GLOBUS MEDICAL ANNOUNCES FDA 510(K) CLEARANCE FOR EXCELSIUS GPS™

AUDUBON, Pa., Aug. 17, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced that the Excelsius GPS™, a revolutionary robotic guidance and navigation system, has been 510(k) cleared by the U.S. Food and Drug Administration. This platform technology supports minimally invasive and open orthopedic and neurosurgical procedures, with screw placement applications in spine and orthopedic surgery. Excelsius GPS™ seamlessly integrates Globus Medical implants and instruments and is compatible with pre-operative CT, intra-operative CT and fluoroscopic imaging modalities. The system is designed to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement.

“Excelsius GPS™ is the culmination of years of research and development efforts and demonstrates Globus Medical’s superior product development capabilities,” said Norbert Johnson, Vice President of Robotics, Imaging, & Navigation.  “We believe the Excelsius GPS™ System will advance patient care and provide tangible benefits for surgeons and hospitals in terms of time, accuracy and reduced radiation exposure through the application of robotic and navigation technology in spine and orthopedic surgery.”

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA.  The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms.  These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends.  Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted.  These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks.  For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission.  These documents are available at www.sec.gov.  Moreover, we operate in an evolving environment.  New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.  Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements.  Forward-looking statements contained in this press release speak only as of the date of this press release.  We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

CONTACT: Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

India introduces price controls for knee implants

NEW DELHI, Aug 16 (Reuters) – India has capped prices of orthopaedic knee implants, in the country’s latest move to bring down prices of medical devices.

The introduction of price controls marks the latest step by Prime Minister Narendra Modi’s government to make drugs and medical devices more affordable. In February, it imposed a 75 percent price cut for certain heart stents – wire mesh tubes used to treat blocked arteries, which caused protests among manufacturers.

India’s drug pricing authority said on Wednesday that orthopaedic implants in India had unjustified, unreasonable and irrationally high trade margins, leading to exorbitant pricing.

Ananth Kumar, Minister of Chemicals and Fertilisers, told a news briefing the government had capped knee implant prices “in public interest.”

Kumar said the price of the widely used cobalt chromium knee implant, priced at up to 250,000 rupees ($3,895) at Indian hospitals, would now be capped at 54,720 rupees ($852).

 

READ THE REST HERE

Stryker’s Spine Division Receives FDA Clearance for Serrato Pedicle Screw

August 16, 2017

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that its Serrato™ Pedicle Screw, intended for use in the non-cervical spine as part of the company’s successful Xia® 3 Spinal System, has received 510(k) clearance from the U.S. Food and Drug Administration.

Serrato Pedicle Screws feature enhanced serrated cutting flutes, a unique dual-thread pattern with an increased number of leads for rapid insertion, and a patented buttress thread locking mechanism designed to minimize cross threading and splaying of the screw head.1,2 The screws accommodate a variety of rod diameters and materials to suit the patient’s needs—5.5 and 6.0mm diameter rods in commercially pure titanium, titanium alloy, and Vitallium.

“Pedicle screws have been used for decades with very few changes to their design,” said Bradley Paddock, President of Stryker’s Spine division. “The design innovations incorporated into Serrato reinforce our commitment to making industry-leading investments focused on providing the advanced spinal products and differentiated technologies that our surgeon customers have come to expect.”

Serrato leverages the broad portfolio of the Xia 3 Spinal System, an orthopaedic spinal system comprised of a variety of shapes and sizes of screws, blockers, and hooks that affix several different types of rods and connectors to vertebrae or the spinal column for purposes of stabilization, or corrective action through the application of force.

Intended Use

The Xia 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. For the full Indications for Use, please refer to the Xia 3 Spinal System Instructions for Use.

About Stryker

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

References

1. Stryker Patent #6,074,391
2. Stryker Design History File DHF0000016688

Content ID TLSER-PR-1_14675

Contacts

Sullivan & Associates
Barbara Sullivan, 714/374–6174
bsullivan@sullivanpr.com

Renowned Orthopaedic Specialists Publish First Collection of Rebound Bracing Clinical Articles

August 15th, 2017

A group of internationally recognized orthopaedic surgeons has published the first collection of clinical cases utilizing Rebound® braces from Össur. The innovative Rebound line includes indication-specific Functional Healing braces designed to optimize patient healing while maintaining function and mobility.

“We are gratified that some of the world’s most respected thought-leaders in orthopaedic surgery have contributed these clinical evaluations of Rebound bracing,” said Dr. Axel Schulz, Medical Director for Össur, the global medical technology leader renowned for its advanced prosthetic and orthopaedic innovations. “Their experience will be very helpful in formulating longer-term clinical protocols for these technologies, which have been specifically designed to help accelerate recovery from PCL, ACL and cartilage-based knee injuries.”

LaPrade Case Demonstrates Rebound PCL’s Effectiveness

The Rebound PCL Brace from Össur is the world’s first dynamic force brace for rehabilitating posterior cruciate ligament (PCL) ruptures. It is part of the Functional Healing® line of innovative indication-specific, dynamic orthopaedic solutions intended to optimize healing while maintaining patient function and mobility.

Össur’s Rebound product family is built on decades of experience and designed to protect bone and soft tissue during healing through innovative technology and proven biomechanical approaches. Rebound PCL, the world’s first and only dynamic force brace for rehabilitating posterior cruciate ligament (PCL) ruptures, reflects the company’s Functional Healing approach to orthopaedic innovation, which focuses on developing proprietary technologies according to specific indication-based protocols and clinically relevant outcomes.

In his case study, Robert LaPrade, M.D., Ph.D., Complex Knee and Sports Medicine Surgeon at The Steadman Clinic, reports that use of the Rebound PCL brace helped aid an adult male gymnast recover after double bundle PCL reconstruction, a complete anatomic posterolateral corner knee reconstruction and a medial meniscus root repair following a severe varus noncontact injury. With full restoration of knee motion and complete healing of his PCL and PCL reconstructions, the patient had an excellent outcome and returned to a national level of competition just one year following his surgery.

According to Dr. LaPrade, PCL reconstruction recovery historically tends to stretch out over time due to the effects of gravity, but the Rebound PCL brace “negates the negative effects of gravity by applying an anterior translation force at higher knee flexion angles,” thereby protecting the PCL graft in early post-op applications.

“Patients with serious multiple ligament knee injuries can be restored back to high levels of activity with modern anatomic-based reconstructions. The additional use of the Rebound PCL brace facilitates a safe initiation of knee motion in the early postoperative period,” he concluded.

Other renowned clinicians who have contributed cases to the Rebound Bracing collection include:

  • Dr. Mats Brittberg, Professor, Region Halland Orthopedics at Kungsbaca Hospital, Sweden
  • Dr. Tobias Jung, Senior Physician, Section Head Knee Surgery and Sports Traumatology at Charité-University Medicine Berlin, Germany
  • Dr. Christos Kondogiannis, Orthopaedic Surgeon at Royal Melbourne Hospital St. Vincent’s Private Hospitals, Australia
  • Dr. Thomas Stein, Executive Senior Physician in the Department for Sport Traumatology at Berufsgenossenschaftliche Unfalklinik Frankfurt am Main, Germany
  • Dr. Peter Verdonk, full knee specialist at the Antwerp Orthopaedic Center, Department of Orthopaedic Surgery at Antwerp University Hospital, Netherlands

The full collection of Rebound case studies is available online at https://www.ossur.com/rebound.

“The clinical community’s response to the current line of Rebound braces has been so overwhelmingly positive that we look forward to introducing additional Rebound products in the future, which will complement our Functional Healing products in the continuum of care,” Dr. Schulz said.

Pennsylvania Hospital Neurosurgeon Performs the First Endoscopic Minimally Invasive Spinal Surgery in Pennsylvania

August 10, 2017-Penn Medicine News

PHILADELPHIA – Spine disc related low back and leg pain is a major challenge and is the second most common reason that patients visit the doctor in the United States—outnumbered only be respiratory infections—and is the leading cause of disability worldwide. Compression of the spinal nerves is one of the most common diagnoses and is frequently reversible with surgery.

Kevin Clark, 51, is one of 200,000 individuals in America who suffer with debilitating back pain, leg cramps, and difficulty standing, bending or walking due to spinal nerve compression and stenosis each year. He sought help from Penn Medicine neurosurgeons, and today, Clark is celebrating three months of being pain-free after suffering debilitating back pain, leg pain and thigh numbness for over a year. He became the first patient in Pennsylvania to undergo a life-changing, minimally invasive spine surgery through a single incision in his side that had him up and walking just hours after surgery. Neil R. Malhotra, MD, an assistant professor of Neurosurgery and Orthopaedic Surgery and the vice chairman of operations in the department of Neurosurgery, performed Clark’s procedure—called an endoscopic percutaneous lumbar spinal nerve decompression and discectomy—at the Hospital of the University of Pennsylvania in May.

Clark, a bridge inspector from Quakertown, Pa., had been experiencing back pain and numbness in his right upper leg and thigh for nearly a year. Clark previously had undergone open spinal laminectomy surgery—a procedure during which a small portion of the bone over the nerve root and/or disc material is removed to give the nerve root more space— three years earlier for nerve compression causing symptoms in the back and below the knees. He had an excellent surgical result, with 100 percent improvement of his symptoms, but he felt that the surgery recovery was tough, with incision pain lasting nearly three months. But since the surgery helped, he was prepared to do it again to get relief from his new problem above the knee. When he heard that there was another option for his problem, Clark agreed to become the first patient in the state to receive the new minimally invasive treatment. Following the procedure, Clark said, “The speed of recovery alone has been amazing. I was able to walk around without pain the same day.” He noted that he had rapid results for his different problems with both surgeries, but with this surgery there was almost no incision pain — relief without suffering the more typical side effects of surgery.

 

READ THE REST HERE

Renovis® Surgical Receives FDA Clearance for 3D-Printed Posterior Lumbar Interbody Fusion Systems

REDLANDS, Calif.Aug. 11, 2017 /PRNewswire/ — Renovis Surgical Technologies, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market posterior lumbar Tesera® porous titanium interbody fusion systems.

These systems feature implants for direct posterior (PLIF) or transforaminal (TLIF) approaches in both straight and curved options. Multiple heights, widths and lengths are available to better fit varying patient anatomies. All Tesera implants are produced through additive manufacturing (3D printing) and the company’s proprietary Tesera Trabecular Technology®, a highly porous structure that allows for bone attachment to implant surfaces and the potential for biologic fixation deep into the pore structure for long-term stability.

This is the fifth product group featuring the Tesera porous titanium structure for which Renovis Surgical has received FDA clearance; the Tesera SA system for stand-alone anterior spinal fusion was cleared by the FDA in October of 2013, the Tesera acetabular system for total hip reconstruction was cleared in April of 2014, the first-generation Tesera posterior lumbar interbody family was cleared in March of 2015, and the Tesera SC system for stand-alone anterior cervical fusion was cleared in March of 2016.

For more information on the Tesera® porous structure, visit: www.teseratrabeculartechnology.com.

About Renovis Surgical
Renovis Surgical Technologies, Inc. was founded in 2009 with the express mission of creating the highest quality implants for orthopedics, spine and trauma. The company is headquartered in Redlands, California.

For additional information on the Company, please visit www.renovis-surgical.com.

 

SOURCE Renovis Surgical Technologies, Inc.

Related Links

http://www.renovis-surgical.com

Xtant Medical Receives FDA Clearance for Calix-C Cervical Interbody Line Extension and Expanded Indications

BELGRADE, Mont., Aug. 09, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that the U.S. Food and Drug Administration (FDA) has cleared product line extensions for the Calix-C family of cervical interbody cages.  The clearance provides for the addition of two larger footprints and importantly, for use with allograft.  This clearance strengthens Xtant Medical’s focus in regenerative technologies, providing a more comprehensive. integrated cervical treatment option for surgeons and their patients.

In Xtant’s continued effort to combine our hardware and biologics products to provide total solutions for our customers, the Calix-C indication now includes use with allograft comprised of cancellous and/or corticocancellous bone graft in addition to the current use with autograft.  Xtant Medical’s 3Demin and patented OsteoSponge technology are ideal allografts to use with Calix-C due to their ability to compress, fill and expand within the interbody’s graft chamber, allowing for ideal bone contact with the vertebral plates and fusion. OsteoVive, a cellular allograft, can also be used in conjunction with Calix-C.  The additional, larger footprints of Calix-C are designed for increased stability against the vertebral endplates, and allow for a larger lumen for bone graft, making it a better surgical option for a greater number of patients.  The addition of the allograft indication and the larger sizes will all be available in PEEK and Titanium plasma coated PEEK.

“This new FDA clearance allows Xtant Medical to leverage the clinical effectiveness of our established allograft product offerings for use with our now expanded line of interbody devices in cervical discectomy and fusion procedures” stated Dr. Gregory Juda, CSO and GM of Xtant Medical. “We expect that the use of these products as a combined spinal fusion solution will result in positive patient outcomes.”

The Calix‐C™ Cervical Interbody Spacer is intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients and is intended to be used with supplemental spinal fixation systems such as Xtant Medical’s Spider Cervical Plating and Certex Spinal Fixation Systems.

Xtant Medical estimates the worldwide market for cervical fusion devices at $1.3B and growing. The worldwide market for Demineralized Bone Matrix (DBM) is estimated at $485M. The Company has initiated collaborative marketing efforts for the current Calix-C offering with the surgeon’s preferred Xtant Medical allograft, and is preparing for the alpha launch of the new Calix-C sizes later this year.

About Xtant Medical

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

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

Investor Contact

CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital

Company Contact

Xtant Medical
Molly Mason
mmason@xtantmedical.com

Hip Innovation Technology Initiates Clinical Trial of its Novel Hip Replacement System for the Treatment of Total Hip Arthroplasty

BOCA RATON, Fla.Aug. 9, 2017 /PRNewswire/ — Hip Innovation Technology, LLC (HIT), a medical device company developing innovative orthopedic device solutions to advance the quality of life and quality of care for patients, today announces the initiation of a Multi-Center Prospective Study in Primary Total Hip Arthroplasty for its lead hip replacement system, the HRS.  Total hip arthroplasty is commonly referred to as total hip replacement.

The objective of the clinical trial is to evaluate the effectiveness and safety of the HRS hip replacement system in 100 – 120 patients receiving a total hip arthroplasty (THA).  Effectiveness will be evaluated using clinical, radiologic, radiostereometric and patient-reported outcomes.  Safety will be assessed through the collection of device-related adverse events.  Patient quality of life metrics will also be closely monitored.

“The HRS is a unique hip implant design that we believe represents breakthrough technology and a significant advancement for patients requiring total hip arthroplasty,” said George Diamantoni, Hip Innovation Technology’s Co-Founder and Chief Executive Officer. “We look forward to confirming potential differentiating clinical benefits including hip stability at extended ranges of motion, reduced risk of device dislocation and greater latitude for placement of hip components relative to the current designs.”

The company has extensively tested the HRS in over 80 standard and unique pre-clinical experiments to assess the product safety and clinical benefits anticipated by the unique system design.

“The bench level data compiled for the HRS is more extensive than any that I have reviewed for currently marketed hip implant systems,” said Thomas Turgeon, MD, Chief Medical Officer of the Orthopaedic Innovation Centre, and Orthopaedic Surgeon at Concordia Joint Replacement Group. “I am impressed with the unique system design.  I look forward to assessing its clinical performance, and am hopeful that many patients will benefit from this novel device.”

Total hip replacements are one of the most effective ways to reduce joint pain and improve functioning for patients with advanced hip problems.  During the 2015 calendar year, approximately 324,000 surgeries were performed in the U.S. and 50,000 in Canada.

About Hip Innovation Technology, LLC

Headquartered in Boca Raton, Florida, Hip Innovation Technology was formed in 2011 to provide market-leading orthopedic device solutions that advance the quality of life and quality of care for patients.  In partnership with healthcare professionals worldwide, our goal is to identify unmet clinical need, then design, manufacture and ultimately market innovative orthopedic reconstructive and related surgical product solutions.

About the HRS

The HRS is a Metal-on-Polyethylene reverse geometry hip prosthesis designed to improve stability at extended ranges of motion and reduce the risk of dislocation.  Like most conventional systems, the HRS consists of a femoral stem, an acetabular cup and a cobalt-chrome ball that articulates within a polyethylene liner.  Unlike other systems, the ball sits on the acetabular cup instead of the femoral stem, and the polyethylene liner is attached to a femoral cup, which attaches to the femoral stem, instead of the polyethylene liner being attached to the acetabular cup.  Despite this technological difference, the center of rotation of the HRS is similar to a normal physiological hip or a well-positioned Total Hip Arthroplasty.  The advanced HRS implant design may provide greater range of motion in all planes with enhanced hip stability while significantly minimizing the risk of dislocation.  In addition, the HRS may provide minimal postoperative restrictions and reduce the need for currently required durable medical equipment such as abduction pillows, elevated toilet seats and shower chairs.  Importantly, the HRS also provides variability of component placement including higher abduction angles and anteversion of the acetabular cup.  The femoral cup articulates around the acetabular ball and overlaps with the acetabular cup as the hip undergoes flexion-extension, abduction-adduction and internal-external rotation.  This forgiving design compensates for suboptimal component positioning which likely provides benefits such as extended range of motion, hip stability and reduced likelihood of impingement.  Simply stated, the HRS appears to uncouple the relationship between component placement, wear and stability.  The unique implant design of the HRS provides optimal surface area contact between the acetabular ball and femoral cup, which may eliminate edge loading.  Elimination of edge loading may provide benefits that include reduced high-contact stresses, decreased implant wear and uniform wear, which minimizes generation of wear debris and associated concerns related to osteolysis.

For more information, visit www.hipinnovationtechnology.com.

Cautionary Statement Regarding Forward-Looking Statements
This news release may contain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Hip Innovation Technology’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially.  Hip Innovation Technology disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.

Contact:
George Diamantoni, CEO
Hip Innovation Technology
InvestorRelations@HIT-IRH.com  

Media:
Kara Golub
JFK Communications, Inc.
(609) 456-0822
kgolub@jfkhealth.com  

SOURCE Hip Innovation Technology, LLC

Related Links

http://www.hipinnovationtechnology.com

ConforMIS Acquires Machining and Polishing Assets from Broad Peak Manufacturing

BILLERICA, Mass., Aug. 09, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants customized to fit each patient’s unique anatomy, today announced that it has acquired the machining and polishing assets of Broad Peak Manufacturing, LLC, a high-precision surface preparation and finishing facility.  The purchase price for the machining and polishing assets is approximately $6.5 million consisting of $5.75 million in cash and approximately $0.75 million in common stock.  Under the terms of the deal, ConforMIS will integrate most of the Broad Peak employees, acquire supplies and equipment, and lease a fully operational manufacturing facility and office space in Wallingford, Connecticut.

Broad Peak has provided polishing services for ConforMIS’ femoral implant component including iTotal® CR, iTotal® PS, iUni® and iDuo® since 2014.  Starting in the first quarter of 2018, ConforMIS estimates that the integration of the Broad Peak polishing operations will result in a reduction in the cost of polishing of up to 50%, and potentially more, with a potential 200 basis point improvement in overall gross margin.

“This acquisition represents an important step in enhancing the manufacturing of our customized knee implants,” said Mark Augusti, Chief Executive Officer and President of ConforMIS. “Our goal is to continuously invest in specific areas of our business that will improve overall operational efficiencies while maintaining our commitment to quality product for our patients.  Integrating Broad Peak’s proven and innovative manufacturing operation directly into ConforMIS’ operations will allow us to further reduce costs, improve gross margin, and add additional manufacturing expertise that we intend to leverage as part of our larger plan to continually improve our manufacturing operations and our gross margin.”

Under the terms of the agreement, ConforMIS will lease the manufacturing facility in Wallingford, CT, and approximately twenty Broad Peak machining and polishing personnel will join the ConforMIS team, including Ed Kilgallen, former Managing Director at Broad Peak, who has joined ConforMIS as its Vice President of Operations.

“As a highly proficient supplier of polishing services to ConforMIS, Broad Peak has a combined 70+ years’ experience in the aerospace and medical device industries, and we are extremely excited about our new role as part of the ConforMIS team,” said Mr. Kilgallen.  “We look forward to playing an even larger role in the development of ConforMIS’ manufacturing technology and to continuing to help deliver high-quality customized knee implants to patients, surgeons and hospitals globally.”

“We anticipate that the integration of Broad Peak’s polishing resources and expertise will deliver rapid and potentially immediate benefits to ConforMIS,” Mr. Augusti added. “As we work to maximize the value of our existing customized knee implant systems and our planned iTotal Hip system, this transaction is just one example of the positive steps we are taking to continually improve every phase of our business.”

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy.  ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital.  In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants.  ConforMIS owns or exclusively in-licenses approximately 450 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

About Broad Peak Manufacturing, LLC

Broad Peak is a high-precision femoral finishing facility strategically located less than 100 miles from both NY Metro and Boston.  Broad Peak is an ISO 9001:2008 & 13485:2003 accredited facility, providing surface enhancement solutions to a variety of femoral components.  The core team at Broad Peak has a long history with femoral manufacturing stretching back to 1998.  Broad Peak has provided a multitude of services to medical OEM facilities in Europe, Asia and North America including, but not limited to, Contract Manufacturing, VMI, Contract Inspection, Packaging, as well as validated Manufacturing Cell Transfers and the suite of required SPPAP documentation. Broad Peak is currently specializing in Patient Specific Femoral machining and finishing.  This complex process requires modeling, programming and manufacturing of individual fixtures for these implants in order to process the components to a finished state.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about cost savings associated polishing of implant components, cost savings or other benefits associated with the purchase of Broad Peak assets, gross margin improvement as a result of the any manufacturing plans or gross margin improvement plans, the progress of any manufacturing plans or any gross margin improvement plans, the impact of the purchase of assets of Broad Peak on ConforMIS’ financial results, the development of the iTotal Hip implant system, economic or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our product development and commercialization efforts, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

 

CONTACT:

Lynn Granito
Berry & Company Public Relations
lgranito@berrypr.com
(212) 253-8881

Investor Contact:
Oksana Bradley
ir@conformis.com
(781) 374-5598

MiMedx Hits Milestone of One Million Allografts Distributed

MARIETTA, Ga., Aug. 9, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has now distributed over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Parker H. “Pete” Petit, Chairman and CEO stated, “We are very pleased about hitting this impressive milestone of supplying our one millionth allograft. We are especially proud of the hundreds of thousands of patients that our allografts have aided in the healing of their respective conditions. The remarkable outcomes produced by the application of our allografts have assisted physicians and their patients in countless areas of care. These include recovery from acute and traumatic wounds that are debilitating and complex; avoidance of limb amputations; supporting various surgical applications to provide a barrier to reduce the amount of scar tissue formation, modulate inflammation and help with the soft tissue healing of the area; and repair and reconstruction of various soft-tissue injuries in or around joints caused by traumas or chronic conditions. The soft tissue injuries treated with our allografts affect various anatomical locations, mainly knee, shoulder, elbow, foot and ankle and hand and wrist injuries, as well as tendinopathies, tendinitis, tendinosis, tendon and ligament sprains, and ruptures.”

Bill Taylor, President and COO, added, “We are also extremely proud of our outstanding safety record. We have extremely stringent screening and quality standards in our recovery of donated placentas, and our patented processing methodology includes both aseptic processing as well as terminal sterilization, which enhances the safety and prevention of infectious disease transmission of our allografts.  Moreover, our strict sterilization processes and proprietary processing methodology does not affect the cytokines, growth factors, regulatory proteins, chemokines and other critical factors that optimize the performance of the MiMedx allografts and enable our allografts to deliver the clinical results that Pete just referenced.”

“Our dehydrated human amnion chorion membrane (dHACM) allografts are described in an official United States Pharmacopeia and The National Formulary (USP-NF) Monograph, which sets the standards for drug substances, dosage forms, excipients, compounded preparations, dietary supplements, and medical devices. A  USP-NF Monograph on a human tissue product is a very rare occurrence and a recognition that allografts claiming to be dHACM allografts are only those produced in conformance with these exceptionally high standards to avoid any potential for adulteration or misbranding. We are very proud to have that distinction,” added Petit.

“The areas of care that our allografts serve are a major burden on the American health care system in both the negative impact they have on the patient’s quality of life and functionality as well as the escalating costs of care. We are pleased that we have and will continue to play an expanding role in helping the healthcare community resolve these burdens by improving outcomes and reducing costs,” noted Chris Cashman, EVP and Chief Commercialization Officer.

In recognition of this achievement, we will be make a donation to a charity recommended by the physician that utilized our one millionth allograft,” concluded Petit.

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; and the potential safety and efficacy, and additional approved uses and markets for our products. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com