Avita Medical touts pivotal trial of ReCell burn injury device

Avita Medical (ASX:AVH) said today that a pivotal trial of its ReCell autologous cell harvesting device met its co-primary endpoints.

The device, designed to help heal deep, full-thickness burns, demonstrated a statistically significant reduction in donor skin requirements compared to the standard of care and achieved comparable wound closure, Avita touted.

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Smith & Nephew touts results from Allevyn Life adhesive dressing hip fracture trial


Smith & Nephew (NYSE:SNN) today released the results from a trial of its Allevyn Life multi-layer silicone adhesive foam dressing, touting that its addition to standard care protocols reduces the onset of pressure ulcers by 71% in elderly patients being treated for hip fracture.

The trial was published in the International Wound Journal, the London-based company said.

“Hip fractures in the elderly are a serious problem due to the high rate of mortality and complications such as pressure ulcers, which occur mainly in the sacral area. Preventive measures play an important role in increasing quality of care, reducing health costs and improving the patient’s quality of life. Our research shows that Allevyn Life is effective at reducing the rate of pressure ulcers in the sacrum in elderly patients with hip fracture. The excellent adhesiveness of this device also enables costs to be kept down,” Cristiana Forni of Bologna, Italy’s Rizzoli Orthopaedic Institute said in a prepared statement.

Data in the trial came from an analysis of 359 fragile hip patients of age 65 or over, with patients divided into a treatment cohort that received the Allevyn Life and those who treated standard care.

Results indicated that 15.4% of patients who received only standard care developed pressure ulcers, while 4.5% of the Allevyn Life cohort developed ulcers, indicating a 71% reduction in pressure ulcer incidence.

The Allevyn Life dressing features five layers, with a breathable top layer, hydrocellular layer, an absorbent lock away core, masking layer and silicone gel adhesive layer, Smith & Nephew said.

“Many global experts and professional bodies8 state polyurethane foam dressings should be considered for use prophylactically on bony prominences in anatomical areas subject to friction and shear. This new research further demonstrates that Allevyn Life is a safe and effective preventative measure suited to be at the heart of a pressure ulcer prevention strategy,” chief medical officer Dr Andy Weymann said in a press release.

Last month, Smith & Nephew touted a 97.3% decrease in readmission rates for joint arthroplasties using its Episode of Care Assurance Program, a bundled payment option designed to reward good patient outcomes.

Acelity to layoff 68 San Antonio employees


Wound care company Acelity is set to lay off 68 employees in San Antonio, Texas, according to a report from the San Antonio Express-News.

The employees are slated to be released from their positions on May 8, according to a Workforce Adjustment and Retraining Notification Act notice from the Texas Workforce Commission posted this week.

“While decisions that affect our valued employees are extremely difficult, health care is rapidly changing and we are taking steps to evolve and grow Acelity to meet both the demands of the marketplace and our customers. We have made some changes to our IT organization that will give us the ability to increase investment in areas like patient connectivity and digital health,” Acelity spokesperson Kathryn Skeen told the paper in an email, according to the San Antonio Express-News.

Acelity has not yet stated any specifics about the individuals being let go, but the layoffs come from its subsidiary KCI USA.

Last August, Acelity released results from a study of cesarean procedures for obese patients, touting a reduction in post-surgical wound complications and narcotic use for patients who underwent closed incision negative pressure wound therapy using its Prevena incision management system.

Smith & Nephew looks to $160m cost-cutting as 2017 earnings top estimates


Perhaps seeking to stave off a hedge fund’s carveout push, Smith & Nephew (NYSE:SNN) today revealed a cost-cutting program it hopes will pare $160 million from its annual operating budget and posted 2017 results that beat earnings expectations.

Last year Elliott Management took out a stake in the British orthopedic and wound care firm, leading to speculation that Elliott founder Paul Singer would push to break the company apart. This morning CEO Olivier Bohuon, who’s slated to step down at the end of the year, told analysts that a breakup is not in the cards.

“We are not newborn babies, we have worked on pipeline management for some time. If we have this set-up, then that’s because we are happy with it,” Bohuon said, according to the Telegraph.

Smith & Nephew logged profits of $1.05 billion, or 87.8¢ per share, on sales of $4.77 billion last year, for bottom-line growth of 2.7% on sales growth of 2.1%. Adjusted to exclude one-time items, earnings per share were 94.5¢, well ahead of the consensus forecast of 88¢. Analysts were also looking for sales of $4.78 billion.

The company said its new, $240 million Accelerating Performance & Execution program, dubbed Apex, aiming to deliver the $160 million-a-year savings by 2022. The plan is to revise its physical footprint around manufacturing and service hubs and refine the supply chain; Smith & Nephew also hopes to cut its general & administrative expenses and streamline its commercial operation.

“We delivered on our promises to improve the top and bottom line in 2017. Our knee implants franchise delivered a standout performance and we returned to double-digit growth in the emerging markets. Our healthy balance sheet, good cash generation and increased dividend demonstrate the robust foundations underpinning our business,” Bohuon said in prepared remarks. “In 2018 I expect Smith & Nephew to build on 2017 by delivering another year of improved performance driven by our strong product portfolio and pipeline of innovative products.

“Looking further ahead, our greater focus on commercial execution gives us confidence we will outgrow our markets and the new APEX programme supports our expectation of improved trading profit margin,” he said.

Smith & Nephew said it expects to improve its profit margin by 30 to 70 basis points on sales growth of 7% to 8%.

In London, SN shares were down -2.3% to £12.18 apiece today in mid-afternoon trading. In New York the stock was off some -0.6% at $34.49 per share in pre-market activity, having closed down -1.0% at $34.68 yesterday.

Chemence Medical wins FDA nod for Exofin Fusion skin closure system


Chemence Medical's Exofin Fusion

Chemence Medical said today it won FDA clearance for its Exofin Fusion skin closure system designed for medium to large wounds.

The Exofin Fusion skin closure system features a self-adhering mesh strip, mesh anchors and a fast-curing 2-octyl cyanoacrylate topical adhesive to close and seal large incisions and form a microbial barrier to protect from infections, the company said.

Alpharetta, Ga.-based Chemence said the Exofin Fusion is designed for multiple uses, but is most applicable for orthopedic procedures including total hip and knee replacements, cardiovascular procedures, plastic surgery, spinal procedures and obstetrics for C-section closures.

“Our new skin closure system can really improve the operating room experience for doctors and patients when closing larger wounds. The self-adhering mesh and anchor system allows for easy application and enables surgeons to close incisions faster than sutures, while the adhesive cures in less than a minute. Meanwhile, the waterproof microbial barrier reduces the patient’s likelihood of readmission due to infection, allows them to shower immediately after surgery, and the innovative anchor system improves comfort during removal. Exofin Fusion brings the features doctors and patients love about topical wound closure adhesives to a whole new array of procedures. Chemence Medical is excited to introduce the next step in topical skin adhesives,” prez Jeff Roberson said in a press release.

Last February, Chemence said it won FDA 510(k) for its Exofin topical skin adhesive designed for wound closure.

Smith & Nephew takes $5m hit from hurricanes


smith & nephewSmith & Nephew (NYSE:SNN) said today that it took a $5 million hit during the third quarter from the hurricanes that devastated Texas and Puerto Rico and guided toward the low end of its outlook for the rest of the year.

The British orthopedics and wound care giant, which only reports profit numbers at the middle and end of the year, said Q3 sales grew 2.9% to $1.15 billion compared with the same period last year.

CEO Olivier Bohuon, who’s slated to step down at the end of the year, declined to comment on rumors about a possible takeover or sale of its divisions or about the Smith & Nephew stake taken by hedge fund Elliott Management, Reuters reported.

“We are not thinking about asset disposal at this stage at all,” Bohuon said. “We do not comment on rumor or speculation and we don’t comment on the identity of our investors unless required to do so under disclosure rules.”

“I am pleased with what we have achieved so far in 2017, where our focus on execution is delivering improvements in performance. Of particular note is the sustained nature of the market-beating growth from our knee implants franchise and the strong emerging markets recovery across the year. We delivered 3% revenue growth in the quarter, in-line with guidance despite the recent natural disasters in the Americas delaying some procedures,” the CEO said in prepared remarks. “After the quarter end we announced an agreement to acquire Rotation Medical. Its pioneering bio-inductive implant is a novel tissue regeneration technology for shoulder repair that treats an unmet clinical need and is highly complementary to our leading sports medicine shoulder portfolio.

“Looking ahead, our focus on accelerating the top-line is unchanged and we are also starting the next stage in our continuing drive to improve efficiency across the group. I am as determined as ever to keep pushing for further success, and to leave Smith & Nephew an even better company,” he said.

Smith & Nephew said it expects full-year revenue growth to come in at the low end of its 3% to 4% guidance, with profit margins also at the low end of its 20 to 70 basis point forecast.

RenovaCare raises $2m on path to improve burn, wound care with its “SkinGun”


RenovaCare's SkinGun

RenovaCare said this week it raised $2.3 million in a new direct offering to support its “SkinGun,” which CEO Thomas Bold thinks could be a significant boon to the burn and wound care industry.

This summer, CEO Bold spoke to MassDevice.com about the company’s SkinGun and CellMist technologies and what he thinks they can do to improve outcomes and reduce pain compared to current wound care treatments.

The company’s SkinGun uses a sample of stem cells collected from a patient’s healthy skin, which are isolated and placed into a water-based solution in a syringe, which is then attached to the device.

“A patient’s stem cells are isolated from a tiny skin sample – something like maybe a square inch – and these stem cells are liberated from the surrounding tissue, suspended in a water-based solution and simply sprayed onto the wound. This takes as little as 90 minutes, altogether,” Bold said. “What’s very important here is that we are not expanding the cells. We are not culturing the cells. We just take them.”

The technique allows for a ‘cell mist’, with 10,000s of small regenerated cell colonies, or islands, which grow outward and connect to each other to create an epithelial skin layer, Bold said.

“Beyond this stage the natural, cosmetic healing happens entirely naturally. We use our treatment only once, and you don’t have to retreat it. Once the layer is closed your skin grows and looks and feels like natural skin,” Bold said.

The system works quickly, taking days instead of weeks or months to produce a dry wound. Bold says the time frame for the treatment is much quicker than mesh grafting, which is the standard-of-care treatment for wounds.

In addition to cutting down time frames for healing, the procedure also saves patient a good amount of pain compared to traditional mesh grafting, Bold added.

“[Mesh grafting] is a surgical process where quite a lot of sheets of healthy skin from a patient are removed and punctured, stretched and stitched onto the wound again. This is quite painful and creates not only additional wounds at each donor site but the results can be very particular – including poor cosmetic outcomes, often with scarred and deformed skin and depending on where it is, restricted joint movement,” Bold said.

RenovaCare’s technology requires much less skin than is normally required with grafting, Bold said, moving from a 1-to-6 or 1-to-8 ratio required by grafting to a 1-to-100 ratio with the SkinGun.

Though the technology is currently being tested on burns, Bold said he thinks the platform is also applicable for other indications, including wounds, scar treatments and cosmetic uses.

The company is still gathering data and planning clinical trials of the device as it pursues pre-market approval from the FDA, Bold said.

In its recently closed $2.3 million offering, RenovaCare floated 915,000 shares of common stock at $2.50 per share and 915,000 common stock purchase warrants with an exercise price of $2.75. The purchase agreements are exercisable immediately and set to expire 5 years from the date of issuance, according to a press release.

Funds raised in the round will support working capital and other general corporate purposes, the company said.

Hill-Rom launches Envella therapy bed for wound care patients



Hill-Rom Holdings (NYSE:HRC) said today it launched its Envella air fluidized therapy bed designed for wound care and patients with advanced wounds.

The Envella bed was unveiled at the Wound Ostomy and Continence Nurses Society Annual Conference in Salt Lake City, Utah this week, the Chicago-based company said.

Hill-Rom said that the Envella air fluidized therapy bed is designed to maximize immersion and envelopment and minimize shear and pressure, as well as regulating the skin’s microclimate. The company claims the technology can lead to better outcomes in patients with complex and advanced wounds .

“Pressure injuries present a significant challenge for the entire healthcare environment. Across the care continuum, pressure injuries are quite common, cause serious concerns both to patients and their caregivers, and create financial burdens for the healthcare system. The Envella bed’s differentiated technology provides an ideal healing environment for the prevention and treatment of advanced pressure injuries,” patient support systems prez Paul Johnson said in a press release.

In April, Hill-Rom said it launched the Monarch airway clearance system designed to provide high frequency chest wall oscillation.

The Monarch device is a mobile vest which uses personal oscillating discs to provide targeted kinetic energy and HFCWO to the lungs to thin mucus and generate airflow, the company said.

Smith & Nephew gains as emerging markets boost Q1 results

Smith & NephewSmith & Nephew (NYSE:SNN) shares are up today in London and New York after the British medical device giant said emerging markets drove strong 1st-quarter results.

Overall sales grew 0.4% to $1.14 billion and 3% on a constant-currency basis for the 3 months ended April 1, the company said. Smith & Nephew no longer reports quarterly profits or earnings. Although sales fell in both the U.S. and established markets overseas, emerging market revenues jumped 13.1% to $173 million compared with Q1 2016.

“I am pleased with the start of 2017, which was in-line with our expectations. In particular, performance in the emerging markets was good, returning to double-digit growth, with China up 14% underlying. Our innovative new products, such as the Lens camera and Werewolf Coblation systems, have been well received, and we look forward to the imminent full market release of the total knee application on our Navio robotics-assisted surgery system,” CEO Olivier Bohuon said in prepared remarks. “Over the last few years we have successfully put in place the right structures and capabilities to make the group stronger, simpler, more agile and efficient. We continue to focus on execution and expect to see progress through the year.”

Smith & Nephew said it still expects to add 20 to 70 basis points to its trading profit this year, on constant-currency sales growth of 3% to 4%.

During a conference call with analysts, Bohuon said he’s focused on organic growth in the short term, rather than acquisitions. Analyst chatter earlier this year had Smith & Nephew as the most likely acquirer of extremity orthopedics maker Wright Medical (NSDQ:WMGI).

Although M&A is “always on the agenda” and acknowledging that extremities are an area of interest for Smith & Nephew, “for the moment, this quarter, I am interested in developing my commercial excellence,” Bohuon said.

“[M&A] is still high on the agenda, but it’s not a top priority for the time being,” he said.

SN shares were up 2.5% to £13.02 apiece today as of about 11:30 a.m. in London; SNN shares rose 3.0% to $33.11 each in pre-market trading in New York.

Material from Reuters was used in this report.

Origin treats first patients in study of nitric oxide for diabetic foot ulcers

Origin treats first patients in study of nitric oxide for diabetic foot ulcersOrigin said today that it treated the 1st patients in its dose-ranging Genesis Phase IIb-equivalent trial. The study is evaluating therapeutic quantities of plasma-generated nitric oxide as a treatment for chronic diabetic foot ulcers.

The 27-week trial is slated to enroll up to 100 patients. Patients will be randomized into 1 of 4 dosing regimens, or receive standard of care as a control, to assess the safety and efficacy of plasma-generated nitric oxide, according to Origin. The company plans to treat the participants for 12 weeks and monitor them for 12 weeks following treatment.

Get the full story at our sister site, Drug Delivery Business News.