CENTRIC MEDICAL™ ANNOUNCES COMMERCIAL LAUNCH OF MTP PLATING SYSTEM

Huntley, IL, April 30th, 2019 —

Centric Medical, the Foot & Ankle division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology announced today the commercial launch of its MTP Plating System. This System is comprised of various plates, screws and other fixation components intended to stabilize bone segments for indications within the foot and ankle.

“Centric Medical’s MTP Plating System is an innovative, patient focused, system that is surgeon friendly and allows for flexibility in the treatment of those patients' who require instrumentation in the mid and forefoot region,” said Timothy Fredrich, DPM of Certified Foot and Ankle Specialistsin Chicago, IL.

The MTP Plating System joins Centric Medical’s full-line of product offerings, which consists of SATURN™ External Fixation System, TARSA-LINK®Stand-Alone Wedge Fixation System, TARSA-LINK Bunion Correction System and ROGUE®Hammertoe Correction System. The MTP Plating System is designed to be constructed for each patient’s unique condition utilizing a variety of structural components and a set of simple instrumentation. The system offers plates that are low in profile and flush fitting screws. Built in compression slots offer 1.5mm of compression, generous window for ease of cross screws placement, 2.7mm and 3.5mm self-drilling, self-tapping locking and non-locking screw options.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois. For more information, please visit:  http://www.centricmedical.com. 

CENTRIC MEDICAL™ ANNOUNCES FIRST CLINICAL CASES WITH SATURN™ EXTERNAL FIXATION SYSTEM

Huntley, IL, March 15th, 2019

Centric Medical, the Foot & Ankle division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology announced today the first clinical cases of SATURN External Fixation System. This System is comprised of various rings, struts, pins, bolts, and other fixation components intended to be used as a means to stabilize bone segments for indications within the foot and ankle. 

“Centric Medical’s SATURN External Fixation System is a well-designed, patient focused, device that is surgeon friendly and allows for flexibility in the treatment of those patients' who are in need of an external fixator,” said Raymond Rowan, DPM of Certified Foot and Ankle Specialists in Palm City, FL.

SATURN joins Centric Medical’s product offering, which consists of TARSA-LINK®Stand-Alone Wedge Fixation System, TARSA-LINK Bunion Correction System, ROGUE®Hammertoe Correction System and MTP Plating System. The SATURN External Fixation System is designed to be constructed for each patient’s unique condition utilizing a variety of structural components and a set of simple instrumentation. The rings offer a generous amount of fixation points and each strut has rapid and gradual length adjustments to provide the physician greater flexibility and precision in constructing the frame.

CENTRIC MEDICAL™ ANNOUNCES 510(K) CLEARANCE OF THE SATURN™ EXTERNAL FIXATION SYSTEM

Centric Medical, a division of Life Spine®, Inc., which focuses on developing surgical implants for the treatment of lower distal extremity pathology, announced today That the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the SATURN External Fixation System which consists of rings, struts, threaded rods, pins, wires and connectors intended to be used as a means to stabilize the foot, ankle and long bone segments.

“I am excited to continue the expansion of our foot and ankle portfolio with more complex solutions like the SATURN External Fixation System. The system has a wide variety of components to allow for a unique anatomical construct for each patient. The key features were designed with the intention to reduce operating time and provide greater ease of use for the surgical team,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine and Centric Medical, “because the procedure involves so many moving pieces, it is crucial for the design to be simple, efficient and user-friendly.” 

The external fixation system is the tenth 510(K) clearance for Life Spine in the last year and can be utilized for fusions, fractures, deformity reconstructions, tumors and Charcot Reconstructions.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois. For more information, please visit:  http://www.centricmedical.com. 

CENTRIC MEDICAL™ ANNOUNCES NEW RELEASE OF STERILE-PACKED ROGUE+™ HAMMERTOE CORRECTION SYSTEM IMPLANTS

HUNTLEY, Ill.--(BUSINESS WIRE)--Centric Medical, the Foot & Ankle division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology announced today the release of the ROGUE+ Hammertoe Correction System. This sterile-packed innovative system adds to the original implant design also available, while providing internal fixation via a dual threaded construct which is inserted between the proximal and middle phalanges so that the opposing threads fixate within the phalangeal canals of the toe to compress the proximal interphalangeal (PIP) joint.

“Centric Medical’s Rogue+ Hammertoe Correction System implant is a well-designed, patient focused, surgeon friendly device that allows for safe and predictable treatment of patients' forefoot problems,” said Gregory G. Caronis, M.D. of Libertyville, Illinois.

The sterile-packed ROGUE+ Hammertoe Correction implant is designed to have less implant extruding into the PIP Joint when reducing the joint, which allows for easier reduction of the joint and less bone removal, maintaining more of the original toe length. It offers benefits of strength, compression, internal bone fixation and simplicity. With streamlined instrumentation to reduce OR time, along with an improved technique, the implant can be consistently placed across the PIP Joint to optimize bone purchase in the proximal and middle phalanx.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.centricmedical.com.

CENTRIC MEDICAL ANNOUNCES FIRST QUARTER PARTICIPATION AT INDUSTRY MEETINGS TO SHOWCASE ITS FOOT & ANKLE PORTFOLIO

Centric Medical, the Foot & Ankle division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology announced today that it will be participating in the 2018 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting which will be held March 6-10 in New Orleans, Louisiana, as well as the 76th Annual 2018 American College of Foot and Ankle Surgeons (ACFAS) Meeting to be held March 22-25 in Nashville, Tennessee. The meetings are expected to attract over 12,000 and 1,800 surgeons, respectfully, with other healthcare professionals from across the globe. 

Centric Medical will be promoting the TARSA-LINK® Stand-Alone Wedge Fixation System, the TARSA-LINK® BUNION Stand-Alone Wedge Fixation System, the ROGUE™ Hammertoe Correction System, as well as the newly FDA cleared Foot Plating System and the Cannulated Screw System. In addition, Centric Medical will highlight their Biologics systems, including OSTEO-LINK® 100% Demineralized Bone Matrix and MARROW CELLUTION™ Bone Marrow Harvesting System. Centric Medical’s booth number at AAOS is 714, and booth number at ACFAS is 339.

CENTRIC MEDICAL ANNOUNCES FDA 510(K) CLEARANCE OF THE FOOT AND ANKLE PLATING SYSTEM

HUNTLEY, Ill.--(BUSINESS WIRE)--Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology announced today the FDA 510(k) clearance of the new Foot and Ankle Plating System. This clearance offers multiple surgical solutions by Centric Medical, to be used in Foot & Ankle reconstruction procedures.

The Centric Medical Foot and Ankle Plating System is comprised of a variety of plates and screws intended to stabilize and fixate bone for a myriad of procedures. The low-profile plates and self-drilling and self-tapping screws were designed to minimize soft tissue disruption and irritation. They are offered in non-sterile, single use implantable components and are provided in a multitude of sizes and shapes which include plates specifically designed for metatarsal phalangeal fusions, lapidus fusions, midfoot fusions and calcaneal slide osteotomies.

“The new Centric Medical Foot and Ankle Plating System is an integral and essential system which adds to a portfolio previously comprised of novel technologies. When paired with our recently FDA cleared Cannulated Screw Internal Fixation System, and our existing OSTEO-LINK® DBM biologics product, we have the potential for excellent clinical outcomes,” said Mariusz Knap, Vice President of Marketing for Life Spine. “As one of the fastest-growing, most innovative companies in our space it is crucial to our surgeons and patients that we continue to advance our offerings.”

CENTRIC MEDICAL™ ANNOUNCES FDA 510(K) CLEARANCE OF THE CANNULATED SCREW INTERNAL FIXATION SYSTEM FOR FOOT AND ANKLE INDICATIONS

Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the Cannulated Screw Internal Fixation System. This clearance further expands the offering of Cannulated Screws for Centric Medical, to be used in Foot & Ankle reconstruction procedures.

"I am excited to add another cannulated screw option to our rapidly growing foot and ankle portfolio. This addition has allowed for a more robust offering for distal extremity procedures including reconstruction, joint fusion, osteotomies, fracture repair, arthrodesis and fracture fixation," said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine. "The system is extremely easy to use, low profile and offers partially and fully threaded options. I am incredibly proud that Centric Medical saw five 510K clearances in 2017 and I think a full cannulated screw selection is an integral step to a complete foot and ankle portfolio."

The Cannulated Screw Internal Fixation System is a streamlined multi-component system comprised of titanium alloy, with a wide variety of diameters and lengths. The new options, which are specifically indicated for the forefoot, come in 2.0, 2.5, and 3.0mm diameters with headed and headless designs. This system complements the previously FDA cleared range of 3.5-7.5mm diameters indicated for the midfoot and hindfoot which also offer designs with and without a head.

CENTRIC MEDICAL™ ACHIEVES RECORD SALES GROWTH OF FOOT AND ANKLE AND BIOLOGICS PRODUCT LINES OVER PAST YEAR

Huntley, IL, September 5th, 2017 –

Centric Medical, a division of Life Spine®, Inc., which focuses on developing surgical implants for the treatment of lower distal extremity pathology, announced today record revenue growth of their TARSA-LINK™ Stand-Alone Wedge Fixation System and ROGUE™ Hammertoe Correction System within their Foot & Ankle division, plus OSTEO-LINK® 100% Demineralized Bone Matrix and MARROW CELLUTION™ Bone Marrow Harvesting System within their Biologics division.

“The groundbreaking TARSA-LINK Stand-Alone Wedge Fixation System, which was the market’s first stand-alone osteotomy wedge with built-in fixation, along with the TARSA-LINK Bunion Correction System designed as the first stand-alone opening base wedge with built-in fixation on the market, have provided us with a leading foot and ankle portfolio offering,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine. “We then introduced the ROGUE Hammertoe Correction System to the market, amongst other products. The revenue gained within Centric Medical in the past eight months alone is over 112% compared to the full year prior. These innovative systems are just a small part of a successfully growing foot and ankle portfolio.”

“Within the Osteobiologics product division, revenue growth of 105% has already been seen in the past eight months when compared to the prior full year,” continued Mr. Knap. According to in-vivo test results, OSTEO-LINK has been engineered and processed to deliver the highest level of osteoinductivity characteristic with 100% DBM by weight. “We are excited to include our new offering called OSTEO-LINK Hydratable ICM (Inductive Carrier Matrix), which is an osteoinductive bone matrix that may be hydrated with saline, blood, BMA, or PRP. We can also offer surgeons the ability to capture BMA with our MARROW CELLUTION Bone Marrow Harvesting System. It is designed to overcome the limitations of a traditional bone marrow needle and results in a bone marrow harvest that is so rich in key stem and progenitor cells that the aspirate may no longer require manipulation through centrifugation prior to application. This allows the surgeon to complete a true bone healing triad for the greatest possible clinical outcomes.” 

Centric Medical™ Announces Initial Cases for Hammertoe Correction System

Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today that the company has successfully completed initial cases with the Hammertoe Correction System. The innovative system offers a dual threaded design and is inserted between the proximal and middle phalanges so that the opposing threads fixate on the phalangeal canal of the toe and compress the joint.

“Centric Medical’s Hammertoe Correction System is the latest in the rapid evolution of permanent implants to improve the results of hammertoe surgery. This outpatient procedure is quick and the Hammertoe System provides excellent fixation and compression to permanently correct hammertoe deformities. Patients no longer need to have pins sticking out the ends of their toes, eliminating the requirement for follow-up surgery,” said Dr. David Friscia of Eisenhower Medical Center in Rancho Mirage, California.

The Hammertoe Correction System is scheduled for a limited release in Q2 of 2017.  The initial case follows the news of FDA clearance of Centric Medical’s Metatarsal Hemi Implant. These systems are part of a growing portfolio which includes innovative osteobiologic products, as well as the groundbreaking TARSA-LINK™ Stand-Alone Wedge Fixation System, the market’s first stand-alone osteotomy wedge with built-in fixation. The system was released to the market in September 2016.

Centric Medical™ Announces FDA Clearance of Metatarsal Hemi Implant System

Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the Metatarsal Hemi Implant System. The Metatarsal Hemi Implant for the metatarsophalangeal joint is intended for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement or without bone cement. 

The Metatarsal Hemi Implant has a round head and tapered stem that is fixated to the first metatarsal. The round head resurfaces the metatarsal head at the metatarsophalangeal joint. The Metatarsal Hemi Implant utilizes a cobalt chrome and highly polished “mirror” finish head that minimizes friction between articulating surfaces, reducing cartilage wear. The implant comes in 5 sizes to accommodate varying patient anatomies, and has an anti-rotational stem to increase implant stability. 

The Metatarsal Hemi Imlant joins a growing portfolio which includes innovative osteobiologic products, as well as the groundbreaking TARSA-LINK™ Stand-Alone Wedge Fixation System, the market’s first stand-alone osteotomy wedge with built-in fixation. The system was released to the market in September 2016. 

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois.

Centric Medical™ Announces FDA Clearance of TARSA-LINK™ Bunion System

HUNTLEY, Ill.--Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance to the TARSA-LINK Bunion Correction System. The TARSA-LINK Bunion System is the first stand-alone opening base wedge with built-in fixation on the market. It is utilized for internal bone fixation for bunionectomies, opening base wedge osteotomies, bone fractures, fusions, or trauma.

“The TARSA-LINK Bunion System vastly improves the standard of care for opening base wedge osteotomy patients,” said Rich Mueller, Chief Operating Officer for Life Spine. “In past opening base wedge osteotomies, a plate and screws were placed on the outside of the first metatarsal for fixation. This type of construct can be irritating post-operatively by protruding against footwear. The TARSA-LINK Bunion System has built in fixation and sits flush within the bone, reducing the possibility of site irritation. This stand-alone system also reduces procedure time and offers stabilization equivalent to traditional constructs.”

The TARSA-LINK Bunion System is the sixth 510(k) clearance in a year, joining Centric Medical’s portfolio which includes innovative osteobiologic products. It is one of seventeen patents pending in Centric’s portfolio including the clearance last week of the state-of-the-art Hammertoe Correction System. The TARSA-LINK Bunion System is scheduled for release in the fourth quarter this year.

“The TARSA-LINK Bunion System vastly improves the standard of care for opening base wedge osteotomy patients”

Rich Mueller, Chief Operating Officer for Life Spine

Centric Medical™ Announces FDA Clearance of Hammertoe Correction System

HUNTLEY, Ill.--Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the Hammertoe Correction System. The Hammertoe Correction System offers a dual threaded design and is inserted between the proximal and middle phalanges, so that the opposing threads fixate on the phalangeal canal of the toe and compress the joint.

The current standard of care for hammertoe correction is to treat patients with wire pins (also known as “K-wires”). Many patients complain about the inconveniences that come with the wire pins, which are exposed out the end of the phalange(s) for multiple weeks. These wire pins can break and dislodge. In addition, a follow up surgery is required to remove the pins.

Dr. Kyle Pearson of Rezin Orthopedics and Sports Medicine in Morris, IL, said, “Due to the advanced technology in this Hammertoe Correction System, the implant provides maintained correction through stability and compression at the PIPJ, and avoids the complications associated with K-wires.” This newest innovation allows the implant to remain within the bone, eliminating the need for the follow up surgery to remove the pin(s), and permanently correcting the pain and deformity of hammertoes.

The Hammertoe Correction System is designed around one of seventeen patents pending in the Centric portfolio, and represents the fifth 510(k) clearance for Centric Medical in the past twelve months. The system joins a growing portfolio which includes innovative osteobiologic products, as well as the groundbreaking TARSA-LINK™ Stand-Alone Wedge Fixation System, the market’s first stand-alone osteotomy wedge with built-in fixation. The system will be released to the market in September 2016.

"Due to the advanced technology in this Hammertoe Correction System, the implant provides maintained correction through stability and compression at the PIPJ, and avoids the complications associated with K-wires"

Dr. Kyle Pearson of Rezin Orthopedics and Sports Medicine in Morris, IL

Centric Medical™ Announces 510k Approval of Subtalar Arthroereisis Implant System for Foot and Ankle

HUNTLEY, Ill.--Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the Subtalar Arthroereisis Implant System for treating hyperpronation of the foot and stabilization of the subtalar joint.

The Subtalar Arthroereisis Implant System is a one-piece titanium implant designed to facilitate correction of pathologic flatfoot deformities by blocking forward, downward and medial displacement of the talus, thus allowing normal articulation of the subtalar joint while deterring excessive pronation. The innovation of the system rests in its gradually softened threads which aid in minimizing edge effects that may lead to pain while resisting migration, in addition to being fully cannulated to guide accurate insertion.

The Subtalar Arthroereisis is the fourth 510(k) clearance in a year for Centric Medical and its suite of innovative osteobiologic products. It is one of seventeen patents pending in Centric’s portfolio including the groundbreaking TARSA-LINK™ Stand-Alone Wedge Fixation System, the first stand-alone Osteotomy wedge with built-in fixation on the market, which was released earlier this year. The Subtalar Arthroereisis Implant System is scheduled for limited release at the end of 2016 with full product release expected in the first quarter of 2017.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois.

Centric Medical™ Announces Full Market Release of TARSA-LINK™ Stand-Alone Wedge Fixation System for Foot and Ankle

HUNTLEY, Ill.--Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today the full market release of TARSA-LINK Stand-Alone Wedge Fixation System, for internal bone fixation of fractures, fusions and osteotomies in the foot and ankle. TARSA-LINK joins Centric Medical’s suite of innovative osteobiologic products. “The TARSA-LINK wedge is a powerful device that can be used to correct flatfoot deformities. It truly allows for the optimal amount of correction needed for each patient’s unique anatomy,” said Dr. Caronis, of Greenleaf Orthopaedics & Physical Therapy located in Libertyville, Illinois. “Because the implant is made from a PEEK material, it provides greater stability than an allograft, while eliminating the risk of donor graft rejection. The implant’s design facilitates the use of screws that can be placed through the wedge, locking in the correction while providing a stable environment for fusion.”

TARSA-LINK is the first stand-alone Osteotomy wedge with built-in fixation on the market. It is primarily utilized for procedures including Evans Osteotomy, Cottons Osteotomy, Bunionectomies, fractures, and fusions. This groundbreaking wedge boasts reduced procedure time owing to the incorporated screws, thereby eliminating the need for an additional plate.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois.

Because the implant is made from a PEEK material, it provides greater stability than an allograft, while eliminating the risk of donor graft rejection. The implant’s design facilitates the use of screws that can be placed through the wedge, locking in the correction while providing a stable environment for fusion.

Dr. Caronis, of Greenleaf Orthopaedics & Physical Therapy located in Libertyville, Illinois