Bodycad Receives EU Product Notification Confirmation for Personalized Unicompartmental Knee System

Posted On May 26, 2017 By OrthoSpineNews In Recon, Regulatory /

QUEBEC CITY, QUEBEC, CANADA, May 24, 2017 /EINPresswire.com/ — Bodycad announced today that it has received product notification confirmation from the Belgian Federal Agency for Medicines and Health Products in Brussels, the legislative capital for the European Union, for its Bodycad Unicompartmental Knee System. This enables Bodycad to commercially launch this truly personalized orthopaedic restoration within the European Union in accordance with EU Medical Device Directive for custom devices. Bodycad is the first Canadian company to receive EU product notification confirmation for a joint reconstruction implant system.

Bodycad’s revolutionary Unicompartmental Knee System is designed to optimize personalized restoration of the patient’s unique anatomical features and kinematics. The system is based on proprietary 3D rendering of medical images of the patient’s anatomy. The restoration is delivered as a “procedure in a box” that completely revolutionizes the way orthopaedic implant and instrument applications are delivered and utilized in the operating room environment.

“The personalized restoration is created only after proper acquisition of data from the patient on an individualized level,” says Etienne Belzile, MD, orthopaedic surgeon and assistant professor at Laval University. “The benefit of personalized restoration is the possibility of a better fit to the individual, less trauma to the soft tissue, and potentially a faster recovery overall.”

Bodycad uses proprietary imaging algorithms to rapidly produce a precise 3D image of the patient’s knee. Its suite of Personalized Restoration Software enables a seamless integration of the image to implant process called the PREP (personalized restoration evaluation process). The efficient and rapid process is designed to increase patient satisfaction, improve manufacturing precision while improving economic quality metrics.

“Our proprietary software is based on 20 years of research in anthropometric data and is the first CAD/CAM software specifically developed for the personalization of orthopaedic implant and instrument design,” says Jean Robichaud, founder and CEO of Bodycad. “I am delighted to have European product notification confirmation to bring this important technological advancement to market. Our goal is to transform the way surgeons, patients and insurers think about the potential of mass customization to optimize patient care.”

About Bodycad

Bodycad is a Quebec City-based developer and manufacturer of personalized orthopaedics. Its personalized restorations offer patients a high level of conformity to their unique anatomy, with the potential for greater comfort, fit and durability that make the pursuit of orthopaedic perfection possible. Learn more at www.bodycad.com.

Andrew McLeod
Bodycad
1 418 527 1388
email us here

SANUWAVE Announces Appointment of LITHOMED as Distributor for Orthopedics Products in Taiwan

Posted On May 26, 2017 By OrthoSpineNews In Biologics /

SUWANEE, GA–(Marketwired – May 25, 2017) – SANUWAVE Health, Inc. (OTCQB: SNWV) is pleased to announce that the company has appointed LITHOMED to act as distributors for SANUWAVE’s Orthopedic products in Taiwan.

Kevin Richardson II, CEO and Chairman, stated, “SANUWAVE has committed to deliver 3-5 new distribution partners in the second quarter and 7-10 by the end of the year. This is the first step in achieving or beating our target. We are also excited to be able to support our science advisor Dr. Chin-Jen Wang, Professor of Orthopedic Surgery at Chang Gung Memorial Hospital, and his newly founded Shockwave Institute in BANG DONG, Taiwan.”

André Mouton, V.P. International Sales and Relations of SANUWAVE, stated, “We are very pleased with this new relationship. LITHOMED has a wealth of experience within this specific indication and will be the right fit for our needs within the orthopedic market segment in Taiwan. Their access and relationships with Key Opinion Leaders (KOL’s) will prove to be of immense value for market development and revenue growth. Taiwan is the first country where we shall have a definitive split within our distribution model. We recognize that Orthopedics and Wound Care have a different customer base and the designated distributor needs to address that. We are expecting sales from this region to be well over $500,000 within the next three years, with a maximum value of $3 million. We have more than 200 of our devices in use in Europe and we are sure the Asia market and usage will progress accordingly. Taiwan will be our second territory within Asia,” concluded André Mouton.

William Kao, Managing Director: “LITHOMED is very pleased to be the distributor for SANUWAVE’s orthopedic products in Taiwan. The orthoPACE® device, with its patented focused shock wave technology, is an important advancement in orthopedic and musculoskeletal care and offers a wide range of non-invasive treatment procedures for hospitals and doctor’s offices. I am certain it will be welcomed by Taiwanese orthopedists and their patients. These innovative products will fit perfectly within our portfolio and will be a welcomed addition to our current network of loyal customers and users. The orthoPACE device has been proven safe and effective for the treatment of chronic tendonitis and joint pain in the musculoskeletal environment. orthoPACE treatments have been especially effective in treating tendonitis and plantar fasciitis, which commonly require surgery. orthoPACE is designed to effectively treat bone conditions requiring osteogenesis, calcific joints, conditions causing painful joints, and chronic pain caused by musculoskeletal disorders. orthoPACE uses focused, shock wave treatments that are non-invasive which dramatically reduce the risk of infection. In many indications, orthoPACE has a proven success rate that is equal to or greater than that of surgery — usually with just one procedure and without the inherent risks, complications, or lengthy recovery time of invasive surgery. orthoPACE treatments require a minimal amount of treatment time. In conditions such as plantar fasciitis, patients can bear weight immediately and return to pre-treatment activity within a few days of the procedure,” concluded William Kao.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB: SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s de novo petition review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

About LITHOMED
Litho Med Trading Company has been established in 1994. The company specializes in distribution of medical equipment with a key focus on Shockwave Technology. It has been involved with clinical studies with OssaTron in 1998 and the company is closely working with the Key Opinion Leaders (KOL’s) within Shockwave technology within Taiwan since. The company is the sole distributor for Edaptms for UST since 2010. The orthoPACE technology and usage will be an added indication to complete the current product offering.

Litho Med Trading Co., Ltd.
TEL:06-2903269 FAX:06-2903297
3F-7, No.293 Sec 3, Dung-Men Road.
Tainan 701, Taiwan, R.O.C.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

CONTACT INFORMATION

Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.comSANUWAVE Health, Inc.
Andre Mouton
Vice President International Sales and Relations
+1-615-823-9907 (Cell)
+1-678-569-0881(Fax)
Skype: andre.w.mouton
Andre.Mouton@sanuwave.com

Antibe Therapeutics Inc. Announces Proposed Offering of Units

Posted On May 25, 2017 By OrthoSpineNews In Financial /

TORONTO–(BUSINESS WIRE)–Antibe Therapeutics Inc. (“Antibe” or the “Company“) (TSXV: ATE) (OTCQX: ATBPF) a diversified biotechnology company announced today that it has filed a preliminary short form prospectus in connection with a proposed marketed offering of units of the Company (the “Units”) for minimum gross proceeds of $3,000,000 and maximum gross proceeds of $5,000,000 (the “Offering”). Each Unit will be comprised of one common share of the Company and one half of one common share purchase warrant (each full warrant, a “Warrant”). The Offering will be undertaken on a “best efforts” agency basis in the provinces of Ontario, British Columbia and Alberta pursuant to the Company’s preliminary short form prospectus dated May 24, 2017 (the “Preliminary Prospectus”), filed with securities regulators in Ontario, British Columbia and Alberta.

The number of Units to be distributed, the price of each Unit and the exercise price and term of each Warrant will be determined in the context of the market. Bloom Burton Securities Inc., Dominick Inc., and Echelon Wealth Partners Inc. are co-agents for the Offering (together, the “Agents”).

The Company has granted the Agents an over-allotment option (the “Over-Allotment Option”), exercisable in whole or in part, at the Agents’ sole discretion, at any time and from time to time for a period of 30 days following the final closing, to offer and sell on the same terms as the Offering up to such number of additional Units as is equal to 15% of the number of Units issued under the Offering.

In consideration for the services to be rendered by the Agents in connection with the Offering, the Agents will receive a fee consisting of cash and broker warrants.

If the minimum offering size is completed, the Company intends to use the net proceeds to: (i) complete its Phase 2 GI safety study for the Company’s lead drug, ATB-346 and (ii) commence metabolic studies for ATB-346. If the maximum offering size is completed, the Company intends to use the net proceeds to: (i) complete its Phase 2 GI safety study for ATB-346; (ii) commence its Phase 2 dose-ranging efficacy clinical study for ATB-346; (iii) fully fund the metabolism studies of ATB-346; and (iv) partially fund IND-enabling pre-clinical studies for its second pipeline drug, ATB-352. In addition to clinical development, the Company intends to use a portion of the net proceeds of the Offering for Citagenix product and business development, working capital and general corporate purposes. For additional detail regarding the use of proceeds, please refer to the Preliminary Prospectus.

The Offering is subject to a number of conditions, including, without limitation, receipt of all regulatory approvals, including the approval of the TSX Venture Exchange. There can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

A copy of the Preliminary Prospectus, which was filed in each of the provinces of Ontario British Columbia and Alberta, contains important information relating to the Offering and the Units, and is available on SEDAR at www.sedar.com or by contacting Bloom Burton Securities Inc., at ecm@bloomburton.com. The Preliminary Prospectus is still subject to completion or amendment. There will not be any sale or any acceptance of an offer to buy the Units until a receipt for the final prospectus relating to the Offering has been issued.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the Units in any jurisdiction, nor will there be any offer or sale of the Units in any jurisdiction in which such offer, solicitation or sale would be unlawful. The Units have not and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any U.S. state securities laws, and therefore will not be offered or sold within the United States except pursuant to exemptions from the registration requirements of the U.S. Securities Act and applicable state securities laws.

About Antibe Therapeutics Inc.

Antibe develops safer medicines for pain and inflammation. Antibe’s technology involves linking a hydrogen sulfide-releasing molecule to an existing drug to produce a patented, improved medicine. Antibe’s lead drug ATB-346 targets the global need for a safer drug for chronic pain and inflammation. ATB-352, the second drug in Antibe’s pipeline, targets the urgent global need for a safer, non-addictive analgesic for treating severe acute pain, while ATB-340 is a GI-safe derivative of aspirin.

Antibe’s subsidiary, Citagenix Inc. (“Citagenix”), is a leader in the sales and marketing of tissue regenerative products servicing the orthopedic and dental marketplaces. Since its inception in 1997, Citagenix has become an important source of knowledge and experience for bone regeneration in the Canadian medical device industry. Citagenix is active in 15 countries, operating in Canada through its direct sales teams, and internationally via a network of distributor partnerships.

Forward-Looking Information

This news release contains certain “forward-looking information” as such term is defined under applicable Canadian securities laws. All statements, other than statements of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements relating to the Offering generally, the terms thereof and the use or proceeds from the Offering) constitute forward-looking information. This forward-looking information reflects the current expectations or beliefs of the Company based on information currently available to the Company as well as certain assumptions including, without limitation, the ability of the Company to complete the Offering in a timely manner and on the terms and conditions described in the news release). Forward-looking information is subject to a number of significant risks and uncertainties and other factors that may cause the actual results of the Company to differ materially from those discussed in the forward-looking information, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on the Company. Factors that could cause actual results or events to differ materially from current expectations include, but are not limited to, the risk that the Company may not be able to raise the minimum amount of proceeds required to complete the Offering; the failure of the Company to effectively obtain the approval of the TSX Venture Exchange for the Offering; the inability of the Company to satisfy all conditions to the completion of the Offering and the risk of unforeseen delays in the completion of the Offering, if at all, whether as a result of market conditions or otherwise. Reference is also made to the risk factors disclosed under the heading “Risk factors” in the Company’s AIF for the year ended March 31, 2016 which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

The TSX Venture Exchange has in no way passed upon the merits of the proposed Offering and has neither approved nor disapproved the contents of this press release. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contacts

Antibe Therapeutics Inc.
Dan Legault, +1 416-473-4095
Chief Executive Officer
dan.legault@antibethera.com

Stryker Returns To DEAN & DELUCA Invitational For Second Consecutive Year With Plans To Honor Military Veteran With Service Canine

Posted On May 25, 2017 By OrthoSpineNews In Extremities, Financial /

MAHWAH, N.J., May 24, 2017 /PRNewswire/ — Stryker Orthopaedics announced today plans to activate in Fort Worth, TX for the DEAN & DELUCA Invitational. For the second consecutive year appearing at the tournament, Stryker will continue to engage with fans through its onsite activation, The Mobility Zone – a destination designed to educate golf fans on the importance of joint health through various engaging activities. New for 2017, on Friday, Army Veteran Robert Baker, Stryker’s Vice President of Operations, will present one well-deserving military hero with a service dog in a special K9s For Warriors ceremony – marking the company’s third donation this year.

As an extension of a successful relationship that began last year, throughout the PGA TOUR® and PGA TOUR Champions 2017 season, Stryker will continue to give a new leash on life to military heroes by sponsoring service canines and empowering veterans to return to civilian life with dignity and independence. Tournament goers can also show their support to veterans by purchasing the same hat that PGA TOUR professionals and longtime brand ambassadors, Fred Funk and Hal Sutton wear on TOUR at the newly renovated Mobility Zone – Stryker’s premiere “joint health” destination. With each hat purchase, Stryker will make a donation to the K9s For Warriors organization.

This year marks the 71st anniversary of the tournament being held at Colonial Country Club – making it the longest running PGA TOUR event at the same venue. While on site, Stryker will showcase its commitment to educate Colonial’s dedicated tournament goers about the importance of leading an active lifestyle and having healthy joints. Inside The Mobility Zone, fans can partake in the new Stryker Challenge – a hands-on experience featuring Art H. Ritis, a life-size model that aims to provide tournament goers with a basic understanding of joint replacement surgery and Stryker’s products. In addition, fans who stop by The Mobility Zone will be able to enter for a chance to win a trip for two to Atlanta, GA for the TOUR Championship® and walk inside the ropes as an honorary observer – a true VIP experience.^1,2

“We are proud to continue to serve as a resource for fans onsite to learn about the importance of joint health, while also paying tribute to our brave service men and women,” said Bill Huffnagle, President, Stryker’s Joint Replacement Division. “Tournament goers can visit The Mobility Zone to support our military by purchasing a Stryker hat and learn more about joint health through fun activities and challenges.”

In an effort to reach fans both on and off the golf course, the company recently embarked on a cross- country road trip with brand ambassadors, NFL Hall of Famer Jerome Bettis and PGA TOUR Champions player and GetAroundKnee® patient, Fred Funk. The two have teamed up alongside Stryker to create a video series, demonstrating various ways to stay healthy and keep your joints moving. Earlier this month, Bettis and Funk stopped by Forth Worth to film the second episode of the video series where they went to the local batting cages to hit a few balls, and made a pit stop at the nation’s largest honky-tonk to learn how to line dance. To follow the “Road Trip to a Healthier Lifestyle” series and learn more about Stryker, visit StrykerChallenge.com.

Healthcare Professionals (HCPs) are not eligible to enter the Stryker Challenge Sweepstakes or participate in the any of these promotions. HCPs are defined as those individuals or entities involved in the provision of health care services and/or items to patients, which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Stryker’s products.
No purchase necessary to enter or win Sweepstakes. Void where prohibited by law. For official rules visit StrykerChallenge.com. Open to legal residents of the US & US Territories, 21+ as of date of entry. Sweepstakes begins at 12:01 am ET on 1/11/17 and ends at 11:59 pm ET on 8/27/17. Sponsored by Stryker.

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.

About PGA TOUR
The PGA TOUR is the leading global platform in professional golf, showcasing the highest expression of excellence, both on and off the course. The PGA TOUR’s mission is to entertain and inspire its fans, deliver substantial value to its partners, create outlets for volunteers to give back, generate significant charitable and economic impact in the communities in which it plays, grow and protect the game of golf and provide financial opportunities for TOUR players.

The PGA TOUR co-sanctions more than 130 tournaments on the PGA TOUR, PGA TOUR Champions, Web.com Tour, PGA TOUR Latinoamérica, Mackenzie Tour-PGA TOUR Canada and PGA TOUR China. Its members represent the world’s best players, hailing from 24 countries (86 members are from outside the United States). Worldwide, PGA TOUR tournaments are broadcast to more than 1.1 billion households in 227 countries and territories in 23 languages. Virtually all tournaments are organized as non-profit organizations in order to maximize charitable giving. In 2016, tournaments across all Tours generated a record of more than $166 million for local and national charitable organizations, bringing the all-time total to $2.46 billion.

The PGA TOUR’s web site is PGATOUR.COM, the No. 1 site in golf, and the organization is headquartered in Ponte Vedra Beach, Fla.

SOURCE Stryker

NovaBone Announces Irrigation Resistant Products with Carriers that have Synergistic Effect in Bone Formation

Posted On May 25, 2017 By OrthoSpineNews In Biologics, Top Stories /

May 24, 2017

JACKSONVILLE, Fla.–(BUSINESS WIRE)–NovaBone Products, a leading biologics medical device company, announces the addition of NovaBone IRM and NovaBone IRM MacroPOR to its portfolio of biologically active bone graft substitutes.

NovaBone IRM, and NovaBone IRM MacroPOR are the most advanced bioactive synthetic bone graft substitutes available to the orthopedic community today. Both formulations optimize osteogenesis, uniquely signal and stimulate osteoblastic activity, and offer angiogenic potential. By design, both formulations are highly irrigation resistant with excellent cohesion and handling properties.

“NovaBone Products’ base Bioactive Glass technology has proven to out-perform traditional calcium sulfate based synthetic products and demineralized bone matrix products,” said Dennis McBride, Vice President of Sales and Marketing. “We are now advancing our science further by providing formulations with carriers that have a synergistic effect in bone formation and retain molded shapes following implantation and irrigation.”

Novabone offers the broadest portfolio of bioactive synthetic bone graft substitutes in the world, with a robust pipeline of products in development designed to expand the regenerative biologics products the company offers. Presently, products offered include minimally invasive (MIS) delivery devices, strip formulations, putty materials that are hydrated using bone marrow aspirate, and putty formulations that are ready-to-use out of the package.

“We are proud to offer products that allow a surgeon to look to one company when addressing bone grafting needs,” concluded McBride.

NovaBone Products, a privately held company based in Florida, USA since 2002 and a recognized industry leader in bioactive glass design and manufacturing, developed the first bioactive synthetic bone graft offered to the orthopaedic community.

Contacts

NovaBone Products
Arthur Wotiz, President
904-651-0607
awotiz@novabone.com

First Surgery Completed Utilizing the Gramercy Extremity Orthopedic™ Systems

Posted On May 25, 2017 By OrthoSpineNews In Extremities, Top Stories /

DALLAS, TEXAS, USA, May 24, 2017 /EINPresswire.com/ — Gramercy Extremity Orthopedics (GEO) is pleased to announce the first surgery using the GEO™ Bone Screw and GEO CART™ systems. The first surgery was performed by Dr. Peter A. Blume, D.P.M., F.A.C.F.A.S. at Shoreline Surgery Center LLC, Guilford, CT, with outstanding results. As the first offering in the company’s product line, this marks a major milestone for Gramercy Extremity Orthopedics™.

Dr. Blume remarked on the advantages of the GEO™ Bone Screw and GEO CART™ Systems, “I was extremely impressed and pleased with the outcome when utilizing the GEO™ Bone Screw and GEO CART™ systems. The ease in which the system operated was noted by the entire Surgical Center staff and felt that the systems created many efficiencies that are lacking in today’s operating environment. The surgical back table was free of clutter and the implant and instruments were truly best of class. The GEO CART™ finally addresses all the pitfalls when operating with orthopedic hardware, whether it be at the Surgery Center or in the hospital setting.”

The GEO CART™ proprietary point-of-sale system reduces delays in surgery, decreases sterility risks to the patient, eliminates billing mistakes and hand written forms, automatically generates the Implant Usage Form and reduces facility operating expenses.

The GEO CART™ is a computerized mobile implant and instrumentation inventory system based on RFID technology. No bigger than the average medical cart, the GEO CART™ system can hold over 2,000+ items.

The GEO™ Bone Screw System offers a comprehensive array of low profile titanium screw lengths, diameters, thread lengths and fully threaded options. All GEO™ Bone Screws are double sterile packaged, self-drilling, self-tapping, reverse-cutting with variable length short and long threads and a hexalobe head to provide additional stability and torque transfer with less potential for head stripping. All instruments within the GEO™ Bone Screw system are also double sterile packaged in single use kits to ensure a new and sterilized instrument is used every surgery.

“We are all very pleased with the results from today’s surgery. Not only did the implant and instruments all work superbly, the case was performed without issue and in an efficient manner,” says Michael P. Simpson, President and CEO of Gramercy Extremity Orthopedics™. “As for the GEO CART™, in my 16 years in orthopedic medical devices, I have never had the ability to see the transactions remotely from a case within minutes of the surgery happening. This is a significant breakthrough in our industry. I want to thank the GEO™ team for all of their hard work in getting this system to the marketplace”

GEO™ will be exhibiting at the AOFAS Scientific Conference, Seattle, July 12-14, 2017. Booth #610.

About Gramercy Extremity Orthopedics™:

GEO™ was formed from the idea that there could exist a more cost-effective, user-friendly way to supply Orthopedic Medical Implants in today’s healthcare environment. This is accomplished through the use of RFID technology, a groundbreaking Point-of-Sale delivery system, and GEO™ designed best in class sterilized single-use orthopedic implants and instruments. GEO™ is the only solution that provides a significant opportunity to lower real operating costs by creating efficiencies and controls throughout the delivery and consumption of orthopedic implants.

Michael Nugent
Gramercy Extremity Orthopedics™
855-436-2278 ext 103
email us here

DERMABOND® PRINEO® Skin Closure System May Improve Outcomes and Lower Hospital Costs

Posted On May 24, 2017 By OrthoSpineNews In Financial, Recon, Top Stories /

SOMERVILLE, N.J., May 24, 2017 /PRNewswire/ — Ethicon^* announced the results of two economic analyses demonstrating that the DERMABOND^®PRINEO^® Skin Closure system, a product that combines a topical skin adhesive with a self-adhering patch, is associated with improved patient outcomes and lower healthcare costs for hospitals. Both studies are being presented at the International Society for Pharmacoeconomics and Outcomes Research’s 22nd Annual International Meeting this week.

The first study, Comparison of Economic and Clinical Outcomes between the DERMABOND® PRINEO® Skin Closure System and Skin Staples in Patients Undergoing Knee Replacement in Real World Clinical Practice,¹ found that the DERMABOND PRINEO System is associated with improved outcomes for patients receiving total knee arthroplasty (TKA) when compared to skin staples. The findings are based on a retrospective analysis of 1,942 TKA procedures using the Premier Perspective^®Hospital Database. Specifically, the DERMABOND PRINEO System was associated with a statistically significant reduction in readmission rates at 30, 60 & 90 days, a reduction in length of hospital stay and a lower probability of being discharged to a skilled nursing facility (SNF). The analysis showed that the 30-day readmission rate for the DERMABOND PRINEO System group was 1.8%, compared to 4.4% for the skin staple group. The costs of 30 day readmissions for TKA have been estimated to be $12,839.² The DERMABOND PRINEO System was also associated with a 12% reduction in length of hospital stay and a 31% reduction in discharge to a SNF or other non-home setting, which could lead to savings in the acute and post-acute setting.

The second study, A U.S. Hospital Budget Impact Analysis of a Skin Closure System Compared with Standard of Care in Hip and Knee Arthroplasty, estimates the 90-day cost impact of the DERMABOND PRINEO System compared to other wound closure methods for hip and knee arthroplasty from a U.S. provider perspective.³ The analysis showed that the use of the DERMABOND PRINEO System DERMABOND PRINEO System in hip and knee arthroplasty may achieve cost savings that could translate into an annual hospital budgetary savings ranging from $28,349 to $39,809 when assuming 500 arthroplasties.³ The predicted cost savings was driven by reductions in dressing materials and post-operative healthcare visits when the DERMABOND PRINEO System is utilized.

“Ethicon is committed to bringing to market innovative products that are designed to provide improved outcomes for patients and enable our customers to provide the best care for their patients,” says Nefertiti Greene, Vice President, Global Wound Closure and Repair Platform Leader at Ethicon. “The DERMABOND PRINEO System has been shown by this research to be an excellent approach to wound closure.”

Reducing the length of a patient’s hospital stay can lead to reduced costs and may also lower the chances of contracting an infection.⁴In addition, reducing readmissions can prevent hospitals from being penalized for readmission rates above the national average for TKA.⁵ The reductions in health care resource utilization demonstrated in these studies are important for hospital systems and health care professionals particularly those who are part of or are considering episode-based payments where both acute and post-acute costs are combined into one payment.

Several benefits associated with the DERMABOND PRINEO System may explain the findings. The product provides significantly greater skin holding strength than skin staples and subcuticular suture,⁶⁺ and acts as a barrier to microbial penetration against organisms commonly associated with surgical site infection.⁷ The DERMABOND PRINEO System requires no postsurgical dressings which may mean easier self-care and greater self-confidence for patients.⁷ Also, if directed by their healthcare professional, patients can shower immediately after surgery⁷ which could lead to a higher level of patient satisfaction.

About Ethicon

From creating the first sutures to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues, and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treating serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.

*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates Ethicon, Inc. is the legal manufacturer of the DERMABOND^®PRINEO^® Skin Closure system. All other trademarks are the property of their respective owners.

+In an ex vivo study, more load in N was required to create a 3-mm gap between skin edges approximated with DERMABOND PRINEO System (22 cm) than with subcuticular 4-0 MONOCRYL® (poliglecaprone 25) Suture or PROXIMATE® Ethicon Endo-Surgery skin staples (P<.001).

073076-170517

¹Johnston S, Sutton N. Comparison of Economic and Clinical Outcomes between the Dermabond® Prineo® Skin Closure System and Skin Staples in Patients Undergoing Knee Replacement in Real World Clinical Practice. Poster Presented at: ISPOR 22nd Annual International Meeting; May 20-24, 2017; Boston, MA.
² HCUP Statistical Briefs website. Available at: https://www.hcup-us.ahrq.gov/reports/statbriefs/sbtopic.jsp. Accessed May 17, 2017
³ Sadik, K, Flener J, Gargiulo J, Graves M, Nunley, R Post, Z, Wurzelbacher, Sutton, N, Hogan, Hollman, S, Ferko, N. A U.S. Hospital Budget Impact Analysis of a Skin Closure System Compared with Standard of Care in Hip and Knee Arthroplasty. Poster Presented at: ISPOR 22nd Annual International Meeting; May 20-24, 2017; Boston, MA.
⁴ Hassan M, Tuckman HP, Patrick RH, Kountz DS, Kohn JL. Hospital length of stay and probability of acquiring infection. International Journal of Pharmaceutical and Healthcare Marketing. 2010;4(4):324-338.
⁵ Centers for Medicare & Medicaid Services Readmissions Reduction Program (HRRP) https://www.cms.gov/medicare/medicare-fee-for-service-payment/acuteinpatientpps/readmissions-reduction-program.html. Accessed May 17, 2017.
⁶ Data on file, Ethicon, Inc.: Kumar A. AST-2012- 0290. Completion Report: Study to compare the tissue holding strength of PRINEO Skin Closure System with conventional wound closure techniques. 2012.
⁷ Data on file. Ethicon, Inc. Dermabond Prineo System Master Claims Matrix.

SOURCE Ethicon

MemorialCare Joint Replacement Center At Long Beach Memorial Now Offering Newest Technology In Total Knee Replacement

Posted On May 24, 2017 By OrthoSpineNews In Recon, Robotics, Top Stories /

LONG BEACH, Calif., May 24, 2017 /PRNewswire-USNewswire/ — The MemorialCare Joint Replacement Center at Long Beach Memorial is the first hospital in Long Beach and North Orange County to offer Stryker’s robotic-arm assisted total knee application for use with its Mako System – and now has successfully performed its first total knee replacement case in that region using this new technology. This latest advancement in joint replacement surgery transforms the way total knee replacements are performed.

Total knee replacements in the United States are expected to increase 673 percent by 2030,¹ yet studies have shown that approximately 30 percent of patients are dissatisfied after conventional surgery.² Mako Total Knee combines Stryker’s advanced robotic technology with its clinically proven GetAroundKnee (Triathlon Total Knee System), which enabled surgeons to have a more predictable surgical experience with increased accuracy during laboratory testing.³

“Mako is changing the way joint replacement surgeries are performed by providing each patient with a personalized surgical experience based on their specific diagnosis and anatomy,” said Andrew Wassef, M.D., medical director, MemorialCare Joint Replacement Center, Long Beach Memorial. “Using a virtual 3D model, the Mako System allows surgeons to create each patient’s surgical plan pre-operatively before entering the operating room. During surgery, the surgeon can validate that plan and make any necessary adjustments while guiding the robotic-arm to execute that plan. It’s exciting to be able to offer this transformative technology across the joint replacement service line to perform total knee, total hip and partial knee replacements.”

The Mako Total Knee application is a knee replacement treatment option designed to relieve the pain caused by joint degeneration due to osteoarthritis. Through CT-based 3D modeling of bone anatomy, surgeons can use the Mako System to create a personalized surgical plan and identify the implant size, orientation and alignment based on each patient’s unique anatomy. The Mako System also enables surgeons to virtually modify the surgical plan intra-operatively and assists the surgeon in executing bone resections.

“We are proud to be the first hospital to offer this highly advanced robotic technology in our area,” said Tamra Kaplan, PharmD, chief operating officer, Long Beach Memorial. “This addition to our orthopaedic service line further demonstrates our commitment to provide the community with outstanding healthcare.”

About the MemorialCare Joint Replacement Center at Long Beach Memorial:

Long Beach Memorial is lauded for superior clinical quality outcomes and has been listed on U.S. News & World Report’s America’s Best Hospitals since the annual rankings began. In this year’s results, Long Beach Memorial received “high performance” rankings in nine clinical specialty areas, including Hip Replacement, Knee Replacement and Orthopedics. It also is among a small percentage of U.S. hospitals consistently recognized for outstanding dedication to patient safety by maintaining a top “A” grade in eight of nine Leapfrog Group Hospital Safety Score evaluations for its ability to prevent errors, injuries, accidents and infections.

JRC specializes in a rapid rehabilitation program – where patients walk the same day of surgery – resulting in a shorter hospital stay – average hospital stay is zero to two days. The JRC features a dedicated unit for joint replacement patients with 15 private rooms, a joint care coordinator to help patients navigate through the program, patient education before and after surgery and “rehab coaches” to provide support as patients take their first steps toward an active lifestyle.

1. Kurtz AAOS. Total knee and hip replacement projections 2030. www.prnewswire.com/news-releases/total-knee and-hip-replacement-surgery projections-show-meteoric-rise-by-2030-55519727.html. Accessed July 4, 2016. 2. Christiaan Keurentjes J, Fiocco M, So-Osman C, et al. Patients with severe radiographic osteoarthritis have better prognosis in physical functioning after hip and knee replacement: a cohort-study. PLOS One. 2013; 8(4): 1-8. 3. Hampp EL, Scholl LY, Prieto M, Chang T, Abbasi AZ, Bhowmik-Stoker M, Otto JK, Jacofsky DJ, Mont MA. “Accuracy Assessment of Robotic and Manual TKA in a Cadaveric Model.” Robotic-arm assisted total knee arthroplasty demonstrated greater accuracy to plan compared to manual technique. ORS 2017 Annual Meeting. San Diego. Poster No.2412.

SOURCE Long Beach Memorial

Boston Scientific is the 2nd biggest dealmaker in medtech since 2012

Posted On May 24, 2017 By OrthoSpineNews In Financial, Top Stories /

Max Stendahl, Biotech Reporter / Boston Business Journal – May 4, 2017

The last five years have seen a flurry of dealmaking in the medical device industry. And according to a new report, Marlborough-based Boston Scientific is responsible for more acquisitions than any other company since 2012 except one.

With 27,000 employees worldwide and around 2,500 here in Massachusetts, Boston Scientific (NYSE: BSX) is the largest medical device firm based in the state by headcount. It’s pulled off eight acquisitions since the beginning of 2012, according to the report by market research firm CB Insights. (The actual number appears to be 10; the report appears to omit one recent deal for an endoscopy firm and another in 2014 for a manufacturer.)

The only medical device company that was more active during this period was Boston Scientific’s rival, Ireland-based Medtronic (NYSE: MDT), which acquired a whopping 15 device firms.

For Boston Scientific, the string of acquisitions has coincided with the tenure of Mike Mahoney, who joined as president in October 2011 and was named CEO a year later. Boston Scientific has seen its stock price increase steadily with the 52-year-old Mahoney at the helm. He remains one of the highest-paid executives among public companies in the state, earning $35.7 million in total compensation plus value realized from past stock awards in 2016.

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Doctor who faced retaliation for raising concerns about double-booked surgeries wins lawsuit

Posted On May 24, 2017 By OrthoSpineNews In Regulatory, Top Stories /

By Jonathan Saltzman – GLOBE STAFF MAY 24, 2017

A prominent Boston neurosurgeon was illegally forced out of his previous job at a New York hospital for strongly objecting to a policy that allowed another surgeon to perform complex spine surgeries on two patients simultaneously, a judge ruled.

Double-booking, as the practice is sometimes called, triggered a fierce dispute among doctors at Massachusetts General Hospital in recent years, leading to the 2015 dismissal of an orthopedic surgeon who opposed it. But Dr. James Holsapple may be the first doctor to win a lawsuit alleging he faced retaliation for challenging the practice.

New York Supreme Court Justice James P. Murphy ruled after a bench trial that University Hospital in Syracuse retaliated against Holsapple after he spoke out about the surgeon running two operating rooms at once.

“Dr. Holsapple vehemently objected and opposed the procedures for valid public health and safety reasons,” Murphy ruled in a 13-page decision received by the neurosurgeon Monday.

Holsapple, now chief of neurosurgery at Boston Medical Center, was awarded $88,277 in lost wages under the New York State whistle-blower statute. His lawyer estimated that the award could top $150,000 because Holsapple is entitled to interest on lost wages.

Holsapple, who resigned under pressure from University Hospital in 2009 and moved to Boston, said he felt vindicated.

“I did what I thought was right, and I’m grateful that the judge who heard the case saw it the same way,” said Holsapple, who heads the neurosurgery department at the Boston University School of Medicine.

The New York attorney general’s office, which defended University Hospital as part of the State University of New York, referred all questions to the hospital. Darryl Geddes, a hospital spokesman, said he could not comment because the attorney general’s office is considering an appeal.

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Month: May 2017

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