Five ways Tom Price could change U.S. healthcare policy in a hurry

Dec 9, 2016 – By JULIE ROVNER

Prospective Health and Human Services Secretary Tom Price, currently the chairman of the House Budget Committee, brings a distinctive to-do list to the agency. And, if confirmed by the Senate, he will have tremendous independent power to get things done.

While he will report to the president, heads of major agencies like HHS — with a budget of more than $1 trillion for the current fiscal year — can interpret laws in different ways than their predecessors, and rewrite regulations and guidance, which is how many important policies are actually carried out.

“Virtually everything people do every day is impacted by the way the Department of Health and Human Services is run,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. HHS responsibilities include food and drug safety, biomedical research, disease prevention and control, as well as oversight over everything from medical laboratories to nursing homes.

Price, a Georgia physician who opposes the Affordable Care Act, abortion and funding for Planned Parenthood, among other things, could have a rapid impact without even a presidential order or an act of Congress.

Some advocates are excited by that possibility. “With Dr. Price taking the helm of American health policy, doctors and patients alike have sound reasons to hope for a welcome and long-overdue change,” said Robert Moffit, a senior fellow at the conservative Heritage Foundation, in a statement.

Others are less enthusiastic. Asked about what policies Price might enact, Topher Spiro of the liberal Center for American Progress said: “I don’t know if I want to brainstorm bad ideas for him to do.”

 

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Amplitude Surgical: Acquisition of a 50% Stake in SOFAB Orthopédie, a Strategic Industrial Subcontractor

December 12, 2016

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

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading player on the global surgical technology market for lower-limb orthopedics, announces having acquired a 50% stake in SOFAB Orthopédie, a longstanding strategic industrial subcontractor.

Commenting on this newly-acquired stake, Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “Following the construction of a logistics site and the launch of work to create our own ‘clean room’, the acquisition of a stake in SOFAB Orthopédie – an industrial subcontractor – is another strategic investment aimed at consolidating our industrial base and our supply chain within a context of the pursuance of our buoyant business growth.

Yann Quinkal, CEO of the SOFAB Orthopédie group, adds: “This deal with Amplitude Surgical will enable us to continue our development alongside a longstanding partner that shares our vision of total quality.

Founded in July 2007 and based near Valence in the Rhone valley, the SOFAB Orthopédie group incorporates FIRM Industrie, POLI ALPES and POLI-TECH’, three ISO 9001 and ISO 13485 certified companies specializing in the end-to-end manufacturing of implants and ancillaries, from machining to polishing and engraving. The Group employs close to 80 staff and generates annual revenue of almost €5 million, 80% of which comes from Amplitude Surgical. Yann Quinkal will continue to head this activity in close collaboration with the Amplitude Surgical teams.

Amplitude Surgical will consolidate in full SOFAB Orthopédie from the second half of 2016-17 and expects this transaction to provide a net positive contribution from 2017-18.

Next financial press release: H1 2016-17 sales, Wednesday February 15, 2017, after market.

About Amplitude Surgical

Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. Amplitude Surgical distributes its products in more than 30 countries. At June 30, 2016, Amplitude Surgical had a workforce of almost 300 employees and recorded sales of over 80 million euros.

Contacts

Amplitude Surgical
Philippe Garcia, +33 (0)4 75 41 87 41
CFO
philippe.garcia@amplitude-ortho.com
or
NewCap
Investor Relations
Marc Willaume, +33 (0)1 44 71 00 13
amplitude@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 98 55
amplitude@newcap.eu

GE Makes Significant Progress with Investments in Additive Equipment Companies

BOSTON–(BUSINESS WIRE)–GE (NYSE: GE), the world’s leading digital industrial company, executed on its agreement to acquire a 75% stake in Concept Laser GmbH of Germany. The agreement, announced in late October, allows for GE to take full ownership over the next several years.

In addition, GE recently concluded its tender offer for the shares of Arcam AB of Sweden, first initiated in September, and purchased 76.15% of the company.

GE now has controlling shares of two important producers of additive manufacturing machines and technology, and has committed significant investments to enhance the portfolios of both companies.

Privately-held Concept Laser has more than 200 employees and is headquartered in Lichtenfels, Germany, with significant operations in the United States (Grapevine, Texas), China, and a global network of more than 35 distributors and agents. Concept Laser is a pioneer in the field of metal additive manufacturing. Concept Laser designs and manufacturers powder bed-based laser additive manufacturing machines. Its customer base is focused on the aerospace, medical and dental industries, with a meaningful presence in automotive and jewelry.

Arcam AB, based in Mölndal, Sweden, invented the electron beam melting machine for metal-based additive manufacturing, and also produces advanced metal powders. Its customers are in the aerospace and healthcare industries. Arcam has approximately 285 employees. In addition to its Sweden site, Arcam operates AP&C, a metal powders operation in Canada, and DiSanto Technology, a medical additive manufacturing firm in Connecticut, as well as sales and application sites worldwide.

“GE has made significant long-term commitments to both Arcam and Concept Laser to enhance their complementary technologies,” said Mohammad Ehteshami, vice president for Additive Integration at GE Additive. “Both companies are important players in the growing additive manufacturing movement, and are foundational to GE’s journey into this revolutionary manufacturing space.”

Additive manufacturing involves taking a digital design from computer aided design (CAD) software and melting/sintering together in a layer-by-layer manner, using either a laser or an electron beam as the energy source. Additive components are typically lighter and more durable than traditional forged parts because they require less welding and machining. Because additive parts are essentially “grown” from the ground up, they generate far less scrap material. Freed of traditional manufacturing restrictions, additive manufacturing dramatically expands the design possibilities for engineers.

GE is a leading end user and innovator in the additive manufacturing space. GE has invested approximately $1.5 billion in manufacturing and additive technologies at GE’s Global Research Center (GRC), and has developed additive applications across six GE businesses, created new services applications across the company, and earned 346 patents in powder metals used for the additive process.

About GE:

GE Additive is part of GE, the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. GE Additive offers a full line of metal additive manufacturing machines, materials and engineering solutions to customers in many industries including aerospace, medical, automotive and luxury goods. Visit GE Additive at www.geadditive.com.

GE (NYSE: GE) is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. GE is organized around a global exchange of knowledge, the “GE Store,” through which each business shares and accesses the same technology, markets, structure and intellect. Each invention further fuels innovation and application across our industrial sectors. With people, services, technology and scale, GE delivers better outcomes for customers by speaking the language of industry. www.ge.com

GE’s Investor Relations website at www.ge.com/investor and our corporate blog at www.gereports.com, as well as GE’s Facebook page and Twitter accounts, including @GE_Reports, contain a significant amount of information about GE, including financial and other information for investors. GE encourages investors to visit these websites from time to time, as information is updated and new information is posted.

Contacts

GE Additive
Rick Kennedy, +1 513 607 0609
rick.l.kennedy@ge.com

UnitedHealth Adopts Bundled Payment Model for Orthopedic Care

By  – December 12, 2016

Healthcare payers are finding that their reimbursement totals show higher spend for hip, knee, and spine surgeries and other orthopedic care when compared to other forms of treatment. Along with the higher spend, members regularly show poor health outcomes, said Michelle Lobe, Vice President of Network Strategy and Innovation at UnitedHealthcare. To counter these problems, UnitedHealthcare announced this month in a press release its new prospective bundled payment model for hip, knee, and spine surgeries.

“The main reason for developing a [bundled payment] program is that, in most large companies, high spend is really associated with orthopedic procedures,” Lobe told HealthPayerIntelligence.com. “For the most part, about 17 percent of company spend is in the orthopedic arena. Hip, knee, and spine procedures constitute about 33 percent of that.”

“Many companies are looking for ways to streamline payment and provide quality centers for their members to have more efficient, high-quality surgery,” Lobe continued. “That was the birth of why we focused on centers of excellence for spine and joint surgery.”

With 17 percent of all healthcare spending based on treating musculoskeletal conditions and 33 percent for hip, knee, or spine treatment, “to put a real number on that, 17 percent of average healthcare spend is about $45 dollars per member per month. That’s real cost for a company,” said Dr. Jon R. Friedman, Chief Medical Officer of Complex Medical Conditions at Optum.

With a large percentage of payer reimbursement based in orthopedic care, health insurance companies that implement bundled payment models and partner with high-quality providers may see a decrease in cost for orthopedic surgeries. The decrease in cost may be related to members spending fewer days in the hospital and stronger population health results, said Lobe.

“We measure across the whole continuum,” Lobe added. “We looking at reductions in a number of measures. We’re looking at population measures. We’ve seen results in reduction in readmission rates and reduction in length of stays.”

Bundled payment models would be a beneficial solution for  cutting costs. Bundles hold healthcare providers accountable for quality of care and patient safety. For instance, providers looking to boost their revenue would be incentivized through a bundle to ensure fewer costly hospital-acquired infections.

By partnering with high quality providers, payers may also find their members experience better outcomes and decreased cost, the UnitedHealthcare press release stated.

 

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Medovex Corp. Completes Sale of Assets of Streamline, Inc. to Skytron, LLC

ATLANTA, GA–(Marketwired – Dec 12, 2016) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that it has successfully completed the sale of substantially all of the assets of Streamline®, Inc. to Skytron®, LLC.

Specific details of the completed sale of Streamline to Skytron are set forth in the Current Report on Form 8-K filed today by Medovex with the U.S. Securities and Exchange Commission.

The sale proceeds will continue to be used to fund Medovex’s general operating needs, including ongoing development of its patented DenerveX™ System, which is designed to provide longer lasting relief of pain associated with the facet joint. Lower back pain is the second most common cause of disability in the U.S. for adults. Studies indicate that 10% of the U.S. adult population suffers from lower back pain and that 31% of lower back pain is attributed to facet joint pain.

Jarret Gorlin, Medovex’s Chief Executive Officer, stated, “We’re pleased to have successfully closed the sale of Streamline to Skytron. These proceeds, when combined with the additional $1 million investment made earlier this week by our Co-founder, Steve Gorlin, VP of Business Development, Jesse Crowne, and another private investor, will help complement our balance sheet and better position us for future growth.”

Medovexs DenerveX System consists of the DenerveX Rotational Ablation Denervation Device Kit, a single use medical device and the DenerveX Pro-40 Power Generator, both designed to be less invasive with faster recovery time than current surgical treatment options. It consists of two procedures combined into one device and is expected to provide for a longer lasting treatment solution while offering potential savings to the health care system. DenerveX System is not yet CE marked or FDA cleared and is not yet commercially available.

About Medovex
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about the company, visit its website at www.medovex.com.

Safe Harbor Statement
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Medovex believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the company’s filings with the U.S. Securities and Exchange Commission. Thus, actual results could be materially different. Medovex expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

  • CONTACT INFORMATION
    Medovex Corp.
    Jason Assad
    470-505-9905
    Email Contact

Alphatec Holdings Announces Board and Executive Leadership Changes

CARLSBAD, Calif., Dec. 12, 2016 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, today announced that its Board of Directors has appointed Terry M. Rich as the Company’s Chief Executive Officer, effective December 10, 2016.  Mr. Rich, who has also been appointed to the Company’s Board of Directors, will replace Leslie H. Cross, who has served as interim Chief Executive Officer since September 2016. The Company also announced today that its Board of Directors has appointed Mortimer Berkowitz III, a current member of the Company’s Board of Directors, as Chairman of the Board effective December 10, 2016, replacing Mr. Cross, who will step down as Chairman, but will remain on the Company’s Board of Directors.  As a result of this transition, the Board will no longer have a Lead Independent Director.  Finally, the Company announced new members of its commercial leadership team and equity inducement awards being granted to three new key employees.

Terry M. Rich Named CEO
With over 25 years of orthopedic, spine and medical device business experience, Mr. Rich has a successful track record of leading global business units, driving sales execution and commercial turn-arounds.  In addition, Mr. Rich has demonstrated experience managing both direct and distributor sales channels.  Most recently he served as President, Upper Extremities at Wright Medical Group N.V. (Nasdaq:WMGI), following Wright’s merger with Tornier, N.V. Prior to this, Mr. Rich served as the Senior Vice President, U.S. Commercial Operations, at Tornier and prior to Tornier, Mr. Rich held senior sales leadership positions in the spine industry at Nuvasive and DePuy Spine.

New Sales Leadership Appointed
In conjunction with Mr. Rich’s appointment, the Company also announced the following additions to the Company’s commercial leadership team:

  • Jon Allen has accepted a newly created position as the Company’s Executive Vice President, Commercial Operations.  In this role, Mr. Allen will be responsible for all aspects of sales, sales training, national accounts, healthcare economics and value creation.
  • Amy Ables, Ph.D., has accepted a newly created position as the Company’s Vice President, Corporate Education & Performance.  In this role, Dr. Ables will be responsible for all aspects of training and development for surgeons, sales representatives, distributors and employees.  Dr. Ables will also drive efforts for an integrated process to involve and align Alphatec’s teams to accomplish the Company’s strategic goals and objectives.

With these appointments, the Company is investing in strengthening its sales leadership in order to improve sales execution and drive future revenue growth.

Tim Berkowitz, Chairman of the Alphatec Board of Directors, said, “This leadership transition is the next step in connecting surgeons and patients in the U.S. with Alphatec’s new and robust spinal fusion products. We are excited to bring in Terry Rich as CEO to lead the next phase of the Company’s transformation and drive superior performance for Alphatec. Terry’s deep experience in the U.S. spine and orthopedics markets and his demonstrated history as an executive leader make him ideally suited for the CEO position.  We are equally excited about the additions of Jon and Amy to the commercial leadership team.  Together, Terry, Jon and Amy were senior executives at Tornier and were instrumental in repositioning Tornier’s U.S. commercial business and positioning the company for a successful merger with Wright Medical in 2015.  Their combined experience and exceptional leadership will be invaluable as we move to unlock the potential of our product portfolio across the U.S. spine market.”

Mr. Berkowitz added, “The Board offers our sincerest thanks to Les Cross for his dedication and contributions to Alphatec as Chairman of the Board for the last five-plus years.  We appreciate his guidance and leadership and we are very pleased that he will continue to serve on the Company’s Board.”

Mr. Rich said, “I am thrilled with the opportunity to lead Alphatec through this pivotal point in the Company’s transformation and aggressively pursue the large U.S. market opportunity we have in front of us. With a new, robust portfolio of spinal fusion products, an improved capital structure and a strengthened senior leadership team, we are well positioned to drive towards future profitability and growth. I look forward to engaging with the talented Alphatec employees, our surgeon customers, our distributors and sales agents, our suppliers and our shareholders as we embark on this new chapter.”

Terry M. Rich Background

With over 25 years of experience in the orthopedic and spine industry, Mr. Rich, 49, is an accomplished leader with a breadth of experience across a variety of commercial roles. Mr. Rich was most recently with Wright Medical Group and Tornier and held multiple roles with increasing responsibility since 2012 in the areas of U.S. sales, global product delivery, sales training, global marketing, commercial operations, research and development, healthcare economics, business strategy, finance and human resources.  Most recently, since 2015 he served as President, Upper Extremities of Wright Medical, where he was accountable for a ~$200M annual revenue business unit. Prior to Wright, he held senior executive leadership positions at Tornier.  Within the spine industry, Mr. Rich has held sales leadership roles at Nuvasive, where he was responsible for annual regional sales of ~$250M, and was a partner in a DePuy Spine distributor in northern California.  Mr. Rich received a B.A. in Labor Relations from Rutgers University.

New Commercial Leadership Background

Jon Allen has held numerous sales leadership and sales operations positions in spine and orthopedics over his 27-year career in medical devices, including most recently Vice President, Healthcare Economics and Reimbursement, at Wright Medical where he had oversight responsibilities for corporate accounts, product positioning, and value creation.  Prior to joining Wright Medical, Mr. Allen held senior executive leadership positions with Tornier starting as Vice President, Sales Operations, and serving on Tornier’s executive committee.  Additionally, Mr. Allen held senior leadership roles within the DePuy franchise where he was responsible for developing pricing and commercial strategy, sales channel management and subsequently owning a multi-state distributorship for DePuy Spine.  Mr. Allen has a long standing reputation being on the forefront of innovative and differentiated initiatives in the spine and orthopedics industries.  In addition, Mr. Allen has served as a consultant to leading orthopedic companies working with U.S. Senators and the Senate Finance Committee in addressing anti-conflict of interest legislation in healthcare.

Dr. Amy Ables most recently served as Vice President U.S. Training and Education at Wright Medical, a position she has held since 2014.  From 2007 to 2014, she served a variety of senior leadership roles at Tornier within medical education, clinical education, sales training and product management.  Prior to this, she served as Assistant Professor for the Department of Kinesiology at the University of Texas, Arlington.  Dr. Ables holds a Ph.D. in Biomechanics from Texas Woman’s University and has published several articles, books and presentations in the area of kinesiology, sports medicine and medical devices.

Inducement Awards Granted

As an inducement to entering into employment with the Company, and in accordance with NASDAQ Listing Rule 5635(c)(4) under Alphatec’s 2016 Employment Inducement Award Plan (the “Plan”), on December 10, 2016, the Compensation Committee of the Board of Directors approved the following inducement awards:

  • Terry Rich – 200,000 restricted stock units (RSUs) and an option to purchase 200,000 shares of common stock; and
  • Jon Allen – 75,000 RSUs and an option to purchase 75,000 shares of common stock; and
  • Amy Ables – 25,000 RSUs and an option to purchase 25,000 shares of common stock.

The RSUs and stock options were granted pursuant to Alphatec’s 2016 Employment Inducement Award Plan (the “Plan”).  Collectively, the RSUs and options were granted as inducements material to the new employees entering into employment with Alphatec in accordance with NASDAQ Listing Rule 5635(c)(4).

The RSUs will vest in equal installments annually over four years on each of the first four anniversaries of the grant date, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec.

The stock options will have an exercise price equal to the closing price per share of Alphatec’s common stock as reported by NASDAQ on the date of grant. The stock options will vest over four years, with 25% of the options vesting on the anniversary of the date of grant and the remainder of the options vesting monthly over the subsequent three years, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the options will fully vest upon a change in control of Alphatec.

The Board approved an amendment to the Plan to increase the shares reserved for issuance thereunder by 600,000 shares, effective December 10, 2016, to accommodate the foregoing awards.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

About Alphatec Spine
Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. via a direct sales force and independent distributors.
Additional information can be found at www.alphatecspine.com.

Forward Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include references to the Company’s: product development pipeline and product portfolio; ability to transform its operations and achieve superior performance; ability to maintain and take advantage of an improved capital structure; ability of the senior leadership team to successfully implement the Company’s strategy; and ability to accelerate its revenue growth or grow its revenues at all.   Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K for the year ended December 31, 2015, filed on March 15, 2016 with the Securities and Exchange Commission, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:
Christine Zedelmayer
Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

OMNIlife science™, Inc. Announces 10th Anniversary of APEX Knee™ System

RAYNHAM, Mass., Dec. 12, 2016 /PRNewswire/ — OMNIlife science, Inc. (“OMNI™”), an established medical technology company targeting the rapidly growing $15 billion global hip and knee replacement medical device sector, today announced the tenth anniversary of the launch of their APEX Knee™ System. Since 2006, the APEX Knee has been used in more than 75,000 total knee replacement procedures worldwide.

Ten years is a significant milestone in the lifetime of orthopedic implants because the results at ten years can generally be used to extrapolate the long term survivorship of the implant. Any device or design-related issues should have become apparent by this time, so device failures would likely be due to wear of the polyethylene components. This is not an issue for the APEX Knee polyethylene because it is EtO sterilized and it has more than 30 years of proven success in other medical devices. According to the latest Australian Registry statistics, the APEX Knee has a survivorship of 99.5%, better than any of its competitors. *

“Our knee implant design philosophy is that the device should allow the patient’s knee kinematics to be dominated by their individual anatomy, not by the implant; that the polyethylene should never see ionizing radiation, and that the instruments should be simple and easy to use,” said George Cipolletti, OMNI co-founder and Chief Technology Officer. “I am really proud that we have accomplished our goal: happy surgeons with happy patients!”

OMNI worked closely with two physicians, Warren Low**, M.D. and Thomas Tkach**, M.D., both at McBride Orthopedic Hospital in Oklahoma City, Oklahoma, to design the APEX Knee. As the first surgeons to implant the knee, they are pleased with its success. “I think the APEX Knee is an excellent implant in terms of sizing, fit, and kinematics as well as in instrumentation,” said Dr. Low. “The APEX Knee has stood the test of time and surgeons are using it in increasing numbers, so they and their patients are demonstrating its efficacy.”

Dr. Tkach commented, “When we started the APEX Knee project with OMNI 10 years ago our goal was simple. To take the experience of the design team accumulated over many years in the OR and in the orthopaedic industry and design a ‘no compromise’ completely new total knee replacement system. I believe we achieved our goal and both my personal clinical experience, as well as that reported from surgeons around the world, indicate that we have created a world class product that remains state of the art in design and performance 10 years after its first implantation. I look forward to seeing what the next 10 years will bring as we continue to improve the implants and instruments that make the APEX Knee System work so well in the hands of so many different surgeons in so many different countries.”

In addition to their hip and knee implants, OMNI has developed OMNIBotics®, an innovative technology platform for robotic-assisted total knee replacement and computer-assisted total hip replacement, enabling a customized procedure for each patient. OMNIBotics is the leading robotic- assisted total knee replacement technology available, with more than 10,000 OMNIBotics procedures performed worldwide.

“The APEX Knee is the foundation of OMNI,” said Rick Randall, CEO. “We have a five year history of combining this outstanding and proven implant with our OMNIBotics technology, resulting in a procedure that goes beyond traditional total knee replacement surgery. It is designed to enable rapid patient recovery through improved implant alignment and kinematic function. We believe it is transformational in its precision and patient benefits.”

About OMNI
OMNI is a privately held company with a proprietary robotic platform, OMNIBotics, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and improve patient care. For more information about OMNI, please visit www.omnils.com.

Forward-Looking Statements
Statements in this press release concerning the future business, operations and prospects of OMNIlife science, Inc., including statements using the terms “plans,” “believes” or similar expressions are “forward- looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based upon management’s current expectations and are subject to a number of factors and uncertainties. Information contained in these forward-looking statements is inherently uncertain, and actual performance and results may differ materially due to many important factors. Such factors include, among others, changes in competitive conditions and pricing in OMNI’s markets, decrease in the demand for OMNI’s products, delays in OMNI’s product research and development cycles, decreases in the use of OMNI’s principal product lines or in procedure volume, unanticipated issues in complying with domestic or foreign regulatory requirements related to OMNI’s current products or securing regulatory clearance or approvals for new products or upgrades or changes to OMNI’s current products, the impact of the United States healthcare reform legislation on hospital spending and reimbursement, any unanticipated impact arising out of the securities class action or any other litigation, inquiry, or investigation brought against OMNI,  increases in costs of OMNI’s sales force and distributors, and unanticipated intellectual property expenditures required to develop, market, and defend OMNI’s products. OMNI cannot guarantee any future results, levels of activity, performance or achievement. OMNI undertakes no obligation to update any of its forward-looking statements after the date of this press release.

Contact
Cindy Holloway, Director of Marketing Communications
Phone: (508) 824-2444

*Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide: AOA; 2016

**Both Warren Low and Thomas Tkach have product development agreements with OMNIlife science, Inc.

SOURCE OMNIlife science, Inc.

Richard Davies Wins “Best CEO in the Biomaterials Industry” Award from European CEO Magazine

Lund, Sweden, 13 December, 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, is pleased to announce that its CEO Richard Davies has won the “Best CEO in the Biomaterials Industry” award. The award was presented by European CEO Magazine based on Mr. Davies’ track record at the forefront of major new healthcare trends and the continuing success of BONESUPPORT™ under his leadership.

Mr. Davies became CEO of BONESUPPORT in January 2016, following nearly four years spent at Hospira, where he served as Chief Commercial Officer. While at Hospira, he drove growth, globalization and modernization across the business. Hospira was acquired by Pfizer at the end of 2015. Prior to Hospira, Mr. Davies spent nine years in increasingly senior leadership positions at Amgen in Europe, Australia and the U.S. His roles included leadership of the U.S. Inflammation sales group, which commercialized Enbrel® (etanercept), the most prescribed biologic medicine in the U.S. at that time. Mr. Davies began his career at Eli Lilly, spending 13 years in increasingly senior positions.

Richard Davies, CEO of BONESUPPORT, said: “I am very humbled to have been given this award. I firmly believe that BONESUPPORT has an exciting future based on the significant potential of its unique CERAMENT™ platform. This platform is truly innovative and enables surgeons to improve patient outcomes across a range of orthopaedic indications, enabling a single stage surgical procedure for osteomyelitis, reduce length of stay in hospital and lower the cost of care. These benefits are based on the platform’s important clinical features including its ability to rapidly remodel to host bone in six to 12 months, as well as being a carrier for therapeutics that enhance the bone healing process.”

BONESUPPORT recently raised $37 million (SEK 327 million) to support the execution of its strategy to deliver significant shareholder value, focused on:

  • Driving the sales of CERAMENT BONE VOID FILLER, CERAMENT G and CERAMENT V (with the antibiotics gentamicin and vancomycin respectively)
  • Generating further clinical data to highlight the compelling benefits that the current CERAMENT products deliver
  • Conduct the FORTIFY study to support a planned PMA filing in the US for CERAMENT G
  • Building the Company’s product pipeline by capitalizing on the unique drug-eluting properties of its injectable bioceramic platform

BONESUPPORT believes that the attractive properties of its CERAMENT platform will allow it to develop products that are both osteoconductive and osteoinductive for use managing a range of bone diseases where enhanced bone growth is needed to improve treatment outcomes.

 Notes to Editor

About BONESUPPORT™

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to 12 months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT G and CERAMENT V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden. www.bonesupport.com

BONESUPPORT™ is a registered trademark. 

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

bonesupport@citigatedr.co.uk

Centrexion Therapeutics Announces Highly Statistically Significant Topline Results from Phase 2b Study of CNTX-4975 in Patients with Knee Osteoarthritis Pain

Boston – December 13, 2016 – Centrexion Therapeutics, a company focused on advancing the treatment of chronic pain with one of the largest exclusively pain-focused pipelines of non-opioid therapies in active development, today announced positive topline data from its Phase 2b study of CNTX-4975 in patients with knee osteoarthritis (OA) pain.

In the randomized, double-blind, placebo-controlled, multicenter TRIUMPH study, CNTX-4975, Centrexion’s proprietary lead pipeline candidate, met its primary endpoint of a reduction in pain with walking through 12 weeks with high statistical significance and demonstrated a duration of effect of at least 24 weeks after a single dose. At the 1.0 mg dose, two-thirds of patients achieved 50 percent or greater reduction in pain and nearly one-quarter of patients achieved a 90 percent or greater reduction in pain.

“As our population ages, chronic osteoarthritis pain is an important and growing problem. Short of joint replacement which carries risks associated with any surgery, there are insufficient options and severe osteoarthritis pain is one of the most common reasons patients take opioids,” commented Nathaniel Katz M.D., M.S., adjunct associate professor of anesthesia at Tufts University School of Medicine. “It is critical to develop effective non-opioid therapies that can avoid the abuse and addiction issues associated with opioid treatments and CNTX-4975 represents an important new approach for pain relief for patients. The results seen in this clinical trial suggest that the medicine warrants further clinical investigation.”

“These Phase 2b data show the largest clinically-relevant reductions in knee osteoarthritis pain reported for any drug treatment, marketed or in development. They demonstrate that CNTX-4975 has the potential to provide a non-opioid and non-surgical approach to osteoarthritis pain relief that would allow patients to return to daily activities, such as walking up stairs, that were previously too painful,” said Randall M. Stevens, M.D., chief medical officer for Centrexion Therapeutics. “We are very encouraged by the extent and duration of pain relief treatment seen with CNTX-4975, particularly at the 1.0 mg dose. We look forward to discussing these results with the FDA and initiating Phase 3 development of CNTX-4975 next year.”

Design and Topline Results of Phase 2b Study

The dose-ranging Phase 2b study evaluated the safety and efficacy of CNTX-4975 in 175 patients with chronic moderate to severe knee OA pain over 24 weeks. Patients were randomized to receive either a single injection into the knee of CNTX-4975 0.5 mg (n=34), CNTX-4975 1.0 mg (n=71) or placebo (n=70). The primary endpoint was pain with walking (WOMAC [Western Ontario and McMaster Universities Arthritis Index] A1) at Week 12.

Secondary outcome measures included knee joint stiffness and function (both assessed by WOMAC B and WOMAC C, respectively), patient global impression of change (PGIC), responder analysis (the proportion of patients improved by percent from baseline pain), and safety and tolerability. Additional follow-up to 24 weeks was conducted to assess the duration of response from a single injection.

Topline results showed that, through 12 weeks:

Both doses of CNTX-4975 were significantly more effective than placebo in the primary endpoint of pain with walking. For the 1.0 mg dose:

oBoth weekly pain and daily pain measures were highly statistically significant (p<0.001)

oTwenty-two percent of patients achieved a 90 percent or greater reduction in pain and 67 percent of patients achieved 50 percent or greater reduction in pain

oCNTX-4975 was significantly more effective than placebo in the secondary outcome measures of stiffness, function and PGIC at every time point

oThe onset of pain reduction occurred within days and reached statistical significance at Week 1

oMaximum effect was seen at Week 5 and a stable, statistically significant  response at every time point was observed through Week 12

 

Topline results showed that, through 24 weeks for the 1.0 mg dose:

The study met the endpoint of duration of response with statistical significance with a single dose of CNTX-4975 compared to placebo

Safety results showed that the Day 1 injection of CNTX-4975 was generally well tolerated. Adverse events were similar to those seen with placebo and there were no drug-related serious adverse events. Laboratory abnormalities were few, generally mild, and associated with comorbid conditions or random fluctuations

Jeffrey B. Kindler, chief executive officer of Centrexion Therapeutics, added, “With these positive data in hand, the recent Fast Track designation for CNTX-4975 in Morton’s neuroma, and our acquisition of three novel pain treatment programs earlier this year, we are advancing a robust and diverse pipeline of non-opioid, chronic pain therapies that have the potential to bridge the safety and efficacy gaps in current chronic pain management.”

Centrexion plans to present the full study results at an upcoming medical conference.

About CNTX-4975

CNTX-4975 is based on Centrexion’s proprietary STRATI® technology (Synthetic TRans cApsaicin ulTra-pure Injection), a highly potent, ultrapure, synthetic form of trans-capsaicin (a medicine traditionally derived from the chili plant). CNTX-4975 is designed to be injected directly into the site of pain to provide rapid onset, large reduction and long duration of relief from moderate to severe pain without affecting touch sensibility or position sense.

CNTX-4975 works by selectively targeting the capsaicin receptor (TRPV1) to rapidly inactivate only the local pain fibers transmitting signals to the brain. With a short half-life, STRATI® is cleared from the body within 24 hours. This approach provides pain relief that can last for months until the ends of the local pain fibers regenerate, while leaving the rest of the nerve fiber functioning as normal, and without the risks of toxicities of NSAIDs and injected steroids or the side effects, including abuse and addiction, associated with opioid treatments.

In addition to the ongoing open-label, multiple-dose extension trial in patients with Morton’s neuroma pain, CNTX-4975 is currently being evaluated in a Phase 2b study for the treatment of chronic moderate to severe pain from knee osteoarthritis (OA) in humans and in a double-blind trial in pet dogs with OA.

About Osteoarthritis

Osteoarthritis (OA) is the most common form of arthritis, affecting approximately 14 million people in the United States.1 It occurs when the protective cartilage on the ends of the bones wears down over time, and the bone around the joints harden and form edges. These changes cause pain, swelling and problems moving the joint. OA also causes an inflammatory process to occur in the affected joint, further damaging the cartilage. Although OA can damage the majority of joints in the body, it most commonly affects joints in the hands, knees, hips and spine. OA can cause pain severe enough that patients experience difficulty walking, climbing stairs or even rising from a chair. Despite currently available therapies, many patients opt for total joint replacement to manage the painful condition.

About Centrexion Therapeutics 

Centrexion Therapeutics, Corp. is focused on advancing the treatment of chronic moderate to severe pain with one of the largest exclusively pain-focused pipelines of non-opioid therapies in active development. Centrexion Therapeutics recognizes the needs of over a quarter of a billion patients living with chronic pain worldwide, and aims to develop new, safer and more effective therapies that overcome the limitations and challenges associated with current pain treatments. Founded by world-renowned leaders in drug development and well-funded by key investors, Centrexion Therapeutics is building a pain treatment powerhouse to address the substantial and growing global chronic pain epidemic. Centrexion Therapeutics has recently relocated from Baltimore, MD to Boston, MA.

For more information about Centrexion, visit http://www.centrexion.com.

  1. Deshpande, B., et al. Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity. Arthritis Care & Research. Published online November 3, 2016

 

Media Contact

Susan Heins, Pure Communications

864.346.8336

Susan@purecommunicationsinc.com

 

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SHOULDER INNOVATIONS LAUNCHES SIMPLE, INNOVATIVE TOTAL SHOULDER REPLACEMENT SYSTEM

HOLLAND, Mich., Dec. 12, 2016 (GLOBE NEWSWIRE) — Shoulder Innovations, an emerging developer of shoulder replacement systems, today announced the commercial release of its total shoulder replacement system. The Shoulder Innovations Total Shoulder System includes patented inset glenoid technology, originally innovated by Stephen Gunther, M.D. Since the system’s first availability, it has been implanted in dozens of patients, and is approved in more than ten hospital systems.

In the US alone, more than 100,000 patients receive shoulder replacement surgery each year, and the demand for the procedure is growing nearly 10 percent every year. Despite increasing demand, driven by expansion of the patient population and higher rates of activity, today’s shoulder replacement technologies continue to fall short of surgeon and patient expectations. Some patient populations are experiencing implant loosening rates as high as 20 percent at five years, and revision rates as high as 50 percent at 10 years, which drives patient dissatisfaction and higher health care costs.

Published results in the Journal of Shoulder and Elbow Surgery show improved implant stability of the Shoulder Innovations inset glenoid, demonstrating an 87 percent reduction in implant micro-motion as compared to conventional glenoid design. Furthermore, the Shoulder Innovations System simplifies shoulder replacement technology in order to improve patient outcomes.

“With the existing shoulder replacement technologies available, deficiency of the bone limits the size and options of replacement devices. This results in unreliable fixation of the glenoid implant, further damaging a patient’s bone structure, which causes glenoid failure and subsequent revision surgery,” said Stephen Gunther, MD, clinical lead of the Shoulder Innovations team.”Our published results show Shoulder Innovations’ new inset glenoid solution provides greater post-surgical implant stability, addressing the leading cause of revision surgery.”

Led by Dr. Gunther, the Shoulder Innovations clinical team designed a revolutionary surgical technique to address these issues. By countersinking the glenoid implant into the scapula, glenoid stability is enhanced providing a solution targeted directly at the leading cause of implant failure. Furthermore, the team has leveraged the elegant simplicity of the technology to create the simplest possible surgical approach, eliminating operative steps, reducing risk, and thereby delivering overall lower cost and operative times.

“We maximized the potential benefits of the inset technology by working with world class surgeons to create a simple, yet robust shoulder replacement system. The inset glenoid surgery requires fewer steps and allows reduced exposure to the glenoid vault,” said Matt Ahearn, president and COO of Shoulder Innovations. “All instrumentation of the Shoulder Innovations’ glenoid and humeral system is delivered in one case, which means less storage, handling, cleaning, and sterilization, resulting in fewer costs, while increasing back table efficiency.”

Additional results published in the Journal of Shoulder and Elbow Surgery show that near-term results of patients treated with severe glenoid bone loss, with minimum of three, and an average of 4.3 year follow-up, have found documented excellent radiographic and functional results using the inset glenoid implant. Separate studies showed a statistically significant increase in range of motion, reduction in pain and high patient satisfaction.

The inset glenoid design offers a number of key advantages to the current on-lay designs. Since loosening of the glenoid component has been a continued reason for shoulder replacement failure, this new inset design offers a strategic advantage over classic glenoid replacement implants. The strong, circumferential, cortical support of the implant around the perimeter shields the implant from rocking horse loosening forces during daily shoulder motion activities. The flat back design, pegs, and cement channels also potentiate the increased fixation strength that decreases the risk of implant loosening.

Additional details on Shoulder Innovations and its Total Shoulder Replacement System are available at shoulderinnovations.com.

About Shoulder Innovations
Shoulder Innovations, LLC is a medical device development company which designs and commercializes innovative products which demonstrate the potential for improved patient care and reduced overall cost to the healthcare system. Leveraging its breakthrough, patented, inset glenoid design, Shoulder Innovations is commercializing a shoulder replacement implant focused on improving outcomes related to the greatest cause of shoulder replacement failure, glenoid loosening. The inset technology reduces micro-motion by up to 87 percent, reducing inflammation and complications. Shoulder Innovations is based in Holland, Mich. Additional information is available at shoulderinnovations.com.

A photo accompanying this release is available at:
http://www.globenewswire.com/newsroom/prs/?pkgid=41982

Brian Burch
(616) 828-9813