News – Page 303 – Selby Spine

FRANKLIN, Mass., Sept. 12, 2016 /PRNewswire/ — In May of 2015 the new motion preserving WristMotion™ hemiarthroplasty implant from Arthrosurface, Inc. (www.arthrosurface.com) was launched. The following month, the first patients were treated by the three co-developing surgeons, Dr. Randall Culp, Dr. Joseph Sherrill and Dr. Insok Yi. The WristMotion™ implant system is designed to intraoperatively map the curvature of the patients’ wrist joint and resurface the arthritic bone with a congruent and robust articular surface implant. To date more than 100 procedures have been performed across the US with new surgeons treating more patients every month. The product was launched at the ASSH Hand Meeting in September of 2015 to an overwhelmingly positive response.

There are a variety of conditions that lead to pain and arthritis in the hand joint, many of which are caused by previous trauma or chronic overuse. Historically, when patients developed arthritis in their wrist, several procedures were performed: a PRC (Proximal Row Carpectomy), a 4 corner fusion (4CF) or a joint replacement with implants. The implants either replaced one side (hemi) or both sides of the joint (Total). In the PRC procedure, the arthritic bones in the middle of the hand were removed and a new articulation formed between the remaining bones. In the 4 corner fusion procedure, the arthritic bones were left intact but immobilized so they no longer move against each other. The idea was that once the bones fused together, the pain would go away. Total replacements were performed more commonly than hemi’s and they involved significant bone resection. The WristMotion™ system consists of an anatomic implant to resurface the arthritic capitate bone. The implant creates a new articulating surface and is designed to preserve more bone than other implants, thereby providing patients with an alternative to other treatments.

Dr. Randy Culp said, “The bones in the hand are very uniquely shaped and contribute to the overall mobility of the hand. Whether we fuse or remove the bones for a PRC, we are making a compromise. Now that we can use an implant to reshape the bones to match each other, we have another way to preserve motion.” Follow-up on early patients has shown that the implants are stable, patients are able to return to their previous activities with pain-free motion and many have returned to sports such as golf.

Previously, surgeons promoted fusions or PRC’s over joint replacements. That thinking is starting to change. As Dr. Joseph Sherrill commented, “In spite of initial successful outcomes following PRC or four corner fusions, there is a significant failure rate over time due to progressive radio carpal arthritis. The WristMotion™ implant is an excellent treatment option for these patients who may be considering fusion but would prefer to maintain wrist motion.”

The WristMotion™ system is based on the same time tested principles of other Arthrosurface joint restoration systems. Match the implant to the patient and restore joint congruency using instrumentation that is reproducible and intuitive. “When I saw how well the knee and shoulder patients of my partners functioned when they used Arthrosurface, I thought that we needed something like that for the wrist. As hand surgeons we operate in a small space so instruments and implants need to be streamlined and small. The WristMotion™ system is extremely intuitive and reproducible which makes the procedure reliable and quick,” said Dr. In Sok Yi.

Steven Ek, CEO, Arthrosurface commented, “We are very excited about expanding our joint preserving technology into the hand and wrist. By adding new products to our extremity portfolio, surgeons have more options to treat disabling arthritis with unique and motion preserving solutions. For Arthrosurface, the extremity product line is a key to driver for our growth.”

About Arthrosurface

Arthrosurface, Inc. is a leader in the design and distribution of orthopedic devices for joint preservation, restoration and resurfacing. The HemiCAP^® system is a unique, less invasive technology that can be used to treat a wide variety of joint conditions caused by trauma, injury and disease. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world.

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SOURCE Arthrosurface, Inc.

Related Links

http://arthrosurface.com

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September 13, 2016

CHICAGO–(BUSINESS WIRE)–Surface Solutions Group, LLC, (SSG) an industry leading automated applicator of coating technologies for the medical device industry, announced today that it will be exhibiting its FluoroBond®-PT process and other coating solutions in Booth #1832 at the Medical Design & Manufacturing Conference & Expo (MD&M) in Minneapolis on September 21-22, 2016.

MD&M Expo attendees are invited to meet with SSG’s team and learn more about FluoroBond®-PT, a revolutionary process that solves PTFE (polytetrafluoroethylene) adhesion problems of PFOA-free (Perfluorooctanoic Acid) coatings in the medical device industry.

“The medical device industry has been experiencing PFOA-free PTFE delamination, primarily on stainless steel guide wires and similar products. The PFOA-free coatings are sensitive to saline, which degrades the hydrophobicity of PTFE, making them vulnerable to electro/chemical attack,” said George Osterhout, President of SSG. “FluoroBond®-PT solves those problems.”

FluoroBond®-PT is a unique environmentally friendly treatment process developed by SSG for stainless steel, nitinol, and other metals that solves the PTFE coating delamination issues experienced in catheterization labs, operating rooms, and doctor’s offices. SSG’s FluoroBond®-PT is used to hyper clean the substrate, and remove free iron and iron oxides from the surface of the substrate, without removing material or changing the dimension of the substrate’s surface. “There has been no delamination in the field on guide wires that were coated with SSG’s unique FluoroBond®-PT process,” stated Osterhout.

About Surface Solutions Group

Surface Solutions Group is dedicated to developing innovative coating solutions for the medical device industry. With over 50 years of coating industry experience, SSG’s coating technologies, extensive automation and state of the art facility provides its customers with consistently applied coatings on medical devices that follow stringent quality processes, and meet its customers’ demanding performance requirements. Its customers include some of the largest names in the medical device industry. To learn more about SSG’s capabilities, visit www.surfacesolutionsgroup.com or call 773-427-2084.

Contacts

Surface Solutions Group, LLC
Mike Osterhout
773-427-2084 x 169
mike@surfacesolutionsgroup.com
or
Custom Direct, Inc.
Patty Martucci
630-529-1936 x 224
martucci@customdirect.com

September 13, 2016

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, today announced the sale of an EOS system to the Carolinas HealthCare System. The system will be located at a dedicated imaging center in Carolina HealthCare’s Morehead Medical Plaza campus in Charlotte, NC. It will be available for pediatric and adult patients in the Carolinas HealthCare System, including those served at the Levine Children’s Hospital, which is also located in the Morehead Medical Plaza. The Levine Children’s Hospital was named a Best Children’s Hospital by U.S. News & World Report in orthopedics¹.

Carolinas HealthCare System is one of the leading healthcare organizations in the Southeast and one of the most comprehensive systems in the country. The organization includes more than 900 care locations and 7,500 beds throughout North and South Carolina.

Marie Meynadier, CEO of EOS imaging, said, “We are pleased that the unique benefits of the EOS system and services will soon be available to patients in the North and South Carolina area. Adoption by such a prestigious group further validates our technology. In addition, this sale marks the entry into another large hospital network in the U.S., which further expands patient access to the EOS technology and provides incremental growth potential within the hospital network.”

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS^®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States, Japan, China, and the European Union. The Group posted 2015 revenues of €21.8 million and employs 122 people. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

¹ http://www.carolinashealthcare.org/about-us

Contacts

EOS imaging
Anne Renevot
CFO
+33 (0)1 55 25 61 24
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Valentine Brouchot
+33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
The Ruth Group (US)
Press relations / Joanna Zimmerman
646-536-7006
jzimmerman@theruthgroup.com

September 13, 2016

NEW YORK–(BUSINESS WIRE)–Empire BlueCross BlueShield has been selected as a payer participant in the Centers for Medicare & Medicaid Services’ Comprehensive Primary Care Plus (CPC+) initiative, a five-year multi-payer model that’s the largest federal investment in primary care transformation to date.

“Empire’s involvement in CPC+ reflects our belief in the important role that the primary care doctor can play as caregiver and navigator by providing physicians with actionable information, tools and value-based payments that reward physicians for improved quality, patient experience and affordability,” said Larry Schreiber, president and CEO, Empire BlueCross BlueShield.

Empire currently participates in the Capital District-Hudson Valley Region Comprehensive Primary Care Initiative (CPCi), a pilot that launched in 2012 and will sunset at the end of 2016. CPC+ represents an opportunity to build on the success of CPCi along with the other value-based, patient-centered care programs that Empire has grown over the last four years under its provider collaboration work, known as Togetherworks.

“Empire has demonstrated our commitment to payment innovation and provider collaboration and transformation,” added Schreiber. “Empire’s selection as a payer participant in CPC+ presents an opportunity to collaborate with CMS, providers and other payers to continue to shift our delivery system to one that rewards quality and value.”

Empire works with nearly 10,200 providers across New York under its own value-based, patient-centered care program. By 2018, Empire and its affiliated health plans in 13 other states aim to have more than half of their combined spending in alternative payment models rather than traditional fee for service arrangements.

Building on the medical home concept, CPC+ intentionally aligns multi-payer payment reform with practice transformation, holding practices accountable for total cost of care and improved quality. Under this initiative, practices will be able to engage in systematic data sharing and collaborative learning experiences and will also have an opportunity to share savings achieved. CMS sought to collaborate with other payers in 20 markets and will work with health information technology vendors to provide products to advanced CPC+ practices.

New York providers who want to participate in CPC+ must apply to CMS and will be announced later this year.

About Empire BlueCross BlueShield

Serving New Yorkers for 80 years, Empire BlueCross BlueShield is the largest health insurer in New York supporting more than four million members and more than 38,000 business, union and small employers in New York. Empire BlueCross BlueShield (Empire) is the trade name of Empire HealthChoice Assurance, Inc., and Empire Blue Cross Blue Shield HMO is the trade name of Empire HealthChoice HMO, Inc., independent licensees of the Blue Cross Blue Shield Association, serving residents and businesses in the 28 eastern and southeastern counties of New York State. Additional information about Empire is available at www.empireblue.com. Also, follow us on Twitter at @empirebcbs.

Contacts

Empire BlueCross BlueShield
Media Contact:
Sally Kweskin, 212-476-1421
sally.kweskin@empireblue.com
@empirebcbs

11:30 AM – September 13, 2016 – Advisory Board

Many medical organizations are protesting a new CMS proposal that would require surgeons to document every 10 minutes of their post-operative patient care activities for certain procedures.

Background

According to Medscape, Medicare reimburses for about 4,200 surgical procedures via global surgical “packages”—lump sum payments for 10 or 90 days that include funds for pre-op care, surgery, and post-op care.

In the final rule for the 2015 physician fee schedule, CMS proposed scaling back global packages so that doctors instead would bill separately for post-op visits after the day of surgery, out of concern that the packages cover a higher-than-average number of post-op visits. However, Congress in the Medicare Access and CHIP Reauthorization Act (MACRA) late last year blocked that CMS proposal, but directed the agency to collect more information about post-op patient visits.

In July 2016, CMS in its proposed Medicare Part B fee schedule for 2017 put forward its plan to gather that data by requiring all surgeons to report one of eight G-codes—care codes that indicate the type and complexity of the visit—for every 10 minutes of post-op care. For instance, GXXX1 would represent a typical inpatient visit, GXXX2 would a complex inpatient visit, and GXXX3 would represent an inpatient visit related to a critical illness.

MACRA authorizes CMS to withhold up to 5 percent of reimbursement from physicians who do not report G-codes.

Reaction

Many medical groups, including the American College of Surgeons (ACS), the American Association of Orthopaedic Surgeons, the American Association of Neurological Surgeons, and the American Medical Association (AMA), have filed complaints with CMS against the proposal.

In a letter to CMS, ACS indicated that patient care cannot easily be coded into 10 minutes increments. For example, a surgeon may review patient files throughout the day, switching from task to task.

“The surgeon would have to stop the timer on the first patient’s pathology review, start and stop timers on the second and third patients when answering the phone, and then restart the timer on the first patient in the office,” the letter said. “This often happens many times in a day.”

The American Association of Neurological Surgeons and the Congress of Neurological Surgeons in a separate letter to CMS said that surgeons would burn out if they had to track every 10 minutes of their non-OR time. In the letter, the groups quoted an unnamed neurosurgeon who called the proposal “soul-crushing.”

Meanwhile, AMA said, “Asking physicians and their staff to use 10-minute increments to document all their non-operating room patient care activities is by itself an incredible burden, and especially so during MACRA implementation—the most significant payment system change in 25 years.”

AMA called on CMS to limit the data collection process to only certain services, noting that “many surgical codes are low volume, which would make it difficult to find a meaningful sample.” The group also urged the agency “to adopt a data collection method that is limited in scope and uses a representative sample to better understand the necessary post-operative visits” (Gooch, Becker’s Hospital CFO, 9/9; Lowes, Medscape, 9/8; AMA statement, 9/9; RAND report, accessed 9/12).

How to improve physician documentation

The transition to ICD-10, value-based purchasing, and emerging public quality metrics make accurate documentation more critical than ever. That’s why over 80 percent of hospitals have a clinical documentation program in place and are working to correct inaccurate documentation.

However, most are investing significant resources in a strategy that focuses on querying rather than sustainable changes in physician behavior. This leaves a lot of money on the table—a 250-bed hospital with superior documentation performance captures $5 million in revenue in a single year over average-performing peers.

We developed the Physician Documentation Improvement Toolkit with strategic and project management resources that map to the four key steps physician champions must execute to advance documentation improvement.

GET THE TOOLKIT

3d-printer-manufacturer-envisiontec-files-lawsuit-against-formlabs-1.jpg

September 12, 2016

DEARBORN, Mich.–(BUSINESS WIRE)–EnvisionTEC, a leading global provider of 3D printing solutions, today issued a statement about its patent infringement lawsuit filed against Formlabs of Somerville, Mass., in the United States District Court for the Central District of California.

In the complaint, EnvisionTEC asserts that Formlabs’ 3D printers infringe upon two patents held by EnvisionTEC.

EnvisionTEC CEO Al Siblani offered the following statement about the company’s decision to pursue this action:

“EnvisionTEC has been inventing, developing, manufacturing and selling 3D printers, materials and other related technologies and services for nearly 15 years. Today, we hold numerous patents around the world covering a variety of our 3D printing products, methods and more. This intellectual property was researched and developed over many years by our innovative team of professionals and is invaluable to our business serving a variety of medical, professional and industrial markets around the world. We are committed to aggressively protecting our intellectual property in accordance with the laws of the countries in which we operate.”

EnvisionTEC’s complaint seeks injunctive relief prohibiting Formlabs from continued infringement as well as remedies in the form of monetary damages for past and current infringement.

About EnvisionTEC

EnvisionTEC is a leading global provider of professional-grade 3D printing solutions. Founded in 2002 with its pioneering commercial DLP printing technology, EnvisionTEC now sells more than 40 printers based on six distinct technologies that build objects from digital design files. The company’s premium 3D printers serve a wide variety of medical, professional and industrial markets, and are valued for precision, surface quality, functionality and speed. EnvisionTEC’s intellectual property includes more than 100 pending and granted patents and 70 proprietary materials. Learn more at EnvisionTEC.com.

Contacts

EnvisionTEC
Sarah Webster
313-888-4460
Email: swebster@envisiontec.com

9-13-2016 – Press Release from: TMR – Research Reports

Degradable and bioabsorbable osteosynthesis devices have reached a point in their commercialization cycle where they now carry the capability to transform the future of the global osteosynthesis devices market as a whole. Although the global osteosynthesis devices market is currently dominated by devices made from non-degradable materials—mainly metals—the future clearly belongs to degradable materials. This also explains why companies have trained their focus on developing innovative materials that can heal fractures and be gradually absorbed by the body. Besides the physical benefits that come along with degradable osteosynthesis devices, the economic benefits are also making them an attractive option – mainly because they eliminate the need for a second implant removal surgery.

Research Report:

http://www.transparencymarketresearch.com/osteosynthesis-devices-market.html

The global osteosynthesis devices market is expected to post strong gains in terms of both volume and value on account of a substantial increase in the number of osteoporosis and osteosynthesis cases reported worldwide. According to a study published by Transparency Market Research, revenue gains in the osteosynthesis devices market are expected to rise at a CAGR of 6.5% between 2015 and 2023. TMR’s valuation of the market by the end of 2023 is US$11.09 bn.

What strategies separate osteosynthesis devices market leaders from other smaller players?

Entering the global osteosynthesis devices market requires a massive economic and strategic effort for new players. The reasons for this can be illustrated with the following points:

DePuy Synthes alone commanded over 48.6% of the osteosynthesis devices market in 2014. The company’s formidable stake in the market was a result of DePuy (Johnson & Johnson company) joining forces with Synthes to gain a wider presence in the market.
The next leading player in the osteosynthesis devices market as of 2014 was Stryker Corporation, boasting nearly 24% of market revenues. The company has an expansive range of products, including but not limited to hip fixation devices and intramedullary nail devices.
Nearly 11.6% of the osteosynthesis devices market, in 2014, was held by Zimmer Biomet. Although the company’s product portfolio comprises numerous non-degradable osteosynthesis devices, it is focusing on developing newer materials and devices that are safety-evaluated by leading agencies.

The sizeable shares and well-established business network that the top three companies already occupy in the market leave the other companies to compete for what remains, making it difficult for new companies to make a foray into this space.

To what extent will product recalls dent the growth of the global osteosynthesis devices market?

Product recalls are arguably the biggest challenge for companies in the global osteosynthesis devices market. Besides recalls, lawsuits filed against leading players also mean that companies have to set aside appreciable portions of their revenues for legal battles and settlement fees. A case in point would DePuy Synthes’ recall of 93,000 implants in 2010. The company also had to shell out an estimated US$4 mn in settlement of lawsuits filed by patients who had undergone hip implants that had inherent problems.

Metal implants continue to be a sore spot in the overall growth strategies of leading companies and this has forced them to look for more innovative materials and osteosynthesis devices.

Categories: Medical_Devices, Osteosynthesis Devices Market

SAN DIEGO, CA–(Marketwired – September 12, 2016) – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced Jason M. Hannon has been promoted to president and chief operating officer. Mr. Hannon will succeed Patrick S. Miles who has been appointed vice chairman of NuVasive, Inc. and will continue to serve as a member of the Company’s Board of Directors.

Jason Hannon Named President and Chief Operating Officer

In this newly expanded role, Mr. Hannon will be responsible for leading NuVasive’s global products and services, including product management and development, as well as operational duties, including manufacturing, customer fulfillment and quality engineering. Mr. Hannon will continue to oversee international operations working alongside NuVasive’s strong international leadership team. In his more than 11 years at NuVasive, Mr. Hannon has led key areas of the Company’s business, including strategy, corporate development, legal and regulatory. Since July 2015, Mr. Hannon has served as executive vice president, International.

“Jason has extensive knowledge about our business operations and the markets we serve, as well as strong relationships with our customers,” said Gregory T. Lucier, NuVasive’s chairman and chief executive officer. “Jason has demonstrated operational acumen as the leader of our international business where he spearheaded a successful revitalization in our global markets with a return to double-digit revenue growth. I am proud of our efforts to develop a deep bench of executive talent, along with a clear succession plan aligned to our long-term strategic goals.”

Patrick Miles Named Vice Chairman

In his new capacity as vice chairman, Mr. Miles will focus on enhancing NuVasive’s strategic plans for the future of spine surgery, supporting technology development and helping the Company become the ultimate partner to NuVasive customers and patients. He will continue to be actively engaged in supporting the Company’s next-generation spine solution research and development efforts.

“Pat is a valuable member of NuVasive’s leadership team and we are pleased that he will continue to advance the execution of the Company’s strategic priorities as vice chairman. With an experienced team in place and a spine business well positioned for continued profitability and growth, we welcome Pat into his new role to help guide NuVasive forward,” said Mr. Lucier.

“I am excited about the future of NuVasive as it continues to lead innovation in spine. I have great respect for the leadership team in place and look forward to partnering with Jason to carry NuVasive’s innovation and operational strategies forward,” said Mr. Miles.

2016 Financial Guidance

The Company is reiterating its 2016 full year financial guidance announced on July 26, 2016, which includes revenue of approximately $962.0 million, non-GAAP diluted earnings per share of approximately $1.64 and non-GAAP operating profit margin of approximately 16.0%. For additional information, refer to NuVasive’s earnings announcement for the quarter ended on June 30, 2016.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 1,900 person workforce in more than 40 countries around the world. For more information, please visit nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. In addition, this news release contains projections for 2016 financial guidance, which represents current estimates, including initial estimates of the potential benefits, synergies and cost savings associated with acquisitions, which are subject to the risk of being inaccurate because of the preliminary nature of the forecasts, the risk of further adjustment, or unanticipated difficulty in selling products or generating expected profitability. The potential risks and uncertainties that contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission.NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

CONTACT INFORMATION

Investor Contact:
Suzanne Hatcher
NuVasive, Inc.
858-458-2240
Email contact

Media Contact:
Michael Farrington
NuVasive, Inc.
858-909-1940
Email contact

Transparent-Background-OrganogenesisLogo-2015-1024x195.png

CANTON, Mass., Sept. 12, 2016 /PRNewswire/ — Organogenesis Inc., a global leader in FDA-approved and FDA-cleared advanced wound care innovation and technologies, today urged the U.S. Food and Drug Administration (FDA) to finalize two draft guidance documents that would clarify the existing regulatory criteria for determining if products qualify for regulation solely as Section 361 Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) – and in doing so, bring needed regulatory oversight to the wound care industry.

Speaking at an FDA public stakeholder meeting, Organogenesis’ Senior Vice President of Regulatory and Government Affairs,Patrick Bilbo, applauded the agency for its efforts to provide clarity around this class of products, and said the finalized guidance is critical to ensure that products currently marketed for healing of chronic wounds undergo the appropriate level of FDA review.

“Leg and foot ulcers that fail to heal are an immense public health challenge, typically affecting the elderly and people with diabetes – and if not effectively treated these ulcers can lead to osteomyelitis, amputation and death. The availability of safe and effective treatments is therefore a critical public health concern,” said the Organogenesis representative. “We believe that patients suffering from chronic wounds should receive therapeutic treatments that have met FDA’s rigorous pre-approval evidentiary standards. Many health care providers, however, are unaware of the regulatory differences and standards. Without guidance that provides clarity for the industry, confusion over which products have met these strict standards will persist.”

Under Section 361 of the Public Health Service Act, Congress permits donated human tissue to go directly to market without any FDA pre-market review for safety and efficacy. In implementing regulations for Section 361, FDA set forth specific criteria for the type of tissue that would qualify for regulation only as a Section 361 HCT/P. Products that meet these criteria are subject only to controls that are intended to prevent the transmission of infectious disease.

“It is clear that Congress never intended that Section 361 would be used by commercial entities to circumvent the FDA regulatory review process to market manufactured allografts as medical therapies to treat, prevent, or mitigate a disease,” said Bilbo.

The FDA meeting, originally scheduled for April 2016, was rescheduled to Sept. 12-13, 2016, to accommodate the number of concerned stakeholders. Other speakers who testified in support of finalizing the Section 361 HCT/P draft guidance included representatives from the clinical, research and development, and patient advocacy communities, who expressed concerns about the current lack of clarity and its impact on patient safety. Several presenters cited confusion regarding the labeling and clinical efficacy of products that are marketed for wound healing despite never having undergone pre-market review or a rigorous clinical trial process.

The availability of safe and effective treatments for chronic wounds is a critical public health concern. Leg and foot ulcers – some of the most common chronic wounds – are a serious public health challenge, with venous leg ulcers alone estimated to affect approximately 2.5 million people in the U.S.¹ Often leading to osteomyelitis and amputation, they are a major cause of disability in the elderly and in people with diabetes, and the annual cost to the healthcare system runs to billions of dollars. The growing prevalence of diabetes and vascular disease – now the leading cause of limb loss in the U.S., according to the Amputee Coalition – makes the need to protect patients and provide accurate product classifications and marketing descriptions to clinicians all the more important.

Unlike the rigorous FDA premarket review paradigm for wound healing products like Organogenesis’ FDA-approved Apligraf® and Dermagraft®, which have undergone large-scale prospective, randomized clinical trials demonstrating their safety and efficacy, Section 361 HCT/Ps have no pre-market review requirements and are subject only to controls that intend to minimize infectious disease risk. A number of allograft manufacturers have seized on this minimally-regulated pathway to market, self-designating their products as Section 361 HCT/Ps when they likely do not qualify as such.

“Many companies are self-designating their products as Section 361 HCT/Ps even though the products do not in fact meet the criteria set forth in section 1271.10. These companies have introduced to the market a host of human tissue products claiming to interact with the body in complex ways. These products are processed in ways that are not minimal, are promoted for uses that fall far outside the realm of homologous use, and claim comparative or superior efficacy to FDA-approved biologics and devices. This situation puts some of our most vulnerable patients at risk and must not continue,” said the Organogenesis representative.

“The draft guidances are a welcome step toward imposing order on an industry that has been operating more or less free from meaningful oversight. It is critical for the public health as well as the future of the regenerative medicine industry that FDA finalize the draft guidance documents with all possible speed,” concluded Bilbo.

The full text of the remarks can be found here.

About Organogenesis

Massachusetts-based Organogenesis Inc. is a global leader in advanced wound care innovation and technologies, including bio-active wound healing and soft tissue regeneration. Organogenesis’ product portfolio includes FDA-approved Apligraf® and Dermagraft®, the best-in-class products for bio-active wound healing, and the recently launched, FDA-cleared PuraPly Antimicrobial™, which manages bioburden and supports healing for a wide variety of wound types.

¹ Brem H et al, Protocol for the successful treatment of venous ulcers. Am J Surg. 2004 Jul;188(1A Suppl):1-8.

Media Contact:
Erin Schmidt, (703) 548-0019
eschmidt@schmidtpa.com

Photo – http://photos.prnewswire.com/prnh/20160912/406508

SOURCE Organogenesis Inc.

Related Links

http://organogenesis.com

VALENCIA, Calif., Sept. 7, 2016 /PRNewswire/ — Bioness, Inc., the leading provider of cutting edge, clinically supported rehabilitation therapies, today announced a series of successful StimRouter Neuromodulation System implantations to manage chronic pain conditions originating from varied peripheral neuralgias. As a minimally invasive device designed to reduce pain by specifically targeting the affected peripheral nerve, StimRouter is designed to be a cost-effective alternative to injections, ongoing medication regiments, and complex surgeries.

Nearly 100 million Americans suffer from debilitating chronic pain, which may be experienced across all areas of the body including the arm, torso and leg. Chronic pain is often secondary to a primary condition (e.g. stroke) and can also result from entrapment or compression syndromes, post-surgical complications or failed surgeries.

“For many years we have had limited solutions to help our patients manage their debilitating pain,” shared William Porter McRoberts, MD, a trained Physiatrist and Interventional Spine and Pain Management Specialist based in Fort Lauderdale, Florida. “As hard as it is to understand the impact of one’s pain, it is easy to see when relief is delivered. I’m very pleased with how well my patients are responding to the StimRouter and believe that the technology will be suitable for a greater range of patients in the future.”

StimRouter was the first FDA cleared non-drug, long-term, minimally invasive neuromodulation medical device indicated to treat chronic pain of a peripheral nerve origin. The patient controlled device is an adjunct to other modes of therapy (e.g., medications) and is being well received by patients and clinicians alike.

The StimRouter is currently being implanted at prestigious clinical institutions across the country to treat chronic peripheral nerve pain, with specific focus on the following conditions or areas:

Axillary nerve (e.g. post-stroke shoulder pain)
Ulnar nerve (e.g. cubital tunnel syndrome)
Ilioinguinal (e.g. post-surgical hernia complication)
Superior Cluneal nerve (e.g. lower back neuralgia)

“As clinicians and patients continue to look for effective and sustainable ways to treat and manage pain, it is rewarding to see patients thrive with our StimRouter technology,” shared Todd Cushman, President and CEO of Bioness. “Pain is more than just a barrier to a comfortable life and pursing employment, it can be what prevents patients from being able to seek therapy to rehabilitate an injury or illness.”

For more information on the StimRouter as well as videos of real patients sharing their StimRouter experience, please visit www.stimrouter.com.

About StimRouter^™ Neuromodulation System
StimRouter is cleared by the FDA to treat chronic pain of peripheral nerve origin. StimRouter is a minimally invasive neuromodulation medical device consisting of a thin, implanted lead with conductive electrode, external pulse transmitter (EPT), and hand-held wireless patient programmer. Electrical signals are transmitted transdermally from the EPT through the electrode, down the lead to the target nerve. StimRouter is programmed at the direction of the physician to meet patient requirements but is controlled by the patient to address the patients specific, changing pain management needs.

About Bioness Inc.
Bioness is the leading provider of innovative technologies helping people regain mobility and independence. Bioness solutions include external and implantable functional electrical stimulation (FES) systems, robotic systems and software-based therapy programs providing functional and therapeutic benefits for individuals affected by pain, central nervous system disorders and orthopedic injuries. Individual results vary. Consult with a qualified physician to determine if this product is right for you. Contraindications, adverse reactions and precautions are available online at www.bioness.com

Media Relations Contact Information
Next Step Communications
bioness@nextstepcomms.com
781.326.1741

StimRouter™ and Bioness® are trademarks of Bioness, Inc. | www.bioness.com | Rx Only | Additional information about StimRouter can be found at www.stimrouter.com.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/improving-the-lives-of-patients-bioness-stimrouter-neuromodulation-system-currently-being-implanted-to-manage-chronic-pain-300323378.html

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