Innovation may Spur Much-Needed Advances in Treating Diabetic Foot Ulcers

Innovation may Spur Much-Needed Advances in Treating Diabetic Foot Ulcers

New approaches to treating diabetic foot ulcers (DFUs) and blood vessel leg ulcers (VLUs) ar painfully required by the medical profession. A review within the August 2014 issue of Advances in medical aid reports that the event of latest treatments for DFUs has stalled over the past 20 years, with the amount of cases of foot ulcerations and amputations remaining constant throughout this era of your time. per lead author A. Veves, the quality of look after DFUs—including surgery, pressure offloading, infection management and revascularization—is identical as twenty years past, and there’s no explicit standout among the 3 treatments for DFUs presently approved by the U.S. Food and Drug Administration is best than the others.

So in what directions can innovation come back from? A slew of future potential therapies exist; as recently highlighted by V. Hackethal in an exceedingly Medscape article, these would possibly embrace stem cell-based therapies, topical neuropeptides, delivery of gene-encoding growth factors via infectious agent vectors, and protein inhibition. What promise will every space hold?

A large and growing literature exists on the promise of stem cells in wound healing. Writing in crucial Reviews in medicine Engineering in 2009, M. Chen et al. reviewed these approaches, and recommended the supply of adult stem cells and elicited pluripotent stem cells from the patient offer opportunities for eventually generating skin while not the chance of immune rejection. though it’s well-known that in the inflammatory section of wound healing, blood-borne immunocompetent cells invade the wound space, proof cited by the authors suggests that bone marrow-derived stem cells are recruited into the wound website.

The second approach, topical neuropeptides, is additionally showing promise in wound healing. for instance, in an exceedingly 2013 paper in growth, K. Albrecht-Schgoer et al. conclude that topical secretoneurin factor medical aid has the potential to accelerate the healing of diabetic wounds. Secretoneurin, associate angiogenic neuropeptide, has been shown to enhance tissue insertion in several animal models by increasing the quantity of vessels in affected areas. The study found secretoneurin considerably accelerated wound closure in mice and assay discovered higher capillary and arteria density within the wounded space compared to manage mice.

Promising work has conjointly been in progress within the space of factor transfer via infectious agent vectors for years. In 2007, for instance, a bunch diode by A. Badillo rumored in Journal of Surgical analysis the positive effects of lentiviral-mediated transfection of stromal-derived growth factor-1alpha (SDGF-1α) in diabetic mice showing notable enhancements in wound healing with complete epithelialization when period of time.

As for inhibition of pro-inflammatory cytokines, one approach showing promise is connective tissue electrical nerve stimulation (TENS). Writing in Inflammation earlier this year, S Gürgen et al., reportage on a study involving forty eight rats, found that particular decreases of pro-inflammatory cytokines discovered within the corium within the TENS cluster recommend that TENS will shorten the wound healing method by inhibiting the inflammation section.

A separate however equally fascinating approach involves the treatment of DFUs and VLUs with a mix of white blood cells together with monocytes/macrophages, neutrophils and lymphocytes obtained from young healthy donor blood. If the white blood cells ar properly treated, the mixture will refill the unbalanced inflammatory setting within the non-healing wound with functionally active immune cells that unharness the mandatory growth factors and ar capable of body process of bacterium and dead cells within the wound bed. By recreating the natural setting for wound healing, the suitable cell activities and issue secretions ar maintained as needed throughout wound healing.

More than five,000 patients are treated to this point victimization this methodology, that is approved in Israel. associate Israeli run harnessing this approach has shown that when solely close to 3 injections right into the wound bed, there was a seventy.9 % healing rate of chronic wounds in VLUs and DFUs, with a mean time to shut of twelve.1 weeks.  Patients enclosed during this trial were a number of the worst cases; it enclosed those with hard-to-heal ulcers with infections, reduced blood flow and history of amputations. Among the topics of the trial was a 58-year-old male with a DFU whose wound was closed when six weeks and 2 injections; a 53-year-old male with a DFU that was fully closed following 2 injections a month apart; and a 61-year-old male with a DFU whose wound was closed following one treatment. currently this treatment is presently in U.S. clinical trials. 2 separate section three clinical trials can judge close to five hundred patients with VLUs and DFUs. The DFU study are going to be completed by the last half 2015, and also the VLU study are going to be completed by the last half of 2016. If results ar positive, we have a tendency to may see this treatment out there within the us within the next few years.

DFUs and VLUs ar big-ticket issues that may seriously have an effect on the standard of lifetime of polygenic disorder patients. The 5 approaches highlighted on top of would possibly provide physicians and their patients a replacement route to advanced wound care, notably for the foremost difficult-to-treat patients.

###

Nissim Mashiach is president and chief operating officer of Macrocure Ltd., a clinical-stage biotechnology company targeted on developing a completely unique therapeutic platform to handle chronic and hard-to-heal wounds. Macrocure’s lead product candidate, CureXcell, may be a distinctive combination of living human white blood cells that are activated to facilitate the healing method and stimulate wound closure.

FDA grants premarket approval to organ transport technology developed in urban center

FDA grants premarket approval to organ transport technology developed in urban center

Patients in want of AN operation can shortly have longer on their aspect. Organ-preservation and transportation technology developed by researchers at the University of American state Health Science Center at urban center has received premarket clearance by the Food and Drug Administration.

Paragonix Technologies INC. cleared another major hurdle toward commercializing the company’s Asian Pak Transport Systems product, that area unit supported operation transportation technology developed by researchers in urban center.

Food and Drug Administration officers awarded 510(k) premarket clearance for the Asian Pak urinary organ Transport System and Asian Pak internal organ Transport System. These regulative clearances permit Paragonix’s systems to be combined and distributed with any FDA-cleared, commercially out there organ-preservation device.

Braintree, Massachusetts-based Paragonix may be a in camera command medical device company. it’s AN exclusive license from the University of American state Health Science Center at San Antonio’s workplace of Technology Transfer and development to promote the merchandise.

ECMO Legacy Transport unit

Repost from MDDI – 510 (K) Statistical Patterns

510(k) Statistical Patterns

Posted in Regulatory and Compliance by MDDI Staff on December 2, 2014

http://www.mddionline.com/article/510k-statistical-patterns-12-02-2014

Check out their  post on www.mddionline.com

Applying Moneyball-style statistical analysis to FDA data yields important insights about the most common pathway to market for medical devices.

By Jeffrey N. Gibbs, Allyson B. Mullen, and Melissa Walker

The majority of new medical devices reviewed by FDA enter the market via the 510(k) process. In 2013, FDA cleared approximately 140 510(k)s for every original PMA application approved.

For most medical device companies, it is critical to understand the 510(k) process, evaluate the likelihood of success, and maximize the odds of obtaining clearance. In particular, companies must answer two commercially critical questions:

  • How long will the process take?
  • What is the likelihood of success?

As mandated by MDUFA III, FDA calculates and publishes some 510(k) statistics that help make these predictions, including average time to decision and the percent of 510(k)s with additional information requests. These documents provide high-level data on key metrics for a particular fiscal year, but a major limitation is that the calculation of averages will mask product-specific or classification-specific variations. However, the agency has also released information-rich databases that enable far more probing analyses than were previously available. These databases can help companies identify trends that affect timing and odds, and, perhaps, help companies improve the chances of a successful 510(k).

In the book Moneyball, author Michael Lewis explained how the Oakland Athletics exploited new insights derived from statistics to gain an edge in baseball. In the intervening years, baseball sabermetricians have developed esoteric statistics, such as wins above replacement (WAR), that most fans do not understand but which are considered more meaningful indications of a player’s value than runs batted in or batting average. The sabermetricians now have new, more comprehensive data sources available, allowing for yet more refined analysis.1

While 510(k)s and baseball may seem to have little in common (except for the authors’ keen interest in both), they share a common trait: New analytical tools can yield useful insights. In that spirit, we have analyzed the 510(k) program in a new light. Using SOFIE, Graematter Inc.’s Regulatory Intelligence System, we analyzed various 510(k) metrics from FDA’s publicly available 510(k) Premarket Notification Database during the five-year period from 2008 to 2012 to gain insights about this primary pathway to market for medical devices.

Third-Party Reviews Take Longer2

During calendar years 2008 through 2012, FDA cleared approximately 3027 510(k)s per year. The total number and type of 510(k)s (e.g., traditional and special) has remained generally consistent across this five-year period.

 

Table 1. Submission Types and Overall Percentages 2008 – 2012 

Submission Type 2008

2009

2010

2011

2012

No. % No. % No. % No. % No. %
Abbreviated 129 4.2 118 3.9 114 4.1 125 4.0 113 3.6
De Novo 3 0.11 4 0.1 3 0.1 10 0.3 13 0.4
Special 655 21.5 683 22.7 612 21.8 705 22.5 676 21.5
Traditional 2266 74.2 2203 73.2 2078 74.0 2288 73.2 2336 74.4
Total 3053 3008 2806 3128 3180

Figure 1. Submission Types and Overall Percentages 2008 – 2012

The vast majority of 510(k) submissions between 2008 and 2012 were submitted directly to FDA for review. On November 21, 1998, FDA began accepting 510(k) reviews from accredited persons.3   This program has had limited use because only select devices are eligible, and companies have reported mixed experiences with their accredited persons. However, recent data show that the effective rate for the third-party 510(k) review process has steadily declined (from 16% in 2008 to 9% in 2012). There have not been any recent changes to this program, so this decrease appears to be attributable to industry’s disuse—perhaps due to lack of interest, dissatisfaction with the program, and added expense—rather than agency policy.

The seemingly forgotten third-party review program may be an area of interest for industry to explore to try to decrease review times for eligible device types. However, it is worth noting that third-party-reviewed 510(k)s have seen longer review times by FDA, increasing from 46 days with FDA after the third-party has reviewed the submission in 2008 to 62 days in 2012. We have no way of knowing how long the third party took to review the submission (or the quality of the review) before making its recommendation to FDA, but these average review times all appear to be in excess of the 30 days FDA is allowed to make its decision after receiving the third party’s recommendation under Section 523 the Federal Food, Drug, and Cosmetic Act.

Abbreviated 510(k)s Are Not Reviewed Any Faster than Traditional 510(k)s

The overall average review time for a 510(k) between 2008 and 2012 was 137 calendar days. There was an increase in the average review time beginning in 2010, which leveled out between 2010 and 2012. This increase also took place across each of the four 510(k) types.

Table 2. Average Number of Review Days by 510(k) Submission Type

2008 2009 2010 2011 2012
Abbreviated 148 150 160 153 173
De Novo 507 676 751 693 687
Special

54 62 73 73 73
Traditional 128 135 160 168 160
All 510(k)s 114 120 142 147 144

 

In addition to the overall increase in review time in 2010, the average review times for abbreviated and traditional 510(k)s are essentially the same, with abbreviated 510(k)s actually taking the same amount of time or longer on average than traditional 510(k)s in all years except 2011. This data is particularly curious because when the abbreviated 510(k) was introduced in 1998, the goal was, in part, “to streamlin[e] the review of 510(k)s through a reliance on a ‘summary report’ outlining adherence to relevant guidance documents.”4   While abbreviated 510(k)s may offer advantages in terms of cost and time to prepare, the projected advantage in review times was not realized in this five-year period.

IVD Products Take the Longest to Review

There are no apparent patterns in terms of the number of submissions cleared within and the number of device types (or product codes) assigned to each specialty. But there is a strong pattern in the medical specialties with the highest average number of review days—many of them relate to in vitro diagnostic devices (IVDs). The four medical specialties with the longest average 510(k) review times between 2008 and 2012 were pathology, physical medicine, immunology, and hematology (in decreasing order).

 

Table 3. Average Number of Review Days for 510(k)s Cleared by Each Review Committee between 2008 and 2012

Reviewing Committee Average Review Days
Anesthesiology 156
Clinical Chemistry 176
Cardiovascular 108
Dental 134
Ear, Nose, and Throat 138
Gastroenterology and Urology 142
Hematology 215
General Hospital 132
Immunology 221
Microbiology 151
Neurology 148
Obstetrics/Gynecology 188
Ophthalmic 171
Orthopedic 121
Pathology 273
Physical Medicine 256
Radiology 92
General and Plastic Surgery 135
Clinical Toxicology 214

 

There are six medical specialties that primarily review IVD 510(k)s—clinical chemistry, hematology, immunology, microbiology, pathology, and clinical toxicology. With the exception of physical medicine, all of the medical specialties with the longest average review times were reviewing IVDs. Out of these six medical specialties related to IVDs, four had average review times greater than 200 days from 2008 to 2012, and all six had review times that exceeded the average number of review days for all 510(k)s (137 days) during this time period. The average review times for each of the IVD medical specialties are generally rising or staying the same (even for those medical specialties for which the five-year average was below 200 review days). Overall, the average review time for IVD 510(k)s between 2008 and 2012 was significantly higher than non-IVD 510(k) review times (183 days versus 127 days) (and had increased dramatically since 2003 when it was 82 days).

Table 4. Average Number of Review Days per 510(k) per Year for IVD Medical Specialties

Medical Special 2008 2009 2010 2011 2012 Overall
Clinical Chemistry 157 161 160 210 185 176
Hematology 114 175 237 301 295 215
Immunology 147 198 246 268 259 221
Microbiology 133 130 185 166 130 151
Pathology 246 264 233 237 324 273
Clinical Toxicology 190 209 241 237 208 214
Overall IVD 151 164 194 215 189 183
All Non-IVD 111 116 137 140 140 127

Figure 2. Average Number of Review Days per 510(k) per Year for IVD Medical Specialties

There could be a number of factors behind the longer review times for IVDs, e.g., more new types of devices, more IVDs supported by clinical data, evolving regulatory expectations, etc. The data show, though, that IVD companies should expect longer review times on average than non-IVDs.

This data is particularly relevant because FDA recently proposed imposing premarket review for Laboratory Developed Tests (LDTs), with a few narrow exceptions.5   LDTs are currently run at numerous laboratories in the United States. If FDA’s proposal is finalized, these same review divisions that already see significantly higher review times will be faced with an increased workload. Under FDA’s proposal, the initial LDT submissions will be for higher risk products, which presumably will take more reviewer time than more routine, moderate risk IVDs.

Review Times Change for Products

Average review times for devices change over time. Review times can change more quickly and dramatically for individual types of devices than across the device program or by reviewing committee, even those that are required most often.

Table 5. The Ten Device Product Codes Cleared Most Frequently between 2008 and 2012

Product Code Total Number of 510(k)s 2008–2012  Regulation Number Device Name Review Time 2008 Review Time 2012
LLZ 403 892.2050 System, Image Processing, Radiological 64 108
GEX 312 872.4810 Powered Laser Surgical Instrument 117 137
HRS 233 888.3030 Plate, Fixation, Bone 112 137
NKB 225 888.3070 Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease 88 104
GEI 223 878.4400 Electrosurgical, Cutting and Coagulation and Accessories 93 156
MAX 214 888.3080 Intervertebral Fusion Device With Bone Graft, Lumbar 87 99
DZE 201 872.3640 Implant, Endosseous, Root-Form 145 224
LYZ 197 880.6250 Vinyl Patient Examination Glove 113 122
FRO 190 Unclassified Dressing, Wound, Drug 153 155
DXN 183 870.1130 System Measurement, Blood-Pressure, Non-Invasive 94 118

 

None of the 10 product codes cleared most frequently between 2008 and 2012 saw any decrease in their average review times during that same period. In fact, all of these device types saw an increase (and sometimes a steep increase) in their average review times during this time period. This increase in review times is consistent with the overall average change in review times across all 510(k)s, which saw an increase from 114 review days in 2008 to 144 review days in 2012 (+30 days). (The average review time in 2012 for seven of the 10 product codes was still below the average for all 510(k)s.)

Three of the top 10 product codes saw an increase in their average review times by more than 30 days (the overall 510(k) average), with two product codes, GEI (cutting and coagulation) and DZE (endoscopic implants), seeing increases in excess of 60 days (63 and 79 days, respectively). This pattern is troubling and puzzling. There is no obvious explanation for this trend. With only one exception, there were no device-specific guidance documents issued for these devices between 2008 and 2012. There may have been category-specific events that led to these increases, but this somewhat surprising trend is worth further exploration.

We did another analysis to look at which product codes saw the greatest increase and decrease in their average review times between 2005 and 2012. We limited our analysis to only those product codes that had a minimum of five 510(k) clearances in each year between 2005 and 2012 (thereby minimizing one-off events and outliers). This limitation resulted in a total of 82 product codes. Only six of those 82 product codes saw a decrease in their average 510(k) review times between 2005 and 2012 (approximately 7%). The remaining 76 product codes saw increases in their average review times, which ranged from two days to 157 days. Thirteen product codes saw an increase in their average review times of more than 100 days.

The biggest increase in overall review times between 2005 and 2012 was product code NBW (over-the-counter blood glucose test systems), with an increase in average review time of 157 review days. This increase highlights an important point in our analysis: When there is a safety concern with a particular device type, the review time for the 510(k)s is likely to increase—and in this case, increase significantly. Beginning in early 2010, FDA began considering industry-wide actions to address concerns around the accuracy of blood glucose monitors. FDA clearly changed the requirements for these 510(k)s around that same time when it withdrew the 2006 guidance documents for insulin pump 510(k)s in 2011. This conclusion is reflected in the average review time for an NBW 510(k), which increased by 126 days between 2010 and 2011.

Figure 3. 510(k) Review Data for Product Code NBW (Over-the-Counter Blood Glucose Test Systems)

On the other hand, the biggest winner in our 510(k) analysis was product code FRO (wound dressing). This product type saw an average decrease of 32 review days between 2005 and 2012; nearly all of that decrease was observed between 2005 and 2008 because this same product code saw an average increase of two days in its review times (well below the average increase of more than 30 days) between 2008 and 2012. This variability again reminds us that patterns and trends can change significantly.

Conclusion

There are many ways of predicting how long a 510(k) review will take. Both the overall 510(k) program data and understanding how quickly particular types of 510(k)s have been cleared provide useful insight. Companies will want to draw upon multiple, complementary resources.

In the end, the single most important variable is the 510(k) itself. A well-written, well-supported 510(k) is the sine qua non. Yet, even well-written, well-supported 510(k)s are subject to other forces and trends that can influence the speed with which a 510(k) is cleared, whether relating to the 510(k) program or the specific device.

Baseball teams now hire statisticians to try to gain a competitive advantage. Similarly, carefully analyzing the relevant 510(k) statistical patterns may prove illuminating and advantageous for device manufacturers.

References

1. C. Martrich, “Shifty Business,” Orioles Magazine, 2014, vol. 3, at 20.

2. This data is based on the datasets in FDA’s publicly available databases as of August 11, 2014.

3. FDA, “Final Guidance for Staff, Industry, and Third Parties, Implementation of Third Party Programs Under the FDA Modernization Act of 1997 “(Feb. 2, 2011).

4. FDA, “Final Guidance, The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications” (Mar. 20, 1998), available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo….

5. 79 Fed. Reg. 59776 (Oct. 3, 2014).

Jeffrey N. Gibbs (a Yankees fan) is a director at Hyman, Phelps & McNamara PC (Washington, DC).

Allyson B. Mullen (a Yankees fan) is an associate at Hyman, Phelps & McNamara.

Melissa Walker (a St. Louis Cardinals fan) is president and CTO of Graematter Inc. (St. Louis, MO)

Blue Ocean Medical Products – We can help guide you in your 510 (k) process.

Repost from Market Watch – Osiris Therapeutics

Osiris Therapeutics Announces Expansion of the Leadership Team

Published: Dec 3, 2014 8:02 a.m. ET

COLUMBIA, Md., Dec 03, 2014 (BUSINESS WIRE) — Osiris Therapeutics, Inc. OSIR, -2.26% the leading cellular regenerative medicine company focused on developing and marketing products to treat conditions in wound care, orthopaedics and sports medicine, is pleased to announce the expansion of the management team with the appointment of Adrian Mollo as General Counsel and Dr. Jon Hopper as Chief Medical Officer, both reporting to Lode Debrabandere, Ph.D., President and Chief Executive Officer. Gregory Law also recently joined the Osiris management team as Vice President of Finance and Principal Accounting Officer, reporting to Philip Jacoby, Chief Financial Officer.

“We’re very pleased Adrian, Jon and Gregory are joining the leadership team,” said Dr. Debrabandere. “In 2014, Osiris successfully transitioned from a research focused company to a fully integrated research and commercial enterprise. Specifically, Osiris expanded its core competencies in sales and marketing operations, health policy & reimbursement, customer service, medical affairs and IP. This significant expansion and strengthening of the leadership team optimally positions the company to execute our strategy of long term revenue growth in wound care, orthopaedics and sports medicine.”

Mr. Mollo joins Osiris after fifteen years with the Washington, D.C. office of McKenna Long & Aldridge LLP, where he served as the lead partner for intellectual property licensing and transactions and as Vice Chair of the Intellectual Property Department. Mr. Mollo’s background spans a broad spectrum of legal areas and he has extensive experience working with both established and emerging growth companies. Mr. Mollo holds a J.D. from the University of South Carolina School of Law where he graduated magna cum laude and a B.A. from Winthrop University.

Dr. Hopper most recently worked at Stryker Corp., serving as Vice President, Global Medical Director where he coordinated clinical evaluation and trials, and provided guidance on clinical aspects of risk management, design control and product development. Prior to joining Stryker, Dr. Hopper spent almost five years in wound care with ConvaTec Inc., serving as Vice President of Medical Affairs, North America and Asia Pacific. Prior to joining ConvaTec, he was Senior Medical Officer at the Devices Clinical Team of MHRA (the UK Regulatory Agency for medicines and medical devices) and practiced medicine as a trauma and orthopaedic surgeon. Dr. Hopper graduated with a M.B. Ch.B. from Birmingham University Medical School UK, is a Fellow of the Royal College of Surgeons of Edinburgh and attained an M.B.A. at Keele University UK.

Mr. Law has over 25 years of finance and accounting experience in a variety of industries including biotechnology, telecommunications, energy, private equity, and consulting. Prior to his appointment at Osiris Therapeutics, Mr. Law was a Principal with Garland Group, where he provided consulting services to public and private companies in the areas of interim CFO and Controllership, financial reporting, mergers & acquisitions, valuation and compliance. Previously, Mr. Law held various finance positions at leading companies, such as XO Communications, MCI and General Electric. He graduated from Virginia Tech with a B.S. in Accounting and earned his M.B.A. from George Washington University.

About Osiris Therapeutics

Osiris Therapeutics, Inc. is the leading cellular regenerative medicine company, having developed the world’s first approved stem cell drug, remestemcel-L for graft versus host disease. Osiris’ products include Grafix® for acute and chronic wounds, Cartiform®, a viable chondral allograft for cartilage repair and the latest addition to Osiris’ line of products, OvationOS®, a viable bone matrix. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution. Osiris has developed an extensive intellectual property portfolio to protect the company’s technology and commercial interests.

Osiris, Grafix, Cartiform, and OvationOS are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company’s website, www.Osiris.com. (OSIR-G)

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding any of the following: our product development efforts; our clinical trials and anticipated regulatory requirements, and our ability to successfully navigate these requirements; the success of our product candidates in development; status of the regulatory process for our product and product candidates; implementation of our corporate strategy; our financial performance; our product research and development activities and projected expenditures, including our anticipated timeline and clinical strategy for marketed Biosurgery products (including Grafix, OvationOS and Cartiform) and Biosurgery products under development; our cash needs; patents, trademarks and other proprietary rights; the safety and ability of our products and potential products to address medical needs; our ability to supply a sufficient amount of our marketed products or product candidates and, if approved or otherwise commercially available products, to meet demand; our costs to comply with governmental regulations; our plans for sales and marketing; our plans regarding facilities; types of regulatory frameworks we expect will be applicable to our products and potential products; and results of our scientific research. Additional risks and uncertainties related to the sale of our ceMSC assets and the related transactions contemplated by the Purchase Agreement with Mesoblast include typical business transactional risks, the risk of changing relationships with customers, suppliers or employees, the risk associated with the disposition of our ceMSC assets and the increased relative dependence on and importance of our other business including our Biosurgery business, the risk that we may not be able to fully benefit from the transactions through milestone payments or royalties, payment risks, including the risk associated with receipt of equity as consideration, in lieu of cash, and the risk of dependence on others to achieve results upon which milestone or royalty payments to us are conditioned. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled “Risk Factors” in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with the United States Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.

SOURCE: Osiris Therapeutics, Inc.

Osiris Therapeutics, Inc.
Amanda Badillo, 443-545-1834
OsirisPR@Osiris.com

Repost from Ten Links – 3Shape Implant Studio gets FDA Approval

3Shape Implant Studio Gets FDA Approval

3Shape_logoCOPENHAGEN, Denmark, Nov 24, 2014 - 3Shape, a leading global innovator of digital 3D solutions for dental labs and dental clinics, is proud to announce that the US Food and Drug Administration (FDA) has granted (510k) market clearance for the sale of its Implant Studio software in the USA.

3Shape Implant Studio software merges CT/ Cone Beam CT imaging with 3D digital surface scans of the teeth and gingival situation to provide a digital view of dental patients.

ImplantStudio-FDA-ClearenceThe software then enables dental professionals to evaluate the clinical situation including bone density and nerve positions for creating prosthetic implant planning and surgical guide design.

3Shape Implant Studio is used extensively in Asia, Europe and South America.

“3Shape is very excited about this FDA (510k) market clearance which opens the door to new service options for both clinics and labs in North America. Importantly, as more and more people are choosing dental implants to meet their restoration needs, Implant Studio will enable dental professionals to more effectively care for them,” says Flemming Thorup, 3Shape’s president and CEO.

Implant Studio and digital technology in general, have had a major impact on dental implantology.

In an interview with 3Shape, leading dental practitioner, Dr. Jonathan L. Ferencz summed up the considerable change by saying: “The difference digital dentistry has made to making a crown is tremendous. But the difference it has made in implant dentistry is night and day.

The dental implant market in the US is projected to reach $5 billion by 2018. With 3 million Americans already having implants. That number is predicted to grow by 500,000 per year, according to the American Academy of Implant Dentistry.

Implant Studio will be available through 3Shape resellers early Q1 2015. Availability to end-users will depend on the specific system configuration.

3Shape experts will be demonstrating Implant Studio including complete workflows using intraoral and CBCT scans, at the 2014 Greater NY Dental Meeting, November 30 to December 3, 3Shape booth 424.

For more information, please visit www.3shapedental.com/implantstudio.

 

Blue Ocean Medical Products, we feature a high tech production facility that is flexible and quickly adaptable to meet your specific needs. Our manufacturing capabilities span a broad range of products and industries.

Repost: Randolph Hospital partners with Florida firm on new wound care center

Randolph Hospital has partnered with a Florida firm to create a new wound care center that will include two hyberbaric chambers used to help speed healing.

Jacksonville, Fla.-based Healogics, the country’s largest provider of wound care services, will provide the hyperbaric chambers as well as members of the clinical staff, including a physician. The hospital will invest about $500,000 to create space for the center.

Barbara Wolfe, vice president of strategy and service development for Randolph Hospital, said a look at the demographics of the county shows a large population with wound care problems, which now are often treated in a more costly, inpatient environment.

“When you look at the volumes in our inpatient and emergency department, there are a lot of patients who present with wounds,” Wolfe said. “With 22 percent of the county’s population uninsured, there is a higher potential for wound healing issues, and financial constraints that would make consuming care in the most expensive parts of the health system difficult.”

Would care centers use hyperbaric chambers to help increase the flow of oxygen to wounds to facilitate healing and the growth of new tissue.

The enclosed, high-pressure chambers are flooded with oxygen, which is then able to reach extremities or other areas with circulation problems to help with healing.

A population survey found about 9,500 adults within a 10-mile radius who have already come to the hospital for the treatment of diabetic ulcers or have the potential to develop such ulcers, Wolfe said.

Those types of ulcers often do not heal easily, in part because of the circulation problems that come with diabetes and obesity.

Angie Orth, chief operating officer at Randolph Hospital, said the wound care center will be in about 2,300 square feet of vacant space near the hospital main entrance.

“We’ll take that space, renovate it and make it conducive to a wound care program,” Orth said. “We will provide the capital for the upfit for the space, and (Healogics) will partner with us to bring their expertise to the table around the physician component, best practices for treatment, as well as clinical expertise around billing and coding and office staff.”

Developing the center will take about six months, Orth said.

“We’re still in the process of drawing the plans,” she said.

Resource link: http://www.bizjournals.com/triad/news/2014/11/24/randolph-hospital-partners-with-florida-firm-on.html?page=all

Check out the new COBALTT NPWT Pump Tutorial Video from Equinox Medical, LLC.

http://www.equinoxo2.com/how-to-videos/cobaltt-npwt-pump-system-video/

 

 

 

Repost: Olive Oil Accelerates Wound Healing in Burn Patients

Past studies have shown that olive oil may be effective in the treatment and healing of skin burns, when used externally. Now, a new study published in the journal Burns showed that consuming olive oil can expedite the healing process, and work from within.

Burn patients have increased nutritional needs in calories, protein as well as minerals and vitamins, so nutrition is an important factor in burn care and healing.
Antioxidant and anti inflammatory therapy have been known to be beneficial in the treatment of burns, so researchers set out to evaluate the effect of a diet rich in olive oil on the healing of burns in hospitalized patients.

The study was conducted on 100 patients who were hospitalized with second- and third-degree burn wounds on 10–20 percent of their body surface area. The patients were assigned to received either olive oil or sunflower oil in their diets.

The patients were examined daily and, while there were no significant differences in terms of in the total body surface area of the burns, there were significant differences in the duration of wound healing and hospitalization. The olive oil group appeared to have accelerated wound healing and decreased the duration of their hospitalization.

Source: http://www.oliveoiltimes.com/olive-oil-health-news/olive-oil-accelerates-wound-healing-in-burn-patients/42404

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EQUINOX MEDICAL INTRODUCES THEIR SMALLEST PORTABLE HALO MINI NEGATIVE PRESSURE WOUND THERAPY PUMP SYSTEM

EQUINOX MEDICAL INTRODUCES THEIR SMALLEST PORTABLE HALO MINI NEGATIVE PRESSURE WOUND THERAPY PUMP SYSTEM 

Smithfield, RI- October 22,2014-Equinox Medical announced at the Medtrade

convention in Atlanta, GA their newest smallest Negative Pressure Wound

Therapy(NPWT) pump system, the HALO MINI NPWT. The pump system was

designed to address the needs of clinicians and nurses for their active mobile

patients. With the recently launched HALO MINI, Equinox now offers a small

compact NPWT device for the continuum of wound care.

Equinox designed this pump with patient’s dignity in mind, to obtain agility at

home, in long term care units, or any place a patient needs to be compliant with

NPWT therapy. This enables patients to continue their needs for specific wound

requirements and maintain comfort, ease of use and cost effectiveness. Rian Mallari,

CEO, of Equinox Medical said” That’s why we designed The HALO MINI pump so; it

can be easy for a caregiver to use and improve a patient quality of life. In addition,

our black foam and white foam dressing can interface with the HALO MINI pump

system.”

Gary Schear, VP of Sales added “By providing clinicians with more choices in NWPT,

we believe we can drive better care, which improves patient outcomes and greater

value for the healthcare organizations. Wound care therapy can be discreet and

mobile. This way patients can return to their routines without compromising the

therapy needed for active wound care patients”

Halo MINI Pump System Features and Functions

• It is lightweight weighing max 2.48 pounds

• LCD Display

• Adjustable Pressure Levels

• Canister Full Monitoring

• Audio and Visual alarms

• 24 hr. battery back up

• Bluetooth Connection

• Continuous and Intermittent mode

• 300cc Integrated Disposable Canister

• Max Pump Capacity/ Air Flow Rate 5.5 liters per minute.

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For more information please visit http://www.equinoxo2.com

About EquinoxO2 Medical, LLC

Equinoxo2 Medical, LLC, headquartered in Smithfield, RI is a privately

held medical device company focused on the development of advanced

wound healing technology. Equinox is dedicated to developing and

designing innovative wound care products that are cost effective and

delivers significant clinical outcomes. Our goal and strategy is to improve

a patient’s quality of life. Our passion and dedication is to provide a better

solution in repairing and healing the human body.

For more information, please visit www.equinoxo2.com.

Media Contact

Gary Schear, Vice President of Sales

Telephone: 800-504-3150 Ext 104

Email: Gary@equinoxo2.com

FDA Invites Participation In Pilot 510(k) eSubmission Program

FDA Invites Participation In Pilot 510(k) eSubmission Program

By Chuck Seegert, Ph.D.

fda_sign

A pilot program for the electronic submission of 510(k) documents is being expanded after a successful initial test period. The online process has been likened to commercial tax software and promises to increase ease of use for companies that are submitting a 510(k) application.

A new electronic submissions (eSubmission) process may go a long way toward improving the 510(k) submission process, according to a recent announcement from the FDA in the Federal Register. While the FDA has been moving toward electronic submissions since 1999, the new approach will provide even greater harmony between the agency and parties performing submissions.

During the pilot study, all 510(k) submissions will have their initial review waived, which is a change that the FDA expects to become a permanent part of the process moving forward, according to the announcement. The new submission software is designed to ensure that each 510(k) is “administratively complete” and will not need further review. Due to the standardized submission structure, the FDA also foresees that fewer questions will need to be answered by submitting parties.

Companies may request to participate in the limited pilot program and are eligible if their submission would be reviewed by the Office of Device Evaluation’s Division of Cardiovascular Devices, Division of Neurological and Physical Medicine Devices, Division of Orthopedic Devices, or Division of Surgical Devices. This group represents an increase in the number of companies that are eligible, according to an article recently published by the Regulatory Affairs Professional Society (RAPS). Originally only a few companies in the Division of Cardiovascular Devices were allowed to participate.

Applications to participate in the program will be accepted through December 31, 2014, or as program needs allow, according to the eSubmission website. A sample of 100 submissions will be processed during this pilot study of the system.

 

 

Equinox Medical, LLC. Just launched their latest negative pressure wound therapy pump at Medtrade 2014 in Atlanta Georgia. The new NPWT pump is called Halo MINI NPWT pump system and its from the same line as the Halo XP and Halo XT NPWT pump system. The pump is small and light and only weighs in at 2.48 lbs. Eventhough it is small npwt pump, this pump is packing a serious motor. The pump has 5 liters per minute of air flow ensuring a continuous and consistent treatment.

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