European scientists develop absorbable bandages

Study co-author Elizaveta Permyakova of Russia’s National University of Science and Technology worked on developing the absorbable bandage.

An international research group has developed a biocompatible bandage material that has antibacterial properties and will not require changing, a potential boon for burn patients.

The material is self-absorbable, and a new bandage can be put directly on top of the old one, alleviating the need for the frequent and often-painful changing of a burn patient’s bandages. The bandages could also help patients with other wounds in which the healing skin is damaged by the changing of dressings.

Get the full story on our sister site, Medical Design & Outsourcing.

The post European scientists develop absorbable bandages appeared first on MassDevice.

PolarityTE registers bone repair product with FDA

PolarityTE updated logoPolarityTE (NSDQ:PTE) said last week that it registered its bone repair product, OsteoTE, with the FDA.

The Utah-based company’s technology is an autologous, homologous product designed to repair, reconstruct and replace bone using a patient’s own cells.

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

The post PolarityTE registers bone repair product with FDA appeared first on MassDevice.

Acelity’s KCI inks NPWT remote monitoring deal with insurer Highmark

Acelity's KCI

Acelity subsidiary KCI said this week that it inked a negative pressure wound therapy remote monitoring deal, using its iOn Progress remote therapy monitoring program, with health insurer Highmark, touting it as the first such agreement of its kind.

The San Antonio-based company’s KCI iOn monitoring program is intended for use with the ACTIV.A.C therapy system, and includes monitoring, engagement and adherence components. KCI said that a remote monitoring device attached to the ACTIV.A.C system allows it to transmit data to KCI, where a team of virtual therapy specialists analyze data and use it to support healthcare professionals to improve adherence.

“The collaboration and agreement with KCI is just the latest example of Highmark’s commitment to working with providers in the health care industry to make sure our members receive high-quality care at an affordable price,” Highmark ancillary provider strategy & management VP Robert Wanovich said in a press release.

KCI touted that 73% of patients showed an increase in NPWT hours of use per day following adherence calls through the system, lowering the average 90-day wound-related costs. The company added that the program will create a “performance-based payment structure for reducing total wound care costs.”

“Since introducing the iOn Progress remote therapy monitoring system two years ago, we have learned a great deal about our NPWT patients through their engagements with our Virtual Therapy Specialist team – all of which have helped us develop and improve an impactful solution. Our aim is to create value across the continuum of wound care and iOn Progress remote therapy monitoring allows us to pursue that by better understanding each patient’s wound care journey. This unique insight allows us to engage patients and their caregivers like no other and better assist them through the healing process, which leads to better therapy adherence and ultimately, better outcomes and reduced costs,” KCI prez & CEO R. Andrew Eckert said in a press release.

Earlier this month, reports emerged suggesting that the privately held company may be considering taking the company public with an initial public offering.

The post Acelity’s KCI inks NPWT remote monitoring deal with insurer Highmark appeared first on MassDevice.

Will Acelity go public again?

Privately held Acelity may go public again, according to news reports this week.

London-based Apax Partners and a pair of Canadian pension funds acquired wound-care company Kinetic Concepts Inc. (now Acelity) for $6.1 billion in a leveraged buyout in 2011.  Apax is now mulling an initial public offering for Acelity by mid-2019, Bloomberg and the San Antonio Express-news reported. Bloomberg cited unnamed sources with knowledge of the possible IPO, the Express-News report said.

Apax has begun discussing a potential listing with advisers, the news outlets said. Sources told Bloomberg that an IPO could value Acelity at $5 billion.

“While we are always reviewing the strategic options available to our company, our policy is not to comment on market speculation and rumors,” Acelity spokesman Maggie Fairchild told MassDevice in an email.

In 2016, Acelity called off an initial public offering that could have fetched as much as $1 billion, citing market conditions.

Earlier this year, Acelity agreed to sell its Systagenix facility in Gargrave, England, to Scapa Healthcare and inked a deal to buy Crawford Healthcare. Then-KCI had acquired Systagenix for $485 million in 2013. The company united Systagenix, LifeCell and KCI under the Acelity brand in 2014 and sold LifeCell to Allergan for $2.9 billion in 2016.

Jim Leininger, M.D., an accident and emergency physician, founded KCI in 1976 to manufacture a critical care bed. KCI raised $50 million in its first IPO in 1988 and took itself private again in 1997, according to the Express-News. The company went public again in 2004, landing a listing on the New York Stock Exchange.

The post Will Acelity go public again? appeared first on MassDevice.

Skin closure tech dev KitoTech Medical raises $2m

KitoTech Medical

Skin closure device maker KitoTech Medical has raised approximately $1.9 million in a new round of debt and options financing, according to a recently posted SEC filing.

The Seattle-based company has developed the MicroMend skin closure device, designed as an alternative to sutures, surgical glue and adhesives trips, according to the company’s website.

The MicroMend strips feature 1 mm micro staples embedded in an adhesive strip to anchor to the skin and close a variety of incisions and lacerations. The system comes in either a butterfly bandage or straight edge bandage, according to the site.

A total of 69 anonymous investors took part in the round, with the first sale dated on December 15, 2017.

The company is looking to raise an additional $1.1 million before it closes the offering, which would bring the total raised up to $3 million, according to the filing.

The post Skin closure tech dev KitoTech Medical raises $2m appeared first on MassDevice.

Smith & Nephew up on Q3 sales gain

Smith & NephewInvestors pushed share prices for Smith & Nephew (NYSE:SNN) up in London and New York today after the medical device giant posted a third-quarter revenue gain and confirmed its outlook for the rest of the year.

The British orthopedics and wound care firm reported that sales grew 1.5% to $1.15 billion during the three months ended Sept. 29, powered by a 4.4% gain to $569 million for its U.S. business.

Sales in established markets outside the U.S. were off -3.4% to $393 million; emerging-market sales were $207 million, up 3.5%.

“Improved underlying revenue growth in the third quarter was led by growth in the U.S. and emerging markets. We are on-track to deliver our full year guidance,” CEO Namal Nawana said in prepared remarks. “These results were achieved whilst successfully redesigning how we will run the company. There is still more to do, and I am pleased with the pace of progress and engagement across the organization.”

Although it affirmed its forecast for underlying revenue growth of 2% to 3% this year, Smith & Nephew said it expects sales to come in at the lower half of the range.

The company also unveiled a new structural model involving its three main segments: orthopedics, sports medicine/ENT, and wound, each led by a president. Smith & Nephew downplayed the impact of the U.K.’s exit from the European Union, saying Brexit won’t have “a significant impact on our long-term ability to conduct business into and out of the EU or UK.”

“We are making good progress with our preparations for the various scenarios,” the company said.

The news sent SNN shares up 7.7% to $35.40 apiece today in pre-market trading in New York. In London, SN shares were up 6.3% to £13.54 each as of about 1 pm local time.

The post Smith & Nephew up on Q3 sales gain appeared first on MassDevice.

Wound tech dev Clozex Medical raises $4m

Clozex Medical

Wound closure tech developer Clozex Medical raised approximately $3.8 million in a new round of equity financing, according to a recently posted SEC filing.

Funds in the round came from 39 unnamed sources, with the first sale dated on October 16, according to the filing.

Wellesley, Mass.-based Clovex is developing wound closure products intended to address limitations of traditional suture and stapling techniques. It’s flagship technology is Clozex Closures, which are intended for multiple uses, including plastic surgery, orthopedics, dermatology, cardiothoracic surgery, emergency medicine and urgent care, according to the company’s website.

The company is looking to raise an additional approximate $490,000 in the round, which would bring the total raised up to approximately $4.3 million, according to the SEC filing.

Clozex has not yet officially stated how it plans to spend funds raised in the round.

The post Wound tech dev Clozex Medical raises $4m appeared first on MassDevice.

Acera Surgical raises $5m

Acera Surgical

Acera Surgical has raised $5.1 million in a new round of equity financing, according to a recently posted SEC filing.

The St. Louis-based company is developing an implantable nanomedical scaffold intended for medical applications including soft tissue repair, according to a St. Louis Business Journal report. Acera also produces a protective wound cover called Restrata.

Acera licensed the surgical mesh technology behind their products from the Washington University Office of Technology Management in 2012, according to the article.

A total of two anonymous investors have joined in the round, with the first sale dated on October 5, according to the SEC filing.

The company is looking to raise an additional $5 million in the round, bringing the total raised up to $10.1 million.

Acera has not yet stated how it plans to spend funds raised in the round.

The post Acera Surgical raises $5m appeared first on MassDevice.

Avita launches pediatric burn trial

Avita Medical

Avita Medical (ASX:AVH) said today that it launched a new trial of its Recell autologous cell harvesting device exploring its use treating pediatric patients.

The Recell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the Valencia, Calif.-based company said.

In the newly launched trial, investigators will compare use of the Recell device to the standard of care for approximately 90 patients under 18 years of age. Patients in the trial will be randomized to be treated with either the Recell system and Biobrane dressing, the dressing alone or the standard of care, silver impregnated silicone lined dressing.

The trial’s primary endpoint will be days to re-epithelization of burn injuries, while secondary endpoints will include pain, patient satisfaction and scarring, according to a press release.

Last month, Avita Medical said that it won FDA premarket approval for its Recell autologous cell harvesting device, now cleared for use in treating severe thermal burns in patients 18 and older, and that it plans to launch the device in the fourth quarter.

The post Avita launches pediatric burn trial appeared first on MassDevice.

FDA deals warning letter to Ocular over eye sealant

Ocular Therapeutix - updated logoOcular Therapeutix (NSDQ:OCUL) said today that it received a warning letter from the FDA over its ReSure hydrogel ocular wound sealant.

The warning letter, dated Oct. 17, relates to Ocular’s compliance with data collection and reporting obligations in a post-approval device exposure registry study, according to the company. The registry study was a condition for approval of the premarket approval application for Ocular’s ReSure product.

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

The post FDA deals warning letter to Ocular over eye sealant appeared first on MassDevice.