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February 2-4, 2017
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BiologicsRegulatory

Regentis Biomaterials Performs the First Cases in GelrinC Pivotal Study

November 30, 2017 OrthoSpineNews

PRINCETON, New Jersey and OR AKIVA, Israel, November 28, 2017 /PRNewswire/ —

Regentis Biomaterials announced today the start of its Phase III pivotal clinical trial of GelrinC for the treatment of focal knee cartilage defects with successful surgery on three patients in the U.S. and Denmark. These procedures are part of a Food and Drug Adminstration (FDA) approved Investigational Device Exemption (IDE) clinical study to compare GelrinC to microfracture, the current standard of care treatment. The clinical study will be used to support a Pre-market Approval Application (PMA) which will allow Regentis to market GelrinC in the U.S.

The US procedures were performed by Dr. Jason Scopp at the Peninsula Orthopaedic Clinic in Salisbury, Maryland and by Dr. Bryan Huber at Mansfield Orthopaedics at Copley Hospital in Morrisville, Vermont while the Denmark procedure was completed by Dr. Martin Lind in Aarhus University Hospital in Aarhus.

“We are entering our next evolution in the field of joint preservation. While many current techniques involve transplanting cartilage from a donor, the GelrinC implant allows us to harness the benefits of our patient’s own mesenchymal stem cells,” said Dr. Jason Scopp from Peninsula Orthopaedic Clinic. “The  technique was extremely quick, adding a mere 10 minutes to a standard practice procedure. Product application to the lesion was easy with the assistance of Regentis’s proprietery delivery device. It completely filled the defect and after a short exposure to UV light, an optimal implant was formed.”

“The success of these three clinical procedures is a significant milestone for Regentis and represents a big step to helping US and European patients recover from damaged articular knee cartilage,” said Regentis President and CEO Alastair Clemow, Ph.D. “In our previous study in Europe, GelrinC demonstrated outstanding clinical outcomes, and we look forward to continue demonstrating the effectiveness of this novel treatment for US patients.”

The FDA trial will appraise the safety and efficacy of GelrinC compared to the raw level data of a historical microfracture control arm. This study design overcomes the limitation of randomized control studies in this field, and is expected to generate faster patient enrollment and significantly reduce the time for product approval.

With an estimated market opportunity in excess of $1 billion, cartilage repair is the largest unmet need in orthopedic sports medicine today. Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. Focal defects of the cartilage layer are extremely painful for patients and usually occur due to sudden trauma. Surgical intervention is often required because of the limited capacity for cartilage to repair itself. The current standard of care treatment is microfracture but this only provides short term relief and often requires surgical re-intervention.

About Regentis Biomaterials
With offices in Or Akiva, Israel and Princeton, NJ, Regentis Biomaterials is a privately held company focused on developing and commercializing proprietary hydrogels for tissue regeneration. The company’s core technology is Gelrin™, a biodegradable hydrogel based on polyethylene glycol diacrylate and denatured human fibrinogen originally developed at the Technion – Israel Institute of Technology by Dr. Dror Seliktar. The Gelrin hydrogel platform combines the stability and versatility of a synthetic material with the bio-functionality of a natural substance for a range of clinical applications. For more information, please visit http://www.regentis.co.il.

For media inquiries, please contact:
Josh Turner
Media Relations
Phone: 011-972-54-949-6526
josh@jtpublicrelations.com

USA
Alastair Clemow, PhD
President & CEO
+1-508-930-8865

Israel
Livnat Ben Zur
General Manager
011-972-52-860-4735

SOURCE Regentis Biomaterials Ltd.

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Biologics

curasan Inc. announces Orthopedic Private Label Distribution Agreement

November 30, 2017 OrthoSpineNews

Kleinostheim, Germany / Research Triangle Park, NC, USA, November 2, 2017 – curasan Inc., the US-subsidiary of curasan AG (ISIN DE0005494538), a leading medical supplier specializing in dental and orthopedic biomaterials, announced a private label distribution agreement with Xtant Medical (NYSE:XTNT Belgrade, Montana USA), a leader in the development and distribution of regenerative and orthopedic fixation medicine products.

Xtant Medical will distribute several key orthopedic curasan products in the USA and Canada utilizing curasan’s flagship CERASORB foam technology using Xtant’s brand Matriform. With the addition of Matriform foam to Xtant’s portfolio, Xtant will now offer an innovative synthetic platform with demonstrated clinical results and excellent handling characteristics complementing their current allograft and hardware portfolio ultimately providing surgeons with a choice in grafting materials.

“We are excited to be enhancing our biologic portfolio offering with a line of synthetic scaffolds, which will make us a comprehensive biologic supplier for our customers and their patients,” said Carl O’Connell, CEO of Xtant Medical. “Our team has been very strategic in finding a partner with a product that meets our expectations for superior handling and clinical efficacy with proven mechanisms of action.”

“Thanks to the cooperation with such a forward-thinking company as Xtant Medical we will expand our distribution footprint within North America substantially,” said Michael Schlenk, CEO of curasan AG. “Xtant has a great reputation for providing innovative and relevant products to orthopedic surgeons.” Therefore, curasan expects the first significant sales from the cooperation in 2018.

Contact at curasan AG:
Investor Relations &
Corporate Communications
+49 6027 40 900-51
ir@curasan.com

About curasan AG:
curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, curasan, Inc., in the Research Triangle Park area, near Raleigh, N.C., USA. curasan’s innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide. curasan AG is a public company listed in the General Standard at the Frankfurt Stock Exchange.

About Xtant Medical:
Xtant Medical Holdings, Inc. (NYSE American:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

02.11.2017 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de
Language: English
Company: curasan AG
Lindigstraße 4
63801 Kleinostheim
Germany
Phone: 06027/40 900 0
Fax: 06027/40 900 29
E-mail: info@curasan.de
Internet: www.curasan.de
ISIN: DE0005494538
WKN: 549453
Listed: Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange

 
End of News DGAP News Service
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Biologics

curasan signs new cooperation with Implantcast for the DACH-region

November 30, 2017 OrthoSpineNews

Kleinostheim, 30 November 2017 – curasan AG (ISIN DE0005494538), a leading specialist for medical products in the field of orthobiologics, has signed an exclusive distribution agreement with Implantcast GmbH, Buxtehude, Germany.

Already starting mid-December the worldwide acting orthopedics company, specialized on primary-, revision- and tumor endoprosthesis will market curasan AG’s bone regeneration materials (CERASORB(R)) in Germany, Austria and Switzerland.

“For many years Implantcast has established itself as a specialist for orthopedics in the DACH-region, especially in the field of endoprosthesis. The company has built up a successfully working worldwide sales structure, which we consider a significant improvement for the distribution of our CERASORB(R) orthopedics portfolio”, explains Michael Schlenk, CEO of curasan AG. “This cooperation will give us to access a considerable number of new potential customers. Together we are going to increase the awareness for our bone regeneration materials and expand our market share. ”

“The cooperation of the two companies will go beyond pure distribution. For example, we also agreed on a joint concept for the inclusion of key opinion leaders, on common medical monitoring projects and studies with leading centers for endoprosthesis as well as on collaborative participation in congresses, symposia and advanced training courses for clinical users”, adds Florian Früh, Head of Product Management of curasan AG. “Our joint measures shall emphasize the importance of the synergies existing between innovative individual implant solutions for the patient and therapies for complete bone regeneration”.

“With curasan’s innovative bone regeneration materials we shall be able to offer a comprehensive treatment concept for various degenerative and pathological diseases of the human skeletal system to clinical surgeons”, says Jens Saß, Managing Director and CEO of Implantcast GmbH. “By combining our resources and our medical and scientific expertise and competence as well as our long-time experience in orthopedics we are going to create a much higher awareness in the market. ”

Both parties consider to expand the distribution agreement also to other countries with an existing Implantcast sales network.

About curasan AG:
curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, curasan, Inc., in the Research Triangle Park area, near Raleigh, N.C., USA. curasan’s innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide. curasan AG is a public company listed in the General Standard at the Frankfurt Stock Exchange.

About Implantcast GmbH:
Implantcast GmbH is a highly-specialized and innovative medical technology company based in Buxtehude near Hamburg, Germany. Today, Implantcast has more than 480 employees. The company operates in the fields of product development, manufacturing, sterile packaging as well as sales and distribution of primary, revision and tumor endoprosthesis to offer an ideal solution for each individual patient. The company also has a worldwide sales network with 10 sales offices and more than 65 sales partners. Its headquarters and R&D are located at Buxtehude, the place of foundation. From here all cooperation partners are provided with endoprosthetics and instruments and in the future also with bone regeneration materials.
www.implantcast.de

Contact:
Andrea Weidner
Investor Relations / Corporate Communications
Tel. +49 6027 40900-51
Fax +49 6027 40900-39
andrea.weidner@curasan.com

30.11.2017 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de

 
Language: English
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Extremities

Scientists Race To Regrow Lost Knee Cartilage

November 30, 2017 OrthoSpineNews

Nov. 27, 2017 – By Kathleen Doheny/WebMD Health News

 Bad knees sideline athletes and mere mortals alike.About 14 million Americans have osteoarthritis of the knees severe enough to cause pain and inflammation, according to the Arthritis Foundation, and more people are getting the condition — also known as OA — as they age.

As the knee’s natural cushioning — the cartilage — wanes, inflammation and pain rise, and people can’t get around as well.

Building knee cartilage has been a dream of researchers, and now several methods are under study. None has yet shown it can prevent or cure osteoarthritis, and all are in early phases, caution the scientists who presented their findings at the recent annual meeting of the American College of Rheumatology in San Diego, CA.

Stopping Excess Bone Breakdown

A treatment known as MIV-711 targets an enzyme called cathepsin K that is thought to play a role in the destruction of cartilage and the breakdown of too much bone.

In adults, bones are constantly being broken down and built up or replaced to maintain a healthy skeleton.  “This [treatment] stops the increased breakdown of bone that happens in OA,” says researcher Philip Conaghan, MD, a professor of musculoskeletal medicine at the University of Leeds in Great Britain. “It inhibits the cathepsin K.” The bone changes happen before the cartilage loss does, he says.

In the study, researchers assigned 244 men and women who have knee arthritis to get one of two oral doses of the treatment or a placebo pill for up to 28 days. The participants’ average age was 62, and many were overweight or  obese.

The researchers did MRIs at the beginning of the study and at week 26 to find changes around the bone, which reflect cartilage change. They found 65% less bone disease progression in the treated groups, regardless of dose, Conaghan says.

But they found no less pain. “It did not help symptoms,” he says.

 

READ THE REST HERE

 

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Spine

Spinal Elements Announces Headquarters And CEO Changes

November 29, 2017 OrthoSpineNews

MARIETTA, GA. (PRWEB) NOVEMBER 28, 2017

Spinal Elements, Inc. today announced plans to move its global headquarters to its Carlsbad, California location. Concurrent with this move, Jason Blain, co-founder of Spinal Elements and currently its President and COO, will assume the role of President and CEO. This change is effective immediately.

“I am excited by the opportunity to lead our talented team of employees and partners and create an even more vibrant and dynamic Spinal Elements in the years to come,” said Jason Blain, Spinal Elements’ new President and CEO. “I thank Chris Fair and the other members of our board of directors for their confidence. Going forward, Spinal Elements will continue to be focused on innovation and execution, driven by differentiated technologies and premium customer service, and we will move quickly to scale new ideas and opportunities into this dynamic marketplace.”

The company’s headquarters move will have minimal impact on Spinal Elements’ Marietta, Georgia-based operations and employees. Added Blain, “The company remains committed to its Marietta campus and our employees based there.”

Mr. Blain’s ascension to CEO will build on the strong foundation and momentum achieved by the Spinal Elements team under Chris Fair’s leadership. “Jason has inspired many of Spinal Elements’ most exciting technologies – past, present and future – while also fostering a team-oriented culture in each position he has held during his career,” said Mr. Fair. “I look forward to supporting Jason and the company across all future endeavors.” Mr. Fair, who resides with his family in the Atlanta metro area, will continue as a member of Spinal Elements’ Board of Directors.

Prior to co-founding Spinal Elements in 2003, Mr. Blain had roles of increasing responsibility in product development, manufacturing, regulatory affairs and quality assurance with Smith & Nephew, Alphatec, and NuVasive.

About Spinal Elements

Spinal Elements is an outcomes-driven spinal surgical solutions company with locations in Carlsbad, CA and Marietta, GA. A leading designer, developer, manufacturer and marketer of innovative medical devices used in spinal surgical procedures, our mission is to combine leading medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. For more information, please visit http://www.spinalelements.com.

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SpineTop Stories

EIT Emerging Implant Technologies Announces First Cases Completed Successfully by Top Surgeons in the United States

November 28, 2017 OrthoSpineNews

ROSWELL, GA. (PRWEB) NOVEMBER 28, 2017

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has now performed the first surgeries in the United States and is able to offer all interbody products for Cervical, ALIF, TLIF and PLIF procedures.

EIT Cellular Titanium® is a 3D printed porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimize cell proliferation and bone ingrowth.

The first surgeons to implant this novel cage technology were:

  • Matthew Gornet, orthopaedic spine surgeon at St. Louis Spine and Orthopedic Surgery Center
  • Gurvinder Deol, orthopaedic spine surgeon at Wake Orthopaedics
  • Faheem Sandhu, orthopaedic spine surgeon at Georgetown University
  • Brandon Scott, orthopaedic spine surgeon at Saint Francis Medical Center

Since that time, EIT has experienced incredible adoption throughout the country and has exceeded initial case volume projections by 250%.

As to why these cages have been so appealing to U.S. surgeons, the initial surgeons have said the following:

Matthew Gornet, MD, a fellowship-trained spine surgeon from Johns Hopkins Hospital as well as author of several published book chapters and research papers said, “I am excited to use this new technology to enhance the outcomes of my patients.”

Dr. Gurvinder S. Deol, MD, is a board certified (FAAOS), fellowship-trained Orthopedic Spine Surgeon for Wake Orthopaedics in Raleigh, NC said “The large surface of cellular porous structure combined with encouraging data from over 15,000 implants throughout Europe and many international markets make a lot of sense to me.”

Faheem Sandhu MD, PhD, is director of spine surgery at MedStar Georgetown University Hospital and professor of neurological surgery at Georgetown University Medical Center said, “I’m very excited about porous titanium cages and the possibility for improving fusion rates while reducing the need for biologic agents.”

Brandon Scott, MD. at Saint Francis Healthcare System is a Neurosurgeon in Cape Girardeau, Missouri. said, “The adaptation of the design of the cervical cage to the cervical anatomy is very nice and allows me to have a perfect fit of the implant with high primary stability.”

“We are thrilled to be working with these thought-leading surgeons since our initial product launch at NASS. The market response and adoption exceeds our expectations by far,” said Guntmar Eisen, cofounder and CEO of EIT.
________

About EIT

EIT is the first medical device manufacturer to exclusively focus on implants for spinal alignment, that are designed according to latest published science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014 by Hans Eekhof and Guntmar Eisen.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 10.000 EIT cases have been performed in over 15 markets globally.

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Biologics

Kuros Biosciences’ Chief Medical Officer to Retire

November 28, 2017 OrthoSpineNews
Schlieren (Zurich), Switzerland, November 28, 2017

Kuros announced today that its Chief Medical Officer, Dr. Virginia Jamieson, has reached retirement age and will retire from full-time employment with effect as of May 31, 2018. Her succession will be announced in due course.

Dr. Joost de Bruijn, appointed CEO of Kuros Biosciences commented: “I would like to thank Dr. Jamieson for her many contributions and years of service as the Chief Medical Officer of Kuros. She successful designed and delivered clinical studies for the Neuroseal and PTH programs KUR-111, KUR-112 and KUR-113. Dr. Jamison will continue to drive clinical development and be actively engaged in identifying her successor.”

For further information, please contact:

Kuros Biosciences Ltd

Harry Welten, MBA

Chief Financial Officer

Tel +41 79 750 15 64

harry.welten@kurosbio.com

About Kuros Biosciences AG

Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland, and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.
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Biologics

CollPlant Expands European Sales Network: The Company Has Signed a Distribution Agreement in Greece and Cyprus for Vergenix®FG

November 28, 2017 OrthoSpineNews

NESS ZIONA, Israel, Nov. 28, 2017 /PRNewswire/ — CollPlant (TASE: CLPT, OTC: CQPTY) – a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products (recombinant human, “rhCollagen”), announced that it has signed an agreement with a distributor in Greece and Cyprus. Under the terms of the agreement, the distributor undertook to make the first order for the product when signing the agreement, in an amount that is not material to the Company. The distributor is a Greek company operating in the field of medical devices, and the agreement is exclusive for a period of three years, with an option for an extension.

Yehiel Tal, CEO of CollPlant: “The agreement is the continuation of the implementation of our penetration strategy of the product into Europe and to increase of sales. This is the fifth distributor that has come on board to distribute the product, while in parallel we are continuing to receive positive feedback from treatments carried out in Europe, reflected in rapid recovery of chronic wounds.”

Vergenix®FG is based on the Company’s collagen technology, and is designed to treat chronic hard-to-heal wounds such as diabetic ulcers, pressure sores, surgical cuts and trauma wounds. The product is injected directly into the wound, filling it and contributing to the healing process until full wound closure, without any side effects.

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics, 3D Bio-printing of tissue and organs, and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary rhCollagen, among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix®STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; and Vergenix®FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds. CollPlant’s business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Contact at CollPlant:

Contact at Rx Communications Group, LLC:

Eran Rotem

Paula Schwartz (for US Investors)

Deputy CEO & Chief Financial Officer

Managing Director

Tel: +972-73-2325600/612

Tel: +1-917-322-2216

Email: Eran@collplant.com

Email: pschwartz@rxir.com

SOURCE CollPlant

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SpineTop Stories

Medicrea Acquires 3 Patents from Dr. Paul McAfee to Enhance Surgical Planning of 3D-Printed Titanium Interbody Devices

November 28, 2017 OrthoSpineNews

November 28, 2017

NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ Adaptive Spine Intelligence™ (ASI) technology, announced today the Company has acquired three patents from Dr. Paul McAfee, of University of Maryland St. Joseph’s Medical Center. These patents cover the methodology used to measure and plan interbody devices used in spinal surgery.

The three patents acquired from Dr. McAfee protect the associated intellectual property around a novel technique for physiologically selecting interbody device height based on patient anatomy to further enhance Medicrea’s UNiD™ ASI platform.

Dr. McAfee stated, “Medicrea is uniquely positioned to benefit from this intellectual property to enhance their industry-leading surgical planning service. Surgeons understand that the effective use of interbody devices plays an important role in determining outcomes for spinal patients and spend significant time intra-operatively testing for the ‘best-fitting’ interbody device based on a limited range of dimensions provided by legacy manufacturers. However, this current technique often leads to compromise between two available interbody dimensions and lacks scientific rationale. Knowing the level of inventory required to deliver a range meeting patient needs in every case is cost-prohibitive for even the largest legacy manufacturers. There is a clear demand for the reliable planning tools and services available with UNiD™ ASI.”

Medicrea’s systems-based approach to spine with engineering services and in-house 3D-Printing capabilities makes the Company uniquely able to deeply collaborate with surgeons to create interbody device solutions that are adapted to their clinical and mechanical preferences, as demonstrated by the recent FDA clearance of the Company’s IB3D™ offering of 3D-printed Titanium interbody devices with AdapTEK™, surgeon-adaptive technology for unparalleled control of the implant design and dimensions provided.

Denys Sournac, President and Chief Executive Officer, stated, “We are focused on fully integrating the important work done by Dr. McAfee into our proprietary UNiD™ HUB surgical planning software. Combining data-driven planning techniques with the ability to deliver personalized implants will significantly reduce the inventory required for each case while ensuring the optimal implant is provided for the patient at each level operated. Acquiring new planning methodologies, as we have done with Dr. McAfee, will allow Medicrea to further provide healthcare shareholders with scientific evidence supporting the surgical strategy and promoting a cost-effective care continuum in line with our Adaptive Spine Intelligence™ technology.”

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 150,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED
LEI: 969500BR1CPTYMTJBA37

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger, +33 (0)4 72 01 87 87
Chief Financial Officer
fkilfiger@Medicrea.com

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ExtremitiesTop Stories

Novastep adds airlockGO® to its cleanSTART® Delivery Platform

November 28, 2017 OrthoSpineNews

Orangeburg, NY, Nov. 27, 2017 (GLOBE NEWSWIRE) — Novastep, Inc., and its affiliates (“Novastep” or the “Company”), a global medical technologies company specializing in the foot and ankle, has announced an expansion of their cleanSTART® Delivery Platform with the launch of their airlockGO® product line.

The airlockGO® system combines Novastep’s UDI-compliant sterile packed, single-use instruments kits and implants into a ready-to-use holder. Each airlockGO® box is designed to address a given pathology of the foot and ankle by assembling all-inclusive, self-contained procedure-specific configurations of implants and instruments into a single container. It eliminates the hassle of onsite sterilization. A single airlockGO®  box replaces the need for sterilization trays which undergo costly, timely and sometimes inexact sterilization cycles.

“AirlockGO benefits all parties involved because each unit has everything you need for a given surgery in a single container that is about the size of a shoe box.”  said Vadim Gurevich, President and CEO of Novastep Inc., adding that “The entire premise behind AirlockGO is to enhance OR efficiency, reduce costs and improve inventory management.”

Operating room efficiency and cost reduction are prime areas of focus for Novastep. The company works directly with hospitals and surgery centers to reduce healthcare costs and improve process flows.  Novastep’s cleanSTART® deployment technology and airlockGO® product offerings allow a systematized, logistics platform that substantially reduces inventory and sterile field volumes, while minimizing lost or damaged instrument delays and lifecycle expenses.

Mark Prissel, DPM at Orthopedic Foot & Ankle Center of Columbus, OH, emphasized that “airlockGO is designed to benefit the patient, surgeon, and facility providing a streamlined case-specific approach to high quality single use instruments and implant technology for foot and ankle surgery, while remaining cost conscious.”  Prissel further explained that “The result is the same outstanding experience I am accustomed to with the traditional Airlock platform, but with improved efficiency.”

About Novastep
Novastep is a global medical device company specializing in the design, development and commercialization of advanced technologies that treat conditions affecting the foot and ankle. The Company is focused on optimizing clinical efficiencies, inventory management and healthcare economics by transforming the way foot and ankle products are deployed and utilized in the surgical environment. Novastep has allied itself with a strategic network of key international opinion leaders to deliver breakthrough technologies, innovative services and compelling medical education programs to the foot and ankle community. Novastep’s portfolio, services and distribution platforms are uniquely positioned to address foot and ankle trauma, deformity corrections and Charcot fracture management.

For further information concerning this announcement and/or Novastep, Inc., send all inquiries to info@novasteportho.com or call 877.287.0795.

Related Links

For general information:  novastep-us.com

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