KCI strikes deal with wound irrigation company

KCI strikes deal with wound irrigation company


Enlarge Photo
Kinetic Concepts Inc.

Images of the V.A.C. system sold by Kinetic Concepts Inc. The InfoV.A.C. System (on left) is a wound healing therapy system designed for patients in the acute care setting.

Kinetic Concepts Inc. has struck a new distribution agreement with B. Braun Medical Inc. to be an exclusive provider of Prontosan Wound Irrigation Solution for use with V.A.C. VeraFlo Instillation Therapy in the United States.

V.A.C. VeraFlo is an integrated wound therapy that couples negative pressure wound therapy with automated instillation of topical wound treatment solutions. The Prontosan Wound Irrigation Solution will now be available in 1,000 mililiter bottles with built-in hangers and cap adaptors that provide quick and simple attachment to the V.A.C. Ulta Negative Pressure Wound Therapy System.

San Antonio-based KCI is a global medical technology company.

FDA Finalizes 510(k) Requirements For HMMD Manufacturers

FDA Finalizes 510(k) Requirements For HMMD Manufacturers

By Nick Otto


Manufacturers of highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostic devices (HMMDs) should be ready to justify their performance characteristics in 510(k) or de novo submissions, according to recently finalized FDA guidance.

HMMDs help in the diagnosis of a variety of infections. The multiplex level used to define them in the new guidance is “the capability to detect ≥20 different organisms/targets, in a single reaction, using a nucleic acid-based technology and involves testing multiple targets through a common process of specimen preparation, amplification and/or detection and result interpretation.”

When submitting applications, device makers need to identify the legally marketed predicate as well as include a table showing similarities and differences between the 510(k) candidate and its comparators, the new guidance says.

Device makers are also asked to list in the intended use section of their submissions the pathogens or drug resistance markers that the test intends to detect, whether it looks at DNA, RNA, or both, as well as the “the specific population(s) for which the test is intended,” the guidance notes.

Additionally, the FDA goes on to spell out several requirements device makers should consider in their test methodology, including: test platforms, specimen collection and handling methods, how to interpret test results, and internal and external controls.

Submissions should include how the device addresses risk factors such as cross-contamination, placement and identity of assay features, false positives, and the possibility of mutations within the target organism, the guidance states.

The Regulatory Affairs Professionals Society points to the FDA’s concern that HMMDs are “not without risk,” and that the agency recommends that both positive and negative controls should be used during testing.

“In general,” the guidance notes, “external positive and negative controls should be run during the analytical and clinical studies as they are necessary to monitor the ongoing performance of the entire testing process.”

During presubmission planning, device makers are urged to consult with the agency on the use of appropriate specimens and on whether certain specimen types should be combined as equivalents. Submissions should also include whether a device’s sensitivity changes when used with frozen specimens versus fresh specimens, as well as the effects both storage temperature and repeated freeze/thaw cycles have on assay performance.

The draft guidance was issued in November 2012.  Equinox Medical Negative Pressure Wound Therapy Pump

Wound repair firm scales up

Wound repair firm scales up


Last updated 05:00 03/09/2014

Jason Creaghan
Mesynthes founder Brian Ward


Jyoti Morningstar: How I keep well ACG expands further offshore Moving your business to the US Sustainable 60 finalists announced Former Olympian drives prefab growth Finding a window of investment CEOs Uncovered: Victoria Crone Behind the scenes at the museum CEOs Uncovered: Darrin Grafton How to spin a crisis

It was way back in January 2008 that the then Wellington-based biomedicine company Mesynthes raised its first seed capital and set its sights on the global “soft tissue regeneration” materials market.

Now with 35 staff, US Food and Drug Administration (FDA) approval for one product and approval pending for another, plus an established distribution network into the world’s biggest biomedical market, the USA, the future is looking bright.

In layman’s terms, Mesynthes is developing and delivering safe and effective new materials to help with human tissue repair and healing.

Founder and CEO Brian Ward says the venture was launched in the belief that there was a growing need for such materials, and in the knowledge that he had found an unlikely – and, in New Zealand, also a plentiful – source for them: the fore-stomach of ruminants such as cows.

From starting in a small leased space at Industrial Research in Wellington, Mesynthes recently graduated to a new warehouse in Auckland which Ward hopes will meet the company’s needs for at least the next five years.

Current staffing levels allow Mesynthes to cover all the bases, from back-office to R&D and from manufacturing to the all-important regulatory compliance, Ward says.

“We’ve changed a lot over the last two years. We’ve broadened out across all functions.

“Mesynthes’ biggest challenge has been recruiting quality and qualified people, especially in areas such as Good Manufacturing Practices (GMP) and compliance. That was one of the primary drivers for the company’s shift to Auckland, he says.

The benefits are already being realised, with improved access to both international and local skills pools.Ward is a veterinarian by training and a member of the UK’s Royal College of Veterinary Surgeons.

But his business chops are far from shabby. He has an MBA and has worked in a range of roles with industry giants such as SmithKline Beecham.

He has also managed investment for the Foundation for Research Science and Technology, and was a founding CEO of biotechnology industry group NZBio.

He’s not prepared to talk about Mesynthes’ sales figures, but will say he is pleased with growth to date and that the company is on track to be where he wants it in five years’ time.

After launching its Endofrom Dermal Template external wound-care product last year, Mesynthes doubled down with research into a product for use inside the body.

These regenerative tissue substitutes are suitable for a range of soft tissue reinforcement and repair applications, but Ward points to abdominal reconstruction of hernias as a major opportunity.

After expected FDA clearance for that product by the end of this year a commercial launch should happen in 2015, he says.

For many Kiwi businesses, developing great products is not the issue – getting them to market is the real challenge. But Mesynthes appears to have dealt with that neatly through carefully chosen partnerships.

Endoform is distributed by Chicago-based global medical company Hollister. Ward won’t reveal who will distribute the new abdominal wall product, except to indicate a partner based on the east coast of the US is already lined up.

Mesynthes is able to develop outside of those existing partnership agreements, but there are very good reasons for focusing on the US market first. “It has high standards, is a big market and is a great place to prove technology,” Ward says.

The Kiwi company has just successfully completed a $5 million capital raising and is “well funded at the moment”, its CEO says. However, other capital raising options are always being considered.

There’s good innovation in biomedicine in New Zealand and several companies are starting to see success, he says. It’s not easy, though, with funding being a major challenge, especially pre-revenue funding.

“It’s tough getting to market in life sciences,” Ward adds.  Risks such as technology change, regulatory compliance and reimbursement uncertainty all weigh on the equation.

“The cycle time is quite long. When you get through those barriers though, the barrier to entry for competitors is quite high. Once you are in, you tend to do pretty well.”

Stereotaxis’ (STXS) Vdrive + V-Loop Receives FDA 510(k) Premarket Notification

Stereotaxis (Nasdaq: STXS) has received 510(k) clearance by the Food and Drug Administration (FDA) to market its Vdrive Robotic Navigation System with V-Loop Variable Loop Catheter Manipulator in the U.S. The Company submitted a 510(k) Premarket Notification for the Vdrive with V-Loop system in March, following completion of a 120-patient, multi-center clinical study.

The Vdrive with V-Loop system is the Company’s second Vdrive product to receive FDA clearance for use in the U.S. In July 2013, Stereotaxis was granted FDA clearance of its Vdrive with V-Sono ICE Catheter Manipulator. This past June, the Company submitted a 510(k) application to the FDA for its Vdrive with V-CAS Catheter Advancement System.

“This is another key step in our efforts to bring our full suite of Vdrive products to market in the U.S.,” said William C. Mills, Stereotaxis Chief Executive Officer. “Our work to continually evolve the Vdrive platform and expand its availability reflects our commitment to achieving greater safety, operator efficiencies and patient outcomes in the electrophysiology (EP) lab through advanced robotic technologies.”

Employed in conjunction with the Company’s Niobe® ES magnetic navigation system, the Vdrive with V-Loop system is designed to remotely control the advancement, retraction, rotation, tip deflection and loop size of a compatible circular mapping catheter, which is used in approximately 60,000 complex EP procedures worldwide each year. With the launch of this new product in the U.S., the Vdrive Duo Robotic Navigation system can eliminate manual manipulation of the two most commonly repositioned diagnostic tools utilized during ablation procedures (variable loop and ICE catheters), enabling single user workflow and greater catheter stability.

Stereotaxis robotic device clears regulatory hurdle

Stereotaxis robotic device clears regulatory hurdle

Sep 4, 2014, 7:25am CDT Updated: Sep 4, 2014, 7:59am CDT
Associate Editor- St. Louis Business Journal
Email  |  Twitter  |  Facebook

Medical device maker Stereotaxis Inc. said Thursday that it received 510(k) clearance from the Food and Drug Administration to market a second Vdrive robotic navigation system in the U.S.

A 510(k) is a premarketing submission made to the FDA to demonstrate a device is substantially equivalent to, or as safe and effective as, a device that is already legally marketed.

Stereotaxis said it received 510(k) clearance for its Vdrive robotic navigation system with V-Loop (variable loop) catheter manipulator. The company had submitted 510(k) premarket notification with the federal agency in March after completion of a 120-patient, multicenter clinical study of the device.

The Vdrive provides remote robotic control of disposable interventional devices for the company’s signature Niobe magnetic navigation system for electrophysiology procedures.

The Vdrive with V-Loop system is Stereotaxis’ second Vdrive product to receive clearance from the FDA for use in the U.S. The company was granted FDA clearance for its Vdrive with V-Sono ICE catheter manipulator in July 2013. This June, Stereotaxis submitted a 510(k) application for its Vdrive with V-CAS catheter advancement system.

“Our work to continually evolve the Vdrive platform and expand its availability reflects our commitment to achieving greater safety, operator efficiencies and patient outcomes in the electrophysiology (EP) lab through advanced robotic technologies,” Stereotaxis CEO William Mills said in a statement.

St. Louis-based Stereotaxis Inc. (Nasdaq: STXS) develops robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. It reported a second-quarter loss of $1.9 million on revenue of $8.05 million. Blue ocean medical products can help you clear your hurldle during your 510 (k) submissions.

K2M receives FDA 510(k) clearance, CE mark for MESA Hooks Featured

K2M receives FDA 510(k) clearance, CE mark for MESA Hooks Featured


K2M received 510(k) clearance from the U.S. Food and Drug Administration to market MESA Hooks — the latest implant addition to the MESA Deformity Spinal System — and also received CE Mark approval.

The MESA Hook extension to the existing MESA Deformity Spinal System provides a low-profile option to this system. The MESA Deformity System, designed for use in complex spine surgeries.


“We are pleased to receive 510(k) clearance and the CE Mark for MESA Hooks, which will enhance our portfolio and support our effort to expand our global penetration of the complex spine market with the MESA Spinal Deformity System. The unique low-profile MESA Hooks in combination with differentiated technology such as the MESA Rail provide surgeons with a wide range of fixation option for patients with severe spinal deformities,” said Eric Major, president and CEO of K2M.

NovaBay’s NeutroPhase skin and wound cleanser receives Chinese marketing approval

NovaBay’s NeutroPhase skin and wound cleanser receives Chinese marketing approval

Emeryville, California
Friday, September 05, 2014, 18:00 Hrs  [IST]

NovaBay Pharmaceuticals, a bio-pharmaceutical company focussing on the development and commercialisation of its non-antibiotic anti-infective products, and China Pioneer Pharma Holdings, Limited, a leading marketer of branded pharmaceutical products and medical devices in China, announced that China’s Food and Drug Administration has cleared NovaBay’s NeutroPhase Skin and Wound Cleanser for sale throughout mainland China. NovaBay will be shipping NeutroPhase to China in the fourth quarter of 2014 to support Pioneer’s launch of the product in early 2015.

Chronic non-healing wounds, such as venous stasis ulcers, diabetic ulcers, and pressure ulcers are serious unmet medical needs that affect a patient’s morbidity and mortality. NovaBay’s FDA cleared NeutroPhase has shown remarkable properties in the management of these categories of wounds.  As cited in a paper published in the peer-reviewed International Journal of Burns and Trauma, “Patients showed a profound improvement and marked accelerated rates of wound healing using NeutroPhase with and without NPWT (negative pressure wound therapy). NeutroPhase was non-toxic to living tissues.”

“The clearance of NeutroPhase in China will help Chinese doctors address major unmet medical needs,” said Paul Li (Mr. Li Xinzhou), chairman, executive director and chief executive officer of Pioneer Pharma. “In China, we are experiencing a ‘catastrophic’ epidemic of diabetes. According to estimates provided by the International Diabetes Federation and the American Medical Association, there are approximately 100 million Chinese already suffering from this condition and its chronic side effects such as diabetic ulcers and other chronic wounds and their numbers are increasing.”

“At the same time, China has the highest number of reported cases of necrotising fasciitis, or ‘flesh-eating’ disease of any nation in the world,” Li added. “NeutroPhase will help with both problems.”

NeutroPhase offers new treatment options for both the chronic wounds of diabetes patients and for deadly flesh-eating disease. NovaBay’s NeutroPhase contains a substance produced naturally by the immune system as a first defense against microbial invaders. Laboratory tests show that NeutroPhase not only kills bacteria that infect wounds and cause necrotising fasciitis, it also neutralises toxins produced by both bacteria and the immune system that impede healing and destroy healthy tissue. Those properties enable NeutroPhase to address acute infections and thereby help promote the healing of chronic wounds.

Physicians like Dr. John Crew, director of the Advanced Wound Care Center at Seton Medical Center in Daly City, California, already routinely manage diabetic ulcers with NeutroPhase to assist healing. Dr. Crew has also developed a method of irrigating flesh-eating wounds with NeutroPhase that has been remarkably successful in saving the lives and limbs of victims of this life-threatening disease, as Crew and NovaBay researchers reported in the journal Wounds.

“China is a significant market for NovaBay’s NeutroPhase. The China FDA approval gives us access to this important market. Pioneer Pharma is a major distributor in the region and is NovaBay’s largest single shareholder. We believe that NeutroPhase can bring a major improvement in medical care in China and the quality of these patients’ lives,” said Dr. Ron Najafi, chairman and chief executive officer, of NovaBay. Similar to this healthcare crisis in China, the American Diabetes Association estimates that 29 million Americans suffer from diabetes.

As part of the partnership deal between NovaBay and Pioneer Pharma, the marketing clearance of NeutroPhase by the Chinese Food & Drug Administration triggers a milestone payment of $625,000 to NovaBay from Pioneer.

MedcoAmerica best NPWT Pump rental company in the US

India will be potential market for wound care: Report

India will be potential market for wound care: Report

(The report said factors…)

HOUSTON: India along with China, Australia, Japan and Brazil is expected to serve as a new revenue pocket for the wound care market which is expected to reach $ 18.3 billion by 2019, according to a new report.

The active wound care market is expected to register the highest growth rate in the wound care market during the forecast period, owing to the continuous launch of new and advanced products, according to rnrmarketresearch.com, a market research website.

The report said factors that would contribute to the growth of wound care market include rising awareness regarding new and advanced products for wound treatment, rising aging and diabetic population and increasing demand in the emerging markets like India, China and Japan.

Furthermore, government support in the form of funding is another major factor providing impetus for its growth.

However, factors such as high costs of wound care products may restrain growth of this market.

FDA Issues Final Guidance on Evaluating Substantial Equivalence in 510(k) Submissions

FDA Issues Final Guidance on Evaluating Substantial Equivalence in 510(k) Submissions

Practices: FDA Regulatory

Printer-Friendly Version

On July 28, 2014, the Food and Drug Administration (“FDA”) issued final guidance regarding the agency’s substantive review of Traditional 510(k) premarket notifications. This document, titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications,” marks a key milestone in FDA’s re-evaluation of the 510(k) program, which the agency initiated in 2009 in response to concerns that the program did not sufficiently assure the safety and effectiveness of devices as well as industry concerns that the program had become unpredictable and opaque.

Below we summarize the key points from the guidance, discuss how FDA responded to criticisms of the draft version of this guidance, and describe further actions that remain to be completed as part of FDA’s 510(k) re-evaluation project.

Key Points from the Guidance

The new guidance is FDA’s first update to the 1986 “blue book” document, “Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3.” FDA asserts that it developed the guidance to inform industry and FDA staff about the agency’s “current review practices,” not to “implement significant policy changes.” Key points from the guidance include.

Elimination of split predicates. The guidance states that the use of a “split predicate” is inconsistent with the 510(k) regulatory standard for demonstrating substantial equivalence. A 510(k) uses a “split predicate” when it compares the device that is the subject of the 510(k) (the “new device”) against one predicate device to show sameness of intended use, and a separate predicate device with a different intended use to show similarity of technological characteristics. Although FDA has been taking this position in practice for several years, this is the agency’s first official, final policy statement on this topic.

Designation of a “primary predicate.” Unlike split predicates, FDA will accept multiple predicates in some circumstances. Multiple predicates are commonly relied upon when a 510(k) combines features from two or more previously marketed devices into a single, new device. In the guidance, FDA generally encourages the use of a single predicate to simplify the decision-making process. It also recommends that, when a manufacturer relies upon multiple predicates, the 510(k) identifies the “primary predicate,” which is “the one with indications for use and technological characteristics most similar” to the new device.

Explanation of “reference devices.” The guidance discusses the use of “reference devices,” which, like the term “primary predicate,” does not appear in the statute or FDA regulations. Reference devices are legally marketed devices, other than the predicate device(s), that are referred to in a 510(k) to help support the use of particular scientific methods or reference values. The guidance states that a manufacturer intending to rely upon a reference device should provide a scientific rationale for its use.

Definitions of “intended use” and “indications for use.” FDA has long recognized a distinction between the “intended use” of a new device, which must be the same as the intended use of the predicate device, and the “indications for use” of a device, which may differ to some extent between the new and predicate device. In the guidance, FDA defines “intended use” to mean the “general purpose of the device or its function,” whereas “indications for use” means “the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.” FDA also repeats the point it has made elsewhere that a manufacturer’s intended use for a device can, in some cases, be determined by facts and circumstances outside the 510(k) submission itself. Although these concepts may sound straightforward, identification of the “intended use” of a device can be a matter of negotiation, and in some cases dispute, between manufacturers and FDA.

Determining whether new “indications for use” constitute a different “intended use.” According to the guidance, FDA may find that changes in indications for use constitute a different intended use when they raise a safety or effectiveness issue not raised by the predicate or have the potential to significantly increase a safety or effectiveness concern raised by the predicate. The guidance contains several illustrative examples of how FDA applies this concept. It also asserts that FDA may rely upon publicly available scientific information or FDA knowledge about how a disease progresses to determine whether indications to treat a certain disease or anatomical site constitute a new intended use.

Determining whether differences in technological characteristics raise different questions of safety and effectiveness. Where differences in the technological characteristics of a new device raise different questions of safety and effectiveness, the new device is not substantially equivalent to the predicate. The guidance describes a logic scheme by which FDA identifies the technological characteristics of a device, compares them against those of the predicate device, and then determines whether there are differences in technological characteristics that raise different questions of safety and effectiveness. FDA states that a “different question of safety and effectiveness” is a question “raised by the technological characteristics of the new device that was not applicable to the predicate device, and poses a significant safety or effectiveness concern for the new device.” Similar to the section of the guidance addressing indications for use, this section of the guidance relies largely on illustrative examples.

Performance data requirements. If the new device described in a 510(k) has the same intended use as the predicate and the differences in technological characteristics do not raise new questions of safety and effectiveness, the remaining statutory question is whether the 510(k) contains information deemed necessary by FDA to demonstrate that the new device is “as safe and effective” as the predicate. The guidance does not discuss this statutory standard at this point in the logic scheme, most likely because FDA’s interpretation and application of that standard is discussed in a separate draft guidance issued on July 15, 2014, titled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics.” Instead, the guidance discusses how FDA applies the statutory “least burdensome” principles by applying a hierarchy of performance data requests starting with descriptive information only, and then proceeding stepwise to include non-clinical bench testing and biocompatibility data, analytical studies using clinical samples (e.g., for in vitro diagnostic devices), and clinical performance data if required.

Encouraging 510(k) “Summaries” rather than 510(k) “Statements.” FDA regulations require a 510(k) submission to include either a “510(k) Summary” or a “510(k) Statement.” A 510(k) Statement is a certification that the manufacturer will make available all safety and effectiveness information in a cleared 510(k) within 30 days of request by any person, other than permitted redactions for patient privacy and trade secret protection. Because FDA can and does proactively post 510(k) Summaries on its website, which facilitates transparency, the guidance “encourages all submitters to utilize the 510(k) Summary option.”

Encouraging greater transparency in 510(k) Summaries. The guidance states that FDA, in an effort to improve the transparency and predictability of the 510(k) program, intends to verify the completeness of the information a manufacturer submits in a 510(k) Summary. The guidance includes appendices describing the content required to be included in such summaries under FDA regulations, provides guidance on what information and data should be included, and includes a sample 510(k) Summary. In particular, the level of detail FDA is requesting be included with respect to clinical studies may be greater than manufacturers have been accustomed to providing in the past.

Responses to Criticisms of the Draft Guidance

On December 27, 2011, FDA announced the availability of a draft version of the 510(k) guidance and invited public comment. FDA received numerous comments, but ultimately made few significant changes to the guidance document. The principal changes were to:

  • Expand the discussion of the use of predicate devices and the reasons for defining a “primary predicate”;
  • Add examples to several sections to clarify FDA’s decision-making process for finding devices substantially equivalent despite differences in indications for use, technological characteristics, or performance characteristics;
  • Add an appendix with a sample 510(k) Summary to demonstrate that level of detail FDA expects; and
  • Remove sections of the draft addressing Special 510(k)s and Abbreviated 510(k)s, due to the relationship between Special 510(k)s and planned FDA guidance on submitting a new 510(k) for a device modification.

What’s Next?

It appears that criticism of the 510(k) program has abated somewhat since FDA launched its re-evaluation initiative in 2009. Nevertheless, there are concerns that the 510(k) guidance reflects narrowed interpretations of the substantial equivalence standard that should have been subject to notice and comment rulemaking under the Administrative Procedure Act. Whether FDA’s 510(k) policies or individual 510(k) decisions will be subject to more frequent appeals within FDA, or legal challenges in court, remains to be seen.

Although it has now finalized the 510(k) guidance, FDA has yet to complete a number of other important actions relating to the 510(k) program. These include:

  • Issuing new draft guidance on when modifications to a device are significant enough to require a new 510(k), after having been required by Congress to withdraw its previous draft guidance from August 2011 on this subject;
  • Issuing new guidance on Special and Abbreviated 510(k)s; and
  • Considering comments received in response to the recent draft guidance, “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics.”

In addition, FDA in the past has stated that it intends to develop new regulations relating to the transfer of ownership of 510(k)s and to develop a public repository of medical device labeling. Ropes & Gray will continue to monitor developments on these proposed initiatives, and other aspects of the 510(k) program.