NEOS Cranial LOOP™ Receives FDA Clearance for CustomizedBone™ Use

Rhea-AI Summary

Kelyniam Global and Fin-ceramica's NEOS Surgery Cranial LOOP™ fixation system receives 510(k) clearance from the FDA for use with CustomizedBone™ hydroxyapatite cranial implants. The system, made of PEEK-OPTIMA™, offers rapid fixation, low infection rate, and pediatric indication, enhancing Kelyniam's sales momentum.

CANTON, Conn., April 2, 2024 /PRNewswire/ -- Kelyniam Global (OTC:KLYG) and Fin-ceramica, Faenza S.p.a., makers of custom cranial implants, announced today that the NEOS Surgery Cranial LOOP™ fixation system has received 510(k) clearance from the FDA for use with Finceramica's CustomizedBone™ hydroxyapatite cranial implant.

The Cranial LOOP™ family of cranial fixation devices is a smart system made of PEEK-OPTIMA™, a biocompatible polymer, for securely fixing bone flaps after craniotomies. With more than 10 years of market experience, Cranial LOOP™ is being used in public and private hospitals in 25 countries worldwide. Cranial LOOP™ was first cleared by the FDA in 2010.  The most recent 510k clearance is for use specifically with Finceramica's CustomizedBone™ hydroxyapatite cranial implant. 

Ross Bjella, Kelyniam's CEO, said, "This approval will further boost Kelyniam's sales momentum which started in Q4 last year. Alongside the low infection rate and pediatric indication, the rapid fixation provided by the Cranial LOOP™ system is now an added benefit for neurosurgeons choosing CustomizedBone™ for their patients."

Since 2004 over 9000 CustomizedBone™ hydroxyapatite implants have been sutured in place. Hydroxyapatite, similar to human bone, facilitates seamless osteo-integration into patients' skulls. CustomizedBone™ is internationally recognized for its reduced infection risk and is indicated for use in children as young as 7 years old. 

The NEOS Surgery Cranial LOOP™ system offers rapid implant fixation in under two minutes using just three devices. Crafted from PEEK (poly ether ether ketone), it ensures radiolucency for artifact-free imaging (CT and MRI) during post-operative monitoring. Cost-wise, Cranial LOOP™ is comparable to traditional plate and screw systems. Kelyniam exclusively distributes CustomizedBone™ implants with the NEOS Cranial LOOP™ in the U.S.

About Finceramica
Fin-Ceramica Faenza S.p.A. founded in as a spin-off from the Institute for Science and Technology for Ceramics (ISTEC-CNR) in Faenza, Italy, epitomizes Italian excellence. Acquired by the Tampieri Financial Group, Finceramica seamlessly blends ceramic tradition with biomedical innovation.  Specializing in organic materials, the company creates medical solutions for bone and cartilage repair. These biomaterials promote rapid recovery by facilitating human cell colonization. Notably, CustomizedBone™ implants enable simultaneous cancer extirpation and cranial cavity reconstruction. Finceramica's global expertise focuses on excellence in niche products that significantly improve patients' lives.

About Kelyniam

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. 

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SOURCE Kelyniam Global Inc

FAQ

What is the significance of the FDA 510(k) clearance for the NEOS Surgery Cranial LOOP™ fixation system?

The FDA clearance allows the system to be used with Finceramica's CustomizedBone™ hydroxyapatite cranial implants, enhancing its market potential.

What are the key features of the Cranial LOOP™ fixation system?

The system is made of PEEK-OPTIMA™, provides rapid implant fixation in under two minutes, has a low infection rate, and is indicated for pediatric use.

How many CustomizedBone™ hydroxyapatite implants have been sutured in place since 2004?

Over 9000 CustomizedBone™ hydroxyapatite implants have been sutured in place since 2004.

What are the benefits of CustomizedBone™ hydroxyapatite implants?

CustomizedBone™ implants facilitate seamless osteo-integration into patients' skulls, have a reduced infection risk, and are suitable for children as young as 7 years old.

Who exclusively distributes CustomizedBone™ implants with the NEOS Cranial LOOP™ in the U.S.?

Kelyniam exclusively distributes CustomizedBone™ implants with the NEOS Cranial LOOP™ in the U.S.