DGAP-News: Curasan starts dynamically into the new year

Posted On May 19, 2017 By OrthoSpineNews In Financial /

Kleinostheim, 18 May 2017 – curasan AG (ISIN DE0005494538), a leading specialist for medical products in the field of orthobiologics, has continued to grow dynamically at the start of the year. Gross sales increased by 15.9 percent to EUR 1.89 million (Q1 2016: EUR 1.62 million). Earnings before interest, taxes, depreciation and amortization (EBITDA) improved by 3.4 percent (Q1 2016: -0.45 m EUR), while earnings before interest and taxes (EBIT) remained virtually unchanged at -0.45 million euros (Q1 2016: -0.45 m euros). However, due to lower interest expense, the net result rose slightly as well by 8.7 percent to -0.46 million euros (Q1 2016: -0.50 m euros).

The consideration of the sales performance according to regional aspects shows that the clear growth of almost all regions was dynamically supported. In Europe, sales rose by 10.6 percent to EUR 0.66 million, in MENA sales more than doubled, rising by 128.6 percent to EUR 0.26 million. In Asia, growth was 7.6 percent, with sales of a total of EUR 0.40 million, while the US markets increased by 7.7 percent to EUR 0.46 million.

Cash and cash equivalents decreased by 78.7 percent to EUR 0.21 million (31.12.16: 1.01 EUR) as of the balance sheet date, whereas trade receivables increased by 11.6 percent to 2.35 million Euro (31.12.16: 2.11 mEUR). At the same time, trade payables rose by 22.2 percent to EUR 1.05 million (31.12.16: 0.86 mEUR). Shareholders’ equity fell by 4.8 per cent to EUR 8.52 million, compared to EUR 8.95 million as of the end of 2016.

“We have shown a strong first quarter and our sales are growing across the board in all regions,” explains Michael Schlenk, CEO of curasan AG. “As projected, we will continue to invest heavily in marketing and registrations for this growth. Since the beginning of the second quarter and under the direction of the Finance Department by our new CFO, Christine Uekert, we are also taking a new approach in terms of our receivables management as well as the working capital and achieving good success here.” In addition, the company announced, with the publication of the 2016 Annual Report, that a capital increase would be implemented in the current financial year. “Our dynamic and sustainable growth is well recognized by institutional investors as well as strategic ones. A good basis for a further growth financing”, Schlenk adds.

Further details on the quarterly figures published today as well as current developments in the second quarter will be discussed by the CEO today at 2.00 pm in the course of an open telephone conference for analysts, qualified investors and journalists. You can register by e-mail via the Investor Relations and Corporate Communications departments (IR@curasan.com).

The complete report on the first quarter of 2017 has been made available by curasan on the Company’s website at the following link:

www.curasan.de/investoren/publikationen/finanzberichte

Contact curasan AG:
Ingo Middelmenne
Head of Investor Relations
+49 6027 40 900-45
+49 174 90 911 90

ingo.middelmenne@curasan.com

Andrea Weidner
Head of Corporate Communications
+49 6027 40 900-51
andrea.weidner@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.

18.05.2017 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

Florida Institute Funds Alachua-based Amend Surgical

Posted On May 19, 2017 By OrthoSpineNews In Biologics, Financial, Top Stories /

GAINESVILLE, Fla. and BOCA RATON, Fla., May 18, 2017 /PRNewswire-USNewswire/ — The Florida Institute for the Commercialization of Public Research (the Florida Institute) announced today that it has finalized a funding agreement with Amend Surgical, an Alachua-based medical device company with newly licensed technology developed at the University of Florida. The Florida Institute supports new company development and expansion based on publicly-funded research, and bridges early funding gaps for companies licensing technology out of Florida-based universities and research institutions.

Amend Surgical is a specialty medical device company focused on enhancing the healing and regenerative capacity of bone grafts, including allograft, xenograft tissues and synthetic materials. The company’s pipeline includes novel, osteoinductive bone extracts, and will expand in the future to disruptive products based on discovery and development of novel therapeutic additives with tissue-specific regenerative characteristics.

“We are committed to advancing the science of orthobiologics by improving the healing capacity of bone grafts. The new funding agreement with the Florida Institute will allow Amend to rapidly expand our research and commercialization efforts on Biomimetic Bone which was licensed from the University of Florida in March 2017,” said Robby Lane, Chief Executive Officer of Amend Surgical.

“Amend Surgical provides surgeons and their patients access to innovative bone grafting options,” said Jackson Streeter, MD, Florida Institute Chief Executive Officer. “By developing and advancing bone grafts and other orthobiologics with enhanced regenerative capacity, surgery patients can identify, with guidance from their physicians, new options that can help them achieve the best possible surgical outcomes.”

About the Florida Institute

Formed by the Florida Legislature in 2007, the Florida Institute for the Commercialization of Public Research is a non-profit organization that works collaboratively with the technology licensing and commercialization offices of Florida’s state universities and private research institutions to leverage a $2.5B+ research base and form investable companies that create clean jobs in new industries that are driving the global economy. With funding from the State of Florida through the Department of Economic Opportunity, and through the generosity of mentors, advisors and donors, the Florida Institute provides company building services, and seed funding through the Florida Technology Seed Capital Fund, to promising Florida startups. Sixty-nine companies have been funded to date, and the Florida Institute’s economic impact through June 30, 2016 in the State of Florida was $630 million.

About Amend Surgical

Amend Surgical is a product development company offering differentiated biologic solutions for surgeons, medical device manufacturers and distributors globally. Amend is targeting the bone graft substitute market with licensed, patented, technology and is focused on spine, orthopedic and dental indications. The R&D pipeline includes products loaded with antibiotics and natural bone morphogenic proteins. Additionally, Amend is commercializing a novel Biomimetic Bone technology licensed from the University of Florida that offers the hope for a synthetic graft with load bearing capability and osteostimulative properties. Amend currently manufactures and distributes the only demineralized bone-bioactive glass combination product approved by the FDA. NanoFUSE® Bioactive Matrix uniquely combines the osteoinductive capabilities of demineralized allograft bone with the osteostimulative properties of 45S5 bioactive glass.

CONTACT:
Jane Teague
Chief Operating Officer
Institute for the Commercialization of Public Research
561-368-8889
jane.teague@florida-institute.com

SOURCE Florida Institute for the Commercialization of Public Research

Zimmer Biomet licenses Intellectual Property from Bonutti Research Inc.

Posted On May 19, 2017 By OrthoSpineNews In Robotics, Top Stories /

EFFINGHAM, ILLINOIS (PRWEB) MAY 18, 2017

Effingham, Illinois – May 18, 2017 – Bonutti Research Inc. and Zimmer Biomet have entered into a license agreement for Zimmer Biomet’s use of two patent families created by Dr. Peter Bonutti. U.S. Patent No. 9,301,845 adds to the strength of the innovative knee systems, Persona® The Personalized Knee System and the NexGen® Complete Knee Solution. U.S. Patent Nos. 9,269,987 and 9,585,725 support the development of the Rosa® robotic total knee application currently underway at Zimmer Biomet.

About Bonutti Research (BRI)

Founded by Peter Bonutti, MD in 1989, BRI is a medical device incubator with over 550 patents and patent applications involving diagnostics, surgical robotics, minimal invasive surgery, soft tissue fixation, and hip and knee arthroplasty. BRI has entered into over 740 licenses in numerous medical and surgical fields. Bonutti Research is a device incubator with in-house design, engineering, regulatory, manufacturing, and intellectual property teams. Learn more about innovations from BRI at bonuttiresearch.com

Contact:
Lucas Wenthe
LWenthe(at)bonuttitechnologies(dot)com
(217) 342-3412 x5111

First AxioMed Viscoelastic Total Disc Replacement Implanted in Sydney, Australia

Posted On May 18, 2017 By OrthoSpineNews In Spine /

MALDEN, MASS. (PRWEB) MAY 18, 2017

Dr. Ralph Mobbs of the Neuro Spine Clinic completed the procedure on April 28, 2017 at the Prince Of Wales Private Hospital. The procedure was performed on a 46-year-old male patient suffering from a degenerative cervical disc at level C6-C7. The patient failed conservative treatments prior to undergoing surgery.

The AxioMed viscoelastic disc is a next-generation disc replacement that restores natural disc height, lordosis, stability and motion in the human spine. AxioMed was approved in 2016 to market and sell their viscoelastic cervical and lumbar Freedom total disc replacements in Australia by the Therapeutic Goods Administration.

Dr. Ralph Mobbs spoke to the advantages of the AxioMed cervical disc after the operation, stating, “The Freedom Cervical Disc is a new and innovative treatment that I’ve been eager to use. I found the prosthesis matched the patient’s anatomy well, restored disc height and fit very well within the intervertebral space. The disc was easily placed with AxioMed’s simple and effective instrumentation. I believe in this viscoelastic technology and its benefits and I look forward to using the Freedom Cervical Disc to treat my patients in the future.”

AxioMed CEO Dr. Kingsley R. Chin explained how an experience like Dr. Mobbs’ aligns with AxioMed’s vision. “AxioMed believes it can replicate the success of total joint restoration in the spine with our innovative and advanced viscoelastic total disc replacements with a high degree of patient satisfaction,” he said.

Dr. Chin added, “With the addition of the lateral lumbar technique, we expect AxioMed to be the worldwide leader in disc replacement surgery.”

Dr. Mobbs currently practices neurosurgery with a special interest in minimally invasive and complex spine surgery.

About AxioMed
Founded in 2001, AxioMed began its journey of exhaustively proving the Freedom® Disc through clinical studies in the USA and Europe, research, development and testing. In 2014, KICVentures recognized the disc’s enormous potential and acquired the company into their healthcare portfolio. AxioMed owns an exclusive viscoelastic material license on its proprietary Freedom Disc technology.

Central Connecticut Neurosurgery and Spine is the First in Connecticut to Offer New Treatment Option for Chronic Pain

Posted On May 18, 2017 By OrthoSpineNews In Neuro, Spine, Top Stories /

PLANO, TEXAS (PRWEB) MAY 17, 2017

Dr. Ahmed Khan is the first physician in Connecticut to implant Nuvectra’s Algovita® Spinal Cord Stimulation System, a powerfully versatile, patient-centric spinal cord stimulation system. The Algovita SCS System has been FDA approved as a treatment option for chronic intractable pain since late last year.

Chronic pain affects over 100 million Americans, according to the Institute of Medicine, more than diabetes, cancer, and heart disease combined. Chronic pain is difficult to treat, but one potential treatment option is spinal cord stimulation, or SCS. SCS works by masking or interrupting pain signals as they travel up the spinal cord to the brain. A small, rechargeable battery is implanted under the patient’s skin and connected to thin wires, called leads, which stimulate the nerves sending pain signals. The stimulation “overrides” the pain signals, and instead of feeling pain, patients may feel a tingling sensation known as paresthesia.

The Algovita SCS System is a new offering to the SCS market, featuring 24 current sources and the broadest overall set of parametric ranges offered for tonic SCS. This combination provides flexible coverage and expanded programming options for individualized patient therapy. Algovita also offers the industry’s only stretchable leads, which are designed to reduce the risk of lead fracture and migration. In addition, the system’s percutaneous leads feature up to 12 contacts for wide coverage of potential pain areas. The Algovita system was designed to be patient-centric and easy to use. The wireless Pocket Programmer fits discreetly in a hand, purse, or pocket and allows a patient to conveniently adjust their therapy on the go.

For more information about Nuvectra and the Algovita Spinal Cord Stimulation system, visit http://www.nuvectramed.com.

About Dr. Ahmed Khan

Dr. Ahmed Khan is a neurosurgeon in New Britain, Connecticut and is affiliated with Bristol Hospital. He received his medical degree from University of Connecticut School of Medicine and has been in practice for more than 20 years. He is one of 2 doctors at Bristol Hospital who specialize in Neurological Surgery.

About Nuvectra Corporation

NuvectraTM is a neurostimulation company committed to helping physicians improve the lives of people with chronic neurological conditions. The Algovita® Spinal Cord Stimulation (SCS) System is our first commercial offering and is CE marked and FDA approved for the treatment of chronic pain of the trunk and/or limbs. Our innovative technology platform also has capabilities under development to support other neurological indications such as sacral nerve stimulation (SNS), and deep brain stimulation (DBS). In addition, our NeuroNexus subsidiary designs, manufactures and markets leading-edge neural-interface technologies for the neuroscience clinical research market. Visit the Nuvectra website at http://www.nuvectramed.com.

10 orthopedic device company CEOs: Who is paid the most?

Posted On May 18, 2017 By OrthoSpineNews In Financial /

Written by Laura Dyrda – Becker’s Spine Review, 09 May 2017

Orthopedic and spine device company leader compensation varies across the board based on the company’s size and market share. While some have a larger base salary, others have higher bonus and stock option value.

Here is the compensation for 10 orthopedic and spine device company leaders based on data from Salary.com. The information is reported according to the proxy statements filed for the 2015 fiscal year.

1. Alex Gorsky. Chairman and CEO of Johnson & Johnson: $21.2 million

2. Omar Ishrak. Chairman and CEO of Medtronic PLC: $15 million

3. Kevin Lobo, Chairman, President and CEO of Stryker: $12.8 million

READ THE REST HERE

Stryker and AlloSource announce collaboration to distribute biologics for use in sports medicine procedures

Posted On May 18, 2017 By OrthoSpineNews In Biologics, Sports Medicine /

DENVER, May 18, 2017 /PRNewswire-USNewswire/ — Today at the 2017 Annual Arthroscopy Association of North America (AANA) Meeting (booth #109), Stryker’s Sports Medicine business and AlloSource^® formally announced their collaboration to provide high quality, innovative biologics for use in sports medicine procedures. This collaboration is driven by the companies’ combined commitment to better serve their customers, help patients in need and fully honor the gift of tissue donation.

“We believe biologics will play a critical role in advancing the field of Sports Medicine, so we are very excited about the opportunity to collaborate with AlloSource given their history of quality and innovation,” said Matt Moreau, Vice President & General Manager of Stryker’s Sports Medicine business. “The collaboration between Stryker and AlloSource will enable us to combine our unique areas of expertise to develop new ways to improve patient outcomes.”

Through the collaboration, Stryker’s Sports Medicine nationwide sales force will distribute AlloSource biologics for use in a variety of sports medicine procedures.

“Deepening our relationship with Stryker through this sports medicine collaboration will help us further advance patient healing and honor our tissue donors by getting biologics in the hands of more surgeons,” said Kerr Holbrook, AlloSource Chief Commercial Officer. “We look forward to working and growing together.”

For more information, please visit Stryker’s website or AlloSource’s website.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

About AlloSource
AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource’s products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world’s largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help heal severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country’s most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website, allograftpossibilities.org.

Media contacts
Jon Zimmer, Stryker, jon.zimmer@stryker.com
Megan Duggan, AlloSource, mduggan@allosource.org

SOURCE AlloSource

VEXIM in Facts, Five Years after the Stock Market Listing on the Alternext Market

Posted On May 18, 2017 By OrthoSpineNews In Financial, Spine /

May 17, 2017

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News:

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces its fifth-year anniversary on the Alternext market.

“After five years of quotation on the Alternext market, VEXIM has made tremendous progress on all fronts. VEXIM has successfully implemented its direct go to market strategy in Europe reaching 10% market share in 2016 and reached profitability on the second half of 2016. VEXIM also attracted and recruited more than 30 talented and experienced employees supporting the growth of VEXIM’s business and serving our customers every day. We also generated value for our shareholders by tripling our market capitalization in 5 years. With the US market, EU market, international expansion and our product portfolio extension projects, VEXIM has a great potential of growth for the next coming years. We would like to thank all VEXIM’s shareholders from the first days and the ones who have joined recently for their trust and support“, said Vincent Gardès, CEO of VEXIM.

EUROPE, A GREAT SUCCESS IN 5 YEARS

In 2012, we launched our Go-to-market strategy in Europe that was to address 90% of the market through a direct sales force organization. After 5 years, VEXIM results are impressive with a compounded average growth rate of our sales of 74% since 2011. We now have reached a 10% market share position¹ as of end of 2016 and a leading market position in France², VEXIM’s domestic market. We aim to continue to gain market share in the coming years in Europe by focusing mainly in Germany and all other countries.

EXPANDING OUR PRODUCT PORTFOLIO

The SpineJack® remains VEXIM’s main product representing close to 90% of our sales but in the past 5 years we also launched new products to extend our portfolio. The Interface™ launched in 2014, a cement with 50% of Hydroxyapatite to be used in younger patients. The Masterflow™ launched in 2015, is a sophisticated solution providing a controlled high viscosity cement injection, at a safe distance³from the radiation field for multi-level procedures. And more recently the Masterflow™ PLUS launched in March 2017 in Germany that allows a Controlled Cement Augmentation Procedure first through vertebral body height elevation, and second by stabilizing the fracture using Cohesion® Bone Cement injection. We have also other projects in the pipeline to extend our portfolio into high energy vertebral fractures and tumor. This promising portfolio will strenghthen our Spine trauma positioning and expertize.

BUILDING CLINICAL EVIDENCE

We have successfully conducted 7 international clinical studies and 4 biomechanical studies to support the efficacy and safety of our SpineJack® product. These studies have led to 14 publications in renowned medical journals⁴. VEXIM is continuously looking and investing to build more clinical evidence. VEXIM’s US FDA 510K clinical study, the clinical and health economic study comparing the SpineJack® vs conservative treatments and the future clinical study in Germany where the SpineJack® will be more evidence based towards a wider range of indications to follow, are demonstrating VEXIM’s commitment to build clinical evidence and demonstrate benefits of its technology.

HIGH PERFORMING ORGANIZATION

VEXIM’s culture of execution, passion and customer focus are key strengths that supported the development of the company on the past 5 years. Vexim more than doubled its number of employees in 5 years reaching 66 employees across all entities with diverse and experienced talents across the company. VEXIM will continue to recruit talents across the globe to sustain its objectives and projects.

STRATEGIC INTERNATIONAL EXPANSION

There has been a growing interest in the SpineJack® across the world. The SpineJack® is today available in more than 15 countries across the world from Central & Latin America to Eastern Europe, Middle East, South Africa and South East Asia. We will continue to expand our footprint by opening new markets such as Brazil, Australia, South Korea, China.

OPERATIONAL AND FINANCIAL EXCELLENCE

VEXIM successfully achieved to turn profitable on a full semester in the second half of 2016 and generated positive cash flows. VEXIM also increased its Gross Margin on sales from 59% to 72% in average by optimizing its production costs and inventory processes. VEXIM aims at reaching profitability on a full year basis in 2017 and future cash flows should allow VEXIM to self-finance, in line with its ambitions.

Click here to consult VEXIM’s 2016 results presentation

Financial reporting schedule:
2^nd quarter sales: July 11^th, 2017⁵

About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital⁶, and from OSEO public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the Masterflow^TM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 66 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on NYSE Alternext Paris since May 3^rd 2012. For further information, please visit www.vexim.com

SpineJack®⁷, an innovative implant for treating Vertebral Compression Fractures
The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

Nom : VEXIM
Code ISIN : FR0011072602
Code mnémonique : ALVXM

¹ Internal Vexim source.
² Internal Vexim source.
³ Mehlman, Charles T., DiPasquale, Thomas G. Journal of Orthopaedic Trauma: August 1997 – Volume 11 – Issue 6 – pp 392-398 Radiation Exposure to the Orthopaedic Surgical Team During Fluoroscopy: “How Far Away Is Far Enough?”
⁴ http://en.vexim.com/professionals/scientific-and-clinical-communication/
⁵ Indicative date, subject to changes.
⁶ Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.
⁷ This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
Tel.: +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tel.: +33 1 44 54 36 66
Tel.: +33 6 48 82 18 94
vexim@alizerp.com

XpandOrtho, Inc. Receives FDA 510(k) Clearance for Its Electronic Soft Tissue Balancing Instrument for Total Knee Replacement Surgery

Posted On May 18, 2017 By OrthoSpineNews In Regulatory, Top Stories /

May 17, 2017

LA JOLLA, Calif.–(BUSINESS WIRE)–XpandOrtho, Inc., a designer of soft tissue balancing instruments, received FDA clearance on April 25^th of 2017 for their electronic soft tissue balancing instrument for total knee replacement surgery.

The US Food and Drug Administration (FDA) awarded XpandOrtho 510(k) clearance for its sterile-packaged wireless disposable device that utilizes multiple miniaturized sensors and actuators to perform multiplanar balancing of the knee joint during a full range of motion. The device uses a novel constant pressure bellows system which wirelessly communicates with a display to provide dynamic multiaxial balance and selection of optimal thickness of the tibial component. The device can be conveniently used by all surgeons regardless of whether they choose to make the femoral cut first or the tibial cut first. Soft tissues can be released with the device in place enabling real time visual feedback to the surgeon. The “universal” design is compatible with almost all total knee implant systems from major manufacturers. This low-cost disposable device can also preserve an electronic record of the entire 3D balance of the knee at the end of the surgical procedure.

XpandOrtho has initiated a clinical study at Scripps Clinic, La Jolla, CA and will be conducting a limited release of their product to selected surgeons in the US. “We are excited to give large and small volume surgeons the ability to reproducibly and accurately balance the ligaments of the knee over a full range of motion during total knee replacement,” said Clifford Colwell, M.D., President and Chairman of the Board, XpandOrtho, Inc.

About XpandOrtho, Inc.

XpandOrtho, Inc. is developing and commercializing orthopedic devices that provide real time visual feedback to surgeons during their surgical procedure. XpandOrtho is a privately held medical device and technology company that is committed to improving the standard of care in total knee replacement surgeries by providing measurable and consistent results to all surgeons and patients. Our future development plans will leverage this technology to provide solutions for a broader range of orthopedic procedures.

Contacts

XpandOrtho, Inc.
Dr. Cliff Colwell, 858-663-7092
colwell@scripps.edu

Titan Medical Completes Initial Formative Human Factors Studies for SPORT Robotic Surgical System

Posted On May 17, 2017 By OrthoSpineNews In Robotics, Top Stories /

TORONTO, ON–(Marketwired – May 17, 2017) – Titan Medical Inc. (TSX: TMD) (OTCQB: TITXF), a medical device company focused on the design and development of a robotic surgical system for application in minimally invasive surgery (MIS), announces completion of initial formative human factors studies for its SPORT single port robotic surgical system. Formative human factors studies involve the evaluation of prototypes by expert users that focus on simulated task exercises that are critical to product safety.

David McNally, President and CEO of Titan Medical, said, “The completion of initial formative human factors studies is a key development milestone, and we are pleased to have achieved it on schedule. We are grateful to the independent surgeons and nurses who participated in these studies. Initial formative human factors studies are a foundational step in the development of a safe and effective complex medical device, such as a robotic system. In addition to evaluating the ergonomics of the workstation and patient cart during simulated procedures, clinicians provided insights regarding the setup and maneuverability of the central unit, the positioning of the insertable camera and the loading of instruments. The results of the studies provide valuable perspectives on user interaction and user experience for the development of the SPORT system. This end-user feedback will be integrated with information gained from the ongoing testing and evaluation of certain subsystems, so that appropriate design enhancements can be prioritized and implemented.”

Mr. McNally continued, “Based on our progress and the commitment of our employees and subcontractors, we remain on track to deliver the next of our stated milestones during the second quarter of the year. While our product development team focuses on system design improvements, other members of management are actively engaged in evaluating prospective strategic facilities for preclinical studies in the U.S. and Europe.”

About Titan Medical Inc.

Titan Medical Inc. is focused on the design and development through to the planned commercialization of a robotic surgical system for application in MIS. Titan’s SPORT Surgical System, currently under development, includes a surgeon-controlled robotic platform that features multi-articulating instruments for performing MIS procedures through a single port. The surgical system also includes a workstation that provides a surgeon with an advanced ergonomic interface to the robotic platform for controlling the instruments and provides a 3D high-definition endoscopic view inside a patient’s body. The SPORT system is designed to enable surgeons to perform a broad set of general abdominal, gynecologic, urologic and colorectal procedures. For more information, visit the Company’s website at www.titanmedicalinc.com.

Forward-Looking Statements

This news release contains “forward-looking statements” which reflect the current expectations of management of the Company’s future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, without limitation, those listed in the “Risk Factors” section of the Company’s Annual Information Form dated March 31, 2017 (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements.

CONTACT INFORMATION

CONTACTS:

LHA
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com

Bruce Voss
(310) 691-7100
bvoss@lhai.com

Our Blog

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Florida Institute Funds Alachua-based Amend Surgical

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Stryker and AlloSource announce collaboration to distribute biologics for use in sports medicine procedures

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VEXIM in Facts, Five Years after the Stock Market Listing on the Alternext Market

Contacts

XpandOrtho, Inc. Receives FDA 510(k) Clearance for Its Electronic Soft Tissue Balancing Instrument for Total Knee Replacement Surgery

Contacts

Titan Medical Completes Initial Formative Human Factors Studies for SPORT Robotic Surgical System

CONTACT INFORMATION