BioStar raises $68M for third, medical device-focused fund
Michigan-based medical device investment firm BioStar Ventures just raised $68 million for its third and largest fund. It plans to focus its investments on devices in cardiovascular and orthopedic medicine.
Its previous two funds collectively raised $65 million – and helped spawn more than 30 companies. BioStar has about 20 active portfolio companies, and 13 that have been acquired by large medical device manufacturers.
MCHENRY, Ill., June 30, 2015/PRNewswire/ – Medela, Inc., has banded together with the Wound Care Education Institute, Inc.® (WCEI), the nation’s driving wound consideration training supplier, to give industry affirmation to Medela’s expert wound consideration staff. The main of its kind, the Certified Wound Care Market Specialist (CWCMS®) system was made to teach proficient groups on proof based current measures of consideration in wound administration. WCEI has effectively prepared and confirmed about 1,000 wound consideration deals and promoting experts in both medicinal services and assembling commercial ventures.
“Medela Healthcare has given Negative Pressure Wound Therapy since 2008 through our accomplished group and PartnerFirst™ Network,” said Alan Cawley, Director of Sales for Medela Healthcare. “This WCEI affirmation backings Medela’s dedication to giving our clients, and at last the patients we accomplice to serve, with unparalleled mastery.”
“This association guarantees Medela deals and advertising faculty keep on having the right stuff and competency in the developing field of wound consideration to bolster clinicians across the nation,” said Nancy Morgan, president and prime supporter of Wound Care Education Institute, Inc. “This sort of exceptionally centered preparing in wound consideration speaks to a developing chance to enhance the general clinical results for wound consideration patients.”
About Medela The Medela family organization, headquartered in the Canton of Zug, Switzerland, was established by Olle Larsson in 1961. Medela focuses on two specialties units: “Breastfeeding,” with essential research that is perceived internationally and driving in the improvement and assembling of breastfeeding items, and “Healthcare,”engineering and assembling very imaginative therapeutic vacuum innovation arrangements. Medela has 18 auxiliaries in Europe, North America and Asia, circulates its items in more than 90 nations, and utilizes more than 1,500 staff around the world. For more data, visit www.medela.com.
About the WCEI Founded in 2003 by Nancy Morgan RN, BSN, MBA, WOC, WCC, CWCMS, DWC, OMS and Donna Sardina RN, MHA, WCC, CWCMS, DWC, OMS, Wound Care Education Institute, Inc. has developed to turn into the main instructive middle of greatness for wound consideration and ostomy instruction in the United States. WCEI’s central goal is to create multi-disciplinary wound consideration experts by offering preparing projects in light of momentum benchmarks of consideration and confirmation based exploration. To date, WCEI has prepared more than 25,000 wound consideration doctors, advisors, medical attendants and deals/advertising experts. For data in regards to WCEI’s instructive projects, visit www.wcei.
MCHENRY, Ill., June 30, 2015 /PRNewswire/ — Medela, Inc., has partnered with the Wound Care Education Institute, Inc.® (WCEI), the country’s leading wound care education provider, to provide industry certification to Medela’s professional wound care staff. The first of its kind, the Certified Wound Care Market Specialist (CWCMS®) program was created to educate professional teams on evidence-based current standards of care in wound management. WCEI has successfully trained and certified nearly 1,000 wound care sales and marketing professionals in both healthcare and manufacturing industries.
“Medela Healthcare has provided Negative Pressure Wound Therapy since 2008 through our experienced team and PartnerFirst™ Network,” said Alan Cawley, Director of Sales for Medela Healthcare. “This WCEI certification supports Medela’s commitment to providing our customers, and ultimately the patients we partner to serve, with unparalleled expertise.”
“This partnership ensures Medela sales and marketing personnel continue to have the skills and competency in the evolving field of wound care to support clinicians nationwide,” said Nancy Morgan, president and co-founder of Wound Care Education Institute, Inc. “This type of very focused training in wound care represents a growing opportunity to improve the overall clinical outcomes for wound care patients.”
About Medela The Medela family company, headquartered in the Canton of Zug, Switzerland, was founded by Olle Larsson in 1961. Medela concentrates on two business units: “Breastfeeding,” with fundamental research that is recognized globally and leading in the development and manufacture of breastfeeding products, and “Healthcare,”engineering and manufacturing highly innovative medical vacuum technology solutions. Medela has 18 subsidiaries in Europe, North America and Asia, distributes its products in over 90 countries, and employs more than 1,500 staff worldwide. For more information, visit www.medela.com.
About the WCEI Founded in 2003 by Nancy Morgan RN, BSN, MBA, WOC, WCC, CWCMS, DWC, OMS and Donna Sardina RN, MHA, WCC, CWCMS, DWC, OMS, Wound Care Education Institute, Inc. has grown to become the leading educational center of excellence for wound care and ostomy education in the United States. WCEI’s mission is to develop multi-disciplinary wound care professionals by offering training programs based on current standards of care and evidence-based research. To date, WCEI has trained more than 25,000 wound care physicians, therapists, nurses and sales/marketing professionals. For information regarding WCEI’s educational programs, visit www.wcei.net.
The Affordable Care Act may have survived one of its biggest challenges last week with a favorable ruling from the Supreme Court on King v. Burwell, but one of its less popular provisions might fall to the legislative process instead. A bill calling for the repeal of a controversial 2.3 percent medical device tax has passed a vote in the House and now heads to the Senate, leaving medical device manufacturers on the edge of their seats as they wait to see how Congress will address the issue.
The excise tax went into effect at the beginning of 2013, pinching just over two percent of the manufacturer’s stated prices from certain classes of regulated medical devices, including replacement joints, pacemakers, and other implantable devices, some of which are becoming increasingly important for remote patient monitoring and healthcare’s Internet of Things.
The FDA has tried to soothe the fears of many health IT companies by saying that it does not intend to place consumer-grade mHealth devices, patient engagement apps, or low-risk medical surveillance tools on the list of taxable devices. Apps and equipment that manage health information or medical data will not be strictly regulated either, said FDA officials earlier this year.
“The FDA seeks to advance public health by promoting innovation and development in this area by continually adapting our regulatory approach to technological advances to meet the needs of patients and consumers,” the agency said in a February blog post. “The medical device data systems (MDDS) guidance confirms our intention to not enforce compliance with applicable regulations for technologies that receive, transmit, store, or display data from medical devices. We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data.”
Still, medical device manufacturers that are subject to the excise tax have raised questions of its potential impact on their ability to innovate and thrive in a highly competitive marketplace. Federal officials have projected that the tax will raise $29 billion in revenue for the government, a significant sum for developers who spent several years at the beginning of the decade wondering when the FDA was going to draw up the rules for the mHealth industry, which had started experiencing rapid growth and incredible demand.
The medical device tax repeal, HR 160, passed a House vote 280 to 140, attracting “yes” votes from both parties. Despite the successful margin, it faces an uncertain political future in the Senate. Even if it clears its second Congressional hurdle, President Obama has threatened to veto the repeal.
Proponents of the tax say that it will continue to produce much-needed revenue without significantly impacting the activities of manufacturers. Advocates of repeal note that the excise has already collected far less than anticipated, and the lost revenue is preventing medical device manufacturers from investing in much-needed innovation, including expanding job opportunities in their home regions.
A 2014 report from the Congressional Research Service projected that the medical device tax would do little to impact manufacturers. “The estimates in this report suggest fairly minor effects, with output and employment in the industry falling by no more than two-tenths of one percent,” the brief stated. “This limited effect is due to the small tax rate, the exemption of approximately half of output, and the relatively insensitive demand for health services.”
“The analysis suggests that most of the tax will fall on consumer prices, and not on profits of medical device companies. The effect on the price of health care, however, will most likely be negligible because of the small size of the tax and small share of health care spending attributable to medical devices.”
“When the tax went into play, my shareholders still expect me to produce the same returns as we produced before,” countered Haemonetics Corporation CEO Brian Concannon to reporters from the Boston Globe. The blood processing device manufacturer has relinquished approximately $4 million in revenue to the tax so far. An equivalent sum would allow him to hire 40 additional engineers. “If that tax goes away, I could spend millions of dollars more on research and development without batting an eye,” he added.
As the legislation moves forward, budget-minded Senators will tussle over how to replace lost revenue from the tax, should it be repealed. While the medical device excise collected approximately $1 billion less than anticipated during its first year, the uncertain impact of repeal on the healthcare industry and the federal budget at large will remain a divisive issue as the bill makes its way through the legislative process.
The Affordable Care Act may have survived one of its greatest difficulties a week ago with a good controlling from the Supreme Court on King v. Burwell, however one of its less famous procurements may tumble to the administrative process. A bill requiring the cancelation of a questionable 2.3 percent therapeutic gadget assessment has passed a vote in the House and now heads to the Senate, leaving medicinal gadget makers on the edge of their seats as they hold up to perceive how Congress will address the issue.
The extract expense went live toward the start of 2013, squeezing a little more than two percent of the producer’s expressed costs from specific classes of managed therapeutic gadgets, including substitution joints, pacemakers, and other implantable gadgets, some of which are turning out to be progressively essential for remote patient checking and human services’ Internet of Things.
The FDA has attempted to calm the apprehensions of numerous wellbeing IT organizations by saying that it doesn’t expect to place buyer grade mHealth gadgets, quiet engagement applications, or generally safe restorative reconnaissance devices on the rundown of assessable gadgets. Applications and hardware that oversee wellbeing data or medicinal information won’t be entirely controlled either, said FDA authorities recently.
“The FDA tries to propel general wellbeing by advancing advancement and improvement around there by persistently adjusting our administrative way to deal with mechanical advances to address the issues of patients and buyers,” the organization said in a February blog entry. “The restorative gadget information frameworks (MDDS) direction affirms our goal to not implement agreeability with appropriate regulations for innovations that get, transmit, store, or showcase information from therapeutic gadgets. We trust that finish of this strategy will make a force for the advancement of new innovations to better utilize and presentation this information.”
Still, therapeutic gadget producers that are liable to the extract expense have brought up issues of its potential effect on their capacity to develop and flourish in an exceedingly focused commercial center. Elected authorities have anticipated that the duty will bring $29 billion up in income for the administration, a noteworthy aggregate for designers who put in quite a long while toward the start of the decade pondering when the FDA was going to draw up the principles for the mHealth business, which had begun encountering quick development and mind boggling interest.
The medicinal gadget assessment repeal, HR 160, passed a House vote 280 to 140, drawing in “yes” votes from both sides. Notwithstanding the effective edge, it confronts an indeterminate political future in the Senate. Regardless of the possibility that it clears its second Congressional obstacle, President Obama has debilitated to veto the nullification.
Advocates of the assessment say that it will keep on creating quite required income without essentially affecting the exercises of producers. Supporters of cancelation note that the extract has officially gathered far not exactly foreseen, and the lost income is keeping medicinal gadget producers from putting resources into greatly required development, incorporating extending openings for work in their home areas.
A 2014 report from the Congressional Research Service anticipated that the restorative gadget duty would do little to effect makers. “The evaluations in this report propose genuinely minor impacts, with yield and job in the business falling by close to two-tenths of one percent,” the brief expressed. “This restricted impact is because of the little duty rate, the exception of more or less a large portion of yield, and the generally obtuse interest for wellbeing administrations.”
“The investigation recommends that a large portion of the assessment will fall on purchaser costs, and not on benefits of restorative gadget organizations. The impact on the cost of human services, in any case, will no doubt be unimportant in view of the little size of the duty and little share of social insurance spending owing to therapeutic gadgets.”
Be that as it may, therapeutic gadget makers see it in an unexpected way. As indicated by them, the duty is keeping them from putting resources into their own development, which thusly affects the capacity of the social insurance industry everywhere to proceed with its change into an information driven, investigation minded wellbeing IT continuum that can saddle the colossal capability of consistent restorative gadget incorporation and interoperable wellbeing data administration.
“At the point when the duty went into play, my shareholders still anticipate that me will deliver the same returns as we delivered before,” countered Haemonetics Corporation CEO Brian Concannon to journalists from the Boston Globe. The blood handling gadget maker has surrendered give or take $4 million in income to the expense as such. An identical aggregate would permit him to contract 40 extra specialists. “In the event that that expense goes away, I could burn through a great many dollars all the more on innovative work without so much as a second thought,” he included.
As the enactment makes headway, spending plan minded Senators will tussle over how to supplant lost income from the duty, if it be canceled. While the therapeutic gadget extract gathered give or take $1 billion not exactly foreseen amid its first year, the dubious effect of cancelation on the social insurance industry and the government spending plan everywhere will remain a divisive issue as the bill advances through the authoritative procedure.
It is a notorious picture imitated amid each and every irresistible ailment flare-up in the most recent century: men and ladies clad head to toe in surgical outfits and surgical covers, keeping an eye on the wiped out or attempting to clean sullied territories. However, notable or not, the US Food and Drug Administration (FDA) has an additionally squeezing concern: Are the outfits successful at shielding their clients from the spread of disease?
The inquiry is the center of another draft direction record issued by FDA, Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.
Under 21 CFR 878.4040, surgical attire is characterized as:
“gadgets that are planned to be worn by working room faculty amid surgical methodology to secure both the surgical patient and the working room staff from exchange of microorganisms, body liquids, and particulate material. Cases incorporate surgical tops, hoods, veils, outfits, working room shoes and shoe spreads, and confinement covers and outfits. Surgical suits and dresses, ordinarily known as scour suits, are prohibited.”
As FDA clarifies in its new draft direction record, not all surgical defensive hardware is controlled similarly.
Under 21 CFR 878.4040(b)(1), surgical outfits and surgical covers are Class II medicinal gadgets and require the accommodation of a 510(k) application and agreeability with both general and uncommon controls built up by FDA under 21 CFR 878.4040(b).
Nonetheless, not all surgical attire is managed as Class II gadgets. Except for surgical outfits and veils, most surgical attire is directed as Class I therapeutic gadgets (21 CFR 878.4040(b)(2)). Class I items are absolved from premarket entries or survey, however must consent to general controls built up by FDA.
As FDA has already noticed, the execution of surgical outfits, and specifically surgical confinement outfits, is basic. In the event that you have motivation to wear a surgical outfit in any case, the exact opposite thing you need to stress over is whether fluid splatter containing an irresistible microorganism will leak through and come into contact with your skin.
The issue, as FDA clarifies in the direction, is that definitional perplexity at present exists in the commercial center. Case in point, a few norms setting bodies utilize the expression “disengagement outfit” to portray what FDA calls “surgical outfits.” That’s conceivably dangerous in light of the fact that FDA considers outfits guaranteeing to give more elevated amounts of hindrance security “to be higher-hazard gadgets than those that claim negligible or low levels of boundary assurance.”
In the event that conflicting definitions are utilized, organizations may accept they are excluded from giving the obliged execution proof, FDA said. “The motivation behind this direction, along these lines, is to elucidate and portray the premarket administrative necessities relating to outfits directed under 21 CFR 878.4040 and the execution testing expected to bolster fluid hindrance claims for outfits proposed for utilization in health awareness settings,” FDA included.
FDA’s direction depends upon a current standard kept up by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) known as ANSI/AAMI PB70. The PB70 standard portrayed four levels of security, with Level 1 insurance offering a “negligible” measure of hindrance assurance, and Level 4 offering “high” obstruction security.
FDA says it considers Levels 1 and 2 to on the whole offer “insignificant or low” obstruction security, and Levels 3 and 4 to offer “moderate or high” boundary insurance.
As FDA’s direction archive goes ahead to clarify, the cases made by a maker about its surgical attire (under 21 CFR 878.4040(b)(2)) will decide how it is controlled by FDA.
An outfit (not a surgical outfit) which is named with articulations that it is expected to give insignificant or low obstruction insurance may be directed as a Class I gadget absolved from premarket survey.
In any case, if that same item is named as a surgical outfit, cases to give “moderate or abnormal state obstruction security,” or is proposed for utilization amid sterile systems, it will be managed as a Class II gadget and be liable to the 510(k) procedure and unique controls set up by FDA.
On the off chance that a 510(k) is needed of a surgical outfit or related gadget, FDA says it must meet the PB70 standard and incorporate execution test information planned to exhibit hindrance adequacy.
Under the new approach, existing items as of now available however obliging a 510(k) will be conceded makeshift mercy, FDA said.
Remarks on the direction record are because of FDA before the end of August 2015.
Consider this: dad’s get in free at the Birmingham Zoo June 21 with the purchase of a child’s full-price admission. If you haven’t been in a while, there are a lot of new attractions. You can feed the Lorikeets in the newly renovated SLorikeet Aviary, ride the new Wild Slide, take an aerial journey 20 feet above ground on the new Soaring Safari Zipline Adventure, experience Predator Zone, or watch an alligator feeding.
The zoo offers extended summer hours. They are 9am–7pm Tuesday, Friday, Saturday and Sunday through August 10th.
‘NETs’ slow healing in diabetic mice, may contribute to delayed healing in people with diabetes
Boston Children’s Hospital
One of the body’s own tools for preventing wound infections may actually interfere with wound healing, according to new research from Boston Children’s Hospital. In a study published online in Nature Medicine, scientists from the hospital’s Program in Cellular and Molecular Medicine (PCMM) found they could speed up wound healing in diabetic mice by keeping immune cells called neutrophils from producing bacteria-trapping neutrophil extracellular traps (NETs).
The study, led by PCMM senior investigator Denisa Wagner, Ph.D., and postdoctoral fellow Siu Ling Wong, Ph.D., suggests that methods of preventing NET production or of cleaving NETs in a wound could, one day, possibly help alleviate wound healing problems in patients with diabetes.
Halo MINI negative pressure wound therapy pump system is now being used for hard to heal wounds. The NPWT pump helps extract exudate from the wound and promote oxidation in the wound.
Delayed wound healing is a common complication of both Type 1 and Type 2 diabetes. Open diabetic foot ulcers, for example, affect a quarter of people with diabetes and are a leading cause of amputations.
When the skin is cut or broken, the body mobilizes a complicated array of cells and proteins to stop bleeding, prevent infection by triggering inflammation and start the healing process. As part of the inflammatory response, neutrophils, which ingest and destroy bacteria, expel their own chromatin (a mix of DNA and associated proteins) in the form of NETs within the wound.
While possibly beneficial as a tool for keeping bacteria out of the body, NETs also have a dark side. ‘NETs predispose patients to inflammation, heart disease and deep vein thrombosis [dangerous blood clots that form within veins deep inside the body], all of which are elevated in patients with diabetes,’ says Wagner, who is also the Edwin Cohn Professor of Pediatrics at Harvard Medical School.
To see whether diabetes primes neutrophils to produce NETs, Wagner, Wong and colleagues at Joslin Diabetes Center and Pennsylvania State University examined neutrophils from patients with either Type 1 or Type 2 diabetes, finding that the cells contained four times the normal amount of PAD4 (a key enzyme in the NET production process) and made more NETs when stimulated. Further lab experiments revealed that neutrophils from healthy donors or mice when exposed to excessive glucose — mimicking the diabetic environment — were also more likely to release NETs than those incubated in normal glucose levels.
Diabetic mice in the study had more NETs in wounds and healed more slowly than normal mice. However, Wagner and Wong’s team found that healing was accelerated in diabetic mice that lacked PAD4 (and therefore could not produce NETs).
To see whether cleaving NETs would have an effect similar to preventing their production, the research team treated mice with DNase 1 (an enzyme that breaks up DNA and therefore can destroy NETs). After three days, wounds on DNase 1-treated diabetic animals were 20 percent smaller than on untreated animals. Interestingly, DNase 1-treatment appeared to accelerate wound healing in healthy mice as well.
Wagner and Wong explain that NETs may impede wound healing in part because the dense, toxic mesh they produce interferes with new skin cells trying to enter the wound site. They also suggest that NETs may be redundant as a defense mechanism against bacteria.
‘We don’t fully understand the functions of NETs, but all of the other antimicrobial functions of neutrophils are preserved even if they cannot make NETs,’ Wagner notes. ‘Any injury that causes inflammation will result in production of NETs, and we think that if the injury involves skin repair, NETs will hinder the repair process.’
The study was supported by the American Diabetes Association (Innovation Award 7-13-IN-44); the National Heart, Lung and Blood Institute (grant number R01HL102101); the National Cancer Institute (grant number R01HL136856); the National Institute of Diabetes and Digestive and Kidney Diseases (grant number R01DK031036) and a GlaxoSmithKline/Immune Disease Institute Alliance Fellowship.
It’s a rare bacteria thriving in Florida’s warm sea waters, sparking a string of illnesses and even two deaths in the sunny southern state. Health officials are warning beachgoers about Vibrio vulnificus, but they’re also trying to dispel rumours that the nasty bacteria is “flesh-eating.”
The bacteria has infected eight people and killed two more this year in Florida, according to U.S. reports. It’s found in warm marine waters – if people swim with open wounds, or eat contaminated seafood, they could come in contact with the germs.
“People get vibrio by swimming, wading and playing in salt or brackish waters with open wounds or scratches or by eating undercooked or raw shellfish, particularly oysters. Vibrio is rare but can be a serious disease,” Dr. Carina Blackmore, Florida’s Deputy State Epidemiologist, said in a video put together by the health department.
“The best way of protecting yourself from infections from vibrio is by performing good wound care, and you do that by covering the wounds with dry, clean bandages until they’re healed and pay attention to minor wounds, scratches and blisters…,” she said.
While it’s incredibly rare – last year, there were about 32 cases in Florida – the infection can lead to vomiting, diarrhea, and stomach pain similar to symptoms of a stomach flu.
Handfuls of U.S. reports suggest that when the bacterium infects an open wound, it can lead to skin ulcers, akin to “flesh eating.” The bacteria doesn’t eat the flesh, but it can lead to infection. In some cases, amputation is required if infection is severe enough.
Last August, health officials had their hands full in making clarifications about the bacteria. Ultimately, Florida’s Department of Health for Pinellas County issued its own “Myth Buster” report.
“The naturally occurring organisms in the vibrio family have been in the news this week, but a lot of ‘myth information’ has scared beachgoers and visitors,” Maggie Hall, the department’s spokesman said, according to one outlet.
Hall said it’s not flesh-eating, contrary to reports. “There is no such medical term and the organism is not a Pac-man consuming pac-dots,” she said.
On Friday, the department put together another press release to correct “inaccuracies about Florida’s beach water.” It suggests its warning is a routine measure as vibrio infections typically pick up between May and October.
Central Peninsula Hospital (CPH) starting late exhibited another framework for gathering people stood up to with the mind-boggling test of a chest tumor finding. Nearby the obvious anxiety and wellbeing stresses that run as an inseparable unit with such a discovering, the starting measure of information, tests and decisions to be made can be additionally over-whelming for the patient. While having the support of friends and family is precious, CPH starting late obtained two new Breast Health Navigators, neighborhood RN’s who got excellent planning in Atlanta, GA and returned home to give what the title recommends: help patients investigate their approach to recovery. “What I fulfill for patients who have been resolved to have chest illness is serve as a specialist or pilot for them. I help guide them through the plan of medicines and the chemotherapy, the therapeutic checkups, the inherited qualities advocate and the nutritionist. I’m a relentless enrollment point for all of them through their experiences,” cleared up Heather Moon, RN at CPH and a starting late arranged patient pilot.
“For a few patients, especially most importantly, having a pilot can have all the impact in the effortlessness with which they progress through the uncharted space of their definite trip: the early on examination, the treatment and finally survivorship. In conjunction with arranging treatment, controls also help direct patients towards distinctive resources in our gathering, for instance, chest prosthesis and wigs. After surgery we help with postliminary: wound care and dressing changes, whatever a patient who is encountering chest malady may need,” said Moon. “What I encourage patients to do is to just manage themselves and we will help manage their thought and likewise help them fathom what is striking them and what’s in store next,” she said in conveying the longing of CPH to get the word out to the gathering. “Despite the way that the Breast Cancer framework has been a bit of CPH for quite a while, in beginning the new program CPH is endeavoring to pass on more thoughtfulness regarding the gathering. We have to tell the gathering that we’re here for them, they don’t have to go to Anchorage any more to get the thought they need,” said Moon. Quickly with the expertise of Heather and Amber Avery as patient pilots, close by the straggling leftovers of the qualified staff at CPH, patients and their families resolved to have chest tumor have section to glorious care and bearing right here at home.