Kelyniam to Become Source Supplier of Custom Cranial Implants Using FDA Approved Polymers
April 28 2009 - 9:00AM
Marketwired
Kelyniam Global, Inc. (PINKSHEETS: KLYG), an advanced Engineering
and Rapid Prototyping Company specializing in the use of CADCAM
technology, announced today that the company will become a Source
Supplier of Custom Cranial Implants and Maxillofacial structures
using our engineering expertise and knowledge of high tolerance
manufacturing and advance polymers.
Kelyniam announced in a press release dated November 10, 2008,
that the cranial implant process the company was involved with was
under FDA inspection. Since this announcement, the company has
decided to create an entire process of its own, removing all supply
line vendors and increasing revenue generation and
profitability.
James Ketner, President and CEO of Kelyniam Global, Inc.,
stated: "I would like to take some time to update the shareholders
on why this decision was made, and what happened to cause us to go
in this direction. Kelyniam's previous role in the Cranial Implant
process was to provide a Tier 1 supplier with models generated from
CT data that were a near perfect replication of the area in the
skull to be replaced. Those models were used by this Tier 1
supplier to create a mold in which a Bio-Compatible Material was
injected that was then going to be the actual piece that went into
the human body. This Bio-Compatible Material then needed to be
sterilized before shipping to a major medical supplier, and that
medical supplier then shipped the finished product to the hospital,
which went into the OR and was implanted into the patient. The
medical products supplier that we were supplying encountered some
difficulties in the sterilization process which required further
inspection by the FDA. These problems had nothing at all to do with
our product. In general, we fixed the problems by taking on the
entire process cradle to grave, and by eliminating any other
manufactures in the process. We will have the ability to sell
directly to the Doctors, or have the possibility of contracting a
major medical supplier.
This new process will be the following:
1. Receipt of CT Scanned Data from Hospital.
2. Translate CT Scanned Data into CADCAM Data.
3. We are going to machine the actual piece that goes into the
body by the use of computerized numeric control (CNC), eliminating
the necessity for creating a mold. The material we are going to use
in the machining process is an FDA approved, PEEK
(polyaryletheretherketone), extremely high grade polymer with
temperature properties which will allow us to sterilize by the use
of steam and pressure instead of Ethylene Oxide which the FDA was
having a problem with.
4. By the use of Stereolithography, we will create a "Host
Bone," i.e. the undamaged part of the body, to use as a "Go, No Go"
check gage which will be inspected using our advanced laser scanner
against the CT Scanned Data supplied to us by the hospital, and the
replacement bone piece will be checked against the mating host
bone.
5. The sterilized machined implant will go directly to the OR,
accompanied by the inspected host bone and laser scanned inspection
data, and will then be installed into the patient.
We are going to initially out-source the sterilization process
in order to reduce the lead time for this new process to become
operational. We are expecting this process to be up and running in
45-60 days after this announcement. By removing any suppliers in
the implant process and by Kelyniam undertaking the entire process
cradle to grave, the time it takes from scan to the delivery of the
implant will be reduced. We also then have nobody to blame for the
success or failure of our products due to quality issues except
ourselves."
Kelyniam created approximately 350 cranial implant models in 9
months of 2008 and is anticipating a conservative estimate to be
able to produce 460 of these per year based on 2008 historic
production of 38 units per month. The company is also investigating
the use of the FDA approved polymers and this type of production
method in all aspects of artificial bone replacements throughout
the human body.
A study, using a well developed in vitro model published by
researchers at the University of Connecticut, observed
differentiated bone cells and mineralization upon the PEEK-OPTIMA
surfaces. This latest observation, along with the growing number of
published findings using the polymer, suggests that PEEK-OPTIMA may
lend itself to Osseointegration -- the direct connection between
the bone and implant surface. www.azom.com/news.asp?newsID=8284
Kelyniam Global, Inc. recently posted a video which explains
more about the company's new and exciting medical process utilizing
CADCAM technology. Please take in consideration that the process
discussed in the video has now changed somewhat, and Kelyniam now
produces the end product. The video can be watched by going to the
company website, and selecting the "Watch our New Medical Video" on
Kelyniam's home page, or by following the link
www.kelyniam.com/video.wmv
About Kelyniam Global, Incorporated:
Kelyniam Global, Inc. service a vast array of clients across
numerous fields and industries encompassing, but not limited to,
medical, automotive, aerospace, jewelry, nautical and consumer
products. The company specializes in the use of CADCAM technology
with recent developments in the production of high precision
replication of artificial bone implants for medical
applications.
More information about Kelyniam Global, Inc. can be found by
following the links provided on our home page. www.kelyniam.com
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Contact: John Mastoloni VP/Sales Engineering Division Kelyniam
Global, Inc. www.kelyniam.com 1-860-832-9331 X221
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