDA acknowledged the company's remediation plan for prior observations, indicating regulatory progress.

Negative

• Kelyniam will remain a 'Pink Limited' filer until the OTC review is complete, potentially limiting investor confidence.

CANTON, Conn., Sept. 30, 2021 /PRNewswire/ -- Kelyniam Global (OTC:KLYG), a maker of custom cranial implants, is pleased to announce that the company has submitted all of the documentation required for establishment as a "Pink Current" filer under the new SEC Rule 15c2-11 ahead of schedule for the September 30, 2021 deadline.  The submission of information to the OTCIQ portal and achieving "Pink Current" filing status is in keeping with Kelyniam's commitment to transparency and shareholder disclosure.

Kelyniam has submitted all of the documentation required for establishment as a "Pink Current" filer

Kelyniam will be considered a "Pink Limited" filer until OTC Markets completes their review of the documentation.  OTC Markets has indicated the volume of companies submitting information has delayed their ability to advance filers to "Pink Current" status until after September 30, 2021.  "Pink Limited" filing companies will continue to have their stock quoted and traded as before. 

"We would like to thank the shareholders who have supported Kelyniam all these years" said Ross Bjella, Kelyniam's CEO. "Our goal is to ensure our shareholders can participate in the financial benefits of our company's success.  "Pink Limited" status will ensure KLYG will continue to trade actively and provide for a liquid market and appropriate pricing of the external float until "Pink Current" status is approved."

In August, the U.S. Patent Office notified Kelyniam that the Integrated Fixation System (IFS) warranted new product review.  Kelyniam will be moving forward to vigorously document and further strengthen the intellectual property protections of our innovative design.    

"The protection of our valuable intellectual property and the use of the IFS technology in many surgeries demonstrates the value and surgical flexibility of this breakthrough technology in the hands of some of the world's leading neurosurgeons," said Bjella.

The Company recently received a letter from the FDA following a response to observations noted in a 483 warning letter previously disclosed by the Company earlier this year.  The FDA letter acknowledged the Company's remediation plan for the majority of the observations and requested regular updates regarding two specific observations.  These observations require certain documentation from both internal and third party sources that are currently in progress.  Kelyniam is aggressively working to provide this additional information.   

Kelyniam Inc., specializes in the rapid production of custom prosthetics utilizing computer aided design and computer aided manufacturing of advanced medical grade polymers.  The Company develops, manufactures, and distributes custom cranial and maxillo-facial implants for patients.  Kelyniam works directly with surgeons, health systems and payors to improve clinical and cost-of-care outcomes. Kelyniam's web site address is www.Kelyniam.com.

As a cautionary note to investors, certain matters discussed in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such matters involve risks and uncertainties that may cause actual results to differ materially, including the following: changes in economic conditions; general competitive factors; the Company's ability to execute its service and product sales plans; changes in the status of ability to market products; and the risks described from time to time in the Company's SEC reports. 

 

View original content:https://www.prnewswire.com/news-releases/kelyniam-global-inc-otc-trading--business-matters-update-301388445.html

SOURCE Kelyniam Global, Inc.

FAQ

What is the significance of Kelyniam Global's 'Pink Current' filing status?

Achieving 'Pink Current' status enhances Kelyniam's market visibility and transparency for investors.

What updates have there been regarding Kelyniam's Integrated Fixation System patent?

The U.S. Patent Office has notified Kelyniam that the IFS warrants new product review, which may enhance their intellectual property.

How did the FDA respond to Kelyniam's remediation plan?

The FDA acknowledged Kelyniam's remediation plan for previous observations, but required regular updates on certain documentation.