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Monday, April 22, 2013 10:03:43 PM
KLYG.. $0.0562..
Kelyniam is a Medical Device Manufacturing Company that specializes in the production of custom prosthetics utilizing computer aided design and computer aided manufacturing of advanced medical grade polymers. The company's Engineering Division is constantly working with medical professionals by allowing them to operate more effectively, improving patient care, and reducing health care cost by providing the highest quality products available with today's technology. Kelyniam is continually researching and developing new products and processes to help patients live more active and productive lives.
Our Engineering Division has recently made significant advancements in the use of Bio-CADCAM technology such as providing near perfect replicated Cranial implants to replace damaged bone structures. Similarly to our most recent acquisitions, Kelyniam is constantly in search of value enterprises and investment opportunities in North and South America. The company's long term business goals are to advance our existing technology and capabilities, and to acquire or invest in High Technology industries which management has extensive experience in order to consistently add shareholder value.
KELYNIAM LATEST NEWS:
Kelyniam Custom Cranial Implants Receive Endorsement From Skull Based Neurosurgeon Dr. Ammirati of The Ohio State University Wexner Medical Center,
February, 01
Kelyniam Global Inc. Announces Record Revenues,
January, 15
============================================================
Kelyniam Custom Cranial Implants Receive Endorsement From Skull Based Neurosurgeon Dr. Ammirati of The Ohio State University Wexner Medical Center
Canton, CT, Jan. 29, 2013 (GLOBE NEWSWIRE) -- (OTC: KLYG) Kelyniam Custom Cranial Implants, designed to fill the boney void in a patient's skull, have been endorsed by Mario Ammirati, MD, Director of Skull Based Surgery, Stereotactic Radiosurgery and the Dardinger Microneurosurgical Skull Based Laboratory, Wexner Medical Center, at the Ohio State University. This is the first product Dr. Ammirati has ever endorsed.
Dr. Ammirati stated: "As a neurosurgeon specializing in skull based surgery and brain tumors, I am encouraged with the advancements Kelyniam has made in patient customized cranial implants. I am extremely happy with the precision fit and the fast service I receive with every case. Complex cranial defects resulting from trauma or oncologic resection present reconstructive challenges. No matter how complex the defect, Kelyniam's implant design team is very responsive to my needs. They understand the surgical plans and are quick to respond to my design requirements. The end result is a product that fits very well and is quick to implant, thereby reducing O.R. time and providing the patient with excellent aesthetic results."
Forward-Looking Statements
Except for historical information contained in this release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this release, words such as "anticipate," "believes," "estimate," "expect," "should," "intend," "projects," "objective" and "appears" and similar expressions, as they relate to the Company or its management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of the Company's management, as well as assumptions made by and information currently available to the Company's management. Among the factors that could cause actual results to differ materially are the following: the effect of business and economic conditions; the impact of competitive products and pricing; capacity and supply constraints or difficulties; product development, commercialization or technological difficulties; the regulatory and trade environment; the impact of reimbursement rates and coverage; and the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to revise any forward-looking statements as a result of future events or developments.
Source: Kelyniam Global Inc.
2013 GlobeNewswire, Inc.
===================================================
Kelyniam Global Inc. Announces Record Revenues
Canton, CT, Jan. 15, 2013 (GLOBE NEWSWIRE) --
Third Quarter
Kelyniam is pleased to announce record quarterly revenues of $382,177 for the third quarter ending September 30th 2012. This represents almost double the product revenue produced in the second quarter 2012. The company continues to penetrate the custom cranial implant marketplace and has sold implants to medical institutions in more than 20 different states. Furthermore, the company has sold the first maxiofacial implants in the fourth quarter as a result of the recent FDA 510k approval in late third quarter.
Fourth Quarter
The debut of Kelyniam maxiofacial implants in the fourth quarter was met with orders. These orders combined with existing custom cranial implant orders propelled revenues to approximately $400,000 for the fourth quarter, exceeding internal expectations of a slow quarter due to multiple holidays and fewer surgeries. Final fourth quarter numbers will be released once a full accounting is complete.
"The final two quarters of the year demonstrate that both the custom cranial and maxiofacial implant markets have capacity for a product of superior design. Management has worked hard to right the ship in 2012 and looks to build on the momentum in 2013" stated President and CEO Tennyson Anthony. "Kelyniam not only has created a product that fills the patient's cranial void, but is filling the void in the marketplace for a timely-delivered well-fitting product."
Upcoming Conference
Kelyniam will be exhibiting once again at the North American Skull Base Society (NASBS) February 15th - 17th, in Miami, FL.
Financial tables can be found on the company's website www.kelyniam.com
About Kelyniam Global, Incorporated
Kelyniam Global (Pinksheets: KLYG), Inc. specializes in the use of CAD/CAM technology to provide patient specific custom implants to assist medical professionals by allowing them to operate more effectively, improve patient care, and reduce health care costs by providing the highest quality products available with today's technology. The company is continually researching and developing new products and processes to help patients live more active and productive lives.
Please visit our website at www.kelyniam.com for more information.
Forward-Looking Statements
Except for historical information contained in this release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this release, words such as "anticipate," "believes," "estimate," "expect," "should," "intend," "projects," "objective" and "appears" and similar expressions, as they relate to the Company or its management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of the Company's management, as well as assumptions made by and information currently available to the Company's management. Among the factors that could cause actual results to differ materially are the following: the effect of business and economic conditions; the impact of competitive products and pricing; capacity and supply constraints or difficulties; product development, commercialization or technological difficulties; the regulatory and trade environment; the impact of reimbursement rates and coverage; and the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to revise any forward-looking statements as a result of future events or developments.
Source: Kelyniam Global Inc.
2013 GlobeNewswire, Inc.
=======================================================
Kelyniam Global Inc. Announces Second Quarter 2012 Revenues
Released October 15, 2012
Second Quarter Results
For the quarter ending June 30th 2012 Kelyniam Global reported a loss of $45,692 on custom cranial product revenue of $196,435, compared to a net loss of $149,000 on revenues of $210,000 in the first quarter 2012. The company attributes the slight reduction in revenue to a slow April. Kelyniam expects the tepid sales of the spring to become robust with the arrival of “trauma season”. Trauma season is the seasonal variation in trauma cases during the warmer weather months, according to the American College of Surgeons. http://www.facs.org/trauma/ntdb/fantus/0906.pdf
In addition to the product revenue, the company realized $100,000 of grant revenue from the Connecticut Department of Economic Development (DECD) in the second quarter.
Professional costs were greater in Q2 from several one-time events; the line-of-credit with Westfield Bank and the DECD funding. The company also incurred higher legal fees defending a lawsuit filed by former employee John Mastoloni. The company expects to incur additional legal costs in the coming quarters as the lawsuit continues and therefore will no longer pursuit fully reporting status. Other one-time expenses for the quarter were costs associated with filing the 510k for craniofacial implant approval with the FDA.
Kelyniam had a productive quarter with its emergence as a multiproduct company with the filing of the 510k to manufacture and market craniofacial implants made from PEEK-OPTIMA. In order to facilitate the anticipated growth of several product lines the company took steps to shore up the financials with the line-of-credit and the DECD aid package.
Recent Business Developments
September - Kelyniam received FDA approval to market craniofacial implants in the United States.
September – Kelyniam President and CEO Tennyson Anthony recently traveled to Kuwait to sit down with government officials to discuss their purchasing of Kelyniam products. Mr. Anthony returned very optimistic that a first order will be coming in the near future. During the visit Mr. Anthony met with various doctors and surgeons interested in using the company’s current products and others who were excited about the company’s future products. Ministry of Health officials were quoted as saying to Mr. Anthony, “[O]ur country puts a priority on our healthcare system and has been rapidly developing it since the liberation, therefore we are only interested in the best products. Kelyniam will be a great fit.”
Research & Development
The company continues to allocate resources on improving efficiencies with the manufacturing process. Currently the company is working on prototypes of 2 products that do not yet exist in the medical device marketplace.
==============================================================
KELYNIAM GLOBAL, INC.
Kelyniam Files 510(k) for Custom Craniofacial Implants & Closes Financings....
CANTON, Conn., June 20, 2012 (GLOBE NEWSWIRE) — Kelyniam Global, Inc. (KLYG), a medical device company focused on the design and manufacturing of custom cranial implants, has filed a 510(k) application with the Food and Drug Administration (FDA) for clearance to market a custom craniofacial implant product made from the Invibio PEEK Optima material. The application has been received and is currently in the FDA approval process 510(k) (FDA# K121755).
Financings
Kelyniam has secured a line-of-credit from Westfield Bank (MA). The company recently closed this financing which will give the flexibility to facilitate the custom cranial business as well as expand in other markets and products.
Kelyniam has also closed on an aid package with the State of Connecticut Department of Economic Development. The aid package is designed to assist the company with asset purchases and hiring local skilled workers in support for an expansion plan laid out by management.
“Kelyniam is pleased to have filed this new application for clearance of its custom craniofacial implant, and look forward to the FDA’s review of the application,” said Tennyson Anthony, President/ CEO of Kelyniam. Mr. Anthony went on to say “Management has worked tirelessly this year to put the company on a greater financial footing. We are ecstatic both institutions are confident in the technology behind the manufacture of Kelyniam Custom Skull Implants and the execution of our business plan. We are excited to have the support of a quality financial institution such as Westfield Bank. Shareholders should find great comfort that both financings are non-dilutive.”
About Kelyniam Global, Incorporated
Kelyniam Global Inc. specializes in the use of CAD/CAM technology to provide patient specific custom implants to assist medical professionals by allowing them to operate more effectively, improve patient care, and reduce health care costs by providing the highest quality products available with today’s technology. The company is continually researching and developing new products and processes to help patients live more active and productive lives.
Please visit our website at www.kelyniam.com for more information.
Kelyniam is a Medical Device Manufacturing Company that specializes in the production of custom prosthetics utilizing computer aided design and computer aided manufacturing of advanced medical grade polymers. The company's Engineering Division is constantly working with medical professionals by allowing them to operate more effectively, improving patient care, and reducing health care cost by providing the highest quality products available with today's technology. Kelyniam is continually researching and developing new products and processes to help patients live more active and productive lives.
Our Engineering Division has recently made significant advancements in the use of Bio-CADCAM technology such as providing near perfect replicated Cranial implants to replace damaged bone structures. Similarly to our most recent acquisitions, Kelyniam is constantly in search of value enterprises and investment opportunities in North and South America. The company's long term business goals are to advance our existing technology and capabilities, and to acquire or invest in High Technology industries which management has extensive experience in order to consistently add shareholder value.
KELYNIAM LATEST NEWS:
Kelyniam Custom Cranial Implants Receive Endorsement From Skull Based Neurosurgeon Dr. Ammirati of The Ohio State University Wexner Medical Center,
February, 01
Kelyniam Global Inc. Announces Record Revenues,
January, 15
============================================================
Kelyniam Custom Cranial Implants Receive Endorsement From Skull Based Neurosurgeon Dr. Ammirati of The Ohio State University Wexner Medical Center
Canton, CT, Jan. 29, 2013 (GLOBE NEWSWIRE) -- (OTC: KLYG) Kelyniam Custom Cranial Implants, designed to fill the boney void in a patient's skull, have been endorsed by Mario Ammirati, MD, Director of Skull Based Surgery, Stereotactic Radiosurgery and the Dardinger Microneurosurgical Skull Based Laboratory, Wexner Medical Center, at the Ohio State University. This is the first product Dr. Ammirati has ever endorsed.
Dr. Ammirati stated: "As a neurosurgeon specializing in skull based surgery and brain tumors, I am encouraged with the advancements Kelyniam has made in patient customized cranial implants. I am extremely happy with the precision fit and the fast service I receive with every case. Complex cranial defects resulting from trauma or oncologic resection present reconstructive challenges. No matter how complex the defect, Kelyniam's implant design team is very responsive to my needs. They understand the surgical plans and are quick to respond to my design requirements. The end result is a product that fits very well and is quick to implant, thereby reducing O.R. time and providing the patient with excellent aesthetic results."
Forward-Looking Statements
Except for historical information contained in this release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this release, words such as "anticipate," "believes," "estimate," "expect," "should," "intend," "projects," "objective" and "appears" and similar expressions, as they relate to the Company or its management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of the Company's management, as well as assumptions made by and information currently available to the Company's management. Among the factors that could cause actual results to differ materially are the following: the effect of business and economic conditions; the impact of competitive products and pricing; capacity and supply constraints or difficulties; product development, commercialization or technological difficulties; the regulatory and trade environment; the impact of reimbursement rates and coverage; and the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to revise any forward-looking statements as a result of future events or developments.
Source: Kelyniam Global Inc.
2013 GlobeNewswire, Inc.
===================================================
Kelyniam Global Inc. Announces Record Revenues
Canton, CT, Jan. 15, 2013 (GLOBE NEWSWIRE) --
Third Quarter
Kelyniam is pleased to announce record quarterly revenues of $382,177 for the third quarter ending September 30th 2012. This represents almost double the product revenue produced in the second quarter 2012. The company continues to penetrate the custom cranial implant marketplace and has sold implants to medical institutions in more than 20 different states. Furthermore, the company has sold the first maxiofacial implants in the fourth quarter as a result of the recent FDA 510k approval in late third quarter.
Fourth Quarter
The debut of Kelyniam maxiofacial implants in the fourth quarter was met with orders. These orders combined with existing custom cranial implant orders propelled revenues to approximately $400,000 for the fourth quarter, exceeding internal expectations of a slow quarter due to multiple holidays and fewer surgeries. Final fourth quarter numbers will be released once a full accounting is complete.
"The final two quarters of the year demonstrate that both the custom cranial and maxiofacial implant markets have capacity for a product of superior design. Management has worked hard to right the ship in 2012 and looks to build on the momentum in 2013" stated President and CEO Tennyson Anthony. "Kelyniam not only has created a product that fills the patient's cranial void, but is filling the void in the marketplace for a timely-delivered well-fitting product."
Upcoming Conference
Kelyniam will be exhibiting once again at the North American Skull Base Society (NASBS) February 15th - 17th, in Miami, FL.
Financial tables can be found on the company's website www.kelyniam.com
About Kelyniam Global, Incorporated
Kelyniam Global (Pinksheets: KLYG), Inc. specializes in the use of CAD/CAM technology to provide patient specific custom implants to assist medical professionals by allowing them to operate more effectively, improve patient care, and reduce health care costs by providing the highest quality products available with today's technology. The company is continually researching and developing new products and processes to help patients live more active and productive lives.
Please visit our website at www.kelyniam.com for more information.
Forward-Looking Statements
Except for historical information contained in this release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this release, words such as "anticipate," "believes," "estimate," "expect," "should," "intend," "projects," "objective" and "appears" and similar expressions, as they relate to the Company or its management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of the Company's management, as well as assumptions made by and information currently available to the Company's management. Among the factors that could cause actual results to differ materially are the following: the effect of business and economic conditions; the impact of competitive products and pricing; capacity and supply constraints or difficulties; product development, commercialization or technological difficulties; the regulatory and trade environment; the impact of reimbursement rates and coverage; and the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to revise any forward-looking statements as a result of future events or developments.
Source: Kelyniam Global Inc.
2013 GlobeNewswire, Inc.
=======================================================
Kelyniam Global Inc. Announces Second Quarter 2012 Revenues
Released October 15, 2012
Second Quarter Results
For the quarter ending June 30th 2012 Kelyniam Global reported a loss of $45,692 on custom cranial product revenue of $196,435, compared to a net loss of $149,000 on revenues of $210,000 in the first quarter 2012. The company attributes the slight reduction in revenue to a slow April. Kelyniam expects the tepid sales of the spring to become robust with the arrival of “trauma season”. Trauma season is the seasonal variation in trauma cases during the warmer weather months, according to the American College of Surgeons. http://www.facs.org/trauma/ntdb/fantus/0906.pdf
In addition to the product revenue, the company realized $100,000 of grant revenue from the Connecticut Department of Economic Development (DECD) in the second quarter.
Professional costs were greater in Q2 from several one-time events; the line-of-credit with Westfield Bank and the DECD funding. The company also incurred higher legal fees defending a lawsuit filed by former employee John Mastoloni. The company expects to incur additional legal costs in the coming quarters as the lawsuit continues and therefore will no longer pursuit fully reporting status. Other one-time expenses for the quarter were costs associated with filing the 510k for craniofacial implant approval with the FDA.
Kelyniam had a productive quarter with its emergence as a multiproduct company with the filing of the 510k to manufacture and market craniofacial implants made from PEEK-OPTIMA. In order to facilitate the anticipated growth of several product lines the company took steps to shore up the financials with the line-of-credit and the DECD aid package.
Recent Business Developments
September - Kelyniam received FDA approval to market craniofacial implants in the United States.
September – Kelyniam President and CEO Tennyson Anthony recently traveled to Kuwait to sit down with government officials to discuss their purchasing of Kelyniam products. Mr. Anthony returned very optimistic that a first order will be coming in the near future. During the visit Mr. Anthony met with various doctors and surgeons interested in using the company’s current products and others who were excited about the company’s future products. Ministry of Health officials were quoted as saying to Mr. Anthony, “[O]ur country puts a priority on our healthcare system and has been rapidly developing it since the liberation, therefore we are only interested in the best products. Kelyniam will be a great fit.”
Research & Development
The company continues to allocate resources on improving efficiencies with the manufacturing process. Currently the company is working on prototypes of 2 products that do not yet exist in the medical device marketplace.
==============================================================
KELYNIAM GLOBAL, INC.
Kelyniam Files 510(k) for Custom Craniofacial Implants & Closes Financings....
CANTON, Conn., June 20, 2012 (GLOBE NEWSWIRE) — Kelyniam Global, Inc. (KLYG), a medical device company focused on the design and manufacturing of custom cranial implants, has filed a 510(k) application with the Food and Drug Administration (FDA) for clearance to market a custom craniofacial implant product made from the Invibio PEEK Optima material. The application has been received and is currently in the FDA approval process 510(k) (FDA# K121755).
Financings
Kelyniam has secured a line-of-credit from Westfield Bank (MA). The company recently closed this financing which will give the flexibility to facilitate the custom cranial business as well as expand in other markets and products.
Kelyniam has also closed on an aid package with the State of Connecticut Department of Economic Development. The aid package is designed to assist the company with asset purchases and hiring local skilled workers in support for an expansion plan laid out by management.
“Kelyniam is pleased to have filed this new application for clearance of its custom craniofacial implant, and look forward to the FDA’s review of the application,” said Tennyson Anthony, President/ CEO of Kelyniam. Mr. Anthony went on to say “Management has worked tirelessly this year to put the company on a greater financial footing. We are ecstatic both institutions are confident in the technology behind the manufacture of Kelyniam Custom Skull Implants and the execution of our business plan. We are excited to have the support of a quality financial institution such as Westfield Bank. Shareholders should find great comfort that both financings are non-dilutive.”
About Kelyniam Global, Incorporated
Kelyniam Global Inc. specializes in the use of CAD/CAM technology to provide patient specific custom implants to assist medical professionals by allowing them to operate more effectively, improve patient care, and reduce health care costs by providing the highest quality products available with today’s technology. The company is continually researching and developing new products and processes to help patients live more active and productive lives.
Please visit our website at www.kelyniam.com for more information.
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