MolecuLight wins FDA de novo nod for handheld fluorescence wound imager

MolecuLight said yesterday it won FDA de novo clearance for its MolecuLight i:X designed to assess wound surface area and help visualize harmful bacteria within the wounds.

The device is designed to improve wound assessments, which are currently made without tools, the Toronto-based company said. The system uses fluorescence to help visualize potentially harmful bacteria which may other be missed.

The device won indications from the FDA as a handheld imaging tool that allows for the diagnosis and treatment of skin wounds at the point of care. The system also allows for the viewing and digital recording of wounds traditionally and through fluorescence emitted images of wounds exposed to an excitation light.

“The MolecuLight i:X platform is a significant advancement in the management of chronic wounds, that is already revolutionizing wound care practice in Canada and Europe. Thousands of patients to date have already experienced a change in their assessment and treatment by clinicians who feel empowered by the wound fluorescence images they are seeing. As reported in multi-centered published clinical studies, clinicians used the images to inform their wound management practices in real-time, in particular, for guided wound sampling, cleaning and debridement.  We’re very excited that US clinicians will soon have the same access to this device as their peers in Canada and Europe,” founder & chief scientific officer Dr. Ralph DaCosta said in a prepared statement.

“FDA marketing authorization of the MolecuLight i:X is a monumental milestone for the wound care industry. Thanks to continued clinical studies and 17 publications to date, the clinical evidence is rapidly accumulating that the MolecuLight i:X is a must‑have device in the hands of all wound care clinicians,” CEO Anil Amlani said in a press release.

Last December, Smith & Nephew (NYSE:SNN), which distributes for MolecuLight, said it launched the MolecuLight i:X handheld imaging device in Europe.

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Gel-E wins FDA OTC nod for gel-e Flex flowable hemostat

Early stage wound care company Gel-e said today it won FDA 510(k) clearance for its gel-e Flex as an over-the-counter flowable hemostat.

The College Park, Md.-based company said the clearance expands the labeling for the local management of lacerations and minor bleeding, and said the products were specifically designed to be usable by both trained professionals and patients.

“This clearance is the next step in expanding our OTC product line, and will be a key component of gel-e’s 21st Century First Aid Kit. We are continuing to develop a tool kit that will provide the best possible options for all manner of chronic and acute wounds. The versatility of these flowable and bandage formats represents an important progression towards our next-generation kit and eventually to products that can be used in surgery,” chief scientific officer Dr. Matthew Dowling said in a press release.

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Avita raises $12m for US debut of Recell device

Avita Medical (ASX:AVH) said yesterday that it raised $12.3 million to back the U.S. launch of its Recell wound treatment.

Melbourne- and Valencia, Calif.-based Avita said the A$16 million round, raised from a consortium of institutional and “sophisticated” investors led by Bell Potter, consists of two tranches: $9.8 million (A$12.8 million) that’s slated to close June 12, and a $2.5 million (A$3.3 million) tranche that must be approved at the company’s July shareholders meeting.

The A50¢-per-share price is a -3.8% discount to Avita’s June 1 closing price and a -6.3% discount to its 30-day volume-weighted average price, the company said.

Avita said it expects the FDA to complete a review of Recell’s pre-market approval bid during the third quarter, “followed by U.S. approval and market launch.”

“We appreciate the support of our shareholder group and the investors in this institutional placement as we proceed toward a transformative series of events for Avita, including the U.S. market launch of the Recell device,” CEO Dr. Michael Perry said in prepared remarks. “Proceeds from this placement will ensure that we are positioned to take full advantage of the expected upcoming PMA approval of the Recell device in the U.S., including establishment of our marketing and sales team, scale-up of manufacturing capabilities and expansion of research and development in areas such as pediatric burns, aesthetics and chronic wounds. The extensive series of clinical data presented at the recent ABA and ISPOR conferences strongly supports the value of Recell in the treatment of severe burns, and we have an exceptional commercial opportunity resulting from the unique combination of improved patient outcomes and substantial health economic benefits.”

“We are pleased to move toward the completion of this institutional placement to ensure that resources are in hand to strengthen our position and ensure that we are fully enabled to take advantage of opportunities facing us, including the upcoming U.S. launch of the Recell device,” added CFO Dale Sander. “We note that the issue price of this institutional placement is higher than that of our last financing round, and is within the range at which our shares have traded for the past 30 days.”

($1 = A$1.30310)

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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.

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

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

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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

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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

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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

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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

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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”

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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.