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.

Hill-Rom launches Envella therapy bed for wound care patients

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Hill-Rom

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.